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Universiteit Vrystaat
EVALUATION OF THE EFFECTIVENESS OF IMPLEMENTION OF
THE PRACTICAL APPROACH TO LUNG HEALTH (PALSA) IN
THE FREE STATE
BOSIELO PHILLlP MAJARA
A thesis submitted in accordance with the requirements for the Doctor of
Philosophy degree in the Faculty of Health Sciences, Department of Community
Health at the University of the Free State.
February 2005
Promoters: Prof G Joubert, University of the Free State, South Africa
Prof OM Bachmann, University of East Anglia, Norwich, UK
I declare that the thesis hereby submitted by me for the Doctor of Philosophy
degree at the University of the Free State is my own independent work and
has not previously been submitted by me at another University/Faculty.
I furthermore cede copyright of the thesis in favour
of the University of the Free State
BOSIELO PHILLlP MAJARA
ii
SUMMARY
Currently, respiratory diseases constitute about one third of patients that present
to primary care clinics in under-resourced countries of the world. Communicable
respiratory diseases such as tuberculosis, acute respiratory infections in adults
and non-communicable respiratory diseases such as asthma, chronic obstructive
pulmonary disease, lung cancer represent about one-fifth of the global burden of
disease measured in disability adjusted life years (DALY). Opportunistic
infections, other respiratory complications, and the widespread use of tobacco
further increase the respiratory disease burden in high HIV prevalence settings.
In developing countries clinic nurses with limited training and basic skills are
entrusted to properly diagnose and treat respiratory patients from overloaded
clinics. We developed an educational outreach intervention, Practical Approach
to Lung Health in South Africa (PALSA) on integrated respiratory case
management aimed at improving the quality of respiratory care in South African
primary care clinics.
The intervention comprised 3 to 4 academic detailing training sessions of primary
care nursing practitioners; dissemination of locally adapted PALSA guidelines
and support materials; changes in prescribing provisions for primary care nurses,
and doctors' sensitization about PALSA.
The impact of PALSA on the processes and outcomes of respiratory care was
evaluated through a pragmatic cluster randomized controlled trial in the Free
State province in 2003.
A total of 1000 patients in the intervention arm and 999 patients in the control
arm presenting with respiratory conditions to the 40 largest primary care clinics of
the Free State province were interviewed at the first post-intervention survey. The
number of patients recruited ranged from 47 to 52 patients per clinic. The follow-
iii
up rate was 92.9% for the intervention arm and 92.7% for the control arm.
Twenty two patients died in the intervention clinics and twenty six died in the
control clinics. During data analysis, four patients in each arm were deleted due
to unavailability of the first post-intervention survey data and/or because they did
not meet the inclusion criteria. Professional nurses in intervention clinics received
a median of 2 training sessions while nurses in the control clinic received nothing.
First post-intervention survey characteristics of the intervention and control arms
balanced as a result of randomization. Almost two thirds of the patients were
females with the most frequent age group being 25-54 years. About 50% of
patients had a smoking history, about 50% had primary education, close to 50%
were unemployed, above 80% walked to get to the nearest clinic and 70% spent
between 2 and 12 hours to travel to and from the clinic.
The inclusion criteria to the study were adults 15 years and older presenting with
a cough or difficulty breathing on the day of the interview, recurrent cough or
difficulty breathing in the last 6 months or cough for less than two weeks with any
of the four severity markers. Rates of cough and difficulty breathing ranged
between 70% and 90%. About 70% of the patients complained about chest
symptoms interfering with their usual activities while around 36% had gone to the
clinic for a check-up on recurrent respiratory problem.
Compared to control clinics, intervention clinics had a significant improvement in
inhaled steroid prescription of 16.1% versus 10.3% (odds ratio 1.70; 95%CI 1.13
to 2.56), and an improvement in sending of sputa for tuberculosis testing of
16.7% versus 11.2% (odds ratio 1.60; 95%CI 1.00 to 2.54). There were also
significant improvements seen on appropriate referral of patients that had one of
the four severity makers of 10.6% versus 4.9% (odds ratio 2.56; 95%CI 1.06 to
6.17), and close to significant improvement of the tuberculosis detection rate of
3.0% versus 1.8% (odds ratio 1.67; 95%CI 0.92 to 3.02). There was a significant
iv
increase in interference with usual activities due to chest symptoms of 68.0%
versus 60.1% (odds ratio 1.44; 95%CI1.13 to 1.85). There was no improvement
on antibiotic prescription of 36.1% versus 38.0% (odds ratio 0.92; 95%CI 0.62 to
1.36) as well as cotrimoxazole prophylaxis of 12.6% versus 9.9% (odds ratio
1.52; 95%CI 0.60 to 3.89). Results of this study suggest that inhaled steroid
prescription, tuberculosis case detection rate, and appropriate referral of patients
with severe respiratory diseases can be improved in nurse staffed primary care
clinics in developing countries and under-resourced settings.
This study exemplifies an evaluation of the effectiveness of an educational
intervention in South African primary care. It shows how a carefully developed
intervention, using a syndromic approach to diagnosis and treatment, can
improve several aspects of clinical care after brief training of primary care nurses.
It also illustrates opportunities for, and difficulties in, implementing such an
intervention, and conducting a large scale trial in this setting. This study suggests
that other international interventions based on dissemination of clinical
guidelines, such as, for IMCI, STls and HIV/AIDS should be developed and
rigorously evaluated locally, given their potential impact on public health and on
services.
v
OPSOMMING
Respiratoriese siektes is tans verantwoordelik vir ongeveer 'n derde van die
pasiënte wat aanmeld by primêre sorg klinieke in hulpbron-arm lande van die
wêreld. Oordraagbare respiratoriese siektes soos tuberkulose, akute
respiratoriese infeksies in volwassenes en nie-oordraagbare respiratoriese
siektes soos asma, chroniese obstruktiewe pulmonêre siekte, longkanker
verteenwoordig een vyfde van die globale siektelas gemeet aan gestremdheids-
aangepaste lewensjare. Opportunistiese infeksies, ander respiratoriese
komplikasies, en die algemene gebruik van tabak vehoog die respiratoriese
seiktelas verder in omgewings met 'n hoë MIV voorkoms. In ontwikkelende lande
word van kliniekverpleegkundiges met beperkte opleiding en basiese
vaardighede verwag om respiratoriese pasiënte korrek te diagnoseer en te
behandel in oorlaaide klinieke. Ons het 'n opvoedkundige uitreik intervensie,
Practical Approach to Lung Health in South Africa (PALSA) ontwikkel, gemik op
geïntegreerde respiratoriese gevalshantering om die kwaliteit van respiratoriese
sorg in Suid-Afrikaanse primêre sorg klinieke te verbeter.
Die intervensie het bestaan uit 3 tot 4 opleidingsessies vir pnmere sorg
verpleegkundiges, verspreiding van plaaslik aangepaste PALSA riglyne en
ondersteuningsmateriaal; veranderinge in voorskrifbepalings vir primêre sorg
verpleegkundiges, en sensitisering van dokters aangaande PALSA.
Die impak van PALSA op die prosesse en uitkomste van respiratoriese sorg is
geëvalueer deur 'n pragmatiese bundel gerandomiseerde gekontrolleerde proef
in die Vrystaat provinsie in 2003.
'n Totaal van 1000 pasiënte in die intervensie-arm en 999 pasiënte in die
kontrole-arm wat met respiratoriese toestande presenteer by die 40 grootste
primêre sorg klinieke in die Vrystaat, is tydens die eerste post-intervensie
vi
opname ondervra. Die aantal pasiënte gewerf per kliniek het van 47 tot 52
pasiënte gewissel. Die opvolgkoerse was 92.9% in die intervensie-arm en 92.7%
in die kontrole-arm. Twee-en-twintig pasiënte is in die intervensie-klinieke oorlede
en ses-en-twintig in die kontrole-klinieke. Gedurende data-ontleding, is vier
pasiënte in elke arm uitgesluit weens onbeskikbaarheid van aanvanklike post-
intervensie data en/of omdat hulle nie aan die insluitingskriteria voldoen het nie.
Professionele verpleegkundiges in die intervensie-klinieke het In mediaan van 2
opleidingsessies ontvang terwyl verpleegkundiges in die kontrole klinieke geen
intervensie ontvang het nie.
Die aanvanklike post-intervensie eienskappe van die intervensie- en kontrole-
arms was soortgelyk as gevolg van die randomisasie. Bykans twee derdes van
die pasiënte was vroulik, met die mees algemene ouderdomsgroep 25-54 jaar.
Ongeveer 50% van pasiënte het In rookgeskiedenis, ongeveer 50% het primêre
skoolopleiding, ongeveer 50% was werkloos, meer as 80% het gestap om by die
naaste kliniek te kom, en 70% bestee tussen 2 en 12 ure om na en van die
kliniek te reis.
Die insluitingskriteria vir die studie was volwassenes 15 jaar en ouer wat
presenteer met 'n hoes of moeilike asemhaling op die dag van die onderhoud,
herhaalde hoes of moeilike asemhaling in die afgelope 6 maande of hoes van
minder as twee weke met enige van die vier ernstige merkers. Koerse vir hoes
en moeilike asemhaling het gevarieer tussen 70% en 90%. Ongeveer 70% van
die pasiënte het gekla oor borssimptome wat inmeng met hulle gewone
aktiwiteite terwylongeveer 36% na die kliniek gegaan het vir 'n ondersoek vir
herhaalde respiratoriese probleme.
Vergeleke met kontrole-klinieke het intervensie-klinieke In betekenisvolle
verbetering in die voorskryf van geïnhaleerde steroïede (16.1% versus 10.3%,
kansverhouding 1.70, 95%VI 1.13 tot 2.56), en In verbetering in die stuur van
vii
sputa vir tuberkulosetoesting (16.7% versus 11.2%, kansverhouding 1.60, 95%VI
1.00 tot 2.54) getoon. Daar was ook betekenisvolle verbeterings in toepaslike
verwysings van pasiënte met een of meer van die vier ernstige merkers (10.6%
versus 4.9%, kansverhouding 2.56, 95%VI1.06 tot 6.17), en na aan betekenisvol
vir die tuberkulose-opsporingskoers (3.0% versus 1.8%, kansverhouding 1.67,
95%VI 0.92 tot 3.02). Daar was 'n betekenisvolle verhoging in die inmenging van
borssimptome met gewone aktiwiteite (68.0% versus 60.1%, kansverhouding
1.44, 95%VI 1.13 tot 1.85). Daar was geen verbetering in antibiotika-voorskrifte
nie (36.1% versus 38.0%, kansverhouding 0.92, 95%VI 0.62 tot 1.36) en ook nie
vir cotrimoxazole profilakse nie (12.6% versus 9.9%, kansverhouding 1.52,
95%VI 0.60 tot 3.89). Resultate van hierdie studie dui daarop dat geïnhaleerde
steroïedvoorskrifte, die tuberkulose gevalsopsporingskoers en die toepaslike
verwysing van pasiënte met ernstige respiratoriese siektes verbeter kan word in
primêre gesondheidsorgklinieke beman deur verpleegkundiges in ontwikkelende
lande en hulpron-arm omgewings.
Hierdie studie dien as voorbeeld van 'n evaluering van die effektiwiteit van 'n
opoedkundige intervensie in Suid-Afrikaanse primêre sorg. Dit wys hoe 'n deeglik
ontwerpte intervensie wat gebruik maak van 'n sindromiese benadering tot
diagnose en behandeling, na kort opleiding van primêre sorg verpleegkundiges
verskeie aspekte van kliniese sorg kan verbeter. Dit toon ook die geleenthede vir
en probleme verbonde aan die implementering van sodanige intervensie en die
uitvoer van 'n grootskaalse proef in hierdie omgewing. Hierdie studie dui daarop
dat ander internasionale intervensies gebaseer op die verspreiding van kliniese
riglyne, soos IMCI, SOS en MIVNIGS plaaslik ontwikkel moet word en noukeurig
plaaslik ge-evalueer moet word gegewe hulle potensiële impak op publieke
gesondheid en op dienste.
viii
Key terms:
Academic detailing
Cluster randomized controlled trial
Effectiveness
Evaluation
Guidelines
Multifaceted intervention
Practical approach to lung health in South Africa (PALSA)
Primary respiratory care
Respiratory conditions
Tuberculosis
ix
ACKNOWLEDGEMENTS
First I would like to thank both the previous and current Heads of Community
Health Department of the University of the Free State, Professor Max Bachmann
and Professor Willem Kruger respectively, and the department's
academic/technical and administrative staff for providing me with office space,
morale and administrative support during the conduct of my studies.
Secondly, I would like to thank my two PhD supervisors, Professor Gina Joubert
and Professor Max Bachmann for the guidance that they provided me with, from
the inception of the PhD protocol, data collection, cleaning, analysis and report
writing. I truly am grateful to both of you.
I would also like to thank all the PALSA research team members for their
valuable contribution to the entire PALSA project implementation, especially the
team leader, Professor Eric Bateman, for mobilizing all resources required for
smooth implementation of the project in a form of human, financial and material.
Due thanks is also extended to Doctors Rene English and Lara Fairall, my two
colleagues in the junior researchers cadre of the PALSA researchers lineup, for
their valuable contribution in producing the locally adapted PALSA guidelines,
and other intervention materials of the project. Due thanks is particularly directed
to Doctor Lara Fairall for all the effort that she put into the randomized controlled
trial in the Free State, especially the clinical input into the entire study. I really am
indebted to the two of you. Thanks is also extended to Dr. Merrick Zwarenstein
for initiating the project, providing technical support during implementation as well
as securing initial funding to support my local needs and requirements throughout
my stay in the Free State.
Thanks is also extended to authorities of the Government of the Republic of
South Africa, national and Free State provincial governments for allowing the
research team to utilize public resources in a form of clinics and clinic staff while
x
implementing the project. Of outmost importance are the former National TB
Manager, Dr. R Matji, Free State Provincial Health Department authorities,
namely, Dr. V Litlhakanyane, (Head of Department), Dr. RD Chapman (General
Manager Health Support services), Mr. MS Shuping (General Manager, Clinical
Health Services), Ms NJ Jolingana (Senior Manager TB/HIV/AIDS and
Communicable Diseases), and Mrs. A Peters (former Free State Provincial TB
Coordinator). District Health managers in the five districts of the Free State, clinic
managers of the 40 trial clinics, as well as clinic managers of the pilot clinics of
the study are all highly appreciated. Special thanks is extended to the district TB
coordinators who served as PALSA trainers during the project implementation,
namely, Sr. A Peters, Sr. L Smith, Sr. S Korkie, Sr. E Bolofo, Sr. F McKay, Sr.
T Mothibeli, Sr. M Thirtle, and Sr. A Exley.
I would like to extend a special thanks to the Director and staff of the Centre for
Health Systems Research and Development (CHSR&D) of the University of the
Free State, namely, Professor Dingie van Rensburg, Mr. C Heunis, Ms. E Janse
van Rensburg-Bonthuyzen, Mr. Z. Matebesi and Ms. 0 Nel. The contribution of
the Centre in recruiting and managing the fieldworkers is beyond explanation. All
the 23 fieldworkers are also worth mentioning, especially the three supervisors,
Mrs. M van Rensburg, Mr. N Khoapa, and Mrs. G Gaga, as well as the six team
leaders, namely, Ms. J Porotloane, Ms. R Bouwer, Mr. T Mazibuko, Ms. A Masia,
Ms. I Duma and Ms. I Masoge (who taak over from Mr. J Nocada) and the rest of
the fieldworkers.
I wish to extend my sincere appreciation to Government of the Kingdom of
Lesotho for granting me an opportunity to further my studies as well as providing
me with financial support through the Lesotho Highland Water Authority (LHDA).
Finally, I would like to thank the International Development Research Centre
(Canada) for funding implementation of the entire project implementation,
xi
particularly Dr. Christina Zarowsky (the team leader of the Governance, Equity
and Health) for believing that South Africa could implement such a giant study.
This thesis is dedicated to my family: my wife Nthabiseng and daughter
Khauhelo.
xii
TABLE OF CONTENTS
Page
Chapter 1: Introd ucti on
1.1 Introduction 1
1.2 Respiratory conditions 1
1.2.1 Global picture 1
1.2.1.1 Morbidity, mortality and trends 1
1.2.1.2 Futu re projections 2
1.2.2 South African picture 4
1.2.2.1 Morbidity, mortality and trends 4
1.2.3 Free State picture 6
1.2.3.1 Morbidity, mortality and trends 6
1.3 The effectiveness of treatment for major 8
respiratory conditions at primary care level
1.3.1 Pneumonia 9
1.3.2 Upper respiratory tract infection 9
1.3.3 Asthma 10
1.3.4 Chronic obstructive pulmonary disease 14
(COP D)
1.3.5 Tuberculosis 16
1.4 Key primary health care policies and 19
strategies relevant to diagnosis and
treatment of lung diseases
1.4.1 International 19
1.4.2 South Africa 21
1.4.3 Free State 25
1.5 Practical approach to lung health (PAL) and 26
PALSA
1.6 Evaluating the effectiveness of educational 27
methods aimed at changing clinical practice
1.7 Cluster randomized trials 29
1.8 Concluding remarks 31
1.9 Aim of the study 32
1.10 Objectives of the study 32
1.10.1 Primary outcomes 32
1.10.2 Secondary outcomes 33
Chapter 2: Methods
2.1 Introduction 35
2.2 PALSA intervention 35
2.2.1 Description 35
2.2.2 Schedule 36
xiii
Table of content (continued)
2.2.2.1 Training of TB coordinators as PALSA 36
trainers
2.2.2.2 Training of clinic nursing staff 37
2.2.2.3 Official communication with district 38
management teams
2.2.2.4 Sensitization of medical doctors 38
2.2.2.5 Provincial drug circular on PALSA drugs 39
2.3 Study design 39
2.4 Study population 41
2.4.1 Clinics 41
2.4.2 Patients 42
2.5 Sample size assumption and estimates 44
2.6 Randomization 44
2.7 Enrolment of participants 47
2.7.1 Assessment of eligibility and enrolment 47
2.7.2 Informed consent 48
2.8 Data collection tools 48
2.8.1 First post-intervention survey and follow-up 48
interview questionnaires
2.8.2 Visual aids 50
2.8.2.1 Eoroqol-5D questionnaire including scale 50
2.8.2.2 Photographs 51
2.8.3 Notification of deceased patients form 51
2.8.4 Personal Digital Assistant (PDA) 51
2.9 Pilot of training and data collection 52
processes
2.10 Interviewers 54
2.10.1 Recruitment of interviewers for the first 54
post-intervention survey and follow-up
interviews
2.10.2 Training of interviewers 54
2.10.3 Blinding of interviewers 56
2.11 Data collection process 57
2.12 Quality control 58
2.12.1 Quality control of the data collection 58
process
2.12.2 Periodic supervisory visits by the PALSA 59
researchers
2.12.3 Single database 59
2.13 Ethics and consent 59
2.13.1 Provincial health department 60
2.13.2 University of the Free State Ethics 60
committee
xiv
Table of content (continued)
2.13.3 Patient consent form 60
2.13.4 Confidentiality 60
2.14 Data checking 61
2.14.1 Data uploaded by PDA on daily basis 61
2.14.2 Data collected by paper questionnaires 61
2.15 Data analysis 62
2.16 Responsibilities of the candidate 66
Chapter 3: Results
3.1 Introduction 68
3.2 Results of the study 68
3.2.1 Characteristics of the clinics 68
3.2.2 PALSA training sessions at intervention 69
clinics
3.2.3 Characteristics of patients- general 70
3.2.4 Characteristics of patients by subgroups 72
3.2.5 Reliability of tracer questions 80
3.2.6 Primary and secondary outcomes 81
3.2.7 Number needed to treat calculations 86
Chapter 4: Discussion and conclusion
4.1 Intrad uction 87
4.2 Overview of the results 87
4.3 Comparison of the study's results with 90
results of previous trials
4.3.1 Antibiotic prescribing 90
4.3.2 Asthma treatment and management 92
4.3.2.1 General practitioners' knowledge about 92
diagnosis and treatment of asthma
4.3.2.2 Asthma specialist nurses 93
4.3.2.3 Asthma patient education 94
4.3.3 Cotrimoxazole prophylaxis 97
4.4 Strengths and limitations 98
4.4.1 Strengths of the study 98
4.4.2 Limitations of the study 101
4.5 Implications for policy 104
4.6 Priorities for future research 106
4.7 Conclusion 107
References 108
Annexes A1
xv
LIST OF TABLES
Page
Chapter 1: Introduction
Table 1.1: Global burden and mortality rates due 2
to respiratory conditions
Table 1.2: Future projections of global respiratory 3
and other diseases in developing
cou ntries
Table 1.3: Top 20 single causes of deaths and 5
years to life lost (YLLs), South Africa,
2000
Table 1.4: Top 10 causes of death for Free State 6
Province in 2000
Table 1.5: Deaths due to infection and parasitic 7
diseases in Free State Province in
2000
Table 1.6: Deaths due to respiratory disorders in 8
Free State Province in 2000
Table 1.7: Summary of treatment of PALSA lung 19
diseases at primary care level
Chapter 2: Methods
Table 2.1: Summary of interviews conducted 53
during piloting of PALSA
Table 2.2 Numerators and denominators for 63
outcomes
Chapter 3: Results
Table 3.1: Characteristics of clinics 68
Table 3.2: PALSA training sessions at 69
intervention clinics
Table 3.3: Number of patients included in the 70
study
Table 3.4: Patients' characteristics at first post- 71
intervention survey
Table 3.5: Patients' symptoms at first post- 72
intervention survey
Table 3.6: Characteristics at first post- 73
intervention survey of patients with
cough> 2 weeks and not known to
have tuberculosis
xvi
List of tables (continued)
Table 3.7: Symptoms at first post-intervention 74
survey of patients with cough> 2
weeks and not known to have
tuberculosis
Table 3.8: Characteristics at first post- 75
intervention survey of patients known
to have tuberculosis
Table 3.9: Symptoms at first post-intervention 76
survey of patients known to have
tuberculosis
Table 3.10: Characteristics at first post- 77
intervention survey of patients with at
least one of the 4 severity markers
Table 3.11: Symptoms at first post-intervention 78
survey training manual of patients with
at least one of the 4 severity markers
Table 3.12: Characteristics at first post- 79
intervention survey of current smokers
Table 3.13: Symptoms at first post-intervention 80
survey of current smokers
Table 3.14: Agreement between repeated questions 81
at first post-intervention survey
Table 3.15 Primary outcomes 82
Table 3.16(a) Secondary outcomes 83
Table 3.16(b) Secondary outcomes 84
Table 3.17 Number needed to treat (NNT) 86
xvii
LIST OF FIGURES
Page
Chapter 2: Methods
Figure 2.1: Study design 40
Figure 2.2: PALSA ReI clinic selection 42
Figure 2.3: Free State Provincial map showing trial clinics 46
xviii
LIST OF ANNEXES
Page
Annex 1: PALSA Guidelines A1
Annex 2: PALSA Training Record A27
Annex 3: Standard letter to district/clinic A29
managers
Annex 4: Doctor's letter A32
Annex 5: Drug circular A34
Annex 6: The selection process A37
Annex 7: Patient screening questionnaire- English A40
version
Annex 8: Patient information and written consent A43
form- English version
Annex 9: Reminder form A46
Annex 10: First post-i ntervention su rvey interview A48
questionnaire- English version
Annex 11: Follow-up interview questionnaire- A82
English version
Annex 12: Photographs A116
Annex 13: Notification of deceased patients at A127
follow-up form- English version
Annex 14: A list of responsibilities of the field A129
workers
Annex 15-1: Part 1- First post-intervention survey A132
training manual
Annex 15-11: Part 2- First post-intervention survey A190
training manual training manual
Annex 16: Follow-up training manual A212
Annex 17: May 2003 re-interview questionnaire A261
Annex 18: PALSA project flow chart A264
xix
List of acronyms and abbreviations
AIDS- Acquired immunodeficiency syndromes
ALHI- Adult lung health initiative
ARV- Antiretroviral drugs
CAP- Community acquired pneumonia
COPD- Chronic obstructive pulmonary disease
DALY- Disability adjusted life years
OOH- Department of Health
OOTS- Directly observed therapy- short course
FS- Free State province
GOLD- Global Initiative for Chronic Obstructive Pulmonary Disease
HIV- Human immunodeficiency virus
IMCI- Integrated management of childhood diseases
IDRC- International development and research centre- Canada
IUATLD- International Union against Tuberculosis and lung disease
LRTI- Lower respiratory tract infection
MRC- Medical Research Council
PAL- Practical approach to lung health
PALSA- Practical approach to lung health in South Africa
PHC- Primary Health Care
RCT- Randomised controlled trial
RR- Respiratory rate
SA- South Africa
SADHS- South African Demographic Health Survey
STG/EDL- Standard treatment guidelines/Essential drug list
T8- Tuberculosis
UCT- University of Cape Town
UFS- University of the Free State
UK- United Kingdom
UNICEF- United nation children fund
xx
URTI- Upper respiratory tract infection
UWC- University of the Western Cape
VCCT/HIV- Voluntary counselling and consent to test for HIV
WHO- World Health Organisation
xxi
CHAPTER 1- INTRODUCTION
1.1 INTRODUCTION
This chapter will give an overview of the burden and primary care of respiratory
conditions in general. A global picture followed by a South African one will follow.
A more focused picture of the Free State, the South African province where the
Practical Approach to Lung Health in South Africa (PALSA) project was
implemented, will then be given.
The overview will be followed by an indication of how the PALSA initiative was
developed in South Africa following the initiative of the World Health Organisation
(WHO).
1.2 RESPIRATORY CONDITIONS
1.2.1 Global picture
1.2.1.1 Morbidity, mortality and trends
Globally, respiratory conditions impose a severe burden on society (Ait-Khaled et
al 2001). According to the World Health Report 2000, the top five respiratory
diseases account for 17.4% of all deaths and 13.3% of all Disability-Adjusted Life
Years (DALYs) in the world (WHO 2000). Lower respiratory infections, including
pneumonia, chronic obstructive pulmonary disease (COPD), tuberculosis and lung
cancer are each among the leading 10 causes of death worldwide (WHO 2002).
Asthma affects about 300 million people worldwide and is the most prevalent
chronic disease in childhood (Beasley et al 2003).
Table 1.1 indicates that each year, globally, tuberculosis kills approximately 2
million people, some 3.8 million people die of respiratory infections and 2.7 million
1
die of chronic obstructive pulmonary diseases (WHO 2003 (a». Lower respiratory
disease, chronic obstructive pulmonary disease and tuberculosis together are
responsible for 11% of all disability adjusted life years in the world (WHO 2003
(a». It is estimated that around 300 million people in the world currently have
asthma, resulting in 180 000 deaths per annum (Beasley et a/2003).
Table 1.1: Global burden and mortality rates due to respiratory conditions (Adapted from
World Health Report 2003(a))
Type of Disease Burden of disease ('1000) in Deaths from Disease
(DALYs) ('1000)
Respiratory infections 90252 3847
HIV/AIDS 86072 2 821
Tuberculosis 35361 1605
COPD 27708 2746
Asthma 15325 239
1.2.1.2 Future projections
As illustrated in Table 1.2 future projections of the global burden of disease predict
that in developing countries respiratory diseases will occupy three of the top ten
places by the year 2020 (Murrayand Lopez 1996). These projections suggest that
chronic obstructive pulmonary disease will be ranked fifth, lower respiratory tract
infections sixth, tuberculosis seventh and HIV tenth as causes of the global burden
of disease. In developing countries, particularly sub-Saharan Africa, additional
problems such as the rise of HIV/AIDS, tuberculosis, tobacco use and indoor air
pollution have significant social and economic implications. Add to this the
contribution made by acute respiratory infections, and opportunistic infections in
retroviral positive individuals, and it becomes evident that developing countries
face a growing problem (Murrayand Lopez 1996).
The deterioration in health service delivery, the spread of HIV/AIDS and the
emergence of multi-drug resistant tuberculosis are contributing to the worsening
2
impact of the disease in developing countries (Ait-Khaled et al 2001, WHO 2003
(a)). It is estimated that between 2002 and 2020, approximately 100 million people
will be newly infected, over 150 million people will get sick, and 31 million will die
of tuberculosis if control is not further strengthened (Murrayand Lopez 1996).
Table 1.2: Future projections of global respiratory and other diseases in developing
countries (Adapted from Murrayand Lopez 1996)
Disease/Injury 1990 1990 2020 2020
Rank % total DAL Ys Rank % total
DALYs
Lower respiratory infection 1 8.2 6 3.1
Tuberculosis 7 2.8 7 3.1
Chronic obstructive pulmonary disease 12 2.1 5 4.1
Trachea, bronchus, and lung cancers 28 0.6 15 1.8
Diarrhoeal diseases 2 7.2 9 2.7
Conditions arising during perinatal period 3 6.7 11 2.5
Unipolar major depression 4 3.7 2 5.7
Ischemic heart disease 5 3.4 1 5.9
Cerebrovascular disease 6 2.8 4 4.4
Measles 8 2.6 25 1.1
Road traffic accidents 9 2.5 3 5.1
Congenital anomalies 10 2.4 13 2.2
Malaria 11 2.3 24 1.1
Falls 13 1.9 19 1.5
Iron-deficiency anaemia 14 1.8 39 0.5
Protein-energy-malnutrition 15 1.5 37 0.6
War 16 1.5 8 3.0
Self-inflicted injuries 17 1.4 14 1.9
Violence 19 1.3 12 2.3
HIV 28 0.8 10 2.6
3
1.2.2 South African picture
1.2.2.1 Morbidity. mortality and trends
According to the WHO Regional Mortality stratum, South Africa falls within the
AFR-E, which is the African region with high child and adult mortality (WHO 2002).
Approximately 80% of tuberculosis cases in the world are found in 23 countries;
the highest incidence rates are found in sub-Saharan Africa and Southeast Asia.
The tuberculosis situation has worsened over the past two decades in Africa
notably South Africa, as a result of the HIV/AIDS epidemic (WHO 2002, Bateman
2002, Raviglione et a/1997). In South Africa, an estimated 28% of all patients
who present to Primary Health Care facilities have respiratory symptoms
(Bateman 2002, Fairall et a/2001).
Table 1.3 indicates that in 2000, the top single cause of mortality burden in South
Africa was HIV/AIDS followed by homicide, tuberculosis, road traffic accidents and
diarrhoea (Reddy et al 2004). HIV/AIDS accounted for 38% of total year life lost
(YLLs) while tuberculosis, lower respiratory tract infection, COPD and asthma
were among the top 20 single causes of deaths in South Africa (Reddy et a/2004).
South Africa is experiencing a quadruple burden of disease comprising the pre-
transitional diseases, the emerging chronic diseases, injuries, and HIV/AIDS.
Unless interventions that reduce morbidity and delay mortality due to HIV/AIDS
become widely available, the burden can be expected to grow very rapidly in the
next few years (Bradshaw et al 2003, Reddy et a/2004).
The 'White Paper for the Transformation of the Health System in South Africa"
states that among priority programmes in South Africa, HIV/AIDS and tuberculosis
rank as high priorities (Department of Health 1998(a». The 1998 South African
Demographic Health Survey found that the smoking rate among adults in South
Africa was 42% for male and 11% among female of 15 years and above. This high
4
rate aggravates high incidences of respiratory infections country-wide (Department
of Health 1998(a)).
Table 1.3: Top 20 single causes of deaths and Years of Life Lost (YLLs), South Africa, 2000
(Adapted from Reddy et a12004)
Single causes Number of Rank Single causes YLLs Rank
deaths
HIV/AIDS 165859 1 HIV/AIDS 4665410 1
Tuberculosis 29553 5 Tuberculosis 595277 3
Lower respiratory infection 22097 6 Lower respiratory 449010 6
infection
COPD 12473 11 COPD 113499 16
Trachea/bronchi/lung 7173 14 Asthma 94069 18
cancer
Asthma 6987 15
Bacterial meningitis 90964 20
Ischemic heart disease 32919 2 Homicide/violence 902592 2
Homicide/violence 32485 3 Road traffic accidents 163544 4
Stroke 32114 4 Diarrhoeal diseases 489979 5
Road traffic accidents 18446 7 Low birth weight 393763 7
Diarrhoeal diseases 15910 8 Stroke 318083 8
Low birth weight 11876 12 Ischemic heart disease 145421 9
Nephritis/nephrosis 7225 13 Protein-energy 171433 10
malnutrition
Suicide 6370 16 Hypertensive heart 127066 13
disease
Septicaemia 6047 17 Fires 123400 14
Oesophageal 5803 18 Septicaemia 115247 15
Cirrhosis of liver 5672 19 Neonatal infections 93973 17
Protein-energy 5511 20 Nephritis/nephrosis 96819 19
malnutrition
5
1.2.3 Free State picture
1.2.3.1 Morbidity, mortality and trends
Table 1.4 illustrates the Free State province's top ten causes of death in 2000
based on death certificates. Infectious and parasitic diseases were the highest
while respiratory disorders ranked the third. In the case of deaths due to infectious
and parasitic diseases, HIV/AIDS related infections and tuberculosis ranked the
first and second respectively, as illustrated by Table 1.5. They accounted for about
40% and 35% respectively from a total of 2060 deaths in the province (Department
of Health 2002(a». According to the 2002 report on the prevalence of HIV/AIDS in
South Africa, the Free State province currently stands in the third position at
28.8% of antenatal clinic attendees (Shishane and Simbayi 2002). In terms of the
highest level of infection amongst all groups, that is, not only for antenatal clinic
attendees, the Free State was ranked the highest in the country with 14.9%
(Shishane and Simbayi 2002).
Table 1.4: Top 10 causes of death for Free State province in 2000 (Adapted from Department
of Health 2002(a»
Disease Total number of deaths Percentage (%)
(N=8500)
Infectious & parasitic 2060 24.2
Symptom & signs unclassified 1736 20.4
Respiratory 1516 17.8
Circulatory 1465 17.2
Neoplasm 462 5.4
External 406 4.8
Endocrine & nutrition 283 3.3
Pregnancy & childbearing 283 3.3
Genito-urinary system 159 1.9
Digestive system 130 1.5
6
Table 1.5: Deaths due to infectious and parasitic diseases in Free State Province in 2000
(adapted from Department of Health 2002(a))
Condition Total number of deaths Percentage (%)
(N=2058)
HIV 823 40.0
Tuberculosis 716 34.8
Diarrhoea & Gastroenteritis 317 15.4
Septicaemia unspecified 107 5.2
Other viral enteritis 48 2.3
Acute amboebic dysentery 19 0.9
Hepatitis 10 0.5
Amboebic brain abscess 8 0.4
Acute poliomyelitis 7 0.3
Typhoid fever 1 0.05
Neurosyphyllis unspecified 1 0.05
Cryptococcus unspecified 1 0.05
During 2000, as indicated in Table 1.6, the total number of deaths due to
respiratory conditions was 1516, with pneumonia accounting for 76%, respiratory
failure 9%, COPD 4% and asthma 3% and other lung disorders accounting for the
remainder (Department of Health 2002(a)).
7
Table 1.6: Deaths due to respiratory disorders in Free State in 2000 (Adapted from
Department of Health 2002(a))
Condition Total number of deaths Percentage (%)
(N=1516)
Pneumonia 1145 75.5
Respiratory failure 137 9.0
COPD unspecified 59 3.9
Asthma 42 2.8
Other disorders of the lungs 39 2.6
Pulmonary oedema 27 1.8
Diseases of upper respiratory tract 24 1.6
infections unspecified
Unspecified chronic bronchitis 20 1.3
Pleural effusion 8 0.5
Bronchitis unspecified 7 0.5
Other intestinal pulmonary diseases with 4 0.3
fibrosis
Lower respiratory tract infections 2 0.13
Common cold 1 0.07
Acute laryngitis 1 0.07
1.3 THE EFFECTIVENESS OF TREATMENT FOR MAJOR RESPIRATORY
CONDITIONS AT PRIMARY CARE LEVEL
There have been several systematic reviews and trials on available treatments at
primary health care level aimed at addressing the abovementioned diseases.
Below is a summary of the systematic reviews of 5 primary health care priority
respiratory diseases, namely pneumonia, upper respiratory infections, asthma,
chronic obstructive pulmonary disease and tuberculosis.
8
1.3.1 Pneumonia
In evaluating the effects of different oral antibiotics to treat patients with community
acquired pneumonia (CAP) in outpatient settings, one systematic review looked at
9 randomized controlled trials involving 1164 people (Pomilla and Brown 1994).
Antibiotics evaluated were amoxicillin, with and without clavulanate, macrolides,
cephalosporins, and quinolones. The review reported clinical cure or improvement
in over 90% of the people regardless of which antibiotics was taken (Pomilla and
Brown 1994). This review indicates that the use of antibiotics for treatment of
community acquired pneumonia can be effective at primary care level.
Regarding evaluation of the effectiveness of clinical guidelines on treatment of
community acquired pneumonia, one systematic review looked at 3 randomised
controlled trials and 7 cohort studies comparing guidelines that incorporated early
switch from intravenous to oral antibiotics and early discharge strategies (or both)
versus usual care (Rhew et al 2001). The study found no significant difference in
clinical outcomes and mean length of hospital stay (Rhew et al 2001). Early
discharge and early switch to oral medication are thus effective for the treatment of
community acquired pneumonia at primary care level.
1.3.2 Upper respiratory tract infection
In evaluating the effectiveness of use of antibiotics for treating upper respiratory
tract infection one systematic review looked at 26 randomised controlled trials
involving 2669 people with sore throat. The review established that compared with
placebo, antibiotics slightly but significantly reduced the proportion of people with
symptoms of sore throat at 6-8 days and shortened symptom duration by a mean
of about 24 hours at day 3 (Del mar et a/2004). The review also established that
antibiotics significantly reduced the proportion of people who developed rheumatic
fever at 2 months compared with placebo (Del mar et al 2004). Smucny and
colleagues reviewed nine randomised trials involving over 750 patients comparing
9
antibiotic therapy with placebo in acute bronchitis or acute productive cough. The
researchers established that patients receiving antibiotics had better outcomes
than those receiving placebo (Smucny ef a/2004).
In South Africa, Meyers and colleagues conducted a study to assess the effect of
a prescribing training intervention for primary health care nurses in the Lowveld
Region of the Northern Province of South Africa (Meyers ef al 2001). The
intervention in this case was a generic training-of-trainers course of a 4-day
effective prescribing course which was presented to 24 provincial trainers who in
turn conducted effective prescribing workshops for 20 primary health care nurses
per workshop. In 1997, 457 prescribers were trained by this method in project
sites. The study investigated the impact of the training on prescribing practices for
two target conditions, in a control and a study group of 11 clinics each, 1 month
after and 3 months after the intervention. Changed behaviour was not only seen in
prescribing for upper respiratory tract infections, used as an example condition,
but also for diarrhoea and/or vomiting, a common condition in the region, which
was not included in the training programme. These results showed that prescribers
not only retained the knowledge gained, but were also able to apply their new
skills to other conditions. The change in the study group was maintained for 3
months after training, while there were no significant improvements in prescribing
in the control group (Meyers ef a/2001).
The above two reviews and one study suggest that use of antibiotics for treatment
of upper respiratory infections and training of nurses on the use of guidelines for
prescribing are effective for treatment of upper respiratory tract infections.
1.3.3Asthma
To evaluate the effectiveness of antibiotics prescribed to patients in the treatment
of acute asthma, a systematic review looked at two randomised controlled trials
involving 97 patients (Graham ef a/2004). The review revealed that currently the
10
role of antibiotics in the treatment of acute asthma is difficult to assess, therefore
further research is still required (Graham et a/2004).
To evaluate the effectiveness of regular versus as needed inhaled short acting
beta-2 agonist in adults with mild or moderate asthma, one systematic review
looked at 22 cross-over randomised controlled trials, 8 parallel group randomised
controlled trial and one subsequent randomised controlled trial (Waiters and
Waiters 2001). The review established no significant difference between regular
and as needed inhaled short acting beta-2 agonists for clinically important
outcomes (Waiters and Waiters 2001).
In evaluating the effectiveness of inhaled long acting beta-2 agonists in people
with stable chronic asthma, 85 randomised studies comparing a long acting
inhaled beta-agonist with placebo were reviewed (Waiters et a/2004). The review
established significant advantages of long acting beta-2 agonist treatment,
compared to placebo, for a variety of measurements of airway calibre (including
morning and evening peak flows), fewer symptoms, less use of rescue medication
and higher quality of life (Waiters et a/2004).
In evaluating the effectiveness of low dose inhaled corticosteroids versus placebo
in people with mild, persistent asthma, one systematic review looked at 52
randomised controlled trials involving 3459 people (Adams et al 2004(a». The
review established that a low dose inhaled corticosteroid, beclomethasone
dipropionate (BOP) versus placebo significantly improved lung function and
symptoms, and reduced the need for short acting bronchodilators (Adams et a/
2004(a». Another systematic review looked at 5 randomised controlled trials
involving 141 adults with mild persistent asthma, comparing inhaled corticosteroids
versus placebo and versus beta-2 agonist respectively. The review found that
regular inhaled corticosteroids versus regular beta-2 agonist or placebo
significantly improved lung function (Nathan et a/2001).
11
Mash and colleagues also conducted a systematic review to establish the
effectiveness of inhaled versus oral steroids for adults with chronic asthma (Mash
et a/2004). The study looked at 10 randomised controlled trials involving 269 adult
patients and revealed that a daily dose of an oral steroid (prednisone 7.5-10
mg/day) appears to be equivalent to moderate-high dose inhaled corticosteroids
(Mash et a/2004).
Nolan and White conducted a study to determine the relationship between asthma
morbidity and the attendance of and prescribing for symptomatic asthma patients
in primary care in England (Nolan and White 2002). Results of the study showed
that asthma management of the majority of the patients was active with high levels
of steroid prescribing. There appeared to be room to increase steroid prescribing
and to improve the structure of care (Nolan and White 2002).
There is thus agreement among the above reviews that use of inhalers steroids for
treatment of asthma has been shown to be effective. There is however a growing
concern that beta agonists ("relievers") tend to be overused compared to inhaled
steroids ("preventers") (Diette et a/1999).
Many third world countries, notably South Africa have endeavoured to measure
the impact of asthma on individuals with asthma and have also attempted to define
the quality of care for this common chronic illness. Green and colleagues
conducted a study with a primary objective of assisting the National Asthma
Program in South Africa with the formulation and delivery of its outreach program
to rural asthmatic patients (Green et al 2001). The researchers conducted
interviews with thirty five adult asthmatic patients and twenty seven parents of
paediatric asthmatic patients at seven rural health clinics across South Africa.
Each interview included extensive demographic details, questions on asthma
definition, symptoms and symptom triggers, family history, age at diagnosis,
frequency of symptoms, and treatment. Of the adult patients, 40% reported
wheezing at least once a week (despite diagnosis and treatment) and 19% of
12
children reported similar symptom exacerbations. Fifty-one percent of adults and
56% of children were awakened at least once a week by cough or wheeze. Fifty-
one percent of adults and 33% of children had been hospitalized at least once for
asthma. Although respondents claimed regular training in use of inhaler device,
only 43% of adults completed each step correctly. The researchers came to the
conclusion that there is a great deal of fear and ignorance surrounding asthma
and, therefore, there is need for a greater level of patient education in the rural
areas of South Africa with special attention being paid to nurses, because they
play a greater role than doctors in management and education of asthma (Green
et a/2001).
Griffiths and colleagues conducted a cluster randomized controlled trial study to
determine whether asthma specialist nurses, using a liaison model of care, could
reduce unscheduled care in a deprived multiethnic area in England (Griffiths et a/
2004). The study included 44 general practices in two boroughs in east London,
and it involved 324 people aged 4-60 years admitted to or attending hospital or the
general practitioner out of hour service with acute asthma (Griffiths et a/2004). At
intervention clinics patients were reviewed by a nurse in liaison with general
practitioners, there was also promotion of guidelines for high risk asthma, and
ongoing clinical support. Control practices on the other hand received a visit
promoting standard asthma guidelines and control patients were checked for
inhaler technique only. The results of the study revealed that the intervention
delayed time to first attendance with acute asthma (hazard ratio 0.73, 95% Cl 0.54
to 1.00; median 194 days for intervention and 126 days for control) and reduced
the percentage of participants attending with acute asthma (58% (101/174) versus
68% (99/145); odds ratio 0.62, 95% Cl 0.38 to 1.01). The researchers concluded
that asthma specialist nurses using a liaison model of care reduced unscheduled
care for asthma (Griffiths et a/2004).
The above two cited studies indicate that nurses play a critical role in managing
acute asthma at primary care level and countries especially developing countries
13
need to invest in them through training. One of the studies was conducted in a
developed country while the other one was conducted in South Africa.
1.3.4 Chronic obstructive pulmonary disease (COPO)
In the evaluation of effects of inhaled anticholinergics for treating chronic
obstructive pulmonary disease, a review of 3 large randomised controlled trials
involving 1461 people comparing ipratropium, salmeterol and formoterol versus
placebo was conducted. The review established that, compared to placebo,
inhaled anticholinergics significantly improved forced expiratory volume in 1
second, exercise capacity and symptoms (Kersijens and Postama 2002).
In evaluating inhaled beta-2 agonists for treating chronic obstructive pulmonary
disease, one systematic review looked at 9 cross-over randomised controlled trials
involving 264 people with stable chronic obstructive pulmonary disease comparing
short acting beta-2 agonists versus placebo for 1 week. The review established
that compared to placebo, inhaled beta-2 agonists slightly but significantly
improved forced expiratory volume in 1 second and also improved respiratory
symptoms (Sestini et a/2002).
In evaluating inhaled anticholinergics plus beta-2 agonists for treating chronic
obstructive respiratory disease, one review looked at 6 randomised controlled
trails involving 2772 people, comparing the addition of ipratropium versus no
additional ipratropium in people using standard dose of short acting inhaled beta-
2. The review established significant improvement in forced expiratory volume in 1
second of about 25% with the combination compared with either drug alone
(Friedman et a/1999).
There is thus general agreement among the above three reviews that use of
inhalers for treatment of chronic obstructive pulmonary disease has been shown to
be effective.
14
Smith and colleagues reviewed evaluations of the effectiveness of outreach
respiratory health care for patients with chronic obstructive pulmonary disease by
looking at 4 randomised controlled trials involving 624 people (Smith et a/ 2004).
The review established that patients with moderate chronic obstructive pulmonary
disease may have mortality and health related quality of life gains from the
programme whereas patients with severe chronic obstructive pulmonary disease
do not. Reduction in hospital admissions were not obtained in severe patients
(Smith et a/2004).
Despite the existence of effective cessation methods, the vast majority of smokers
attempt to quit on their own (Hammond et a/2004). To date, there is little evidence
to explain the low adoption rates for effective forms of cessation assistance,
including pharmaceutical aids. Hammond and colleagues conducted a study that
sought to assess smokers' awareness and perceived effectiveness of cessation
methods and to examine the relationship of this knowledge to cessation behaviour
among 616 adult daily smokers over 3 months in South-Western Ontario, Canada
(Hammond et a/ 2004).The researchers established that participants who
perceived cessation methods to be effective at baseline, were more likely to intend
to quit (odds rati01.80; 95% Cl 1.12 to 2.90), make a quit attempt at follow-up
(odds ratio 1.80; 95% Cl 1.03 to 3.16) and to adopt cessation assistance when
doing so (odds ratio 3.62; 95% Cl 1.04 to 12.58). The researchers came to the
conclusion that many smokers may be unaware of effective cessation methods
and most underestimate their benefit and this lack of knowledge may represent a
significant barrier to treatment adoptions (Hammond et a/2004).
The review and study thus indicate that outreach respiratory care and smoking
cessation interventions can be effective for treatment of chronic obstructive
pulmonary disease.
15
1.3.5 Tuberculosis
It is assumed that preventive therapy for tuberculosis will only be considered by
programs with high rates of case detection and cure of smear positive tuberculosis
(Borgdorff ef a/2002). it is further estimated that in the absence of treatment, each
smear positive case of tuberculosis would be infectious for 2 years and thus
generate 2B infection (where B is the number of infections generated per case per
year) (Borgdorff ef al 2002). Each new self reporting case detected after, on
average, 4 months would have infected 0.33B contacts. Without treatment, each
infectious case would generate on average one other first generation infectious
case, and treatment of each case would prevent 0.73 new infectious cases
(Borgdorff ef a/2002).
In assessing the effects of short course chemotherapy «6 months) versus longer
term (>6 months) on cure rates in people with active tuberculosis, one review
looked at 7 randomised controlled trials involving 4100 patients (Gelband 2004).
The review established that longer periods of treatment result in higher success
rates in patients with active tuberculosis even though the difference is small
(Gelband 2004).
Another systematic review on tuberculosis was conducted by Mwanduaba and
colleagues to compare the effectiveness of rifampicin-containing short course
chemotherapy regimens, given 2 or 3 times a week with similar regimens given
daily in adult patients with pulmonary tuberculosis (Mwanduaba and Squire 2004).
One randomised controlled trial involving 399 patients compared the treatment of
3 times a week with daily treatment for a period of 6 months. The review revealed
no difference in the cure rate between the two arms with an exception that five
patients relapsed in the intermittent therapy compared to one in the daily therapy
(Mwanduaba and Squire 2004).
16
Volmink and colleagues reviewed trials that compared policies of directly observed
therapy with self-treatment at home in people requiring treatment for clinically
active tuberculosis (Volmink and Gamer 2004). Six randomised and quasi-
randomised studies involving 1910 patients were reviewed. The review
established that the effect of directly observation therapy on cure or treatment
completion rates was similar to that of self-administered treatment (Volmink and
Garner 2004).
There is thus general agreement among the above three reviews that treatment of
tuberculosis using internationally accepted regimens can be effective.
Prevention and early treatment of infections is the mainstay of the medical
management of the majority of people with HIV infection, especially those who live
in low income countries without access to antiretroviral drugs. Cotrimoxazole is
cheap and is effective against a wide range of organisms (Grimwade and Swingier
2004). Tuberculosis is one of the life threatening opportunistic infections among
HIV positive patients. To evaluate the effectiveness of routinely administered
cotrimoxasole on death and illness episodes in HIV infected adults, a systematic
review looked at four randomised and quasi-randomised trials involving 1476
people (Grimwade and Swingier 2004). The review established that cotrimoxasole
prophylaxis had a beneficial effect in preventing death and illness episodes in
adults with early and with advanced HIV disease (Grimwade and Swingier 2004).
Zachariah and colleagues conducted a cross-sectional study to verify compliance
with cotrimoxazole prophylaxis in human immunodeficiency virus infected
tuberculosis patients during the continuation phase of anti-tuberculosis treatment,
and to assess the sensitivity, specificity and positive predictive values of verbal
verification and pill counts as methods of checking compliance in Malawi
(Zachariah et al 2001). Results of the study showed that in a rural district in
Malawi, compliance with cotrimoxazole prophylaxis as an adjunct to anti-
tuberculosis treatment in HIV infected tuberculosis patients was good, and can be
17
assessed simply and practically by verbal verification and pill counts (Zachariah et
a/2001).
Zachariah and colleagues conducted a subsequent cross-sectional study in the
same setting as above, this time to determine 1) the proportion who continues with
cotrimoxazole prophylaxis for the prevention of opportunistic infections, and 2) the
reasons for continuing or stopping prophylaxis, in human immunodeficiency virus
infected individuals with tuberculosis who complete anti-tuberculosis treatment
(Zachariah et a/2002). The results of the study showed that in rural settings, the
great majority of HIV infected individuals continued with cotrimoxazole after
completing anti-tuberculosis treatment.
There is general agreement amongst the above reviews and studies that
cotrimoxazole prophylaxis in rural settings is an effective intervention in preventing
death and illness episodes in adults with early and advanced HIV with or without
tuberculosis co-infection.
Table 1.7 below gives a summary of systematic reviews on treatment of the 5
priority lung diseases of PALSA. The table suggests that all 5 priority respiratory
diseases can be effectively managed at primary health care level by drugs which
can be issued at that level. Antiretroviral (ARV) treatment effectiveness was not
reviewed as these drugs were not yet generally available at primary care level in
South Africa at the time of the study. For management at primary health care level
however, clinician competence in diagnosing and treating these diseases is
needed.
18
Table 1.7: Summary of treatment of PALSA lung diseases at primary care level
Condition Treatment Effective/Non-effective
Community Acquired Pneumonia Antibiotics Effective
Upper Respiratory tract infection Antibiotics Non-effective
Asthma Antibiotics Unclear
Inhaled beta-2 agonist Effective
Inhaled long acting beta-2 Effective
agonists
Inhaled corticosteroids Effective
Chronic obstructive pulmonary disease Knowledge on smoking Effective
cessation options
Outreach respiratory care Effective
Tuberculosis Short course Effective
Long course More effective
Intermittent therapy Non-effective
DOTS Effective
Self-treatment Effective
Cotrimoxasole prophylaxis Effective
1.4 KEY PRIMARY HEALTH CARE POLICIES AND STRATEGIES RELEVANT
TO THE DIAGNOSIS AND TREATMENT OF LUNG DISEASES
1.4.1 International
The World Health Organisation (WHO), as the technical advisory body of the
United Nations (UN) to countries on all health related issues, spearheads
development of health-related policies, protocols, guidelines and strategies (WHO
2004(b». Individual countries then adapt these documents to suit their conditions
and requirements. WHO is also responsible for monitoring and evaluating
implementation of the documents as well as maintaining a database that indicates
implementation and status of each member country (WHO 2004 (b».
19
In an attempt to fight against all these above mentioned life-threatening respiratory
diseases. WHO in collaboration with other international agencies and
governments, has for a long time been promoting implementation of several
national programmes. Of major importance is the fight against tuberculosis which
has for a long time been one of the top killer diseases in the world (Borgdorff et al
2002, Hopewell 2002). In 1993 and 1997, the 1st and 2nd editions of Treatment of
Tuberculosis: Guidelines for National Programmes were published by WHO (WHO
2003 (b)). The guidelines were adapted by each country as National Tuberculosis
Programmes were being implemented, especially in low income countries where
tuberculosis is one of the leading causes of death in adults (Dye et al 2002,
Enarson et a/1996). The 3rd edition of the guidelines compiled in 2003 is the latest
version of the guidelines (WHO 2003(b)).
Another important policy that was developed through WHO initiative was the
Integrated Management of Childhood Illnesses (IMCI) strategy. This was a joint
venture between WHO and UNICEF and it was initiated in 1995. IMCI offers a set
of interventions that promote rapid recognition and effective treatment of major
killer diseases of children under five from an integrated approach (WHO/UNICEF
2001). This approach emphasises syndromic management, in which limited
diagnostic skills and resources can still lead to appropriate treatment for most
patients.
Another policy document that was developed through WHO initiative was the
Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD). This was a
joint venture between WHO and the United States National Heart, Lung and Blood
Initiative (NHLBI) and it was initiated in the early 1990s. Through WHO's initiative,
guidelines were developed to classify chronic obstructive pulmonary disease
(COPD) patients according to 4 stages of the disease severity using the
spirometer measurements (pauwels et a/2001).
20
It was on the basis of the policies discussed above that the Adult Lung Health
Initiative (ALHl) which later became the Practical Approach to Lung Health (PAL)
(See 1.5) was adapted.
1.4.2 South Africa
There are several primary care policies and strategies that the national Health
Department has developed. Many of these are based on WHO policies. National
policies are passed on to the nine provincial health authorities to also adapt and
implement at provincial level (Department of Health 2000(b». Among these is the
tuberculosis (TB) programme that is currently being implemented in all nine
provinces, although with different degrees of intensity and success (Bamford et al
2004). Each province has a provincial TB coordinator who supervises district TB
coordinators to ensure smooth implementation of the programme at district level.
Referral and reporting systems follow the same route on a quarterly basis, that is,
from district to province and then to national and vice versa. An annual report that
highlights trends of morbidity and mortality due to tuberculosis is compiled at
national level with contributions from the provinces (Bamford et al 2004). The
report also makes a comparison between and amongst the nine provinces on an
annual basis. South Africa is currently implementing the TB Strategic Plan for
2001-2005 which was adopted following the Amsterdam Conference on TB in
2000 (Bamford et a12004, WHO 2004(b».
In 1996 the National Government of South Africa adopted the Integrated
Management of Childhood Illnesses (IMCI) strategy that was developed by WHO
and UNICEF in 1995. Full political and administrative support from the highest
levels of government was given for commencement of implementation in all nine
provinces by incorporating IMCI as part of the PHC package for the country
(Department of Health 2002(b». Commencement and level of IMCI
implementation in three out of the nine provinces namely, Gauteng, the Western
Cape and Free State was evaluated in 2002 and a draft report compiled thereof. In
21
summary, these three provinces are implementing IMCI at different levels
(Department of Health 2002(b)).
The implementation of AIDS policy in the first four years after 1994 has been
characterized by a lack of progress and a breakdown of trust and co-operation,
both within government and between government and NGOs (Schneider and Stein
2001). There were generally difficulties of implementing the comprehensive
response to AIDS in a country undergoing restructuring at every level. This was
characterized by "inadequate political will" as an explanation for lack of progress.
Involvement by politicians has, in fact, been experienced as a double-edged sword
in South Africa, with inappropriate, "quick-fix" actions creating conflict and
hampering a more longer-term, effective response (Schneider and Stein 2001).
The importance of groups like the Treatment Action Campaign (TAC) which
function outside government in promoting effective policy actions, and the types of
leadership required to mobilise a broad range of actors around a common vision
can not be overemphasized (Schneider and Stein 2001).
In 2000, the HIV/AIDS Strategic Plan for South Africa 2000-2005 was adopted by
government. The strategic plan contains four priority areas namely: 1) prevention,
2) treatment, care and support, 3) research, monitoring and surveillance, 4) human
rights (Department of Health 2000(a». There have been developments to different
degrees by each of the nine provinces regarding implementation of the strategic
plan. In 2003 government approved a proposed budget for implementation of roll-
out of antiretroviral drugs (ARV) as part of the treatment, care and support priority
area 2 of the strategic plan (DOH 2003(a), Mbewu and Simelela 2003). Each
province has drawn up its own implementation plan of the roll-out, most of which
started implementation in 2004 (Mbewu and Simelela 2003). This is a follow-up to
several trials that were conducted at provincial level to establish the effectiveness
of treating symptomatic HIV positive patients with WHO approved antiretroviral
drugs (Doherty and Calvin 2004). In 2003 the National Department of Health
22
adopted a policy of providing antiretroviral treatment to people in advanced stages
of HIV/AIDS (Department of Health 2003(b».
Following the 1994 political changes in South Africa, the health care delivery
system was changed on a number of fronts and several policy documents were
developed as a result. On December 3, 1998, the Minister of Health of South
Africa launched the First Edition of the Standard Treatment Guidelines (STG) and
Essential Drug List (EDL) for adults and children at hospital, and the Second
Edition of the STG/EDL for Primary Health Care (Zweygarth and Summers 2000).
The STG/EDL lists and defines diseases that are of public health importance at
either a hospital or primary health care clinic, non-drug and drug treatment of such
diseases and essential drugs to be prescribed (by what cadre of health
professional) at each level (Department of Health 1998(b), Zweygarth and
Summers 2000). The hospital STG/EDL is currently being reviewed and updated
through official channels throughout South Africa.
In South Africa, as in most low-middle income countries, primary health care is
provided at low or no cost to users through public sector health services or publicly
subsidized agencies (Department of Health 1996, Segall 2003). Due to constraints
on resources, as well as relatively unattractive incentives for doctors, such care is
mainly provided by primary care nurses (Green et al 2001, Louwagie et al 2002).
In South Africa most nurses undergo a four year college or university training to
obtain a recognised professional nursing qualification. In response to the national
government's policy of adoption of the primary health care package norms and
standards, provincial health departments requested universities and nursing
colleges in their provinces to provide training to professional nurses (Louwagie et
al 2002). This is done through post-basic nursing courses aimed at equipping
participants with necessary skills for effective delivery of quality, comprehensive
health care at primary care level. KAComprehensive Primary Health Care Service
Package for South Africa" was developed in 2000 by the National Department of
Health. This booklet summarises all health services that are supposed to be
23
rendered at primary care level in terms of who should to what and how at primary
care level (Department of Health 2000(b».
Non-communicable diseases such as hypertension, asthma, diabetes and
epilepsy are placing an increasing burden on clinical services in developing
countries and innovative strategies are therefore needed to optimize existing
services (Coleman et al 1998, Louwagie et al 2002). Coleman and colleagues
conducted a study that aimed at describing the design and implementation of a
nurse-led service based on clinical protocols in a resource-poor area of South
Africa (Coleman et al 1998). Diagnostic and treatment protocols were designed
and introduced at all primary care clinics in a district, using only essential drugs
and appropriate technology. The protocols enabled the nurses to control the
clinical condition of 68% of patients with hypertension, 82% of those with non-
insulin-dependent diabetes, and 84% of those with asthma. The management of
non-communicable diseases of 79% of patients who came from areas served by
village or mobile clinics was transferred from the district hospital to such clinics.
Patient-reported adherence to treatment increased from 79% to 87% (p= 0.03)
over the 2 years that the service was operating. The use of simple protocols and
treatment strategies that were responsive to the local situation enabled the
majority of patients to receive convenient and appropriate management of their
non-communicable diseases at their local primary care facility (Coleman et al
1998).
Louwagie and colleagues conducted an audit aimed at comparing the clinical
competencies of nurses who underwent a one year "Advanced Diploma in Health
Assessment, Diagnosis and Treatment" course at the University of the Free State
with those who did not. The primary objective was to assess the clinical
management of one chronic and one acute disease (diabetes mellitus and acute
respiratory tract infections in adults, respectively) for these two groups of nurses
(Louwagie et a/2002). The researchers reviewed records of 286 consecutive visits
for adults with diabetes and 293 consecutive visits for adults with an acute
24
respiratory tract infection (ARTI). Nurses completed questionnaires on nurse
characteristics, while the researchers obtained the information about the clinics.
Recording of important generic (for ARTIs) and disease-specific steps (for
diabetes) in patient management were assessed. When comparing results of
patients of "trained" and "non-trained" professionals, and adjusting for nurses',
clinics' and patients' characteristics, there was generally little evidence of patients
being thoroughly managed (Louwagie et a/ 2002). The researchers concluded that
formal training was marginally associated with better care for ARTls (p = 0.06) but
not for diabetes (p = 0.47). Other factors associated with more thorough care were
years of experience in curative primary health care (p = 0.006) and additional
nursing degrees for ARTls (p = 0.03) and the presence of enrolled or assistant
nurses at the clinic for diabetes (p = 0.06) (Louwagie et a/2002).
Evidence provided by the above two studies and others cited earlier in the chapter
supports an argument that there was a need to design a simple nurse oriented
syndromic approach that would attempt to manage respiratory care service
delivery in South Africa, hence the adoption of PALSA
1.4.3 Free State
The Free State, one of the nine provinces of South Africa, also follows and adapts
policy guidelines, strategies and protocols from the National Health Department.
Currently the province implements the following policies that are related to the
PALSA project and are adapted locally:
1. Tuberculosis (TB) treatment and diagnosis guidelines
2. IMCI training manual
3. Asthma treatment guidelines
4. Hospital and primary care level Standard Treatment Guidelines and Essential
Drug List (STG/EDL).
25
These policy documents are periodically reviewed and updated as and when
required by the provincial authorities in consultation with the National Department
of Health. Technical input from local and international experts is incorporated.
1.5 PRACTICAL APPROACH TO LUNG HEALTH (PAL) AND PALSA
The Practical Approach to Lung health (PAL) is a WHO initiated syndromic
approach to management of patients (above 5 years old) who attend primary
health care service for respiratory symptoms (WHO 2003(c». The initiative targets
multi-purpose health workers, nurses, doctors and managers in primary health
care settings with successful TB Control Programmes in low and middle-income
countries (WHO 2003(c». PAL, which was initially known as the Adult Lung Health
Initiative (ALHl) was developed as a result of several studies that revealed that up
to one-third of patients over the age of 5 years attending primary health care
settings seek health care for respiratory symptoms (WHO 2003(c».
The main objectives of PAL are to improve quality of respiratory case
management for the individual patients as well as to improve the efficiency and
cost-effectiveness of respiratory care within the health systems. Components of
PAL comprise of standardisation of health care service delivery through
development and implementation of clinical practice guidelines as well as
coordination of all role players at all levels of health care, the TB Control
Programmes and organisation and management of general health services. It is
noteworthy that PAL is organised within the WHO TB Control Programme,
specifically as part of the Global Directly Observed Therapy Expanded Plan. The
WHO TB programme is particularly interested in PAL's role in expanded
tuberculosis case detection. Requirement for introducing PAL into a country
include, among several conditions, political commitment to adapt and implement
the strategy, assessment of existing conditions to adapt the strategy, formulation
of an agenda for adaptation and development and implementation of the strategy
(WHO 2003(c)).
26
The idea of adapting ALHI (now PAL) in South Africa (PALSA) dates as far back
as 1999 through the involvement of one of PAL's senior researcher (then an
employee of MRC SA) at meetings of an international organisation called the
Pragmatic Randomised Controlled Trials in Health Care (PRACHTIC), an
organisation with interest in pragmatic randomised controlled trials to influence
health policies in countries throughout the world. Eventually the adaptation and
implementation of the strategy was conducted on trial basis through a cluster
randomised trial which started in 2003. This was a joint venture between the Free
State Provincial Health Department and University of the Free State's Community
Health Department, Centre for Health Systems Research and Development and
Biostatistics Department as well as the University of Cape Town Lung Institute.
The project has been financially supported by the Canadian International
Development Research Centre, the WHO, the Government of South Africa
(National and Provincial) and the Government of Lesotho. Results of the trial will
be used for making informed decisions about implementation in the entire province
and, later on, the whole country (IDRC 2004).
1.6 EVALUATING THE EFFECTIVENESS OF EDUCATIONAL METHODS
AIMED AT CHANGING CLINICAL PRACTICE
There have been several systematic reviews to evaluate the effects of clinical
practice guidelines on patient outcomes in primary health care. Grimshawand
colleagues conducted a systematic review to establish the effectiveness and
efficiency of guideline dissemination and implementation strategies (Grimshawet
al 2004). A total of 235 randomised controlled trials, controlled clinical trials, and
controlled before and after studies, reporting 309 comparisons were reviewed.
Guideline dissemination and implementation strategies were the main
interventions evaluated. Commonly evaluated single interventions were reminders
(38 comparisons), dissemination of educational materials (18 comparisons) and
audit and feedback (12 comparisons). There were 23 comparisons of multifaceted
27
interventions involving educational outreach. The majority of interventions
observed modest to moderate improvements to care. The median absolute
improvement in performance across interventions were 14.1% in 14 cluster
randomised comparisons of reminders, 8.1% in four cluster randomised
comparisons of dissemination of educational materials, 7.0% in five cluster
randomised comparisons of audit and feedback comparisons and 6.0% in 13
cluster randomised comparisons of multifaceted interventions involving
educational outreach. The review concluded that there is imperfect evidence to
support decisions about which guideline dissemination and implementation
strategies are likely to be efficient under different circumstances. Decision makers
need to consider potential clinical areas for clinical effectiveness activities, the
likely benefits and costs required to introduce guidelines and the likely benefits
and costs as a result of any changes in provider behaviour (Grimshawet a/2004).
Hulscher and colleagues reviewed available data on evaluation of interventions to
improve delivery of preventive services in primary health care. They reviewed 55
randomised trials, controlled before and after studies involving 2000 professionals
and 99000 people (Huischer et al 2004). The researchers established that in
comparing interventions that used randomised groups, the effectiveness varied
extensively. Five comparisons of group education versus no intervention showed
absolute changes of preventive services varying between -4% and 31%, nine
comparisons of physician reminder versus no intervention showed absolute
changes of preventive services varying between 5% and 24% and fourteen
comparisons of multifaceted intervention versus no intervention showed absolute
changes of preventive services varying between -3% and 64%. Six comparisons of
multifaceted interventions versus group education reported absolute changes
varying between 28% and 31%. This review reveals that effective interventions to
increase preventive activities in primary care do exist, but there is considerable
variation in the level of change achieved, with effect sizes usually small or
moderate. The review also indicates that tailoring interventions to address specific
barriers to change is important and that multifaceted interventions may be more
28
effective than single interventions because more barriers to change can be
addressed (Huischer et a/2004).
Thomson Q'Brien and colleagues conducted a systematic review of studies to
evaluate the effects of outreach visits on improving health professional practice or
patient outcomes. The researchers reviewed 18 randomised controlled trials
involving 1896 physicians (Thomson Q'Brien et a/2004). The targeted behaviours
were mainly prescribing, and preventive services including counselling for smoking
cessation (Thomson Q'Brien et al 2004). Positive effects on practice were
observed in all studies, although at different magnitudes. The authors concluded
that educational outreach visits, particularly when combined with social marketing,
appear to be a promising approach to modify health professional behaviour,
especially on prescribing (Thomson Q'Brien et a/2004).
Trials that have been cited in the above reviews were mainly randomised
controlled trials, controlled clinical trials as well as controlled before and after trials.
Most of these trials compared intervention groups with controls or placebo.
Findings of the above three reviews suggest that implementation of .clinical
guidelines, preventive services and outreach visits are some of the most effective
interventions that can be provided at primary care level. Because their
effectiveness varies considerably in size, that is, from modest to moderate, there is
a need to further explore their value.
1.7 CLUSTER RANDOM.SED TRIALS
A cluster randomised trial is one where a group of patients rather than individuals
are randomised to different groups that are managed in different ways (Campbell
and Grimshaw 1998, Donner and Klar 2000). An example of this is when patients
of general practitioners who have received special training are compared with
patients of general practitioners who have not received the training (Bland and
Kerry 1997). Reasons for adopting cluster randomization are diverse, but include
29
administrative convenience, a desire to reduce the effect of treatment
contamination and the need to avoid ethical issues that might arise (Klar and
Donner 2001, MRC 2002). The main consequence of adopting a cluster design is
that the outcome for each patient can no longer be assumed to be independent of
that for other patients (which is the case in an individually randomised trial)
(Donner and Klar 2000). Patients within anyone cluster are more likely than
patients in other clusters to have similar outcomes. For example, the management
of patients within a single general practice is more likely to be more similar than
management across several practices (Campbell and Grimshaw 1998).
There are several reasons why cluster randomised trials are currently considered
instead of other designs, but the following reasons are most commonly given.
1} The intervention to be studied is itself delivered to and affects groups of
people rather than individuals, e.g. use of local radio for health promotion.
2} The intervention is targeted at health professionals with the aim of studying its
impact on patient outcomes, e.g. education about guidelines for a particular
medical condition.
3) Likely contamination of control arms by interventions aimed at intervention
arms (e.g. nurses in control arms being inadvertently exposed to educational
interventions because they work in the same clinic).
It is however worth noting that, because outcomes among subjects in the same
cluster may be similar (e.g. patients in different geographical areas may be more
severely ill than in other areas) and because their management may also be
similar (e.g. if different clinics have different norms or if some nurses are more
effective than others) independence of observation cannot be assumed in the
analysis. This non-independence is taken care of by estimating and adjusting for
intra-cluster correlation of outcomes within clusters (Donner and Klar 2001). The
non-independence has the disadvantage of reducing a trial's statistical power,
and therefore larger sample sizes are usually needed to achieve a given degree
30
of power. One method of adjusting for such cluster sampling design effect is
incorporated in the Stata statistical package (StataCorp 2003).
Many cluster randomised trials have been conducted globally and locally to
evaluate the effectiveness of health service interventions. Most of these trials
investigate the effectiveness of implementing guidelines for management of
certain diseases that are of public health importance (Kerry and Bland 1998,
Flottorp et al 2002)
1.8 CONCLUDING REMARKS
This chapter has given an overview of the current burden and primary health care
of respiratory conditions. Respiratory conditions of public health importance
discussed are upperllower respiratory tract infections, chronic obstructive
pulmonary disease, asthma and tuberculosis combined with HIV/AIDS. A global
scenario followed by that of South Africa and the Free State province were given
in terms of the current morbidity, mortality and trends, followed by future
projections of each disease.
From the literature reviewed, it is evident that adult lung diseases that are of public
health importance to South Africa and other developing countries, notably,
tuberculosis, upper and lower respiratory tract infections, asthma, and chronic
obstructive pulmonary disease (COPD) can be managed at primary health care
level. The challenge is to determine whether this is true in a resource limited
setting like rural Free State.
Effective treatments have been shown to be available. Of importance are
implementation of treatment guidelines and essential drug lists that are developed
at national and local level and adoption of effective information dissemination
strategies of national policies. Nurses are an integral component of health care
service delivery. However, their formal training for improvement in diagnosis and
31
treatment of these respiratory conditions has not proven to be effective, thus
warranting the need for further research to plan effective training methods.
It was with these points in mind, and using the best available evidence, that a
team of PALSA researchers developed a training package for primary health care
nurses in a South African setting with high logistical and human resource
constraints. The purpose of the trial was to assess its effectiveness through a
cluster randomised controlled trial.
Alongside the randomized controlled trial was a validation study of the South
African adapted guidelines that was conducted in Cape Town. Results of the
validation study will soon be out and shared with relevant stakeholders as well.
1.9 AIM OF THE STUDY
The aim of the study was to estimate the effectiveness of implementation of the
Practical Approach to Lung Health in South Africa (PALSA) on the processes and
outcomes of respiratory care in Free State Government primary health care clinics.
1.10 OBJECTIVES OF THE STUDY
The objectives of the study were to estimate the effectiveness of the intervention
on the following outcomes:
1.10.1 Primary outcomes
To improve the process of care
1.10.1.1 To reduce the rate of antibiotic prescription.
1.10.1.2 To increase the rate of inhaled steroid prescription.
32
1.10.1.3 To increase the rate of sending of sputa for tuberculosis testing.
1.10.1.4 To increase appropriate use of cotrimoxazole prophylaxis in
known tuberculosis cases.
To improve health outcomes
1.10.1.5 To reduce the rate of interference with usual activity due to
illness.
1.10.2 Secondary outcomes
To improve the process of care
1.10.2.1 To increase appropriate referral of patients with severe
respiratory disease (appropriately defined as respiratory rate
~ 30 breaths/minute, breathless on talking or at rest, use of
accessory muscles, temperature ~ 38 degrees Celsius).
1.10.2.2 To increase the percentage of patients offered VCCT/HIV
counselling.
1.10.2.3 To increase the percentage of current smokers receiving
counselling for smoking cessation.
To improve health outcomes
1.10.2.4 To increase the rate of readiness to quit smoking among current
smokers.
1.10.2.5 To increase the rate of smoking cessation among current
33
smokers.
1.10.2.6 To increase the tuberculosis case detection rate.
1.10.2.7 To reduce the rate of mortality.
1.10.2.8 To decrease the frequency of difficulty sleeping due to chest
symptoms.
1.10.2.9 To decrease the frequency of chest symptoms during daytime.
1.10.2.10 To decrease the frequency of interference of chest problems with
usual activities.
1.10.2.11 To improve each domain of the Ea-50 quality of life measurement
and the combined score.
Health Care utilisation
1.10.2.12 To reduce the rate of unplanned visits to clinics.
1.10.2.13 To reduce admissions to hospitals.
34
CHAPTER 2- METHODS
2.1 INTRODUCTION
This chapter will start by giving a description of the PALSA intervention. This will
be followed by an overview of the design and methods of the randomized
controlled trial to evaluate the effectiveness of the PALSA intervention.
2.2 PALSA INTERVENTION
2.2.1 Description
The PALSA intervention package was intended to reduce the burden and costs of
priority lung disease in the Free State, and to also provide evidence to support
rational decision-making regarding implementation.
The intervention comprised the following components, described in detail below.
1. Academic detailing consisting of 3 to 4 training sessions of primary care nursing
practitioners per clinic delivered on-site by district TB co-ordinators over 9 weeks.
2. Dissemination of clinical practice guidelines and support materials e.g. desk
blotter, pens, penholders and butterfly fridge magnets for each trained nurse.
3. Changes in prescribing provisions for primary care nurses (cotrimoxazole
prophylaxis for symptomatic HIV infected persons, initiation and step-up or step-
down of inhaled steroids for asthma, short course oral steroids (prednisone) for
exacerbation of asthma and COPD).
4. Doctor sensitization about PALSA by personally addressed letters.
35
2.2.2 Schedule
2.2.2.1 Training of TB coordinators as PALSA trainers
In February 2003, 13 district TB coordinators received a one week training as
PALSA trainers in Cape Town. The training was facilitated by a privately employed
anthropologist. Other resource persons were PALSA researchers who were
involved in the designing and production of the PALSA intervention materials. The
training involved theoretical lectures on the following 6 topics: severity markers of
respiratory diseases, upper and lower respiratory tract infections, asthma, COPD,
TB and HIV/AIDS. Participants were given an opportunity to design their own
training plans and methods using the PALSA intervention materials. PALSA
materials included the locally adapted guidelines (attached as Annex 1), a desk
blotter, a flip chart, an inhaler, and fridge magnets. The theoretical lectures were
followed by teaching exposure by teaching clinic nurses in two primary care clinics
in Cape Town with each trainer's teaching lesson video taped. The teaching
sessions were followed by comments from PALSA researchers assigned to the
two clinics on how each session was conducted, with special attention drawn to
time taken, innovation and involvement of the trainees. Each trainer was given an
opportunity to review the recorded session and also received comments from the
rest of the training resource persons through a joint session. Each trainer indicated
suitable dates for conducting PALSA trainings in their respective districts. From
these individual trainers' schedules an overall training schedule for the whole
province was drawn up by PALSA researchers, from April to August 2003. At the
end of the week long training, the 13 trainers were issued with certificates as
PALSA trainers.
During training of PALSA trainers (TB coordinators) in Cape Town, it was decided
by PALSA researchers that, prior to commencement of the clinic staff training, one
of the researchers responsible for the qualitative assessment of the project would
undertake three regional quality check sessions of the trainers. The quality check
36
sessions entailed conducting training of clinic staff in non-trial clinics by PALSA
trainers under supervision of PALSA researchers. The training sessions were
video taped and feedback given immediately to the trainers on their performance
in preparation for the PALSA training.
2.2.2.2 Training of clinic nursing staff
The PALSA training of trainers was followed by delivery of intervention materials to
each trainer. The quantity of materials varied according to the number of clinics
each trainer was allocated and the number of trainees in each clinic. Each
package comprised the PALSA Clinical Practice Guideline and support materials
namely, a desk blotter, pen and penholder and a butterfly fridge magnet. These
support materials bore short key messages on respiratory diseases, together with
a PALSA logo. Trainees were mainly primary care nursing practitioners who had
received full PHC training and who therefore saw sick patients and prescribed in
the clinics. They included chief professional nurses, senior professional nurses,
professional nurses, and senior enrolled nurses, depending on how each clinic
operated. The allocation of clinics for training was done in such a way that no
trainer was overburdened with more than four clinics. The main reasons for this
were to avoid fatigue and because trainers had other responsibilities other than TB
or PALSA related activities in their respective districts.
Each clinic received a total of three to four training sessions from each PALSA
trainer. The training was conducted at each clinic to avoid having to take the
nurses away from the clinic for a period of time. During each training visit, the
trainer took 50% of the nurses for about thirty minutes covering at least three of
the six PALSA topics. After the first session, the trainer then trained the remaining
50% of the clinic staff. After every training session at the intervention clinic, each
trainer completed a training form that indicated the number of clinic nurses trained
by cadre, topics covered, time spent at the clinic, amount of money spent on
37
refreshments and fuel during that particular visit. An example of the training form is
attached as Annex 2.
2.2.2.3 Official communication with district management teams
Delivery of PALSA intervention materials to the clinics was followed by official
letters to district management teams in each of the five districts of the province.
These were mainly the district manager him/herself, Chief executive officer, Senior
executive officer, local area managers and clinic managers. The letter informed
them about PALSA as an intervention project, progress made so far and planned
PALSA training due to take place in their respective districts. The letter explained
the types of support expected from each district management to ensure the
success of the project. A copy of such a standard letter is attached as Annex 3.
Data on the 40 trial clinics regarding nursing staff complement, operation hours,
and special/fast lanes were provided to the PALSA researchers by the district
management authorities, who were mainly district and clinic managers. These
data helped plan how much training/intervention material was required by each
intervention clinic.
2.2.2.4 Sensitization of medical doctors
Concurrent to the district management letters, "sensitization" letters were sent to
doctors operating in those hospitals to which the intervention clinics refer their
patients, those doctors who are assigned to the intervention clinics on a part or
full-time basis, and private doctors operating in the neighbourhood of intervention
clinics. The letters were in both English and Afrikaans. The letters were issued
because these doctors interacted with potential PALSA patients and therefore had
to be aware of changes that were to be brought about by the intervention,
especially to the prescribing responsibilities of clinic nurses. An English version of
the doctors' letter is attached as Annex 4.
38
2.2.2.5 Provincial drug circular on PALSA drugs
Prior to commencement of PALSA training, which was scheduled to start on the
week beginning April 7th 2003, the provincial health department through the office
of the General Manager, Health Support, Or. Ron Chapman, wrote a circular
defining changes to prescribing to clinic managers of intervention clinics. The
circular informed clinic managers about the department's decision about changes
to prescription for PALSA patients during the trial. The managers were urged to
ensure that the referred to drugs were ordered on time and stocked effectively to
avoid stock out at all cost. The managers were referred to specific offices to
ensure smooth operation. The circular is attached as Annex 5.
2.3 STUDY DESIGN
The study was a cluster randomized controlled trial. The unit of randomization was
a primary health care clinic. Inferences about the effectiveness of primary care
nurse training were based on examination of patient level outcomes. Patients and
personnel recording outcomes were blind to the intervention or control status of
each clinic. It was however not possible to blind health care staff at the
intervention clinics even though the researchers referred to anything related to the
training of clinic staff as PALSA while anything to do with the data collection
process as Lung Health survey. Figure 2.1 below is an illustration of the study
design.
39
Figure 2.1: Study design
Intervention clinics Control clinics
20 clinics 20 clinics
INTERVENTION PACKAGE Usual practice
(a) PALSA guidelines
(b) Academic detailing training (3-4 sessions)
(c) Changes in prescribing by nurses
(d) Doctors sensitization
lo
1st post-intervention survey 1st post-intervention survey I
4 weeks after training
Follow up Follow up
3 months after 1st post- 3 months after 1st post-
intervention survey intervention survey
40
2.4 STUDY POPULATION
2.4.1 Clinics
The study took place in the 40 largest primary health care clinics of the Free State
Government with the following exceptions: Bloemfontein clinics were excluded due
to frequent rotation of nursing staff and because many Bloemfontein patients are
managed by doctors. Nurse rotation could have led to contamination of control
clinics with trained nurses, and doctors could have diluted effects of nurse training.
Thaba Nchu area clinics were used for piloting the project's intervention materials
and data collection tools and were therefore also excluded from the study. A
purposive sample of the 40 remaining largest clinics was therefore selected for
logistical and recruitment purposes of eligible patients. Figure 2.2 shows how the
40 trial clinics were arrived at from a total of 236 primary health care clinics in the
Free State province.
41
Figure 2.2: PALSA Rel clinic selection
236 Primary health care clinics in the Free State
25 Bloemfontein clinics excluded (frequent rotation of nursing staff
and patients seen by doctors)
11 Thaba Nchu clinics excluded (pilot sites for intervention and data
collection materials)
200 Primary health care clinics
l
40 largest primary care clinics selected by size (above 5 year olds during t" quarter
2001), stratified by health district and randomized in blocks of 4.
Thaba Mofutsanyane (12), Lejweleputswa (12), Northem (10), Motheo (4), Xhariep (2)
,
20 Intervention clinics 20 Control clinics
Thaba Mofutsanyane (6) Thaba MoMsanyane (6)
Lejweleputswa (6) Lejweleputswa (6)
Northern (5) Northern (5)
Motheo (2) Motheo (2)
Xhariep (1) Xhariep (1)
2.4.2 Patients
We aimed to recruit 50 patients per clinic, that is, 2000 patients in total.
42
The patient inclusion criteria were as follows:
- All patients 15 years and older.
And one or more of the following:
_ Patients reporting difficulty breathing on the day of presentation or in the
last 6 months.
Patients reporting cough for more than a week or recurrent cough in the last
6 months.
- Patients reporting cough for less than 1 week but with a marker of severe
disease (respiratory rate ~ 30 and/or temperature ~ 38°C).
The exclusion criteria were as follows:
- Unconscious patients
- Patients who appeared unable to breathe adequately to be interviewed
- Patients who were unable to talk adequately to be interviewed
- Patients who appeared psychotic (clearly hallucinating, unable to sit still,
aggressive)
- Patients who were only seen by a doctor on the day of presentation.
Patients were selected from the general queue as well as the TB queue at each
clinic.
43
2.5 SAMPLE SIZE ASSUMPTION AND ESTIMATES
Results of the pilot study revealed the following points:
70% of patients interviewed had antibiotic prescriptions
17% of patients interviewed had inhaled steroid prescriptions
50% of patients interviewed had problems with their usual activities
To decrease antibiotic prescription by 10% (from 70% to 60%) with 90% power
and 5% significance, we would require 500 patients per arm. Because of cluster
randomisation, we assumed that we needed to double the number and therefore
needed 1000 per arm.
To increase inhaled steroids prescription by 10% (from 17% to 26%) with 90%
power and 5% significance, we would require 458 patients per arm. Because of
cluster randomisation, we assumed that we needed to double the number and
therefore needed 916 per arm.
To decrease the frequency of problems with usual activities by 10% (from 50% to
40%) with 90% power and 5% significance, we would require 538 patients per
arm. Because of cluster randomisation, we assumed that we needed to double the
number and therefore needed 1076 per arm.
From the above assumptions, we estimated that the sample size had to be
approximately 1000 in each arm of the trial.
2.6 RANDOMISATION
The 40 largest primary care clinics in the province were first ranked by size
(headcount of patients over 5 years old during the 1st quarter of 2001), stratified by
district and then randomised in blocks of 4. All the 5 districts of the province were
44
represented. Figure 2.3 below is the Free State provincial map showing the
distribution of the trial clinics by district.
In randomising the clinics some complexities arose. Initially the 40 largest clinics
were from only four districts of the province, namely Motheo, Lejweleputswa,
Northern and Thaba Mofutswanyane. The district that was not represented was
Xhariep. It however came to the attention of the researchers just before
commencement of PALSA training of trainers that one of the Northern district's
clinic, Koppies appeared twice in the sample of randomised clinics, but under
different names. The next largest clinic, Petrusburg, was from Xhariep which was
originally not represented. To include another clinic from the same district, the next
largest clinic in Xhariep, Matlakeng was included. This meant that the last largest
clinic in the Northern district, Sasolburg town clinic, had to be excluded from the
study.
Two months after commencement of field work, but before field work commenced
at the clinic, one of the control clinics, Osizweni, had to be closed down due to
logistical and administrative problems beyond our control. Patients attending the
clinic were for logistical and administrative reasons referred to three neighbouring
clinics, one of which was Sasolburg town clinic which had been excluded from the
study. A decision was then taken by the researchers to once again include
Sasolburg town clinic to the study's control arm, for the following reasons:
- Patients from Osizweni clinic were already being referred to Sasolburg town
clinic for logistical and administrative reasons, meaning that most of the patients
would have still been from Osizweni clinic anyway.
- Sasolburg town clinic had initially met the criteria for selection to the study
(which was size) but had only been excluded to make way for the Xhariep district
clinic. If it had been in the clinic sample instead of Osizweni it would have been
allocated to the control group. Substitution was done without the researchers' prior
45
Figure 2.2: Free State Provincial Map Showing Trial Clinics by District (Adapted from DHLG 2004)
+>-
0\
~.~.
I = Intervention Clinics
. ~~0~..u.PP.O.u. C = Control Clinicss ....
. • . . •WATERKLOOF·
"
knowledge of Sasolburg town clinic's performance, or types of services provided at
the clinic.
2.7 ENROLMENT OF PARTICIPANTS
2.7.1 Assessment of eligibility and enrolment
After registering and while waiting to be seen by the clinic nurse and/or doctor,
patients were screened for eligibility to participate in the study by using the
screening question, "Do you have cough and/ or difficulty breathing today or in the
last 6 months?" This was asked of a" patients that were 15 years or older. All
patients whose response was "yes" to this screening question were then
requested to report to the interviewer to provide more details about their illness,
after being seen by the nurse/doctor and collecting medication. A systematic
selection process was applied to avoid eligible patients having to queue for
interviews. The selection process is attached as Annex 6.
After being seen by a clinic nurse and/or doctor and collecting medication, patients
who had been identified by team leaders as potential candidates were further
screened by the interviewers for inclusion. This entailed establishing the severity
and duration of the presenting respiratory problem and taking respiratory rate and
temperature. A patient screening questionnaire (Annex 7) was used for
establishing the severity and duration of the respiratory problems of eligible
patients. Temperature and respiratory rates were measured using an alcohol
and/or mercury thermometer and a stop watch, respectively. Patients who had
only been seen by a doctor on that day were excluded from the study. However
those seen by both the doctor and nurse were considered for inclusion. Upon
qualification, informed consent was then sought from eligible patients for
enrolment to the study after a thorough explanation of what the study was about.
47
2.7.2 Informed consent
Eligible patients were asked to complete a consent form that briefly explained the
background, purpose and methods of the trial. It also clearly stated that:
participation was voluntary; that a patient could withdraw at any time and would
not be discriminated against by the trial or clinic staff; that he/she would be
interviewed by a field worker and would at the end of the interview be requested to
come back for a follow-up visit three months after the initial visit. The consent form
also indicated that all participants were entitled to a food voucher/parcel worth
sixty Rand (R60) that they would receive on the day of the follow up visit to the
clinic or at a place of their choice. If they consented, each participant was asked
to sign a consent form that was written in either Sesotho, Xhosa, Zulu, Afrikaans
or English. The English version of the patient information and written consent form
is attached as Annex 8.
At the end of the interview, participants were given a reminder form, indicating the
exact date of the follow-up interview as well as venue for the interview. The
reminder form is attached as Annex 9.
2.8 DATA COLLECTION TOOLS
2.8.1 First post-intervention survey and follow-up interview questionnaire
Both first post-intervention survey (Annex 10) and follow-up (Annex 11)
questionnaires were developed with clinical input of respiratory disease physicians
from the UCT Lung Institute. The questionnaires comprised questions about the
presence of a cough and or difficulty breathing, in terms of severity and duration.
The questionnaire then went on to establish presence of other symptoms related
to either the upper or lower respiratory tract infections and their severities during
the day and night. The questionnaire included 3 respiratory questions adapted
from the St. George's Hospital respiratory questionnaire (Barr et al 2000). These
48
covered difficulty sleeping due to chest symptoms, chest symptoms during the day
and interference with usual activities due to chest symptoms.
The questionnaire also included the international EuroQol-5D questionnaire (The
EuroQol group 1990). This comprises questions about 5 dimensions of quality of
life, namely mobility, self-care, interference with usual activities, pain/discomfort,
and anxiety/depression. EuroQol-5D questions are combined into a weighted
scale, indicating quality of life. A score of 100 represents perfect health and a
score of 0 represents death. Permission was sought from and granted by the
EuroQol group to the PALSA team to translate and pilot test the translated
versions of the EuroQol questionnaire. The questionnaire was translated to
Sesotho, Zulu, Xhosa and Afrikaans. Approval for its use was granted upon the
EuroQol group's satisfaction that the translation and pilot testing procedures were
followed appropriately.
Questions regarding smoking habits and counselling on cessation also formed part
of the questionnaire. An abbreviated form of a questionnaire devised by
DiClemente and Prochaska, which classifies patients according to their readiness
to quit smoking, was used (DiClemente and Prochaska 1982).
Also included were questions on details of the patients' consultation with nurse
practitioners, further tests ordered, emergency treatments given, prescriptions
given, regular/on-going medication taken by patients and referral to a doctor at the
clinic, to hospital, or to other health care service providers.
Questions on health care utilisation and their financial implications on the patient
also formed part of the questionnaire. In particular these questions established
different health care providers that the patient utilised in the last three months and
expenditure incurred on each visit to such health care providers. Several utilisation
questions covered variables to be used for an economic evaluation, which is
beyond the scope of this thesis.
49
There were several differences between the first post-intervention survey and
follow-up questionnaires. Firstly, the first post-intervention survey questionnaire
had a patient screening section by which eligible patients were identified whereas
the follow-up did not. Secondly, the follow-up questionnaire had a number of
questions on patient satisfaction with health care at the clinic where she/he
regularly went or where the interview was conducted. Satisfaction in this case
pertained to clinic staff attitudes and availability of essential resources such as
adequately skilled nursing staff and drugs.
Because of the diversity of languages in the Free State, the first post-intervention
survey and follow up questionnaires, reminder, and consent forms (issued during
the first post-intervention survey) were translated from English into four local
languages that are commonly spoken in the province. These are Sesotho,
Afrikaans, Xhosa and Zulu. In total the questionnaire was in five different
languages and interviews were conducted in an individual patient's choice of
language.
2.8.2. Visual aids
As part of the questionnaire (first post-intervention survey and follow-up),
interviewers used a visual aid document that assisted interviewees to identify and
give correct answers to some questions. The visual aid comprised of two main
parts namely:
2.8.2.1 Euroqol-5D questionnaire including scale
This was a locally adapted Euroqol-5D questionnaire which included a scale,
written in the 5 different languages of English, Afrikaans, Zulu, Xhosa and Sotho.
This part was meant to assist patients to identify where they fell in relation to
health-related quality of life within the five domains i.e. mobility, self care, usual
activity, pain/discomfort and anxiety/depression (See pages 7 and 8 of Annex 11).
50
2.8.2.2 Photographs (Annex 12)
This was a set of photographs relating to the following required information:
a) Different modes of transport used in the province, and this included a taxi,
train, bus, animal wagon, private motor vehicle, ambulance, bicycle and
walking.
b) Other health care providers in the province, and this included a hospital,
another primary health care clinic, mobile ambulance, workplace clinic, private
doctor, traditional healer and pharmacy/chemist.
c) Prescription information showing different reliever and preventer inhalers,
antibiotic tablets for other respiratory conditions and nasal sprays.
2.8.3 Notification of deceased patients form
For patients who died during the 3 month period between the first post-intervention
survey and follow-up interviews, interviewers were asked to request a copy of a
death certificate of the deceased patient, duly stamped and signed by appropriate
authorities. The collected death certificates were then forwarded to the PALSA
data management centre in Cape Town. In the absence of a death certificate,
interviewers completed a notification of deceased patients at follow-up form
(Annex 13) developed by PALSA researchers and submitted it in place of the
death certificate.
2.8.4 Personal Digital Assistant (PDA)
A PDA is a small hand-held device that was used for collecting data in place of a
paper questionnaire. It functions as a small computer by having the questionnaire
in the 5 languages formatted into it. The questionnaire can be retrieved and
administered as with a paper version. The device was able to take up to 12
completed questionnaires at a time and to store them until the information was
51
11& 4-l81~
uploaded to a toll-free number to which it was connected from a direct land-line.
This was a new method of data collection process pioneered by the Medical
Research Council (MRC) of South Africa. It took about 3 minutes to upload 12
interviews from each PDA daily.
During the first week of the first post-intervention survey data collection, the first
four teams that did field work used paper questionnaires because the PDA was
not yet ready for use. Subsequently, all four teams used PDA. The remaining two
teams also started with paper versions and switched to PDA on week two of their
schedule. In total about 500 paper questionnaires were used, including only two
used during follow-up. This happened when two interviewers of the Bethlehem
Team had gone to the village in search of patients who were supposed to come for
follow-up interviews at the clinic but did not turn up. It was while they were away
that two other patients arrived at the clinic and the team leader interviewed them
using paper questionnaires because she did not have a PDA at the time.
2.9 PILOT OF TRAINING AND DATA COLLECTION PROCESSES
Table 2.1 summarises interviews conducted during piloting of training and data
collection tools. In November 2001, piloting of intervention materials, and in
particular the academic detailing method of training, was conducted for nursing
practitioners from three primary care clinics of Thaba Nchu district. The clinics
were Gaongalelwe, Thaba Nchu and Tiger River. A total of 8 Chief Professional
Nurses (CPN) from the three clinics received the academic detailing training in two
sessions, each lasting for an hour. Training materials used were the flip chart, the
guidelines and the desk blotter. From then on the three clinics were used for
piloting other project intervention materials and data collection tools.
The pilot exercise concentrated on the academic detailing method of training and
data collection tools, particularly the screening and the first post-intervention
survey questionnaires, both the paper version and PDA. Information obtained from
52
the pilot was used to adapt the training to local conditions, to make an assessment
of the number of eligible patients that could be interviewed per day per clinic, to
assess feasibility and duration of an interview, and to assess possible obstacles to
follow up patients. The pilot also served as a final check of clinic staff knowledge
and skills needs.
Table 2.1 Summary of interviews conducted during piloting of PALSA
Date Purpose Number interviewed Interviewer(s)
08-10/11/02 To pilot test draft lof 3 in T/Nchu clinic B.Majara
the first post- 4 in GAO clinic
intervention 2 in Tiger River clinic
questionnaire.
(paper version)
28-30/12/02 To pilot test draft II of 4 in T/Nchu clinic B.Majara
the first post- 3 in GAO
intervention 2 in Tiger River clinic
questionnaire.
(paper version)
12-13/02/03 To pilot test draft III of 3 inT/Nchu clinic B.Majara
the first post- 4 in GAO clinic
intervention and 3 in Tiger River clinic
screening
questionnaire.
(paper version)
18-19/03/03 To pilot test draft IV 9 in T/Nchu clinic B.Majara (Supervisor)
(final) of the first post- 6 in GAO clinic C.Seegreht (PDA
intervention and the supervisor)
screening I.Duma
questionnaires. V.Rammile
(paper &PDA version)
03/07/03 To pilot test draft III of 2 in T/Nchu clinic B.Majara (Supervisor)
the follow-up 1 in GAO clinic I.Duma
questionnaire. V.Rammile
(paper &PDA version)
53
Because of the role that the three clinics played in serving as pilot, they were
excluded from participating in the trial even though they were large enough to
have been included.
2.10 INTERVIEWERS
2.10.1 Recruitment of interviewers for the first post-intervention survey and
follow-up interviews.
A total of 23 field workers were recruited to collect data. They were recruited by
the Centre for Health Systems Research and Development at the University of the
Free State from 6 strategic areas within the province. The aim was to assign each
team enough clinics to conduct interviews without incurring unnecessary
expenditure, given the limited budget for the project. The teams were recruited
from Parys, Bothaville, Welkom, Bloemfontein, Bethlehem and QwaQwa. The
candidates were mainly matriculants, some with tertiary education in nursing and
social sciences. Ages ranged from 24 to 45 years. Each team comprised 3 to 4
field workers depending on the locality and number of clinics assigned for
conducting interviews. The teams comprised a team leader and 2 to 3
interviewers. Three supervisors were recruited to monitor and oversee 2 of the 6
regional teams each, these being allocated by region and proximity. A list of
responsibilities of the field workers is attached as Annex 14.
2.10.2 Training of interviewers
The training of the field workers for the first post-intervention survey interviews
was conducted during April 28 to May 2, 2003 in Bloemfontein. The training was
conducted at the Centre for Health Systems Research and Development,
University of the Free State. Facilitators were PALSA researchers who were
involved in the development of the first post-intervention survey questionnaire as
we" as staff of the CHSR&D with experience on the data collection process. The
54
training focused mainly on the first post-intervention survey questionnaire itself,
interviewing techniques, clinical respiratory signs and symptoms as well as
appropriate data collection techniques using paper questionnaires and PDA,
thermometers and stop watches. Participants were then exposed to practical
experience by conducting interviews at three of the pilot clinics in Thaba Nchu
area.
At the end of the three day training, all 40 clinics of the trial were listed
alphabetically and each assigned a two digit code. Field workers were also
grouped by teams, listed alphabetically within each team and each was assigned a
two digit code as well. At the beginning of an interview, whether using the paper or
PDA version of the questionnaire, the interviewer was required to fill in the clinic
and interviewer codes on the questionnaire before proceeding with the contents of
the questionnaire. This was meant to facilitate tracing a questionnaire if further
clarification was required during the editing process.
Training of field workers for follow-up interviews was conducted during July 19-20,
2003, also in Bloemfontein. Only 18 field workers were trained this time because
three had resigned from the project while two were unable to come for training due
to ill health. Field workers were given a summary of how the first phase of the first
post-intervention survey data collection had gone, that is, what had gone well or
not well. They were then taken through the follow-up questionnaire.
Because follow-up interviews were going to be conducted either at the clinic or the
patient's home, logistical implications of such trips were discussed with CHSR&D.
Logistical and administrative issues relating to food parcels that were to be given
to patients during follow-up interviews were also discussed with teams. New
responsibilities of team leaders were discussed. The training took one and half
days.
55
Training of fieldworkers on first post-intervention survey and follow-up interviews
was conducted using the questionnaires' fieldwork manuals compiled by Dr. Lara
Fairall from the UCT Lung Institute, and Mr. Bosielo Majara from the University of
the Free State. The manuals are attached as Annexes 15-1, 15-11 & 16
respectively. The manuals included the respective questionnaires, as attached in
Annexes 7 and 8.
2.10.3 Blinding of interviewers
To avoid contamination of data to be collected, both the patient and the interviewer
were blinded as to the intervention or control status of each clinic.
A "Blinding Circular" was drafted by the PALSA researchers and circulated among
themselves and the PALSA trainers (TB coordinators). This stated that in order to
ensure blinding in the trial, the two activities, the PALSA training and recruitment
of the cohort, should be separated from each other. Anything to do with training of
clinic staff in the 20 intervention clinics was referred to as "PALSA" while anything
to do with interviews of patients with respiratory problems in the 40 trial clinics was
referred to as the "Lung Health Survey (lHS)". The circular requested PAlSA
trainers to refrain from assisting PALSA researchers with anything to do with the
LHS interviews. Responsibility for administrative and logistics support of the LHS
was left in the hands of LHS supervisors and the PAlSA researchers themselves.
Schedules for both the training and field work were compiled so that both activities
did not take place in the same week in one clinic. Field work at a given intervention
clinic was conducted exactly four weeks after that clinic had received at least two
sessions training. Control clinics, on the other hand. had interviews conducted
without any particular order as blinding was unnecessary.
During training of the field workers no mention was made about the survey being
part of a trial that involved intervention and control arms.
56
2.11 DATA COLLECTION PROCESS
For the first post-intervention survey interviews, the 6 teams were each assigned 7
to 8 clinics, belonging to both intervention and control arms, according to their
location in the province. Data collection commenced on the week beginning May
5th 2003 for the first post-intervention survey and the week beginning July 28th
2003 for follow-up interviews. The entire data collection process started on May 5th
and went up to November 28th 2003.
The teams spent three to five days at a clinic, recruiting a target of about 50
patients per clinic during the first post-intervention survey interviews. Patients were
then requested to return for follow-up interviews three months after the initial visit
at a place of their choice, this being either at the clinic or their homes. All recruited
patients were issued with consent and reminder forms that served as proof that
they were seen and interviewed at the first post-intervention survey.
Follow-up interviews were conducted three months after the first post-intervention
survey using a follow-up questionnaire that differed slightly from the first post-
intervention survey questionnaire. Lists of the 50 patients recruited at each clinic
during the first post-intervention survey interviews were consolidated by the MRC,
Cape Town, and the research team's data management centre. The lists had
patients' name, folder number, age and/or date of birth, contact address and
telephone numbers where applicable. The lists were sent to the supervisors and
team leaders a week before follow-up interviews to facilitate contacting and
reminding of patients about the follow up interview. The interviews were conducted
at either the clinic or at patients' homes, based on their preference.
If patients failed to come for a follow-up interview at the clinic on agreed upon
dates, the interviewers waited until 1200H, after which they went to look for the
patients at their homes using residential addresses provided during the first post-
intervention survey interviews. In the case of patients who died during the 3
57
months period, relatives were requested to provide interviewers with certified
copies of death certificates or to complete a notification of deceased patients form
(See 2.7.3). Relatives were given the food parcel that was due to the deceased.
For hospitalised or too ill to be interviewed as well as untraceable patients,
interviewers confirmed reasons why such patients could not be interviewed during
the follow-up period and conveyed a written confirmation to that effect to PALSA
data management centre in Cape Town.
2.12 QUALITY CONTROL
Quality control of implementation of the project was done in three separate ways.
2.12.1 Quality control of the data collection process
During the first post-intervention survey and follow-up interviews, team leaders of
the six teams conducted quality control of patient interviews by re-interviewing
20% of the patients using five key questions extracted from both the first post-
intervention survey and follow-up questionnaires. The five re-interview questions
were chosen from the questionnaire by PALSA researchers on a monthly basis.
The team leader compared the answers he/she obtained with those of the
interviewer. In the case of a difference they verified the results with the patient
while still at the clinic and infonned the interviewer about the difference. If the
same interviewer continued to make the same mistake over a certain period
he/she was warned that disciplinary measures could be taken. This did not
happen, however.
On the last Friday of every month, the PALSA data management centre in Cape
Town compiled a full report of all re-interviews conducted by team leaders,
highlighting important omissions and common mistakes during that month. These
reports were e-mailed to all the supervisors for onward transmission to the team
leaders for action. This had to be done before starting field work at the next clinic.
58
The May 2003 re-interview questionnaire is attached as Annex 17.
2.12.2 Periodic supervisory visits by the PALSA researchers
Even though the project had recruited a team of 3 supervisors whose main
responsibilities were to monitor and ensure smooth data collection, PALSA
researchers also conducted periodic visits to the project sites, providing technical
and back-up support to both the PALSA trainers and field workers though
separately. The main task was checking of completed paper questionnaires,
especially during the start of cohort recruitment when the PDA was not yet in use.
The researchers also supported the supervisors in ensuring that PDAs were
uploaded on a daily basis, and providing feedback to the supervisors on specific
data collection errors that required certain interviewers' attention.
2.12.3 Single database
To ensure a standard channel of transmitting collected data, researchers agreed
on MRC, Cape Town to be the PALSA data management centre. All paper
versions of the questionnaire were collected by team leaders after proof-reading,
sealed and couriered to Centre for Health Systems Research & Development for
onward transmission to MRC, Cape Town. Information collected by PDA was
uploaded on a daily basis and transmitted to MRC, Cape Town using two toll-free
numbers by team leaders. The uploading process either took place at the clinic
where interviews were conducted or at the team leader's home.
2.13 ETHICS AND CONSENT
The intervention posed minimal risk of causing harm, since it was mainly a training
strategy that was meant to build on existing methods. The main ethical issues
were therefore confidentiality and consent. Upon completion of the follow-up
interviews, patients were thanked and given a food parcel worth R60 that they had
59
been informed about by interviewers during the first post-intervention survey
interviews. The food parcel was meant to motivate patients to return for follow-up
interviews as well as to serve as a token of thanks by PALSA researchers.
2.13.1 Provincial Health Department
PALSA researchers were granted permission to conduct the randomised
controlled trial using the government's health facilities, that is, primary care clinics,
clinic staff and patients by the Free State Provincial Health Department through
the office of the Director General (DG), Department of Health.
2.13.2 University of the Free State Ethics Committee
Prior to field work, that is, collection of data for the trial, the research team
submitted a protocol of the study for approval to the Ethics Committee of the
Faculty of Health Sciences, University of the Free State. Permission was granted
by the Ethics Committee for the researchers to conduct the study (ETOVS NR
42/03).
2.13.3 Patient consent forms
Upon meeting the criteria for eligibility to participate in the study, each patient was
given a thorough explanation of what the study was about, what it entailed and
requested verbal and written consent (See 2.6.2).
2.13.4 Confidentiality
Patient identities and questionnaire responses were treated as confidential and
were known only to the researchers. Paper and electronic records were stored
securely and were only known to researchers. Clinic identities were treated as
confidential. Staff identities were not recorded.
60
2.14 DATA CHECKING
2.14.1 Data uploaded by PDA on daily basis
The interviewers were advised during training, particularly during the first post-
intervention survey questionnaire training, to upload data on a daily basis to the
toll free numbers in Cape Town to avoid loss of data. The uploaded data were
immediately entered into the database upon receipt. Data that were not entered
correctly and/or had queries were compiled into a weekly list that was sent back to
supervisors and team leaders for follow up and rectification. This was routinely
done by researchers based in Cape Town from the beginning up to the end of the
data collection process.
2.14.2 Data collected by paper questionnaires
Data that were collected using paper questionnaires were first checked by
supervisors before being sent to the Centre for Health Systems Research and
Development, University of the Free State for forwarding to the data management
centre in Cape Town. Questionnaires that were not complete or had queries were
sent back to team leaders for tracing and following up with patients in question.
Upon correction and/or rectification by team leaders who also signed for the
corrections on the questionnaire, the paper versions were then couriered to the
PALSA data management centre at MRC, Cape Town for entry into the research
database.
Prior to final entry of all paper questionnaires onto the research database, all
paper questionnaires were checked for completeness of the questionnaires,
correct skipping of questions and making sure that incorrectly spelt names were
corrected by the Sotho speaking PALSA researcher based at the Community
Health Department of the University of the Free State (B. Majara). This was
because about 90% of the participants were Sotho speaking and were therefore
61
interviewed in Sotho. The edited paper questionnaires were then entered, using
the double entry process by data capturers at MRC, Cape Town.
2.15 DATA ANALYSIS
Statistical analysis aimed to estimate the precision (95% confidence interval) of
each measure of effect, and to estimate the probability (P value) of obtaining at
least as large an effect if the respective null hypothesis was true (Altman 1991).
Five primary outcomes were specified in advance (see section 1.10.1), to reduce
the probability of finding a significant effect by chance as a result of multiple
hypothesis testing. However we also examined a larger number of predefined
secondary outcomes of interest (see section1.10.2), bearing in mind the chance of
finding significant effects due to multiple comparisons. Table 2.2 below
summarises the numerators and denominators used for each outcome.
Outcome variables were compared between patients in intervention and control
arms. For binary and ordered categorical outcome measures we compared
proportions, and calculated odds ratios (that is, the odds of each outcome in the
intervention arm divided by the odds in the control arm). For normally distributed
continuous outcome measures we compared means (and standard deviations),
and estimated differences between means. For continuous outcome measures
with distributions that were not normal we compared medians, and estimated the
odds ratio of having a higher value in the intervention arm compared to the control
arm.
62
Table 2.2: Numerators and denominators for outcomes
Outcome Numerator Denominator
Primary outcomes
1. Antibiotic prescription Number with antibiotic All patients recruited at the first-
prescription at the first-post post intervention survey
intervention survey
2. Inhaled steroids Number with inhaled steroids at All followed up patients
prescription the first-post intervention survey
or follow-up
3. Sputa for TB testing Number with TB sputa sent All at the first-post intervention
survey with cough> 2 weeks,
excluding known TB cases
4. Cotrimoxazole prophylaxis Number with prescribed Known TB cases at the first-post
cotrimoxazole intervention survey
5. Improvement in Number with improvement in All followed up patients
interference with usual EO-5D interference with usual
activities (EO-5D) activities from the first-post
intervention survey to follow-up
among all followed up
Secondary outcomes
1. Appropriate referrals Number with referral to any All patients with any of the 4
health service provider severity markers at first post-
intervention survey (respiratory
rate ~ 30. breathless on talking or
at rest, use of accessory muscles,
temperature ~ 38°C)
2. VCCT/HIV counselling Number who received All followed up patients
VCCT/HIV counselling at the
first-post intervention survey or
follow-up
3. Counselling for smoking (a) Number who received Current smokers at the first-post
cessation smoking counselling at the first- intervention survey
post intervention survey
(b) Number who received The first-post intervention survey
smoking counselling at the first- smokers followed up
post intervention surveyor
follow-up
4. Increased readiness to quit Number with increased The first-post intervention survey
smoking readiness to quit between the smokers followed up
first-post intervention survey
and follow-up
5. Smoking cessation Number of smokers who have All the first-post intervention
quit smoking at follow up survey smokers
6. TB case detection rate New TB cases All followed up patients excluding
63
TB cases at the first-post
intervention survey
7. Mortality rate (a) Patients deceased at follow All followed up patients including
up
(b) All known TB cases found All followed up TB cases
deceased at follow-up
8. Difficulty sleeping due to Patients presenting with All followed up patients
chest symptoms difficulty sleeping at follow-up
9. Chest symptoms during Patients presenting with chest All followed up patients
daytime symptoms at follow-up
10. Interference with usual Patients presenting with All followed up patients
activities due to chest interference with usual activities
symptoms at follow-up
11. Domain of EQ-5D and
combined score
(a) Mobility Patients responding to EuroQo~ All followed up patients
5D mobility question
(b) Self-care Patients responding to EuroQo~ All followed up patients
5D self-care question
(c) Usual activity Patients responding to EuroQo~ All followed up patients
5D usual activity question
(d) Pain/discomfort Patients responding to EuroQ~ All followed up patients
5D pain/discomfort question
(e) Anxiety/depression Patients responding to EuroQo~ All followed up patients
5D anxiety/depression question
12. Number of visits to other Number of patients who All followed up patients
health care providers reported visiting other health
care providers between the first-
post intervention survey and
follow-up
13. Admissions to hospitals Number of patients who All followed up patients
reported admissions to hospitals
at follow up
The cluster randomised study design necessitated adjustment of confidence
intervals and P values to take account of cluster sampling design effects, which
are determined by intra-cluster correlation coefficients (ICCs) (Donner and Klar
2001). ICCs in this study were the proportions of the total outcome variances that
were accounted for by variances between patients within each clinic, as opposed
to variances between clinics (Donner and Klar 2001). ICCs were estimated with
64
Stata statistical software, using the "large analysis of variance" ("Ioneway")
command (StataCorp 2003). Confidence intervals and P values for comparisons
between intervention and control arms were adjusted with the following regression
methods in Stata, using Stata's "cluster" option for each model (StataCorp 2003).
For binary outcome variables we used multiple logistic regression. For normally
distributed continuous outcome variables we used multiple linear regression. For
ordered categorical and count variables we used ordinal logistic regression. For
count variables that appeared to be normally distributed on histograms (e.g.
numbers of visits to other health care providers) we also used multiple linear
regression as secondary analyses, to assess the robustness of the primary
analyses. In each multiple regression model, intervention versus control arm was
the main explanatory variable of interest. Because the randomisation of clinics was
stratified by (five) districts, we also included dummy variables for district as
explanatory variables in each model.
In primary analyses involving all subjects recruited, or all subjects who were
followed up, we did not adjust for any potential confounding between intervention
and control arms. This was supported by the finding (see section 3.2.2) that
patients in each arm at first post-intervention survey were comparable with regard
to potential confounding variables, as a result of randomisation. However some
outcomes were compared only among four subgroups of the study population,
these being patients with cough for more than 2 weeks, not known TB cases,
patients who are known TB cases, patients with one of the four severity markers,
and current smokers at first post-intervention survey. For these subgroups too we
compared patients' characteristics, symptoms and signs at the first pot-
intervention survey. These comparisons generally provided reassurance that
characteristics of intervention and control patients within each subgroup were
balanced. For one subgroup namely patients with indicators of severe illness
requiring referral, first post-intervention survey prevalence of certain prognostic
symptoms differed between intervention and control groups. Therefore, as a
65
secondary analysis, we added these prognostic symptoms as explanatory
variables in the regression model.
For outcomes differing significantly between the intervention and control arms,
numbers needed to treat were calculated.
2.16 RESPONSIBILITIES OF THE CANDIDATE
The PALSA project evaluation was a complex activity that involved a number of
institutions and individuals each tasked with specific responsibilities (See Annex
18). The candidate undertook the following specific responsibilities:
a) Participated in the designing and eventual write up of the randomised
controlled trial's protocol that was submitted to the Ethics Committee of the
Faculty of Health Sciences University of the Free State.
b) Conducted focus group discussions and attended meetings during
development of the guideline.
c) Participated in the training of district TB coordinators who served as PALSA
trainers.
d) Participated in the drafting and refining of both the first post-intervention
survey and follow-up questionnaires.
e) Led the process of piloting of data collection tools i.e. the screening
questionnaire, first post-intervention survey and follow-up questionnaire
(paper and PDA versions) for further refinement of the tools.
f) Participated in the translation process of the data collection tools to the five
local languages especially the Sesotho version, because Sesotho is the
most commonly used local language in the Free State. This included
translation of the English version of the Euroqol-5 questionnaire and
instructions.
g) Was responsible for communicating in writing with district health
department authorities i.e. district mangers, hospital and clinic managers
66
about the trial's requirements, implementation dates and responses to any
queries or clarification sought by the authorities on the project.
h) Compiled the 40 trial clinics' profiles i.e. number of clinic nurses by staff
category (e.g. Chief Professional Nurse, Principal Professional Nurse and
Professional Nurse), daily patient load, and number of fast lanes by type of
disease and operating hours. Such information was sought from and
provided by the district and clinic authorities, namely district and clinic
managers.
i) Participated in the distribution of intervention materials to the PALSA
trainers for distribution to clinic nurses during PALSA training sessions.
j) Participated in the drafting of the first post-intervention survey and follow-up
training manuals.
k) Participated in the training of interviewers on both first post-intervention
survey and follow-up questionnaires.
I) Conducted supervisory and support visits of field work teams during the
data collection process.
m) Checked for completeness, spelling mistakes and proper filling of answers
on all paper questionnaires prior to entry of collected data to the entire
database.
n) Archived consent forms of all participants by clinic.
0) During the data cleaning process, checked discrepancies between the first
post-intervention survey and follow-up demographics of patients, and
checked that patients met inclusion criteria.
p) Assisted and discussed statistical analysis of data, which was led by the
candidate's supervisors. The candidate was present during almost all
analyses. He clarified the interpretation of relevant variables, and which
patients comprised the respective numerator and denominator population
for each outcome. During this process, the purpose and interpretation of
each statistical test was discussed with him.
q) Wrote the doctoral thesis.
67
CHAPTER 3- RESULTS
3.1 INTRODUCTION
This chapter will give an overview of results obtained from the trial. First, to assess
the effectiveness of randomization and the comparability of the trial arms, the
characteristics of clinics and patients in intervention and control arms at the first
post-intervention survey will be compared. Second, to assess the effectiveness of
the intervention, patient outcomes will be compared between intervention and
control groups.
3.2 RESULTS OF THE STUDY
3.2.1 Characteristics of clinics
Table 3.1: Characteristics of clinics
Characteristics Intervention clinics Control clinics
Number of CPN (Median, 1 (0; 3.50) 1 (0; 2)
laR)
Number of SPN (Median, 1 ( 1; 2.25) 1.5(1;2.25)
laR)
Number of PN (Median, 3.5 ( 1.75; 6) 3 (2; 4)
laR)
All levels of PN (Median, 6.5 (5; 9.50) 6 (5; 7.25)
laR)
Weekly patient load 530 (428; 732) 485.5 (393; 637)
(Median, laR)
Number of fast lanes 4 (3;4) 3 (3;4)
(Median, laR)
Number with separate TB 19 (95%) 20 (100%)
queue (Number, %)
Number providing 24/7 4 (20%) 2 (10%)
services (Number, %)
IQR- Interquartile range
24fT= Operating 24 hours, 7 days a week
CPN= Chief professional nurse, SPN= Senior professional nurse, PN= Professional nurse
68
Table 3.1 indicates that the staffing patterns of all levels of professional nurses for
intervention and control clinics were similar at the beginning of the trial. The clinics
each had median values of 6.5 and 6.0 professional nurses for intervention and
control arms respectively. The intervention arm had a median of 529.5 patients
weekly versus 485.5 for control, with the number of fast lanes, and number of
separate tuberculosis queues all similar.
3.2.2 PALSA training sessions at intervention clinics
Table 3.2 below is a summary of the number of training sessions that nurses in
each intervention clinic received from PALSA trainers. Even though the intention
was to conduct a minimum of 4 sessions at each clinic, nurses only received a
median of 2 sessions. Some missed contact sessions due to various reasons such
as being on leave, and/or attending other meetings on behalf of the clinic.
Table 3.2: PALSAtraining sessions at intervention clinics
Clinic Training sessions per nurse (median)
Albert Luthuli 3
Bethlehem 3
Botthusong 3
BotshabeloB 1
BotshabeloU&S 1
K-Maile 2
Mphohadi 3
Namahali 2
Petrusburg 2
Phahameng 3
Phomolong 2
PAJ< 0
Riverside 2.5
Seeisoville 1
Tebang 1
Thusanong 4
Tseki 2
Tshepong 2
Tumahole 2
Welkom 3
Median number of training sessions 2
69
3.2.3 Characteristics of patients- general
Table 3.3 below is a summary of numbers of patients included in the study, from
the time of recruitment up to follow-up. At the end of the recruitment period, we
had recruited 1000 and 999 patients for intervention and control arms, with
between 47 and 52 patients per clinic. During data analysis, four more patients in
each arm were deleted due to unavailability of the first post-intervention survey
data and/or because they did not meet the inclusion criteria. During follow-up, both
arms had an almost equal number of patients who were not followed up due to
hospitalisation, being too ill to be interviewed, relocated and/or dead. Follow-up
rates were 92.9% and 92.7% for intervention and control arms.
Table 3.3: Number of patients included in the study
Intervention Control
Number of patients interviewed 1000 999
during the first post-intervention
survey
Analysed at first post- 996* 995*
intervention
Hospitalised/ilUrelocated 2 3
Lost to follow-up (no reason 47 44
provided)
Deceased 22 26
Followed up 925 (92.9%) 922 (92.7%)
• 4 patients in each group were excluded from analysis because they were without the first post-intervention survey data
and/or did not meet inclusion criteria
Table 3.4 is an illustration of the patient characteristics at the first post-intervention
survey. This shows that patients in the two arms were balanced as a result of
randomisation. In both arms almost two thirds were females and the most frequent
age group was 25-54 years. Where discrepancies between date of births recorded
at the first post-intervention survey and follow-up occurred, that is, date of birth as
reflected in the patient's clinic folder number, ages were defined as missing. About
50% of patients had a smoking history, about 50% had primary education, close to
70
50% were unemployed, above 80% walked to get to the nearest clinic and 70%
spent between 2 and 12 hours to travel to and from the clinic.
Table 3.4: Patients' characteristics at first post-intervention survey
Intervention Control
Demography
Gender N=996 N=995
Male 35.8% 34.1%
Female 64.2% 65.9%
Age N=981 N=985
15-24 8.0% 8.6%
25-54 66.2% 68.8%
~55 25.9% 22.5%
Smoking history N=996 N=995
Current 16.5% 19.4%
Ex-smoker 31.4% 30.2%
Never smoked 52.1% 50.5%
Educational background N=996 N=995
Never attended school 16.8% 15.5%
Attended primary school only 46.6% 43.5%
Attended secondary school 36.5% 41.0%
Employment Status N=996 N=995
Employed 13.7% 18.5%
Self-employed 1.9% 2.3%
Unemployed 49.4% 45.3%
Student/learner 2.5% 3.1%
Looking for work 5.1% 6.8%
Receiving Grant/pension 27.2% 23.1%
Other 0.2% 0.8%
Mode of transport to health facility N=996 N=995
Walk 83.4% 83.1%
Bicycle 0.5% 0.9%
Taxi 12.6% 10.5%
Bus 0.4% 0.3%
Private motor vehicle 2.9% 5.1%
Other 0.2% 0.1%
Time taken to travel to clinic and back N=977 N=993
Overnight 0.3% 0.0%
Between 2- 12 hrs 66.5% 67.4%
Less than 2 hrs 33.2% 32.6%
Table 3.5 compares the patients' clinical symptoms at the first post-intervention
survey. The table shows a balance between the two arms. Rates of cough and
71
difficulty breathing ranged between 70% and 90%. About 70% of the patients
complained about chest symptoms interfering with their usual activities while
around 36% had gone to the clinic for a check-up on recurrent respiratory problem.
"Check-up" meant planned visits to the clinic, while "first visit" meant unplanned
visit. The distinction between these two meanings were poorly understood by the
fieldworkers during training and also by patients during interviews, hence the
surprisingly high number of patients who said they had come to the clinic for a
check-up for a respiratory problem and a low number of patients who had come for
first visit for a respiratory problem.
Table 3.5: Patients' symptoms at first post-intervention survey
Intervention Control
Symptoms
Cough >2 weeks 78.4% (N=995) 76.5% (N=992)
Cough<2weeks with respiratory rate ~ 30 2.7% (N=993) 0.6% (N=991)
Cough<2 weeks with temperature ~ 38°C 0.8% (N=992) 0.7% (N=991)
Phlegm/Slime 49.7% (N=881) 50.3% (N=887)
Yellow/green phlegm/slime 48.1% (N=696) 52.0% (N=703)
Haemoptysis 51.2% (N=881) 48.8% (N=887)
Difficulty breathing today or in last 6 months 89.4% (N=995) 87.1% (N=995)
Chest problems interfering with usual activities 76.5% (N=995) 70.6% (N=995)
Frequency of chest problems on patient's N=760 N=702
usual activities
1- 2 times per month 3.3% 4.7%
1- 2 times per week 20.9% 25.4%
Most days 75.8% 69.9%
Reasons for presentation to clinic today N=995 N=989
Check-up high blood pressure 27.0% 22.7%
Check-up diabetes 1.7% 2.5%
Check-up respiratory problem 36.6% 36.2%
Check-up other problem 9.5% 17.1%
1si visit respiratory problem 3.0% 7.1%
1si visit other problem 23.6% 23.1%
3.2.4 Characteristics of patients by sub-groups
As some trial outcomes were only relevant to subgroups of patients, the first post-
intervention survey characteristics of these subgroups were compared between
72
intervention and control arms. These subgroups were 1) patients with cough for
more than 2 weeks and not known to have tuberculosis, 2) known tuberculosis
cases,3) patients with at least one of the severity markers indicating need for
referral and 4) current smokers at first post-intervention survey. Table 3.6 shows
characteristics at first post-intervention survey of the subgroup of patients with
cough more than 2 weeks excluding known tuberculosis cases.
Table 3.6: Characteristics at first post-intervention survey of patients with cough >2 weeks
and not known to have tuberculosis
Intervention Control
Demography
Gender N=643 N=667
Male 35.2% 33.0%
Female 64.9% 67.0%
Age N=632 N=662
15-24 6.5% 6.5%
25-54 64.9% 67.8%
~55 28.6% 25.7%
Smoking history N=643 N=667
Current 18.7% 22.6%
Ex-smoker 30.8% 28.8%
Never smoked 50.5% 48.6%
Educational background N=643 N=667
Never attended school 18.7% 17.5%
Attended primary school only 47.1% 44.7%
Attended secondary school 34.2% 37.8%
Employment Status N=642 N=667
Employed 13.9% 19.5%
Self-employed 1.7% 2.6%
Unemployed 47.4% 42.7%
Studentllearner 2.3% 2.7%
Looking for work 5.3% 6.6%
Receiving Grant/pension 29.3% 24.9%
Other 0.2% 1.1%
Transport mode N=628 N=665
Walk 83.3% 81.4%
Bicycle 0.6% 0.8%
Taxi 11.8% 12.8%
Private vehicle 3.7% 4.8%
Other 0.3% 0.2%
Time taken to travel to clinic and back N=626 N=665
Overnight 0.35% 0.0%
Between 2-12 hrs 69.3% 68.9%
Less than 2 hrs 30.4% 31.1%
73
Table 3.7 compares clinical symptoms of patients in the subgroup of patients with
cough for more than 2 weeks and excluding known tuberculosis cases at first post-
intervention survey. The arms were balanced.
Table 3.7 Symptoms at first post-intervention survey of patients with cough >2 weeks and
not known to have tuberculosis
Intervention Control
Symptoms
Cough> 2 weeks 100% (N=643) 100% (N=667)
Cough <2 weeks with respiratory rate ~ 30 0.0% (N=643) 0.0% (N=667)
Cough <2 weeks with temperature ~ 38°C 0.0% (N=643) 0.0% (N=667)
Phlegm/slime 48.3% (N=630) 51.7% (N=662)
Yellow/green phlegm/slime 47.1% (N=496) 53.0% (530)
Haemoptysis 49.7% (N=630) 50.3% (N=662)
Continuous difficulty breathing problem 87.4% (N=643) 85.5% (N=667)
Chest symptoms interfering with usual activities 75.1 % (N=643) 71.4% (N=667)
Frequency of chest symptoms interfering with N=482 N=476
usual activities
1-2 times per month 3.1% 5.3%
1-2 times per week 22.0% 23.3%
Most days 74.9% 71.4%
Reasons for coming to clinic today N=642 N=665
Check-up high blood pressure 29.6% 27.1%
Check-up diabetes 2.3% 3.0%
Check-up respiratory problem 36.1% 35.0%
Check-up other problem 9.4% 20.5%
1st visit respiratory problem 3.0% 7.2%
1st visit other problem 24.8% 22.9%
Attendance to the clinic in last 3months 77.5% (N=643) 74.1% (N=667)
Table 3.8 shows patient characteristics for the known tuberculosis cases subgroup
at first post-intervention survey. This table also indicates similarity between the two
arms at the first post-intervention survey, in terms of demography, gender,
smoking history, educational background, employment status, transport mode and
time taken to travel to clinic and back. What is interesting about the subgroup is
that almost 60% of the patients in the sub-group have a smoking history compared
74
to 50% of all enrolled patients. There is also a balance of 50% male and female in
both arms and a slight increase from 8 to 12% of the 15- 24 age group.
Table 3.8: Characteristics at first post-intervention survey of patients known to have
tuberculosis
Intervention Control
Demography
Gender N=143 N=132
Male 49.7% 55.3%
Female 50.6% 44.7%
Age N=141 N=130
15-24 12.1% 10.0%
25-54 76.6% 81.5%
2:55 11.4% 8.5%
Smoking history N=143 N=132
Current 11.2% 15.9%
Ex-smoker 44.1% 43.9%
Never smoked 44.8% 40.2%
Educational background N=143 N=132
Never attended school 9.1% 8.3%
Attended primary school only 46.2% 43.9%
Attended secondary school 44.8% 47.7%
Employment Status N=143 N=131
Employed 7.0% 12.2%
Self-employed 2.8% 2.3%
Unemployed 71.3% 64.1%
Studentllearner 1.4% 3.1%
Looking for work 5.6% 3.8%
Receiving Grant/pension 11.9% 13.7%
Other 0.0% 0.8%
Transport mode N=142 N=132
Walk 83.8% 88.6%
Bicycle 0.0% 3.0%
Taxi 14.1% 4.6%
Bus 0.0% 0.8%
Private vehicle 2.1% 3.0%
Time taken to travel to clinic and back N=142 N=132
Between 2- 12 hrs 46.5% 48.5%
Less than 2 hrs 53.5% 51.5%
Table 3.9 shows clinical symptoms for patients within the known tuberculosis
cases subgroup at first post-intervention survey. The subgroup indicates a sharp
increase in cough for more than 2 weeks as well as continuous difficulty breathing
75
as compared to all enrolled patients. There is also an increase in the number of
patients who visit the clinic for check-up of respiratory problems in this sub-group.
Table 3.9: Symptoms at first post-intervention survey of patients known to have
tuberculosis
Intervention Control
Symptoms
Cough> 2 weeks 83.2% (N=143) 84.1% (N=132)
Cough <2 weeks with respiratory rate ~ .30 2.1% (N=143) 0.0% (N=132)
Cough <2 weeks with temperature ~ 38°C 0.0% (N=143) 0.0% (N=131)
Phlegm/slime 50.7% (N=126) 49.3% (N=116)
Yellow/green phlegm/slime 46.2% (N=104 53.9% (N=101)
Haemoptysis 51.9% (N=126) 48.2% (N=116)
Continuous difficulty breathing problem 93.7% (N=143) 93.1% (N=132)
Chest symptoms interfering with usual activities 88.8% (N=143) 80.3% (N=132)
Frequency of chest symptoms interfering with N=126 N=106
usual activities
1-2 times per month 3.2% 3.8%
1-2 times per week 11.9% 31.1%
Most days 84.9% 65.1%
Reasons for coming to clinic today N=143 N=131
Check-up high blood pressure 8.4% 6.3%
Check-up diabetes 0.0% 0.0%
Check-up respiratory problem 39.9% 43.8%
Check-up other problem 9.1% 7.0%
1st visit respiratory problem 0.7% 1.6%
1st visit other problem 19.6% 25.8%
Attendance to the clinic in last 3 months 80.9% (N=256) 76.4% (N=165)
Table 3.10 shows characteristics of the subgroup of patients with the one or more
of the severity markers indicating need for urgent referral at first post-intervention
survey. Even though the total number of patients whose data was analysed was
. more by a 100 in the intervention arm, the percentages was the same in both arms
as far as distribution of gender, age, smoking habits and other characteristics were
concerned. Compared to Table 3.4, this table shows a slightly lower percentage of
patients falling within the 15- 24 age group in this subgroup and a higher
percentage of patients who never attended school.
76
Table 3.10: Characteristics at first post-intervention survey of patients with at least one of
the 4 severity markers
Intervention Control
Demography
Gender N=256 N=165
Male 31.3% 29.1%
Female 68.8% 71.0%
Age N=252 N=161
15-24 5.6% 5.6%
25-54 67.9% 67.1%
~55 26.6% 27.3%
Smoking history N=256 N=165
Current 16.0% 15.2%
Ex-smoker 30.9% 29.1%
Never smoked 53.1% 55.8%
Educational background N=256 N=165
Never attended school 23.1% 16.4%
Attended primary school only 49.2% 54.6%
Attended secondary school 27.7% 29.1%
Employment Status N=256 N=165
Employed 11.0% 17.6%
Self-employed 1.6% 1.2%
Unemployed 47.3% 41.8%
Student/learner 1.6% 3.0%
Looking for work 3.9% 6.7%
Receiving Grant/pension 34.4% 27.9%
Other 0.4% 1.8%
Transport mode N=251 N=165
Walk 82.9% 77.6%
Bicycle 1.2% 0.0%
Taxi 11.6% 13.9%
Private vehicle 0.0% 0.6%
Other 4.0% 7.9%
Time taken to travel to clinic and back N=250 N=165
Overnight 0.8% 0.0%
Between 2-12 hrs 73.2% 71.5%
Less than 2 hrs 26.0% 28.5%
Table 3.11 shows clinical symptoms at first post-intervention survey of patients
with one or more of the severity markers. The table shows the following
differences between arms in terms of symptoms. Intervention patients were more
likely to report phlegm production, haemoptysis and yellow/green coloured
77
Table 3.13: Symptoms at the first post-intervention survey of current smokers
Intervention Control
Symptoms
Cough >2 weeks 81.7% (N=164) 87.6% (N=193)
Cough <2 weeks with respiratory rate ~ 30 1.8% (N=164) 0.0% (N=193)
Cough <2 weeks with temperature ~ 38°C 1.2% (N=163) 0.5% (N=193)
Phlegm/slime 46.5% (N=152) 53.5% (N=183)
Yellow/green phlegm/slime 47.1% (N=126) 52.9% (N=146)
Haemoptysis 39.6% (N=152) 60.4% (N=183)
Continuous difficulty breathing problem 89.0% (N=164) 85.5% (N=193)
Chest problems interfering with usual activities 78.1% (N=164) 61.7% (N=193)
Frequency of chest symptoms interfering with N=127 N=119
usual activities
1-2 times per month 3.9% 5.9%
1-2 times per week 22.1% 26.1%
Most days 74.1% 68.1%
Reasons for coming to clinic today N=164 N=191
Check-up high blood pressure 23.2% 17.8%
Check-up diabetes 0.6% 0.0%
Check-up respiratory problem 26.2% 33.0%
Check-up other problem 11.6% 22.0%
1si visit respiratory problem 4.3% 7.9%
1st visit other problem 22.6% 21.5%
Attendance to the clinic in last 3 months 68.9% (N=164) 68.4% (N=193)
3.2.5 Reliability of tracer questions
At the first post-intervention survey there were questions on difficulty breathing
and cough on the day of the interview that eligible patients had to answer twice to
assess test-retest reliability. Table 3.14 indicates good agreement between the
repeated questions using the Kappa statistic.
80
Table 3.14: Agreement between repeated questions at first post-intervention survey
Questions asked Intervention arm Control arm
Kappa 95%CI Kappa 95%CI
Do you have difficulty breathing 0.80 (0.75-0.84) 0.84 (0.81-0.88)
(tight chest, shortness of breath,
wheeze) today?
Do you have a cough today? 0.87 (0.82-0.92) 0.92 (0.88-0.96)
3.2.6 Primary and secondary outcomes
Table 3.15 shows the comparison of primary outcome variables between the
intervention and control arms of the trial. The results are given as percentages,
odds ratios, 95% confidence intervals, p values and inter-cluster correlation
coefficients (ICC). The five primary outcomes that were measured were antibiotic
prescription, inhaled steroid prescription, sending of sputa for tuberculosis testing,
cotrimoxazole prophylaxis among patients with tuberculosis and interference with
usual activities. The table shows that, in comparison to the control group, the
intervention did not have any effect on antibiotic prescribing. However, there was a
significant increase in inhaled steroid prescription as well as on the sending of
sputa for tuberculosis testing. Compared to the control group, the intervention had
no effect on prescribing of cotrimoxazole prophylaxis. or on improvement of
interference with usual activities.
81
Table 3.13: Symptoms at the first post-intervention survey of current smokers
Intervention Control
Symptoms
Cough >2 weeks 81.7% (N=164) 87.6% (N=193)
Cough <2 weeks with respiratory rate ~ 30 1.8% (N=164) 0.0% (N=193)
Cough <2 weeks with temperature ~ 38°C 1.2% (N=163) 0.5% (N=193)
Phlegm/slime 46.5% (N=152) 53.5% (N=183)
Yellow/green phlegm/slime 47.1% (N=126) 52.9% (N=146)
Haemoptysis 39.6% (N=152) 60.4% (N=183)
Continuous difficulty breathing problem 89.0% (N=164) 85.5% (N=193)
Chest problems interfering with usual activities 78.1% (N=164) 61.7% (N=193)
Frequency of chest symptoms interfering with N=127 N=119
usual activities
1-2 times per month 3.9% 5.9%
1-2 times per week 22.1% 26.1%
Most days 74.1% 68.1%
Reasons for coming to clinic today N=164 N=191
Check-up high blood pressure 23.2% 17.8%
Check-up diabetes 0.6% 0.0%
Check-up respiratory problem 26.2% 33.0%
Check-up other problem 11.6% 22.0%
1st visit respiratory problem 4.3% 7.9%
1st visit other problem 22.6% 21.5%
Attendance to the clinic in last 3 months 68.9% (N=164) 68.4% (N=193)
3.2.5 Reliability of tracer questions
At the first post-intervention survey there were questions on difficulty breathing
and cough on the day of the interview that eligible patients had to answer twice to
assess test-retest reliability. Table 3.14 indicates good agreement between the
repeated questions using the Kappa statistic.
80
Table 3.14: Agreement between repeated questions at first post-intervention survey
Questions asked Intervention arm Control arm
Kappa 95%CI Kappa 95%CI
Do you have difficulty breathing 0.80 (0.75-0.84) 0.84 (0.81-0.88)
(tight chest, shortness of breath,
wheeze) today?
Do you have a cough today? 0.87 (0.82-0.92) 0.92 (0.88-0.96)
3.2.6 Primary and secondary outcomes
Table 3.15 shows the comparison of primary outcome variables between the
intervention and control arms of the trial. The results are given as percentages,
odds ratios, 95% confidence intervals, p values and inter-cluster correlation
coefficients (ICC). The five primary outcomes that were measured were antibiotic
prescription, inhaled steroid prescription, sending of sputa for tuberculosis testing,
cotrimoxazole prophylaxis among patients with tuberculosis and interference with
usual activities. The table shows that, in comparison to the control group, the
intervention did not have any effect on antibiotic prescribing. However, there was a
significant increase in inhaled steroid prescription as well as on the sending of
sputa for tuberculosis testing. Compared to the control group, the intervention had
no effect on prescribing of cotrimoxazole prophylaxis, or on improvement of
interference with usual activities.
81
Table 3.15: Primary outcomes
Intervention arm Control arm Odds Adjusted P value ICC··comes
ratios 95% er- --
1ary outcomes niN (%) nIN (%)
ntibiotics prescription 360/996 36.1 378/995 38.0 0.92 (0.62-1.36) 0.68 0.102
[st post-intervention
ey among all patients
haled steroid 149/927 16.1 95/925 10.3 1.70 (1.13-2.56) 0.01 0.060
cription at first post-
vention survey or
w up among all
wed up
puta for TB testing at 112/669 16.7 76/680 11.2 1.60 (1.00-2.54) 0.050 0.058
post-intervention
ey or follow up
ng all followed up,
cough> 2 weeks
uding known TB
~s
otrimoxazole 18/143 12.6 13/132 9.9 1.52 (0.60-3.89) 0.38 0.133
hylaxis among TB
~s
rprovement of 363/923 39.3 316/922 34.3 1.25 (0.96-1.63) 0.10 0.032
rference with usual
lIities from first post-
rvention survey to
w up among all
wed up
·ConfidenceIntervals
** Intra-clustercorrelation coefficient
Tables 3.16(a) and 3.16(b) show comparison of secondary outcome variables
between the intervention and control arms of the trial. The results are also given
as percentages, odd ratios, 95% confidence intervals, p values and inter-cluster
correlation coefficients (ICC). Significant effects were seen on appropriate referral,
with tuberculosis case detection rate, and admission to hospitals being close to
significant. Significant adverse effects were seen on interference with usual
activities due to chest problems and severity of anxiety and depression.
82
Table 3.16(a): Secondary outcomes
Outcomes Intervention arm Control arm Odds Adjusted
P ICC-
ratio 95"10Cl· value
Secondary outcomes niN ("lo) nIN ("lo)
0.0319
1. Appropriate referral (if one of 4 severity 27/255 10.6 8/165 4.9 2.56 (1.06-6.17) 0.036
marxers present) at first post-intervention
survey
0.0330
2. VCCTII-UV counselling 75/925 8.1 67/922 7.3 1.13 (0_69-1.84) 0.63
3. Counselling for smoking cessation
(a) Only at first post-intervention survey among 83/163 50.9 86/193 44.6 1.35 (0.92-1.98) 0.13
0.0176
current smokers at first post-intervention survey
(b) First post-intervention surveyor follow-up 100/147 68.0 111/179 62.0 1_36 (0.90-2.05) 0.14
0_0034
among current smokers at first post-
intervention survey
4. Increased readiness to quit smoking among 19/70 27.1 20/78 25.6 1.04 (0.5~2.05) 0.91 <0.0001
current smokers at first post-intervention
survey-
s. Smoking cessation at follow-up among 39/138 28.3 43/159 27.0 1.00 (0.57-1.77) 1.00 0.0645
current smokers
6. Tuberculosis case detection rate
(a) Excluding known TB eases at first post- 28/925 3.0 17/922 1.8 1.67 (0.92-3.02) 0.091 0_0006
intervention survey
(b) Including patients who started tuberculosis 25/996 2.5 17/995 1.7 1_48 (0_77-2.86) 0.24 0_0080
treatment Jess than 28 days before interviews
started
7. Mortality rate
(a) All at follow up 22/947 2.3 26/948 2.7 0.84 (0.46-1.53) 0.57 0_0048
(b) Among patients with tuberculosis at first 10/136 7.4 5/129 3.9 2.00 (0 ..51-7.75) 0.32 0.0726
post-intervention survey
8. Difliculty sleeping due to chest symptoms at 627/925 67.8 603/922 65.4 1.12 (0.89-1.41 ) 0.34 0_0322
follow-up.
9. Chest symptoms during the day at follow up 637/925 68.9 623/922 67.6 1.07 (0.81-1.40) 0.64 0.0772
10. Interference with usual activities due to 629/925 68.0 554/922 60.1 1.44 (1_1~1.85) 0.003 0.0744
chest symptoms at follow up
*Confidence Intervals
** Smaller denominator because only 148 of the first-post intervention survey smokers answered both
questions
*** Intra--cluster correlation coefficient
83
Table 3.16(b): Secondary outcomes (continued)
Outcomes Intervention ann Control ann Odds Adjusted P ICe-
ratios 95%CI· value
Secondary outcomes (continued) nIN ('Yo) nIN ('Yo)
11. Improvement of each domain of Ea-50 and
change in the combined score at follow up
a) Mobility
No problem in walking about 465/923 50.4 5021922 54.5 0.84 (0.44-1.59) 0.59 0.0623
Between no problem and some problem 52/923 5.6 67/922 7.3
Some problem in walking about 364/923 39.4 330/922 35.8
Between some problem ad confined to bed 22/923 2.4 121922 1.3
Confined to bed 20/923 2.2 11/922 1.2
b) SeIf-care
No problem with self-care 770/923 83.4 798/922 86.6 0.77 (0.40-1.50) 0.45 0.1129
Between no problem and some problem 28/923 3.0 36/922 3.9
Some problem washing or dressing 105/923 11.4 75/922 8.1
Between some problem and unable to wash or 7/923 0.8 5/922 0.5
dress
Unable to wash or dress 13/923 1.4 8/922 0.9
c) Usual activities
No problem with performing usual activities 340/923 36.8 401/922 43.5 1.18 (0.69-2.01 ) 0.55 0.0607
Between no problem and some problem 53/923 5.7 53/922 5.8
Some problem with performing usual activities 373/923 40.4 364/922 39.5
Between some problem and unable to perform 36/923 3.9 28/922 3.0
usual activities
Unable to perform usual activities 121/923 13.1 76/922 8.2
d) Pain/discomfort
No pain or discomfort 2561923 27.7 291/922 31.6 1.04 (0.59-1.83) 0.90 0.0846
Between none and moderate pain or discomfort 49/923 5.3 50/922 5.4
Moderate pain or discomfort 403/923 43.7 401/922 43.5
Between extreme and moderate pain or 49/923 5.3 41/922 4.5
discomfort
Extreme pain or discomfort 166/923 18.0 139/922 15.1
e) Anxiety/depression
No anxiety or depression ·297/923 32.2 351/922 38.1 1.66 (1.41-1.95) <0.001 0.1123
Between none and moderate anxiety or 49/923 5.3 37/922 4.0
depression
Moderate anxiety or depression 290/923 31.4 279/922 30.3
Between extreme and moderate anxiety or 38/923 4.1 30/922 3.3
depression
Extreme anxiety or depression 249/923 27.0 224/922 24.3
Change in the combined EQ-5D score
Mean (SO) 0.10 (0.44) 0.12 (0.41) -0.03 (-0.08-0.03) 0.37 0.0367
12. Number of visits to other health care
providers between the first post-intervention
survey and follow up
(a)Median (laR) 2 (1-3) 2 (1-3) 1.19 (0.82-1.72) 0.37 0.0984
(b)Mean (SO) 2.0 (1.5) 1.8 (1.4) 1.19 (0.82-1.72) 0.37 0.0984
13. Admissions to hospitals between the first 26/925 2.8 41/922 4.5 0.62 (0.38-1.02) 0.062 0.0023
post-intervention surve}' and follow up
IOR= Interquartile range, SD- Standard deviation, ·Confidence Intervals
- Intra-cluster correlation coefficient·
84
Since first post-intervention survey differences were observed between the two
groups when analysing patients with indicators of severe illness requiring referral
(secondary outcome 1), haemoptysis, phlegm and sputum colour were added as
explanatory variables in the regression model. The adjusted odds ratio was 2.54
(95% Cl 1.01 to 6.38) and p-value 0.047. This shows that the first post-intervention
survey adjustment did not influence the estimated effect.
First post-intervention survey differences were also observed between the two
groups when analysing patients with difficulty sleeping due to chest problems,
(secondary outcome 8), patients with chest symptoms during the day (secondary
outcome 9), and patients with interference with usual activities due to chest
symptoms (secondary outcome 10). The first post-intervention survey adjustment
was therefore done for all the three outcomes. For difficulty sleeping due to chest
problems, the adjusted odds ratio was 1.12 (95% Cl 0.89 to 1.41), for chest
symptoms during the day the adjusted odds ratio was 1.07 (95% Cl 0.81 to 1.40),
and for interference with usual activities due to chest symptoms the adjusted odds
ratio was 1.44 (95% Cl 1.13 to 1.85). This also implies that the first post-
intervention survey adjustment did not influence the estimated effect.
Ordinal logistic regressions of the EuroOol-5D sub-domains were done adjusting
for the first post-intervention survey values of the same variables. Stata output
warned that the resulting standard errors were questionable, so these results
should be interpreted with caution. However comparison of anxiety and depression
at follow-up using Cusick's non-parametric test for trend, but not adjusting for
cluster effects or the first post-intervention survey values, also found this to be
significantly worse in the intervention arm (p value=0.03)
For change in the combined EO-5D score, the coefficient (and 95% confidence
interval) are difference in score instead of odds ratios. The change in score is
normally distributed, so linear regression is an appropriate method of comparison.
85
3.2.7 Number needed to treat calculations
Table 3.17 below is an illustration of numbers needed to treat in order to see the
effects of the study. As indicated, eighteen patients would need to be seen by a
PALSA trained nurse for one extra patient to be prescribed an inhaled steroid.
Seventeen patients would need to be seen by a PALSA trained nurse for one extra
appropriate referral to be made. Other differences were not significant (95%
confidence intervals include 0)
Table 3.17: Number needed to treat (NNT)
Outcomes RD (95% Cl) Number needed to (95% Cl)
treat (NNT)= 1/RD
1. Inhaled steroid 0.055 (0.017; 0.094) 18 11; 59
prescription
2. Sputa sent for TB 0.44 (-0.004; 0.89) 2.3 -250; 1.1
testing
3. Appropriate 0.058 (0.008; 0.11) 17 9.1; 125
referral
4. TB case detection 0.011 (-0.002; 0.025) 91 -500; 40
rate
5. Hospital -0.015 (-0.030; -0.001) -67 -33; 1000
admissions
86
CHAPTER 4- DISCUSSION AND CONCLUSION
4.1 INTRODUCTION
This chapter will discuss the results of the study. Strengths and limitations of the
study will follow, as well as implications for policy. Finally, a conclusion about the
study will be given.
4.2 OVERVIEW OF RE5UL T5
The results of the study show that the PALSA intervention led to a significant
improvement on inhaled steroid prescription, with a prescription rate of 16.1% in
the intervention arm compared to 10.3% in the control arm (odds ratio 1.70; 95%CI
1.13 to 2.56), and a marginally significant improvement in sending of sputa for
tuberculosis testing, with 16.1% in the intervention arm compared to 11.0% in the
control arm (odds ratio 1.60; 95%CI 1.00 to 2.54). There were also significantly
higher probabilities of appropriate referral of patients that had one of the four
severity markers at first post-intervention survey, that is, 10.6% for intervention
compared to 4.9% for the control arm (odds ratio 2.56; 95%CI1.06 to 6.17); and of
interference with usual activities due to chest symptoms at follow-up of 68.0% for
intervention and 60.1% for control arms (odds ratio 1.44; 95%CI 1.13 t01.85). A
close to significant difference was found in the tuberculosis case detection rate,
3.0% for intervention compared to 1.8% for control arm (odds ratio 1.67; 95%CI
0.92 to 3.02). All but one of these outcomes was improvements in health care
processes rather than in patients' health status. It is however reasonable to
predict, based on previous research, that earlier tuberculosis treatment and
increased asthma preventive therapy would lead to improved health status in
patients with these conditions, although it would take longer than three months for
health gains to be detected (Borgdorff et a/2002, Griffiths et a/2004). The marked
improvement in inhaler prescribing could have been due to the permission that
was granted by the provincial health department authorities to nursing practitioners
in intervention clinics to prescribe inhalers during the study rather than to the
87
intervention itself. This permission was part of the intervention package, and so its
effects cannot be distinguished from the educational components.
There was no significant effect of the intervention on 3 of the 5 primary outcomes
of the study, these being reduction of antibiotic prescription, increase in
cotrimoxazole prophylaxis among known tuberculosis patients, and improvement
of interference with usual activities due to chest symptoms. The latter primary
outcome (improvement of interference with usual activities) was the difference
between interference after three months and at first post-intervention survey, in
contrast to the secondary outcome reported in the previous paragraph, which did
not account for interference at first post-intervention survey. One plausible
explanation for the lack of effect on cotrimoxazole prescribing was that during the
course of the study, the province had an interruption of the supply of
cotrimoxazole, even though the province had adopted a policy on cotrimoxazole
prophylaxis that had been budgeted for.
Numbers needed to treat provide an estimate of absolute, rather than relative
effectiveness. As illustrated in Table 3.17, only 2.3 patients with chronic cough and
without known tuberculosis would need to be managed by a PALSA-trained nurse
for one more such patient to have sputum sent for testing (95%CI-250 to 1.1),18
patients would need to be managed by a PALSA-trained nurse for one more
patient to be prescribed inhaled steroids (95%CI 11 to 59), and 17 patients with
signs indicating severe disease would need to be managed by a PALSA-trained
nurse for one more patient to be referred to a doctor or hospital (95%CI9.1 t0125).
Given the large numbers of such patients managed every day in Free State clinics,
and the capacity of such patients to benefit from such care; these appear to be
substantial effects.
The screening questions about cough and difficulty breathing were broad and
could include patients with heart problems and not necessarily respiratory
problems. For example, high percentages of patients reported that they were
88
attending the clinic for hypertension. These questions were possibly overly
sensitive in the screening context, and thus lack specificity for conditions that are
the target for intervention. The guidelines and medication for respiratory conditions
would not be expected to benefit heart disease patients. The inclusion of such
patients in the study could have thus led to an underestimation of the effect of the
intervention on respiratory patients alone. This also raises the cost of
implementing the intervention.
The results also showed an extraordinarily high prevalence of certain respiratory
symptoms, especially since only about 40 percent of patients were attending for
respiratory problems. This is seen on Table 3.5, where in the intervention group
persistent cough accounted for 78%, troublesome respiratory symptoms
accounted for 76% of which 76% were daily, and haemoptysis accounted for 51%.
The proportion of ex-smokers (31%) was also surprisingly high, especially as two
thirds of the attendees were women. This might reflect medical advice given to
patients with respiratory symptoms, which would suggest a highly effective prior
smoking cessation practices in the clinics. Steyn and colleagues determined
smoking patterns in South Africa, and identified groups requiring culturally
appropriate smoking cessation programmes by conducting interviews of a random
sample of 13 826 people (> 15 years to identify tobacco use patterns and
respiratory symptoms as part of the 1998 South African demographic health
survey (Steyn et a/2002). Results of the study showed that adults (44.2% of males
and 11.0% of females) smoked regularly. About 24% of the regular smokers had
attempted to quit, with only 9.9% succeeding. The researchers came to the
conclusion that smoking in South Africa is decreasing and should continue with the
recently passed tobacco control legislation (Steyn et al 2002). Culturally
appropriate tobacco cessation programmes for the identified target groups need to
be developed (Steyn et a/2002).
89
The primary outcomes that were not significantly different were antibiotic
prescription, cotrimoxazole prophylaxis and interference with usual activities. This
could either be due to no true effect, or due to the study having insufficient power
to detect a significant difference. Estimations from the pilot study were worked out
to reduce antibiotic prescription by 10%, with 90% power at the 5% significance
level. It however turned out that the intervention had no significant effect on
antibiotic prescription, 36% versus 38% for intervention and control arms (odds
ratio 0.92; 95%CI 0.62 t01.36). The present study only had 14% power to find
such a small difference significant at the 5% level, ignoring the reduced power due
to cluster randomization. A 2% difference in antibiotic prescribing would in any
case be of questionable clinical significance. Similarly, the study had only 7.4%
power to detect a true difference in cotrimoxazole prophylaxis in patients with
tuberculosis of the magnitude found (12.6% versus 9.9% for intervention and
control groups), ignoring the cluster randomization design effect.
4.3 COMPARISON OF THESE RESULTS WITH RESULTS OF PREVIOUS
TRIALS
The results of this study will now be compared with those of similar trials of
interventions aimed to improve diagnosis or treatment of respiratory diseases in
primary care.
4.3.1 Antibiotic prescribing
Several studies have been conducted to assess the effectiveness of interventions
aimed at reducing antibiotic prescribing for respiratory conditions at primary care
level. In one trial, Welschen and colleagues conducted a randomized controlled
trial in The Netherlands to assess the effectiveness of a multifaceted intervention
aimed at reducing antibiotic prescription rates for symptoms of the respiratory tract
among general practitioners in primary care (Weischen et al 2004). The
90
intervention comprised group education meetings for the practitioners, monitoring
and feedback on prescribing behaviour, group education for assistants of general
practitioners and pharmacists, and education materials for patients. The control
group did not receive any of these elements. From 89 general practitioners who
completed the 9 months study, there was a difference in the prescription rate of -
12% (95% CI-18.9% to -4.0%) between the intervention and control groups. There
was also high patient satisfaction which did not differ between the two arms
(Weischen et a/2004).
In another trial on antibiotic prescription, Zwar and colleagues conducted a
randomized controlled trial in a community setting in New South Wales to examine
the effectiveness of prescriber feedback and management guidelines in reducing
antibiotic prescribing for undifferentiated upper respiratory tract infection by general
practice trainees, and in improving the choice of antibiotic for
tonsillitis/streptococcal pharyngitis (Zwar et a/1999). Of the 157 trainees enrolled
for the trial, 78 were randomly allocated to the intervention while 79 were assigned
to the control arm. The trainees completed three practice activity surveys, each of
110 consecutive patient encounters, with 6-month intervals between surveys.
Prescriber feedback and management guidelines on use of antibiotics for upper
respiratory tract infection and choice of antibiotic for tonsillitis/streptococcal
pharyngitis were delivered in a written form between surveys 1 and 2. An
educational outreach visit to high prescribers occurred between surveys 2 and 3.
Outcome measures were the rate of antibiotic prescribing for all indications, for
upper respiratory tract infection and prescribing of select antibiotics for
tonsillitis/streptococcal pharyngitis (Zwar et a/1999). Results of the study showed
a decline in antibiotic prescribing by the intervention group over three occasions
from 25.0 to 23.3 to 19.7 per 100 upper respiratory tract infection problems, while
the control group increased from 22.0 to 25.0 to 31.7 per 100 upper respiratory
tract infection problems (p=0.002). Prescribing in agreement with accepted
guidelines for tonsillitis/streptococcal pharyngitis increased over time in the
intervention group from 55.6 to 69.8 to 73.0 per 100 problems, but decreased in
91
the control group from 59.6 to 57.5 to 58.5 (p=O.05) (Zwar et a/1999). Even though
this study was conducted in a developed country as compared to our study which
was conducted in a developing country, the study provides a model for targeting
educational input to those prescribers who are in most need to change their
behavior in prescribing antibiotics.
The above two cited studies were conducted in developed countries and both
targeted medical doctors as compared to our study that was conducted in a
developing country and targeted primary care clinic nurses. Results of our study
were not consistent with these two studies in that the effect of reduction in
antibiotic prescription as a result of outreach training of primary care practitioners
was not significant (p=O.68)..
4.3.2 Asthma treatment and management
4.3.2.1 General practitioners' knowledge about diagnosis and treatment of
asthma
Tomson and colleagues conducted a study to assess the effect of an intervention
on general practitioners' knowledge about the diagnosis and treatment of asthma,
including the prescribing of anti-asthmatic drugs, and asthmatic patients'
knowledge about their disease in Sweden (Tomson et a/1997). In the intervention
area, 44 general practitioners at 21 health centres were visited by a clinical
pharmacologist and a pharmacist presenting oral and written information. The
basic messages were: (1) the central role of inhaled glucocorticoids; (2) the use of
peak expiratory flow (PEF) meters; and (3) the use of reversibility tests. In the
control area, there were 19 general practitioners at nine health centres. The
general practitioners' knowledge about the intervention message was evaluated by
a questionnaire pre- and post-intervention. The ratios of prescribed inhaled beta-
adrenoceptor agonists to inhaled glucocorticoids were determined. At the 26 local
92
pharmacies, all asthmatic patients who presented a prescription for anti-asthmatic
drugs, issued at the 30 trial health centres, were given a questionnaire before and
after the intervention regarding their knowledge of asthma and its treatment.
Results of the trial showed that general practitioners in the intervention area
showed significantly more knowledge about item numbers 2 and 3 in the above-
described intervention message than did the general practitioners in the control
area. The data on prescriptions showed lower but not significant ratios of beta-
adrenoceptor agonists to glucocorticoids in the intervention area than in the control
area. After the general practitioners' intervention, the patients' knowledge about
asthma had increased in the intervention area, as assessed by the questionnaire
filled in by the patients. However, there was no significant difference from that in
the control area. The authors found changes in knowledge, attitudes and actual
practice, the latter being measured by the prescriptions (Tomson et a/1997). The
difference between our study and the above cited trial is that our study was
conducted in a developing country and it targeted nursing practitioners while this
one was conducted in a developed country and targeted doctors. Our study shows
that in place of general practitioners, if properly trained and supported, clinic
nursing practitioners can equally improve adult asthma management at primary
care level.
4.3.2.2 Asthma specialist nurses
Griffiths and colleagues conducted a cluster randomized controlled trial to
determine whether asthma specialist nurses, using a liaison model of care, reduce
unscheduled care in a deprived multiethnic area in london (Griffiths et a/ 2004).
The study involved 44 general practices in which 324 people aged 4 to 60 years
were admitted to or were attending hospital or the general practitioner out of hour
service with acute asthma. The intervention comprised of patient review in a nurse
led clinic and liaison with general practitioners and practice nurses comprising
educational outreach, promotion of guidelines for high risk asthma, and ongoing
clinical support. Control practices only received a visit promoting standard asthma
93
guidelines, and control patients were checked for inhaler technique. The main
outcome measures were percentage of participants receiving unscheduled care
for acute asthma over one year and time to the first unscheduled attendance.
Primary outcome data were available for 319 of 324 (98%) participants.
Intervention delayed time to first attendance with acute asthma (hazard ratio 0.73,
95% confidence interval 0.54 to 1.00; median 194 days for intervention and 126
days for control) and reduced the percentage of participants attending with acute
asthma (58% (101/174) v 68% (99/145); odds ratio 0.62; 95% confidence interval
0.38 to 1.01). In analyses of specified subgroups the difference in effect on ethnic
groups was not significant, but results were consistent with greater benefit for
white patients than for South Asian patients or those from other ethnic groups. The
results of the study showed that asthma specialist nurses using a liaison model of
care reduced unscheduled care for asthma in a deprived multiethnic health district
(Griffiths et aI2004).
The above cited study differed from ours in that it was conducted in a developed
country and at secondary care level. Our study's results were however consistent
with the cited trial in showing that training nurses on asthma management can
produce significant results in improving asthma management. However, nurses in
the cited trial received two one hour visits by specialist nurses compared to our
study where nurses received a median of two half an hour visits, adding up to only
one hour.
4.3.2.3 Asthma patient education
Premaratne and colleagues conducted a randomized controlled trial to evaluate
the effectiveness of an asthma resource centre in improving treatment and quality
of life for asthmatic patients aged 15-50 years in 41 general practices in
Greenwich with a practice nurse (Premaratne et al 2000). The intervention
comprised a nurse specialist in asthma who educated and supported practice
nurses, who in turn educated patients in the management of asthma according to
the British Thoracic Society's guidelines. Outcome measures were quality of life of
94
asthmatic patients, attendance at accident and emergency departments,
admissions to local hospitals, and steroid prescribing by general practitioners. Of
24 400 patients randomly selected and surveyed in 1993, 12 238 replied; 1621
were asthmatic of whom 1291 were sent a repeat questionnaire in 1996 and 780
replied. Of 24 400 patients newly surveyed in 1996, 10 783 (1616 asthmatic)
replied. No evidence was found for an improvement in asthma related quality of
life among newly surveyed patients in intervention practices compared with control
practices. Neither was there evidence of an improvement in other measures of the
quality of asthma care. Weak evidence was found for an improvement in quality of
life in intervention practices among asthmatics registered with study practices in
1993 and followed up in 1996. Neither attendances at accident and emergency
departments nor admissions for asthma showed any tendency to diverge in
intervention and control practices over the study period. Steroid prescribing rates
rose steadily during the study period. The average annual increase in steroid
prescribing was 3% per year higher in intervention than control practices (95%
confidence interval-1% to 6%, P=0.10). The authors came to the conclusion that
this model of service delivery is not effective in improving the outcome of asthma
in the community (Premaratne et a/2000). Further development is required if cost
effective management of asthma is to be introduced.
Smeele and colleagues conducted a randomized controlled trial to assess the
effectiveness of an intensive small group education and peer review programme
aimed at implementing national guidelines on asthma/chronic obstructive
pulmonary disease on care provision by general practitioners and on patient
outcomes (Smeele et a/1999). This was a study with pre-measurement and post-
measurement (after one year) in an experimental group and a control group in
Dutch general practice. The education and peer review group (17 general
practitioners with 210 patients) had an intervention consisting of an interactive
group education and peer review programme (four sessions each lasting two
hours). The control group consisted of 17 general practitioners with 223 patients
(no intervention). The effectiveness of the intervention was measured by
95
knowledge, skills, opinion about asthma and chronic obstructive pulmonary
disease care, presence of equipment in practice; actual performance of peak-flow
measurement, non-pharmacological and pharmacological treatment; asthma
symptoms according to the Dutch Medical Research Council guidelines, smoking
habits, exacerbation ratio, and disease specific quality of life (QOl-RIQ). Data
were collected by a written questionnaire for general practitioners, by self
recording of consultations by general practitioners, and by a written self
administered questionnaire for adult patients with asthmalCOPD. Data from 34
general practitioners questionnaires, 433 patient questionnaires, and recordings
from 934 consultations/visits and 350 repeat prescriptions were available.
Compared with the control group there were only significant changes for self
estimated skills (+16%, 95% confidence interval4% to 26%) and presence of peak
flow meters in practice (+18%, p < 0.05). No significant changes were found for
provided care and patient outcomes compared with the control group. In the
subgroup of more severe patients, the group of older patients, and in the group of
patients not using anti-inflammatory medication at the first post-intervention
survey, no significant changes compared with the control group were seen in
patient outcomes. Except for two aspects, intensive small group education and
peer review in asthma and COPD care do not seem to be effective in changing
relevant aspects of the provided care by general practitioners in accordance with
guidelines, nor in changing patients' health status.
Our study differed from the above two studies in that instead of looking at
specialized facilities such as asthma centres and intensive small groups education
programmes, we used a team of specially trained nurses to train primary care
clinic nurses on respiratory conditions in general. Our study also slightly differed
from the above two cited studies in that we investigated the effectiveness of a
locally adapted set of guidelines that addressed respiratory care at primary care
level instead of a national set of guidelines. An addition that our study brings into
the respiratory care field is to show that localization of internationally developed
96
set of guidelines that addresses respiratory conditions of public health importance
can be effective in rural primary care settings.
4.3.3 Cotrimoxazole prophylaxis
Several studies have been conducted to establish the effects of cotrimoxazole
prophylaxis on known tuberculosis cases. In one study, Mwaungulu and
colleagues conducted a cohort study to estimate the effect of cotrimoxazole
prophylaxis on the survival of HIV-positive tuberculosis patients in Malawi between
1999 and 2000 (Mwaungulu et a/2004). Of the 355 and 362 tuberculosis patients
registered in 1999 and 2000 respectively, 70% were HIV-positive. The overall case
fatality rate fell from 37% to 29%, meaning that, for every 12.5 tuberculosis
patients treated, one death was averted. Case fatality was unchanged in HIV-
negative patients, but fell in HIV-positive patients from 43% to 24% in the 2 years.
The improvement was most marked in patients with smear-positive tuberculosis
and others with confirmed tuberculosis diagnosis. The researchers concluded that
survival of HIV-positive tuberculosis patients improved dramatically with the
addition of cotrimoxazole prophylaxis to the treatment regimen (Mwaungulu et al
2004). Our study tried to establish if the intervention increased prescribing of
cotrimoxazole prophylaxis. There is still a need for further research in this area
under conditions when cotrimoxazole is available.
Brou and colleagues conducted a survey in Cote d'lvoire, Africa, among
healthcare providers, on the knowledge of prophylactic use of cotrimoxazole to
prevent opportunistic infections in HIV-infected persons (Brou et a/ 2003). The
survey was conducted in 15 health centres, involved or not in the 'initiative of
access to treatment for HIV infected people'. Between December 1999 and March
2000, 145 physicians and 297 other health care providers were interviewed. In the
analysis, the health centres were divided into three groups: health centres
implicated in the initiative of access to treatment for HIV-infected people with a
great deal of caring for HIV-infected people, health centres implicated in this
97
initiative but caring for few HIV-infected people, and health centres not specifically
involved in the care of HIV-infected people. Six per cent of physicians and 50% of
other health care providers had never heard of cotrimoxazole prophylaxis. The
level of information about this prophylaxis is related to the level of HIV-related
activities in the health centre. Among health care providers informed, knowledge
on the exact terms of prescription of the cotrimoxazole was poor. The authors
came to the conclusion that the recommendations for primary cotrimoxazole
prophylaxis of HIV-infected people did not reach the whole health care provider
population. Most physicians are informed but not other health workers, even if the
latter were often the only contact of the patient with the health centre. The only
medical staff correctly informed were the physicians already strongly engaged in
the care of HIV-infected people (Brou et a/2003).
The similarity between our study and the above two cited studies are that they
were all conducted in developing countries and in primary care settings. Even
though our study was not meant to establish the knowledge level of health care
providers on cotrimoxazole prophylaxis, its implementation could be translated into
level of awareness among health care providers. Even though affected by the
provincial stock out of cotrimoxazole during the course of the trial, the fact that the
intervention had no effect is a cause for concern.
4.4 STRENGTHS AND LIMITATIONS
4.4.1 Strengths of the study
The study recruited a total of 1991 patients, 996 for intervention and 995 for
control arms. This was a large sample that provided adequate power to detect
fairly small differences between the two arms, even taking into account the cluster
randomization.
The randomization succeeded in balancing the characteristics of the clinics as well
as the patients at the first post-intervention survey. In almost all the subgroup
98
analyses, the first post-intervention survey characteristics of patients of the two
groups were balanced.
The fact that the PALSA project was implemented at clinic level ensured that
contamination was minimized. Unlike studies that randomize individual participants
and not clusters, our study randomized participants attending a given clinic. This
resulted in no participants from the control arm being seen by a PALSA trained
nurse from the intervention arm.
The clinic follow-up rate was complete, that is, follow-up interviews were
conducted in all 40 clinics and the patient follow-up rate of 92.8% was high, thus
enhancing the internal validity of the study. The high follow-up rate can be
attributed to the food parcel incentive, as well as the diligence of the fieldworkers,
clear instructions on how to arrange a follow-up interview, and what to do during
emergency situations such as when a patient does not show up for an interview. In
cases where logistical problems were encountered innovative corrective measures
were taken. An example of this innovation was during follow-up interviews in one
of the control clinics, Marakong, where due to miscommunication on dates for
follow-up interviews, field workers gave patients wrong dates for coming back.
When reminded about the follow-up dates by the PALSA researchers, last minute
preparations had to be done in order to prepare for field work at the clinic. In order
to inform and request patients to come for interviews at the clinic that week, field
workers sought assistance from local authorities to inform patients about the
interview dates and a local radio station was used for informing patients who were
due for follow-up interviews to report themselves at the clinic during that week.
Even though the overall follow-up rate for that clinic ended up being 80%, which
was below the average 92.8%, this reflected dedication and diligence by the field
workers on the project.
The Centre for Health Systems Research and Development, University of the Free
State coordinated the data collection process. The Centre has conducted national
99
and provincial studies of different magnitudes, all of which reflect a wealth of
experience. It is this wealth of experience that has contributed to the success in
attaining high follow-up rate.
The use of the personal digital assistant (PDA) could have also contributed
significantly to the high follow-up rate due to the fact that it was a new method of
data collection which fascinated the relatively young interviewers, compared to the
traditionally used paper questionnaire, which can be unappealing due to size. It
also became apparent during the study that some patients felt more confident of
the PDA's confidentiality in that the information they were providing could not be
easily retrieved or seen once entered into the computer-like device compared to a
paper questionnaire that one can look at anytime. The success of using the PDAs
in this study shows that such technology can be applied in health facility settings.
Use of the visual aid as part of the data collection tools assisted patients to easily
identify and therefore give correct responses to questions relating to medication
normally used or prescribed on the day of interview.
The blinding of clinic staff and field workers contributed significantly to the internal
validity of the study.
The study population was intended to be as broadly defined as possible, so as to
include all patients who might benefit from the intervention. That is, it included all
adults with difficult breathing or with cough of more than one week because it was
believed that any such patients could potentially benefit, regardless of their reason
for arriving there. Even patients who attended a clinic for another reason, for
example, for treatment of a rash, hypertension or an injury, would be at higher risk
than the general population having a respiratory illness such as tuberculosis or
asthma and so could potentially benefit from appropriate diagnosis and treatment.
100
4.4.2 Limitations of the study
The study's results can be generalized to a wide range of primary care patients
since broad inclusion criteria were used. This, however, has drawbacks as well.
Patients who were recruited to the trial according to the inclusion criteria were
diverse as shown by the reasons for presenting to the clinic on the day of the
interview. These included check-up for chronic diseases such as diabetes and
high blood pressure as well as check-up for respiratory diseases. Other patients
indicated that this was their first visit for the above illnesses. According to Table
3.5, which shows patients' symptoms at the first post intervention survey, more
than 20% of the patients presented with high blood pressure, implying that these
patients were a mix of patients with cough and difficulty breathing problems. This
posed a problem of defining appropriate denominators of populations during the
analysis process. To address this problem, apart from the analyses being done on
all patients at the first post intervention survey and all patients followed up,
participants were divided into four subgroups, these being,1) patients with cough
for more than 2 weeks and not known to have tuberculosis, 2) known tuberculosis
cases, 3) patients with at least one of the severity markers and 4) current smokers
at the first post intervention survey. In order for the analysis to be as inclusive as
possible and to be by intention to treat, all subjects were included in the
comparisons of outcomes unless it was illogical to do so. But if subgroups of
patients could not possibly achieve particular outcomes, they were excluded from
the particular comparisons. For example, patients currently being treated for
tuberculosis could not possibly be newly diagnosed as having tuberculosis, and
non-smoking patients could not possibly quit smoking. Although it would have
been possible to identify subgroups of patients who would be more likely to benefit
from particular diagnoses or treatments, for example, a subgroup of patients
whose symptoms indicted that they were at higher risk of having asthma and could
have been analyzed to compare asthma-related outcomes. This higher probability
does not equate with logical entailment. Therefore the latter types of subgroup
analyses were not performed. Since randomization was done not at the level of
these subgroups, the subgroups could have been unbalanced, but as discussed
101
before within subgroups intervention and control patients usually did not differ with
regard to measured first post-intervention survey characteristics.
Staff movement in the form of transfers and resignation is common in the public
health sector. Such staff movement usually reduces the magnitude of effects of an
intervention. Chief nursing officers in the control clinics were contacted to establish
if any of trained nurses from the intervention clinics were transferred to the control
clinics during the project period. Responses were that none were transferred to
their clinics. This means that there was no contamination caused by staff
movement as a result of transfers.
Follow-up interviews were conducted within a short space of time three months
after the first post-intervention survey which is four months after the training had
taken place. Therefore long term effects on health outcomes, especially effects on
chronic diseases could not be adequately determined.
The fact that the training targets were not met, with most intervention clinics
nurses having received half of what was required, that is, one hour only could
have affected the results of the trial and sustainability of the intervention.
Although PALSA trainers were cautioned not to inform intervention clinic nurses
that they were going to be evaluated, clinic nurses may have anticipated being
evaluated, which could have influenced their practice.
This was a cluster randomized trial with a primary care clinic being a unit of
randomization. This design reduces the power to detect the effect of an exposure
as compared to trials involving individuals.
This project had many stakeholders with a broad expertise base. Contributions to
development of data collection tools were diverse with different expectations and
this sometimes resulted in omission of relevant questions or erroneous question
formulation in the questionnaires. For example, the follow-up questionnaire did not
102
ask whether patients had received any preventer inhaler(s) in the last 3 months
(since the first interview). The questions tried only to establish if the patient had
received an inhaler on the day of the interview or was currently using an inhaler.
To ensure that adequate numbers of patients would be recruited, the study was
conducted in the province's largest and busiest clinics with heavy daily patient
loads. Our study was not designed in such a way that it compared the intensity of
effects of the intervention on different sizes of clinics, that is, variation between
large, medium and small sized clinics. In a randomized controlled trial conducted
by Freemantie and colleagues to estimate the effectiveness of educational
outreach visits on United Kingdom (UK) general practice prescribing and to
examine the extent to which practice characteristics influenced outcome, the
authors established that in large practices, educational outreach alone is unlikely
to achieve worthwhile change. The authors concluded that there is good evidence
to support the use of educational outreach visits in small practices (Freemantie
2002).
The pilot study helped with questionnaire and study design but was misleading in
some respects. The pilot study indicated higher percentages of antibiotic
prescription and interference with usual activities and a lower percentage of
inhaled steroid prescriptions than those found in the trial. In the pilot study the
percentages were 70%, 17% and 50% for antibiotics prescription, inhaled steroid
prescription and interference with usual activities respectively. In order to decrease
the percentages of antibiotic prescription and interference with usual activities and
increase inhaled steroids prescription each by 10% with 90% power it was
estimated that we would require a sample size of 2000 participants for the study,
that is, 1000 per arm. Results of the study however showed a prevalence of 38%,
10.3% and 34.3% for these three outcomes in the control group. These large
differences imply that the pilot study was conducted on patients who were more
severely ill than patients in the trial.
103
4.5 IMPLICATIONS FOR POLICY
Differences of 5.8% in inhaled steroid prescription, of 5.5% in sending of sputa for
tuberculosis testing, and 5.7% for appropriate referral are large enough
improvements to be worth considering in policy formulation. That is, for every 20
eligible patients managed using PALSA methods, management of about one extra
patient would be improved in each of these ways. The fact that these effects were
obtained within a 3 months period suggests that even better results may have
been obtained had the duration of the study been longer. Positive effects of the
study do give an indication that such an intervention can be considered as a
training strategy for clinic nurses who provide services in settings such as this
South African province, however due consideration must be given to the
associated costs of other equally important competing priorities in the settings.
The intervention was developed internationally, and it was tested to establish if it
can be implemented in developing countries. Because the study was done in a
resource-poor province of the country, it is possible to generalize its results to
similar low income settings. It would therefore be beneficial to implement PALSA
training in addition to or as part of the primary care nurse training.
There are 238 primary care clinics that provide services to a population of about
2.4 million people in the Free State and if the PALSA project were to be rolled out
to cover the whole province, thousands of people would benefit from an
improvement in inhaled steroid prescription and tuberculosis case detection rate.
Implementation of this PALSA training could be done in phases in order to ensure
smooth adaptation and accommodation of limited resources. This could be started
first at provincial level, then proceed to national implementation and hopefully at
international level. The intervention may need to be adapted for different provinces
or countries.
The cost effectiveness of this intervention needs to be considered. A cost effective
analysis of the intervention is currently being conducted alongside the trial by one
104
of the PALSA researchers, Dr. Lara Fairall. A large portion of the first post-
intervention survey and follow-up questionnaires comprised questions about cost
implication of respiratory care to patients and the health sector. However, this was
a relatively low cost intervention, especially as it required clinic staff to spend
relatively little time away from their patients. The training was conducted by public
officials and not private trainers, and took place inside clinics compared to the
normal conduct of training outside clinic premises. The intervention utilized public
resources in the form of officials, transport and venues for conducting trainings.
Much of the cost was incurred in the development of training materials and
methods. Providing these on a larger scale as a result of expansion provincially
and nationally would have relatively low marginal costs.
Reasons why PALSA achieved some objectives and not others should be further
investigated. One of the conditions set by the principal funding agency of the
project, the International Development Research Centre (IDRC), was that the
researchers had be able after conducting the trial to account for why some
objectives were met and not others. A qualitative researcher is currently analyzing
qualitative data showing different levels of acceptance and implementation by
nursing staff in the intervention clinics. This data was collected prior and post
implementation of the intervention. Results of the qualitative research will assist in
explaining the perception of the clinic staff about the intervention and why some
objectives and not others could not be achieved. These results could be used to
improve the intervention.
In resource poor settings, health care is provided by nurses instead of doctors
(Green et al 2001). Nurses normally lack adequate skills and knowledge to make
right decisions especially on respiratory conditions. They end up either delaying to
refer severe conditions on time or misdiagnose respiratory disease, both resulting
in heavy financial burden to governments and families. Increase in appropriate
referrals by clinic nurses to specialists in higher levels of the service is highly
recommended as expressed in most guidelines (Lalloo et al 2000). Increase in
105
appropriate referral of patients result in reduction in morbidity and mortality.
PALSA type of primary care training could be considered for other conditions than
respiratory conditions. Currently, this concept has been extended to
implementation of PALSA Plus which forms part of the antiretroviral drugs (ARV)
roll-out in the Free State. PALSA Plus is also being evaluated by a randomized
controlled trial and qualitative research.
As with the integrated management of childhood illnesses (IMCI), sexually
transmitted diseases care and tuberculosis/HIV, the syndromic management of
diseases of public health importance in poor resourced countries continues to be a
promising approach to training multipurpose primary care workers.
4.6 PRIORITIES FOR FUTURE RESEARCH
Results of the evaluation are to be disseminated to stakeholders throughout the
province, mainly district health management teams comprising managers, CEOs,
clinic managers, district tuberculosis coordinators and other relevant role players
during this year. Upon approval of the reports and intention to roll-out the
intervention, first, to the control clinics and then the entire province, it will be
important to conduct observational studies of the large scale roll-out of the PALSA
project itself.
It is important for decision and policy makers to understand why certain
interventions work and why others do not. Information can be obtained by
conducting qualitative research alongside quantitative studies. Qualitative
research was conducted alongside the randomized controlled trial by one of the
PALSA team members. It will be important for findings of the qualitative study to
be shared with Free State authorities for decision making purposes about the fate
of PALSA. This will provide insights into the human and organizational aspects of
the intervention and the setting, which will help to explain why various effects were
or were not found, and how the intervention could be improved in future.
106
Future trials need to be conducted for similar interventions for different conditions.
An example is the PALSA Plus trial currently ongoing in the Free State province
related to the roll-out of antiretroviral drugs.
The Practical Approach to Lung Health project {PAL} is currently being
implemented in three countries but using different approaches, namely, Nepal,
Morocco and Brazil. Nepal, which is also a developing country like South Africa
decided to implement PAL through a trial approach to establish its effectiveness
prior to national implementation. Results of the trial will be peer reviewed and the
intervention will be adapted by the relevant authorities on the basis of results
obtained. A WHO PAL Advisory committee with membership from all the
implementing countries is scheduled to hold biannual progress report meetings
from which individual countries will learn from each others' reports and therefore
amend its own project accordingly.
4.7 CONCLUSION
This study exemplifies an evaluation of the effectiveness of an educational
intervention in South African primary care. It shows how a carefully developed
intervention, using a syndromic approach to diagnosis and treatment, can improve
several aspects of clinical care after brief training of primary care nurses. It also
illustrates opportunities for, and difficulties in, implementing such an intervention,
and conducting a large scale trial in this setting. This study suggests that other
international interventions based on dissemination of clinical guidelines - such as
for IMCI, STDs and HIV/AIDS - should be carefully developed and rigorously
evaluated locally, given their potential impact on public health and on services.
107
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119
ANNEX 1
PALSA Guidelines
Al

CONTENTS
PATIENT WITH .DIFFICULT.BREATHING AND/OR COUGH
Classify according to symptoms 1
Symptoms <2 weeks: ASSESSMENT AND INITIAL MANAGEMENT 2
Further treatment of the wheezing patient: AS-THMAlC0PD:EXACERBATI.oN 3
Discharge plan for the wheezing' panent who has respondêd to;treathlent 4
Further treatment of the patient-wlthfever and/or_pain on breathing ,'and'.qoughihg:LOWER RESPIRATORY TRACT INFECTION 5
UPPER RESPIRATORY TRACT INFECTIONS
Mildlyill patient with runtiy/bloc-ked nose: RHINITIS '.' ····--6---
Mildly ill patient with-pain and/or. tenderness oversinuses: A.CWTE:SlNI,J.SITIS . . 7
Mildly lll patient with sore throat ,AClJTEPHARYNGITIS, TONSILtJ1JS.,;,()R)\L:CANDIPA 8
Mildly ill patient with ear problem: ACUTE AND CHRONIC 'EAR':PROBLEMS 10
Dry mopping the ear . t1
SYMPTOMS > 2 WEEKS
w>- Diagnosing obstructive lung disease 12
Management· of chronic a sthma 13
Management of chronic obstructive 'pulmoAary disease JPOPD} 14
Chronic cough with or without sputum produqtioo; no breathlessness: ;CHRONIC BRONCHITIS 15
TUBERCULOSIS (TB).
Diagnosing TB 16
Sputum results 17
Follow-up plan forRegimen One 18
Follow-up plan for Regimen'Two 19
HIV/AIDS ------_ ..,--_... _ ..,------
Suspecting HIV/AIDS 20
Follow-up ofthe known HIV-positive patient 21
Who is eligible for long-term cotrirnoxazole (Bactrim) prophylaxis? 22
• Name
• Age
• Medical history
• Presenting symptoms
• Purpose of the visit
>~-
Exclude TB Exclude TB • Asthma (Go to page 13)
(Go to page 16) (Go to page 16) • COPD (Go to page 14)
Consider Chronic Consider Asthma • TB (Go to page 16)
Bronchitis orCOPD • HIV/AIDS (Go to page
(Go to page 15) (Go to page 12)
IF ONE OR MORE SYMPTOMS PRESENT, ASSESS SEVERITY
MILD
- ----------------------.
per minute
100-119 per minute
Blood streaking
-- - .--"----- ...._..---I
;> ASK, LISTEN: ASK,
VI MEASURE:
Wheezing, tight
chest? Fever and/or pain on
breathing or
Most likely asthma coughing
or chronic and/or sputum
obstructive production
airways
disease (COPD) Most likely LRTI, TB
exacerbation. or suppurative lung
disease.
Go to page 3 Go to page 5
. FURTHER TREATMENT OF THE WHEEZING PATIENT:
ACUTE ASTHMA/COPD EXACERBATION
"--t;:~\9~~~~~
• 4 puffs beta-agonist via spaeer every 20 minutes for one hour then reassess.
OR
Nebulise using beta-agonist every 20 minutes for one hour then reassess .
• Give 1 dose of oral prednisone 40 mg stat.
>0-\
OBSERVE FOR ONE MORE HOUR, REPEAT ABOVE TREATMENT AND FOllOW TREATMENT. PLAN FOR
THEN FOllOW DISCHARGE PLAN ASSESS WITHIN ONE HOUR SEVERE PATIENT ON PAGE 2.
ON PAGE4 If worsening of symptoms, treat as
severe and refer.
If no response within two hours, refer.
-tncrease the dose and frequency of the inhaled bronchodilator to a maximum of 2 puffs 4 times a day.
-If the patient is already on inhaled corticosteroids: check compliance (are medications taken twice a day, every day)
: check inhaler technique (are the inhalers used correctly)
-If poor compliance and/or techriique instruct patient on correct drug usage .
•Give 40mg of prednisone orally (once daily) for 7 days to patients with the following:
-History of recent emergency visits for asthma.
-Worsening of asthma symptoms in the months or weeks prior the onset of the acute attack.
-History of previous hospital or intensive care unit admission for asthma.
-If the patient reports a cough with new or increased sputum production and/or change in sputum colour (yellow, green) and/or fever,
> add Amoxycillin 500mg three times a day for 7 days OR if penicillin-allergic, Erythromycin 500mg four times a day for 7 days.-...J -If the underlying lung condition is unknown, go to page 12 to make diagnosis .
• Encourage all patients to stop smoking cigarettes, pipes or dagga .
• Book follow-up visit before medicines are expected to run out.
TELL PATIENT TO RETURN IF:
.Symptoms get worse .
•Not better after a course of oral prednlsone has been completed.
IS THIS PATIENT AT HIGH RISK OF SEVERE NOT AT HIGH RISK OF SEVERE RESPIRATORY
RESPIRATORY INFECTION? INFECTION?
• ~ 60 years old
I) Frail with suspected AIDS • Bed rest at home
o Known: Lung disease • Encourage high fluid intake
Heart disease • No smoking
Liver disease • Treat pain and fever with paracetamol 1-2 tablets 4 times a
Diabetes Mellitus day.
• If new or increased sputum production with colour change,
prescribe Amoxycillin 500mg orally three times a day for 7
days OR if penicillin-allergic, Erythromycin 500mg orally 6
>- hourly for 7 days.
00 • Look for signs of HIV/AIDS (Go to page 20)
• Ask about symptoms of TB (such as loss of weight, night
Immediately give 1 gram Amoxycillin orally sweats) (Go to page 16)
OR
If penicillin-allergic, Erythromycin 500mg orally Refer if:
AND • Getting worse, or no response.
REFER TO NEXT LEVEL FACILITY OR CLINIC • Still not completely better within 7 days.
DOCTOR
Ask about associated If:
• Mild sore throat Symptoms on most days for 2:: 4 weeks, ask about
• Fever • Sneezing
• Itching
Consider: Common cold Consider: Allergic rhinitis (hayfever)
>-
\0
REASSURE PATIENT THAT • 0.9% saline nose drops. • 0.9% saline nose drops.
ANTIBIOTICS ARE NOT
NECESSARY. • Chlorpheniramine 4mg 3-4 • Chlorpheniramine 4mg 3-4
times a day when necessary times a day when necessary
Beware: Side-effect is Beware: Side-effect is
Consider oxymetazoline 0.05% sedation. ,: sedation.
nose drops, 2 drops in each nostril
every 6-8 hours for no longer than • Refer to next level facility for
1 day. steroid nasal spray.
• Clear nasal discharge. • Symptoms ;:::7 days.
4» Mild pain over sinuses. • Severe symptoms regardless of duration.
o Post-nasal drip. • Pussy nasal discharge.
• Face or tooth pain and tenderness.
Consider: Bacterial sinusitis
.,-..".:,?:!:~-
• Amoxycillin 500mg orally three times a day for 10 days
OR
If penicillin-allergic, give cotrimoxazole (Bactrim) 2
tablets (80/400mg) twice a day for 5 days.
>- • Instruct patient to mix 1/2 teaspoon salt + 1 teaspoon • Instruct patient to mix 1/2 teaspoon salt + 1 teaspoono bicarbonate of soda in 500mllukewarm water. Sniff up bicarbonate of soda in 500mllukewarm water. Sniff up
each nostril every 4-6 hours. each nostril every 4-6 hours.
OR OR
0.9% Sodium chloride drops in each nostril every 4-6 0.9% Sodium chloride drops in each nostril every 4-6
hours. hours.
• Oxymetazoline 0.05% nose drops.ê drops in each • Oxymetazoline 0.05% nose drops, 2 drops in each
nostril every 6-8 hours for no longer than 5 days. nostril every 6-8 hours for no longer than 5 days.
• Paracetamol 1-2 tablets 4 times a day. • Paracetamol 1-2 tablets 4 times a day.
Refer if:
• Tooth abscess suspected.
• Swelling around eye or face.
• Failure to respond to medication after 10 days.
RED THROAT RED THROAT, WITH WHITE PATCHES ON
WITHOUT PUS PUS OR WHITE CHEEKS, GUMS,
PATCHES ON TONSILS TONGUE AND PALATE
Consider: Bacterial tonsillitis Consider: Oral candida (thrush)
REASSURE PATIENT THAT • Salt water mouthwash (1/2 • Nystatin lozenges 100000 IU - 4
ANTIBIOTICS ARE NOT teaspoon salt in a glass of warm times a day for 10 days.
NECESSARY. water). Gargle twice a day. OR
• Phenoxymethylpenicillin (Pen VK) Nystatin 100000 IU/mI1-2 ml
:> 500mg orally every 6 hours for 10 4 times a day for 10 days.
days.
OR
If penicillin-allergic, give • Exclude HIV infection.• Salt water mouthwash (1/2
teaspoon salt in a glass of warm Erythromycin 250mg 6 hourly
(Go to page 20)
water). Gargle twice a day. before meals for 10 days.
• Paracetamol 1-2 tablets 4 times a
• Paracetamol 1-2 tablets 4 times a day.
day.
Refer if: Refer if:
• Severe swallowing problems. • No response to Nystatin within 5
• Inability to open mouth. days. Fluconazole to be prescribed
• More than 4 documented by doctor.
episodes per year. • Extensive disease.
• Recurrent episodes.
~
C'O
C'O
.-C.Cl)t:Cl)
e
E
C'O
)(
W
A12
• Give Flucloxacillin ~::~~Mj\i~~•~~Give Flucloxacillin 250mg ~~'i~ • Dry mop ear . The ear can only heal if
250mg orally 4 times a ~:';~~*i1!.~~ orally 4 ti.mes a day. ~f"t•'.j~"'1; (Go to page 11) _1l~ll!l11l1· dry.:-> tt; 1~i1 OR d.1!l~;"';;;day OR ._.~'1,v1~_-..I,~~ If penicillin-allergic, give ~~ •• Amoxycillin 250mg ~ltB~~1111~£·_.D~ry1mop ear.w If penicillin-allergic, give ~~.iil;;~tt:-4:~~f"'',rtj'; Erythromycin stearate \~vt~::;::.;a orally three times a day B~\:'$l~,Iti.(4f-l1i:Jfi;ti (Go to page 11)Erythromycin stearate 1:Ni":f~"i~~fJ250mg 4 times a day for <~kfJ"l\i~.'i~f.'J;·ff,~250mg 4 times a day for $]i~@~'\m~~I~5 days ~!';i~~;@t;:!1ï!.)!"*'"r>'~!il for 5 daY~R •• . Paracetamol 1-2 tablets5 days. ~]~~~1~~1] tl. If penicillin-allergic, give ~~lUI~{W$l~]fJg;:!l~[f~ 4 times a day for pain,
• 2 0,'< Acetic, aci•d• aIeohol, .~~"~"~>.".".,,.,,0 In c ~~ Bactrim 2 tablets• Paracetamol 1 - 2 $«t.~r~{~~W~,i{t~~"J6 hourly for 5 days. ~r~'!Wilil %'!:; (80/400mg) twice a daytablets 4 times a day for for 5 days.
pai.n. lr,;-.m~Y~~iW\!~/r*i,~'f~I~i.,·.~.~·~~. tD~~ry mop ear. •.~~'i.'~"",;.~
(Go to page 11) "l-~. Paracetamol 1-2 tablets
,!}i't'ë®!!_.'_~.,.~...2~f1 4 times a day for pain.
• Paracetamol 1 - 2 tablets
4 times a day for pain.
,""'"""'ffii&Y",,'Jii R f 'f ~i\
i!lli';~I(i:•~e er I : ti ·tN
~J~{.~~'4.~i~,,:Jtirt;.;F"~~~ Refer .if''
Refer if: ~~.~ - - No response after 5 .ti,~~., '\•\"l(#i.i !•."'~- ~<,$!.No Improvement after 4'?~
• Diabetic. 4;;:~._:"'~-;-~i.. days. ~~~~~~! n ;~~~ ,;.;" weeks.!ir~~• If no response within 1· Swelling and tenderness ~",,1,-~,,,!,~~. -'~~$;lji--i"'l!¥~ill
~\'-,-:fdf,flJij,l~§j~l;'l1m:i~' il>.g-ilR~~ i~·
Fou I-sme Irmg d'ISCharge.
~eer~e tfi'~!' "')ll;~- ~~ .".. .48 hrs. of skin behind ear. ,,';iLila.rge hole In eardrum.
= _,_ • Persistent pain. ~~~~. Hearing loss.
Otitis Externa Acute Otitis Media Chronic Otitis Media
Inflamed eardrum
Red swollen ear canal
Dry perforation
Inflamed, swollen
>-- outer ear"""
Demonstrate method to patient.
• Roll a piece of paper towel into a wick.
• Insert wick into ear and remove once it is wet.
• Repeat 4 times a day until ear is dry.
• Insert acetic acid ear drops if indicated (go to page 10) - 4 drops in affected ear.
• Never leave the wick or any other object inside the ear.
",.~,,?'!''-
Ask if:
Symptoms started during childhood or early adulthood. • Symptoms started later in life (usually after the age of 35 years).
History of hayfever, eczema and/or allergies. • Symptoms slowly worsened over a long period of time.
Family history of asthma. • Long history of daily or frequent cough and sputum production
(usually starts long before the onset of shortness of breath).
Symptoms only during attacks with periods of normal breathing in
between. • Short of breath for most of the day, rather than at night or during the:-> early hours of the morning only.Symptoms are usually worse: at night; in the early hours of the\Jl morning; during an upper respiratory tract infection or when the • History of heavy smoking eg. more than 20 cigarettes / day for 15weather changes. years or more.
Symptoms improve or disappear after using inhaler.
TREAT AS ASTHMA. TREAT AS COPD.
REFER TO DOCTOR WITHIN 1 MONTH REFER TO DOCTOR WITHIN 1 MONTH.
Go to page 13 Go to page 14
(If unsure, treat as asthma)
If s 1 feature of asthma, and no significant history of smoking, consider a cardiac or non-lung cause of breathlessness, especially if
associated hypertension, ischaemic heart disease and/or diabetes mellitus .
._~." .~.....«.,.;,~"~"..>.~".".#.~.,,.~~-""!_'-~"~*,W:~:~~~~~~~~E(~,::;:yr~m~~?·~~~~~~~f1~~~~~~r~~~~~~~*~~~:.g:)~["~~}::,
The aim of asthma management is to obtain complete control of all features of asthma.
Aim for:
1) Minimal (ideally no) daytime and night time symptoms
2) Min~imal or~no exacerbations (asthma attacks)3) Minimal need for quick-relief medications~3',£(,'~.;'>,iJ~~~~~*~'!ili!t.m\~~I£\!!:1-'£,"2¥.i'!lK®i:1'~,,<!§~f!l<~i\l.ka~~~i:iilicWJ.,~J~~o ~~~=~~~~
...1. t'!...T. TIM!: C:VMDTnMC:
>-
0\
IF COMPLETE CONTROL AT ANY LEVEL OF IF POOR CONTROL AT ANY LEVEL OF TREATMENT
TREATMENT Increase to next level of treatment (step-up).
• Continue current medication. Consider adding prednisone 40mg orally once daily for
o At next visit, reduce treatment to previous level (step- 7 days and reassess in 1 month.
down ) if control is still complete.
Schedule next appointment.
• Encourage patients to stop smoking in order to prevent worsening of disease.
• Improve symptoms with inhaled bronchodilators.
• Recognise and treat acute exacerbations early.
ENCOURAGE THE PATIENT TO STOP SMOKING
Ask: Identify and document all tobacco use at each visit.
Advise: Strongly urge the patient to quit.
Assess: Determine willingness to make a quit attempt.
Assist: Help the patient to quit.
Arrange: Schedule follow-up contact.
I MODERATE I SEVERE I1t~ft.~éi~r8N'gITH ~:CTION ~---1
»_-. !I Symptoms I Mild-·b-;~~.;~I~ssnesson I B~~~~~ï~ssnes~on minimal I Ankle oedem~""""""'"
: Increased sputum _ I
I i purulence or colour I-J usual activity I activity or continuously. change to yellow/green i
~-._...- ' ..- ---1·-·---- ..)
1 Treatment Options
I Bronchodilators
I Inhaled salbutamol 2 puffs when needed 2 puffs when needed 2 puffs 4 times a day 2 puffs when needed
Inhaled ipratoplum 2 puffs when needed 2 puffs 4 times a day 2 puffs when needed
bromide (up to 4 times per day) (up to 4 times per day)
'- ._L~ tablet 2 times per day 11 tablet 2 times per day 1 tablet 2 times per day! 1 tablet 2 times per day!
Amoxycillin 500mg three
times a day for 7 days
OR
If penicillin-allergic,
Erythromycin 500mg
four times for 7 days.
Prednisone 40mg orally '1
L.._~o~~_~~.~.~]_4!~d~a~ys
f;.~~mtIf.J:~~trn:k~ic!@
II Usually in heavy smokers, or those with lung damage.
o Daily cough with or without sputum production for months or years.
9 Usually begins in middle or old age.
• Heavy occupational (dust. mines. industry) or domestic air pollution (indoor fires or gas stoves) exposure in some.
;>
00
THE MOST EFFECTIVE TREATMENT IS TO REMOVE THE CAUSE!
• All patients should be advised to stop smoking.
• If possible. avoid domestic pollution. occupational exposure and substance abuse (eg. dagga).
Refer:
• If no history of smoking.
SUSPECT TB WHEN:
• Patient reports cough for ~ 2 weeks.
III Unintentional weight loss.
e Loss of appetite.
• Night sweats and fever.
o Blood-stained sputum.
Known HIV-positive or AIDS patients.
Test sputum: Label bottles before dispensing them to patients.
METHOD OF SPUTUM COLLECTION
Patient: Nurse:
>.....-.. • Must stand in a well- • Must not stand in front of
\0 ventilated room or patient during the
outside. procedure. Day 1: For Acid-Fast Bacilli Day 1: For Acid-Fast Bacilli
• Replace and secure the (AFB's). (AFB's).
Cl Rinse mouth with water. lid immediately.
• Wash hands after Day 2: Early morning sputum, Day 2: Two early morning
• Take a deep breath, and handling specimen. at home, for AFB's. sputa, at home.
cough forcibly. e Place specimen in bag II 1 for AFB's
and store in fridge while III 1 for culture and sensitivity
awaiting collection. testing.
CXR report does not suggest active TB or other condition
requiring immediate referral.
Repeat 1 sputum for AFBs
Schedule follow-up
Sputum AFB-
• Give Amoxycillin 250 mg orally 3 times a day for 7
days .
• Schedule follow-up.
Little improvement Improvement
;J> o Repeat 1 sputum • Suggests other
oN for AFBs respiratory diagnosis
• Notify and register patient.
• If new case, or previous confirmed TB treatment for < 4 weeks, register as NEW CASE; SPUTUM-POSITIVE PULMONARY TB
and start the intensive phase of REGIMEN 1. (Go to page 18)
• If previous TB treatment tor z 4 weeks, register as RETREATMENT PATIENT; SPUTUM-POSITIVE PULMONARY TB, and start
the intensive phase of REGIMEN 2. (Go to page 19)
o Offer HIV test to all patients. (Go to page 20)
Select DOT su
-v; ",- ,~:::, . • ~
.:,.. ..... -.:"-'
Sputa AFB+ AFB- OR Sputa AFB+ AFB+
• Continue intensive phase for 1 more month.
At the end of 3 MONTHS, repeat 2 sputa for AFBs
• Schedule follow-up.
:> l.'I!~~~%~%r;i~
N Sputa AFB+ AFB- OR Sputa AFB+ AFB+
• Take sputum for culture and sensitivity.
• Schedule follow-up.
• If susceptible, continue. If resistant refer to MOR unit.
.~.:.1;-::
START CONTINUATION PHASE < 50 kg
Rifampicinllsoniazid 150/100mg. 3 tablets
Rifampicinllsoniazid 300/150mg.
. At the end of 5 months of treatment, take 2 sputa for AFBs. Schedule follow-up.
r~.~~'ï~J'~1~~~Ë'"Jlf~~~frrrlfa::~j ~~~~l~~~6.~1.f'!l~~~~~~~~~1&~~4H~~~~~~fj:S~~~ t:;J(fr::~:·~:~I-,~;:~·\.;"·,::~;.·~'!~.,·2·:j~~,:.~,'·::.
Sputa AFB- AFB- or unable to produce sputum. Sputa AFB+ AFB- OR Sputa AFB+ AFB+
• Stop treatment and register as CURED. • Register as TREATMENT FAILURE.
• Discharge from TB clinic. • Take sputum for culture and sensitivity
• Refer HIV-positive patients to the general clinic for • Re-register as a RETREATMENT patient, and refer to follow-up
further management. plan for Regimen 2.
START INTENSIVE PHASE
Rifampicin/lsoniazid/Pyrazinamide/Ethambutol 120/60/300/200mg (given 5 days a week) PLUS
Streptomycin (given 5 days a week) intramuscularly.
THIRD MONTH
Rifampicin/lsoniazid/Pyrazinamide/Ethambutol 120/60/300/200mg (given 5 days a week) ONLY 4 tablets 5 tablets
_"U~·:;:~ ~4£~;~f~-''''''':;:~·é:·.
At 6 ~w-eeks r-e._v-_i.ew-.-the_--s-._us_c-e-~p~ti~b~ili.t_y---_.-r-e-sults of the initial sputum. If:. "'.-.'- --'- .. _,_, _'-, .. .....
Susceptible
• Continue treatment
i}~~~,t~:!~:~~~srZ::)i?-~.t:·i-~,:_;~~~;.'·~:;~~~~}'·."~'·'"
At the end of 3 months, repeat 2 sputa for AFBs
»- • Schedule follow-up
tv
tv ~1?i:~2%1f,gi~~~~r&f~~?~~[~t~~~~~~if;j~}t4!~
Sputa AFB+ AFB- OR Sputa AFB+ AFB+
.• Repeat sputum for culture and sensitivity
.• Schedule follow-up
--.·..~,.~t
START CONTINUATION PHASE . < 50 kg ~50 kg
Rifampicin/Isoniazid 150/100mg + Ethambutol 400mg 3 tablets + 2 tablets
Rifampicin/Isoniazid 300/150mg + Ethambutol 400mg 2 tablets + 3 tablets
~*.i~;;jL1.~~:.~'.i&i~tFb~~j:_i:~~~1;~:%.;j~].)r.~,):;:::;:::?~_~;,~_:~,.'.~.~.;y'...:'-:.~ .~~f'1:!5;?!i,:,-m-;~;:):,-:);.):'c.';_~t.:~Fj~:f~~'~~f.:j.i;~:;:f:..~~S{.,!~~~~~~~~'U;i$tf:.£~~.~~t~*;~;B2~~~~~:i:'f.i:i~~·:W.:;~:J~1~.¥tf~fJ,I~~:r~·:?11;1ft~j:~.~·_,~~:t:l<:iJ:~~:~;;~~i;!'v.~';:~:;·r".:~·~~J.h~~}:';:~::\~;\;;~:-~·'·.f~
At the end of 7 months of treatment, take 2 sputa for AFBs. Schedule follow-up.
~:..~~j._it.~·,$4'?§jal;~!~;:.é-ji1;5..tt't~~~'t·:'".:.~.j.~.;:~,?.....:::~.~:~,: ·;:"?~·~~:·-$i;,'_! ~;~:il-;,~,,;:'/;.~;~i~';~·.:~;!~.~~~~:';}~:!!~s:.~~r.~"'P;~~~7t?¥~.~ "P :~;:j}.;:,.:..:~~s:,:'if'i:~.:".;.~:·.f::' ,r ~~::.·{r.~'~..' ,.:, ""~.:.~:.';"',';:";-,:}."'-".'.
, Sputa AFB- AFB· or unable to produce sputum. Sputa AFB+ AFB- OR Sputa AFB+ AFB+
• Stop treatment and regislerasCURED. • Register as TREATMENT FAILURE.
• Discharge from TB clinic. • Take sputum for culture and sensitivity.
• Refer HIV-positive patients to the general clinic for management. " Refer to MOR unit.
I) Painless swollen glands
• Recurrent respiratory infections • Long history of diarrhoea
• Mouth lesions eg. Oral candida • History of engaging in high-risk behaviour (eg. Vaginal, anal or oral
• Skin infections eg. Herpes Zoster sex without a condom)
o Severe weight loss
IJ Unexplained fever for> 4 weeks
• Sexually transmitted infections
White patches in the mouth, which are scratched off with difficulty, causing bleeding (ORAL THRUSH/CANDIDA).
Painful rash with blisters, confined to one part of the body (HERPES ZOSTER).
Bluish-black patches or lumps on skin or mouth (KAPOSI'S SARCOMA).
Evidence of severe loss of weight.
Genital ulcers or discharge.
;l>
tv
\jj
INFORM ABOUT VOLUNTARY CONFIDENTIAL COUNSELLING AND TESTING (VCCT)
Educate patient about HIV/AIDS, methods of transmission and risk factors.
Explain about VCCT:
Who will perform the counselling and the testing.
That it is completely voluntary .:
That testing is confidential.
How testing is done.
When and how results are given.
What the results means.
• If patient agrees to have VCCT, refer to the lay counsellor for testing.
• If a lay counsellor is not available, refer to health facility where testing is available.
~~.::.::~:::-\''-:;};:-r': c, ::::'~':'~' '<::;~"~~>~-:~··;~:'1:';.;:1.·~:~d:'~:':::::~~t:~·)~
ei Establish a relationship with the patient and encourage regular follow-up.
o Respect his/her right to confidentiality.
fil Refer to the lay counsellor should the patient require further counselling.
El Encourage safer-sex practices.
IJ Provide medical care at each visit.
Cl! Look for and treat HIV-related diseases.
)- ORAL ASYMMETRIC LARGE ANY OTHER HIV-
~tv THRUSH/CANDIDA GLANDS RELATED DISEASES
. Refer: Refer to:
For exclusion of extra- South African Department
pulmonary TB. of Health booklet:Recommendations for the
prevention and treatment
of opportunistic and HIV-
related diseases in adult.
(www.htlp://196.36.153.56
/doh/aids/docs/adult.html)
WHO IS ELIGIBLE FOR LIFE-LONG COTRIMOXAZOLE (BACTRIM) PROPHYLAXIS? ..
(2 SINGLE STRENGTH TABLETS (80/400MG) PER DAY)
• All HIV-infected TB patients. • Cotrimoxazole (Bactrim) prophylaxis is started at a higher-
level facility.
• All symptomatic HIV patients (World Health Organisation (WHO)
stage 2,3,4). Refer below.
al If previous diagnosis of Pneumocystis carinii pneumonia.
.' ..
•-. ••'.C,'_·'-
ADAPTED FROM THE WORLD HEALTH ORGANISATION (WHO) CLINICAL
STAGING FOR HIV INFECTION
STAGE 1 STAGE 3
)0- Without symptoms. Significant unintentional weight loss.
N Acute viral illness following HIV infection. Diarrhoea for more than a month.
Vi
Persistent swollen glands < 2 cm and symmetrical. Fever for more than a month.
Oral thrush/candida.
STAGE 2 Pulmonary TB in the last year.
Unintentional weight loss. Severe pneumonia or other bacterial infections.
Minor mouth and skin conditions (dry skin, mouth ulcers, fungal Vaginal candida for more than one month, or poor response to
nail infections). therapy.
Herpes Zoster within the last 5 years.
Recurrent upper respiratory tract infections (eg. sinusitis). STAGE4
Chronic weight loss plus diarrhoea or fever.
Diagnosed opportunistic infection.
Extra-pulmonary TB.
Kaposi's sarcoma.
HIV dementia.
Diagnosed cancer (eg. Lymphoma).
AUTHORS ,
Dr R. English
Professor E. Bateman ...-..n-rQII~fOIIIH
> Dr M. Zwarenstein -"""""tv
0\
CONTRIBUTORS
Members of the PALSA project. -
~MRC
-=:zma
.. ~IU:..1.M..C.t",.
ACKNOWLEDGEMENTS
Professor S. Naidoo for the use of the images of oral candida.
Professor C. Prescott for the use of the images of the various ear conditions.
\~m\~ J
WClM.DlCItlnl~
ANNEX2
PALSA Training Record
A27
PALS A TRAINING RECORD
Please complete for every training visit Fax completed forms to Bosielo Majara 051 4489278
Name of Trainer:
Name of Clinic:
Date of Training session:
A TTENDANCE REGISTER (complete at clinic)
First Name Surname Rank e.g. CPN, SN, Year qualified from nursing
EN college
TOPICS COVERED DURING SESSION (S)
Tick topics covered during the trainiru visit. You may tick more than one topic.
Severely ill respiratory patients Asthma I COPD
URTI TB
LRTI HIV
TRAVEL DETAILS
Indicate type of car used for travel to the clinic. You may tick only one box.
Subsidized government car Private vehicle
Car from government pool ~!~: ';'(l"Jj,Ji)lP;t<!~""iIl:;":;t.l'. ;,.~;t.,,.~•• ~~,1:"~,..". •:i.I"' • .(".. \~~ ·'."~'~~tm• t":~~;E~~lt,Cf
Enter if petrol or diesel: Enter engine capacity in litres
Enter year of manufacture: I.~\~'tj;~». ~.ái:;~~''r~.;~.".:' ";;,ii(;;'!:!i:~'""'· ...aft;.'· ~-t:~~'.~~!o/".'·~'K~
Enter km at start: Enter km at end (return journey):
REFRESHMENT COSTS VENUE HIRE (if applicable)
Enter amount spent: I Enter cost: I
TRAINER TIME Enter time to nearest half hour (e.g. 30 mins, 2 Y, hours etc)
Time spent traveling 1,~~i~·:.j!(li,:;$t·*:.f1~~frlf'>'~l~:~~;U·:·t~;:~~~,'iilljt~:y$~..iKf~
Time spent on PALSA activities at Time spent on non-PALSA
clinic activities at clinic
A28
ANNEX3
Standard letter to district/clinic managers
A29
THE UNIVERSITY OFTHE ORA"ICE FREE~"ATE
Department of Community Health Faculty of Health Sciences
Mr. B.P.Majara Dept. Community Health (Research Unit)
PO Bnx 339 (GS2) Telephone: 27 (051) 4()53625, fax: 44R927R
Bloemfontein 'JJOO, South Africa Email: gngmhpm@med.uovs.ac.1.1
The District Manager
Ms T Morigihlane
Lejweleputswa District
Kopano Complex
Private bag X 15
WELKOM
9460
Tel: 057 3524375
Fax: 0573529277
26 March 2003
Dear Ms Morigihlane
This is a follow up to a letter dated 26 March 2003 which was transmitted to you by fax
on the same day regarding the Practical Approach to Lung Health in South Africa
(PALSA) Project. Kindly note that following that letter, the following developments have
taken place regarding the project:
I. Some of scheduled training of professional clinic nurses by PALSA trained TB
Coordinators in your district have commenced. We are keeping record of all trained
clinic staff and this activity is scheduled to go up to September- October this year.
2. Preparations are underway to conduct Lung a Health Survey to establish the extent of
adult lung problems in the province. As part of the survey, we wish to collect some
information in the 40 trial clinics in the province, some of which fall within your
district. We will be sending field workers to collect data on lung disease in the 40
clinics at the beginning of May through to November this year. These field workers
will receive training on all aspects of data collection for the project next week.
By this letter, we hereby solicit the following administrative support from you and your
district health team:
(a) That our field workers be provided with office space for conducting interviews with
patients presenting with respiratory disease at the primary care clinic. The fieldwork
is expected to take a maximum of five days per clinic.
(b) That during the fieldwork (preferably at the end of each day), our field workers be
allowed to use the clinic's telephone line to transmit data to a central information base
for the project through a toll free number. This will be done by down loading from a
A30
PDA, a device used for collecting data in place of a paper questionnaire. This will
have absolutely NO financial implications on the clinic's monthly telephone bill.
(c) That you kindly convey the above two messages (a &b) to management of clinics that
fall under your supervision.
We promise to cause minimal disruption to clinic operations during our fieldwork. I will
follow up with the clinics' management on the exact dates of the fielding of our data
collectors and will keep you informed all the way.
Below once again is a list of clinics in you district which are part of the survey which our
field workers will be assigned to visit:
For further clarification on the above issues, please do not hesitate to contact me at any of
the above contact addresses.
Regards, £
Bosi·e10Ma·Jara I"
Community Health D artment. UFS
List of clinics
I. Khothalong
2. AM Kruger
3. Hoopstad
4. Bothaville
5. Bophelong (Odend)
6. Thabong
7. Tshepong
8. K-Maile
9. Albert Luthuli Mem
10. Phomolong (Henn)
Il. Welkom
12. Boithusong
A31
ANNEX4
Doctor's Letter
A32
Dear Doctor March 2003
The Practical Approach to Lung Health in South Africa (PALSA) is a WHO initiative to improve the
management of adult patients with respiratory disease in primary care, particularly the initial care
provided by frontline nurses.
It follows in the footsteps of the widely successful Integrated Management of Childhood Illness
(IMCI) in that it has adopted a syndromic approach whereby patients are categorized and treated
according to symptoms.
Clinicians and Researchers from the University of Cape Town Lung Institute, Medical Research
Council and University of the Free State have adapted the package for local use in collaboration
with primary care physicians and nurses, and the Free State Department of Health.
The next step is to test whether the programme improves the treatment of patients. This will be
achieved by means of a controlled trial involving 40 clinics in the Free State between April and
November 2003. District TB co-ordinators will train nursing practitioners at clinic level and the
impact on rational prescribing practices, TB case detection and the health status of patients will
be measured. An economic evaluation will examine at what cost any benefits are obtained.
Implementation of PALSA should have little impact on your clinical activities. However, you might
recognize changes in the nature of patients referred and the treatment that has been initiated in
the pilot clinics. These include the following:
1. PALSA will teach nurses to identify severely ill adult patients requiring transfer to the
next level facility using "danger signs".
2. Provision has been made for Primary Care Nursing Practitioners (PCNPs) in pilot
sites to initiate cotrimoxazole prophylaxis in HIV-infected symptomatic patients.
3. These PCNPs may also initiate inhaled steroids in known or suspected asthmatics
provided that the patient is reviewed by a doctor within weeks of starting treatment
4. PCNPs may also prescribe short courses of oral steroids for patients with
exacerbations of asthma and COPD.
These provisions have been approved by the Pharmaceutical and Therapeutics Committee of the
Department of Health of the Free State for the purpose of the study, and policy will be reviewed at
the end of the pilot phase.
Your understanding and assistance is integral to the success of the programme and we look
forward to sharing the results of the pilot phase with you.
Should you require further information please contact:
Dr Lara Fairall Mr Bosielo Majara
University of Cape Town Department of Community Health
Lung Institute University of the Free State
Phone: 021 4066850 Phone: 051 4053625
Email: Ifairall@uctgsh1.uct.ac.za Email: gngmbpm@med.uovs.ac.za
Best wishes
The PALSA Team
A33
ANNEX5
Drug Circular
A34
FREE STATE PROVINCE
M. Makhele
Clinic Manager
Botshabelo Clinic B
PO Box 5051
Botshabelo
9781
Fax: 051 5341096
Dear M. Makhele
Re: Practical Approach to Lung Health in South Africa
Changes in prescribing provisions for Primary Care Nursing Practitioners
This letter follows previous correspondence detailing the Practical Approach to Lung
Health training programme which is being 'piloted in your clinic.
The following changes in prescribing provisions have been made for Primary Care
Nursing Practitioners (PCNPs) trained in the programme. They are as follows:
1. PCNPs may initiate lifelong cotrimoxazole prophylaxis (dose = 2 single
strength tablets or 960mg daily) in HIV positive patients with symptoms.
2. PCNPs may initiate inhaled steroids (Inflammide® maximum daily dose of
800mcg) in known or suspected asthmatics provided patients are reviewed by
a doctor within one month.
3. PCNPs may prescribe short courses of oral steroids (40mg daily for 7 days) in
patients with asthma ICOPD exacerbations.
These changes have been approved by the Pharmaceutical and Therapeutics
Committee of the Free State Department of Health and financial provision has been
made under the TB programme. The drugs are available from the Medicines Depot on
request. The changes will be reviewed at the end of the pilot in order to inform policy in
the rest of the province.
In order to maximize the benefits of the PALSA training in your clinic, we ask that you
please ensure that these medications are available to Primary Care Nursing Practitioner
staff in your clinic from commencement of the PALSA training. ~-r.~
~ .. ~ o.,..._OIIa...1do
~.~":: :::::-.:-:':'=
':;;;::;~;;~:i~;a;,'.~D:ep..artmc..nt of Health 'I" De_p,a_ r.tc,_m_' ent v_._an__ G' es"o_'n, d._h.,.e._id ._~._""L__ef_ap__-.._h..a L- a-._B.. op- .helo Bo Botle '·7:;;~';;~~;~;;·~"'1j-
General Manager - Health Support, Dr RI) Chapman, • PO Box 227, Bloemfontein 9300 • Tel: 051-4033431
Fax: 051-4098008 e-mail - chapmard@doh.ofs.gov.za • Room 505, Lebohang Building, St Andrews Street. Bloemfontein
A35
If you have any further queries please contact the Medicines Depot or Mrs. Annatjie
Peters, Provincial TB Coordinator. The contact details are as follows:
Medicines Depot (Attention Johan Meiring or Elzabe Oliveer)
P. O. Box 7622
Bloemfontein
9300
Phone:0514303091
Fax: 051 4302208
Mrs. Annatjie Peters
Provincial TB Coordinator
P. O. Box 396
Kroonstad
9500
Phone: 0562122271
Cell: 082 8231050
We look forward to working with you in the coming months and sharing the results of the
pilot with you.
Kind regards,
Ki) U+"A/C'"
Dr RD Chapman
General Manager: Health Support
'7 jll- I '-CD ::s
",~,.""..(""""",~,
, .... 'J....•• '........~'" Departmcnt ol Health v Departcmt::nt van CC~c:'!'.dhcid " '=-.t!.~'pl'-iL\.~.Hophe lo Bo Botle , ......"';..,..,,_,,,... \O~'_... ........~.~.., ••
General Manager - Health Support, Dr lW Chapman, • PO Box 227, Bloemfontein 9300 • Tcl: 051-4033431
Fax: 051-4098008 e-mail - chapmard@doh.ofs.gov.zlI • Room 505. Lebohang Building, St Andrews Street, Bloemfontein
A36
ANNEX6
The selection process
A37
HOW TO SELECT PATIENTS FOR INTERVIEWING
AFTER CONSULTATION
1. From the fast track queue for ill patients:
• Select every patient who answers "yes" to:
"Do you have or had you had any difficult breathing and/or
cough today or in the last 6 months?"
• Exclude patients who are clearly too ill to complete an hour long
interview. Clear examples of patients who are toll ill to
participate are:
o unconscious patients
o patients who are not breathing
o patients who are unable to talk
o patients who are psychotic
2. From the general queue:
• On arrival obtain the headcount from the previous day. If you
are interviewing on a Monday use the headcount for the
previous Thursday.
• Use the tables on the next page to work out how often you
should select a patient who answers "yes" to difficult breathing
(DB) and/or cough (today or in the last 6 months) in the general
queue.
• Example: You determine that you should select every 3rd
patient for interviewing. Ask every patient in the general queue
about difficult breathin~ and/or cough (today or in the last 6
months). Ask every 3r patient who answers "yes" to meet the
interviewing team after their consultation with the nurse today.
A38
SELECTION OF PATIENTS FROM THE GENERAL QUEUE
WITH 2 INTERVIEWERS
Headcount from previous day Select .... Patients who answer
(General queue) yes to DB / cough
Up to 70 patients Every patient
71 - 140 patients Every second patient
141 - 200 patients Every third p_atient
201 - 270 patients Every fourth patient
271 - 340 patients Every fifth patient
341 - 41 0 patients Every sixth patient
411 - 480 patients Every seventh patient
WITH 3 INTERVIEWERS
3. From the fast track TB queue
• This will differ from clinic to clinic based on the number of
patients attending for TB treatment at each clinic
• You will receive specific instructions for each clinic.
• Team leader to identify on what day of the week, most patients
attend the TB service at that particular clinic. This day is to be
set aside for interviewing TB patients and reaching your "TB
target".
Compiled by Lara Fairall
A39
ANNEX7
Patient screening questionnaire- English version
A40
Patient Initials: I I Date: I I Clinic: I I Interviewer code: I
FREE STATE LUNG HEALTH SURVEY
SCREENING QUESTIONNAIRE
PATIENT DETAILS
3 ' Enter first name: • 4 : Enter surname:
I I
5 Gender: ' Male I I Female j(Mark with an X)
6 ; Enter folder no: 7 I Re-enter folder no: !
i
DOESTHE PATIENT QUALIFY FOR THE FULL INTERVIEW?
8 I What is your date of birth? If you don't know your date of birth, enter age at last birthday.
\9 i Date: I I Month! • Year I ! --> 1987 of after? -) do not continue
I 11 ! Age at last birthday: I i --> 14 years or younger? -. do not continue
12 Have you participated in this study before (full questionnaire ± 1 hour)?
YES I ~ do not continue
NO i _. go to the next question
I
Were you seen ONLY by a doctor today?
13 YES I ~ do not continueI
! NO iI I --> go to the next question
! i
! Were you seen by a nurse/nursing sister today?
I
14 I YES I I -> go to the next question
I NO I ..-. do not continue
I
i Do you have difficult breathing (tight chest, shortness of breath, wheeze) todáy?
I
15 I YES I _, CONSENTi I! _., Skl.p to questi.on 17
: NO ! _, go to the next question
;
1
,: Have you had difficult breathing (tight chest, shortness of breath, wheeze) in the last 6 months?!
! YES !
16 _...CONSENTi
i .....g. o to the next question
: NCl--- ! _, go to the next question
I i
COMMENTS FROM EDITOR ! COMMENTS FROM DATA CAPTURER I
Please correcUcomplete Fieldworker tiek ! Fieldworker tick • Please II Fieldworker tiek I Fieldworker tiek Capturer tick ithe following question (s) if completed: : if completed: : correcUcomplete the if comPlet~d: if completed: if completed:
! 1 following guestion (s) II
! I I !J
I I I I I
A41
Patient Initials: I Date: I Clinic: I I Interviewer code:
Do you have a cough today?
17 YES I I -> go to the next question
NO I .1 ......do not continue
For how long have you been coughing?
Choose one ootion and enter number.
Days ...~ 19. Enter number:
18 Weeks ......19. Enter number:
Months -+ 19. Enter number:
Years -> 19. Enter number:
20 Interviewer: For how long has the patient been coughing?
6 days or less - go to the next question
7 days or more .....C. ONSENT if haven't already done so
-> skip to question 22
21 Have you had another episode of cough like this one in the last 6 months?
..._-----
YES .....CONSENT if haven't already
..~,go to the next question
NO _" go to the next question
22 Interviewer: What is the respiratory rate?
Count number of breaths over 1 full minute.
Enter Respiratory Rate (breaths/min)
I I
23 Interviewer: What is the respiratory rate?
29 breaths I minute or less ~ go to the next question
30 breaths I minute or more ~ CONSENT if haven't already
-+ go to the next question
24 Interviewer: What is the patient's temperature?
Take the temperature with the thermometer.
Enter Temperature (in degrees Celsius) I
I
25 Interviewer: Is the temperature 38 degrees Celsius or more?
37.9 Celsius or less -+ Patient consented already? .....c..ontinue with question 27
.... Patient not yet consented? -+ do not continue
38Cëlsius or more _, CONSENT if haven't already
.., complete full questionnaire
-. go to question 27 (top of page 3)
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
Please correcVcomplete the Fieldworker tick If Fieldworker tick if PI~a~a correct/complete the FieldwOrker tick if Fieldworker tick if Capturer tick if
followin~ ouestion(~) . completed completed; fOltowir19_9.uestion{~ comQleted: colTlQleted: completed: -
A42
ANNEX8
Patient information and written consent form- English version
A43
PATIENT INFORMATION AND WRITTEN CONSENT FORM - LHS
Study Number: _
Patient's Initials: _
You are invited to participate in a Randomised Control Trial. Before you agree to take part you need to
understand what it involves.
Purpose of study
Researchers from the UFS Community Health Department are studying patient's who present to primary
health care clinics with a complaint of difficult breathing and/or cough.
The reason for doing this study is to test better ways to diagnose and treat lung disorders. We will compare
nurse diagnoses of respiratory diseases using PALSA intervention compared to a nurse without PALSA
intervention.
What are the possible benefits of participating in this study?
The information that we obtain from the study will help us improve the diagnosis and treatment of respiratory
disease by nurses at primary health care level. You will be entitled to a R60 worth of food upon your return
to the clinic for a follow up visit 3 months from today.
What are the possible drawbacks or discomforts in participating in this study?
None since this is only a training intervention.
Do I have to participate in this study?
Your participation in this study is voluntary. Should you agree to participate, you are to sign this form. You
are free to withdraw from the study at any stage and this will in no way affect your management. Likewise,
should we feel that further participation in the study would not be in your best interest we will withdraw you
from the study.
What will happen to me if I participate?
After being seen by a clinic nurse who will record information about your medical history and your current
condition, you will be screened for whether you qualify for inclusion to the study and questionnaire.
Thereafter, you will be escorted to another cubicle where you will be interviewed by a research assistant
using an exit interview questionnaire. Information regarding your medical history and current condition will
also be recorded. You will then be requested to return to the clinic 3 months from today for a follow up visit.
Will the information remain confidential?
Should you agree to participate in the study all your records will be viewed by the researchers only. Your
information will not be viewed by any other persons or parties not involved in this study. All the information
will be safely stored on a computer and at the study site. At no time will anyone be able to link the
information stored on the computer to your name.
1.1 Contact details of the study staff
Should you have any questions relating to this study, please contact any of the following members of our
researchers.
Name __ Phone Number _
Name __ Phone Number _
A44
1,.........•.•....•.•....••...•.•...•..•.••.•.•.•••..••..•..••••.•.••••..•••.•.•.•••••.••••.•••....•••••
(Name of Patient in block letters)
have read and understood all the information given to me about my participation in this study and I have
been given the opportunity to discuss it and ask questions. I voluntarily agree to take part in this study and
understand that I will receive a copy of this consent form.
Signature of Patient Date
1.2 Printed name of Patient
I have explained the nature and purpose of the study to the Patient named above.
Signature of Principal Investigator or delegate Date
1.3 Printed name of Principal Investigator or delegate
A45
ANNEX9
Reminder form
A46
DEAR (lnsert name of patient)
We would like to schedule a follow-up interview for 3 months' time to check-up on your
progress and state of health. This interview will be similar to the one we have just
completed, and we will ask you about your quality of life, regular medications and visits
back to this clinic or other health care providers.
The interview may be conducted here at the clinic or at your home, depending on what
you and the interviewer agree to today.
If you agree to meet at the clinic, bear in mind that it may be on a different day to your
next check-up visit. If this is the case you will not be required to wait until after you have
seen the nurse. Remember to bring along your regular medications so that we can record
the details at this interview.
At the follow-up interview you will receive a small food parcel in appreciation of your
participation in this survey.
Once again, thank you tor your participation today.
DATJE OF FOLLOW-UP INTERVIEW:
I DAY OF THE WEEK I DATE I MONTH
!FOLLOW-UP AT •.•.
(Choose one)
THIS CLINIC Lj ENTER NAME OF CUNIC: ..
AT PATIENT'S HOME L.,
A4?
ANNEXIO
First post-intervention survey interview questionnaire- English version
A48
Interviewer code:
ht chest, shortness of breath, wheeze
Do you have difficult breathing (tight chest, shortness of breath, wheeze) today?
27 YES .- .-..-.--t-. I ----------"< skip lo question 29 -
NO I ' go to Ihe next question
Have you had difficult breathing (tight chest, shortness of breath, wheeze) in the last 6 months?
28 ____ o_YES
NO
For how long have you had or did you have difficult breathing (tight chest, shortness of breath, wheeze?
..f.hoQ~.~..one option a~2.~JlJ.~..!!um_~~~.:. _ _ __ __.____ ..__ . _ .
Days -., 30. Enter number:
---_._._--------+-----_ .-.1--._---_ ._. ------_._-- -----------
29 Weeks .. 30. Enter number:
Monlhs . 30. Enler number:
Years . 30. Enter number:
31 Does this difficult breathing trouble you continuously, so that your breathing is never quite right, or does it trouble
'''~~~f~ri~~~~!y ':~tal~ay'~ g~ts <:()rnPI~rIY betterr . - ..- .
Does this difficulty breathing trouble you only when walking fast on the flat or uphill or also when resting?
32 ....9.!!!Y. ..---····--·-··--· ..-··-..·-...-.··..··.·.··..·--T..·-··..·-..-··-r·.·.------·-··-····· .·.·.·-.··.·..·.·.··-···-···when walking fast I uphill I
When restlnq (sittinq etc.) I I
Do you experience sharp chest pain on breathing in deeply with this current illness?
33 .\' .. . .
-y!=..§ .
NO I·· ..
Does your che·s·t ··w-.h·.·e··e-z-·e_(·m·a·k-e-.a=w=hi-s-tli~ng-=s-o-uFnd=) ~w-hle-n-.·-.y·-o·u··b·re_a·th34 -e·-with you.-.r .·c.u-r-rent illn-e.s_s-?----..- _ ---.-._...
YES
NO
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
Please cO(f'f)ciiëOlltpiëïëltte··------""'F::-,.7,dw:--o,'-ke·-,.b""c""k;7,'--r-::Fi'""'eI7ctw-07,k-.,''''ticl<''''-';-if·---t-'p"-la:-::as=.C::co=,=,.::'-cu:::co=m:::pIWaI-=-. "'lhe::--"'-;F~ie-;:;'~w=o::::;rI<:::'e,:-:IIC:;'ck:-:if;- -.,.-;F:::ie-;:;Id\=yo::::;rI<ca~':-:,id<~if,.---r-,;C::cap::::,u.".recc' 7ticl<77i1--j
followl"l1..'lllOSIlOlllsJ.. __ .. _ . compleled , +-"C0;o."'",,'P ",-110;;;.10<1",:___ follOWing quoslion {S) t-.;:;co"'m"'pll""el.;:;ed:.:... t-='com",n""pll""el.;:;ed,,-' -+.:::co",m~PII::::'el::::ed,,-: .. _
---------- -.-.-----+--- .-.---+-------.---- .-.-.----f---.-.--. --.-- .-.--
---- .·.-------I------ .-.-t--------+----------I--------+-------·- ---..-..-..--
A49
Patient Initials: Interviewer code:
35 Do you have a cough today?
YES --.-.---.-.-.-r.------.---.=r: ------_._.-.-. go to the next question
'Nc)' I ... -'-=~'skip to question 43 ( top of page 5)
36 Are you coughing up phlegm or slime with your current illness?
YES
~
What colour is your phlegm I slime with this current illness?
. g.t1.()2.~_one o~tion i.,
37 J:;I~_êE.L..:.W-=h-"it::;e,--_._
.Yello.~ I Green
Other
Are you coughing up blood with this current illness?
38 YËs --T" ------------_._ - _- .. _--_.
NO -I
Do you experience sharp chest pain on coughing with this current illness?
39 YES
NO
Do you experience sharp chest pain on breathing in deeply with this current illness?
40 ...--' _- --_.- - - .. ._--+,-------,---_._._._---_._ ..- "'-._' _._ _-_ .._ -~~S -------- .. -1
Does your chest wheeze (make a whistling sound) when you breathe with your current illness?
41 ~~§ ..-.-:~~-=--.--.--_ -.- ~·~=·::=F~-·--~=i-·---·-····----·-·------.----- ..- - - -..-.-------
Did the nurse who saw you today ask you for how long you have been coughing?
42
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
Please correcucomplete Ihe Floldworker tick it FieldwOfker hek il ~leldl.vo,ker liCk il ._- -cap'!urcr tick jf-"--
fOllowinqfluestiorlj!L. __ .__._._ ....E.?~P-.l.~~~.;.. +",COO""",I",OI..,=, .~!!!OJeled:_- completed'
----------.--.--1------+-----+--------j------I----- t-------I
1---------+------+------11--------1--------·--···-- -.-.-...--..-.------1-------
ASO
Patient Initials:
43 With this current illness, do you sweat a lot at night so that your pajamas or bed clothes are wet?
YES I I
NO 1 1
44 Do you have a runny or blocked nose with this current illness?
_._-_._--- ._--------------_. __ ._-------
.~~?.- _···_-_·_--------_ ._. --+·--·1
Do you have a sore throat with this current illness?
45 YËS_·~.·.._.·..·..·..-·.~._.-·--.....·.-.·..·-----·- ..--~ I..·-·-·-,I------------.-.------..-------·---.-----.-------.---.----..------.--------- -NO - .' . -{-- .
Is your ear leaking pus with your current illness?
46
..Y.ES. _ .._ _ . --I'" -- ....-r--.-.··--·---
NO
Are you losing weight these days?
47 .._ ........ _._.---------
YE~.
NO _·_------------~
II--~I ,...
Has a nurse or doctor told you thai you might have TB recently?
48 ..._.__ ......._-_ .._._-,----,.---_._---_. __ ...__ ....__ ..__ .....- .. _ ....~.?.. __ .
NO ...····..·.·.·..·1-----·---- ..1
Before this illness now, have you ever had TB before?
49 ..-...----.- ---- ..-------. ". ·.._.....·._..·....-..--·1i
_Y_ES _. .._...._ __ .. _.. _.._ .._.._........ _
NO
Have you ever worked underground in a mine?
50 --yEs ..=-~_.-.-_·-._-_-._._-_-._=.-=_==-=.=_~I-=====~~.I.·=_;·:-:'5-1=.~F~o;r.:.:h;::y~-w.:.::.E.:e--~..a:.-~:r::::::;s-::?n=:L=;_..-lC. . _
~ L I
Interviewer: Is the patient breathless no-w+during the interview (e.g. breathless while seated, breathless while talking, unable to52 speak in full sentences without stopping to breath~)_?. ~~S -.-.--..----.---- ..------- ... .1 ..-.-----.-- ...--.-------- ..
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
I-.-- .-.--.-----f----- .-.----.I-------+~--_.---_t__-------.-----.-.----.-..--
r·------------+--------·-I-----+--------+------+------~---~
A51
Have you had difficulty in sleeping because of difficulty in breathing and/or cough in the last month?
54 YES I I _, go to the next question
NO I I .....s.kip to question 56
Select a category:
55 1 - 2 times per month I I
1 - 2 times per week I I
Most nights I I
Have you has your usual chest symptoms during the day (cough, wheeze, breathlessness) in the last month?
56 YES I I ~ go to the next question
_. NO I I -> skip to question 58
Select a category:
57 1 - 2 times per month I I
1 - 2 times per week I I
Most days I I
Has your chest problem interfered with your usual activities (e.g. work, study, housework, family or leisure
activities) in the last month?
58
YES I . I ~ go to the next question
NO I I -> skip to question 60 (top of page 7 )
Select a category:
...
59 1 - 2 times per week I I
1 - 2 times per month I I
Most days I I
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
Please eerreescomplete the Fiel\:lworker lick if Fieldwofker !lek if P&ease ccrrecscercete the Fieldwonc:er lick if Fialdworker lick if Capturer tick if
followinR Queslion (5) completed: comolete<!: rQllowinA Question (s) comOleted: complele<!: completed:
A52
Patient Initials: I IDate: I IClinic: I LInterviewer code: 1
HEALTH-RELATED QUALITY OF LIFE TODAY
Read to patient (and complete with the help of the visual aid)
By placing a tick in one box in each group below, please indicate which of the following statements best
describe your own state of health TODAY.
I
MOBILITY
60 LJ CJ [J LJ CJ I
I
I have no problems in I have some I
walking about problems in walking
I am confined to I
about bed i
SELF-CARE
61 LJ LJ U D U
I have no problems I have some I am unable to wash
with self-care problems washing ordressing myself or dress myself
USUAL ACTIVITIES (e.g. work, study, housework, family or leisure activities)
62 LJ LJ LJ 0 LJ
I have no problems I have some
with performing problems with
I am unable to
usual activities performing usual
perform usual
activities activities
PAIN I DISCOMFORT
63 LJ CJ ;-._;[] LJ 0
I have no pain or I have moderate pain I have severe pain
discomfort or discomfort or discomfort
ANXIETY I DEPRESSION I
64 CJ CJ r-"-)L_i [J
I am not anxious or I am moderately I am extremely
depressed anxious or depressed anxious or
depressed
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
Please correcVcomplete Ihe ~:~;l:ick~ir :r Fieldworker lick if Please ccrrecucompjete the FieldwCfker lick 11 Fielctworker tick (f Capture, lick"follow ... question (s) completed: IOIIow"ll_glJeslon Is) comp_leted· completed: completed: I
!---------
I
A53
Patient Initials:
65. Read: Best
imaginable
To help people say how good or bad a health state is, we have drawn a state or health
scale (rather like a thermometer) on which the best state you can imagine 100
is marked 100 and the worst state you can imagine is marked o.
We would like you to indicate on this scale, in your opinion, how good or
bad your own health is today. Please do this by drawing a line from the
box below to whichever point on the scale indicates how good or bad
your state of health is today.
o
Worst
imaginable
state 0f hea Ith
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER I
Please corectrccmpete Ihe F:etdworker lick if Fieldworker l.ieti if Please correct/complete the Fieldworker tick if FieldwOtker litk if Cap.ure< lid< n
rolJowing question (5) COIl1DIeted: ccmpleted: follow"" _$lion (sI comple.ed: comple.ed: completed: I
i
- i
I
A54
Patient Initials: I IDate: I IClinic: I linterviewer code: 1
HEAL TH-RELATED QUALITY OF LIFE IN THE LAST MONTH
Read to patient (and complete with the help of the visual aid)
By placing a tick in one box in each group below, please indicate which of the following statements best
describe your own state of health IN THE LAST MONTH.
MOBILITY
66 I I..i U LJ U LJ
I have no problems in I have some
walking about problems in walking
I am confined to
about bed
SELF-CARE
67 LI L.j L_iI U l.J
I have no problems I have some I am unable to wash !
with self-care problems washing ordressing myself or dress myself i
USUAL ACTIVITIES (e.g. work, study, housework, family or leisure activities)
68 CJ CJ CJ LI :...J
I have no problems I have some I am unable to
with performing problems withpêrforming usual perform usualusual activities activities activities
PAIN I DISCOMFORT
69 [_I ] lj r-] [-1
I have no pain or I have moderate pain I am have severe
discomfort or discomfort pain or discomfort
ANXIETY I DEPRESSION
70 ,_j ij 1L-J' : 1 it ...•
I am not anxious or I am moderately I am extremely
depressed anxious or depressed anxious or
depressed
COMMENTSFROMEDITOR COMMENTSFROMDATACAPTURER
PleDSCcorrecucomplere the -_."_ Flerdwcrxer I ick If I FUl!dworker tick if Please ccrrectrccmpete the Fteldwcrxer lick if
- Fieldworitef lick if Capturer lick if
foill)V/ing question (~j __::_~~!..!2.leteti _ complcl(;,.>d: following guestlon ~_. completed: cometetee. completed:
-- 0' I -- ._-_._._--_ --_.__._--_ . -
I
A55
71. Read: Rest
imaginable
To help people say how good or bad a health state is, we have drawn a state of health
scale (rather like a thermometer) on which the best state you can imagine 100
is marked 100 and the worst state you can imagine is marked O.
We would like you to indicate on this scale, in your opinion, how good or
bad your own health has been in the last month. Please do this by
drawing a line from the box below to whichever point on the scale
indicates how good or bad your state of health has been in the last
month.
Your own state
:: of health in the
last month
o
Worst
imuginahl«
SW!!: of henhh
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
Please ccnecsccnoete the Field\."of'ker trek rt --- 7iëidWOrk'3l tick it Please correcëccmpete the Fieldworkef trek if rtek:fworker lick if Capturer hek if
fonowing question !&____ . cam toted: conlrle~ ___ ,.~9Utlstion (s) •._ completed: - completed: completed:
A56
Patient Initials: Interviewer code:
72 Have you ever smoked?
I
YES I I _, go to the next question
NO I I _, skip to question 91 (top of page 12) I
73 Do you smoke currently?
1Y-ES--------- I I - go to the next question
NO I I --,skip to question 82(this page)
On average how many of the following items do you smoke per day? I
74 Mark appropriate boxes and enter average number smoked per day. Check all that apply. ;
to Shop-bought cigarettes - 74. Enter no. smoked per day:
76 Hand-rolled cigarettes - 75. Enter no. smoked per day:
Pipefuls of tobacco -, 76. Enter no. smoked per day:
When did you start smoking regularly (at least one cigarette I pipe per day)?
Interviewer: You may enter the i:lfie OR the year:
77 AGE I I --> 78. Enter é1_g_e:
YEAR I I _, 79. Enter year:
Did the nurse who saw you today advise you to reduce or quit smoking?
80
YES I I
NO I I
Which of the following best describes your thoughts about stopping smoking now?
Interviewer: Read all 3 statements to patient and ask them to choose one.
81 I will stop smoking - skip to question 91 (top of page 12)
I plan to stop smoking but not now - skip to question 91 (top of page 12)
I do not plan to stop smoking soon -> skip to question 91 ( top of page 12)
When did you stop smoking?
Interviewer: You may enter aqe OR year:
82 AGE I I ---;83. Enter age:
YEAR I I ~ 84. Enter year: ,
When did you start smoking regularly (at least one cigarette I pipe per day)?
Interviewer: You may enter the age OR the year:
85
-A-G_E .- I I -., 86. Enter age:
YEAR I I _,.87. Enter year:
On average how many of the following items did you smoke per day?
88 Mark appropriate boxes and enter average number smoked per day. Check all that am>h',
to Shop-bought cigarettes -> 88. Enter no. smoked per day:
90 Hand-rolled cigarettes -. 89. Enter no. smoked per day:
Pipefuls of tobacco -. 90. Enter no. smoked per day: I
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
Fielctworker tick if FielcM.'Orker ~ick it
:~:~~~~~~~~~~~athee Please ccnecvccmpete the Fieldworker lick if Fleloworker lick if Capturer tick jfcompleted: completed: following question (5) competed completed" completed:
1-----_._. _._
I 1------- -
--------_ 1---'---
A5?
Interviewer code:
Read:
We would like to ask some questions about the treatment you received at the clinic TODAY. The following
questions all ask about treatment and tests done TODAY, on the same day as this interview. We do not want
information about investigations completed previously for the same illness or for other illnesses. For example
we do not want to know about blood tests taken 6 months ago, only those taken today.
92 What was the reason for coming to the clinic today?
Interviewer: Check all that apply. Mark boxes with an X.
Check-up for diabetes ('suqar")
Check-up for a respiratory problem
Check-up for other problem
First visit for a respiratory problem
First visit for other problem
Other -+ 93. Specify:
94 Did the nurse who saw you today tell you what is wrong with you?
YES J _I -'0 go to the next question
NO I I ~'skip to 096
What did she tell you?
Interviewer: Probe with examples like cold, 'flu asthma. TB, high blood etc. Enter resQonse below: I
95
Old the nurse who you saw today collect any phlegm I sputum samples for testing?
Interviewer: Show patient examples of sputum iars in visual aid.
96 YES I I -+ 97. How many did she collect?
NO J I
Did the nurse who you saw today ask you to collect any phlegm I sputum samples at home? \
Interviewer: Show patient examples of sputum jars in visual aid.
98 _.-YES I I ~'98. How many did she ask you to collect?
NO I I
Did the nurse who saw you today take any blood for tests?
99
YES I I
NO I I
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
Please correctrcompiete the Fieldwotker tick il Fieldworker lick if Please correct/complete the Fieldworker lick if Field\vOfker lick if Capturer lick if
following question (s) completed: completed: following question (s} completed: completed: completed:
r---.----.--.- _.-
i----.-..-..-.----.-----.- ....
;
AS8
Patient Initials:
Interviewer: Show patient photo's of inhalers in visual aid (pages 28 and 29).
First ask patient to identify inhalers they received to take home today. Complete the tables below.
Then ask them to identify the inhalers they usually use af home. Complete the second set of tables below.
100 Did you receive an inhaler to take home today?
YES I I ~ complete the following 2 tables (Reliever & Preventer inhalers)
NO I I ~ skip to question 116 (this page)
RELIEVER INHALERS RECEIVED TODAY (Interviewer: Check all that apply)
1--- YES NO
101 Fenoterol (Berotec) -, 102. Does this inhaler improve your difficult
breathing minutes after usill9_it?
103 Fenoterolllpratropium (Duovent) -> 104. Does this inhaler improve your difficult
breathing minutes after usill9_it?
105 Ipratropium (Atrovent) ~ 106. Does this inhaler improve your difficult
- breathing minutes after usill9_it?
107 Salbutamol (Asthavent) -' 108. Does this inhaler improve your difficult
breathing minutes after usill9_it?
109 Salbutamolllpratropium (Combivent) _...110. Does this inhaler improve your difficult
breathina minutes after using it?
111 Salmeterol (Serevent) -> 112. Does this inhaler improve your difficult
breathing minutes after using it?
PREVENTER INHALERS RECEIVED TODAY (Interviewer: Choose oriel
No. of times to be taken each day No. of puffs to be taken eachtime
113 Budesonide 100 114 115
113 Budesonide 200 114 115
113 Budesonide (don't know the dose) 114 115
If you didn't receive an inhaler today, do you usually use an inhaler?
116 YES I I -> complete the following 2 tables (Reliever & Preventer inhalers)
NO I I -, skip to question 132 (top of page 14)
RELIEVER INHALERS USUALL Y USED AT HOME (Interviewer: Check all that apply)
YES NO
117 Fenoterol (Berotec) -~ 118. Does this inhaler improve your difficult
f-- 1-.---- breathing minutes after usill9_it?
119 Fenoterolllpratropium (Duovent) --i 120. Does this inhaler improve your difficult
breathillg minutes after usill9_it?
121 Ipratropium (Atrovent) ~ 122. Does this inhaler improve your difficult
- -. breathing minutes after using it?
123 Salbutamol (Asthavent) -> 124. Does this inhaler improve your difficult
breathing minutes after using it?
125 Salbutamolllpratropium (Combivent) --> 126. Does this inhaler improve your difficult
breathing minutes after using it?
127 Salmeterol (Serevent) -> 128. Does this inhaler improve your difficult
breathing minutes after using it?
PREVENTER INHALERS USUALL Y USED AT HOME (Interviewer: Choose one)
No. of times to be taken each day No. of puffs to be taken each
.. time
129 I Budesonide 100 I 130 1 131 ...L
129 I Budesonide 200 I 130 I 131 J
129 I Budesonide (don'! know the dose) I 130 I 1311
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
Please ccrrectrcomple,ste) the Fieldworker lick if I FieldwOlker Ock if Please correcVcomptele the Fieldworker tiel< if Fieldworker lick if Capturer tick if'o!lawinQ cueeren com leted; completed: following Question (5) com leteet c0"le..leted. completed:
I
I
A59
Interviewer: Show patient photo's of antibiotics in visual aid (pages 30 and 31).
First ask patient to identify the antibiotics they received to take home today. Complete the tables below.
Then ask them to identify the antibiotics they usual/y_use at home. Complete the second set of tables below..
139 Did you receive an antibiotic to take home today?
~-?.-.--- ..-.....-.~...~.~~.~:•~-:~.-·..~-..·~.-.~..·r=·=·=···--r=:":~;~:~:~-~-~-i'-~O-nl-I~-;-~n-(~-ht-i:-bp-I:-~-:-~-ti-bi-o-tiCS---re-c-e--iv.-..e..-.d--'-t-o.-d- -a'-y-])'
ANTIBIOTICS RECEIVED TODAY (Interviewer: Check all that apply)
No. of times to be No of tablets/capsules No. of days to be
taken each day lo be taken each time taken for
._.'.-..-._._-_._--:--==----,.------ -I---r--'---'--'- ..(~on of course) .._.
140 Amoxicillin 250mg capsules
___ (Betamax ?50L_. .. . + _ 141 142 143.--t--------- --.-..-.-..-.-...---".'-'-.-.
144 Amoxicillin 500mg capsules 145 146 147
__.__. _ ..(Betamox. 50QL_ .. _ --------.-.--I-----!----I---- ------- .-.---J-.--I-------
148 Amoxicillin/calvulanic acid tablets 149 150 '151
....._.._. (BiO-AfT!.Q!<siklaYL... .....- ... _._ .._ ..-._ ....- _ ..._-_ .. -.. . -..- -------1---+-----1
152 Cotrimoxazole tablets 154 155
____ (Cozole L~actri!!l) . 153--1------11----1--·-· .·.··-·- ----- -.--------+---1------1
156 Doxycy~line capsules 157 158 159
...__ ... (Qoxy'g.~n2__ . .__..__ ....'
160 Erythromycin tablets 161 162 163
jRu~!!IY..~.!!!L_. .._ .._...._ ---+---!I---_. _._._.-. ..-..
164 Flucloxacillin capsules 165 166 167
..jFloxa~ ..__ .
168 Fluconazole tablets 169 170 171
1- jQiflu~!)L .._ __ ._. ._.__._.-"' - .
172 Penicillin VK tablets / Pen VK tablets 174 175
(Betapen) 173
If you didn't receive an antibiotic today, do you usually use an antibiotic at home on a regular basis?
176 - YES ~ ..~:~:-. ·:·~~·.-=-:·~===-=~T----r··:-êOriïpÏëïe.ilii.foll()wing table (An~~~lic~~~IJ..~I!t~ecÏ)~=.=_~=:~~-=-~~-=-~
NO I I .~ skip to question 186 (lop of page 16)
ANTBIOTICS USUALLY USED AT HOME (Interviewer: Check alllhat _apply)................ _- ... ---_ ..__ .--- ".- ..._ ..__ ....__ .__ ..._._-_ .._._-,-----_,-
'. _.__._.__.. No. oftimes taken each day
No of tablets/capsules laken each
,..- .._ __ . time__ ------------1
177 Cotrimoxazole tablets 178 179(Cozole / BactriITlL_ _ _._._ __.. . . ._ __..
180 Doxycycline capsules 181 182
(Doxycy.!::~!:1_J_·_. ·_· ·I-----+_---
183 Fluconazole tablets 184(Diflucan) 185
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
Ploaseconectlcompleh:: U'I!j' '-'.,. -~ '-fiëidW(;ikê'itlGj{";;'---- Fieldwlner lick if Please coeecsccmplete lhe Finktwot1ccrlick it FiektWOrkCriiëk"it-·- • Gap'mer lir..yk --
_!~lbwinJ!.~~ __ ._ ... _ •. ~~~e'".d!'-: f...oc:!!om!!tnD,!!!lle~IC"''!:..: If-'I~ol""="lng~~-"'q,""Os""I''''on'-''(s''-) -+_~~Pl~~ . _~~~_. .. cornpleled: _. _
----.-------- .-..-- ----------li-------
.-..-----.-.--.--.-- ------..-.-.-----.-----.--.1--- .-..-- -.---.-.-.---.-.-.- -.---.-.---r---.----t--.-----t--.-----
A61
Patient Initials:
Interviewer: Show patient photo of prednisone tablets in visual aid (page 29).
First ask patient to identify whether they received prednisone to take home today.
Then ask them to identify whether they usually use prednisone at home.
132 Did you receive any prednisone tablets to take home today? [--_._-_ .._-_ .._,------_._._.
No. of limes to be of tablets to be No. of days to be
1---=-:---..-.-_..-........ . ._ ... _ __ ______ ~:~"eTd.Y= 3-4:_Ïh~- ~~~ofcto~ursfe);
YES
--_._ .._ ..._-_ ...._----_.-. __ .._----_.
NO . go to the next question
136 DOyou usually take prednisone tablets at home on a regular basis?
. ·No_'oTiirÏÏë-s"'to-:-be--:-ta-:-k-e-n-e-a-ch:---r-N-o-.-o-f--ta·-bl-et-s-t'-o-b'-e-t-ak-e-n-e-a-C-h-t-im-e--
day
YES
137 C". ~~=~-]~._-~_~.:-.~.-.".:-_=~=~~~
~ ...
. ..). go to the next question (top of next page)
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
~ë corocscornpjete the Field\vorkc(lick jf Fieldworxcr lick if Please ccrrccucompiote tho Fioldworker tiele II Fioh1wOrker lick II
~9~.£.~~!!?!!J~J. 0 ••••••••••••• _ •• ~~.~_P.~!'::..~_'_ .~~llle'OI~.~.; _ ._. ... .r_~~'!!!.!lJ_q~I."-!'.jS.L ...__..__..._c.~!!'P.!'!~:._.. _ . . _C_C>~p'I_e_I!,~I:_
A60
Interviewer: Show patient photo's of other medication in visual aid (pages 32 and 33).
First ask patient to identify other medication(s) they received to take home today. Complete the table below.
Then ask them to identify the other medicalion(s) they usually use at home. Complete the second table below ..
186 Besides the inhalers, prednisone and the antibiotics, did you receive any other medication to take home with you
today?
rY-E-S---.---------- _._. --------+ ----- J ~ complete the fOIlO-Mngtabl~-(Other medication received to~ ___ .
NO I --, skip to question 188 (this page)
OTHER MEDICATION(S) RECEIVED TODAY (Interviewer: Check all that apply)
Acetic Acid Eardrops
: ê~<::IQ!!1ethasone~as~§p..!.~y" _
r-£b!Q!p'h~niramine tablets (Allerg~ _
~P.!l! tablets (Renitec)
187 ~_Exp~~orant coug,--,h~m,,-,i;_;cxt:.::uo.:re=--_--_-,,--I
~i'tatin suspension (Nystacidl Canstat)
Oxymetazoli!le nasal spray'__(Dri.~i!_1t_:lL.._. '_" '_d' • _
Paracetamol tablets (Painaf!l..2!)____ _ _
Paracetamol/codeine tablets (Painamol
Plus)
Salbutamol tablëiS-(Vëntëïëy--·----·--
Theophylline tablets (Nuelin SA)
Besides the inhalers, prednisone and the antibiotics, do you usually use any other medication at home on a regular
188 ~:b.-asis? .-..- ..-.-..---------------,- ---------------:-:-:,-----:---:-----:---:-----
'Në>- ---.-----]-------------:1---: ~~i~~~e~:::~i~~II~~~7t~~b~~ ~~ci:~~-~~dicatiO'~ usui3l!y_~s~~)
OTHER MEDICATION(S) USUALL Y USED AT HOME (Interviewer: Check all that apply)
~-- -- -----._---- ~_._-_.._----~_._--_.._--_ .._------_. __ ._-
Acetic Acid Eardrops
"_0'0-_"-' ...... ,.--_.-._ ... .__ " .._--.-
Beclomethasone Nasal SQ@Y.
~t!!.q!p-'h_~!~c:lmin_etablets (Allergex) ....__ ..._- ..-
EnalaP.!l!.tablets (Renitec) ____..___ __
,,_, -_-------_----_.-
189 ._Mist Ex~ctorant cough mixt~~ _______._
Nystatin sl,l~pension (Nystacidl Canstat) --
_Ox~metazoline nasal spray_(Q!ixin~l _____._
paracetamol tablets _(Painamol)_..______ ._......
Paracetamol/codeine tablets (Painamol
-Plus) ----- •.._-_._-
Salbutamoltablets i.Y~!1.!~z..~_L_.._.
Theophylline tablets (Nuelin SA)
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
f------------ .-.---- .----------.-f----.-.--------- ----·_--------------·----+-------1--·--·--- .-.-·--------------.--
r--------------- ~-----------+_--------~------------~----------+_--------~--------_4
A62
Patient Initials: Interviewer code:
FOllOW-UP APPOINTMENT
Did the nurse ask you to return for a follow-up appointment?
190 Interviewer: Check all that apply. Mark boxes with an X.
On a specific date
If you feel worse
If you don't get better
When you run out of medication
Before you run out of medication
No instructions
REFERRALS
Did the nurse who saw you today refer you to a doctor?
191
YES I I -+ go to the next question
NO I I -+ skip to question 193 (top of page 18)
Did the nurse refer you to a doctor ...
Interviewer: Choose one. Mark appropriate box with an X.
in a hospital casualty or ward
192
at this clinic to be seen today
at this clinic for another day
in a hospital outpatient department J
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
Pktase correCVcomptete lhe Fieldworker lick jf Fieldworker liel( if Please correctlcomplete the F iek:tworker tick if Fiekfworkel tick (f Capturer tick if
following queSlion(!l. completed: completed: following Question (5) completed: completeo: completed:
J
A63
Patient Initials: I IDate: I IClinic: I I Interviewer code: I
INCOME AND CHANGES DUE TO ILLNESS
Read: We would like to understand more about your visits to this clinic or any other health care provider for your
current illness. If you have been ill for some time we would only like you to tell us about any visits or admissions in the
last 3 months. We wish to understand what your current illness is costing you and your household, in terms of fees
paid to health care providers, travel costs and lost earnings.
VISITS TO THIS CLINIC IN THE LAST 3 MONTHS
Read: We will start by going through your visits to THIS clinic in the last 3 months. We will use your folder to help you remember
when you came to this clinic in the last 3 months.
193 Have you attended this ctinic in the tast 3 months?
Intervi~~~!~ .Q()_lJ~Le_:S:-I}_~-t;:~.!!lJ?l'lfQfmati~thfe folder __ .... _ .. -_"_--- _ ........ .. _ ...•..- ._ ..-._----_
YES J -'-.' go to the next question
-NO - ----- j -> skip to question 262 (top of pagë~--------·--
194 Are you currently attending this clinic for TB treatment?
Choose one (Mark with an X)
-:~:r---'--I~~: ._.- _._--------------~f-- -----.~- ~~~----~:---:~~-- ~ i~Ot~h:u::;i~~u1e;;i~:~i: ~~::)
195 When did you start your TB treatment at this ctinic?
Interv~~~~_~~_.p..9_t!F_t"!!-~~.9W y'ou their TB treatment card
Date: I Month --r--·---·-·-------·l·-year--··-----·--..J---------·-·--··-·-'--.-J
196 How many times a week do or did you attend the clinic for TB treatment?
_Interviewer: Choose one (Mark with an Xl . .. ..._. .. . ._
-O_nce._--------------+----
Twice
Three times
Four times
Five times
197 Do you have a patient-held or facility-held record with you?
:'_~~S ---------~=~=--.-f~=---_:J~:f~:~=:~:e:s~ïheëndOrïhis-pag~~~·=·~~~~:·:====~~-=
198 Interviewer: Are you able to locate the folder?
....... __-
YES
NO .·1·-··~·-···:···-~F~~:~~l1!:r~fi~f:~{r~-f~~i:;~:t~=:r-~·:~{=:··::·...=._=---_-......_._::----
INSTRUCTIONS A (details of clinic visits using folder as a prompt):
Read: I will now go through each visit documented in your clinic folder for the last 3 months in order to refresh your memory. If you
are a TB patient I will ask you about visits other than visits to collect your TB medication.
Interviewer: Open folder and locate all entries for the last 3 months. Exclude return visits for TB medication. Start with the earliest
entry. Read the date of the visit and if clearly documented, the reason for attendance. Establish that the patient recalls this visit and
enter date.
INSTRUCTIONS B (details of clinic visits without folder as a prompt)
Read: I would like you to tell me about all visits to this clinic in the last 3 months since ..... (Interviewer: provide date e.g. start of
February as reference point for the patient). If you are a TB patient I will only ask you about visits other than those to collect TB
medication.
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
Please ccrrecscompiete Ihc:----,-"'Fie::-:kJw=o':;7.ke:::-' "'tic'"k"il --'-"'Fie::-:'dw=ori<'::.:::-' t"'ic""kif ----t-npklea=.-=-. c=o:::"e=c;;:Vc=on:::'p:;:,e:::te:-;;the:::-~F""ie:;:ldw;:::o::-:'k;;t:;::e;i:c:-k:"' 'if;----r'F""ie'-'Irlw""ork=e,:-7tick="'if ---'""'c""a""pt-:ure""'-:;-tic:-;:-k"",,·---l
foUowinQ Queslion (r.) completed: com leted: followinq _C_ JlI9stion (~l_ I-c:~P..!.~~~~_~_.._._...__ +.::c;:::o''''nP:.:::llec:;:ted=: l_'''co:::.:mJ::pl,::.:ete::.-:;d-:;_-: -I
--.-j--------I--.---------------- -------- --------t-------
---.--.--.----.---------.---.--t------+-----j
A64
199 Date of Visit 1 to this clinic in last 3 months Date of Visit 2 to this clinic in last 3 months
200 204
I Date: I I Monlh: :=c-_~=_-~.---rD-ale:--I----I·Mon-th: --I "_"2Cï1""-r=~as the reason for attendance for clinic visit 1? 205 What was Ihe reason for attendance for clinic-visit-2?~~
Interviewer: Check all that acolv. _.._________ Interviewer: Check all that apply. ______ .___
Check-up f-o-r_hig.h_b-lo-o-d-p-re-s-su-r-e- - --C-heck-up for high blood pressure - _.- .. --.--_. _- ..-
Check-up for diabetes ("sugar") Check-up for diabetes ("sugar")
Check-up for a respiratory problem - Check-up for a respiratory problemCheëk-Uj)iëii Other- problerrï . . - .. . Check-up for other problem --.__.
First visit for a respiratory problem F--ir-s-t--v_is.it_.fo_r-a respiratory proble_m.- ...._ .. "-- .•._'.- _.'._"_.
~Fi~rst~vis~it f~or!otehear ~pro~ble:m~~~~;-L.:~:--:-._-~-]-·-·.~_.~~.~:= First visit for other problemOther (please specify): ·-T200·--- --.- ...... _ .._ .._ .._ ..._-_ ......-. "._._._.- ...
..,- ...._-- .,- '.-- . ..._-----
203 Interviewer: Enter data for another clinic visit? _ 207 ..··"interviewer: Enter data for·an
-YES --T-:::: ....go to question 204 (next block) -Y-E=S-=--~-Tgo~to-q-ue-s-tio·n--oÏ_tier··cl·in·ic-·--;'is·it-?208 (next block) ----·_-
Në) ..._.:.s,kip to question 231 (top of page 21) - NO --" skip to question 231 (top of page 21)
212 Date of Visit 4 to this clinic in last 3 months
" ___~~~~Sit I~to t~is clini;~~:~~~.~~~~~~ '~--.._.~--
Date: ---T ~_:=--=r_~~-·::__~
·2-09----W-h1at-w-as--th-e-re-as-o_n ·fo_r a-tte-n-da----_· .._-----;:--:-;:;-nce for clinic visit 3? 213 What was the reason for attendance for clinic visit 4?
___ Interviewer: Check all that a~_[l!Y_. Interviewer: Check all tha.t ap1!!~._Check-uI? for .!!)gh blood pressur~ ..__. ._- ..gheck~p for _blghblo()d pressui.~_. __.____.
_S;heck-u[l for diabetes ("sugar")___ r---- Check-uI:! for diabetes {"sugar") _..__ ._..__ 1--_.
Check-up for a respiratory problem -- _gheck-.l!J>for a resJ>iratóry_J>roblem
_Ql_eck-u[l fOr:_9ther[lroble~ __ ._ .. Check-up for other problem -----
First visit for a respiratory problem .Brg visit for a res[lk~!Q.ry.~~I!)_ __ ~=== ..-
First_yisit for other [lroble~ ____ _.- First visit for other problem ---- ---_._ ..__ .._---
_Other_(please sl:!ecifYL [ 210 . --_ ... _ ..• ..9t!_l~_(plea~~_s[lecifY1. ____..__.__ .m4--··· -
---._--_ .._ .. - .._-------
211 Interview1e.·r·:' Enter d·ata for another clinic visit? 215 _Interviewl!;...!~nter. data ~ora~2J.~egri!:!!£. visit? ___ .YES .. go lo question 212 (nexl block) ---.-.- .._..-..-.-. YES - .• go to question 216 (next ~É~~ _.__.__._
NO -., skip to question 231 (top of page 21) NO I ....skip to question 231 (top of page 21)
COMMENTS FROM EDITOR .HiC:=O::=M",M=E=-N::;T:=:S::,:F,;.:R=O~M,=,D",A-,-T:.!.A~C=rA.;;.P~T~U~R",E:-;R;:;:..,,"-_----ro==o=:=;:-;;,.---------r~-,-----,-,...,,----I
Pleaseccrrecëconpete the F'ieldworker tiek if Fieldwt'Jrkerlick jf Please ccrtectzcormlete the Fioldwor1<etrick if Fieldwotker tick if Cepturer tick if
fonowing Q1J9st"n (51 completed. __ t-"co""m=p'tet""ad"_: +",fO::::llow",in",nQ,-"", Q,uo""st""ion.!JII::J.;s_l_ • . ~~I'É~:. .~!!'.E,,,,lel,,,,,,,"-I: t-=co"'m:r.:p11e"'ted=-.. -------I
I--------+-------·----·-r--------I-------·-·-····---·---·.--.-.-.-. ---.-.--.---.----j------I-------I
-------------4---------~---------_t------------------.r_-.---------
--------.---- ..-.-.-.--f--.-------+-----------j------+-----.---t---.-------t
A65
Patient Initials:
216 Date of Visit 5 to this clinic in last 3 months 220 Date of Visit 6 to this clinic in last 3 months
L Date: I I Month: I Date: I I Month:
217 What was Uïë'reason for attendance for clinic visit 5? 221 What was the reason for attendance for clinic visit6?
Interviewer: Check all that a~ply. Interviewer: Check all that aooiv.
Check-up for high blood pressure Check-up for high blood pressure
cheëï(.·uplor- diabetes ("sugar") -.-.-. '- . Check-up for diabetes ("sugar") .-----.--- ..--.- ..-..
l-aïëëk-llp'for-a respiratory problem Check-up for a respiratory p..roblem. _._- .~_.
Check-up for other problem Check-up for other problem
ï=iiSïïiisi,'ffoorr a respiratory problem First visit for a respiratory problem r--FTrStViï;~' oiii-ërprótiÏe"iTi"--'--'--- ' ..- .. - ..
-'6ïh_l3rT~~ï;~i£~ïëiïYF ~JJi1ïï'-...... ===.~~:.~:~=- ï:irsT~isiïïëiroïiier problem --.-.---- r--'
. ..·?ihër(pi:~-~~-~:~~)=-~·~~=~~~~_-~_~·=~~~:~-~=~:]
219 Interviewer: Enter data for anOther cliiïië iiisit? .. _ 223"" - Interviewer: Enter data for another clinic visit?
-YES'--r -:-golo'q~ësiio~220i;lë~tbïock)- . YES- . r . goïoq~esïion 224 (;'e~I"t)lock')
NO I -, skip to question 231 (top of page 21) 'Nê)'-"--r .. skip to question 231 (top of page 21)
224 I Date of Visit 7 to this clinic in last 3 months 228 I Date of Visit 8 to this clinic in last 3 months
_.....__ LDat~:_ __ L_.~_._._..__ ._J~~_!!1.~ J -.==~...~-..-~ . _._..__J_!)_ate:._.._. _ .._L._. __._..__. .LM2!.l!!E .__ _[==---=~~
~-....-:--:-"-"-"'-'------'--'-"-.'-'-"---"""--'-"'-"-------- _._.-1-._--- -..-.-..
227 I InterviewI·er: Enter data for another clinic visit?I y..~.s. :_£!~.~_g_uesti?2n28_(nex!E_lockL_. ". . -, now go to question 231 (top of next page)NO -., skip to question 231 (top of page 21)
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
r.;;'>';e::a =s.!!';,'"o,=,.,:';""'com==rple:;:,.:'i,'Ehe:'='irF"'Ie:T.'dicwo=="';;:.:-;,,"';ck"W""--'--'FIe=trt=wor1<=.;'""'k::;:;k"-'j·i-ëase correct/complate the _:..: rf.;etdworker !ick-if ..····-""r.,::i:irtw=ork;;:e:O' ';:;~k;-;i',...--,---;C-=3P="-:'''':::-, ;;:,t;:"". rt..--l
(ollowing que5lion_(~)_ com letëc. corn letad: follOwing quostion s) corn !clod: corn IDled: completed:
-.-------- --------. ------- ...-.-..-.-.---.-f-------+----.-.-,-- ----.-.-..--.--.
-.----.----.-----t-.-----+--------+-------'---, 1-------- --------j-----j
r----------_r--------~--------+---------------r_-------,_----_r---------
A66
Patient Initials: I IDate: 1Clinic: 1 linterviewer code: 1
VISITS TO THIS CLINIC IN THE LAST 3 MONTHS cont'd
Interviewer: Show patient transport photo's in visual aid_{Q_age34}.
231 How do you usually travel to this clinic?
Use visual aid to select a mode of transport. Choose one (Mark box with an Xl
Walk
Bicycle
Animal (e.g. donkey)
Taxi 232 -'233. Enter amount paid for return fare to clinic by taxi: R:
Bus 234 -'235. Enter amount_j)élid for return fare to clinic ~ bus: R:
Train 236 -->237. Enter amount paid for return fare to clinic by train: R:
Private motor vehicle
Ambulance 238 ->240. Tariff paid? Enter amount: (enter 0 if no tariff paid) R:
Other
241 How long does it usually take you to travel to the clinic and back home again (travel time + time spent at clinic)?
Choose one (Mark box with an X)
Overnight -+243. Enter rands spent on accommodation R:
-+245. Enter rands spent on food and drink R:
Between 2 and 12 hrs
Less than 2 hours
246 Does someone usually accompany/escort you to the clinic?
YES -->go to the next question
NO -+ skip to question 262 (top of page 22)
247 What is the employment status of your usual companion/escort?
Choose one (Mark box with an X)
Employed 248 __.go to question 249 (next block)
Self-employed 248 -->go to question 249 (next block)
Unemployed
StudenUScholar 258 ->259. Days unable to attend schooll college because of
accO~allïll'lQ_ï_ou to the clinic:
Looking for work 260 ->261. Days unable to look for work because of
accomoanvlna you to the clinic:
Recelvlnq GranUPension : .
Other '__::'
249 On what basis is your companion/escort employed?
Choose one (Mark box with an Xl
Casual 250 ->251. Enter average no. of days worked per week
-+252. Enter average amount brought home per day
(after deductions e.q, tax)
-->257. Enter no. of days unable to work to accompany you to
the clinic
Weekly 253 ->254. Enter average amount brought home per week
(after deductions e.g. lax)
->257. Enter no. of days unable to work to accompany you to
the clinic
Monthly 255 ->256. Enter average amount brought home per month
(after deductions e.q, tax)
->257. Enter no. of days unable to work to accompany you to
the clinic
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
Please correct/complete the Fieldworker lick if Fieldworker tick it Please correct/complete the Fieldworker lick if Fieldworket' lick if Capturer tick if
following Question (~) completed: completed: t\>llowjrlg Que.tion (S) completed: completed: co~ted:
A67
Patient Initials: , , Date: , , Clinic: , 'Interviewer code: ,
VISITS TO OTHER HEALTH CARE PROVIDERS IN THE LAST 3 MONTHS
Show patient: Pictures of other health care providers on visual aid
Read: We also wish to know whether you have been to any other health care provider besides this clinic in the last 3
months. Other health care providers include hospitals (public, private, mine), other primary care clinics besides this
one, private doctors, traditional healers etc. We would like to know about al/ visits to other health care providers,
whether you attended as an outpatient or were admitted. In particular, we wish to know what these visits to other health
care providers are costing you and your household, in terms of fees paid to other health care providers, travel costs and
lost earnings.
262 Have you been to another health care provider besides this clinic in the last 3 months?
~~~s~_~~-~_~_..·_.~.._=._:~.__~_.~_=._-.~-_-. .., complete questions 263 - 303 (this pag~ and_.~'!.neext pagel._ ......_ ...
--, skip to question 46B (lop of page 32)
VISIT 1 to other health care provider in the last 3 months: questions 263 - 303
263 When did you visit another health care provider other than this clinic in the last 3 months?
Choose one (Mark with an X)
-1~-'--1--" I Feb I MarchI Augusl l- I Sept .i~~I·==~·l~J-MI·N~-a~ï--·~'r·'-_---....JJiJnë''''''-r-- -_.ov I I Dec I
264 On this occasion, which of the following health care providers did you visit?
Use visual aid lPJ!ge3~} lo select a health ~~J!!:QYider. Choose one (Mark box with an JC)
~H. ospit.a._l -(P-_ub._lic--o_r .P_r_iv...a. te or Mine) ,265. Enter name of hospital:__ - ----------------
Other PHC Clinic _ .._ ..--_. ---_ .. _._-------_ ...
-M-o-bi-le-C-lin-ic--_._------ ------
Workplace I Min-e--C-l_in.ic_._._._~-_..._- _._._-_ ..-
.P-r-iv_at-e-D-o-c-t-o-r -----
Traditional Healer
.- .._-_.__ ._--- ------
Pha._rm--a-c-y-_I C- __ --h-e-mist
Other
266 What was the reason for this visit?
Check all that al!l2lï. Mark boxes with X. - -----_._--_._.- --' _ ...•.".- -_ .._-_.__ ..__ ...._--_._-------.-
Check-up for high blood pressure
.._-_ ..- ..._ ... .... _ ... ._-
-Check-up for diabetes ('sligar") .. _ ....__ .._ .....•
C-heck-upfOr;:Ï·rës-piraiOr-y-probiëiïl··-
. chëëïï:up for other problem
'-First visit for._a_r-e_ .s.._p-ir-a-t-o_ry-_pr..o...b.•. l_e.m-.-. AO. _____ __ "_0" .......-
First visil for other problem
Other'--- - ... ----- .. ------.-.--------.--- 1----- ---------_._------_._--
~·267. Specify:
26B Did you stay overnight at this health care provider? -_.._----_- ...... _._._---_._ .... _ .._----_ ..._-
YES ----- --'269. Enter number of nights: --
NO
270 Did the health care provider charge you for that visit! admission (consultation fee + medication)?
~~~S - --.---.-- ..--.-----.-------__:F .-'T .-"271.' How much? (consultation fee + m~dic~on~: --R'---- ..--------
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
Please cceecsccopete Ihe - Field\vorkcf lick if FielctNol1<erl1ck if Please r.orfACI/complAle tha FiAldworkot lick if - Fiolcfworker lick if CAp'urer lick if
following question (s) COlli leted; corn leled: folk>w'l!J Q\JeS'ion (s) compleloO' ccmeerco. completed .. ____
r--------- .-.-.--..-.-.-..-..-.-...-. .._----- -_ r-------- r-.---- ------ f----
----- 1---. '_- .. -_ .._-----_._-
1---------- 1---,--, --
A68
Patient Initials: I IDate: IClinic: I I Interviewer code: I
272 How did you travel to this health care provider for that visit / admission?
Use visual aid to select a mode of transport. Choose one (Mark box with an Xl
Walk
Bicvcle
Animal (e.Q. donkev)
Taxi 273 ->274. Enter amount paid for retum fare to HCP by taxi: R:
Bus 275 ....2. 76. Enter amount paid for retum fare to HCP by bus: R:
Train 277 --278. Enter amount paid for return fare to HCP train: R:
Private motor vehicle
Ambulance 279 ->281. Tariff paid? Enter amount: (enter 0 if no tariff paid) R:
Other
282 How long did it take you to visit the HCP from the time you left home until the time you got back home again (travel
time + time spent at HCP)?
Choose one (Mark box with an Xl
Overnight ··.·..284. Enter rands spent on accommodation R:
....2. 86. Enter rands spent on food and drink IR:
Between 2 and 12 hrs
Less than 2 hours
287 Did someone accompany you to the health care provider?
YES I -> go to the next question
NO -> skip to question 303 (at bottom of page)
288 What is the .employment status of your companion?
Choose one (Mark box with an Xl
Employed 289 .....go to question 290 (next blocl1
Self-employed 289 .....go to question 290 (next block)
unemotoved
Student/Learner 299 -300. Days unable to attend schooV college because of
accompanvinq vou to HCP:
Looking for work 301 ·.·..3. 02. Days unable to look for work because of
accompanying vou to HCP:
Receivino Grant/Pension
Other
290 On what basis is your companion/escort employed?
Choose one (Mark box with an)
Casual 291 _,292. Enter average no. of days worked per week
-·293. Enter average amount brought home per day
(after deductions. e.c. tax)
-298. Enter no. of days unable to work to accompany you to
the HCP
Weekly 294 -295. Enter average amount brought home per week
(after deductions e.g. tax)
·-'298. Enter no. of days unable to work to accompany you to
the HCP
Monthly 296 _,297. Enter average amount brought home per month
(after deductions e.o, tax)
-+298. Enler no. of days unable lo work to accompany you to
the HCP
303 Is there another visit in the last 3 months to a health care provider other than this clinic which we have not
discussed? !I
YES I ....g.o to the next question (lop of page 23)
NO .....skip to question 468 (top of page 32)
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
Please COI'i'ectlcomplele the Fieldwortter liCk if Fieldworker tick if Please correcVcomplete the FieldWorker tick if Fieldwo","er lick il Capturer tick if
fonowlnQ eoeenen (s) completed: completed: fOllowing Question 5 completed: completed: com_2leled:
A69
VISIT 2 to other health care provider in the last 3 months:_questions 304 - 344
304 When did you visit another health care provider other than this clinic in the last 3 months?
Choose alle (Mark with an X)
.~~~: : :~~ust : : ~:~~h : ~~;il: I ~:~..--, -. -..~~=····E::~=
305 On this occasion, which of the following health care providers did you visit?
Use visual aid (page 35) to select a health care provider. ChQose alle (Mark box with an~. __ ._ ...__ .... .. .__
Hospital (Public or Private or Mine) ~·306. Enter name of hospital:
Other PHC Clinic'·'· -. - - ..- - --- -.. ' -- -..---'." - -- -------- .
Mobile Clinic
W-o-rk'-pl-a-ce--I M_in.e_C-li_nic._-_._--- ---
Private Doctor
Traditional Healer
Pharmacy I Chemist
I--c---- .
Other
307 What was the reason for this visit?
.Ch~ck §l_ll_!ha.~tpp.ly;M§l.~.~.b..C>.)(E;!.!i.~!!~_~: _.. " _._ _ __ . _. .__ ._. ._ .
Check-up for high blood pressure
C._h-e-c-k--up--for diabetes ('sugar") . .-.---.._---- ---_ .
Check ..up for a respiratory problem
Check-up for ëiïi1ërprobïêiri .
First visit for other problem _._._ ..._---_._._ .._ ..__ ..__
Other "308. Specify:
309 Did you stay overnight at this health care provider?
.~- -'310. Enter number of nights:
NO ------~~---------------
311 .~D.id~the~.~h.e.a~lth.c=~are.~prov~ide.r:-=~cha-.r-g~e.~.yo~=u fror·~tha~t..v=isit=! admission (consultation fee + medication)?: I~.::::1.~i.·~I:!~~r:'1..~~?j~~~u~ation ..!~~_.m+edical_i?n}: ~ __. _ .~. ~-··-··
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
Please correctzcompjetethe "-~'FTOIdWOfkP.r'ïlër;;- __..- Fië-Jd\~ë~kë;:ïiëk:W--"--'... Pease eorrecucomciere the Freldworkl;!rlick il .FioJdworker lick il Capture, lick if
_!9!~~!:~n..~~~~.i.i:~>.!L~ ._.. _t2C!!!.!P_~~':.~..:_._. __ . r-,,£ompluled: followrn_9_questlO(Sn). __ cornplel~: ~lated: .._._. . completed:
=--=-----------.-..·--·.·~.·:·=.-·F- ~- .--r---.-----t------f------j-----j '-1
A70
Patient Initials: .1 IDate: IClinic: I I Interviewer code: I
313 How did you travel to this health care provider for that visit I admission?
Use visual aid to select a mode of transport. Choose one (Mark box with an Xl
Walk
Bicycle
Animat te.c. donkey)
Taxi 314 ~315. Enter amount paid for return fare to HCP by taxi: R:
Bus 316 -317. Enter amount paid for return fare to HCP by bus: R:
Train 318 ~319. Enter amount paid for return fare to HCP train: R:
Private motor vehicle
Ambulance 320 -'322. Tariff paid? Enter amount: (enter 0 if no tariff paid) R:
Other
323 How long did it take you to visit the HCP from the time you left home until the time you got back home again (travel
time + time spent at HCP)?
Choose one (Mark box with an X)
Overnight ~325. Enter rands spent on accommodation IR:
-'327. Enter rands spent on food and drink R:
Between 2 and 12 hrs
Less than 2 hours
328 Did someone accomcanv yOUto the health care_provider?
YES _, go to the next question
NO --+ skip to question 344 (at bottom of page)
329 What is the employment status of your companion/escort?
Choose one (Mark box with an X) ,
Employed 330 - go to question 331 (next block) -~
Self-employed 330 _, go to question 331 (next block) !
Unemployed
StudenVLearner 339 -341. Days unable to attend schaall college because of
accomjJanyinQvou to HCP:
Looking for work 342 ->343. Days unable to look for work because of
accomoanvinu vou to HCP:
Receiving GranVPension
Other
331 On what basis is your companion/escort employed?
Choose one (Mark box with an )I
Casual 332 -333. Enter average no. of days worked per week
-'334. Enter average amount brought home per day
(after deductions e.q, tax)
~339. Enter no. of days unable to work to accompany you to
the HCP
Weekly 335 -336. Enter average amount brought home per week
(after deductions e.q. tax).
-~339. Enter no. of days unable to work to accompany you to
the HCP
Monthly 337 ->338. Enter average amount brought home per month
(after deductions e.g. tax)
-339. Enter no. of days unable to work to accompany you to
the HCP
344 Is there another visit in the last 3 months to a health care provider other than this clinic which we have not II
discussed? i
YES -go to the nexl question (top of page 26)
NO I -> skip to question 468 (top of page 32)
COMMENTS FROM EDITOR COMMENTS FR
Please correct/complete the Fieldworker lick if Fielctworker lick if
followino Question s comoleled: comejerert :=~~~~:~:
OmMth~DeA~TeAtCeAPTURERFietdworker tick if Fieldworker tick if Capturer tick ifcomoleled: comolet8d: completed:
-
A71
VISIT 3 to other health care provider in the last 3 months: _guestions 345 - 385
345 When did you visit another health care provider other than this clinic in the last 3 months?
.Choose one (Mark with an X)
~-~- I Feb I I March +-------. J I .-- --TJuly I I ~:I 1 I ~i~-~~..=...-.=....-t..--- ..-. +~~e_August ..J-ISem
346 On this occasion, which of the following health care providers did you visit?
Use visual aid (page 35) to select a health care provider. Choose one (MélEkbox with an ~ ----_._
-H--o--s_p.ital (Public or Private or Mine)
-,,347.
--_.------- --.--_._-- ------_ E_n.-t.er name of hospital:.. ...__ ...._--_._._._--._---
O,--_ther PHC Clinic.. ------- .... _ .. _- '_ . -"'_'_- .. _,
Mobile Clinic _._.0.0-_0- .. ._ .... ._--->,-
~W-or-kp-la_ce .I_Min-e-C-lin-ic.
Private Doctor
-_' ___ -0_-'-' . -_. _ .... _-_._--
-Tr-ad_itiona..l_.H_e_a.l_e_ .r..... - -•...__-----
Pharmacy I Chemist
___ '-'0 •• ....-._-_ ....._ .._--_.-
Other
348 What was the reason for this visit?
..9leck_~I!that a~~I~. Mark boxes with X,______.___._ .._.__ ._._ ..._.-._,-_- ..._ ..._-_._-
Check-up for high blood pre.s_sure
------------
- - .- -_ .... _ .._._
Check-up for diabetes ('sugar")
Check-up for a respiratory 'probleriï-'-'
~Check-u_p_fo.-r._o.t_h..e._r...._p-r-o_bl_em..
First visit for a respiratory problem
-'.
First visit forOthe..r_p--r-o_b...l.e_m-_ ..._-_ ... ---_ --- ,------ ..._. __ ...._--_ ......_-_.__ .--
Other ~·349. Specify:
350 Did you stay overnight at this health care provider?
~~S -------- -- ~-:~~=~._.=_r._--.=~_~E_n~~e~rnumber of nighis~~~:~-=__=~ __
352 _D_id the health care--_pr.o_v.-id_e-r_ charge.._.-~._y-ou for that visitl admission (consultation fee + medication)?YES. -----_ ..__ .- .-._-__ .- ............ ---- --'353 . How much? (consultation fee + medication): R.'-
NO
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
Please ccnect'comptste the Flêldwor1l.er lick it Fieldworker lick If ~=;:;~~~o Fioldworkcr lick if Fieldworker lick if CapllaDr lick ilfollowing qucsncn (S)' comp!cted: completed: the completed. complo1ed: r.omptotod:
.-
A72
Patient Initials: I IDate: (Clinic: I linterviewer code: I
354 How did you travel to this health care provider for that visit / admission?
Use visual aid lo select a mode of transport. Choose one (Mark box with an Xl
Walk
Bicycle
Animal (e.g. donkey)
Taxi 355 ~356. Enter amount paid for return fare to HCP by taxi: R:
Bus 357 ~358. Enter amount paid for return fare to HCP by bus: R:
Train 359 ~360. Enter amount paid for return fare to HCP train: R:
Private motor vehicle
Ambulance 361 -+363. Tariff paid? Enter amount: (enter 0 if no tariff paid) R:
Other
364 How long did it take you to visit the HCP from the time you left home until the time you got back home again (travel
time + time spent at HCP)?
Choose one (Mark box with an X)
Overnight ~366. Enter rands spent on accommodation R:
~·368. Enter rands spent on food and drink R:
Between 2 and 12 hrs
Less than 2 hours
369 Did someone accompany you to the health care provider?
YES ~ go to the next questen
NO -+ skip to question 385 (at bottom of page)
370 What is the employment status of your companion/escort?
Choose one (Mark box with an X)
Employed 371 -+ go to question 372 (next block)
Self-employed 371 -+ go to question 372 (next block)
Unemployed
StudenVLeamer 381 -'382. Days unable to altend school! college because of
accompanying you to HCP:
Looking for work 383 -~384. Days unable to look for work because of
accompanying you to HCP:
Receivin[l GranVPension
Other
372 On what basis is your companion/escort employed?
Choose one (Mark box with an )(
Casual 373 -+374. Enter average no. of days worked per week
-+375. Enter average amount brought home per day
(after deductions e.a. lax)
-+380. Enter no. of days unable to work to accompany you to
the HCP
Weekly 376 -+377. Enter average amount brought home per week
.(after deductions e.a, tax)
-+380. Enter no. of days unable to work to accompany you to
_"---- the HCP
Monthly 378 -379. Enter average amount brought home per month
(after deductions e.q. tax)
'-'380. Enter no. of days unable to work to accompany you to
the HCP
385 Is there another visit in the last 3 months to a health care provider other than this clinic which we have not
discussed? _.
YES ->go to the next question (top page 28)
NO -+ skip to question 468 (top of page 32)
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
Please carred/complete the Fieldwcrter tick if Fieldworiter lick if Please correcllcomplale tho Fieldworkertickif Fioldworkor tick if Capturer lick if
fOllowing (IIJ.Sllon_IS)_ compleled: compleled: following question (s) completed; completed: compIeled:------- -r--'
A73
VISIT 4 to other health care provider in the last 3 months: questions 386 - 426
386 When did you visit another health care provider other than this clinic in the last 3 months?
Choose one (Mark with an X)
Jan I I Feb I I March I I April I I May I I June I
July I I August I I Sept I Oct I I Nov 1 I Dec I
387 On this occasion, which of the following health care providers did you visit?
Use visual aid (page 35) to select a health care provider. Choose one (Mark box with anX)
Hospital (Public or Private or Mine) -'388. Enter name of hospital:
Other PHC Clinic
Mobile Clinic
Workplace I Mine Clinic
Private Doctor
Traditional Healer
Pharmacy I Chemist
Other
389 What was the reason for this visit?
Check all that apply. Mark boxes with X.
Check-up for high blood pressure
Check-up for diabetes ('sugar")
Check-up for a respiratory problem
Check-up for other problem
First visit for a respiratory problem
First visit for other problem ----
Other ~390. Specify:
391 Did you stay overnight at this health care provider? ----
YES -~392. Enter number of nights:
NO
393 Did the health care provider charge you for that visit! admission (consultation fee + medication)?
YES -- ->394. How much? (consultation fee + medication): R
NO
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
ro~:!~:Q=:"~~ta FieldwOf1(er lick if AeldwOfker lick if Please corecsccmcete the FieldwOl'k9r tick if Fieldwor1<er lick ifthe completed: completed: tOlbwing question (s) completed: completed: ~~~~~~if
-------- --
A74
Patient Initials: I IDate: IClinic: I I Interviewer code: I
395 How did you travel to this health care provider for that visit / admission?
Use visual aid to select a mode of transport Choose one_iMark box with an~
Walk
Bicvcle
Animalle.o. donkey)
Taxi 396 ->397. Enter amount paid for return fare to HCP by taxi: R:
Bus 398 ~399. Enter amount paid for return fare to HCP by bus: R:
Train 400 ~401. Enter amount paid for return fare to HCP train: R:
Private motor vehicle
Ambulance -- 402 ~404. Tariff paid? Enter amount :_ienter 0 if no tariff paid) R:
Other ..'
405 How long did it take you to visit the HCP from the time you left home until the time you got back home again (travel
time + time spent at HCP)?
Choose one (Mark box with an X)
Overnight ->407. Enter rands spent on accommodation R:
->409, Enter rands spent on food and drink IR:
Between 2 and 12 hrs
Less than 2 hours
410 Did someone accompany you to the health care provider?
YES I --> go to the next question
NO -> skip to question 426 (at bottom of page)
411 What is the employment status of your companion/escort?
Choose one (Mark box with an X)
Employed 412 -> go to question 413 (next block)
Self-employed 412 ~ go to question 413 (next block)
Unemploved , __
StudenVLeamer 422 ....4. 23. Days unable to attend schooll college because of
accompanying you to HCP:
Looking for work 424 -'425. Days unable to look for work because of
acco~anying_you to HCP:
Receiving GranVPension
Other .., __c
413 On what basis is your companion/escort employed?
Choose one IMark box with an )I
Casual 414 -415. Enter average no. of days worked per week
-416. Enter average amount brought home per day
(after deductions e.q. tax)
-421. Enter no. of days unable to work to accompany you to
the HCP
Weekly 417 .....418. Enter average amount brought home per week
(after deductions e.g. tax)
->421. Enter no. of days unable to work to accompany you to
the HCP
Monthly 419 -420. Enter average amount brought home per month
(after deductions e.g. tax)
-421. Enter no. of days unable to work to accompany you to
the HCP
426 Is there another visit in the last 3 months to a health care provider other than this clinic which we have not
discussed?
YES ~go to the next question (top of p~e 30)
NO -. skip to question 468 (top of page 32)
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
ro~~~~Oa~ecs~~:;~~ete Fieldworiter tick if Fieldwor1<er lick if Please correct/complete the Fieldworker lick jf Fieldworker lick if Capturer lick ifth comoleted: com leted: rollo~.slionJ& cO'!!P_leted: cOI!!P_leted: completed:
A7S
VISIT 5 to other health care provider in the last 3 months: questions 427 - 467
427 When did you visit another health care provider other than this clinic in the last 3 months?
Choose"'Ton"e-(-M-a'-rkTwFiteh an X)..'Jan' b---r- I Marëïi- r "---TApiiï-"'-'" ---TMay--··-r· lJiJi1ë
July I I August I I Sept I I Oct' I Nov I I Dec
428 On this occasion, which of the following health care providers did you visit?
Use visual aid (page 35 ) to select a health care_provider. Choose one (Mark box with anX)
Hospital (Public or Private or Mine) . -429. Enter name of hospital:
"oiiïër PHCClinic .-.--------------.-.-.- ' -..-.- -- -..- --- - - -.-.- - - -..-- --- --.---- ..--
-M-ob-ile-C-lin-ic-----------_._.
Workplace I Mine Clinic
--------------1·---4
Private Doctor
I-Tr-a-d-iti-on-a-I-H-e-a--l-e----r_. __ ._----
1---_ ._. --_._.__._._...-
_P._ha-_rm. a-c-y_ .I...C..~he, __.m_ .._is.t~._.. --_ .•.•,.. -.__ •._.__ .-_ •..__ ..' ---_._-
Other
430 What was the reason for this visit?
~~k a.!!_that~p-Q.lYM..ark boxes w!tt'!..~:__' r- . -j
Check-up for high blood pressure
Check ..up for diabetes ('sugar")
Check ..up for a respiratory problem
Check ..up for other problem
First visit for a respiratory problem
First visit for other problem ---- ..
--- ..- ..- ..--.-.--.- ..-- - - - '..-. ---. --- .:----::-c--::---:-:~- --- -.- -- -- ..---------- ..---
Other ~~.~_.~._'.431. Specify:432 i~~.~~·~.=~=~~~=~·t.~==~:~ ..~ .i-d;el-r~?=-_.4~~3~3~~.~E~~n~.t~.-e0_~-fr~_n-~n_igu~._~.h-m_~_t~--S.b.-__:.e-~_..r=. =======-_-_---.=- .._. -..=. ~._~.._._=...
434 Did the health care provider charge you for that visitJ admission (consultation fee + medication)_?._-_ ...._ ... _ ...._ .•..__ ... _ ...__ ....._-_ ..
YES ..__ ._._.._ ..._. .... ._. ..__ .._ ..._.. . -,'435. How much? (consultation fee + medication): R ............._._
NO
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
Pleasecorrecrcompete the FiclcJworkelrick ir Fiord\~orkerïiëk-iï ··Piëasëëorreciïëëfn-piëlëïtle--· ··FiëidWëfker tick iI-- ""F""je;:<'ldw=o::;:rker='ic:i:'k r--'-'c"'.p::7'u-=rc"'r ';;::k:""k~-;-
l--""O:::;IIow",qinlU"""g"lO"""'sli:::::on.:..>{""s) -4_;c"'on:::JnP:::::'Ie::::'e.."_'d_:_ .~ _~p.~.!£~:. following queStiOll Is). completed: completed: compteted:
t----------t---------r--.-- --.-,-.- .-.-----t----- .-.-j------.- t-----j
f---- ..----.-- ..-.- ...-......-.-- ....-.-.--- .-. I-------+--------J------l------j.-----!
f---.. ..--..-----.------+-------f------j------f-------
A76
Patient Initials: I IDate: IClinic: I I Interviewer code: I
436 How did you travel to this health care provider for that visit / admission?
Use visual aid to select a mode of transport. Choose one (Mark box with an Xl
Walk
Bicycle
Animal (e.g. donkey)
Taxi 437 ->438. Enter amount paid for return fare to HCP by taxi: R:
Bus 439 ....4..40. Enter amount paid for return fare to HCP by bus: R:
Train 441 ....4..42. Enter amount paid for return fare to HCP train: R:
Private motor vehicle
Ambulance 443 ->445. Tariff paid? Enter amount: (enter 0 if no tariff paid) R:
Other
446 How long did it take you to visit the HCP from the time you left home until the time you got back home again (travel
time + time spent at HCP)?
Choose one (Mark box wilh an X)
Overnight ->448. Enter rands spent on accommodation R:
-450. Enter rands spent on food and drink R:
Between 2 and 12 hrs
Less than 2 hours
451 Did someone accompany you to the health care _p_rovider?
YES -i go lo the next queslion
NO -> skip lo question 468 (top of next page)
452 What is the employment status of your companion/escort?
Choose one (Mark box with an X
Employed 453 - go to question 454 (nexl block)
Self-employed 453 -> go lo question 454 (next block)
Unemployed
Student/Leamer 463 ·-'464. Days unable to attend school! college because of
accomnanvlnq you to HCP:
Looking for work 465 ·->466. Days unable lo look for work because of
acccmcanvino you lo HCP:
Receivino Grant/Pension
Other I
454 On what basis is your companion/escort employed?
Choose one (Mark box with an Xl
Casual 455 ....4..56. Enter average no. of days worked per week
--'457. Enter average amount brought home per day
(after deductions e.c. tax)
-'462. Enter no. of days unable to work to accompany you to
the HCP
Weekly 458 ....4..59. Enter average amount brought home per week
(after deductions e.c, tax)
....4..62. Enter no. of days unable to work to accompany you to
the HCP
Monthly 460 ->461. Enter average amount brought home per month
(after deductions e.q. tax)
->462. Enter no. of days unable to work to accompany you to
the HCP
467 Is there another visit in the last 3 months to a health care provider other than this clinic which we have not
discussed? I
YES I _, maximum number of visits entered, go to question 468 (top of page 32)
NO I -> go to question 468 (top of page 32)
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
Ploase correcllcomplete the Fiekfworkcr lick if Fieldworker tick if Please correct/complete the FieldworXer tick if FieldwDfker lick if Caprurer tick if
following queslion (si com leted; completed: foltowng cuesnon (s) completed: compleled: compleled:
------
A77
Patient Initials: IDate: IClinic: I IInterviewer code: I
CAREGIVER COSTS IN THE LAST 3 MdNTHS
Read: We wish to understand what this illness has cost your family and friends in terms of time caring for you at home. If
you have been ill for some time we would like you to tell us about the person who has cared for you in the last 3 months.
If more than one person has cared for you please tell us about the person who looked after you the most.
468 Has anyone (including family or friends) looked after you at home because of any illness in the last 3 months?
YES -_._--_ ...__ ._------_ ..._ _. go to the next question
NO _. skip to question 484 (top of page 33)
469 What is the employment status of your caregiver?
Choose one {Mark box with an X
Employed 470 -> go to question 471 (next block)
f-=-
Self-employed 470 -+ go to question 471 (next block)
Unemployed ...
Student/Learner 480 -->481. Days unable to attend school! college because of
looking after you al home in the lasl 3 months
Looking for work 482 -+483. Days unable to look for work because of
looking after you in the lasl 3 months:
.:
Receiving Grant/Pension
Other ,-; <.":-." .'~' ,'0'
471 On what basis is your caregiver employed?
Choose one (Mark box with an JC)
Casual 472 -->473. Enter average no. of days worked per week
....4..74. Enter average amount brought home per day
(after deductions e.g. tax)
->479. Enler no. of days unable to work because of looking
after you at home in the last 3 months
Weekly 475 -4476. Enter average amount brought home per week
(after deductions e.q. tax)
....4. 79. Enter no. of days unableto work because of looking
after you at home in the last 3 months
Monthly 477 -478. Enter average amount brought home per month
(after deductions e.q, lax)
-+479. Enter no. of days unable to work because of looking
afteryou in the lasl 3 months
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
Please correclftomplete the Fieldwor1<er lick if FiektNOr1<.er tick if Please correclftomple!e !he Fietdwo<ker tick it Fiel_ertickif Cepturer tick if
followinQ QUestion (s) completec!: COO1I>Ieted: fottowinQ Question (s) completed: comoleted: compteted:
A78
Patient Initials:
498 In the last 3 months how much income have you lost as a result of not being able to work because of any Illness?
Choose one (Mark with an Xl
Less than R100
R100 - R500
R500 - R1000
More than R1000
503 In the last year, have you lost your job as a result of any illness?
YES I .1 --> go to the next question
NO 1 1 --> skip to question 505 (this page)
504 When you used to work, how much money did you bring home in a usual working month (after deductions e.g. tax)?
Enter amount below:
R. ................ per month I .
505 In the last year what did the household do to cope with your medical costs?
Interviewer: Choose all that apply. (Mark boxes with X)
Used own income
Used savings
Sold assets e.g animals, appliances,
clothes
Medical Aid
Help from relatives
Help from friends
Borrowed money
Other
Not applicable
506 Did the nurse who saw you today talk to you about HIV?
YES I I
NO I I
507 Did the nurse who saw you today refer you for HIV couselling and/or testing?
YES I I
NO I I
508 Did you have an HIV test (rapid testl ftngerprick method or drawing of blood from your arm) at the clinic today?
YES I I
NO I I
509 Have you been tested for HIV in the past?
YES I I
NO I I
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
Please cc-ecvcompete the Fleld\..e. rker lick if FieldW'ori<.er tick if Please correcvcomplele tha Flek:lworkar lick if Fieldwotl(er tick If Capturer lick if
following queslion (s) ccmpjeteë; com leted: following question (s) com leted: completed: completed:
--
A80
,
Patient Initials: I IDate: I 1Clinic: L linterviewer code: 1
ECONOMIC IMPACT OF ILLNESS
Read: We would like to understand what the economic impact of your illness has been on you and your household.
In order to do this we need to know some background about your education, employment status, history and
household income. We would like to remind you that all the information you give us is confidential.
484 What was the highest standard/grade you passed at school?
Choose one (Mark box with an Xl
Did not attend school'
Sub A or Grade 1
Sub B or Grade 2
Standard 1 or Grade 3
Standard 2 or Grade 4
Standard 3 or Grade 5
Standard 4 or Grade 6
Standard 5 or Grade 7
Standard 6 or Grade 8
Standard 7 or Grade 9
Standard 8 or Grade 10
Standard 9 or Grade 11
Standard 10 or Grade 12
485 Which of the following best describes your employment status?
Choose one (Mark box with an X)
Employed 486 - go to question 487 (next block)
Self-employed 486 -> go to question 487 (next block)
Unemoloved
StudenULearner 499 ->500. Days unable to attend schooV college because of any
illness in the last 3 months
Looking for work 501 ->502. Days unable to look for work because of any illness in
the last 3 months:
Receivina Grant/Pension
Other
487 On what basis are you employed?
Choose one (Mark box with an Xl
Casual 488 ->489. Enter average no. of days worked per week
->490. Enter average amount brought home per day
~after deductions e.s. tax)
->497. Enter no. of days unable to work because of any illness
in the last 3 months
Weekly 491 ->492. Enter average number of weeks worked per month
->493. Enter average amount brought home per week
_lafter deductions e.q. tax)
-'497. Enter no. of days unable to work because of any illness
in the last 3 months
Monthly 494 ->495. Enter average number of months worked per year
->496. Enter average amount brought home per month
(after deductions e.q, tax)
->497. Enter no. of days unable to work because of any illness
in the last 3 months
COMMENTS FROM EDITOR COMMENTS FROM DATA CAPTURER
~~:!~~o~~:cs~~~~lete FleldwOfker lick if Fieldworker tick if Please correct/complete the FieJdworker tick if Fieldworker tick if Capturertick ifthe comDleted: comoleted: foUowina Queslion s comDIeled: col!!.2!.eted: com leted;
A79
Patient Initials: Interviewer code:
510 What is your home address?
1--
1-----.-.
511 Do you have a telephone at home?
YES _, 512. Enlernumber:
NO
513 Do you have a cellphone?
YES -> 514. Enter number:
NO
..
515 Do you have a work address?
Enter below:
J
517 Do you have a work telephone number?
YES -4518. Enter number:
-
NO
..
519 Do you have an alternative telephone number (friend, relative, neignbour)?
YES -> 520. Enter number:
-) 521. Enter name of contact:
-> 522. Enter how you are related to this contact (son, friend,
neighbour):
NO
524
SCHEDULE PATIENT FOR FOLLOW-UP INTERVIEW AFTER 3 MONTHS
Enter date below:
DATE: I I MONTH: I _l YEAR:
END OF BASELINE INTERVIEW
A81
ANNEX 11
Follow-up interview questionnaire- English version
A82
LUNG HEAL TH SURVEY FOLLOW-UP QUESTIONNAIRE (English version)
University of Cape Town Lung Institute
Centre for Health Services Research and Development, University of the Free State
Department of Community Health, University of the Free State
Medical Research Coun""c""il'-- _
Patient initials: Interviewer code
8 Do you know the year of your birth?
YES I 9 I -+ Enter year of birth & go to question 11:1
NO I 110 I -+ Enter age at last birthday & go to question 11:
11 Remember when we last spoke to you here at the clinic 3 months ago. Think carefully back to
with your state of health on the day of the first interview, do you think your state of health today Is ..•
X.
SYMPTOM SEVERITY IN THE LAST MONTH
I am now going to ask you some questions about how your chest has been in the last month. You will recognize the questions
from the first interview. Please think carefuliy about your symptoms IN THE LAST MONTH before answering each question.
12
13
14
15
16
17
A83
Read to patient (and complete with the help of the visual aid page 4)
I also want to ask you about the state of your health TODAY. Again you will recognize the questions from the first
interview. Just as before you will need to choose one box per group to describe the state of your health TODAY.
MOBILITY
18 , I I] IJ U
I have no problems in I have some
walking about problems in walking
I am confined to
about bed
SELF-CARE
19 I.J LJ [I LJ
I have no problems I have someproblems washing or I am unable to washwith self-care dressing. m_ïl>_elf or dress myself
USUAL ACTIVITIES (e.g. work, study, housework, family or leisure activities)
20 il i I D [I [-II _J
I have no problems I have some I am unable to
with performing problems with
usual activities performing usual
perform usual
activities activities
PAIN I DISCOMFORT
21 i] [l l : U
I have no pain or I have moderate pain I have severe pain
discomfort or discomfort or discomfort
ANXIETY I DEPRESSION
22 CJ LJ [J Cl [I
I am not anxious or I am moderately I am extremely
depressed anxious or depressed anxious ordepressed
A84
Read to patient (and complete with the help of the visual aid page 6)
I also want to ask you about the state of your health IN THE LAST MONTH. Again you will recognize the questions from the
first interview. Just as before you will need to choose one box per group to describe the state of your health IN THE LAST
MONTH.
MOBILITY
24 I j j"1 l_ LJ
I have no problems in I have some I am confined to
walking about problems in walkingabout bed
SELF-CARE
25 LJ iLJI LJ lj
I have no problems I have someproblems washing or I am unable to washwith self-care dressing myself or dress myself
USUAL ACTIVITIES (e.g. work, study, housework, family or leisure activities)
26 [J IJ t. lJ II
I have no problems I have some I am unable to
with performing problems with
usual activities performing usual
perform usual
activities activities
PAIN I DISCOMFORT
27 lj CJ L.. .! U LJ
I have no pain or I have moderate pain I have severe pain
discomfort or discomfort or discomfort
ANXIETY I DEPRESSION
28 U LJ LJ 0 LJ
I am not anxious or I am moderately I am extremely
depressed anxious or depressed anxious or
depressed
A86
Best
imaginable
To help people say how good or bad a health state is, we have drawn a state of health
scale (rather like a thermometer) on which the best state you can imagine
is marked 100 and the worst state you can imagine is marked O. 100
We would like you to indicate on this scale, in your opinion, how good or
bad your own health is TODAY. Please do this by drawing a line from the
box below to whichever point on the scale indicates how good or bad
your state of health is today.
o
Worst
imaginable
state of health
A8S
Besl
imaginable
To help people say how good or bad a health state is, we have drawn a slate of health
scale (rather like a thermometer) on which the best state you can imagine
is marked 100 and the worst state you can Imagine is marked O. 100
We would like you to indicate on this scale, in your opinion, how good or
bad your own health has been IN THE LAST MONTH. Please do this by
drawing a line from the box below to whichever point on the scale
indicates how good or bad your slate of health has been IN THE LAST
MONTH.
o
Worst
imaginable
state of health
A87
Interviewer: Are you conducting this interview at the patient's home or at the clinic?
Choose ONE. Mark box with an X.
30 At the patient's home I I _, skip to question 33 (this page)
At the clinic I I --+ go to the next question
Including today, have you been back to the clinic (to collect meds, for a check-up, to see a nurse or doctor etc.) in the
last 3 months after our first interview?
31 Interviewer: Indicate NO if the patient has not been back to the clinic after the first interview and is attending the clinic today
ONLY for the purpose of the interview.
YES I I --+ go to the next question
NO I I --+ skip to question 156 (top of page 14)
Interviewer: Have you confirmed in the folder that the patient attended the clinic in the last 3 months after the first interview?
32 YES I I --+ skip to question 34 (this page)
NO I I _, skip to question 34 (this page)
Have you been back to the clinic in the last 3 months after our first Interview?
33 YES I I --+ go to the next question
NO I I --+ skip to question 157 (page 14)
I would like to know about ALL your visits back to this clinic in the last 3 months after our first interview and including this visit
today (if attending the clinic for reasons besides the interview). As with the first interview, we will use your folder (if available)
to help refresh your memory.
TB Patients: I will only ask you to tell me about visits besides when you came to collect your TB medication.
34 Besides visits to collect TB medication, how many times have you been back to the clinic In the last 3 months after
our first interview?
Enter number of times:
A88
35 43
39
40
41 49
42
A89
THIS CLINIC IN THE VISIT 4 BACK TO THIS CLINIC IN THE
51 59 LAST 3 MONTHS
Month of Visit:
58 66
A90
THIS CLINIC IN THE
67 75
74
A91
VISIT 8 BACK TO THIS CLINIC IN THE
83 91 LAST 3 MONTHS
Month of Visit:
87
88
90
A92
99 Has a nurse at this clinic collected any phlegm/sputum samples for testing in the last 3 months after our first
interview?
Interviewer: Show
YES
NO
101 Has a nurse at this clinic asked you to collect any phlegm/sputum samples at home in the last 3 months after our
first interview?
Interviewer: Show
YES
NO
103 Have you been diagnosed with TB in the last 3 months after our first interview?
YES I I --+ go to the next question
NO I I --+ skip to question 108 (this page)
109 Have you had a chest X-ray in the last 3 months after our first interview?
YES I I --+ 110. How many Chest X-Rays have you had?
NO I ~~m:~;!I~ N';~,!,;~.ili\:~"l'~i~";:U;U:'3 i'l:~" o;.<:i;;:::tt~~:;';:~~'''Ïi~;~:·:~~'~·';;j;;jt!:k.~~:··;:"f~~1i·
A93
112 Did the nurse refer you to a doctor at ....... (insert name of clinic) clinic?
.__ .__ .
""'YES"" --,_, - ---_. -. 1- go to the next questionr-tN--Ox-r- 1 -> skip to question 115 (this page)
113 Have you seen the doctor yet?
YES ---- --I I ------114. How many times in the last 3 months?
NO -I I
115 Did the nurse refer you to a doctor at another clinic or hospital?
YES
NO
SMOKING
116 Have you ever smoked?
YES- -- --- I ' go to the next questionNO ,- I - skip to question 125 (top of ~e 13)
117 Do you smoke currently?
YES - -- ----------- 1_ -< ~ the next guestion ---NO ---1 , skip to question 123 (this page)
When did you stop smoking?
123 I-B=-e-:-fo-re-t=-hie-n--t=efïj~-r-s;~-t---- -
After the first interview
NO
A94
143 On what employed?
Choose
Casual ->145. Enter average no. of days worked per week
->146.
->151.
-148.
-151.
->150.
->151.
A95
157 Have you been diagnosed with TB in the last 3 months after our first Interview?
YES I I _. go to the next question
NO I I _. skip to question 160 (this page _Smoking)
158 Where were you diagnosed with TB?
Interviewer: Enter clinic/hospital name below.
159 Where are you receiving your TB treatment?
Interviewer: Enter clinic/hospital name below.
SMOKING
160 Have you ever smoked?
YES I I _, go to the next Question
NO I I - skip to question 169 (top of page15)
161 00 you smoke currently?
YES I I _, go to the next question
NO I I -. skip to question 167 (this page)
When did you stop smoking?
167 r=B-e7fu-re~th-e~fir-s~t~in~te-rv-i~e-w------------'------'----------~----~----------------------------------4
After the first interview --o 0 to the next question
Has a nurse at this clinic advised you to reduce or quit smoking in the last 3 months after our first Interview?
168 rY~E~S~---------------------r-----mr.~~
NO
A96
170 Have you come to the clinic today just for the purpose of this interview or also to see a nurse/doctor?
Just for the purpose of the interview I I _, skip to question 230 (top of page 17)
Also to see a nurse/doctor I I _, go to the next question
MEDICATION RECEIVED TODAY
INHALERS RECEIVED TODAY
Interviewer: Show patient photo's of inhalers in visual aid (pages 28 and 21).
171
RELIEVER INHALERS THAT YOU ARE USING NOW (Interviewer: Check ALL that apply).
172 Fenaterol (Berotee)
174 Fenoterolllpratropium (Duovent)
176 Ipratropium (Atrovent)
178 Salbutamol (Asthavent)
180 Salbutamolllpratropium (Combivent)
182 Salmeterol (Serevent)
No. of times taken each day No. of puffs taken each time
184 Budesonide 100 185 186
184 Budesonide 200 185 186
184 Budesonide (don't know the dose) 185 186
NO _, go to the next question (top of page 16)
A97
Interviewer code:
ANTIBIOTICS RECEIVED TODAY
Interviewer: Show patient photo's of antibiotics in visual aid (pages 30 and 31).
191 lnterviewer Did the patient receive an antibiotic on the chart to take home today?
- -
YES - -_. --- "," . --1--;- co~plete the following table 0_ni.~b!()~~!ha~you are using now)~. I I - skip to question 228 (this page)
ANTtBIOTICS RECEIVED TODAY (Interviewer: Check ALL that apply)
-- - . No. of times to be No of Nc. of days to be
taken each day tablets/capsules to taken for
- - .- be taken each time (DuratlOIl.~! course ._,_
192 Amoxicillin 250mg capsules(Betamox 250) 193 194 195
500mg - -
_ ... -
196 Amoxicillin capsules
----- - -- -
(Betamox 500)__ _ 197 198 199-- ._--- -----
200 Amoxicillinldavulanic acid tablets(Bio-Amoksiklav) 201 202 203f----
Cotrimoxazole tablets --204 (Cozole I Bactrim) 205 206 207--- .._ - ._.. -------- __ . ------._--_ .._.-
_20-8 Doxycycline capsules(D2_XY9!.!Jl. ___ 209 210 211_ .. - _.--- 1---- - - _" --"-_.
2~2 Erythromycin tablets(Rubimycin)_ _ 213 214 -_._- 215
216 Flucloxacillin capsules
--
(Floxa(!en) 217 218 219
- ----I
_.
220 Fluconazole tablets 221 222 223
__(.Q!flucaDL. __........ - _ .. .... - .. . '.....
Penicillin VK tablets I Pen VK tablets .---J224 (Betapen) 225 226 227 !i
OTHER MEDICATION RECEIVED TODAY
Interviewer: Besides the Inhalens,prednisone and antibiotics, did the patient receive any other medication shown on the chart
to take home today? - ---,------- -
228 YES - complete the following table(Other medication received toda:i)
NO • skip to question 230 (top of page 17)
OTHER MEDICATION RECEIVED TODAY (Interviewer: Check ALL that apply)
229
A98
· INHALERS THAT YOU ARE USING NOW
Interviewer: Show patient photo's of inhalers in visual aid (pages 28 and 29).
230 Are you currently using an inhaler(s) at home?
- -_._--_ .. -
YES I --, comelete the following 2 tables (Reliever & Preventer inhalers)
I -, -_.-NO I skip to question 247 (this page)
~.~~~~~~~NH~~=~~~~.~ T YO~_~R~_~~I~~_.~~~ (I~~~~i~:~r: ~~~~~_~~~~~~~~.~ty). ._._. . _.. X§_~_~~.:~_Q.._.
231 Fenoterol (8erotec) -. 232. Does ,!,is inhaler improve ~ou~ difficult
__ __._ _._.._._ _ __ __ _.. .____ _._. ..__ .._.._.__ Q~athlng ml(lutes after uSing it? _.._ _ .
233 F t III I . (0 t) -. 234. Does this inhaler improve your difficult
......_.+_e_n_o __e_ro_~~_~~.~~_ uoven breathing minutes after using it? ...__ ..._. ..._ ......_.
.....236. Does this inhaler improve your difficult
235 Ipratropium (Atrovent)
._. __ ..breathing minutes after usin9.J!1___ ._. '--"'-"'-'r---
237 Salbutamol (Asthavent) -.. 238. Does this inhaler improve your difficult
..._..._.-...-.-------------------f--.---- ..~..~;;Ithil}g ..T_!'IJ..l)uteasfter usingXL .
., 240. Does this inhaler improve your difficult
239 Salbutamolllpratropium (Combivent)
r---'" breathing minutes after using it?'242. Does,this inhaler improve your difficult
241 Salmeterol (Serevent)
breathing minutes after using it?
Interviewer: Is the patient using a preventer inhaler al home?
243 ~::.-:·~=:-~~=~-=-.·::===~==:=::~.=.·=-.r==:·.=l:~=~~~~~ï~n8:ii:~:~:;~~~ers)-·----·--·-·--·:=
PREVENTER INHALERS THAT YOU ARE USING NOW (Interviewer: Choose ONE).
. - - - -.-------1
No. of times taken each day No. of puffs taken each time
1---.-- -----.------,----t--,---------j---,--.-------.-- ....
244 Budesonide 100 245 246
--r------ ..-.-..--.--..--. ...-.- ..-..-.- ..-------.-.----.-.-t---t-----.------t----!---------
244 Budesonide 200 245 246
244 Budesonide (don't know the dose) 245 246
PREDNISONE THAT YOU ARE USING NOW
Interviewer: Show patient photo's of prednisone tablets in visual aid (page 29).
Interviewer: Is the patient using Prednisone tablets at home on a regular basis (this means daity or almost every day)?
------. __ ._-_.
No. of times taken each day I No. of tablets taken each time
247 -_..
YES 248 249
---------- 1 1 1
NO - go to the next question (top of page 18)
A99
, Interviewer code.
ANTIBIOTICS THAT YOU ARE USING NOW
Interviewer. Show patient photo's of antibiotics in visual aid (pages 30 and 31).
250 Interviewer: Is the patient using any of the antibiotics on the chart at home on a regular basis?
YES I I _. complete the following table (Antibiotics that you are using now}
NO I I -+ skip to question 278 (this page)
ANTIBIOTICS THAT YOU ARE USING NOW (Interviewer: Check ALL that apply)
No. of times taken each day No of tablets/capsules taken each
time
Amoxicillin 250mg capsules
251 252
(Betamox 250) 253
Amoxicillin 500mg capsules I
254 (Betamax 500) 255 256
Amoxicillin/clavulanic acid tablets
257 (BicrAmoksiklavl 258 259
Cotrimoxazole tablets
260 261 262
(Cozole I Bactriml
Doxycycline capsules
263
(Doxvclin) 264 265
Erythromycin tablets
266 267 268
(Rubimycin)
Flucloxaciltin capsules
269 270 271(Floxapen)
Fluconazole tablets
272 273 274
(Diflucan)
Penicillin VK tablets I Pen VK tablets
275 276 277
(Betapen)
OTHER MEDICATION THAT YOU ARE USING NOW
Interviewer: Besides the inhalers, prednisone and antibioties, is the patient using any other medication shown on the chart?
278 ..... complete the following table (Other medication that you are usingYES
now)
NO
-+ skip to question 280 (top of page 19)
OTHER MEDICATION THAT YOU ARE USING NOW (Interviewer: Check ALL that apply)
AIOO
patient: Pictures of other health care providers on visual aid
Read: As in the first interview, we wish to know whether you have been to any other health care provider besides this
clinic in the last 3 months after the last interview. Other health care providers include hospitals (public, private, mine),
other primary care clinics besides this one, private doctors, traditional healers etc. We would like to know about all
visits to other health care whether attended as an or were admitted.
281 How many times have you been to another health care provider besides this clinic in the last 3 months after our first
interview?
Interviewer: Enter number below. Then enter details for the visits.
AWl
Interviewer code:
(travel
employed?
Enler average no. of days worked per week
home per day
Enler no. of days unable to work lo accompany you lo
the HCP
Enter average amount brought home per week
AI02
AI03
LHS Follow-u e22
Interviewer code
332
333
Bus 335
Train 337
Private moto~vehicle
Ambulance 339 '341. Tariff aid? Enter amount: (enter 0 if no tariff_paid)
Other
342 How long did it take you to visit the HCP from the time you left home until the time you got back home again (travel
time + time spent at HCP)?
Choose one Mark box wilh an X
Overnight '344.
Between 2 and 12 hrs
Less than 2 hours
347 Did someone accom
YES
NO
348 What is the employment status of your companion?
Choqseone~~=b~o~x~w~it~h~a~n~X~~~-'r- .- __ ~ ~ __ ~~ __ ~~~ _
Employed
Self-~mploy~ __
Unemployed
SludenVLeamer
----j359361--
Receiving GranlÏPenSiorï -- .- -
350 On what basis is your companion/escort employed?
Choose one Mark box with an
Casual 351 '352. Enter average no. of days worked per week
'353. Enter average amount brought home per day
after deductions e. . tax
Enler no. of days unable to work lo accompany you to
Ihe HCP
Weekly 354 Enter average amount brought home per week
(~f!_erQ~ucti<?'I!;I_!Ul.tax _
Enter no. of days unable to work to accompany you to
the HCP ---:--:-----;-
Monthly 356 '357. Enter average amount brought home per month
after deductions e. . tax
'358. Enter no. of days unable to work lo accompany you to
the HCP
363 Is there another visit In the last 3 months (after our first interview) to a health care provider other than this clinic
which we have not discussed?
YES
NO
AI04
AI05
Interviewer code:
employed?
-. 393. Enter average no. of days worked per week
-'394. home per day
'_.- ...,--~"--_..... -
395 ·"396. home per week
~399.
397 ·'398. home per month
-,399. Enter no. of days unable to work to accompany you to
the HCP
404
AI06
AI07
Interviewer code:
;440.
Weekly ~437.
-'440.
Monthly 438 ··-'439.
445 visit in the last 3 months (after our first interview) to a than this clinic
discussed?
AI08
AI09
Interviewer code
-0475. Enter average no. of days worked per week
-0476. home per day
-0481.
Weekly 477 home per week
Monthly 479 -0480. home per month
-0481.
486 than this clinic
already entered the maximum number of HCP
Alla
Casual 491 ~492. Enter average no. of days worked per week
Allt
are you employed?
Choose one (Mark box wilh an Xl
Casual '507. Enler average no. of days worked per week
-'508. Enter average amount brought home per day
~ ~~~~~!JI. ~ _ ___ ._
Enter no. of days unable lo work because of any illness
_t- --+ -"in.:...l:o.he:=...;.la:=;s:o;I...::3o.;m:.=0.;.;n;::.th;.::s_'-_-_______
'510. Enler average number of weeks worked per month
'511. brought home per week
f-=-=~"""~=:=!.:!!..:"'"u.: tax} _
,515. no. of days unable to work because of any illness
I-_._+-._..".,..,..--='-""=!!!.~ 3 month~
Monthly 512 '513. Enter average number of months worked per year
- _.
-'514. Enter average amount brought home per month
-'515. days unable to work because of any illness
months
516 how much income have you lost as a result of not being able to work because of any illness?
~~~~;_g~09,se Ofl{_E. _Ma!!.~~ w!th a.!:' x.
521
522 When you used to work. how much money did you bring home in a usual working month (after deductions e.g.
tax)?
A112
A1l3
Finally we would to ask you some questions about what you think the care you receive at this clinic. The following
questions all ask what you think of your last visit to the clinic nurse. If you have not been back to this clinic in the last 3 months
think back to the consultation with the nurse on the day of our first interview. We would like to remind you that your answers will
be kept entirely confidential and will not be shown to any of the clinic staff so feel free to say what you wish.
The following questions are all set out in the same way. Some of the questions will appear similar. This is deliberate. For each
question you will be asked to select and answer that is closest to what you think. You may only choose ONE answer per
question.
'Neutral" means that you have no feelings either way.
527 I was totally satisfied with my visit to the nurse/clinic.
Interviewer: Choose ONE. Mark the box with an X.
StronglyAgree I Agree I Neutral I Disagree I Stronglydisagree
528 The nurse was very careful to check everything when examining me.
Interviewer: Choose ONE. Mark the box with an X.
StronglyAgree 1 Agree I Neutral I Disagree I Stronglydisagree
529 I follow the nurse's advice because I think he/she is absolutely right.
Interviewer: Choose ONE. Mark the box with an X
StronglyAgree I Agree I Neutral I Disagree I Stronglydisagree
530 I felt able to tell this nurse about very personal things.
Interviewer: Choose ONE. Mark the box with an X.
StronglyAgree I Agree I Neutral I Disagree I Stronglydisagree
531 The time I was able to spend with the nurse was a bit too short.
Interviewer: Choose ONE. Mark the box with an X.
StronglyAgree I Agree I Neutral I Disagree I Stronglydisagree
532 The nurse told me everything about my treatment?
Interviewer: Choose ONE. Mark the box with an X.
StronglyAgree I Agree I Neutral I Disagree I Stronglydisagree
533 Some things about my consultation with the nurse could have been better.
Interviewer: Choose ONE. Mark the box with an X.
StronglyAgree I Agree I Neutral I Disagree I Stronglydisagree
534 There are some things the nurse does not know about me.
Interviewer: Choose ONE. Mark the box with an X.
StronglyAgree I Agree I Neutral I Disagree I Stronglydisagree
535 The nurse examined me very thoroughly.
Interviewer: Choose ONE. Mark the box with an X.
StronglyAgree I Agree I Neutral I Disagree I Stronglydisagree
A114
Strongly disagree
Disagree Strongly disagree
Disagree Strongly disagree
Neutral Disagree Strongly disagree
Neutral Disagree Strongly disagree
Disagree Strongly disagree
542
Disagree Strongly disagree
Disagree Strongly disagree
Disagree Strongly disagree
546
547
Thank you very much for participating in our study and returning to the clinic today for the follow-up
interview. The results of the study will be used to improve primary care services for patients with
respiratory illnesses. Please accept this food parcel as a sign of our agpreciation foryour participation.
AIlS
ANNEX 12
Photographs
A116
QUESTION 94
Did the nurse who you saw today collect any
phlegm/sputum samples for testing? D
Het die verpleegkundige, wie jou vandag gesien het,
enige slymlsputumproefmonsters geneem vir toetsing? D
Na mooki ya 0 boneng kajeno 0 nkile dikgohlela bakeng
sa diteko? D
Ingaba unesi/umongikazi oyewambona namhlanje
uyewaqokelela isikhohlela sakho ukuzesikwazi D
ukuyokuxilongwa?
Ingabe unesi obonane naye namhlanje ukuthathe
izikhwehlela ukuze ziyohlolwa? D-
Al17
QUESTION 96
Did the nurse who you saw today ask you to collect any
phlegm/sputum samples at home? o
Het die verpleegkundige, wie jou vandag gesien het, vir
jou gevra om slym/sputumproefmonsters tuis te neem? o
Na mooki ya 0 boneng kajeno 00 kopile hore 0 ilo o
tshwela dikgohlela lapeng?
Ingaba unesilumongikazi oyewambona namhlanje
uyewakucela uqokelele izikhohlela ekhaya zezikwazi D
ukuxilongwa?
Ingabe unesi obonane naye namhlanje ukucele ukuthi uze o
nesikhwehlela ekhaya?
Al18
RELIEVER INHALERS
Generic Name: Fenoterol Generic Name: FenoteroVlpratropium
Trade Name Berotec Trade Name Duovent
Generic Name: Ipratropium Generic Name: Salbutamol
Trade Name Atrovent Trade Name Asthavent
Generic Name: SalbutamoVlpratropium Generic Name: Salmeterol
Trade Name Combivent Trade Name Serevent
Al19
Generic Name: Budesonide 200
Trade Name Inflammide 200
PREDNISONE TABLETS
Generic Name: Prednisone
Trade Name Be-Tabs PrednisonelPredeltin
A120
ANTIBIOTICS
Generic Name: Amoxicillin 250mg Generic Name: Amoxicillin 500 mg
Trade Name Betamox 250 Trade Name Betamox 500
Generic Name: Amoxicillin/ClavulanicAcid Generic Name: Cotrimoxazole
Trade Name Bio-Amoksiklav/Augmentin Trade Name CozolelBactrim
Al21
ANTIBIOTICS (continued)
Generic Name: Doxycycline Generic Name: Erythromycin
Trade Name Doxycfin Trade Name Rubimycin
Generic Name: Flucloxacillin Generic Name: Fluconazole
Trade Name Floxapen rradeName Dfflu~n
Generic Name: Pen VK {Phenoxymethyl penicillin
Trade Name 8etapen
A122
~"I~ ..... t..
""t ....l.%_~"
""'_ .... 1'I'IIDI .....
Generic Name: Theophylline Generic Name: Salbutamol
TradeName NuelinSA Trade Name Venteze
Generic Name: Paracetamol Generic Name: Paracetamol/Codeine
TradeName Painamol Trade Name Painamol PluslBetacod/
Dolorol Forte
Generic Name: Chlorpheniramine Generic Name: Enalapril
Trade Name Allergex Trade Name Renitec
Al23
Generic Name: Oxymetazoline Generic Name: Beclomethasone
Trade Name Drixine Trade Name Beclate
Generic Name: Acetic Acid Eardrops
Trade Name Acetic Acid Eardrops
Generic Name: Mist Expectorant Generic Name: Nystatin
Trade Name Mist Expectorant Trade Name NystacidlCanstat
A124
Walking Bicycle
Animal, e.g. Donkey Taxi
Private Motor Vehicle Ambulance
A125
Hospital Other Primary care Clinic
Private Doctor Traditional Healer
Pharmacy/Chemist
A126
ANNEX 13
Notification of deceased patients as follow-up form- English version
Al27
LUNG HEALTH SURVEY 2003
University of Cape Town Lung Institute
Department of Community Health, University of the Free State
Centre for Health Services Research and Development, University of the
Free State
Medical Research Council
FOLLOW-UP FIELDWORK
NOTIFICATION OF DECEASED PATIENTS AT FOLLOW-UP
Clinic where patient was recruited: ....................................•.....................
First name of patient: .
Last name (surname) of patient: ..•...........•..•....•...•...................................
Date of birth: 1 ..
Folder number: ...........................................................•........................
Date of death of patient: .........................•....•.........•.................................
Place of death (if hospital, give name): .
If known, supply reason for death: ....•....................................•.................
....•.•••.•.•...•...•........................................................................•..............
Please donate the patient's food parcel to the surviving relatives.
Fax completed forms to Dr. Lara Fairall (021 4066878) before end of
fieldwork in clinic.
AI28
ANNEX 14
A list of responsibilities of the field workers
A129
List of responsibilities of tbe field workers
1. Field worker
The tasks of the fieldworker/interviewer comprise the following:
e Becoming thoroughly familiar with the questionnaire as well as the procedure to
identify and establish contact with the targeted respondents (in dose cooperation with
the team leader).
o Conduct interviews of respondents selected by the team leader/selector.
Q) Visit all selected respondents to conduct follow-up interviews after three months.
• Take responsibility for the first level of quality control; this entails accepting
responsibility for the quality and completeness of the questionnaires.
• Return to a respondent if the information on the questionnaire is found to be
inadequate by the team leader, supervisor and/or researcher.
• Maintain a high standard of courtesy and meet the ethical standards of the project.
• Maintain the anonymity and confidentiality of all information gleaned from
interviews and never to compromise the safety of any respondent or co-fieldworker.
• Communicate all problems and queries to the team leader/supervisor.
• Keep the data safe before handing it over to the team leader/supervisor.
• Briefly record experiences/constraints regarding the fieldwork task and communicate
these to the team leader/supervisor/researcher.
• Will be answerable to the team leader/selector
2. Team leader/Selector
The team leader/selector will assume overall responsibility of the data collection process
in all clinics assigned to his/her team. His/her tasks will include but not be restricted to:
• Being responsible for all logistics arrangements on behalf of the team he/she is
assigned to.
• Being responsible for conducting selection of potential patients to be included in
the cohort and assigning them to the field workers for interviews.
• Being responsible for ensuring that data collected on daily basis is either
transmitted to a central research base or safely stored for transmission on agreed
upon frequencies.
A130
• Coordination oftravel and accommodation arrangements of team members at all
times.
• Allocate number of respondents to be interviewed evenly among team members.
• Keep record of interviews conducted by each field worker.
o The team leader/selector will remain with the team he/she is assigned to through
out the data collection process.
o The team leader/selector will be answerable to the supervisor.
3. Supervisor
The supervisor will be overall responsible for smooth administrative and logistical
operation of teams assigned to him/her by region. Responsibilities will include hut not
restricted to:
• Conducting a minimum of two visits to each clinic, the first one being prior to
field work in order to arrange for office space and accommodation offield
workers, and the second one mainly for trouble shooting.
• To monitor on weekly basis the process of data collection and ensure that the
collected data is transmitted to the researchers on an agreed upon frequency.
• To liaise with the researchers for solving any administrative or technical problem
that may arise during the course of data collection process.
• To settle any dispute that may arise amongst the field workers and/or with health
faci lity management.
• The supervisor will be answerable to the Director, CHSRD UFS.
Al31
ANNEX 15-1
Part 1- First post-intervention survey training manual
A132
THE FREE STATE
LUNG HEALTH SURVEY
RESEARCH TRAINING AND FIELDWORK
MANUAL
University of Cape Town Lung Institute
Department of Community Health, University of the Free State
Centre for Health Services Research and Development, University of
the Free State
April2003
Al33
FREE STATE LUNG HEALTH SURVEY
1. Overview
1.1 Origin
Lung diseases are very common in South Africa and their prevalence is increasing due to the HIV
epidemic. Respiratory conditions account for I in 3 visits to primary care in this country. For this
reason it is essential to evaluate how they are being treated in primary care so that services can be
planned accordingly.
Common respiratory conditions include TB, upper and lower respiratory tract infections and
obstructive lung disease (asthma / COPD).
Research shows that pneumonia is one of the leading causes of death in adult South Africans and that
TB is the leading cause of death in South Africans living with HIV/AIDS. Both of these conditions are
treatable if recognised and treated early, with potential to save lives and reduce the burden of illness in
patients with HIV/AIDS.
The quality of health care provided at primary care clinics is crucial in treating lung disease since this is
the first port of call for most patients. Currently this health Care is of poor quality forcing many
patients to bypass clinics (especially in emergency cases) and seek care elsewhere, often at great
expense.
This survey aims to measure the quality of care provided to patients with respiratory problems in
primary care, and quantify the economic implications for the patient and their household.
Itwill run over a period of 6 months (May to November 2003) and 2000 patients will be interviewed
twice, once at baseline and again after a 3 month period. Data on the care received, health-related
quality of life, use of alternative health care providers and the economic implications for the patient and
their household will be collected.
The 6 month survey period is essential when dealing with respiratory problems to avoid interviewing
patients only during a 'flu epidemic or any other period where respiratory conditions are known to
worsen (e.g. asthma in spring). This could lead to "skewed" data and not provide a balance picture of
respiratory disease throughout the year.
1.2 DEFINITIONS
Respiratory System
The respiratory system is divided into the upper respiratory tract (everything above the vocal cords -
nose, sinuses, throat, and tonsils) and lower respiratory tract (everything below the vocal cords - large
airways called bronchi and the 2 lungs).
A134
Common Respiratory Symptoms
The 2 most common respiratory symptoms are cough and difficult breathing.
Cough
This can be dry or productive of sputum. Sputum or phlegm is mucus or slime which originates from
the lungs and should not be confused with watery saliva. Sputum can be clear, yellow or green or even
blood-stained. Patients can also cough up frank blood.
Difficult Breathing
Difficult breathing includes the feeling of a tight chest, wheezy breathing and shortness of breath. The
shortness of breath must occur at rest or on usual exertion such as walking fast on the flat or with
activities of daily living like dressing etc. It does not include the shortness of breath that occurs on
heavy exercise like running.
Wheeze and Tight Chest
Some lung diseases like asthma result in narrowing of the airways in the lung causing airflow to
become obstructed. In these cases air is forced through the narrowed airways producing a whistling
sound called a wheeze. Patients may report this symptom or the wheeze may be audible to those
around them. This is often but not always accompanied by a feeling of discomfit or tightness in the
chest and patients often report a "tight chest".
Respiratory illnesses
These include all illness that involves part of the respiratory system. The Respiratory system is often
the site of many common infections. These can either affect the upper respiratory tract (nose, sinuses,
throat, tonsils) or the lower respiratory tract (large airways called bronchi or lungs). Common
respiratory infections managed at primary care clinics include:
• The common cold (nose and throat)
• 'Flu (nose and throat)
• Sinusitis (infection of the sinuses)
• Pharyngitis (sore throat)
• Tonsillitis (infection ofthe tonsils)
• Laryngitis (infection of the vocal cords resulting in a hoarse voice)
• Acute Bronchitis (infection ofthe large airways or bronchi)
• Pneumonia (infection of the lung tissue itself)
The respiratory system is also the site of many chronic diseases. Again these can involve both the
upper and lower respiratory tracts. Common chronic respiratory conditions managed at primary care
clinics include:
• Hayfever or Allergic Rhinitis (nose and sinuses; rhinitis means nose)
• Asthma (small airways situated deep inside the lungs)
• COPD which stands for Chronic Obstructive Pulmonary Disease (airways and lung tissue)
• Chronic Bronchitis (inflammation of the large airways or bronchi usually due to smoking)
• Emphysema (destruction of the lung tissue usually due to smoking)
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Asthma
This is an inflammatory disease that involves the small airways deep inside the lungs. These airways
are inflamed and swollen, causing them to be narrowed and making it difficult to breathe. The
condition tends to run in families and is associated with allergic diseases like hayfever, eczema (skin)
and food allergies. Patients with asthma suffer from cough (especially at night), shortness of breath
when performing light activity, wheeze and often complain of a feeling of tighrness in their chest.
Severe asthmatics experience symptoms every day but milder asthmatics may have long periods of
feeling well interspersed with attacks of cough, wheeze, tight chest and shortness of breath. Asthma
symptoms can be controlled with inhaler medication.
COPD or Chronic Obstructive Pulmonary Disease
o Obstructive means that the airways are narrowed and so the normal flow of air through them is
obstructed.
• Pulmonary is the medical term for conditions relating to the lung.
COPD is a common abbreviation used in primary care and refers to patients with chronic bronchitis
and/or emphysema. COPD is usually due to smoking but can also be caused by long-term exposure to
dusty environments like mining underground. These patients usually present with a persistent cough
often productive of phlegm (mucus). They also complain of feeling short of breath with light activity
and may complain of a wheeze or tight chest. The symptoms are very similar to those of asthma but,
unlike asthmatics, these patients tend to have symptoms every day of the year and are often older with
a background of smoking.
In fact the symptoms of asthma and COPD are very similar. "Asthma" is a popular term in the
community (and easier than "COPD") and many patients with COPD will tell you that in fact they have
asthma when this is not necessarily true.
Tuberculosis (TB)
TB is a chronic infection of the lung which takes months to clear on treatment It is caused by a germ
which is transmitted through respiratory secretions on coughing and sneezing. But, unlike colds and
'flu, TB is quite difficult to catch and really only occurs in people who have been exposed to it on a
daily basis for some time.
It is a curable infection but requires at least 6 months of treatment. Patients who have TB more than
once, tend to be run-down and often have another disease which prevents their bodies from fighting
infections properly like HIV/AIDS. These patients are usually treated for 9 months with additional
injections in the first 2 months.
2. The tieldworker/interviewer
It cannot be overemphasised that the fieldworker/interviewer occupies a central position in this project,
as he/she is the one who collects the information from the respondents. Therefore, the success of the
project depends to a great extent on the quality of each fieldworker/interviewer's work.
A136
The tasks of the fieldworkers/interviewers comprise the following:
o Becoming thoroughly familiar with the questionnaire as well as the procedure to identify and
establish contact with the targeted respondents (in close cooperation with the fieldwork manager).
.. Visit all selected respondents and conduct interviews.
.. Take responsibility tor the first level of quality control; this entails accepting responsibility for the
quality and completeness of the questionnaires.
o Return to a respondent if the information on the questionnaire is found lo be inadequate by the
editor, fieldwork manager and/or researcher.
o Maintain a high standard of courtesy and meet the ethical standards of the project.
.. Maintain the anonymity and confidentiality of all information gleaned from interviews and never
compromise the safety of any respondent or co-fieldworker.
.. Communicate all problems and queries to the fieldwork manager/editor.
• Keep the data safe before handing it over to the manager/editor.
.. Briefly record experiences/const.raints regarding the fieldwork task and communicate these to the
manager/ed iter/researcher.
2.1 Training or fieldwor~!:rs/intervicwcrs
Although some people arc more skilful at interviewing than others, onc can become a good interviewer
through practice. Training will comprise of theoretical information and practical experience. The
training manual and questionnaire should be carefully studied hefore each training session. Write down
any questions, and these can be discussed during the training session. Interviewers can learn a lot from
each other by asking questions.
During the training, the questionnaire sections, questions and instructions will be discussed in detail. It
is important that you understand the questions and how to ask them before embarking on your first real
interview. Practice reading the questionnaire out loud to another person several times so that you can
become comfortable reading the questions aloud. This is an important assignment and prepares you for
role-playing, during which you will interview another trainee. Later you will conduct a practice
interview at a clinic during which you will interview real patients with respiratory diseases. You will be
required to check and edit the questionnaire just as you would do during the actual fieldwork.
Your training ns an interviewer does not end when the formal training period has been completed. Each
time your tieldwork manager/editor meets with you to discuss your work in the field, your training is
being continued. The formal training merely provides you with basic knowledge and information
regarding the research process and questionnaires. Continued observation and supervision during the
actual fieldworkcomplete the training process. This is especially important during the first few days of
fieldwork. If you are uncertain about anything, discuss it with your fieldwork manager/editor.
2.2 Supervision of interviewers
Training is a continuous process. Observation and supervision throughout the fieldwork are a part of
the training and data collection process. Your fieldwork manager/editor will play a very important part
in continuing your training and ensuring the quality ofthe data. Your fieldwork manager/editor will:
Al37
o Do spot checks to ensure that you interviewed the identified respondents.
G Meet with you on a regular basis to discuss any problems.
Any fieldworker/interviewer, who is not performing at the level necessary to produce high quality data,
may be released from service.
3. Project regulations
Your presence, interest, participation and co-operation are of the utmost importance over the next few
months. During this time you will be provided with the necessary information, training, tools and
support to accomplish your task. The following regulations have been generated to ensure that the
workload is equally divided and the support equally shared.
• You have a very important task to perform during the fieldwork. If you are chosen to be an
interviewer, and accept the position, your presence is required for each day of fieldwork.
• Except for illness, any person who is absent during any part of the training or fieldwork (i.e. whole
day or part of a day) without permission will be dismissed.
• There is a great deal of work to be completed over the next few months; therefore late arrivals will
not be tolerated during the training sessions or fieldwork.
• Your conduct must at all times be professional and your behaviour must be pleasant when dealing
with the public. We are only able to do our work with the good will and cooperation of the people
we interview. Therefore, any team member who is consistently overly aggressive, abrupt or
disrespectful towards people in the field may be dismissed.
o Conduct all work required of you in terms of the agreement undertaken. The scope and type of
work may change from time to time.
• Complete the training session preceding the fieldwork.
• Become thoroughly familiar with the different research instruments.
• Conduct practice fieldwork during the training session.
• It is critical that the data gathered during the fieldwork be both accurate and valid. Spot checks will
be conducted to control for inaccurate and invalid data. Interviewers may be dismissed at any time
during the fieldwork if their performance is considered inadequate.
• Provide missing or faulty information, should the quality of the data be found unacceptable.
• The data gathered is confidential and must not be discussed with anyone, including your fellow
interviewers. Interviewers breaking this rule may be dismissed.
Furthermore, it is expected that no tieldworker/interviewer will:
• Neglect his/her duty, due to poor performance.
• Refuse to adhere to instructions given by the researchers.
• Be under the influence of alcohol or drugs while performing his/her duty.
• Be out of contact for a period of more than three days.
• Behave in such a manner that is prejudicial to the maintenance of good order.
o Attempt to use violence while perfomling his/her tasks.
AB8
4. Interviewing
4. t Conducting the interview
The ability to conduct a successful interview is an art. It should not be treated as a mechanical process.
Each interview provides us with new information, therefore we need to make it as interesting and
pleasant as possible. The art of interviewing develops with practice, however, there are a few basic
guidelines followed by every successful interviewer.
4.1. t Building rapport with the respondent
You (fieldworker/interviewer) and the respondent are strangers, and one of your main tasks as an
interviewer is to establish rapport with the respondent. The respondent's willingness to co-operate with
you will depend on his/her first impression of you. Ensure that your appearance is neat and your
manner friendly when you introduce yourself.
4.1.2 Make a good first impression
When you first approach the respondent, do all that you can to make himlher feel at ease. Start the
interview with a smile and a greeting such as "Good afternoon. How are you?". Then proceed with your
introduction.
An example of a good introduction is:
"My name is . I'm a fieldworker from . We are
conducting research about the health services available to patients with respiratory conditions. I
would like to talk to you and ask you some questions."
4. t.3 Always have a positive approach
Do not have an apologetic manner and use words such as "Are you too busy?", "Would you spare a few
minutes?" or "Would you mind answering some questions?". Such questions invite refusal before you
even start. Instead, tell the respondent "I would like to ask you a few questions" or "l would like to talk
with you for a few minutes".
4.1.4 Stress confidentiality of responses when necessary
If the respondent is not eager to answer questions or asks what the data will be used for, explain that
the information you collect will be kept confidential and all information will be pooled to write a
report. Do not discuss specifics about other interviews that you have conducted or show completed
questionnaires to other interviewers or supervisors in front of a respondent or any other person.
4.1.5 Answer all the respondent's questions frankly
The respondents may ask some questions about the research, or how he/she has been selected for the
interview before he/she agrees to be interviewed. Be direct and pleasant in your answer. The
A139
respondent may also want to know how long the interview will take. If she asks, tell her that the
interview usually takes about 45 minutes.
4.2 Tips in conducting interviews
4.2.1 Be neutral throughout the interview
Most people are polite and will try to give answers that they think you want to hear. Therefore, it is
very important that you are absolutely neutral when you ask the questions. Do not ever let your facial
expression or the tone of your voice allow the respondent to think that he/she has given the right or
wrong answer.
The questions are all carefully formulated to be neutral, so that they do not suggest that one answer is
preferable to another answer. If you fail to read the complete question, you may destroy this neutrality.
Therefore, it is important that you read the whole question as it is written. If the respondent gives an
ambiguous answer, probe in a neutral way, by asking questions such as "Can you explain a little
more?" "I did not quite hear you. Could you please tell me again?" "There is no hurry. Take a moment
to think about it?"
4.2.2 Never suggest answers to the respondent
If the respondent's answer is not relevant, do not prompt her by saying something like "I suppose you
mean that ... is that right?" Usually, she will agree with your interpretation of her answer, even if that
was not what she meant. Rather probe in such a way that the respondent himself/herself comes up with
the relevant answer.
4.2.3 Do not change the wording or sequence of the questions
The wording and sequence of the questions in the questionnaire must be maintained. If the respondent
misunderstood the question, repeat the question slowly and clearly. If she still does not understand, you
may reword the questions, but be careful hot to change the meaning of the original question. Provide
only the minimum information to get an appropriate answer.
4.2.4 Handle hesitant respondents tactfully
There will be times when the respondent says "I don't know", gives an irrelevant answer, acts bored,
contradicts something she has already said or refuses to answer the question. Spend a few moments
talking about things unrelated to the interview (e.g. his/her family, the weather, etc.).
If the respondent is giving irrelevant or elaborate answers, listen to what she has to say and do not stop
him/her abruptly or rudely. Try to steer him/her gently back to the original question. Maintain a good
atmosphere throughout the interview. The best atmosphere is one in which the respondent sees the
interviewer as a friendly, sympathetic and responsive person who does not intimidate him/her, and to
whom he/she can say anything .. If the respondent is reluctant or unwilling to answer a question, try to
overcome this reluctance by explaining once again that the same question is asked of other respondents
and that the answers will all be merged together. If she still refuses, write "REFUSED" next to the
A140
questions and proceed as if nothing has happened. On the PDA you will find a R (for Refused to
answer) button in the lower left corner. When you have completed the interview, you can try to obtain
the missing information at the end, but do not push too hard for an answer. Remember that the
respondent cannot be forced to give an answer.
4.2.5 Do not form expectations
You must not form expectations about the ability and knowledge of the respondents. At the same time,
remember that differences between you and the respondents can influence the interview. If the
respondent feels that you are different from him/her, he/she may be afraid or mistrustful. Always
behave and speak in such a way that he/she feels at case and comfortable talking to you.
4.2.6 Do not hurry the interview
Ask the questions slowly so that the respondent understands. Once the question has been asked, pause
and give her time to think. If the respondent feels hurried, or is not allowed to formulate his/her own
opinion, he/she may answer, "I don't know" or give an inaccurate answer. If you think that the
respondent is answering without thinking to speed up the interview, say to him/her "There is no hurry,
your opinion is very important, so please consider your answers completely".
4.3 Language of the interview
The questionnaires have heen translated into the language that you will need to conduct the interview
in. There may, however, be times you will have to slightly change the wording of the questions to tit
the local dialects and culture. It is very important not to change the meaning of the questions when you
rephrase it.
5. Fieldwork
5.1 Supplies
Before leaving for the field, ensure that you have adequate supplies for the day's work. These supplies
include:
o Your targus bag containing your PDA, modum, rechargeable batteries, thermometer and digital
watch.
• A su fficient supply of paper questionnaires to serve as back-up in the event that you encounter
technical failure of the PDA.
• A sufficient supply of the paper consent forms
• Your copy of tile training manual
• Letter of introduction
• A clipboard
• Pencils (sharpeners and erasers) to till in the questionnaires
• A briefcase or bag in which to carry the questionnaires
o Any personal items that you will require to be comfortable given the circumstances and area in
which you are working.
A141
5.2 Checking completed questionnaires
The fieldwerkers must check each questionnaire once the interview has been completed. This should be
done before the patient leaves the clinic to ensure that every appropriate question has been asked, that
all answers are clear and reasonable and that your handwriting is legible. Also check that the skip
instructions have heen correctly followed. You can make minor corrections, but the respondent must
clarify serious errors. Apologise, explain that you made an error and ask the questions again. Do not
recopy questionnaires. The answers need to be clear and readable, it is not necessary that the
questionnaire itself be neat. Each time you rewrite the answers on a new questionnaire, you increase the
chance of an error. Explain anything out of the ordinary by writing by in the margins or at the back of
the questionnaire. These explanations are helpful to the fieldwork manager/editor when checking the
questionnaires. Explanations are also read in the office and used to resolve problems encountered
during coding the questionnaires.
A142
THE PDA (PERSONAL DIGITAL ASSISTANT)
Getting Started
Your Palm m500 series handheld
Expansion card slot IR port Power buttoni
Insert expansion cards Exchange data and Backlight controj/
to add additional applications with any lED indicetor
applications or infrared-enabled Palm Press here to turn
memory, or to back u OS handheld that's your handheld on
your data. nearby. and off. Hold it down
for a few seconds to
turn on the backlight.
Appiications Also blinks to
Launcher indicate alarms.
TaptIJe
Applications
icon to see
all your
applications. Gtaffiti'~t\writing
area
Use the stylus to
enter Graffiti'~· text
and numbers here.
or to access the
onscreen keyboard.
Scroll buttons
Press the top button
to scroll up and the
Date bottom button to
Book scroll down.
Application To Do Note
buttons List Pad·
Charging your handheld
Just place your handheld in the cradle for two hours for
an initial charge before you use it. Then place it in the
cradle for a few minutes each day to recharge the
battery to full capacity. If your handheld shuts down
because the battery has fully discharged, you still have
about a week to recharge the battery before you lose the
data on your
Synchronizing data: Performing the first HotSync
operation
The HotSyne process automatically synchronizes-
that is, exchanges and updates - data between your
hand held and Palm Desktop software. Changes you
A143
make on your handheld or Palm Desktop software
appear in both places after a HotSync operation.
-- ..._ ..-.._--_ .._- ---'-"
<,
".......
1. Place your handheld on the HotSync cradle.
2. Press the HotSync button on the cradle.
3. Wait for a message on your handheld indicating that
the process is complete.
Tip: To remove your handheld from the cradle, rock it
gently forward, then lift.
Entering Data
There are several ways to enter data into your handheld:
the onscreen keyboards, Graffiti ® writing.
Entering data with the onscreen keyboards 1. Open any
application ( such as Address Book). 2. Tap any record,
or tap New. 3. Tap" abc" or tap" 123" to open an
onscreen keyboard.
Tap here for L(J • .. Tap here foralphabetic .-!-c~,..o--f_numerickeyboard keyboard
.....
~
Note: Graffiti writing area shown with contrast
adjustment. Some models do not use contrast
adjustment.
A144
4. Tap the characters to enter text and numbers.
-Carriage return
Tap here to display
Numeric alphabetic keyboard IInternational I
Tap here to display Tap here to disJ)lay
numeric keyboard international keyboard
5. Tap Done to close the onscrccri keyboard.
Entering data with Graffiti writing
Graffiti characters art: similar to uppercase letters that
are formed with a single- stroke. Your writing turns into
text wherever the blinking cursor appears on the
handheld screen. Graffiti writing is easy, fun, accurate,
and fast (up to 30 words per minute). It's worth taking
a tew minutes to learn.
I. Open any application ( except Note Pad).
2. Tap any record, or tap New.
3. Tap the line where you want the text to appear.
4. Write Graftiti characters in the Graffiti writing area.
A145
Write letters herel Write numbers here
oevF[F---v- G Graffiti~~G Helpscreen
~ivision merks
Lift 11\11>1(1:01£IrlG IhIrI
·---·stVIUS
N here IJlo<ILIMINIOIPIOI~1ISllIUIVIWIXI~IZIStartstroke at --
heavy dot lol J 12131LIsl51l1 g Iql
( Done J
Graffiti tips
ct To display Graffiti Help (shown above), tap the
Menu icon, tap Edit, and then tap Graffiti Help.
• Write big and press firmly. Draw strokes that
nearly fill the Graffiti writing area to improve
accuracy.
• To delete characters, set the insertion point to
the right of the character you want to delete and
make the backspace stroke ( a line from right to
left) in the Graffiti writing area.
• Write at natural speed. Writing too slowly can
generate errors.
• Do not write on a slant. Vertical strokes should
be parallel to the sides of the Graffiti writing
area.
• Install the Graffiti writing game, Giraffe, to
practice writing.
A146
Get to Work
Adjusting the screen.
If lighting conditions make it difficult to see the
information on your handheld, you can use the backlight
to adjust your screen. On Palm TM m500 series
handhelds that use contrast adjustment, you can also use
the contrast control to adjust your screen. Using the
backlight I. Press the power button for about two
seconds. Release the button when the backlight turns
on. 2. Press the power button tor about two seconds to
turn off the backlight.
Note: The backlight also turns off automatically after a
period of inactivity defined by the Auto- off setting. See
" Setting General preferences" later in this chapter for
details. Adjusting the contrast I. IJyour m500 series
handheld uses contrast adjustment, tap the Contrast icon
in the upper- right corner of the Graffiti ® writing area.
2. Adjust the contrast setting.
Tap to left or right of slider
to make small adjustments
Drag slider to make
large adjustments
Tip: You can also use the up and down scroll buttons on
the front of your handheld to adjust the contrast setting.
3. Tap Done.
AI47
SCREENING PATIENTS AT THE CLINIC
Who must you interview?
The screening criteria select patients on the basis of respiratory symptoms. The
patient does not need to be attending the clinic for these symptoms but may be there
for another reason e.g. a patients attending for a blood pressure check up but who has
a chronic cough would qualify.
The selection criteria are as follows:
1. All patients must be 15 years or older. This means children will not be
tagged before the nurse consultation for interviewing afterwards. This
criteria is checked again at the time of entering the date of birth or if this is
not known age at last birthday before starting the interview.
2. All patients must have been seen by a nurse on the day of the interview.
They may also have been seen by a doctor, but must definitely have been
seen by a nurse. Do not interview patients who have only been seen by a
doctor. This will apply to those clinics where nurses and doctors see
patients. Usually all patients are first seen by a nurse and then referred on
to a doctor, but in clinics where the doctor only visits on certain days, there
may be patients who have been asked to attend specifically to see the
doctor and so won't be seen by a nurse on that day.
3. The remaining criteria are based on symptoms and signs of respiratory
disease.
Patients who qualify fall into one of the following groups:
1. Difficult breathing today or in the last 6 months.
2. Cough of more than 1week's duration.
3. Cough of less than 1 week's duration but the second/more episode in
the last 6 months.
4. Cough ofless than 1 week's duration but with a marker of severe
disease (temperature ~ 38 degrees Celsius, respiratory rate ~ 30 breaths
per min)
4. What is difficult breathing?
Difficult breathing includes the feeling of a tight chest, wheezy breathing
and shortness of breath. The shortness of breath must occur at rest or on
usual exertion such as walking fast on the flat or with activities of daily
living like dressing etc. It does not include the shortness of breath that
occurs on heavy exercise like running.
Patients usually understand the term if you use short phrases like tight
chest, wheeze, shortness of breath to explain it.
A148
HOW TO SELECT PATIENTS FOR INTERVIEWING
IN WAITING ROOM (BEFORE CONSULTATION)
24 Hour Clinic:
1. Arrive as early as possible at the clinic.
2. Ask clerk to identify the first booked patient (patient attending for a check-up
or to collect repeat medication) to arrive at the clinic that day.
3. Starting with first booked patient, ask each patient individually and in the
sequence thaI they are standing or sitting in the waiting area, the screening
questions below.
8am - 5pm clinic:
1. Arrive as early as possible at the clinic.
2. As patients enter the door ask each patient individually and in sequence of
entering the clinic the screening questions below.
Screening Questions (to be asked before the patient sees the nurse/doctor)
Ask patient the following (repeat word for word):
I. How old are you?
If patient is 15 years or older ask:
2. Do you have a cough and/or difficult breathing / tight chest / shortness of
breath today or have you had any of these problems in the last 6 months?
If patient answers yes, select patients for further screening according to the
targets which have been set for your clinic (these will be given to you during
training or before you start fieldwork in a particular clinic).
3. Exclude those patients who are too ill to participate and require immediate
emergency treatment:
* unconscious patients
* patients who are not breathing
* patients who are unable to talk
* patients who are psychotic (clearly hallucinating, manic and unable to
sit still, aggressive)
4. Explain to the patient that we are conducting a lung health study and would
appreciate their help. Ask them to meet an interviewer at the
interviewing station after their consultation today and to bring their tolder with
them.
AT INTERVIEWING STATION (POST CONSULTATION)
Start the questionnaire on the PDA. Within a minimum of I question (and a
maximum of 9 including taking the patient's respiratory rate and temperature
you will know if the patient has qualified). The PDA will alert you every time
the patient answers a question which results in a patient qualifying for the full
interview.
A149
Stop the questionnaire, consent the patient (including sign the consent forms)
and then continue.
The PDA screen display will disappear if you do not use if for some time (like
when you are consenting the patient). Press the power button to restart the
interview. The last screen you entered will appear.
If you are using the paper questionnaire you will notice it comes in 2 parts: the
screening questions on pages I and 2, and the remainder of the questionnaire
(pages 3 - 35). This is to avoid you having to waste complete questionnaires
on patients who do not qualify.
You will notice that you are not required to complete patient contact details for
patients you screen, but who fail to qualify for the full interview.
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THE QUESTIONNAIRE EXPLAINED
BEFORE STARTING
You will notice that the numbers that appear in the paper questionnaire are often out
of sequence and seem to follow an illogical order. This is because the questions
match those in the PDA and the PDA version of the questionnaire differs in design to
that of the paper questionnaire.
For example the PDA is unable to accommodate tables which are used frequently in
paper questionnaires. Instead the PDA asks items in a table as a sequence of
questions, branching off to more details when one of the options is selected. For this
reason the questions appear more straightforward on the PDA as the non-applicable
options are "hidden". The disadvantage is that the accompanying paper version is
very cumbersome, long and difficult to follow (77 pages in all). For this reason we
have designed a paper version containing tables ete to facilitate easy completion in the
event that you are forced to fall back on paper. The trade-off is that the sequence of
numbers in this paper version has been disrupted. The PDA numbers have been
retained to allow the paper data to be captured and reconciled with the PDA data you
upload.
DATE OF INTERVIEW
You enter this by clicking on the displayed date. A calendar will appear with the
option TODAY in the lower right of the screen. Click on this and it will
automatically register the date for you.
In the paper version, you must write the date at the top of each page, together with the
patient's initials, clinic:name and interviewer code (see later). This enables pages to
be reconciled before data capture in the event that they become separated.
1·f?a~iênflniti~lsI:JS I Pát~: I 12/5/2003 I :Clinic: I Welkom IlllleNlewer code: I 3915
INTERVIEWER CODE
This is a 4 digit code. The first 2 digits denote the clinic and can be obtained from the
list below. The second 2 digits are your own personal identification code and will be
assigned to you during the training week.
CLINIC NAME LOCATION CODE
Albert Luthuli Clinic Wesselsbron Ol
AM Kruger Clinic Odendaalsrus 02
Bethlehem Clinic Bethlehem 03
Bohlokong Clinic Bethlehem 04
Boithusong Odendaalsrus OS
Bophelena Clinic Odendaalsrus 06
Bog_helongClinic Kroonstad 07
Bothaville Clinic Bothaville 08
Botshabelo B Clinic Botshabelo 09
Botshabelo J Clinic Botshabelo 10
Botshabelo U & S Clinic Botshabelo Il
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Hill Street Clinic Kroonstad 12
Hoopstad Clinic Hoopstad 13
K- Maile Clinic Bothaville 14
Khotalong Clinic Virginia 15
Koppies (Kganya) Clinic Koppies 16
Ma-Haig Clinic QwaQwa 17
Marakong Clinic QwaQwa 18 --
Matlakeng Clinic Zastron 19
Mpohadi Clinic Bethlehem 20
Namahali Clinic QwaQwa 21
Osizweni Clinic Sasolburg 22
Paballong Clinic QwaQwa 23
PAX Clinic Viljoenskroon 24
Petrusburg Clinic Petrusburg 25
Phahameng Clinic Frankfort 26
Phomolong Clinic Henneman 27
Phuthaditijhaba QwaQwa 28
Reitz Clinic Reitz 29
Riverside Clinic QwaQwa 30
Seeisoville Clinic Kroonstad 31
Tebang Clinic QwaQwa 32
Thabong Clinic Welkom 33
Thusanong Clinic Sasolburg 34
Thusanong Clinic Kroonstad 35
Tseki Clinic Witsieshoek 36
Tshepong Clinic Welkom 37
Tumahole Clinic Pl;Il"YS 38
Welkom Clinic Welkom 39
Wepener Clinic Wepener 40
PATIENT DETAILS (Questions 3 -7, Page 1)
First enter the patient's first name, surname, gender and folder number. Take care
when entering the folder number, transcribing 2 - 4 digits at a time. If not folder is
available you may leave this blank (but only if you really have made a concerted
effort to locate the folder). If you really can't locate the folder, you may click NEXT
on the PDA.
PATIENT DETAILS
3 Enter first name: John 4 I Entersurname: I Smith
5 Gender Male Ix i Female i ';(mark with an X): ! j
I .:"6 Enter folder no: 7 --Re-enter folder no: I
8763421 8763421
Questions 8 - II (Page I)
Patients should be considered for the study if they are 15 years or older.
In Question 8 you ask the patient their date of birth. If they are 15 years or older they
will tell you that they were born in 1986 or before. These patients should be
considered for inclusion. Enter their date of birth. Do not use the "date of birth"
A152
recorded on the folder to complete this question as this has often been incorrectly
documented.
If they are 14 years or younger they will tell you that they were born in 1987 or after.
These patients should Dot be considered for inclusion in the study. Do not continue
with the questionnaire.
If patients do not know their date of birth you must default to question 10 and ask
them their age at their last birthday. You do this on the PDA by clicking on the
DON''T KNOW button in the lower left of the screen. If you have already entered
their date of birth you may skip this question and go to question 12. The PDA will do
this automatically.
8 What is your date of birth? If you don't know your date of birth, enter age at last birthday.
9 I Date: 126 I Month I 10 I Year 11970 I _, 1987 of after? _, do not continue
11 ! Age at last birthday: 1 I _, 14 years or younger? -> do not continue
Question 12 (Page 1)
You must nol consider patients who have previously completed the full questionnaire,
You may consider patients you have screened previously but who did not qualify for
the full questionnaire at that stage, but who have now returned to the clinic.
For example a patient attends the clinic on Monday with a cough. He doesn't qualify
for the full questionnaire because he has no difficult breathing, a cough of less than a
week's duration, no past cough in the last 6 months and no marker of severe disease.
On Friday he returns to the clinic. He now reports that his cough has been ongoing
for more than 7 days. Therefore this patient now qualifies for the study and the full
questionnaire can be completed, once you have consented the patient.
12 I Have you participated in this study before (full questionnaire ± 1 hour)?
YES I - do nol conlinue
NO X -+ go lo Ihe nexl question
Questions 13 - 14 (Page 1)
Most clinics are staffed by nurses and doctors only visit once or twice a week. In
these clinics you may come across patients who have been asked to attend on these
days specifically to see a doctor. Usually they will not see a nurse again on that day.
These patients who have been seen only by a doctor, and not by a nurse as well on the
day of the interview, must not be considered for inclusion in the study.
Patients should be considered for inclusion in the study if they have been seen by a
nurse (usually a nursing practitioner) on the day of the interview.
Some patients may have also seen a doctor. This usually occurs when the nurse has
asked the doctor for a second opinion. These patients must be considered for
inclusion in the study.
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· Were you seen ONLY by a doctor today?
13 YES -> do nol conlinue
NO X - go lo Ihe nexl question
IWere you seen by a nurse/nursing sister today?
14 i YES X -> go lo Ihe nex1question
I
! NO -> do not conlinue
Question 15 (Page 1)
Difficult breathing is defined in the glossary. You must use the terms tight chest,
shortness of breath and wheeze to illustrate to the patient what exactly difficult
breathing entails.
Patients who report difficult breathing on the day of the interview qualify for the
study and full questionnaire. Stop the screening process and consent the patient
before continuing with the questionnaire.
After you have done this, skip question 16 and continue with question 17. The PDA
will not lose your data when you stop to consent the patient. Click the grey power
button on the top right to recommence with the interview.
Do you have difficult breathing (tight chest, shortness of breath, wheeze) today?
YES
15 IX -CONSENT
I _, skip to question 17
NO ! - go to the next question
Question 16 (Page I)
Difficult breathing is defined in the glossary. You must use the terms tight chest,
shortness of breath and wheeze to illustrate to the patient what exactly difficult
breathing entails.
Patients who report difficult breathing in the last 6 months, even if they are not
symptomatic on the day ofthe interview, qualify for the study and full questionnaire.
Stop the screening process, and consent the patient before continuing with the rest of
the questionnaire.
After you have done this, continue with question 17.
r Have you had difficult breathing (tlght'chest, shortness of breath, wheeze) in the last 6 months?
t
YES
16 X - CONSENT
-> go to the next question
NO _, go to the next question
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Question 17 (Page 2)
This is a relatively straightforward question. It is worthwhile pointing out that cough
need not be the reason for attending the clinic today in order to answer yes. You must
enter yes for any patient with a cough on the day of the interview, regardless of
whether it was the reason for them coming to the clinic today or not.
Do you have a cough today?
17 . YE-S----. , X J-~go to the nexï·questio~------------·---------
NO---·----·-- --.---+-'-','-----+-,--.= do not continue ..... ---.-.--------
Questions 18 - 19 (Page 2)
This is an extremely important question. The study is looking at the delay between
onselof respiratory symptoms like cough and an accurate diagnosis 01"1'13. The
longer people are symptomatic in the community without being diagnosed and
treated. the greater the chance that more people will be infected with '1'13. This study
will look at the average delay between onset of symptoms and diagnosis in the Free
State and is therefore an essential part of planning TB services. It is therefore
extremely important that you pay particular attention to this question.
Ask the patient the question and then allow a silent pause. Jumping in with
suggestions like 3 weeks, 2 days will lead the patient and give you an unreliable
answer. Be patient. Allow the patient time to think and give you a considered
response.
If the pat ient is really at a loss you can ask then whether their symptoms have been
troubling them for a matter of days, weeks, months or years. Allow them to select a
category and again wait for them to produce a spontaneous answer.
If it is a matter or weeks or months and the patient is still struggl ing to recall the exact
duration, you may use notable calendar highlights to help them remember.
Example: "Did this difficult breathing start before or after Easter?" A calendar with
the Public Holidays highlighted is included in the visual aid to help you (pages 2 3).
Beware of the patient who answers "last of last week/month/year" or "the day before
the day before yesterday". These are colloquial expressions and do nol relled actual
duration accurately. Prompt these patients with days, months, weeks or years.
Once you have obtained rul answer, mark the relevant category (days or weeks or
months or years) and enter the number alongside. The PDA will skip to a screen
which says "Enter number" when you select a category.
For how long have you been coughing?
Choose one option and enter number.
Days
18 --_ ..__ ...._-_ ..------_._._._._--_._- _.- ~ 19. Enter number:Weeks X -~ 19. Enter number: 2
Months ---. _.• 19. Enter number:
Years ~ 19. Enter number:
A155
Question 20 (page I)
This question is directed at you, the interviewer, and should be completed based on
the response to the previous question (Questions 18 - 19: duration of cough). Do not
be tempted to use a shortcut and substitute asking patients if they have been coughing
for 7 days or longer instead of "For how long have you been coughing?" This will
lead the patient and provide you with an unreliable answer.
Patients who have been coughing for 7 days or longer qualify for the study and full
questionnaire. Stop the screening process and consent the patient before continuing
with the questionnaire.
Aller you have done this, skip question 21 and continue with question 22.
Question 21 (Page I)
Patients qualify for the study if they have heen coughing for less than 7 days, but have
had a similar episode or episodes in the last6 months. Stop the screening process and
consent the patient if you haven't already done so belore continuing with the
questionnaire.
After you have done this, continue with question 22.
21 Have you had another episode of cough like this one in the last 6 months?
....,..,yE=S=----- .--- -.-- ...-.--- ... '- x .....-..-.-----.- --- -----------------1• CONSENT if haven't already
.-" .--.-..------.-.-----.--f-----.- -. go to the next question . ..__. _.__ . ._. ..__..
NO -. go to the next question
Questions 22 - 23 (Page 2)
The respiratory rate is how fast the patient is breathing and is measured in breaths per
minute. A high respiratory rate is tin indicator of respiratory disease.
How /0 measure (/ respiratory rate:
I. Count the number of breaths over lfull minute.
2. Wait for the second function on your digital watch to register "00" before
starting.
3. Watch the patient's chest in the area of the sternal notch (this is the area just
above your ribcage in the centre of your throat, visible above the patient's
collar) and count" I" every time you see this area rise. This corresponds to
one breath.
4. Count the number oftimes the chest rises over the full minute. Stop when the
second function of your watch registers "00" again. Note the number of
breaths per minute.
Breathing is controlled automatically by your brain. It can come under voluntary
control like when you hold your breath when swimming under water. As soon as you
tell someone that you will be counting how fast they are breathing they become
conscious of their breathing and control switches from "automatic" to "voluntary".
This may lead to a false result and you risk not capturing their normal respiratory rate.
A156
This can be avoided by "masking" what you are doing. Most patients are familiar
with the procedure of taking a pulse rate. This involves feeling for the pulse on the
inside of the wrist (the pulse can be found on the "thumb" side) while watching your
watch. We recommend that you pretend lo take the patient's pulse and while doing so
counl the respiratory rate.
Tryout this exercise with a friend:
l . Tell him/her you are first going to measure their pulse rate. Pretend to
measure their pulse while counting their respiratory rate. Remember this
respiratory rate.
2. Now tell them you are going to measure how fast they are breathing. This time
watch their chest without pretending to take the pulse rate.
3. How does the first measurement compare with the second one'?
You wiIl note that patients tend to breathe faster when they arc conscious 0 f the fact
that you are measuring how tast they breathe.
Patients with a respiratory rate of 30 breaths per minute or more, qualify for the study
and full questionnaire if they haven't done so already. Question 23 is directed at you,
the interviewer, and should be completed based on the respiratory rate noted in
Question 22. If the respiratory rate is 30 breaths per minute or more stop the
screening process, consent the patient if you haven't done so already and then
continue with the questionnaire (question 24: temperature),
22 Interviewer: What is the respiratory rate?
Count number of breaths over 1 full minute.
Enter Respiratory Rate (breaths/min) I 22
. ::
23 Interviewer: What is the respiratory rate?
.-
29 breaths I minute or less X - go to the next question
-30 breaths I minute or more -. CONSENT if haven't already
-. go to the next question
Qlli,;stions 24 -:26 (Page 2)
A high temperature indicates an infection, which may be respiratory in nature.
Normal body temperature is 37 degrees Celsius.
How to measure the patient's temperature using CJ digital thermometer:
I. Take the thennometer out of the plastic holder.
2. Ensure that the metallic tip is clean (wash / wipe between patients)
3. Switch the thermometer on by pressing down the power button.
4. The thermometer will beep when it is switched on.
5. The screen will first display 188.8, indicating that the LCD screen is
working.
6. Within seconds it will display a flashing "L degrees Celsius" indicating
that it is ready to be used.
7. If the "L degrees Celsius" stops flashing, push the power button and
start again.
Al57
8. Place the metallic tip under the tongue of the patient and instruct
himlher to close hislher mouth. Ask the patient not to bite the
thermometer.
9. Wait for the thermometer to start beeping. This will take approximately
30 seconds.
10. When the thermometer stops beeping, remove it from the patient's
mouth and read the temperature.
Il. Switch off the power button when finished.
12. Rinse the metal probe and replace in the plastic holder.
The thermometer is battery-powered but one battery has sufficient power to take 4000
temperatures.
Note the temperature in the space provided. Question 25 is directed at you, the
interviewer, and should be completed based on the temperature recorded in Question
24. lf the temperature is 38 degrees Celsius or more, stop the screening process,
consent the patient if you haven't done so already and then continue with the
questionnaire (Question 27: More questions on difficult breathing).
NB: If the patient has a temperature of37.9 degrees Celsius or less and has not
qualified on a previous criteria (i.e you have not already consented the patient) the
patient does not qualify for the interview. Do not continue.
24 Interviewer: What is the patient's temperature?
Take the temperature with the thermometer.
Enter Temperature (in degrees Celsius) I .'
37.5 I
25 Interviewer: Is the temperature 38 degrees Celsius or more?
37.9 Celsius or less _. Patient consented already? -> continue with question 27
X --+ Patient not yet consented? _, do not continue
38 Celsius or more -> CONSENT if haven't already
-> complete full questionnaire
- go to question 27 (top of page 3)
MORE QUESTIONS ON DIFFICULTY BREATHING (Questions 27 - 34, Page 3)
Questions 27 - 28 (Page 3)
These are repeats of the screening questions to determine whether you should
complete further questions on difficulty breathing. If the patient has either difficulty
breathing today, or has had difficulty breathing in the last 6 months you must
complete the questions in this section. Jfthe patient reports no difficulty breathing at
all you can skip these questions and go to Question 35 at the top of page 4 (More
Questions on Cough).
Do you have difficult breathing (tight chest, shortness of breath, wheeze) today?
27 YES I I -> skip to question 29
NO IX I -> go to the next question
Have you had difficult breathing (tight chest, shortness of breath, wheeze) in the last 6 months?
28 YES - Ix I -> go to the next question
NO I I -. Skip to Question 35 (top of page 4 )
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Questions 29 - 30 (Page 3)
This asks the patient about the duration of their difficulty breathing. As with cough
duration, this is a particularly important question. Please see Question 19 for
instructions.
Question 31 (Page 3)
Patients with asthma usually have intermittent symptoms meaning that they have
periods where they feel quite normal, Patients with chronic bronchitis and
emphysema tend to have persistent symptoms meaning that they arc never have
"normal" days without symptoms. The severity of these symptoms usually worsens
with every passing year. This question risks patients to distinguish between difficult
breathing which is persistent ("continuously, so that your breathing is never quite
right") vs. difficultbreathing which is inteiwittent ("repeatedly, but il always gets
completely better").
Indicate which option applies by marking the adjacent box with an X.
31 Does this difficult breathing trouble you continuously, so that your breathing is neve,r,qUiteright" or does it trouble \
--~~~t~~:~:~dIY but always gets comPletel~_J.l.~~~.r.r_· ·__· · "_· · ----------.--------1
Repeatedly ----.- I X I
Question 32 (Page 3)
Patients with heart failure may also report difficult breathing. Usually they only have
symptoms on physical exertion (like walking fast on the Ilat or uphill) but not at rest.
On the other hand, patients with lung disease often have shortness (If breath on
physical exertion as well as at rest.
This question asks patients to distinguish between difficult breathing "only when
walking on the flat or uphill" vs. "when resting (sitting ete)".
Indicate which option applies hy marking the adjacent box with an X.
Does this difficulty breathing trouble you only when walking fast on the flat or uphill or also when resting? 'I
32 -~~~nwr~:~n~a;::;~~a;:2Phiïï" ,. '.-- ..~Fx==-".·-..-~---r-------..--,-----------------./
Queslion 33 (Page 3)
See glossary for definition of wheeze.
Please stress to patient that we want lo know about "this current illness" meaning their
present state of health. We want to know about these symptoms whether or not they
were the reason the patient came to the clinic today.
Indicate which option applies by marking the adjacent box with an X.
Does your chest wheeze (make a whistling sound) when you breathe with your current illness? I
34
YES Ix I I
NO I I
27
L
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MORE QUESTIONS ON COUGH (Questions 3S - 42, Page 4)
Question 3S (Page 4)
This is a repeat of one of the screening questions to determine whether you should
complete further questions on cough. If the patient has cough on the day of the
interview, you must complete the questions in this section. If the patient reports no
cough you can skip these questions and go to Question 43 at the top of page S (Other
Symptoms of this Current Illness).
35 Do you have a cough today?
YES IX _I -) go to the next question
NO I I ---> skip to question 43 ( top of page 5)
Questions 36 - 37 (Page 4)
See glossary for explanation or a dry and productive coughs. Patient may not
understand the terms "phlegm" or "slime" but responded quite well to the phrase
"solid-like" during the piloting of this questionnaire C'Do you produce something
solid-like when you cough?).
Please stress to patient that we want to know about "this current illness" meaning their
present state of health. We want to know about these symptoms whether or not they
were the reason the patient came to the clinic today.
Phlegm or slime may be different colours. Clear or white sputum usually indicates
chronic bronchitis or asthma. Yellow or green sputum often indicates an infection.
Do not confuse sputum with saliva. If in doubt you may want to clarify this with the
patient ("Are you sure this is not saliva from your mouth?").
Indicate which option applies by marking the adjacent box with an X.
36 Are you coughing up phlegm or slime with your current illness?
YES Ix I ~ go to the next question
NO I J -+ skip to question 38
What colour is your phlegm I slime with this current illness? I
Choose one option.
37 Clear IWhite
Yellow I Green X
Other
Question 38 (Page 4)
Patients may cough up different amounts of blood from cupfuls of frank blood to
blood specks in the sputum.
If the patient reports coughing up any amount of blood (from a blood specks in the
sputum to pink sputum to frank blood) you must indicate "yes".
A160
Are you coughing up blood with this current illness?
38 YES IX J
NO I 1
Question 39 - 40 (page 4)
There are several types of chest pain. Many patients complain of a central dull pain
on coughing when they have bronchitis. This should not be confused with pleuritic
pain or the sharp pain which occurs on breathing in deeply (or coughing) and which is
a sign of pneumonia or TB. These questions ask first about this pain on coughing and
then about this pain on breathing in deeply.
Please stress to patient that we want to know about "this current illness" meaning their
present state of health. We want to know about these symptoms whether or not they
were the reason the patient came to the clinic today.
Do you experience sharp chest pain on coughing with this current illness?
39 YES Ix I'
NO I 1 -' '.
Do you experience sharp chest pain on breathing in deeply with this current illness?
40 YES Ix I' ", _' , '
NO I I
Question 42 (Page 4)
Establishing the duration of cough is a very important part of the medical history for
patients with respiratory illnesses. This question asks whether the nurse the patient
saw today carried out this important task.
Indicate which option applies by marking the adjacent box with an X.
Old the nurse who saw you today ask you for how long you have been coughing?
42 YES .. Lx INO I _L .":
OTHER SYMPTOMS OF THIS CURRENT ILLNESS (Questions 43 - 53, Page 5)
Question 43 (Page 5)
Patients with TB have severe night sweats so that their pajamas or bedclothes become
wet with sweat. Often the clothes are become so wet that they need to get up in the
middle of the night and change.
This question asks patients whether they are having such night sweats with their
current illness.
Please stress to the patient that we want to know about "this current illness" meaning
their present state of health. We want to know about these symptoms whether or not
they were the reason the patient came to the clinic today.
Indicate which option applies by marking the adjacent box with an X.
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43 With this current illness, do you sweat a lot at night so that your pajamas or bed clothes are wet?
YES ____._~=~.=====.=~.=--I· I
NO Ix I
Question 44 (Page 5)
Runny or blocked noses occur with many common respiratory tract infections like the
common cold.
Please stress to the patient that we want to know about "this current illness" meaning
their present state of health. Wc want to know about these symptoms whether or not
they were the reason the patient came to the clinic today.
Indicate which option applies by marking the adjacent box with an X.
44 Do you have a runny or blocked nose with this current illness?
~~s -.~~.-~~~'--....-.-... ~--:~':·l.~=:~==~r·-·-····-··--·-·-···---·-··-·--·---··----'--
Question 45 .(page 5)
A sore throat occurs with many common respiratory tract infections like the common
cold.
Please stress to the patient thal we want to know about "this current illness" meaning
their present stale of health. Wc want to know about these symptoms whether or not
they were the reason t:he patient came to the clinic today.
Indicate which option applies by marking the adjacent box with an X.
Do you have a sore throat with this current illness?
45 ._---- . f.-~--- f_-.-.-· . -.-.--.---.-.~.- ..-.. -.-..--.-.-'¥---------.- ..-..----~~s ---.-_ ..--.-.----- - --------~----'---..,.,_'_-_1
Question 46 Wage 5)
Please stress to patient that: we want to know about "this current illness" meaning their
present state of health. We want lo know about these symptoms whether or not they
were the reason the patient came to Ihe clinic today.
Ears which leak pus usually indicate infection in that ear, usually a chronic infection.
Patients with leaking ears often complain that their carts) is "wet". There may also be
pain (earache) and hearing loss but we only want to know whether the ear is
"leaking".
Please stress to the patient that wc want to know about "this current illness" meaning
their present state of health. We want to know about these symptoms whether or not
they were the reason the patient came to the clinic today.
Indicate which option applies by marking the adjacent box with an X.
A162
Is your ear leaking pus with your current illness?
46 YES I J
NO Ix I
Question 47 (Page 5)
Weight loss is a sign of many different illnesses like TB, emphysema and other non-
respiratory illnesses like cancer. It may precede other symptoms like cough and
patients may not realise that they are connected.
Therefore, we have not used the phrase "this current illness" in this question but have
rather left it more open by using the phrase "these days".
Indicate which option applies by marking the adjacent box with an X.
Are you losing weight these days?
47 YES Ix I
NO I I ... ':' .. . ~..
Question 48 (Page 5)
If the patient is on TB therapy at the time of the interview, or is being tested for TB or
even has just been told that he/she might have TB recently you must indicate yes.
Indicate which option applies by marking the adjacent box with ah X.
Has a nurse or doctor told you that you might have TB recently?
48 YES , .; " '0, •I I ........ ::' ,:.' . '.' '.' "
NO Ix I .Ó: .: "
Question 49 (Page 5)
"This illness" refers to the patient's current illness or present state of health. It can
refer to illnesses other than those for which the patient has come to the clinic today.
This point is particularly important for patients who are currently receiving TB
therapy or being tested for TB. We want to know whether these patients have ever
had TB before the current episode.
Indicate which option applies by marking the adjacent box with an X.
Before this illness now, have you ever had TB before?
49 YES Ix I
NO I I
Questions 50 - 51 (Page 5)
We want to know whether patients have been exposed to the dusty environments of
working underground in a mine.
A163
If the patient has worked as a clerk, cleaner ete in a mine (on the surface) you must
indicate no. If the patient has worked as a miner underground you must indicate yes
and enter the number of years worked in the main in the space provided.
Indicate which option applies by marking the adjacent box with an X.
Have you ever worked underground in a mine?
50 YES Ix I ~ 51. For how many years? 17
NO I I ..
Question 52 (Page 5)
Breathlessness at rest or while talking is a sign of severe respiratory disease. These
patients can be recognised because they appear "out of breath", breathe fast when
sitting quietly and are unable to speak in full sentences without stopping to breathe.
This is a question directed at you, the interviewer. If you note any of these signs in
the patient you must indicate yes.
Indicate which option applies by marking the adjacent box with an X.
Interviewer: Is the patient breathless now during the interview (e.g. breathless while seated, breathless while talking, unable to
52 speak in full sentences without stoppin!l to breathe)?YES Ix I
NO I I
Question 53 (Page 5)
During normal quite breathing you cannot make out the muscles in the neck. Patients
with respiratory disease tend to use these muscles to help them expand their rib-cage.
In these patients you will see that the neck muscles stand out, are easy to see and
appear strained.
If you can see the patient's neck muscles standing out when they breathe while sitting
quietly with you during the interview, you must indicate yes.
Indicate which option applies by marking the adjacent box with an X.
Interviewer: Is the
YES
NO
SYMPTQM SEVERITY IN THE LAST MQNTH (Questions 54 - 59, Page 6)
We want to know the frequency of chest symptoms during the day and night and the
impact on the patient's usual activities.
Please note that the time frame for these questions is the last month. You must
emphasise this to the patient.
If the patient answers yes to the questions you need to prompt the patient with the
three response categories (1 to 2 times per month or 1-2 times per week or most
A164
nights/days). After prompting the patient with these categories allow a silent pause
and time for patient to answer. If necessary, repeat the response categories.
Questions 54 - 55 (Page 6)
Difficulty in sleeping can because of many reasons including waking up frequently to
pass water. Patients who have difficulty sleeping specifically because of difficulty in
breathing and cough must answer yes to this question. Patients who have difficulty
sleeping for other reasons must answer no to this question.
Have you had difficulty in sleeping because of difficulty in breathing and/or cough in the last month?
.---...-.-..-.--.-·-.---...-1----,--1--, -go-to-t-hën'"ë;tquestion
1X 1 .)skip to question 5~. .:...__.-.-..--..--.----.-.--.-======~--.-.--.==----__l
.............. __._--._-----------
Questions 56 ....57 (Page 6)
Ir a patient reports any of the three symptoms in brackets, you must answer yes to the
question. It is not necessary tor patients to have all three symptoms to answer yes to
the question.
Have you has your usual chest symptoms during the day (cough, wheeze, breathlessness) in the last month?
56 YES
-_ ..._.- -NO-----------~
-.,......,-----------------_._---_._-_. __ ..
Select a category:
57 ~-~::~::~:~~;~--~.=-~==.·.~==r-;=-~-I
Most days I I
Questions 58 - 59 (Page 6)
Usual activities include work, study, housework, family or leisure activities. Jfthe
patient has been limited in any of these usual activities by their chest symptoms in the
last month, you must indicate yes.
Has your chest problem interfered with your usual activities (e.g. work, study, housework, family or leisure
activities) in the last month?
58 ~===:=~==~===~-I~~=~~=t=~::.r::;lg-.ë.·i·ïoïhë .i.iexi-quesiion·-.---.~=~===__==-~=~.~.~-~~~:~~~:=.====-NO skip to Question 60 (top of page 7 )
I----r-::-:----,--------------.- .-.---.-.-..- .-.--.---------.------------.-----
Select a category:
59 1 - 2 times per week I I
1 - 2 times per month I I
Most days IX L
A165
HEALTH-RELATED QUALITY OF LIFE (Questions 60 - 71, Pages 7 - 10)
These questions measure how health problems impact on quality of lite, specifically
on mobility, self care, usual activities, pain/discomfort and anxiety/depression. There
are two parts to measuring the quality of life, the first part is to ask how health
problems impact these specific areas and the second part is to ask a patient to give an
overall rating on their general health related quality of life (on the scale which
resembics a thermometer).
The questions are first asked for the stale of the patient's health on the day of the
interview and then repeated for the state of the patient's health during the last month.
It is extremely important to stress this difference to the patient. First ask them to
concentrate on their health status today and complete all the questions. Then ask them
to cast their minds back to the last month and repeat the questions
Questions 60 _.:6. 4 (today m Page 7) and 66 - 70 (last month . Page 9)
rOT each facet of quality of life you will see three statements, each corresponding to a
level or severity. The first statement always reflects no problem, the second statement
a moderate problem and the third statement a severe problem. These will be laid out
on the visual aid in a. horizontal format, with the 110 problem statement on the far left
and the extreme problem Oil the far right, setting up a type of scale with no problem
on one end and extreme problem on the opposite end. You will notice thai each
statement has a corresponding block bullhat there are two blocks between the
statements.
For each facet of the level of quality of lite, you must read all three statements to the
patient and allow the patient time to digest them. The patient must indicate to you
which block best describes their health status. If they feel that none of the three
statements accurately captures their health status and that ralher they fall somewhere
in between two statements, they may choose the block between those two statements
as shown below.
MOBILITY
60 [J o o [j LJ
I have some
I have no problems in problems in walking I am confined to
walking about about bed
A166
You may nol explain the wording of the response categories to the patient because
you risk introducing your own set of values into the question. What we want to know
is how the patient perceives their own quality of life and how they would judge
themselves compared to other people's standards.
If the patient asks you what you mean, repeat the categories word/or word. You may
not give any examples as this will lead the patient and compromise their answer. This
is particularly relevant to the pain/discomfort and anxiety/depression question where
patients are asks to distinguish between moderate and extreme states. It is up to the
patient to decide what he/she considers moderate and what he/she considers to be
extreme and then choose. Giving examples disrupts this process.
A note on the PDA. The PDA does not allow sufficient screen space for you to view
the options for each category in their entirety. For this reason, and to help the patient
visualise the exercise, we have laid out the full versions (in all 5 languages, both for
quality of life today and for quality of life in the last month) in the visual aid. Please
use this to complete these questions.
Questions 65 (today - Page 8) and 71 (last month -- Page 10)
This question is designed to assess the patient's overall health related quality of lite
using a "thermometer". Explain to the patient that at the bottom of the thermometer is
the worst state that they can imagine. Bc sensitive to the fact the patient might
imagine this state as being worse than death. This will differ from patient to patient
and so do not illustrate this end of the scale with examples like death or extreme
suffering. It is up to the patient (and nol you) to decide what they think is their worst
state of health.
Explain to the patient that al the top of the thermometer is the best state that they can
imagine. Be sensitive to the fact the patient might imagine this state as being worse
than better than normal. This will differ from patient to patient and so do not illustrate
this end of the scale with examples like being tilled with vitality and energy. It is up
to the patient (and not you) to decide what they think is their best state of health.
Be sensitive to the fact that "normal" for the patient may be anywhere on this scale.
Do not suggest lo the patient that halfway be/ween the 2 points (reading = 50)
indicates "normal". If you do this you will find that most patients choose 50. If the
patient requires clarification, rather say something like "normal for you may be
anywhere on this scale".
After explaining how the scale works to the patient, ask the patient to indicate to the
point on the scale where they feel best describes how they feel today. On the paper
questionnaire mark this point. On the PDA record the number pointed out on the scale
(the "thermometer reading").As with the statement part of quality of lite, you will
repeat this process for the last month.
SMOKING (Page 11, Questions 72 - 90)
The first two questions (72. ever smoked and 73. smoke currently) establish whether
the patient is a never smoker, current smoker or ex-smoker.
If the answer to both questions is no, the patient is a non-smoker and the questions are
not applicable. Skip all the questions in this section and go to the top of the next page
A167
(Details of the Consultation) and question 91. The PDA will automatically skip to
this section for you.
If the patient answers yes to both questions he/she is a current smoker. Proceed
immediately to the next question (74 to 76. number cigarettes, pipes ete smoked per
day) and complete questions 74 to 81. You will then be instructed to skip to the next
page.
If the patient answers yes to the first question (72. ever smoked) and no to the second
question (73. smoke currently) then he/she is an ex-smoker. Skip to question 82 on
the same page and complete questions 82 - 90 which brings you to the end of the page
and section.
72 Have you ever smoked?
YES IX I -> go to the next question
NO I I ._'skip to question 91 (top of page 12)
73 Do you smoke currently?
YES I I - go to the next question
NO Ix I -, skip to question 82(this page)
Questions 74 - 76 and 88 - 90 (Page 11)
This asks on average how many cigarettes and pipes the patient smokes (or used to
smoke) per day. Go through each item and mark the adjacent box ifit applies. Then
enter the average no. smoked per day alongside. You must check all that apply. The
PDA will ask you each item individually. If the patient does not use one of these
items you may choose the N/A button (N button in the lower left of your screen).
On average how many of the following Items do you smoke per day?
74 Mark appropriate boxes and enter averace number smoked per day. Check all that apply.
to Shop-bought cigarettes X - 74. Enter no. smoked per day: 10
76 Hand-rolled cigarettes X -4 75. Enter no. smoked per day: 2
Pipefuls of tobacco - 76. Enter no. smoked per day:
Questions 77. 82 and 85 (Page 11)
These questions ask the patients when they started smoking, and in the case of the ex-
smokers when they stopped. Patients tend to remember the age at which they started
smoking and the year in which they stopped (e.g. "I started smoking when I was 14
years and I stopped 5 years ago in 1998"). For this reason you may enter the age or
year for both of these dates. Indicate which one you prefer to enter by marking the
box adjacent and entering the details alongside. The PDA will ask you to choose
which one you enter and will then proceed to a screen which asks you to enter the
details (Enter age or Enter year).
When did you start smoking regularly (at least one cigarette I pipe per day)?
Interviewer: You mav enter the aae OR the vear:
77 AGE Ix I - 78. Enter age: 14
YEAR I I -'> 79. Enter year:
A168
Questions 93 and 94 (Page 12)
These questions ask the patient whether the nurse told them what was wrong, and if
so, what she said. Patients who have a good idea from the nurse what the problem is
tend to do better and so this is an indicator of the quality of care provided at the clinic.
These may be sensitive questions especially if the patient has attended for a sexually
transmitted infection or has HIV/AIDS. Be gentle and patient with these questions. If
the patient does tell what the nurse said record this in the patient's words in the space
provided. Do not rephrase what he/she says in your own words.
What did she tell you?
Interviewer: Probe with examples like cold 'flu asthma TB hiah blood etc. Enter reseonse below:
94
High blood and sores in my mouth.
Questions 95 - 98 (Page 12)
This asks whether the patient had any sputum collected for tests. Usually but not
always this is taken to look for TB, so we are particularly keen to know how well the
clinics are screening the community for TB.
Usually the first sample is taken that day at the clinic and the patient is given an
empty container to take home and cough into the following day, and then return to the
clinic. For this reason we first ask whether samples were collected at the clinic, and
then whether they have received instructions to collect further samples at home.
Patients may not be familiar with the term "phlegm / sputum samples" but they are
familiar with the containers in which this is collected. Use the pictures of these
containers in the visual aid (pages 26 and 27) to help you.
Old the nurse who you saw today collect any phlegm I sputum samples for testing?
Interviewer: Show patient examples of sputum jars in visual aid (page)
95 YES I X I ....9..6. How many did she collect? 1
Did the nurse who you saw today ask you to collect any phlegm I sputum samples at home?
97 Interviewer: Show patient examples of sputum jars In visual aid.YES I X I __, 98. How many did she ask you to collect? 1
NO I I •.....•.. .
Question 99 (page 12)
This asks whether the patient had any blood taken at the clinic today. In many clinics,
there is the facility to do this at the clinic. However, in some clinics, patients may be
referred to a nearby hospital for blood tests. We want to know whether the blood was
physically taken at the clinic on the day of the interview. Do not answer YES if the
patient has been referred elsewhere for testing, but the blood was not actually taken at
the clinic.
Did the nurse who saw you today take any blood for tests?
99
YES Ix I:
NO I I
A170
Question 81 (Page Il)
This question asks current smokers to weigh up their teelings about quitting. Read all
three statements in full to the patient first, and ask them to choose which one best
describes their thoughts about stopping smoking now. Do not rush the patient. They
will need time to consider the statements first before making their decision. Once
they have made a decision, mark the adjacent box. You can only mark one box.
On the PDA you will notice that the statements may not be displayed in full. For this
reason they are provided in the visual aid (in all 5 languages) on pages 24 and 25.
Which of the following best describes your thoughts about stopping smoking now?
Interviewer: Read all 3 sta!ements to patient and ask them to choose one. ._ ...... -. ..
81 .I will stop smoking ----_._-~_ -. skip to question 91 (top of page _12)... ..._-
I plan to stop smoking but not now X ..•, skip to question 9.!..Lt~!:lo.f page 12) -------- ._ ..__ ..._._-
I do not plarïïo·siïiïïsmoking soon - skip to question 91 ( top of page 12)
DETAILS OF CONSULTATION (Page 12, Questions 91 - 99)
These questions ask patients about their treatment they received at the clinic today, on
the day of the interview. Please stress to the patient that we only want to know about
tests etc. done that day, the day of the interview.
Question 91 (Page 12)
This asks the patient why they are here at the clinic today, on the day of the interview.
Patients either are at: the clinic to attend a check-up usually for a chronic disease like
high blood pressure or diabetes (these appointments are known as "check-ups" or
"booked" visits), or IClI· a new problem like recent onset of 'flu symptoms etc. Go
through each item on the list and indicate whether the patient has attended the clinic
today for that reason or not. You must mark all the options that apply. If there is an
"other" reason you must mark the box next to "other" and enter the reason alongside .
.lust a word about "respiratory" ...this refers to all conditions involving the respiratory
tract trom colds and 'flu to asthma, bronchitis and TB. You will need to explain this
to the patient.
You will not see the "other" option in the list presented by the PDA. If this applies
click on NEXT and the PDA will present a second screen to you with provision for
you to enter this "other" reason.
91 What was the reason for coming to the clinic today?
i-=:=:In:!:te:::.:rv_:,:.::.ieC:.:.::w:::_..:::hee=:=::.=:cr::_:::.:kth:.=.:a::!:.:_.:!tI!:a..p:1~pIIIL.y:......!!M::::a:;:rk:.:.,;:bo:::'.;x:::e::::s:..;w:_;!!_!i_th.!..!:!a!~.!~,n_.~!:~X~. ~ ..•..
Check-up for high blood pressure. X
. Check-up for diabetes ('sug~._ .. __ ... _
Check-up for a respiratory problem .r!----.-
Check-up for other problem
r.:,F::..;irs::..:t...:v.;.:iS::;itc..:fo;:_:r....:a::,.:..::re:.p::s.:._<l:r.P::.iio::.:.:;.r:ab;l_.::_:.:et:m=!,=o-ry_:.L.._..I'_.....
First visit for other problem
Other X .....9.2. Specify: check-up for epilepsy
A169
PRESCRIPTION DETAILS (Pages 13 -16, Questions 100-189)
This has potential to be a particularly difficult section to complete, as both
fieldworker and patient can be intimidated by the task of remembering and recording
the names of medications.
We have tried to simplify this by only asking whether the patient takes any of the
medication displayed in the visual aid. We do not need to know the details of any
other drugs which the patient may have received.
We want to know about 4 different types of drugs:
I. Inhaler medication (particularly relevant for patients with respiratory
problems)
2. Prednisone
3. Antibiotics
4. Other medications commonly used for respiratory problems.
The questions are structured in such a way that you first ask the patient whether they
received any of these medications today, and then whether they usually use any of
these medications at home.
The idea is that you start by asking the patient to look at the pictures of the inhalers in
the visual aid (pages 28 -- 29). You then ask them whether they received any of the
inhalers on the chart. today. In most instances they will have this medication with
them, so the process involves matching what they have with them with inhalers on the
chart. Once you have done this, you can move to the questionnaire and work
systematically through the questions on the inhalers received today.
You then ask the patient whether they usually use any of these inhalers at home. They
may usually use an inhaler but not have received one at the clinic today because they
still had sufficient medication at home, or they came for another reason. On the other
hand, the medication they received at the clinic today may be their usual medication.
lf this is the case you do not need to record all the details all over again (NB).
You then repeat this process for the prednisone tablets, the antibiotics and the other
medications. This will take you up to question 189 and the end of page 16.
Inhalers (Page 13, Questions 100 - 13]">
There are 2 types of inhalers or pumps. The tirst type is called the reliever inhalers
because they provide rei icf immediately when the chest is light ("open the chest").
The reliever inhalers are:
Feneterol (Fe-no-re-rol)
Trade name: Berotec.
Used for asthma and emphysema / bronchitis.
l'enoterol / lpratropium (Fe-no-te-rol / I-pra-tro-pium)
Trade name: Duovent
A combination drug used mainly for patients with severe asthma and emphysema.
Ipratropium (l-pra-tro-pium)
Trade name: Arrovent
A17l
Used mainly for patients with emphysema.
Salbutamol (Sal-but-a-mol)
Trade name: Asthavent or Ventolin.
The most common reliever inhaler used for asthma and emphysema.
Salbutamol/Ipratropium (Sal-but-a-moll l-pra-tro-pium)
Trade name: Combivent
A combination drug used mainly for patients with severe asthma and emphysema.
Salmeterol (Sal-met-e-rol)
Trade name: Serevent
Similar to salbutamol but lasts longer. Used for severe asthma or emphysema.
The preventer inhalers do not open the chest immediately when tight, but rather
prevent asthma symptoms when used regularly on a daily basis. They do not cure
asthma but "prevent" the symptoms hence the name. There is only one type of
preventer inhaler available in the Free State public service, but it comes in 2 strengths
(100 and 200). It is easily recognizable to patients because it comes in a big box
which also contains a spacer. This is a plastic bottle shaped device used with the
inhaler. It increases the amount of drug which reaches the airways.
Budesonide (Bu-des-o-nide)
Trade name: Inflammide
Preventer inhaler used for asthma.
Reliever Inhalers (questions 101 - 112 and 117 - 128)
If the patient uses a reliever inhaler, indicate the name by placing an X in the adjacent
box. You must then complete the question alongside about difficult breathing. You
must check all the inhalers the patient uses, and ask the difficulty breathing question
for each one.
The PDA will ask you to indicate whether the patient uses an inhaler or not separately
for each inhaler on the chart. If you indicate YES it will automatically skip to the
difficult breathing question before returning to the list of inhalers.
A word of caution - patients may not be familiar with the terms "reliever" and
"preventer". Ask them instead to identify medication from the chart.
RELIEVER INHALERS RECEIVED TODAY (Interviewer: Check ali that apply) YES NO
101 Fenoterol (Berotec) X .....102. Does this inhaler improve your difficultbreathina minutes after usmc it? X
Fenoterol/lpratropium (Duovent) X .....104. Does this inhaler improve your difficult103 breathing minutes after using it? X
Preventer Inhalers (Questions 113 - 115 and 129 - 131)
These inhalers are very expensive and for this reason we want to know all the details
about how the patients are using them.
Ask patients using Budesonide whether they know if they are on the 100 or 200
strength inhaler. Some patients may not know. For these patients mark Budesonide
(don't know the dose). Then ask them how many times they use the inhaler per day,
Al72
and lastly how many puffs they use at a time. This will enable us to calculate how
many inhalers they would need in a year and give us an indication of cost.
PREVENTER INHALERS USUALL Y USED AT HOME (Interviewer: Choose one)
No. of times to be taken each dav No. of puffs to be taken each time
129 I Budesonide 100 I 130 I 131 I
129 I Budesonide 200 Ix 130 I 2 131 I 2
129 I Budesonide (don't know the dose) I 130 I 131 I
Prednisone (Page 14, Questions 132 - 138)
Prednisone (pred-ni-sone) is an anti-inflammatory medication used for asthma and
sometimes emphysema. It is also used for other chronic disorders like in patients who
have had a kidney transplant.
Patients with asthma or emphysema either receive it when they have a bad attack or
sometimes, in very severe cases, take it every day to prevent symptoms.
They are easily recognizable because they are small white tablets. When used for
attacks they are usually taken 8 at a time, once in the morning.
First determine whether the patient received prednisone today. If yes, enter the
number oftimes it is to be taken each day, the number of tablets at a time and the
number of days t will be taken for.
132 Did you receive any prednisone tablets to take home today?
No. of times to be No of tablets to be No. of days to be
taken each day taken each time taken for
(duration of course)
YES X 133 1 134 8 135 17
1 1
NO -; go to the next question
Then ask if the patient usually uses prednisone on a regular basis. If yes, again enter
the number of times it is to be taken each day and the number of tablets to be taken at
a time. You will note that you are not required to enter the duration of the course
because if the patient uses it regularly at home. it is taken every day.
136 Did you usually take prednisone tablets at home on a regular basis?
No. of times to be taken each
day No. of tablets to be taken each time
YES X 137 1 138 1
1 1
NO -; go to the next question (top of next page)
Antibiotics (Page 15, questions 139 - 185)
Again you follow the same procedure as with the inhalers and the prednisone, first
asking about antibiotics received today and then about those usually used. Remember
that patients might not realize that the packet of tablets in their hands is an antibiotic;
rather compare the medication they have with that on the chart.
Al73
Amoxicillin (Aemox-i-cil-lin)
Trade name: Betamox, Amoxil
This is a very commonly used antibiotic especially for respiratory tract infections
(sinusitis ete). It comes in 2 strengths, 250 and 500. Both are purple and blue
capsules but the 500 is twice the size of the 250.
Amoxicillin / clavulanic acid (Avmox-i-cil-lin / clav-u-lan-ic acid)
Trade name: Bio-Amoksiklav, Augmentin
This is used less commonly for respiratory tract infections. It comes in a bottle.
Cotrimoxazole (Co-tro-mox-a-zole)
Trade name: Cozole, Bactrim
This is used tor respiratory tract infections but also for patients with HIV. When
taken every day it prevents some of the infections people with HIV/AIDS get as their
immune system becomes progressively weaker.
IJ comes in a blister pack. Patients often know exactly what you mean when you say
"the one in tin foil". Don't confuse it with other medications which come in blister
packs especially paracetamol which has a similar appearance (large round white
tablet).
Doxycycline (Dox-y-cy-cline)
Trade name: Doxyclin.
Can be used for many different types of infections some of them respiratory
(bronchitis). Patients with damaged lungs sometimes get very frequent infections and
use Doxycycline every day to prevent these.
Erthromycin (Ery-thro-my-cin)
Trade name: Rubimycin
Used for respiratory tract infections especially in patients who are allergic to
penicillin. Rubimycin tablets are hard to miss - they arc a neon pink!
Flucloxacillin (Flu-clox-a-cil-lin)
Trade name: Floxapen
A form of penicillin used for infections in the ear and of the skin. Smallish capsules.
Fluconazole (Flu-con-a-zole)
Trade name: Diflucan
Used lor fungal infections like thrush both of the mouth and of the vagina.
Fluconazole is usually reserved for patients with HIV as they get very bad thrush of
the foodpipe which can prevent then from swallowing. Often patients with
HTV/AIDS take this every day. It comes in a plastic bottle and the tablets are pink
and squarish in shape.
Penicillin VK (Pen-i-cil-lin VK)
Trade name: Betapen.
This has a very long name which is a bit of a mouthful (phenoxymethylpenicillin) so
is called Pen VK for short.
Used tor a wide range of infections but most frequently for tonsillitis and pneumonia.
Once again you will need to indicate whether the patient has received the medication
or not, how many times it is to be taken each day, the number of tablets at a time and
the duration of the course.
A174
You will notice that for "antibiotics usually used at home" you will not need to fill in
details of the course duration, as these are usually taken every day. Also, only 3 of
these antibiotics are used as regular medication explaining why the lists for "received
today" and "usually used" are different.
The PDA will ask you to indicate YES or NO to each of these antibiotics in turn. If
you indicate YES, it will automatically skip to the questions about no. oftimes per
day, duration of course etc.
ANTIBIOTICS RECEIVED TODAY (Interviewer: Check all that apply)
No. of times to be No of tablets/capsules No. of days to be
taken each day to be taken each time taken for
I (duration of course)140 Amoxicillin 250mg capsules
(Betamax 250) Ix 141 13 142 12 143 15
Other Medication (Page 16, Questions 186 - 189)
This asks about a variety of other medications commonly used for respiratory
problems. Follow the procedure as before, but this time you only need indicate
whether the items are "received today" or "usually used". We do not require more
detailed information for these. The items are displayed in the visual aid according to
whether they are tablets, nasal sprays ete, but listed in alphabetical order.
The items appear in a single list on the PDA. You must check all the items that apply.
Acetic Acid Eardrops
Used to dry out leaking ears.
Beclomethasone Nasal Spray (Be- clo-me-tha-sone)
Trade name: Beclate
This is used for the treatment of hayfever and "sinus". It comes it a little brown glass
bottle.
Chlorpheniramine (Chlor-phe-ni-ra-mine)
Trade name: AlIergex
This is an anti-histamine used for allergies, hayfever and sometimes the itch of
eczema. It comes as small yellow tablets.
Enalapril (E-na-Ia-pril)
Trade names: Renitec, Hypace
This is a blood pressure medication. The reason that we want to know about it is that
it causes a troublesome cough as a side-effect. It comes in a blister ("tin-foil") pack
with the days of the week written on the packaging.
Mist Expectorant (Mist Ex-pec-to-rant)
Trade name: same
This is cough mixture.
Nystatin suspension (Ny-sta-tin)
Trade names: Nystacid, Canstat
This is a suspension for thrush in the mouth. It comes with a little dropper for patients
to suck up a ml at a time. This is then dropped into the mouth and rinsed around.
A175
Questions 191 - 192 (Page 17)
This asks whether the nurse referred the patient to a doctor. This doctor may either be
at the clinic itself and available the day of the interview ("at this clinic to be seen
today") or coming to the clinic later in the week in which case the patient will have to
return to see himlher. The nurse may also have referred the patient to a doctor in a
hospital. This may either be on an urgent basis when the patient is transferred
immediately ("in a hospital casualty or ward") or to see a doctor at a clinic ("in a
hospital outpatient department"). Check carefully which option applies and mark the
adjacent box with a X.
REFERRALS
Did the nurse who saw you today refer you to a doctor?
191 ~------------------------r--.1---.--J--.-..-.-.--------------------------------------YES X go to the next_9uestion
NO I I -> skip to question 193 (top of page 1B)
Did the nurse refer you to a doctor ...
Interviewer. Choose one. Mark appropriate box with an X.
in a hospital casuallY or ward '.
192 at this clinic to be seen today
at this clinic for another day X
in a hospital outpatient department •••• ,., •. 1 .. '...... ::' ..
INCOME AND CHANGES DUE TO ILLNESS
This is a long section and you will find it a challenging one to complete. Essentially
illness has many economic implications from the obvious like paying to go to a
private doctor to the more subtle like missing an opportunity to spend time looking for
ajob.
We have divided it up into different sections as follows:
1. The costs associated with attending this clinic in the last 3 months.
2. The costs of attending other health care providers in the last 3 months.
3. The costs of a caregiver in the last 3 months.
4. Economic Impact of illness.
We are using a time frame of3 months because firstly, it is difficult to remember
all the details of what you spent when, and what healthcare providers you have
visited over longer periods. Secondly it will allow us to compare it with a second
3 month period between the baseline interview and the follow-up.
It may be useful to know when this 3 month time period started when you are in a
particular clinic, to help the patients visualize the exact time frames e.g. In 3
months time the Bloemfontein team will be doing the baseline questionnaire at
Botshabelo U & S. Itwould be good to say to your patients "we want to know
about all your visits to this clinic in the last 3 months, since mid-April and the
Easter weekend". You will immediately see a smile light up on the patient's face
as they will now visualize the time period you are talking about. You too can feel
confident knowing that the information you then elicit from the patient is reliable,
and is really about the last 3 months.
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Oxymetazoline Nasal Spray (Oxy-meta-zo-line)
Trade name: Drixine
This is a decongestant nasal spray used mainly for patients with sinusitis.
Paracetamol (Pa-ra-ce-ta-mol)
Trade names: Painamol, Panado
This is the most common painkiller in primary care.
Paracetamol/codeine (Pa-ra-ce-ta-mol / co-deine)
Trade names :Painamol Plus, Betacod, Dolorol forte
This is slightly stronger than paracetamol alone and commonly used in primary care.
Salbutamol (Sal-but-a-mol)
Trade name: Venteze
This is the same as the reliever inhaler but in tablet form. Venteze tablets are easy to
recognize as they are lilac in colour.
Theophylline (The-oph-yl-line)
Trade name: Nuelin SA
This is a medication used for asthma and emphysema
OTHER MEDICATION(S) RECEIVED TODAY (Interviewer: Check all that apply)
Acetic Acid Eardrops ' "
Beclomethasone Nasal Spray
Chlorpheniramine tablets (Allergex)
Enalapril tablets (Renitec)
187 Mist Expectorant COUQhmixture X
Nystatin suspension (Nvstacidl Can slat)
Oxymetazoline nasal spray (Drixine) X
Paracetamollablets (Painamol) X ..~
Paracetamol/codeine tablets (Painamol
Plus)
Salbutamol tablets (Venteze)_
Theophylline tablets (Nuelin SA) ''''. ".,
DETAILS OF CONSULTATION cont'd (Page 17, Questions 190- 192)
These questions round off the information about the details of the patient's visit to the
clinic on the day of the interview.
Question 190 (Page 17)
First ask the patient whether they have been asked to return to the clinic by the nurse.
(fyes, ask them when. Patients will often tell you when their medication runs out etc.
Allow them to volunteer an answer, as chances are it will be the same as one on the
list, saving you time. If not able to volunteer this information read through the list
and mark where appropriate. You must check all that apply.
FOLLOW~UPAPPOINTMENT
Did the nurse ask you to return for a follow-up appointment?
190 Interviewer: Check all that apply. Mark boxes with an X.
On a specific date ". ~,
If you feel worse X
lf you don'l gel beller
When you run out of medication X
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You start with visits to this clinic. Work very systematically here and you will be
fine. The PDA has an advantage here as all the skips (and there are many) are
automatic ensuring that you don't miss out any data unnecessarily. If you have to
resort to paper, please ensure that your team leader edits this section very carefully
as it is possible to miss sections without realizing it.
VISITS TO THIS CLINIC IN THE LAST 3 MONTHS
Here you can use the patient's folder to assist you. The folder should be used to help,
not to confuse you or the patient. All you need to extract from the folder are the dates
of the visits in the last 3 months, and if you feel confident the reason for attendance.
Do not try tofill in the details of the visit requiredfram the notes {Yl thefolder as you
will struggle. Visits are poorly documented at the best of times, writing can be
illegible and there are usually many abbreviations. All you should aim to achieve by
looking in the folder is to see if and when the patient attended the clinic in the last 3 .
months.
This can be used to prompt the patient: "I see you came to the clinic in mid-May. Can
you remember that visit? Can we discuss it now?"
You may want to prompt the patient further by providing the reason for attendance.
This is usually the first line of the entry and is usually a symptom: "I see you came to
the clinic in mid-May with a cough. Can you remember that visit? Can we discuss it
now?"
Be sensitive when prompting with the reason for attendance. NEVER prompt with
sensitive diagnoses or symptoms like HIV, sexually transmitted disease, discharge
from penis, beaten up by husband etc. This requires common sense to recognize these
diagnoses/symptoms and sensitivity not to mention them. If you do mention sensitive
diagnoses, you will find yourself immediately alienated from the patient, and the rest
of the interview will be very difficult.
Question 193
First establish whether the patient has been to the clinic in the last 3 months. You
must double check the patient's answer by looking in the folder if available.
Remember that recalling exactly when you were last at a clinic is a difficult task. If
you find a discrepancy between what the patient has told you and what is in the folder,
have understanding and be patient.
193 Haveyou attended this clinic in the last 3 months?
Interviewer: Double-check this information in the folder
YES I X I -+ go to the next question
NO I I -> skip to question 262 (top of page 22)
Questions I97 and 198
Obviously, if the folder is at hand and you are able to prompt the patient with the
information it contains, then the information is likely to be more reliable than just
asking the patient to recall the visits on their own. We need to know this information
when we analyse the data, so have asked you to record the presence or absence of a
folder. The instructions you give the patient will differ depending on whether there is
a folder available or not.
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197 Do you have a patient-held or facility-held record with you?
YES I I -+ skip to Instructions A at the end of this page
NO IX I _, go to the next question
198 Interviewer: Are you able to locate the folder?
YES IX I -> skip to Instructions A at the end of this page
NO I I -+ skip to Instructions B at the end of this page
Questions 194 - 196
The aim of this section is to collect all the data about all visits to the clinic in the last 3
months. Provision has been made for you to enter a maximum of 8 visits both in the
PDA and in the paper version. Obviously patients on TB treatment will have been to
the clinic more than this in the last 3 months. To avoid having to enter each visit
individually we first establish whether the patient has received treatment for TB in the
last 3 months, when this started and how many times they visit per week to collect
medication.
This information is readily available from the TB Treatment card which the patient
carries with them. Ask the patient if you can see this card as it will make collecting
this information straightforward.
You are required to enter information for non- TB medication visits to the clinic for
TB patients. Usually these are rare as other problems are dealt with by the TB sisters
who see the patients regularly. You must establish from the patient if their have been
any other visits to the clinic besides those to collect TB meds. If they came to the
clinic tor an entirely separate reason like seeing the doctor to check on their high
blood pressure, you must complete one of the blocks for a visit on pages 19-20.
194 Are you currently attending this clinic for TB treatment?
Choose one (Mark with an X)
YES IX I ....g.o to the next question
NO I I -+ skip to question 197 (this page)
195 When did you start your TB treatment at this clinic?
Interviewer: Ask patient to show you their TB treatment card
Date: I 24 I Month I 4 I Year 12003
196 How many times a week do or did you attend the clinic for TB treatment?
Interviewer: Choose one (Mark with an X)
Once ..... ' ...... ,
Twice
Three times
Four times
Five times X
Questions 199 - 230 (Pages 19 - 20)
Here you must complete one "block" for each visit. First enter the date of this visit
from the folder. If you are without the folder and the patient doesn't know the date,
you may leave this out but you must enter the month. If you don't know the date click
on DON''T KNOW on the PDA in the lower left of the screen.
Then establish what the reason was for that visit. Follow the same process as for the
reason for attendance at the clinic today (question 91, page 12), on the day of the
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interview. You must enter more than one reason if applicable. If the reason is "other"
enter this reason in the space provided. If "other" on the PDA press NEXT to bring
up screen with provision for you to enter this reason.
Finally ask the patient whether there is another clinic visit in the last 3 months which
you have not yet discussed. If yes, enter a separate block for the second, and third, and
fourth visits etc. If no further visits skip to question 231 and the top of page 21.
199 Date of Visit 1 to this clinic in last 3 months Date of Visit 2 to this clinic ill last 3 months
200 204
Date: 122 Month: I Feb Date: I 16 I Month: I March
201 What was the reason for attendance for clinic visit1? 205 What was the reason for attendance for clinic visit 2?
Interviewer: Check all that apply. Interviewer: Check all that apply.
Check-up for high blood pressure Check-up for high blood pressure
Check-up for diabetes ("sugar') Check-up for diabetes ("sugar")
Check-up for a respiratory problem X Check-up for a respiratory problem X
Check-up for other problem Check-up for other problem
First visit for a respiratory problem Firslvisit for a respiratory problem
First visit for other problem ,. First visit for other problem ..
Other (please specify): 1202 X toothache Other (please specify): 1206
203 Interviewer: Enter data for another Clinic visit? 207 Interviewer: Entër data for another clinic visit?
YES 1 -+ go to question 204 (next block) YES 1 -+ go to question 208 (next block)
NO 1 -> skip to question 231 (top of page 21) NO 1 -+ skip lo question 231 (top of page 21)
Questions 231 - 330 (Page 21)
This section is about how the patient usually travels to the clinic. Since most patients
live reasonably close to the clinic they tend to use the same means of transport every
time they have to come to the clinic. Show the patient the pictures of the different
types of transport in the visual aid (page 34) and asked them to point out how they
usually travel to the clinic. They may only select one option. Mark this option with
an X in the adjacent box.
In the case of public transport (taxi, bus, train) you must then proceed to ask them
how much they usually pay to travel to the clinic and back home again using this form
oftransport. Emphasise that we want the cost of a return journey, not just one way to
the clinic. Enter the amount in Rands.
It is unlikely that a patient usually travels by ambulance to their local clinic. In the
event that they do travel by ambulance you must ask them whether they had to pay a
tariff for the service and if yes, how much. Enter the amount in Rands in the space
provided.
The PDA asks this question somewhat differently. First ask the patient to select their
usual form of transport using the visual aid. The PDA will then ask you, one by one,
whether the patient travels by bus, taxi etc. When you reach the option the patient has
selected, enter YES and it will skip automatically to a question about the fare for the
return journey for that particular mode of transport. Enter the amount in Rands and
press NEXT. The PDA will automatically skip to the question about travel time
(241 ).
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231 How do you usually travel to this clinic?
Use visual aid to select a mode of transport. Choose one_{_Markbox with an_&
Walk
Bicycle
Animal (e.q. donkey)
Taxi 232 X -+233. Enter amount paid for return fare to clinic by taxi: R: 15
Bus 234 -+235. Enter amount paid for return fare to clinic by bus: R:
Train 236 ->237. Enter amount paid for return fare to clinic by train: R:
Private motor vehicle
Ambulance 238 ->240. Tariff paid? Enter amount: (enter 0 if no tariff pai~ R:
Other
Questions 240 - 244 (Page 21)
This asks about time away from home or work because of a visit to the clinic. It asks
the patient about the total time spent attending the clinic meaning that we want to
know how many hours it takes them from the time they leave home until the time they
return home again (so called door-to-door time). This includes time spent travelling
and the time spent at the clinic itself.
Some patients may need to travel overnight to attend a clinic especially if they are
coming from a neighbouring country (Lesotho) or province (Eastern Cape). You must
ask these patients if they spend money on accommodation when travelling overnight.
If yes, enter the amount in Rands in the space provided. You must also ask them to
estimate how much they usually spent food and drink when travelling overnight.
Enter the amount in the space provided.
The PDA will automatically skip to these questions on money spent on
accommodation and food and drink if you the "overnight" option for question 241.
241 How long does it usually take you to travel to the clinic and back home again (travel time + time spent at clinic)?
Choose one (Mark box with an >Ó
Overnight --+243. Enter rands spent on accommodation IR: 60
X --+245. Enter rands spent on food and drink IR: 25
Between 2 and 12 hrs \ ~. ..
Less than 2 hours . : " .": , ..,
Questions 245 - 257 (Page 21)
These questions ask whether the patient is usually accompanied when visiting the
clinic. This is particularly important for elderly or frail patients who may be too
unwell to attend on their own.
Often, family members or friends take time out from their daily lives, including work,
to take sick relatives or friends to a clinic. This has obvious cost implications as these
people are missing work, and losing productive time at home to help. These are the
costs we want to capture with these questions.
Note that the word companion is used to denote the person who accompanies the
patient to the clinic. It does not refer to the patient's spouse or partner.
NB: If the patient is usually accompanied to the clinic the companion may actually be
with the patient on the day of the interview and it will save time if you ask the
companion these questions. Note that the companion might be waiting at the
pharmacy tor medication or just outside the clinic. If the patient tells you that they are
with someone on the day of the interview arrange tor this person to be called.
Al81
If more than one person accompanies theiPa.tientto the clinic enter data for the main
adult companion only.
Question246 asks about the employment status of the .patient' s usual companion or
escort. Go through all the options' on-the-list- .with the patient and choose one. Mark
the adjacent box with an X. If the companionis employed you will then be asked to
go onto the next block (questions 249 -257r Ifthe usual companion or escort is a
student/learner or looking for work you must then proceed to ask the patient (or
companion jf present) how many days on average they miss of either' activity when
accompanying the-patient to the clinic, Enterthe number in the-space provided.
Questions 249'~ 257 attempt to capturethe loss (either tM1!e'cOllmMion)lis!herself or
to their employer) incurred by the companiQn'accompanyingihepátient to.the clinic.
It first.establishes on.what basis.ïcasual, weëkly or monthly) the companion is
employed. Choose one option and mark thee adjacent box.
In the case of casual workers you must establish 3 facts-the 'average number of days
worked per week, the average amountof money brought home for each day workêd
and the typical number of days of work the companion misses in order to accompany
the patient tothe.clinic.
In the-case of weekly and monthlyworkers.you must estaplisp the amount brought
hotnê.pcr week(or.per month) a.l14,.thely'pi~!iJ!lump.erof qf\Ys ofwotk the companion
misses' in.order to accompany .the:patient'to'~e;clfnic.
A182
VISITS TO OTHER HEAL TH CARE PROVIDERS IN THE LAST 3 MONTHS
(Questions 262 - 467, Pages 22 - Jl)
This section aims to capture the costs incurred because of attending other providers
besides the clinic you are physically conducting the interview in. Other health care
providers include all types of hospitals ~~Fc, Private and Mining), other primary
care clinics besides the one you ate cmtdÏlcting the interview in, mobile clinics,
workplace clinics, mine clinics, private doctors, traditional healers and pharmacies or
chemists.
When patients receive poor quality h.ealthc9,re.in primary care, they are forced to go
elsewhere like hospitals and private GRs .. \ve are attempting to' capture the cost of
recei ving care outside of the pii~ry,.c~ clinics..
There is provisi~mfor YOU to, enter ii visi'tsJb 'health care providers· (Heps) other-than
the cliriié (you are conducting the imér'View ·ili:) In the last 3 m6ntJls; You. must
therefore prioritise "big" visits like hospital adIÏlissions as these are very costly. If a
patient has been to a pharmacy 5 times and admitted to the nearby hospitalonce, be
sure 'to document the hospital admission and rather leave out one of the. pharmacy
visits. Other 'big" items may-include VIsits to a-traditional. healer (where patients may
spend a few days); If there are any visit to HCPs where the patient has had to spent a
few days be sure to documentthe details for these visits.
Each visit is recorded over 2 pages, and most of it is the same as the information
collected for visits to "this'tclinic.
Question 262 (Page 22)
This asks the patient whether he/she has been to another health care provider besides
"this" clinic in the last 3 months. Show the patient the pictures of the health care
providers in the visual aid and ask them whether they have attended any of these in
the fast J,months. If the patient says no, mark an X in th.e adjacent box and skip to
q.!1estion 4:68. and .the top of page 32 (Care giver costs in the last 3 months). If the
patient says ye~"il)dl~at('j this wlthcan;X'ii} the adjacent box and, establish what health
care pro:vh:ler(s) he/she has been to. Remember.to prioritise hospitil,l admissions (this
is usUa,.llyq\lÏt'e a dl'i!D:iatiCevent in the patieI1tJSlife and he/she usually remembers the
details weil) and any-visit to, a provider where the patient was admitted or spent a
couple of days. Proceed to question 263 and start to enter the details of this
visit/admission.
2E>2.Have 'you'bêëh'to another heálth care provider beSiêl~:sttlis ellrilc:lrfthe'last 3 rnónths?
YES
NO IX 1_,!)qniplele questions 263 - 303{this page and the next p"ge).I ....s.Kipto q~ê~tiêln 468(ipp of page 32)
Question 263 (page 22)
First establish during which month the patient attended the BCP. Since all the 3
months time periods tor the survey' fall within 2003 there is no need to record the
year. Mark the apptl'lpriate month by placing an Xln the adjacent space (February
shown in the example below). The PDA will present. you with a drop-down list.
Click on the selected month and press NEXT.
Al83
medication he dispenses. The total charge is RrOG and the question is completed as
follows:
270 Did the health (lare provider charge you for th!,tv[sitJ,adi,lission (consultation fee + medica~On)?
YES I X I ...2...71. H()w much? (consultation fee + medication): R 100
NO I CN:;~:i;;:<iM".t:"y,.,;';; ;"kYi~"Y:::'~;;;;(,:<ili ._ :::_~
Questions 272 - 281 (Page 23)
This is a repeat of thetransport questions .for this clinic (Qu~~tions 231 - 330). The
transport questions' are asked for each visit to a Hep as the mode' of transport to
different Heps. may vary (e.g. ambulance to hospital, walk to pharmacy, private
motor vehicle to traditional healer ete).
Questions .282 - 286 (Page 23)
Again this is a repeat of questions 241- ,?45 (Page 2U ~ time spent away from home
to visit the Hep. The information is collected separately for each visit to another
acr.:
Questions 28J - 302 (Page 23)
These questions about persons accompanying the patient to the Hep are also asked
separately for each Hep visit as events like hospital admissions often result in special
arrangements in families to accompany sick patients to Heps. If more than one
person accompanied the patient to the Hep, enter details for the main adult
companion,
Again note that the term "companion" 1:S used to denote the person accompanying the
patient to the Hep. It does not refer to the patient's spouse or partner.
Question 303 (page 23)
This is a check question to see whether there. are any other. visits to Heps that still
must be discussed. If yes, go to question 3:04 and the top of the next page and collect
data.for the next visit. Ifno further visits-need to be recorded, skip to question 468
and.ihetop ofpage 32 (CaregiverCost,S.in the last 3 months).
eAREGIVER eQSTS lN THE LAST3 MONTHS (Questions 468. - 483, Page 32)
This sections attempts to capture the. lost-work or opportunity to work of people who
care, for the patient.athome.
Many patients With,longstanqing illm:s~es:have caregivers in the family who helplook
after .them at'home and assisrwith.bathing etc. These caregivers may also' accompany
patients to the. cIihics:.-orQtl1er HCPs))ut:we,have ,already' captured those .costs. Here
we are attempting-to .qualify how.muchtime they are spending caringfor the patient
athome.
Again the time frame is the 'last 3 months.
A184
If the patient has more than one caregiver, limit the patient to the person who spends
the most time looking after hirnlher.
If no-one has looked after the patient at home, answer "no" to question 468 and skip
to question 484 at the top of page 33.
468 Has anyone (Including'family or friimds)lo·oked'áfter.you áthome because. Clhny illness in thlHast 3 months?'
YES I I c-+ gQ to the next que'stiob .
NO
Questions 469 - 48:3 (Page 32)
These questions ate. similar to those-fot companions to "this clinic" (288 - 302, Page
23) and other Heps (329 - 343, Page 25).
The only difference is that they 'ask you to enter the number of days unable to work in
the last. 3 months qeca1,l,Seof caring for the patient at home (instead of accompanying
thepatient'to the CliniCIHCP).
470 On,WI\át'báiiis'is yoiJr"caregi\tëH!ri1ployeil?
Choose one (Mark' box with-an X)
Casual 47,2 ~473. Enter average rib. of days worked per week
-'474. Enter average amount brought home per day
{after deductions ,e.g. tax)
• ->479. Ehter no. of days unable to work because CIflooking
,after,vou at'horne in the laSf3 months
, Weekly ->476. Enler allerage amount.brought' home per week
(after,dedtJclion6e~9,.tax)
'-'.479. Ent~r·ho ..of:d::lysuhable,to work-because of looking
.aftê(you·athbme'in the.'lasi3' months
Monthly 471 ->{t8. E:i'I[êri~venig~,illfi'ounfbroug'hl home-per month
.X .;iafi~rJdeduétioris e;Q;;taxi R650
_'4?~:.· Ei;ïiërn6: ó(d~y.s.una~le·to,workb.~cause'of·lookin9
aiter-.you in.tI:ie last 3'months 8
ECONOMIC IMPACT OF ILLNESS (Questions 484 - 504, Pages 33 - 34)
These questions capture the literacy Ievel of the patient (important for interpreting
heatth-retatedqualifycf'life data) and information of the patient's employment status
and-work missed due to any illness.
Qilestion.484 (Page 3J)
This is important.irr terms ofinterpreting thehealth-related quality pflife data. You
must stress to the pati(;!nt that we warïtto ·ki:tow llbóu! the ll\st grade/standard they
passed at schooi. This may not necessarily correspond to -the grade/standard they
were enrolled in when they left school. Mark-the appropriate option by placing an X
in the.adjacentbox.
54
A185
Standard 2 or Grade 4
Standard 3 or G.rade 5
Standard 4 or Grade 6
Standard 5 or Grade..7
Siandard 6 or Grade 8
standard 7. or Grade·.9.
Standard'8 or Grade 10 x
Standard 9 Or Grade 11
Standard 10 or Grade 12
Questions485.-, 502 (Page 33)
These questions are similar to those that you have ëncountérëd previously for
companions 'to "this" clinici otf).cr HGFs, an4 Gary~Lv~r.s•. ]here· are some subtle
changes. Bere we want-to know ab~liJthe total nliIrib\1r:Qfcia.o/s of wenk missed (or
school missed, or d(iys looking for.work missed) in the last 3 months {illstead of days
missed because of accompanying the patient to. the clinic/HCP or Icoking after the
patient at home). We want to know about work missed because of {my illness. We do
not differentiate between work missec;l because of a' resp-iratory problem vs. a non-
respiratory problem or worked .mlssed for the reason the patient is attending the. clinic
vs. work missed for other health reasons, Having said-this, we eo not want to kn:ow
about work missed for any reason :b()sides ill health (e.g. leave, compassiónate leave
to attend funerals ete).
Since this is now the actual patient We. are talking about, we want their employment
data in more detail. You will now be required to. complete average number of days
per week worked (casual' workers), weeks per month (weekly workers) or months per
year (rnopthly workers). You must also complete the average amount brought home
per day (casual wqrkers); per' W~~k(,'\Y.eél{l_yworkers) or per month (monthly
w<:)1;I<~rS): Firw'fly you must enter the fïunibei' of d~ys the patient has been unable to
work because ofiHhess in.the last 3,'months.
Remember you may only choose one option' (casual, or weekly or monthly). Then
enter the above information for that.option,
The FDA will first instruct you to ask the (employed) patient on what basis they are
employed. Once you have established this, the ,PDA will ask you whether the patient
is employed on .a easual, weekly Or mOIl1hly .basis. in. the form of a sequence of
separate questions. When you enter "yes' to the; option the patient selected, it will
automatically skip to the 3 questions
A186
486 . Onwhat basis are you employed?
Choose one'(Mark box with an X)
Casual 488 -489, .Enter average no, of days worked per week
.....490:.· El)ter:average amount brought home per day
-(aftetCfeductions;e,g, tax)
-'411'7, Enter'Tlo: ofday~ unable to work because of any illness
iri;the'last.·3inonths
Weekly 491 -'492. EriW ali9:tage nul)iber of weeks worked per month
A~j: Enter ávElrage ~nioUnt brought home per week
(afté'r.dédliêtiÓns:e:i!,taX)
-'497, En\~r no, oUj~ys'unablê to work because of any illness
in:the'last·j months
Monthly 494 ->495, Enter average nUmber cif months worked per year
5
. -'>496. Entei'ailerage.ampuntbr.ought home per month
x (áfter.de.duciions.e.g.Jax) R780
'-'497. Enter no; ofda'ys unable-to work because of any illness
inthe last.3moriths 2
Question498 (Page 34)
This asks the patient to estimate the amount ofincome they have lost as the result of
not being able to work because of illness .in the last 3 months. Allow the patient to
volunte.erthisinfórm!ltionspontaneously first. You may only choose one category.
The example- below shows a patient who volunteers that he has lost R200 in the tast 3
months because of inability to work because of illness.
Questions 503 - 504 (Page 34)
'Phis .asks the patient: whether they have lost 4job ill the last year as a result of illness.
Note that the timeframe used here IS different to the standard 3 months used
elsewhere, Ifthe p~tieÏlt answers yes, proceed to question 504 and enter the average
amount the patient used to bring home in li usual working month. If the patient
answers no, skip to question 505. The FDA will skip automatically,
503 In thelast year,. have ·You :Ióst.yourjób 'as'a~result'cif-anY illrïesa?
YES I - goto the nextquestion
Ouestion504 (Page34)
This asks how the househeld-has: adapted in order to pay the medical costs. incurred by
the patient. Read aU the options to the patient and.markall those' that apply. You will
need to explain the term "assets" to the patient. Assets are any possessions (from
A187
animals to appliances to clothes to m.ore s~bStantiaFjtems like houses) that can. be
exchanged to redeem debt Fór example 'if th,ê'patient's household has had to sell
their hi-fi ete to pay a doctor's bill, this is considered an asset and you must mark this
option.
In the event that the patient has not incurred costs on the household, check "not
applicable" (you will find this as one of the buttons in the lower left of the screen on
the PDA).
505
Questions·506 - 509 (Page34)
These questions all concern HIVand, because of-their sensitive.nature, have been left
to the end of the questionnaire to enable you to have established a rapport with the
patient by this time, and so as not to compromise the rest of the questionnaire.
The first question is really a gentle introduction to the topic, so that patients do not
feel threatened by immediately confronting them with questions about whether they
have been referred for testing ór even.tested,
Even if the nurse simply provided education as to how HIV is transmitted, this is
sufficientto answer:yes to this question.
The.next question asks whether the patient was refer.reg for counselling and/or testing.
Many clinics 'now have trained lay counsellors attachee).tothem, and.most nurses
prefer-to refer patients-to them first for counselllng beforebeing tested,
There are 2 methods.available at clinic.level for testing for HIV. The.first is the rapid
test method 'which involves'putting a drop ofthe patient's blood onto a strip (similar
to those- used to tesfl:>!boc:l.~ugi1n'ldf iabeties).and 'waiting 2 minutes.before-reading the
result. This method forms part of the VeeT pr.ogranll1)e(Vólunta:r:yCounseUipg and
Testing) and the strips should be available in most clinics, A positive result (the
patient has HIV) is followed up with a conventional blood test where blood is drawn
A188
from a vein in the arm and sent away to the laboratory. If the patient has had either of
these methods of testing, you must answer yes to. this question.
508 Did you have an HIV test (rapid lest! fingerprick melhod or drawing of blood from your arm) at the clinic tOday?
YES
NO
The final question establishes whether the patient has been tested in the past, and is
the most .sensitive ofall these questions. Be-aware of this when you ask it, and treat
the .response neLifraJ,ly.
Questions 510 - 523 (Page 35)
These ate the patient's contact details. Bear in mind that you are to schedule a follow-
up interview with the :p~ient for 3 months from the date of this interview. If the
patient doesn't arrive.' atthisfollow-up: interview, you will be required to chase up the
patient. Complete and accurate contact details are therefore to your advantage.
Remember this when collecting them.
You will give the patient a.reminder card with the date of the follow-up interview on
it. This card also "primes" the patient for the second interview, telling him/her that
many of the questions about quality.oflife, clinic attendance ete will be repeated at
this time. They will be asked to bring their regular medication with them in order to
facilitate completion of the prescription section.
ENI) OF BASELINE INTERVIEW
A189
ANNEX 15-11
Part 2- First post-intervention survey training manual
Al90
"FHtE F;IR!~E STA TE
LW:~(S~:Ê~h.r·t:I-SURVEY
RES1E:A'f,l(}:HTRAllNil:N'C; AN:D FIELDWORK M,AJNiWAL
(Part 2)
University of Cal1e Town Lung Institute
D~par:tm_entGf C.()l11muni(tyHlêé:llth, Univêrsity of the Free State
Centre for He.él'l~hServi'ces :Research and Development,
University- Qf the Free State
M,edical Re$.e,arch :C(i):Uflci'I, Cape Town
April 20:O:S
A191
CONTENTS
1. Interviewer Codes page 3
2. Sampling page 3
3. Editing Nates , , page 7
4. PDA: How te 4p1eac:al nd common problems.................. page 10
5. PUA: Wbento upl~ad , page 20
A192
1. INTERVIEWER COIDES
Please find your individual interviewer code in the table below. When
asked to enter your interviewer coe1~,el!lt~r the code.fer the climie in which
you are working (2 digit code) firsffollowed by your personal- interviewer
code (2 digit code). The PDAWil!,h~r,êll()'w'¥olJ'to pt0c.~ed;,ur:lJess you
have entered these 4 digits. Rérme'r;lih)eIto·Write:'tffi~~ei:fdurdigit5 at-the top
of each page in the paper questionnaire in the $,pa~~'pr(!)vit:led.
INTER\tfËWER NAME TEAM
06
Q7
08
Nrateng-Sel;:ji QwaQwa 09
Thulani Ma;tibuko Qwaqwa HJ
Baaseny,a.Mo.tikoe Bêfh'lehem 11
12
Agnes Mosia Bëfhl~l1.eh:l·
Victoria Ramrnile BI,Q'eh1tc>nteiR- 15
16
17
Innocenli,aJ)uma 6.IQemfenteih 18
Dina,h, Ma,kgQ,e: Parys 19
20
21
Josh Nocancla Parys 22
2. SAMPUN$: HOW T0 SELEGT PATIENTS FOR INTERVIEWING
BEF0RE CONSULTATION
From .the Jasttr:ack queue,for ilLpatierits:
• SelecfeYeJo/ patient who answers "¥es!' to:
"lJlo,you have orhád you had any efiffic.ult breathing and/or cough today
or in the last6 months?"
• Excluc:1e patients Who ar~éli~arly toe ill to complete an hour leng ,
interview, Clear examples of patients who are t00 ill to participate are:
o unsonseleus patients
o patiéntsw,ho are not bre;athing
o patienfswhoare,unable;to-talk
o patients w.ho are psychotic
A193
TB TARGETS
CLINIC NAME LQCATlgN SAMPLE
Ge:neral Patients on
Patients TB treatment
Tseki Clinic
RiversicJ.e <::;Iihic 12
7
8
P:a'baIIQr;jQQlinic 12
12
2
43 7
39 11
B.efhl$hem 45 5
Ma. ..Haiq Clinic O'w.aQwa 43 7
Botshabelo
PetruspurgCJinic Peffius,burg 46 4
42 8
37 13
38 12
Wepener: Clinie VVepenef 48 2
45 5
Pacys 43 7
P.t0< Clirti.C o
7
$,ásQlpurg 4'8.
47 3
Hili $tre:efCiJnic Kr00nstad 49 1
K-l\I1ail.e Clinic Both.Cclville
Aloert Luthuli Clinic Wesselsbron 34 16
Boith,wsol7IQ Ocleodaalsrus 39 11
41 9
48 2
BoP,he.Ié;>.ng.G:linic Odéndacilsm$ 12
3eeisoyille' C:lini.c ..Kroonstad 4.0 10
I<roon.s_tad
WelkomCJinic W.elkom 40 10
Tsnepoll9 QHmic 31 19
Phomqloo_g_ Qliriic 28
Khot:a.long.Clinic 18
AM Kruger Clinic 45 5
A195
From the generahgueuë:
• On arrival obtain th.'e;headcql;Jof.frómJhe previous day. If you are
interviewing OR a'MOhday lI$e,;tR.~headcount for the previous
Thursday.
• Use the tables on the next pa~;e to work out how often you should
select a pati~nt- who, answers' "yes" to, difficult breathing (DB) and/or
cough (tóclay or ir! the last 6 m<:mths)in the general queue.
• Example: '(ou', determine that you should select every 3rd patient for
interviewir:tg. .A.sRevel;Y4~átierit in the'gener:al qi:Jel:Jéat.>0ut.;difficult
breath'ing, and/er C!Dugtl ~tóday or ih th-e la'sf6 months). Ask ev.ery 3rd
patient who answers "yes" to meefthe interviewing team after their
consultation with the nurse today.
SELECTION OF PATIENTS FROM THE GENERAL QUEUE.
WITH2 INTERMfE\IVERS
Headeountfrom previous day S.eléct .... Patients who answer yes to
(<P.e.l1,eJal.qU~lJe) p·aJ G.oY9h
o - 70 pati$fits
Ëye.r:ysecénd J!)atient
,JE\lerw fifth. patient
E~eJYs.ixth patient
43·1 - 50a patiE:mts EVery seventh patient
WITH '3 INTERVIEWERS
He;::tqtountfrom. prevJous.·day .8.eleët .... Patients who answer yes to
(G'eQer:al,·qP.el:!e) OBI cough
I3veW·.p. alient
431 - 540 patIents
Fróm the fásUra.ck TB queue
• This·will differ f!iom Clinic to Clihic baseë .on the number of patients
attend ing for TB, tré~trrï:eht at eaph clin lo
• You will receive .speciflc insfructir,ms for each clinic;
• Team .leader to iclenti'fy on whéltday:·oHhe week, most patients attend
the TB:service al théltparticl,Jlar ëlinic. This d.ay is to be set aside for
interviewing TB patients and reaching your "TB target".
A194
34 16
~robnstad 45 5
NOTES:
1. The screening process occuts ih\2 .warrts;ail?fiëf .sereen before the
patient §.~e~.the nurse {resPe:>l1lsipjlityqtt~g/fe'~1\BTeêlcier)··anda more
tho.rowgh screen after-the patient sees.the norse (responsibility ofthe
interviewer).
2. Betere the patient sees the nurse they are selected fOJfwlther
sereening by the team leader. All patients with C0t:19.1:l anW.orqifficult
breathing qualify at this stage. This means that patients with difficult
breathing alonequalify, as do patients with cough alone as well as
patients with both symptoms.
3. Patientsmay have no symptoms on the day oftheinterview, but have
had symptoms in the last 6months; This is particularly relevant when
you are screening patients attending for TB treatment.
4. Note the headcounts used tework out yGur sampling strategy as well
as tne f.i.e,qqeQuntfGrtne day of fiéldwork: on.tl'le'f0J"rli1prC)vided. This is
the re~p·onsi9:ïlity orthe: netarri Le~~d~r~.ndshól.lldbe fihtd in the arch-
lev.er·.fjle pro:vided. ·This'allows.usJo adjust,the data. if the patients you
inter:Vi~w do ndt reptesentthe people attehding the clinic.
What do you ëe if the He.adcount is not available?
If the headcount is .unavailable estimate the number of patients in the queue
by counting.the number in Qnef9W «;In(i:HnultlJ1)lyiI1th9is by<tAe number of rows
(e,g. 8,patiernts per rew.·xerows = 6,;;t::r;yaliënts).Use this figure êlsa,g.uide to
determine how many··pa.ti~mts..rmlJsLQe',S:end·thrGu9htothe, interviewers. Bear
in mind th«;lt y,Quioe$Gftp ~~I~ctt8'p'êlJi.~.nt!:t:o>,complete to interviews per day
(when y.ou have 2·'intetv.iewers available) and 2,7 patients to complete 15
interviews per daY' (when you have 3 interviewers).
What do you do jf you have selected insufficient patients on a day?
You may find thatyeu have<seléotedto,o few patients to complete the t·arget
numb~r;bftlÏte.rviews.on a ~pecific ctay by selecting 1 in 2, 1 in .3. ete with
coqgm ánd/ordiffiêqlt .br;ëathing.fodélY aM/or léi'St6 months, Ifthis is the oase
select lTlore.patients the fo.llowing· day e:9·; on.DcW 1 you selected 1 in 2
patients, for yoUr team of2 in~erViewers (Wi,th .~.tar,g~t of 10 intervlews for the
day) but only managed to cemplete 7 interviews. The following day the same
number ofpatients attend the clinle. In 'order to selectsuff.icie.ntpatients you
now select every patient with cough/difficult breathinginstead of every second
patient.
A196
3. EDITING NOTES
The.following points·hay~·'peen;réli$,l3'(.f;~G·~;jing,thefirstdays of.data collection.
It is important that both'te~m léa~ef.~;;aliiiti8t$rvlewefs. rea,d through each point
carefully so that mistakes are correQteei:early during the fieldwork.
1. Ente.ring, the name,,()ftl:te. clinic
Top éf every ,pa-!ife on paper Ejuestiónhaire
Question 2 on P,DA '
The Jull'name of the clime mlil13tb~ entered. This applies particularly to
thelB0tsl!fabeloGliFiics tf3. U &,$, J), l3opfuelor)g Clirli'cs'('*fOOrl and
Odend~lalsrus) and the Thusanon~rClinics (Kroon and Sasol) so that
we can easily identify to which clinic a respondentbetongs.
2. S'créltch'i'tlg our inc,orre.'ctánswets
When ,Working on paper qLiestibnnairesplease ensure that incorrect
answers are clearly'scratched btJlby usirlg 'one clear line to' cross out
the incorrect answer. These chaf;lges must.be initialed (sign )':our
initials next to-áscnatched out question) so that they ate not que,ried at
the time of data capture.
T~xtural· tiJata'is .tha.t data lR,af 'n1I.J:spl,~; written OlJt or tY:Ped into the PUA
e.g. Specify other reason:f0r 'a,tl$ndance; Please ensure that all such
iAform~tibrr is recorded in E:'rnglisheven-when using a non-English
questiohn~'ire or PDAversiOI'l.
4. Re:p.eat~d·<ll~es:ti()J'S
Questions,riS: & 4;~)-.t1'6 :&~9;), {,17 & 3S}, (34&41), (34 &-42)
You will noti~~.tbaLe~'[taih:G1q$sti(l)rlS are repeated in the screening
sectïon at1dl.flh'ë S~€Óh(2I;;part;@nhé 'questionnaire (e.g, cough tocay,
difficult br~athifug:). thi$'''$10:~h,s!i!li~thaHDati~hts with either or both
symptoms ;qnswer further:questioms about their symptoms .(e,.g.
cougthim~ patiefitsansw:er.qwestions;;abowt coughing up sputum, blood
etc. Pafi'enJs with diffiGultbr,eatnihg~answ~r questions about whether
this o.cQurscontinuously orrepeat~<lI¥ eté.)
The CJP~stions.ab'Qut.êhestpáiM err breathing in deéplY'and wheeze are
repeateduJi'laerthe. Gough·sec-tion ·and difficult breathing section. This
is so-that pafieAts witl:l onlyone ofthese symptoms (either cough·only
or difficult breathinq only) are asked about pain on breathing in deeply
and wheeze,
A197
5. Health-Related quality of Lifé
Questi6ns .61 - 65 aREl 67 - 11
Be sure to only JTIatkor:Je..of,\tl;l~ifi~.(~.·bl(:)G~fsor each.question (mobility,
self-care ete).•.l.ftm,e pati~Fl#I\jl:l.s,t{i~l€l.i~a,'tedablack "hetween!' statements
(a block which has nostateme'nt,;áUê,G.f:fedt0 it), mark that block. Do
not mark both blocks on either side oftlili's statement
6. Year inWhich ,patientstor:>ped/started'smOking
Questions 80, 85 and 88
Wh~n eht,~f:in;g the, y.~ariD. whic~,the:·Pélti,ent<stQp'pe:C1jf~t~rt~.El smokl ng
be Sl:fre,t() enter fh,e,'ftjILYear, 'For:e*amph:!,'ifctliê P:êti.ent r~porjt'sJhat
he/She stopped.Sm'oláng §yearsaQ.0, enter "1~98"_ Do notenter "5".
7. Reasc:)nfor Y-is'it·to this clinic and ,c:)therhealth care providers
Questions (92&93), (202 & 203).,(206 &207),210& 211), (214 &
2'1$), (218 & 219), (2,22&223), (229 & 227), (230 & 231), (267 & 268),
(308 & 309), (349 & 350); (39b & 391), (431 &432).
When s,pecifyin~ the other reason for attenëancetothis clinic (tOqa¥ or
for any oftMe visits in-the I,ast 3 moths) or other health care. provider:s
(any v,isit.in tb~ tat 3months)', rer;T1e'rrï,b~tro r~c.:::Q~~dI:)er$~son in
ËngJish. Probe the',patient.sothat you rec0rdcsfi)eGific data. Reasons
like. "SpeeialT'reátment", "@thertteafment" are not specific ana require
further clarification.
R:~member that you may recqrd more than one reason for any visit
Ch~e.ckaU the options that apr:>ly,
8. "Other" J'r!QéHpéitjQn:
Questioms4al - 1'9'0
The "Other;' tvledk:atieo oril;)' applies40 the: "other' medications in your
visual 'aid. If tile Pêti~nthas recEiivea medicatlon depicted in the "Other
Meatcation" se.cti()A 0fthe vi~l'J~1ai,dyeu'm!-lst.gnswer yes., and .mark
the medicationsdn th,e'r:T;1,tilti'"s,electlist~check all options that élPply). If
the p~tiérïrhas.n~ttéc~!véÉ1 "Ott;J$r" medi,catiQns depicted in the visual
aid, butbas,reG~ived qjfhe;r,rri~qip.~tióri (Le, mêd,icatipn'whiéh is not
dEmiCfed in, the visuakaiCl), indicate<ne. Remember we are only
intérestea in certain meCjic~ti()r1s used for patients with respiratory
eroblems. '
9. Antibiotics
Questions NO - 186
Know your antibiotics well. DU(ing ,editing. I notic.:::ed·thatélPêltient
receiving Ar:noxicillin was deeurnenteë as receiving Fluëloxa9illin and
that some antibietics ha,a been written on the "Ofher:Medicatior;." page
but not eompleted en the "Antibiotic"'page. If you are unsure, open the
A198
packet the patient has received, élmGliook at the actual capsulesltablets
so that you can eomsarethese Wittl'the photos in the visual aid.
10. Visits to this clinic in the last 3'·months
Qu~stions 1§~ ..231' . . .. '..
. . . ,.
In this seotien. it:firstasks.you,to,er;itêr'lhle'd.~ta,ils of the patient's visits
for "PfBtreatrnent(:Whe.f:I;.did. YQU ~t~ri~~~;,lrft~tment, How often do you
attend for TB treatment etë ...l Th$têfbre you must not record TB visits
in the space for. recording the 8 \tisitstc>: this clif\lic: in the last 3 months
b~causewewilJ end up·dp,!Jbl~-'S<:ll;!ritifl'g·thv~li3i.ts'for' TB medieatien,
Also, patië.r<l'ts a.ftemd.rê9,uJa)iIYJO(TB.tl)edigatiGtt and you will fun out of
SPace",for fecQr~iil1lgfbéS'é'·Mis!ts·as\we ilave (:)ól¥ provided space for you
to record 8 viSitstdthis dlihic in the last3 months.
11. Tran$"pprt and usual companten to thls clinic
, Questions 232 - 262
You must complete these questions whether the patient has been to
the clinic ln the lasL3 months or not. Remember that the patient is at
the din.ic,0nthe ~ay of-the inte.rv.iew.,so we want to kn<1>whow the
pafiërittvavelléC:f Jh~re··a.nq .wh&th.êr ~óyotlé acc"OrrU:iiatlié.d.him/hér.
12.Thn~j,uria~l~tq.vv,(),;k:f~r,~,of11J)~mi.p.f:l
Q. ;.uëstions 2'58, 29~, 340, >'.'3'81,42,:2,463'
Dutill'9 the fir$Uew days oteditih'g I Aqticed that some patients 'had
res.P'(i)hdeclt~hat their cGpnpaniqr.1sh.a~t.ll'issed lijP to 2 days of work even
thoW.@h·tt;,tveisit.*otlilfJ'cl.irHclot~'~F~I)rf.~'p,:I~f~d;]asletesds than. 1 day, .0.17
even l~sstha,n.2hp·tJrs. 'I:n ~~~~;;~:$'g~,plë!=iisepr:qbe the patient and/or
companion if ava'ilaJiilete.en$ll!r~:,tt;iat,this inforrnédien is-correct e,g.
"Are y(ju surelh~tiYou rilisSE3Pi;4,:d~y$dfwoi:k?Tfue visit only lasted a
few hours?" lReffiTIerribertb,reGoi:d orilydaysofactual work missed.
Days.of leave a'o nm cé,unt.
Here I A0ticedtrna,lsome patients were responaing that they had lost
mone,y imthe la,st·3 mont.tiisas a'resultof nOt being able to work, even
though they had answered thaHhey were unemployed, and had not
lost ajotD.ln the last year. If you do get such answers, make sure you
probe carefully to establish what is really'going on in terms if their
employment.
A199
4. PDA: UPLOADING AND COMMON PROBLEMS
PDA: HOW TO UPLOAD
1. Insert fully-charged rechargeable batteries (orange and green penlight
batteries) into back of modem.
NB: The modem has no means of showing you how full the batteries
are, so ensure that you fit fully charged batteries before you upload.
This will entail charging your batteries overnight. The re-charger will
indicate when the batteries are fully charged (re-charger light will go
green).
2. Take telephone line and insert jack into modem ensuring that you hear
it "click" in.
3: Insert other end of telephone line into wall jack once you have
disconnected phone. Again ensure that you hear this "click" in. Do not
insert the jack into the telephone itself.
4. Insert PDA into modem so that the screen is facing you. Again ensure
that you hear it "click" in.
5. Go to home page and select HotSync icon in centre of screen.
A200
6. PDA will now display HotSync screen. Ensure that the "modem" button
and not the "local" button is selected. When selected it will display a
dark background and a telephone will appear on the HotSync icon.
7. Ensure that Palm Modem is selected. This is displayed immediately
below the HotSync icon and next to a drop-down arrow. The toll-free
number appears below this.
8. To upload your completed interviews click on the Hot Sync button
located on the bottom section of the modem (not the PDA) in the
centre. Alternatively you may click on the HotSync icon on the PDA
screen itself.
A201
9. The PDA screen will display the screen below while uploading your
data to Cape Town. The average upload takes less than 1 minute for 5
completed questionnaires.
10. Do not press "Cancel" while the PDA is uploading.
11. When the PDA has finished uploading it will display the HotSync
Screen again.
12. Press on the 2 buttons on either side of the modem to release the
PDA from the modem.
PDA PROBLEM 1: DIGITIZER (CALIBRATION)
This occurs when the touch pad of the PDA screen and the display are out
of alignment. The result is that the PDA will not select the button you have
touched with the stylus.
This can be corrected by resetting the Digitizer. This must be checked
before starting an interview. If correct at the start, you will have no.
problems during the interview. Remember the PDA buttons should
respond to light pressure. If you having to press too hard, you may need
to reset the Digitizer.
A202
PDA will now display Preferences screen.
A203
2. To activate the digitizer select the drop down menu located in the top
right hand corner (by clicking on the drop-down arrow) and select the
Digitizer menu item from the menu
3. The PDA will now display the digitizer screen
4. To complete this operation tap the middle of the target with the stylus.
Continue doing this until the target disappears. You will need to do this
3 times (once in the top right of the screen, once in the bottom left of
the screen and lastly in the centre of the screen). Once finished the
Preferences screen will be displayed.
A204
5. To return to the Home page press on home.
PDA PROBLEM 2: LOST CURSOR
Whenever you need to enter data (numbers, word etc) you need to make
sure you can see the cursor. If you cannot see the cursor you have "lost"
your cursor. The PDA will not allow you to enter data unless you recover
the cursor. Below is an example of a screen where the cursor has been
lost.
1. Reactivate the cursor by touching that part of the screen where you
would usually see the entered data being displayed (see arrow on
screen below).
2. The cursor will re-appear and you can then proceed to enter data. It will
not re-appear if you touch the Graffitti pad.
A20S
Tap stylus here
to re-locate
cursor
Do not tap
stylus here
PDA PROBLEM 3: SCREEN BACKLIGHT
1. The PDA can display the screen with and without a back-light. The
back-light lights up the screen but uses a lot of power, meaning that
you may run out of power in the middle of an interview and risk losing
data.
2. You must ensure that the back-light remains off when interviewing.
3. You can switch the back-light on and off by holding down the power
button for 2 seconds.
A206
2. Click on the drop-down arrow next to "General" in the top right hand
corner. A drop-down list will be displayed. Select "Date & Time".
3. The PDA will display the Date and Time screen as below:
4. Select the time by clicking on the actual time displayed. The PDA will
then display the time screen as below:
5. Change the time by selecting on the hour button and using the arrow to
increase or decrease until you reach the desired hour. Then click on
A208
PDA PROBLEM 4: SETTING THE DATE AND TIME
You can set the date and time on your PDA. This means that the correct date
will automatically be displayed when recording the date of interview.
1. Go to the PDA page and select the "Prefs" icon.
2. PDA will now display Preferences screen.
A207
each minute button and increase/decrease until you reach the desired
minute display. Ensure that the AM/PM button is correctly selected.
6. Then click on OK. The PDA will return you to the Date and Time
screen displaying your new settings.
7. Select the Date by clicking on the actual date displayed on the Date
and Time screen. The PDA will then display the date screen as below:
8. Change the year by selecting the arrow buttons on either side of the
year. The left arrow button will decrease the year and the right arrow
button will increase the year. Do this until you have reached the desired
year.
9. Change the month by selecting the desired month.
10. Change the day by selecting the desired day. Once you have selected
the desired day, the PDA will return to you to the Preferences page.
11.Click on home to return to the home page.
A209
4. SCHEDULE FOR UPLO.ADING
We are in the process ofs~ttiï:lg up:a!:i~~~r;at~ totl-free line for each team so
that each team has ac;ce~'$Jotbe~nr'1.~:i~V;ánytime and can upload data
without encountering an ef).gag)~Glf($;t§Jjiálf1hese lines will be up and running
by mid June. . ".
. .
In the irlterirm'We ..h.~ve2.lineS.~hicf:l'hWiU:~~~:i$]fuê~~~~j~~¥.j.6\X4rena~ms,. In order
to avoid encouA~erj"r;lg,an' er;lgag~cd,sign ':. "..'.·.'~~fllJ~.~~Jhle.scAe.qulfeor
uploading be'low, .The nUlll)1b,19ryoun'eed;' .·\id'i~'I;;:i.$:;~t.io~e~'d~,!i)rreIÓaodnetdoyour PDA. If you do en€ouhter an !3Á~~·g.~ds'i!ll~$f;'try. upJoad a little later.
Team ..'
tP.FT1- 3pm
4pm-4pm
Team
Parys (@ OSiZWeni Clinic;)
Bethle.hem (@ Mar~kong CliniC')
A210
ANNEX16
Follow-up training manual
A211
J'~11fF:~~;E:s~~mi',
LUlM:$: H1EALTH S~IiliJ,!It<:Vlm:Y
Follow-up Ques:tionnaire
Fiel:dw,o:a'!k"Mêi'llua,1
Univ~r$;ify ef C(l,p,~TáWrl LJjng InstittJte
1DE!;f1)álftm'e'nt of QpmiTt:l4nity,He.~U~hl,Hiiv~r$:itY of the Free State
C:enffef()f Health Services Res.eareh and:Deve,lopl11ent,
University Qt the Free State
Medical Res,ea'rchCO.uncil
JUly 2003
A212
CONTIENTS
1. General Comments on fieldwork completed to date 3
2. Common paA problems and hoW to solve them 5
3. Who'mustbe·'inte.rvi'ewed at'f()ilow-up? ...•~ ~ 7
4. Re..inler:v.iéw1n.g and qua'Ïity control ~ 0 8
5. C:ommon q.Qestionnaire errors ;............•..................... 0 9
6. The ·Work S.tud,y: , ~..t1
7. The·Foll()w~!JP ·Questio.nnaire explaine:d., 1'6
lotêl"'ii.eWêt e:o'de$.~.....•..... ~ ; 17
Path~l;l,t,G).eta'ils·" , o 0 0 0 0 0 ••• 0 17
Tran~itioi<l AS$êSSnléf1t ~.~ 19
S:·ymptóm Sev,erity ,in,th.eJast month ~20
Heallh· ,r:.êla,t~dql!J~l'i.fy:of:tife, , " 21
V,isit$: b~ë.!k<to,t1ïi~;<?I!h,it.nc ·th~i'~~t·3'rn9nth$ 24
Care;"r.êcêivé:d,:at·,this,;ciIn'i:ë.in the~I~st 3 rnO:Ij~hs 29
$linpl<_i'(i'g· '," ••........: ~" ." 0 .••• : •••.•• " , 33
Tra::Vêlt~:ttiiscliliiG,ltftijel'~$t;.~ 'ro~n~ms, , ; , 35
Pa:tients·Who have not.been ba'ek te this clinic in the: last 3 months
• i.o- ••••• ,'~ •• a, ,.-.: •• ,••..•.• I,' '••.• ,•• ~.' ••.•••••.•••••• ' :•••••••••••••••. 1. li." ~ 3'5
Medi'eatio.n ~ , 36
Vi$;it,$'to"otl:i~r''h:~a:ltlrkc,arep.rov.id~rs in the lasf3 months .42
Cate:siver ·(i;.os:tSin ttl~ I~$.t.3.mori,th's. ~ ;,; 43
Ec,Qllomic Impact:'of<iUness ...•....... , ~ .44
HIV , '.'~ , ' 45
Patient satisfactian with servlees proVidêd at the clinic 4'5
8. The Follow-up Qwestionnaire (Eng,li$h vérsi'<;m) 48
A213
GENERAil COMMiENTS GN FIELDW;ORiK COMPLETED
T0 DATE
On the whole, the fieldWork already completed has been of a high quality and
no group has recruited ,less than the 50 patients per clinic. Well done!
The Data. CapJUFi9fSa;tthe MRC are itT,lpres§~~wiitl;)'t~'~"G.~l'T1pletenessand
quality of the paper quesfiennaires. ~ver:y:.'~if;1glel¥~;« fnterviewwhich has
been completed has been successfUlly LJPlbadedte .~'a",e Town.
There are ortly-a few-comments I would lil<eto make.
DURATiION OFlN1fERVIÉW
There are 2 factors Which play a role: in prolonging an interview (other than a
long questionnaire to start offwith!). The firsf.factor is related tointerview.er
delays caused by wtitingdowri information, following'skip instructions, writing
in iGlentifyil)gfeatures(initials etc.) at·thetop 0f.each,pageetc. Thesedelays
haMe:lárg,ely b~eh min,ill'iit~d; by'tbe Ul;~ ofJtJe PQA Th.ls means that the
interviewers are nbw extremely effitient. Th'e advantages, bfthe pbA system
are tl<iat it allows you to f0.el.l§'YQur'(ê3~etiti()r.lonthe Patiêl1t'eand not, a.paper
q~estiOr:lnait~) ar:ip preve,nl$,thë,p,i;jtienti.s:'attentionfrotnWi:lnc!ering While you
are writing or following skip instructlons.
The second factor contributing to the duration of an interview are patient
delays. These eccurbecausé-manz ~li'sually most) questions require the
patiehttb refli:ict bn pastst~tes (;t"héá'ltl'i, vis'.its to th.eGlinic or other health
care J:)fovider.s, dur,atitm of.sYmptorn~d9tê·. "Ehis "thinking" can be visualized as
a sort ofTRteH~ctual gyrnnasfi~s ar:lp,;t~k~~ tim~. YQ.u cannot speed this
process uP' 1:>.¥~beir1a,ng 'efflil:ient int~,rvl$,wer. A gqo(;/i(ltewiéwer slows this
process db,Wn.~i\iing ·the pati~ntefloughtime to consider the questions
being asked arid, how to responq. '
My concern is that the efficiency oftM PDAtempts interviewers to rush
patients through the interview, pr~ventillg.them from having time to consider
questions .and responses. Remember that patients may feel intimidated by
the technqlogy and yoUr sPeed on it, ~n,Q,feel. pushed tq respond prematurely
to 'q.l:Ie$tibA,S".Iris up to'you te> creaté the~sensethêWou have .all day to
intervieW me P!3tient, and.'ihaty,o~ qre;r,~CI,lIyjnteres.te(jl:iowhat they 'have-to
say. Ger.itlePtbbing ("Ar~yotlstlrer?~, "Db Yóu need timétothihl< about it")
slows down the pace ofthe interview.
The, baseline and follow"up interview should take ao less th,an30 minutes. If
you do take less thanthts, you need to 'reconsider your interviewing style and
whether the patient was not being rushed.
The. tem,ptátion to ru~h throughlhé que$tionlJ,;;'ire wil,l be greé!t d:uring the
follow-up, p~;r-tlyI;>~q,a\'ls~th' ere Willl;ié a qu~,lilf¥:'Qfp~tiem~ Wa,iti,l1I.tgo, be
inteNiewed by 'you, {since the patients'v.iiii:rriostly,·'be-comimg I;)a'ek:tottre clinic
only to s,eeyou) élnd l'1artly because-the' patientwilFbe familiarwith most of the
questions. Be very conscious abouttakl'ng timete ihterview.
A214
MONDAY READINESS
The fieldwork has many logistical considerations which need to be sorted out
before Monday morning and the start or fieldwork in a new (or in the case of
follow-up, old) clinic.
A disproportionate n,uITtlberofinterviews complete(jholilJi),~fPeTarecGnducted
on Monday,s tlll:am.al?y'0~herdayof tAewe~k, :R~P,l:~,~iGl~e,§ti(Di'ilnaires·ifl~ur
many costs (addill<)fliil:'eEJitingt,ransp0rtba,ck~t0;ë.ap~.'itb'lv,r;:id',~{!3camuring
etc.) which c0uld'háve been avoided with thé PDA. Gommon· excuses for
completihg interviews brl.'paper are:
1. Le,!3vingP0,A.~;~th0Fhe.
2. HA'PIbein~'erased off the PDA (See P[)A problems)
3. PlJAs i10tbeing cbé:u;ged.
Please ensuretbatyourPDAswill be arthe clinic onthe Monday (even if
another member clthe Team has t~kenthem hoiT1$Jorup,loading), thatthey
have been charged anCiLthatyou carry the power lead and extension set with
you (so thatyol,l, canchafQ.e them at.the clinic: if necessary).
GOo.D CLINICS AND SAD CLlNIOS
Many (Myouha.'Ve remarked' on.the servicesavailabie-at-tae clinics used for
fieldwork.,.especially if they haV:e;beenpeer.
It can beverytempting to become:Jrvvolvedin.a debate-with clinic staff about
poor ql,Jality.,s~tiiices>ê$pe~iallywheny,o.ubave been exposed to different
levels .Qfsérvites ,atdirfereJit clinics, Vou must resist this. Remember you are
there-to observe and document.
Ifnursing staff become aware thaiyouare uaimpressed with the services
previded at the clinic, you risk being treated as hostile and you risk changing
the regular practices of the clinic for thefdtiration of your fieldwork.
Remember that you are there to capJure theclinlc's usual practice, no matter
how go,odor how bad. Retaining the. status of.an objective observer improves
the validity of your observations and ultitnate,ly.their ability. to change practices
in the future.
A215
COMMON P:IDA PR€>:Ia.Tt.EH'MESM .AND HOW 1'0 S~OLVE
Most of these were inCluded in Part 2 of the Baseline Training Manual
distributed in the. firs:tweek oUieldwork. Subsequently a few problems have
been raised. Thisare be covered here,
t. LOSING HAPI
Sev~ral.Jiel~V\f,0rkEarshave hé!cLthe urif()rtunat~ e)(p>~riE:lD~beJ having HAPI
erasedfrom theirPDAs. This can be caused by2 prOblems.
The first is that the PDAhas' been, stbred'withafl~tbattêW, S'eme power
is required to prevent the programmes loaded ,dr:itp tt.ié I?J:DAJr:om being
erased, Aftér approximé!tely one week a P:IDA with ad'Ját: fuattery will erase
the prO£lrai:nrnes (including, any compieted interviews whiGh have not yet
been uploaded). Please ensurethat.the PDA is stored fully charged.
The second reasen is thc;JOhe,res:etbuttQO has been. iriGlqVerlentJypi,;lshed.
Thé resefbutton is a very ;stnall bQttqA rêcessed bh the: back ofthé !?DA.
Ycu need 10 .stick' a .pencil or sharp' object int0 it to push it Pl;Jshing the
reset button wipes Qut any programmes (inCluding any cempleted
interviews whiCh have not yef been uploaded); Children are often tempted
to.·push. sh,arp objects into tiny holes and sa mus! not be allowed to play
with your' PIDA.
,SO~,bóW.'do{you:a.V;()iCJWAPJfj:óitt'b,é'iflq"e'aseiJ,'frorn :\fOl1f'PDA?
Never push your reset button,
Never give your PDA to someone 'else to. play with.
U,pload as qften as possible so that if your battery does run out and erase
H~PI, you have not lost-any completed interviews.
Store your PDA charged.
Dqn't store 'your PDA! (lJse the iélddress beck, the diary ete fer yeur own
personal use)
Infor-m the MRG as .sopn 'as YOu detect that HAPI has been deleted from
yeur PDA Monday merning atthe clinic is too late!
2. UPLOADING:PROM A TELKoM PRE~PAIDPHONE
Some fie.ldv(e»fKers,hél,ve enoount~.re.d d,ifficulties when uploacjing, from a
pre-paid Telkom 'phone.
This is because the palm requires-a completely "open" line and the prepaid
system requires that you enter a pin number after dialing the phone
number.
This "pin" system can be disabled by completing the following steps:
A216
1. FromtheTelkom-pre-paid telephone, dial *#55
2~Press 3 for Personal Options
3. Fellowthe voice prompts to disable the pin cede.
A217
Everyone )Mho was interviewed at baseline! MQst of you have asked
the patients to return to the clinic for the follOw..,upinterview. If a patient
does not return to the clinic it is your re,$pon$ibiliWto trace, the patient (to
their home if necessary) during the week O:f'fol{q.w."'qp>fiélc:lWork.
There r:Til~ybé. §'OJlB~"R~tightswt:l0·.ha:y,~.i~,'~·jlW,::' g:;ft;W~;~l ,rTil<i'nth. interval
betwe~n··i,rlte:l'Xii~W..~"t'i~' .y.,0tJr rt~$@<:)F!sfbiIJit&l,t.~~"~,.<L~~tJ(t:~êiiM.Lea€ler
(and the, team bt?Glderthe $tJpervis~r) dl,a,9.¥':i§W~!?i,'Q~~:e.~.,Viou must try
and Glscerttaiii'Wh?rj,~i:1d wh,ére t~e pi:itie:n:t.êtJ~~:·:ff:~jii]i:t~~'t~rGlt!vesb, that
hospital recordstcan be reviewed iA erderte déte'rmi'nethe cause of death.
NB: P~f~~I1!$. Who: are interviewed at ..tbe q!iHic mli!st only be
interviewe,CJ AF1?JiR any conSlil!t~ti9:n (or ~pp:(Jfntrrleiit tó collect
mediêa,tifj)ti) wni"ch has beer; sC;hêt.iluled to.,.' thê same day as the
fbllow ..up ihterview.
The follêW-Up interview aims to €aptl.lre all healtheare events durin§lhe 3
month interval betWeen interviews. Thi,s inclades the day of the follow-up
interviéw right up un.til th~ start of the interview. Patients may also be
schedered fer fOllow-up care at the clinic on the day of the follow-up
intery,iew, Please ensure tmat yC>.ui'rlt~rwi~w these patients after their
corl~ult~tiÓIÏ' áma d<(p:QQA:ï,~@t tfje,det~.iIS ot tni~ vi$it (aha any medi,catibn
prescribed ± pafient satisfádion~with the consultation)"
A218
RE·4NTERVtEWlNG AND QUALITY CQ'NTROL
This section is included to remind you of the re-interview,ing process which,
together with ecHting,comprise the quality control measures designed to
ensure consistently high quality data.
20% of all patients should be re-intel"llieW~d~s$ul'lJi.mg..thc:ittAe.average
fieldworker intewiews' appJoxirnately $ipatLër:,tsp',eri;I~~:Y,I~fj't!;1edAterviewer
interviews more than this nulTibêr, tne'r;:ïl:JJr\!i>er,(:)f'p!:iti,$rrei!-tiSnterviewed rises
accordingly. '
The questions'te b~,,~sed-:fc:>:rre'Yiht!$)¥I~Y\titJgi'árre'ip.)'$7q~~$rrnir;reds;ataHrtheo,f
every newIT:l0:rlth;:offi~!owoF~,aI11P;idi.stfii):liit!idztQ;Jfu$;'$~~~b;ii,$lt.~ils'isth·;e
reSp0f1sil?ility"ol'fmé,t~alTi Lê'?id~rlO'1ê'h§.~:i(M~ :)~tttl~yH~vê;'S11!T]fl'Gicéoj;pjties of
the new re-interviewing questions before starting ,any new fieldwork.
Please bear 'in mind that differ-ent-questions will 'be' used for baseline and
follow-up questioanaires .and that some teams will complete both baseline and
follow-up iriter.views during.the, same month. Team Leaders mustplease
ensure that they have copies of the, re'-interviewing €Iuestions for both baseline
and fQlloW-up ihterViews.
The re",iMt~rv,iewin.g;,r;e,spoose~:I11l!)st:pe"c()rnapareg'wthiteAoriginal,Je.~ponses
arid any (ji$,~r:~P.:êACied,.Si$:élfjs:s:~Wd itt'rtlir~,rële¥a,nt iritetv,iewer. This preeess
offeedback is meéinfto serve-as a:rneams,for.discussimQ},thequestionnaire
anEl,waYS to, irnprbvecthe réliabiiitY of,resp,c:ms.es(allowin9 patients more time
to cOl1sidei'their fes.ponsé§ï rrlorê tnoJo!,:lgA pFobing etc.). The feedback
pr;ocess<shoUIQ~'n()t:bec;d:elayed;so,thattheinterviewer and Team Leader forget
the details ofthe @~ti$f1tiriterv.iëWed.
In the case of p,aper'q;uestionnaires, re-interviewinq feedback can be
completed on the s.amecday,
In the case (jf PUA interviews, the original responses will be sent back to each
team via the supervisor at the end of the week of fieldwork. It is the
responsit.:>ilityofthe team Leader to ask the .superviser for these original
responses.
What:db~\W.ë,'idb,df..;tl:ie4)atiént;qa\ié2th.(MnterViewe"éind:tlle. learn Lea,der
e/lfferentJiitiswets;;to,'iHe:sarné':qiJê-stl.6ii?
Manyq,uestions' have.whatweeall-a Ipw test-retest reliability. This is
because, on reflectien, the patient may have revised his/her answer (~.g.
durattsn ofsymptoms). The Team Leader should explore discrepant answers
with the ihtérviE;wet, blJtbe'awa~e thatsemetimes the patients may really
have gi:ven them' differeAt answers.
Questions about dearly defined facts Oike date ofpirth, level' of education ete)
have a hi§h test-retest reliaBility and should not differ.
A219
Taking armpit (axill~ry) not-erel (mol;Jth:}Jemperatures.
Recent intakeof a cold beverage.
Loose fit of the thermometer under the tongue.
Not waiting for the thermometer to complete the reading(taking it out of the
mouth befóreyou heara "bleep" !;;o.!,md).
If y0U.do encounter a S!!l~nQrrliiê!F~~mp.:ê~a.t:u.t~N::ilea.$·é,:F$f.t¥itl'pkF.~.~fera~ly with
a second ·tl:l~rrnofTléter. If;pér;!5i§te~(I~·,i(j~YQm':m·~Y;~l'1te[·tnë:,$ul:hnormal
reading. .
Questions whieh ask about similar "thingslJ (paper -and-PVA)
Some. of the"questiqns in the intervieW seem very simnar. This is deliberate
and desiqned.to testthe lo·g.icof the-respenses (er-whatwe refer to:as
"internal consistency").
Logical responses can be improved' by rernemb.ering lDa.tie.nfs'lDteVious
responses, (Q.4i1dY: I>a· viSq:a:p1iCftJte,Pf:ttl:e:pa.tient.?!1~their he,álth in your miMd
as you interview) and probing when faced with inconsistent reeponses.
For example if a,~atient reports that. he his chest problem has interfered with
his usual actiMities.Jrr,the;last-month (Symptom S.everity in the last month), you
wqulq .e,*péê,tJ~~J;,~~·WouIQi;fep,Rtl;;,~f91ïi'em$,wit.hu.shui~a.l ~ctivitiesduring'the
health#el'ate~tq!Jality.óf;lifeJFl·.theJa~t,rilo'nth.secti0n. l.fhe.dGesn'Jitis'yOiJr
resPQhsi_i:)iliW·to,p>:toa.lnDdé'a$'kwhy nQt/sihêe,ine has"8'lfeadytold you that he
has had prOQIï;lms,
This r:eq'ui'resthatth$ in{erviêllVer be very f~miliarwith the questionnaire in
order to identify inconsistentresponses and investigate.
Reasons foratten.dance (clil1ic.and oth~r Hep visUs) (paper .and PDA
versions)
If you choose to enter the patient's reasen foratténdance under the "other"
0ptic),!1p, lease>provid.e specific informatien.
See' instructions under the. "Follow-up Questionnaire Explained" for further
details (Pé3ge27).
Employment Status
You' may on ly cheese one option to desctroibe the employment status ofGQh1p~niën$to this clinic" c0rnpc;mic>rlsc oth~tHPRs, cate~~iversand the
patient him/herself. Many fi.eldworke,rshave éhe,ck~:m0re tAan .Or-leoption.
Choose the option that best fits tbe-patient's description ofthéir employment
status, and which has the greatest potential to be affected by illness or by
accompanying a patient to a health care provider.
A221
C.O'MM.QN'fMISj1[~;~ES:·MA£;)(:IN TH:(:'.BAS'JElINE
QUE'STIONNArRE
These are included here because there are many similarities between the
baseline and follow-up questionnaires.
Identifying features written at the t9pofpages (p~p'ervetsion.only)
Please ensure thát.the.patient's initials, date ofintervi~W; di'Mic'and
interviewer cede are clê~Fly'entered at.the.top ofëac~ !?l:ig,t?,oft~epaper
questionnaire. B~' sure, to write the ,full name .Qf-theclirriieáS;;SQFi1e"Clinics
(Botshabels B, U & S, J fOf example can be:easily corifuse iiL)
Patient 'initials. (paper version onl}')
Initials often dornittally with .the patients' first,and last narnes or only one letter
has been filled iri.
Initials = the'fir$t letter ofth,e p~tienfs,firstlCh<ristian name +
firstletter of'thepatient's last.nameïsurnarne.
For example my name is l.ara Pairatl. My initials are L.F. Please ensure that
these ar:e corre,ctly fined in as they are used to reconcile any pages which may
become separated.
InterviewerCodes,;(papJmand PipA J(ef"$io.ns)
These ár~ often ·fined in ihcorrectly especially on the PDAwhere we rely on
the code, to identity the clinic where the ,patient was reer,uited.
Instructions for filling in the interviewer code are repeated in this manual.
Please enter the 2 digit clinic code first, then your 2 digit interviewer code.
Foldêrnambef"$.;(paper andPDA·Yér$ionS)·
Despite (hefátt that,marny elinies-have dIsorganized systems-tor filing, usually
a. unique identifying number apPl3ari:1)Qnthê,fblder. Plea~e attempt to locate
this number and r~c0rd it, ever) if it means discussing the clinic's system with
the clinic clerk. at the start of every weeK.
Some teams have resorted to entering dates of birth, Please investigate
whether,unique folder numbers den'texist.and record-them instead. If not,
date's Of birth can be used.
Folder nurnberswill.be reqLiiredJor linking sputum results with interview
responses so please make an effort to. record them correctly.
Temperatures (paper.and PDA versións)
Many fieldwo[kers have reported subnormaltemperatures for patients. All
tetnperatuH::ii; below 36 degrees Celsius mustoe eonsidsred subnormal,
Common reasor:J$JOr subnormal temperatures include':
A220
For example a part-time student may also be looking for work. However, days
of coltege missed (as opposed to days looking for work) constitute the greater
loss incurred by accompanying a sick relative to a health care provider.
Whendo companions, ~ar~givers and patients miss wor.klschoolllooking
for work? (p~perand PB'Aversio.ns)
Many interviewers are fa.<3edwith long- complex stories of GCZlr:t1panions,
careqivers ete who wPI'k',part-time and aceompaAythep<3tient'tb the cliAic or
look after the p(:ltiérilté3thome. IHh'e cqrnpariiónlëáregiyer·aC1t1a'Uy.missed
planned W0JR</sCho0lltlrnespent looking for work because, of accompanying
the patient.to the cfinic or looking.afterthe patient at home then this should be
counted as days of wGflsischopl/rooking·for work:Q1i,sse.q.
If a companionltaregiverWor.ks or sfua,ies part-time and used free time to,
aceempany the patient or look after tl1ém át.hotne (but.does notmissany of
their planned activities) itshould not be counted as time missed. For.exarnpie
a companion who casuals. én ei Monday a'ndWednesday but áccompanies the
patient to the clinic on a Tuesday dees not-miss any work. Should the patient
fall ill unexpectedly ona Tuesdc;lyandthe .s. ame companlen.accempany the
patient tbAne .CIin:i(f:e; ran eni'ergencyvisit, then the companion mustoe
documented as missing work.' .
Car:egivers(paper andPDAversions)
Many fiel(:iW0fkers have documented thatthe patients interviewed have
earegivers, Be.sarets-estebflsn'thattheeareqiver is look:ing after the patient
at home because of poor health and not for any other reason
A222
THE WORK STUDY
lntroductien
The major cost of caring for respiratory patients at primary .care level is the
staff time they consum~ and the medication.theY·GIi'epr~l)crib.ed. The cost of
the medication is being captured by the-basenne an(jff611(!)w~up
questionnaires. The work study captures the staff time consumed by
respiratory patients,
A work st\:J(:!yis an'óbserv;3tiónal stqdy in whic;:hth~time ré~uired to eernplete
a specific task (in our case a eonsuliatlon] is measured.
The L,ungH~alth SlJr\I~y Work Stucly wiH be cpmp,l~t(a(jd)¥.the T13am Leader. It
entails beirrg stationed o,titside a n,ur$~'{nptdoct(jrY:com;(J/tatioi'FI;C)O",and
briefly inter./i'ewing patients before they are seer, b.yth~ nurse '(to est~blish
whether they have a respiratory problem or not) and then noting the time they
enter; and exitthe consultation room,
This will be carried out durihg 2·:sess/on$' en specified days.
On what days. do I.coinplete:aworkstudvs'ession?
The "rhythm" of .cliniclite is known to. vary during the. week (for example
Mondays are wsualiy,"always busler th<ilI7lFrid~ys)and for this reason each
clinië has be,erTrandoiftWallocate,(J;2 week days on which a work study
sessien must be complet~'(L
Th~$e,d~y,s h~ve 'b;e~nsp,~éified fi:)t ~atih clinic andtne:wQrk stlJdy must not
be'completed on other d~ys because of convenience. Please find belowthe
days, on which the work study must be cor.npleted for each 'clinic:
CLlNIGNAME LGCATION Day 1 of Day2 of
WorK S:U.Jdy Work St,u<;ly
Alb~rt LClthuliClinic WesselSbron Tuesday Wednesqay
FridaY
Betl;\lel:l'er:n Clinic Wedl'lesciay Thursday
130hlokQngCiin'ic Frioay
l3oithus:Qr'l§ Th.lJrSday
8QPheloriQ Clinic Monday i=ridav
8ophéIQng;C}inic Thursday
B6tháviHe' Tuesday Wednesday
aot~hab~r9;;8,.Clihic Tuesdáv
8Q{shabe.I\}J'Clinic a,btshabelo Wedl'lesday Thursday
8otsháti)'elo Wë.dne.sdáy Thursday
Hill $treêWClinic' Weonesday Thursday
:aofhaville
Kho:tal~nQ CIi,bic Virginia
KOppies (Kgé1!1ya) Clinic Koppies Monday Tuesday
Ma;;l'-laig,Qlinic QwaQWa l.Ne-clnesday
MoncláY Tuesday
Matlakeng Clinic Zastron Thursday Friday
A223
How IongAs one,;work.studV;::seSsion:?
One '!;)~~$ibn'r:nu$t:l~st ~til~~$ti;¥ip''Q,qtscor.a:.maximLimof 50 patients seen.
UsuaUyJhis corresponds WeU ""ith~t;l rnoming or áftemoori session of
cons.u,ltatidns.
Whafdo Jlellthe'nui:se.?
You Will.beistafib.Red outside a nurse's eensultation.roern and so must ask the
pei1nissien ofthe nurse to.,thne hér consultations. It is Cldifficult task to put
the nurse atease .and.make her feel-thatshe is not being examined, Try
sornethinq like the following:
"Hello. I am .. , ... " fmmthe. Univers'ity o.fthe Free State. We are interviewing
respiratory patients we reeruited at-this ólinic 3 mqnths aqo. As part of the
folloWHJp fieldwork IwoUld lik:e-to time yeur consultations today to see how
much efyeur time rerspiratory patierit~ take as opposeqto non-respiratory
patients .. The timing wHI not interfere' with your usual clinic.al practice in any
way, I will stafion myself outside yO.ur room and ask each patient you see a
few quesJions befqre they ~htér.your room. twill also notethe 'time they enter
and leave your room,"
WhodoJ, interview?
Ever:y.onel Old.and young. Respiratory and non-respiratory, The questions
used for-the work study are slmllarto those ws'eo for inclusion in the main
study, although you will net.be required to select out patients or consent these
patients,
A224
It is not good practice to demonstrate a bias (preference) towards some
patients directly outside the nurse's consultation room (by only recording the
time in and out of those patients who would have qualified for the main
survey). For this reason please ask all patients waiting outside the nurse's
room the questions and note the time they enter and leave the room.
This will mean asking some children the questions. But be sensible, don't
choose to station yourself outside the room of a nurse only seeing children
that day. We are primarily interested in adult patients.
What do I ask the patient?
The same questions used to decide on whether a patient was suitable for
inclusion in the main survey. These have been included in a new
questionnaire (on PDA and paper) for the work study.
Note that you do not need to record the patient's name. Please ensure
patients that this information cannot be identified as belonging to them in any
way .:
The questions are shown below. You will note that you can skip the difficult
breathing last 6 months question (question 4) if the patient reports difficult
breathing today.
Also, you can skip the cough duration and recurrent cough questions
(questions 6 and 7) if the patient does not have a cough today. Please take
the respiratory rate and temperature of all patients.
A225
Do I needtocon$.ent these patitmts?
No, but you ~hOlJld ask for verbal permission to ask them ~aféW questions and
take their vitalsigns (!11ulseand temperature --:remember we "mask" the
respiratory rate by telling the patientwe are taking his/her pulse).
Do not interview or time patients who refuse verba! eonsent.
flow do·Itime' ëoi'lsultations:?
The s.tar::toftl;l~ consultation is ~~fin'e;ëiaj s.the;.tim~,at whiêh the patient
enters the consultation room.
The erJcJ(.iJfthe consult~tion is .defined as the time at.which·the, patient
leaves. the consultation room.
You willbe priltl'arilyusingthePDAto cor:npleteAheworkstudy. Tnetime is
autor:naticéllly óaptured hy the .PDA. ..All yóu hé!Ve to dCJ is pré$s "e.nt$t'" ti:le
moment thepéltiehtw;aIKS into the;consultatioh room on the screellthatsa_ys:
Entertime Péltient\eAters consultatlonreom. The same.applles for when the
patentleaves the room.
If you exp,efienqe'te$bnicaldiff.i~~ltie,s,~itR tla;e'P[)A;a.ndn,e~q, to resert to, t~~
pap:~r tr~§k';;lilP'Y.9~·r:T1t{§t>liJ~êth'~'djgilal'~átêhptoYia.~,d (~(:>tir;i1ethe..:re'&piratory
rate') to time',;fhe,conswitation. N'otê"tl1eHime:the patient enters anddeaves<tfue
room us'ing a 24,h0ur·clqck. This m.~án!?Jhara time. bf 1::30pm is noteêl as
13h30. The',digitalwatë:A uses8"24-,ClqCk display" You may nottiiTIethe
consultation usir:rg the stop watêh functi:(j)r;Ion the watch.
In order't0prevent rushing througll the questions during the short time periocf
during whiCh erre pati~nt leaves and the next patiént enters the consultation
room, ybWmust=sereen" the next patient in 'the quewewhile the first patient is
bwsyJn the ecnsultatien.rsom Yo.uwillnotetha.lttle,'PQAfir:sf asks you
quësticnis fqr th~ fi rst p~V~nt, then the,Jirii~ ,th~ li'r$t páti~ht ente rs the
ci,:ms.ultati'ohrO'GJT1,fhen'fhê,questions forAhe. second, patient, then the.time the
first pati~nt le8ves'the)·$Qr;l'sllJtátio;mrQor:i1~'~hd tht;fl fhe time the seeend pa.tient
enterslhé oOh,sulta.tio.Mrbo.rrrand's0.QA. Ithasheén designed to' replicate the
natural flow of"patients in.andout of a consultation room.
Whá.tiabó:ut(/j'átifliits wh,a are se,én moré :than.onCeduring one work
studv'ses~iop? '
Often patient mél¥ be sent for investlg~tion's (urine testetc.) hy the nurse after
the first consultation and return é\gaïh to discuss,;the results.and decide on a
plan. Treatthese returning pátieriis'as oomptetely new entries. Wé are
looking at the tota'l time consumed by respiratory patients,
A226
TU(>1;)E" F."'\"iL;I;'L'"",:-"\iO;;11\V:A'¥'_'I:' 'u' :-p' Q.'L,J,,,,~r.::,S' 'T'IO"' ' 'N.. ';N' HA:<'!I'"R,iE'C, ::~E.V~:_P' .L,,A;~'I,II(I',~iE: "'D--,'
BEFORE STARTING . "
You will notice that the numbers thaté!ppe.ar<in the Pé!Pe.r;q,"l~stio.nnaireoften
appear to skip qw~stj§>n~and seem to foll(;jW<ani i!I~9,i~~I;:Qt@~..F.lih,isds
because t!Je qqestj"(jr:iSnUrribe.rsmatch~ttlose in,tt:ieXP;Ê?~téiltf,)0ugl1;youwill
notice that.qu~~tioR nurn.b.ersare nbt.di.splayed:dn;,iné~g;A:~. .
The PDAhas aJotofëx1ra 'questions (often directe'q tQwar:ê!sy:o.u, the
intervi~Wer)wnj'eh d:<tnotappearonthe p'apervei:S.ion., "TIf,li~li$because the
PDA i~"unalDH,~to Jlcc~mliT'lqdate'taOles;wh ,cl;l;are,lI~,i;l~:.frequê'r:)tl¥in Pa!=ler
qU,estiol'l naires. ln$t~a.·g"thëP[)A:'.i'r~k~,it~;rj1ê:ih(1:it~~I:ë'~~;3, $gqlI!,~r;l~€tQf
questions, 'bri;lnching, 6fH6 'more ~etails;whén ,one·(j'ffme' Pr;>ti:9~',$iiSW,eleGted.
For tb !1'Freaspn-the.·q,qesti(.lfl$f:)pp~'é3rnQr~',$tr:~i9f\tf.~rw.~(~o; ri t~e ,PblA as all
no.n'\aP'Pljc~ple0.p.tioh$'ate "h'i.cjdenj, <K ~uto'rnêtibaliy ski~J~·e~lIi:h.e
djsad"amt~g:~"'i?that:tti1e,,acGornp:apyingi.papef'version"ls·very;G~rn.b,er$~@1e,
long 'and, <ïlifflq\;!lt:t0.foll.oW(77pagës,ir:f.a-u). Fofthls r:e:as0b·w.e·liIáy,e;,dë~,giied
a separ-ate paper version C011h::iinihgtablesete.te facilitate easy cOn:lp'letibn in
the event that Y:OI.J are forced toJali Qi:lck on Pélper. The 'trade-off is that the
seq,l:.!enG~ófnumber:s in {hispape,r','vet$ion.l:!as been disrLlPte(J. The RUM\
nur:hbersh~ve been·f<etained,to.allowtlgep,ali>er data to be captured-and
poeled with the other P[)Ad~tayou l.JPló?id.
TIME FRAMES
The 'tiliT1e.fr:arnet.o wh:icfu· ~Q~,tqUes;tle~s .réfer IS the period between-the, 2:
interviews; flrOom lffe.,iti.o.m~nt.t1Je"p~.(;(jhtleft the' b,aseline.interView until
the .start of-the fo1iow~up,JnteNie.w.
This r:nei:lnsthatiquëstions.abQut refën:~:lIsi'sputum tests etcapply to
ever:y:thjn~l,tla~rha$ h~p'per:te,d!jntne geriod. b,etween the 2: interviews. ,For
example yo~willb,e,teqqi(é'd'lq.capt0t$dëtails olvisits, refetrá'lsetc~ fer
patients who., ~fter,tf:ié)fïr§t.lnterviêW; wete transferred immediately to hospital.
You will also bé. req,ui$d'to capture. a:n the d~t~ilsofany tests-or iriv~stigatiohs
complete<Von the d~y qf tn.e follow-up interView should the patient also be
attending the clinic nurse/doctor.
Mest o.fthe questions will bef~mUlarto yo,u, Questions about symptoms
severity, heatth-related qUéllity onifé, medication currently being; used, visits to
this q!i6i.c, vismr to ottier' hé~ltnbáre'pr.ovideu?·,and inV~$fJg~tions are a~1I
repeated.
TIre ·ijtll.~--fr~mé ,fbr Vis.'~ ~~ 'tt:lé,ë lin,ic.. v'iS'i~ t9 ()tlJ.~r,h~álth .ca re
prbvidersaf'\dlirwestrg~ti0ns is the. :3,mpnth peri'Qd'be'tWeen,.the2
interviews startil\lg itT1rTie~iatelyafter the has,eline interview and ending just
before the follow-up interview.
The,·tiriJ~-fr:a.n.e.,fQr $ympt()rn;s'e'Ïe'~ity él89 'h~altfHél~t~d q~ality Qf life is
the last m0i;jlh"before~tt1'eJollow~up ~uesti0nl1aiÏle. The quaiity.,of life
questions.ere also asked ,forthe ;3ctual,oay' df'flie;.fel!ow~up. interview,
A227
Ensure that patients understand the period the questions referto exactly
before answering questions.
PATIENT INITIALS
These have frequently not being filled in correctly duril1g' the first wave of
fieldwork,
Initials = the,fi~t'lettenl,0.M!il. "V<;;hr'isti8n.narhe +
firs.t',Ie'm~(;of~t~ei8.~t!: i':~tlOt~~rP~·
For example,my :nai:h,é'is:i.t.:~ta.Rciinê.iE;'}'" ii1@~.ts,~~r~;)!"r,e,'lf~:,1'l})~rensure that
initials are filled' irfco(,r~ctl¥;andJtaJ!~X", ' " .': ,eJ.W~ti~nt!s;nrstl'l~triï~ and last
name; Initials 'tnlJ,st,aP.p:eá~,c?n.;~\;~ty;'~á·ge.0fi,thep' a,pé~,:que.gtioMflaire, so that
any pages' which~EicolT-lês:epar~ted;~~n'~e rép6riéil~d with the rest of a
completed question(:jaire. This~me.ans:wriitin.g the iflitials· on the top of every
page even when pa@j:lsihave'been s.k!ppep. '
DATE OF INTERVIEW
." .."": .
'fqu enter.this. by I::lié::~ing'onthe,qiSplaye~~Oa,te. Acalend,ar wiltappearwith
the option TODAY in the lower :rig~ttif fhe screen. Click on this and it will
automatically register the date foryou.
In the, pap.er version, you must write' the d,ate at the tQP of each paqe. together
witn the patient's initials, clinic nam,e and interviewer code (see later).
,,~,. ,..........;;,.,jj' to ~ <_;~,,/~ ''''''''; .•.•. :,,:L~~;i.,,'i!:';~/.;.:~..~'~t-;~lW~,_i;;,.;::i'i:i;~;',::;~~Vjj~~:··:\i:f~k:~k;,L.!;;,;;,.J.,;~;..~-; :,... ·;~~......;;~:~....~x:,~...:.:S.;.;i:Z::~:·~,::.~.<1...~;....,.;~. ':)' .;."j",,,;.;2 ;,._.,.·.•. v
1;-
INTERVIEWER CODE r.,
Again'tl1is':has',often',been,incorrecflyoc,aplured(especially on PDA
qoestiomlaires') durihg, the, first wavf!: of fieldwork.
This is a 4 digit code. Thefil'st.:2 dfgjts denote the clinic and can be
obtained f,r,qrn the list belo"",. The $.~~~mi:t.2gig/ts are your own personal
i(le.ntification:·codeafld were-asslqned to you d.uring thefirsttraining week.
CLINIC NAME
Albert Luthuli'Clinic W~.SsËl.lS'br.bn Ot
B().hl~k0i}g.OliriiG l3ethl.ehem 04
_. ' '·~'7nn.,•~i",~C'"~il',.,,cc ~OK~rQ007n.es~,tna~dda~a~ls~r_+~·~70_b7'6' ~~ ~rr. ,
l3othavHle: oe
A228
K- Mi:lile Clinic Bqthavjlle 14
Khqté;llong Clinic \,/ir!'linia 15
Koppies (Kganya) Clinic Koppies 16
Ma:>Haig,Clinic 17
MarakonQ·Clihic QwaQwa
t9
Mpoha.di Clinic Bethlehem 20
Nall1atilali 0Iir1i,c QwaQwa ,2t
Osizweni Clinic Sasolburg 22
(replaced with Sasolburg Town
Clinic)
Pa.ballOn9 Clinic QwaQwa
PAXOiinic Viljoer:l'skroon'
25
Phahé;lméng;Glihic Frankfort .26
Pt:l0m.~I.d,niLC.liniC 27
Phuthaditijha:bél 28
Seeisëville ,Clinic i<f.oohstac:i 31
Tebano Clinic 32
Thabong Clinic 33
Thusanong Clinic Sasqlburg 34
Thusanong Clinic Kroonstad 35
TSeki ~lirH6 36
TsHepo.nl'l.'QJini,C Well~om
38
Welkom,Clinlc. ,Weikom
Wepener CliniC 40
,TEAM CQPE
Welkom 01
T$hidkN.gce~lJlfa. Wélkom
'VVél,korn 04
.BofhaVille
Rosina Bouwer BQfh.aviile, dJ
08
Nraienq Seléli OwaOwC! 0.9
Thulahi.,MazibuRo QwaQWa 10
Bethléhem 11
'MathapeloMonfsitsi Bethlehem 12
13,
Agnes; Mosla 14
Victori~r Ra.rnmile
Syl,,!a: MQloele BJoemfontellil
t7
Bloemfonfe.in, 18
Dinan Mé:lkgoe paryS 19
Ingricf 1II10$0ge P,arys 20
PLilen!,,!JV1okhobo Parys 21
JOsh Ni:>êaridél PC!rvs 22
A229
PATIENT DETAILS
Page 1 : Questions 3 -10
First enter the patient's first name, surname, gender and folder number. Take
care when entering the folder number, transcribing 2 - 4 digits at a time. You
will be asked to enter the folder number twice. If not folder is available you
may leave this blank (but only if you really have made a concerted effort to
locate the folder). If you really can't locate the folder, you may click the "N"
button ("next") on the POA or enter the patient's full date of birth.
Please attempt to locate a unique identifying number on each folder, as we
will be tracing laboratory results for patients and therefore need their folder
numbers. If in doubt ask the clinic clerk to help you locate the folder number.
Questions 8 - 10
Patients were considered for the study if they were 15 years or older.
The year of birth (or age at last birthday if the patient is unable to remember
the year of their birth) is one of a few information elements (including name,
gender and folder number) which enable us to identify patients so that we can
compare how they have changed from one point of data collection (the'
baseline questionnaire) to the next (the follow-up questionnaire).
You must enter either the year of birth (if known) or the age at the last
birthday. The POA will skip age at last birthday if the year of birth is entered.
If the patient doesn't know the year of their birth click on the "0" button ("don't
know") and the POA will default to the age at the last birthday question. It is
not necessary to complete both the year-of birth and age at last birthday on
the paper questionnaire.
8 Do you know ltie year of your birth?
YES I 19 I ....E.nter year of birth & go to question 11:
NO Ix 110 I -> Enter age at last birthday & go 'to question 11: 46
TRANSITION ASSESSMENT
Page 1: Question 11
This question asks the patient to compare their health on the day of the follow-
up interview with their health 3 months ago on the day of the baseline
interview. It is what we term a "transition assessment".
First set the scene for the patient: "Remember when we last spoke to you
here at the clinic 3 months ago. Think carefully back to that day."
A230
Read all the response categories ("Better', "The same", "Worse") to the
patient slowly, pausing between each one. Ask the patient to choose one
category. Mark the box with an X.
You must give the patient time to consider their state of health 3 months
ago, their state of health today and how it has or hasn't changed. This
exercise requires "intellectual gymnastics' and cannot be rushed. Remember
to create the impression that you have all day to complete this interview. This
will put the patient at ease and allow him/her to think back to the day of the
baseline interview.
If a patient is quick to respond you may want to probe with comments like "Are
you sure", "Have you had enough time to think about it?" Encourage the
patient to take their time when giving a response.
SYMPTOM SEVERITY IN THE LAST MONTH
Page 1: Questions 12 - 17
These questions are a repeat from the baseline questionnaire and ask about
the frequency (this means how often something occurs) of chest symptoms
during the day and at night and their impact on the patient's usual activities.
Please note that the time frame for these questions is the last month. This
refers to the last month leading up to the follow-up questionnaire. You must
emphasise this to the patient.
If the patient answers yes to the questions you need to prompt the patient with
the three response categories (1 to 2 times per month or 1-2 times per week
or most nights/days). After prompting the patient with these categories allow a
silent pause and time for patient to think and then answer. If necessary,
repeat the response categories.
Questions 12 - 13
Difficulty in sleeping can occur because of many reasons including waking up
frequently to pass water. Patients who have difficulty sleeping specifically
because of difficulty in breathing and cough must answer yes to this question.
Patients who have difficulty sleeping for other reasons must answer no to this
question. If necessary probe to clarify that the difficulty in sleeping is
because of difficulty in breathing and/or cough and not for other reason? (itchy
skin rash, loud music nearby etc.)
A231
The questions are first~sk:~d{0r. the state ofthe páti~mts'health on the day of
the-follow-up- interview al1d~,then<repeated-forthe state ofthe:pati~nt's health
during the last month.
It is extremely important-to stress this,qifference to the patient. First ask them
to concentrate on their health status today and complete all the questions.
Then ask them to cast their minds back to the last month andrepeatthe
questions.
Questions 18.- 22.(tbday..., Page 2J and 24 ...28l1astmonth ~Paqe·4)
Foreach facet ef'qua'lityof'lifeyou will see threestatements, ,fi'lach
corresponding to a leyél ofseve'rity.
The first statement always reflects no prqbJem, the seeonë stéit~ment'a
moderate prol:llem .and the third statement a sev.ereproblem. These will be.
laid 'out on the' VIS ual.a id ina<herizohtéMórmai withthe.noJirobl$m'státement
on the"fat léf.t':ai1cLthé.eX1:remEplroblém on:tliefár right. s~ftlrig.·li!P~:átyJt~b. f
scale with no pr0bleiTrononeehd.and extreme problem on the opposite end.
You will.notice tha'te"áGh staternenthas.a corresponding bleek but that.there
are two blocks without statements bétween(hem.
For eacMa~t .bfJhe le.V,~1ófq4é1 lity.Qf!'IiW, y.0um.ustre,~<;I{~Wth:ré,es:tátéiTié,hts.:
to. the [>a,tiënt ánd á"()Vdh'~ pi(tiêhFti.rTlé,i-tQ,cf,gé,sf'andu'nderstancFthem. _The
patient must indicate to youwnlcn bi~ck';b~stdescribeSJheii" hl'!!'llth status. If
thêy feêl th.~t none oHhe:th~ee';statérr\~nt~'aCC;:.lJratelycaptures theirhealth
status: and-that ratnerthey fail"s0mévJh~re',in between, twó.statements., they
may choose the block- between those two statéments as shown below.
Example: A patiemt with mobility problems who feels he .falls between "no
problems" and "some Ptobll'!mS:'.
MOBILITY
18 n o ·0 r o
I have noproblemsin Ih'1ves.qmeproblems In walking Iam .c6tiiïlfined.towalkifl9·~bout id .about .
A233
Have you had difficulty sleeping because of difficulty in breathing and/or cough in the last month?
12 YES
NO
Select a cate 0 Interviewer: Choose ONE. Mark bo ith
1 - 2 times er month
13
Questions 14- 15
This question asks about the frequency of chest symptoms during the day.
Chest symptoms include cough, wheeze (whistling sound in the chest) and
breathlessness (shortness of breath, tight chest). If a patient reports any of
the three symptoms in brackets, you must answer yes to the question. It is not
necessary for patients to have all three symptoms to answer yes to the
question.
Have you has your usual chest symptoms during the day (cough, wheeze, breathlessness) In the last month?
14
15
QuestIons 16·17
Usual activities include work, study, housework, family or leisure activities. If
the patient has been limited in any of these usual activitiës by their chest
symptoms in the last month, you must indicate yes.
Has your chest problem interfered with your usual activities (e.g. work, study, housework, family or leisure
activities) In the last month?
16 YES
NO e2)
Select a cat
1 -2 times
17 1-2limes
Most days
HEALTH-RELATED QUALITY OF LIFE
Pages 2 - 5: Questions 18 - 29
These questions measure how health problems impact on different aspects of
daily life, specifically on mobility, self care, usual activities, pain/discomfort
and anxiety/depression. There are two parts to measuring the quality of life,
the first part is to ask how health problems impact these specific areas and
the second part is to ask a patient to give an overall rating on their general
health related quality of life (on the scale which resembles a thermometer).
A232
You may not explain the wording of the response categories to the patient
because you risk introducing your own set of values into the question. What
we want to know is how the patient pescelves their own quality of life and not
how they would judge themselves compared to other people's standards.
If the patient asks you what you mean, repeat the categories word for word.
You may not give any examples as this will lead the patient and compromise
their answer. This is particularly relevant to the pain/discomfort and
anxiety/depression question where patients are asks to distinguish between
moderate and extreme states. It is up to the patient to decide what he/she
considers moderate and what he/she considers to be extreme and then
choose. Giving examples misleads a patient and disrupts their own process of
deciding what they believe to be no problem, moderate and severe.
The PDA does not allow sufficient screen space for you to view the response
categories as whole sentences. For this reason, and to help the patient
visualise the exercise, we have laid out the full versions (in all 5 languages,
bothfor quality of life today and for quality of life in the last month) in the
visual aid. Please use this to complete these questions.
Also, the PDA does not have a system whereby the blocks could be easily
depicted on the screen. We have therefore compromised and inserted
"dashes" between statements to depict those categories which fall between
statements.
The same patient with a problem with mobility falling somewhere between "no
problem" and "some problems" would therefore be depicted on the PDA as
follows:
A234
Questions 23 (to.day - Page-3) atld 29.flast :mon-th --,Page 5)
This,question is designee tE) assess the patient's dve~lrhealth related quality
of life using a "thermometer". Expl'ain to the petient-tbstat-tbe bettorn of the
thermometer is theworst slate thatthey can imagine. Be sensitive to the fact
the patient might imagine this state as being,worsethandeatb. This will differ
from patient.to' patient. Clnd so do not jIIuslr;ate this E:)ntffbf:the s~l~ with
examples like death 'Of extrem.e suffer;lhg~It is up to the patient (aAd not you)
to deGidewhatfhey think is:theirworststate of health.; , .
Explain to toe.patientthar at the 'top of the thermometer is the best state that
they can imagine. Be sen_sitjv~ctQt~eJélctJDe;patient;might ir:n~gi,nethis state
as being l'il~tt~rthaI'! nqrtri_al.This will' differfrorh p~~ient.t(:)patient and so do
not illustrate .fhis·endottf.le sG:aleWithexamples like b,éimgcfilledwjtbvitality
and en~[gy. It is lJP to the Pêlti~Qt(an,(j ,rl()t you) to,oeeide whatJl1ey think is
thei r best state .of' health.
Be sensitlee to' the facl th~t""nonTral;' f()r the p~fient may be>a,nyW'hereon this
scale. Do not sl1,gge$t te),Jhe patient tbath.alfNva,y between tbe"2, p'Q;n(s
(reading::: 50);inflii:at~s "nom#J/". Ifyqu <;Jbthi$.Youwill findthat.m0st
patients choose 50. IHhe patientrequires clarification, rather say something
like "normal for you may be anywhere on:this scale".
After e*plaining how the, scale w,orks>tothe;.patient"ask the patient-te imaieate
to the point on the §.~ale,'W.t:lg,r;~~th~Y"fé~I;P,êsrQ~sptibheoSw th,~y fe$1 tolll,ay.
On the 'P,élP~r'q,l:I~$ti~.flna.ireriTl:élr;~,this;p<b;5nint~h~:.;PDA'recQrd'the numb,er
p0imted'outon·,the s'calei(ïf.le'\(ther;rnomefer:féaêing"),Ás .w• itn.:thestatement
Pi'lrt,of q,Uéllityof life."you 'will repeat thi~·pJ'o~e~sf0r theIast month,
VISITS BACK TO THIS CLINIC IN THE LAST 3 MONTHS
Pages 6 -10: Questions 30 - 98
These ques.tions ~stat:>l,i'swhhetherthe,patient has retumed to the clinic during
the period betwe.en the :2 interviews; ,including 0n,the day ottbetcllow-up
assessment, and take into :accQu.ri~.,wh~JhéYrOq ~re \1on9Wcting'the interview
at the clinic, or at lhe patient's Mme. Y0u'will be' teq,uir.edto trace patients
who' clon'tr:étwrn to the, diriic'fofthe folloW-Up'irit~rV!ieWto their homes if
neeessary.
Note tbat.veu are required to record tl~r.eonly the details of visits to the exact
Same clinic,where the Péltiéntwas initially recruited. Ifthe patient has been to
a ê.ifferent Clinic!duringthe'peri0db.etw~efl interviews, y0uwill.recordthe
dêt~il~ ofthO$'e \llslt$ ung~nhe seqti'ort: "Visi(S tb othér h,éalttj care providers
besides-this clinic". . . :
We'ceHec{ irif(jrmati0[) en the\élvail~biHty (jftbecclihic folder aNhetitl1e'of the
inteTViewbecause, intel"i.ïewscwherey0u have been able to use the patient's
folder to cheek-up on vi.sjts bélCkto the clinic, tend to contain more reliable
information than when you have, not had access to the folder to check up on
details.
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Question 30;(Paa_e·6)
In the event that-the p:ati~nt<dOEl$f:l.9treturn t6 the Clinic fQr- theJqllow-up
interview, you will bërequirë!d :to'.follë>w,upthe patient at h()mec The phrasing
of future questions asking wl;)E!ttier-the.patient has returned to'.the clinic
between interviews déj:>êr\dsbfnvnêreyou are conducting thefóllOW-up
interview. Choose one option-and mark the box with an X
If you are cOnducting ille interviewat the patient's home s~ip the next2
questions and conti.nue~with que_stion33 (same paqe). If you are conducting
the iritervie'IVatth~ Clinic proceed,to the next question.
Inle.lVlëwer: Are you·c~lndU.êti(lg:ttiis iriisiVlew at,the páiient's home or atthe ciiiiié?
Choose 'ONE. Mark':box with.anX.
30 Af Uie.patienfs home I I - skip to question 33 (this pagë)
At the clinic I X I ~'gi:l'to the next question
Question 31 tPagé 6)
ThiS question estaglishes whether a P::itient, b~ing interviewed. át the.clinic,
has been back to-the dinlC forany ffl;;'$On :betweenthe2 interviews.
Remempet th.~tsonii3,p~tiënts'cmé;'tY't>É:l'?tten9!btglj'e êlinic'fqrcare as well as
for the fbllow'-'up intërview, .These patients must be·intérviewecl after they
have seen the nurseldoctor so that-you. can capture the details of that
consultation.
You must indicate-no ónly iHhe pé;ltienthasA'tbeen back tothe élinic'at all
between the Q Interviews, ~nd:is,only at the clinic for the purpose of the
foHow-up inter:view, If the patient has been back to tt;,eclinic at all, even if only
to qbllect mediéfition' (withoutseeirig a nUr~e/<:!oGtorV) Ol! must lndlcate.yes,
If'tRepatietit has not been bae~ to the clinic at all, you must-skip all the
que~tic?ns about G.arereceived ·aU.h.eClinic in the, last 3 rnqhths and proceecl to
question 156;,at-thetop:ofpage 14 (Patiemtswho have-rrot been back to. the
clinié.iri:the laSt3month$),
riicrudlng;t.O:l!á~;,~a:v~:yo~ue.e.iï);ïl!¥k/~oJheclinic (to collect ineds, for á'check;uPi to'set) a nurse'i)r'doctor'!ê§:r1n the
last'3:riiónthS,aftero·ur:ffrs·t·inter'l.irm?
31 Interviewer: Indicate NO. it.the patient has not been back lo the ctlnlcatter the first. interview and is attending the cliQi~ today
ONLY for the ouroose of.the·interviewl.
yes I x I ~ go to uie nexlqu.ëstiori
Question 32, (Rage ·6)
Thisasks'y:oMq'Confirrn .inJhe'folderJbé;'tFthe.p::itiënt ftas been back'to the
clihic in the 'ast 3.mo.riths. R$rn$.r:iib.erthat we treat information about' clime
visits ete, as being more reliablewhen it has been double-checked with fólder
entries.
If ttie folder is aVéÏHableplease chéék tHattt;,e patient-has been baCk to ~he
clinicafterthe báselil1e,intel¥iew, Iftne fOlder90ntgins np :docurnentation cf a
visIt .d. urihg··thiS:tiiTié,pe(io~!;;pl~l:Is(f prob..é'Jg~'8atiêh~ ·~~·ol,lt,éX~~tIY)Wnétl·
helshe' returned-to the·'c1inic, Bear irrrnirrd tht:Rthe patierit maywë".h.ave
A236
returned to the clinic between interviews but that the visit may not have been
documented.
It is Worthwhile noting.the number of visits after the baseline interview
documented in the· folder. This will. assist you when later you are required to
enter the details of all visits betweeri interviews.
Interviewer: Have you confirmed In the folder that the patient.attended the c::liril,: in, thEl'Iast'3' months aïtertne first interview?
32 YES I,X
NO I
Question j3.mage 6J
Thlsquestien establishes whether a patient, being interviewed at.home, has
been back to the clinic. for any reason between the 2 interviews.
You must indicate no only iftre patie.rithasn't' been back to the clinic at all
between the;2 intérviews. If'the patient ,has been pack to the. clinic at êlll, even
if only to collectmediealion (without seeing a nurse/doctor) you rnust.indlsate
yes.
If the. patient has not been 'back.tothe clinic at.all, you. must Skip all the
questions about care received .at the.clink: in'th~ last. 3 months and proceed to
question 1'57 at-the-top of page 14 (Patients who have notbeen back to the
clinic in the lastS; months).
Have:youbeen'back.to the-clinic iri·thë:.:lasf3··montlis;~ftei"~óurfl.f:St:lnlêrJiiew?
33' YES Ix I - gcitO 1l1:EInil¥1 g~i(~tion;
N.Q I I·....; sRip.ito Questión :lS7':(~ge 14)
Question ,34 (Rage '6)
Here you'are required to capture all the-details ofever:y visit ,back to-the clinic
betwei:in ~1:iE!'2'irit;ëri\liew,sir;iCl~i:ling.C!ny;-visitson..tbé day ofthe, interview itself
(hence the importance of interViewing,these patients after they have been
seen-by the nursëïëcctor).
As·with the -baseline.,interview,;yo.u dO not have to record the details-of visits to
collect TB iTJedica,ti,P.ol:,ls·yqu will onIY'l:!e·,aIJpwedto capture tletp'ils for 8
visits. Patiemtswh0'areb$ingtr~ated f~r'TB are likely to have-attended the
clinic more than 8limes' in a:'3·mon.thperiod." .
You- can use the foiderlo help the patient remember the number of visits back
to :the clinic during the 3 nïOnthperiotl. Again pear in miOd that.some pages
may he missill9, and'thal some visits .rnay not have been documented.
Enter the; number óf times the.patient" has been back to the clinic between
interviews (but-exclude visits to collect TB medicafien).
For t31<amplelA: tQas~lirieYQI,l ii:lferviëWed,"'.pati$htwith a IbnQ$têMdipg ,qQugh.
He was ,asked",to cóliecf,sputum at.home for.testing forTS. ,Hi:H;!Jp'sequently
returned once to.the cliiiic;to;Tetur;n,the sputum; and again a M(eek;h:iterfor the
results where he was.informed thathë had· téstedposifive ferTê. Hewas
A237
then asked to report to the TB clinic the following day to commence treatment.
He has since attended twice a week for TB medication.
Total number of non-TB medication visits between interviews = 2.
I would like to know about AlL your visits back to this clinic in the last 3 months after our first interview and including this visit
laday (if attending the clinic for reasons besides the interview). As with the first interview. we will use your folder (if available)
to help refresh your memory.
TB Patients: I will only ask you to tell me about visits besides when you came to collect your TB medication.
34 Besides visits to collect TB medication, how many times have you been back to the clinic In the last 3 months after
our first Interview?
Enter number of times:
VISITS TO THIS CLINIC IN THE LAST 3 MONTHS
Pages 7 - 10: Questions 35 - 98
Here you are asked to record details of all non-TB medication visits back to
the clinic in the 3 month period between interviews (right after the last
interview ended up until right before the follow-up interview starts).
You will record 2 clinic visits per page on the paper questionnaire and both the
paper questionnaire and the PDA format permit you to complete details for up
to 8 clinic visits.
Remember only to record details of visits back to the same clinic (where you
first interviewed the patient). You are required to capture any visits to other
primary care clinics under the section: Visits to Health Care Providers besides
this clinic in the last 3 months.
You are first required to enter the date (month only) of the visit back to the
clinic.
You are next required to enter the reason for attendance in the patient's own
words. Many interviewers recorded the reason for attendance from the
notes. Please do not do this. We are interested primarily in why the patient
sought care, not what the nurse or doctor made of the patient's symptoms.
For example a patient may seek care because of a cough for 2 weeks. On
examination the nurse finds a skin rash and records it in the notes but makes
no mention of the cough. If you ask the patient why they attended the Clinic
on that occasion you will be told that it was because of a cough, If you relied
on the notes you would record the skin rash but exclude the cough which was
the real reason for the patient attending,
Patients usually attend the clinic either for a check-up (usually for a chronic
disease like high blood pressure or diabetes - these appointments are known
as "check-ups" or "booked" visits), or for a new problem like recent onset of
'flu symptoms etc. Go through each item on the list and indicate whether the
patient attended the clinic on that occasion for that reason or not. You must
mark all the options that apply with an X. If there is an "other" reason you
must mark the box next to "other" and enter the reason alongside. You may
check all the boxes that apply as well as enter an "other" reason. You will not
A238
see the "other" option in -the list presented by the PDA. If this applies click on
the UN" ("Next") button and the PDA will present a second screen to you with
space for you to enter this "other" reason.
Probe the pati~nt wh()"s~~rn~ n~ttQ,kFlOW why th~y a!:tenQt3cfth~,clinic on a
pa rtieu lar ,ocyasion, '~Q~t .P.ê~,lfjpt~/hêVeSOrTIe,uncj~r~tanqin.g~.t>fwh¥ they
came to,the, clinic on,a.p.articular d'a¥. Do not.betermJ§téd;'tiSl,:res:ortto the
patienti:iotes. '
Try to q;~aHwellldes as .far as .PQs$,ibJe".Forex~rnRI~."t0·Coll~crmedication" is
very n0fl:,sP'e'9if:i'B'~MeFg~$1'10, c(:)llecta?}hm:a rned[~~~ipn"pro~lidéS very
seeclfie an~e~~€t inf.oJ'T;tra~iQans to the.,re.asPFIfor ,~lf,en~~9m®. $imilarIY,
"check-l1P"i$,: al~o v.~ry m0n"~pe.:Oifi'oWh$r,e.~s"9n~QI:<7C!p:f.(i)rA'1::~i~I(f)r:ho.~, '
pressu rë~pr,ovia:es·eXaët::refi~blé, data. This Qfte.n r~(:f~j~~s~jp't~t)'Ii:lg"the'patient
for more infbrrna'fiql't·;;ïnd:is,.'the. hallmark' ofa:qpálified af;l'cf~x~êrit+nt~:rVi~wer.
Rememberthattm<Dstpatiemts will be unfamiliar with the term ur~~piratoryJl and
it is your resg(1)nS,it;jilityto explain itto the P9tients~ "R~s~iratóryJl refers to all
conditions involving the respiratory tract (ears, noseand throat, airways and
lungs).from col(:l$.and 'flu t(ij asthma, bro.nchiti~ and TB.
The nextque$ticm is··.éI.iffer~nttotb:e;~baseHmel'riteivjew" an~ askswhe,ther'the
patient ·saw:aJli,J,rse.; .ê. ,pctqr or:,p:Q!h:;.~tVif:i~tQ.CGé:)'siP¥fOLU,fTl'aY be, rê,quij;e~tto
probe tfue.p'atiemrwh0·re$f)onês>thaVh~/shé sáw' :6.tily./á"n, urse or' a dQctor'on
that occasi~n(uf\r:e you swteP;', "Qiril you Apt'also see-adsctor?", '~Didyou not
also see a' n~i±$e?"). You may c:hp~$éone option. Markthe relevantbox with
an X and proceéd to the nextquestion.
The neoot'qqe~tiGn'asks ¥Qu, th~ intervieWer, .Whether the. patient saw a 'nurse
(± a.d0etbr~ (lmlh,atoccasibn. this is beeause we'wantto ..undévstand more
a'bQut th~ quatity'Qfn~r:$~, t.::Qn$(.jJ~~tiQn(:Ws h~thét tb~ 11'1;If,Siieif(' }r:m:eq'the
patient Qt théir c!HagnQsis orassessmentetc.). If yes proeeed to the next
question. Uno skip the foll'owing2' qpestions (go to: Interviewer: Enter data
for another visit?).
The. ri~X12 qu.~~ti(,)ns,,$$k.yOu firs,t tQ é$.t~tz;li$hwn~therthe nurse informed the
patient ab0tJtwh'átwas:.wron'g~with,them{EhferYes or Nq).'and if yes-asks you
to ente.r'wh.at,the;rnl;Jr'~e,tQI(;l:'.ttie.~,aV~,Át ,.Ag,ain.r~r:nëmber th~t yoLi rtlu$tus.e
thé.p~tiehr'S 'own WQté!lslb.r~qArq Wh'~;tthe:nuF~~ tolq him/her: Coming:away
from a C0J1Suitation with' a ~rood underStanding :of your health problem is a
marker êf'g.bO.(j:.quálity care,
Finally you will be asked whether yeu want to enter details of-another clinic
visit. .Ifyes pWGeed to the next bJ0ck (e.ith~r actt?:eentor on the next .page). ,If
no, skip toquestior. 9'9 at the-top of page '11 (Care received at this clinic in the
last 3 months),
A239
Collect results of TB tests
38
39 : Did the patient indicate that he/she had seen a nurse on this occasion whether or not he/she also saw
CARE RECEIVED AT THIS CLINIC IN THE LAST 3 MONTHS
Page 11: Questions 99 -109
These questions ask about investigations (and in the ease of TB their results)
completed at the clinic in the 3 month period between the 2 interviews. They
are similar to the questions asked about the consultation at the time of the
baseline interview.
A240
Questions 99 and 1.00 (page 11)
This asks whetherthe patient had any sputum collected for tests, Usually
(but not always) this is taken to look-for TB, so we are particularly keen to
know how well the clinics are screening the community for TB.
Usually the first sample is taken on the day of the conslJ,lt$tigr:)·atthe clinic and
the patientis given an empty containerto take home andfii;Ol'Jghd.ntothe
following day, and then return.to the clinIC: FortRis;",réaso~n,W~;fir;stask
whether,s<;IniplE;lswere physië13llyc.0,11.~,9tea.atth~:cJirii~,and',iK~f;\wh~~her they
had received instructions to colléctfuithersamplesaKhorne. Patiemfsmay not
be familiar with, the term "phlegm I sputum samples" belt they are familiar with
the containers in Which this is coliecteq. Use the pictures of these containers
in the visual aid (pages 26 and 27) to help you. .
If the patient has. either haci'·~put9m, samples,:coHectetjat the clinic itself, or
received,:instructibns to'Colleëtsamples afhame, indieateyes and enter the
number ofsarhples·colleqtêd oraskeidtp be.collected,
our
Questions 1:()3· 10NPage'11.J
These Ciue~tions ask: the. patient whéfher'they have been di::i9nosed, with TB
during 1he,3 mo~th:perio.cFbetW,een intervIewS, <'lnd if yes, for some basic
details oftheir diagnosis,andtreatment. It is' important to collect this
ihfótmati(,;jn,lïere'~~$ \N~:have, purpps~Hy excluqeq' itfr6m the visits baekto the
Clinic in the lasLa:'rhbntns.
Fi~t.yOliJ;liVill askaH patients whoH?ve been back-to-the clinic in the 3 month
period between interviews Whether ll:!ey have been diagnosed with TB after
the baseline interview. Wyes you will be required to CQmpJete the next 4
questions. If no you may skip to question ros (same page).
Forthose patieDtsWho have beerl di~gnb'~',eqwith T~ after the baseline
interview, enter wn.ere theywere dié\gno,sedwithTB (Choose one option),
wherl:lthey é\re<;urt~ritly receivihg th~ir TBfr~atment (C,Moo!?eo,ne,option),
whenthey sta rted tMir tB 'tteatg)l~:m.t(this information' is usually on tne TB
treatment CC! rd which most TS, pati~'rits/carry with them at alf times) and how
often they attend the éJinic fOr'tréatmerit.
Patients may hii:-ze'started 9ft attendihg tne clinic every day but<then move to
once a week etc. Oh'obse the category which best describes the patients
A241
attendance patterns during the 3 month period between interviews.
Remember that you may only choose one option.
103 Have you been diagnosed with TB in the last 3 months after our first Interview?
YES Ix I - go to the next question
NO I 1- skip to question 108 (this page)
104 Where were you diagnosed with TB?
Interviewer: Choose ONE. Mark box with an X.
In a hos ital
At this clinic
At another clinic
une Year 2003
107 How often do or did you attend the clinic for TB treatment?
Interviewer: Choose ONE. Mark box with an X.
Once
Twice x
Three times
Question 108 (Page 11)
We want to know whether patients who have received care at the clinic in the
3 month period between interviews have had any blood tests taken,
regardless of whether they were taken at the clinic or elsewhere. Many clinics
do not have the facilities to do blood tests and may refer patients elsewhere
for testing. We want to know about all blood tests (not just those taken at the
clinic) since it is likely that any blood tests completed are in some way linked
to a consultation at the clinic where the nurse has referred the patient for
further assessment or investigations.
This differs to the baseline interview where we were only interested in any
blood tests actually done at the clinic on the day of that interview. Bear in
mind that some patients may have been referred on for a blood test on the
day of the baseline interview and had it a day or 2 later. The place to capture
those tests is here.
108
Question 109 (Page 11)
This asks whether the patient had any Chest X-Rays (at the clinic or
elsewhere) in the 3 month period between interviews. Chest X-Rays are an
A242
important but expensive investigation commonly carried out in patients with
respiratory diseases.
Patients may not be familiar with the term "Chest X-Ray· (although most are)
but will recognise the process of having a Chest X-Ray taken which is
depicted in the visual aid on page 37 together with an example of a Chest X-
Ray film (add-on visual aid page). If the patient answers yes ask him/her how
many times they went for an X-Ray (so that we can determine the costs of
these investigations). Be aware that one Chest-Xray involves many views
which are not to be mistaken as number of X-Rays. The number of times the
patients reports having an X-Ray taken in the 3 month period between
interviews is what must be entered.
109 Have you had a chest X-ray in the last 3 months after our first interview?
YES Ix I -t 110. How many Chest X-Rays have you had? 2
NO I '~'.,.,;. . ~t~~~:_
Question 111 (Page 121
The following 4 questions all ask about the nurse referring the patients to
doctors during the 3 month period between interviews. We distinguish
between doctors at the clinic itself (who attend usually once or twice a week)
and doctors outside of the clinic.
First ask the patients whether a nurse at the clinic referred him/her to any
doctor (at the clinic or outside of the clinic) in the 3 months between
interviews. If the patient answers yes, you will be required to proceed to the
next question. If the patient answers no you must skip to question 116.(same
page - smoking).
111 Has a nurse at the clinic referred you to a doctor (at the clinic or elsewhere) in the last 3 months after our first
interview?
YES Ix I ~ go to the next question
NO I I .....s.kip to question 116 (thiS page - Smoking)
Questions 112· 114 (Page 121
Now establish whether the patient has been referred to a doctor at the same
clinic (insert the name of the clinic into the question) during the 3 month period
between interviews. If yes, you must proceed to the next question and
establish whether the patient has already been seen by the doctor and if so,
the number of times the doctor saw the patient.
If the patient has not been referred to a- doctor at the same clinic (but rather a
doctor outside the clinic) indicate no and skip to question 115.
112 Did the nurse refer you to a doctor at ....... (Insert name of clinic) clinic?
YES Ix I ...g.o. to the next question
NO I I ...s.k.ip to question 115 (this page)
113 Have you seen the doctor yet?
YES Ix I ...1..1.4. How many times in the last 3 months? 2
NO I I
A243
Question 115 (Page 12)
Here you ask the patient whether the patient was referred to a doctor at
another clinic or in a hospital. If you have followed the instructions carefully
the answer to this question should always be yes. The PDA (and paper
questionnaire) will then remind you that you will later be required to enter the
details of any such referral visits/admissions that have taken place under:
visits to other health care providers besides this clinic in the last 3 months.
Bear in mind that a patient may have been referred to a doctor outside the
clinic but is still waiting for the appointment. In this case indicate yes to
questions 115, but do not record the details of the visit since it has not taken
place in the 3 month period between interviews.
115 Did the nurse refer you to a doctor at another clinic or hospital?
YES - remember to record all details of visits to doctors In other primary care dinics
under. VISITS TO OTHER HEALTH OARE PROVIDERS BESIDES THIS ONE
IN TH.E.. LAST 3 MGlNTHS (Paqe 17)NO ~ ",. " ;" <.,;?,k.~{l~~~ilkW'"
SMOKING
Page 12 : Questions 116 - 124 ; Page 14 : Questions 160 - 168
You will notice that the smoking questions are repeated twice in the
questionnaire. This is so that both patients who have been back to the clinic
in the 3 month period between interviews as well as patients who haven't are
asked these questions.
The first two questions (116/160. Ever smoked? & 117/161. Smoke
currently?) are repeats of questions in the baseline interview, and establish
whether the patient is a never smoker, current smoker or ex-smoker.
If the patient has never smoked (no to question 116/160) you may skip the
questions in this section. Go either to question 125 (top of page 13) or 169
(top of page 15).
If the patient has smoked but is not currently smoking (yes to question
116/160; no to question 117/161) skip to question 123/167.
, SMOKING
116 Have you ever smoked?
YES Ix I - go to the next question
NO I I - skip to question 125 (top ot page 13)
117 Do you smoke currently?
YES Ix I ...g.o to the next question
NO I I - skip to question 80 (this page)
Questions 118 - 120 (Page ·12)& 162 - 164 (Page 14)
This asks on average how many cigarettes (shop-bought or manufactured and
hand-rolled) and pipes the patient smokes per day. Go through each item and
enter the average no. smoked per day alongside. You must check all that
A244
apply. The PDA will ask you each item individually. If the patient does not
use one of these items you may enter zero or, if completing a PDA interview,
choose the "N" button ("Not applicable") in the lower left of your screen.
On average how many of the following Items do you smoke per day?
Mark appropriate boxes and enter average number smoked per day. Enter 0 for those items not smoked. Check ALL that
118 <mQIy,
to Shop-bought cigarettes 118 Enter no. smoked per dav: 2
120 Hand-rolied cigarettes 119 Enter no. smoked per dav: S
Pipefuls of tobacco 120 Enter no. smoked per day: 0
Question 121 (Page 12) and 165 (Page 14J
This asks whether a nurse at the clinic has provided smoking cessation
advice (advised the patient to reduce or quit smoking). Again the time frame
is the 3 month period between interviews and does not include any advice
given during the consultation which preceded the baseline interview (and
which was captured during the baseline interview).
I have noticed that, despite anti-smoking advice being recorded under "Wbat
did the nurse tell you?" for individual consultations, this question has being
answered as no. If the patient receives any advice to reduce or quit smoking
(temporarily or permanently) you must indicate yes to this question.
Question 122 (Page 11) and Question 166 (Page 14)
This question asks current smokers to weigh up their feelings about quitting.
Read all three statements in full to the patient first, and ask them to choose
which one best describes their thoughts about stopping smoking now. Do not
rush the patient. They will need time to consider the statements first before
making their decision. Once they have made a decision, mark the adjacent
box. You can only mark one box. .
On the PDA you will notice that the statements may not be displayed in full.
For this reason they are provided in the visual aid (in all 5 languages) on
paqes 24 and 25.
You must then skip the questions for ex-smokers (123+124 and 167+168) and
proceed to question 125 (top of page 13) or 169 (top of page 15).
Which of thlt following best describes your thoughts about stopping· smoking now?
Interviewer: Read ali 3 statements to patient and ask them to choose ONE. See visual aid palle 24 .
122 I will stop smoking .....skip to Question 125 ( top of page 13)
I plan to stop smoking but not now X .....skip to question 125 ( top of page 13)
I do not plan to stop smoking soon .....skip to question 125 ( top of page 13)
Question 123 (Page 12)and Question 167 (Page 14)
This asks patients whether they stopped smoking before or after the baseline
interview. If they stopped after the baseline interview, we would like to
A245
" ~' ..... ,.
MEDICATION
Pages 15 -18: Questions 169 - 279
This section. is set out differently compared with the ba$elihé;iht~rvieW-; since
the follow-LIP interview is not linked toa consultatio.n"alth0qgh~:pl:ltients might
have come back to the clinic.to see a doctor/nurse or-collectimedication' on
the day of the foll0w"uj:> interview.
Because of. this we-first est~bli$h whéthér the pg:ti$rit .is béXhgTinterv.iewed at
the clinic and, if YeS, if their visit to the clinic is iA an:VWéI)llinked to receiving
care (see a nurse/doctor, collect medication). lfthe patient has received care
from the clinic,Jhevrnayhaye teceive,d med.icatibn to tak~ home, and we want
to capture the details orfhis prescription.
169 Ihterviewer:'Are:Y6ui:;Ói1dliëtii')g:this'iiltérview.'at';lhe·:patiëiirstiomêdr.;at·the:ciihic1
At.the patient's home I
Atthe clinic
170 Have;you come to'the ct.inti: toa~yJust for the llufp.óSe'oHhisjrite'iViêW oï':<itso 'to'sêe a riursélélêêtoi?
Just.tor the:purpóse of the intél'lliew I I - sklpto questiorï.230 (top of page 17)
Also to see a nlirse~d_odor I,x I -+ 9P to the ne~t question
As with the baseline inte~il:lW, we have limit~d our drugs of interest to those
used for common respiratory problems. These are:
1. Ihnale.r medication
2, PrednisQne
3, A;ntibiptiê$ .
4. Other medications c·omrrionly. used-for respiratory problems.
Ifthe mec:liéatjó.n:t~E:!patientha;; receiv~:d today or is using now at home does
not appear on the' visual aid, we. don't need.to know about it.
In'tl;1e'báselil1e'iht~,ryi,eWi(wliêre'YQi,I ~ne,wthatallthe'patient$ had already
seen-a. nurse' tt,lat.dqy) you sbow.edthe fjatienUne:relevant items 0n,tl:ie'visual
aid an'd then ~~ketJ't!i~m~)whett;l~rth~y ~éiq r~CéiVedJtie it~\'TltbOay and' bl if
not received today, do 'they, reguiárly usethe.item·ai home, .
Depending on what items they i:I,sed,Y9LJWere also req~irecl to complete "sub-
questiensrelated tothatpartieular drug'f'Ooes youf'difficulty breathing
improve wMi:t you. use thi);; ir'lh'alet?" fOr ~eliever ihhi'llers; "How many tablets
must'youtake al a;timeq'" fcrpredntsone and antibibtics and so on):
The fóllow~\JP inte'rv'ieW.·ql,lestiQl1sare'stfu,ctur,ed a little:.differeqtly. Not all
patients will halle. seen Cl nurse/dbctc:won the. day bftne interview and SQ,to
avoid as~ihQ}'r(l patieti,tS!a,bbut:~~~iCationr§lqêiYed to"day, y_otf fitst 9ap.t!Jf,e
th'e det;8il$ 6f...~herneqication pa.ii~nt$;\ii.(ho!did.·see a nl:l~éldocJor r,ecelyed
today, and then. asK about riieë.icátiblltheyarecurrently usinq.at home.
We have used the.phrase "medicatii:>n'thatyou are-using now" to.capture
medioation-that patients use.on a reqularbasis at-home. In some cases this
may be every dClyorneaf(yeveiYday (a'ig, BudesolÏi~te, Thepphyllii1e tablets).
A247
establish if them quitting was in any way related to smoking cessation advice
received at the clinic. If they stopped smoking before the baseline interview,
skip to question 125 (top of page 13) or 169 (top of page 15). If they stopped
smoking after the baseline interview, proceed to the next question and see
instructions for questions 121 and 165.
When did you stop smoking?
123 Before the first interview I I - skip to question 125 (top of page 13)
After the first Interview Ix I - go to the next question
TRAVEL TO THIS CLINIC IN THE LAST 3 MONTHS
Page 13: Questions 125 -155
These are repeats of questions contained in the baseline interview and should
be completed by all patients who have been back to the clinic in the 3 month
period between interviews.
Please see instructions in Training Manual for baseline questionnaire.
PATIENTS WHO HAVE NOT BEEN BACK TO THIS CLINIC IN THE LAST 3
MONTHS
Page 14: Questions 156 -159
The first question asks you, the interviewer, to confirm in the. folder that
patients who report not being back to the clinic in the 3 month period between
Interviews really haven't been back to the clinic. This applies only to patients
who are being interviewed at the clinic where you will have access to their
folders.
You then ask these patients whether they haven't being diagnosed or treated
for TB after the first interview, and, if yes, record where they were diagnosed
and where they are receiving treatment.
157 Have you been diagnosed with TB in the last 3 months after our first interview?
YES Ix I - go to the next question :
NO 1 I - skip to question 160 (this page - Smoking)
158 Where were you diagnosed with TB?
Interviewer: Enter cllniclhosPital name below.
8Qtshabelo Hospital
159 Where are you receiving your TB treatment?
Interviewer: Enter cliniclhosoital name below.
TIger River Clinic
A246
In others it may be less regular (e.g. Salbutarnol inhpler orily when the chest is
tight~.
The questions (a rid "sub-questions") asked for eaoh med ication type are
otherwise the same as in the baseline interview, ex~pttharwe have included
all the antibiptics ifl the .section "Medication that YOll~a)IeLJ§ii.tgn9W" (Follow-llP
questioFlAaire}vs ..only.cotrimoxazole, doxY€;YGlilje·aAd',fluep8azole under
"Medleation uSually used" CIB~~elii1equesti9nn~ire.:), .
I2n#hJailJe'ts~fR...áge,.'.1.;5i.· Q. 'u.'e''S. ti.ó.ns'171.7 .. .1..(1.i,6~'áti.d~.lf.!,.a(!,i.i.1..,'#Gllt;r.iê'Stl.oris:/230-
There are 2:ty,pes ofil1hale.rs OPpUrJ.1ps.The [IrsHype is c~lHedthe reliever
inhalers because th,ey:provide relief' imme.diatelyw~en. the' chest- is. tight
("open the ches. t"). The relieve. (i.rihalérs:~r:e.·:' - ,,'
Feno.te.rol (Fe-,-nP'-"t~r91)
Tradê name: Berot~c. .
Useê for-asthma-and ,emphysema Fbronch ifis,
Fenoterolllpratropium (Fe~no-te-rolll-pra-tro-pium)
Trade Flame: Duoven]
A comQir.tatiQn drqg used mainly for patients with severe asthma and
emp.hysema.
"pjattt9piiJirt(i~pi;a;frto~pitijJlX
Tr:a~:e,narne: Atr(:)Y~!Ït
l:J's:eQmainly fo.r patiêhts With erTiphy$ér:na.
Sall?ÏJtam~/··(S;t/".lJtJt~a~moQ
Tr~de~;f'I'élme~A:stfl.avent orV$ntQ.lin,
The mQstcoml11ontelieverihhalerusedforasthmaand emphysema.
Saibutain(;)Jllp~tli()'PIPm···tSal-but-ia-itnol,ll;.pra,,,ftoilpIUmj
Trade name.: Cbrnbiv~nt ".
A cOrrlQinatibri d'rt;Jg used mainlY for Patients with severe. asthma and
emphysema.
Sal".,êterof(Sal,.met~e~rol)
Trade, name; Serevent
Similar to salbutamol but lasts longer. Use<:lfor severe asthma or
emphysema.
The preventer inhplers (:1'0 not bPen4o~fch,é~t4ml,T:le(ji~tely w~.entight" bi:Jt
r.athe'rprev.erit .asthma syrnptomswnen usedsr;e9UI~rly;,ona daily' tiJasis..,They
do nQt':G~r~:flSmma't?~':tPr'~V§'!Jli1!!i~:'~y,~p,t,Q'rm~'hEi.r:1C~1ri.lt8t:m1e', THére is
on Iyonel~p'e 'ofprevel1terinti~lêfax~Habh:Háthe FreeSta:te public service,
but it Gom:es~irl 2 s~féf;l'~~bs(tOo i8nCl!'~.()O). It is.ea$ilyre,cQ~ni;zable to patients
because itcbmé'S in'ai:>igboxWhicl1:.ál.só contains aspaeer. This isa plastic
bottle shaped dëvice used with the ihhaleL It increases-the amount of drug
whi~hTeaché$ the alrW~ys.
A248
Bude~onide·(Bu~d~s·o·nide)
T:r.ade·name: If::iflámmiqe
Preventer inhaier used for asthma.
Relie.llertlhhiilers4êaqe 15,Questions.1,72 ....,·1.8:landi.1!'1i'iF.!aqe:1],
Quest/oils 2if1 ~ 242)' ". .. ,.,
If the patient uses.a reliever inhaler, indicate the rnarl1,eli>y~p!;:icEiti~l'awXin the
adjacentbox. You mu~tthen completethe.qqe~~!J;in;,~lg@~i:~ê ai:)out difficult
breathing. You must check a/lth~ relie.ver:fr:ih~l~tsJlife]):~iierlt"uses. and ask
the difficulty breathing question for each OAe ..
The .·.PDA·will.ask,youJojlJdicatewhetner.ihe;p~tient;lI}''e~;apc'lb,h~lE?por not
sep.ara'te1y fór'e.ach:;n:Jj!J/~r onothê· ë~~tr !fy~lj;i@i$~të.'Y.ES'it;~i.l:l' .
automatieally Skip to'the;difficult"breatning question betore rëtl;Jil1ihg,to the list
of inhalers.
A word of. caution,- patients may notrbe familiar with the terms "reliever" and
"prevenfer". A~I<them inste.ad't6 ioëhtify .rnedicatión ftoin the chart.
RELIEVER INHALERS THAT' YOU' ARE:USING NQW.(lnterviewer, Check. All that apply),
YES NO
172 Fenoterol'(Elero!ec) x -'11j,PQes.Jj1isirihaler,irriprove ypur'difficult x
brêathing minutes' after usingrit?:
174 Fenoterolllpratropium (Duovent) x --i 17~.Does ~hisjfit\aiêi"improvê .yqur difficult x
brealhind.miriutes'.ilfteruslnQ i~?
2Ri;;e'j.;vte6n;te,2tH~nh~a)'l.e·r·s/(.Rage\1.:5., ...J.iltiest.ld.,ii's ..1.8..4'''' .',.1:86;,..P.a.ge.·..;.1t:guestlo.n.s
The$i3 inhill,ef;s' aré.ve,fiY êX;Pi3nsiveahd for'thisrëa$Oh w~wahfto know all the
cietailsabbuthow,tl1ê JDatientsare using Wml.
ASK pati~'nt$ :9~ing 8,\Jëlespl1iêle;''l/hethêr:tli~y know if.tl1êY'91reon the tO,Oor
20Ó' str.ength ihha'ler,. ,Some patients m~y; not know,' For-these patients m3fk
Budë!i()Mi~e,(cjom(kl5nowthJ;dPse). Ther:Lá$k't~em how mé!ny,tfmeslhëy use
tl)e.inoaler p.~tdáy:;and lê~tly hQ.Virtj'~r'lY.pJi~·thë.y use at.a tfh1e: Thi$will
enable us to,calculate hew-many inhalers,they'wouldineed In-a-year and:give
us an ihdication of cost. .
PREVENTERINHALERS RECEIVE!!) TODAY (Inter'.llewer:Ch6osi;i ONE).
NO, oHimes,taken each day No. of-puffs taken each-time
184 Budesonide 100 '185 186
184 BlJdesonide 200 x 185 2 186 l
184 Bu(fesqnide (don:t knOVf the t!pse) 1'86
A249
Pr&dnjs'one,(Rage3f4;f(l)U~tions,J;32"-_ 138)
Prednisone (pred~nH;on€!) is,an~ariti;'ij:jflámmé;ltory medica:tion usedfor asthma
and sometimes emphyse'r'na, It is also used for other chronic disorders like in
patients who have had a kidney transplant
Patients with asthma or emphysema either receive it when they have abad
attack or sometimes, in véry severe cases, take it every day to prevent
symptoms,
They are easily:te,cbgr'lizéjble.·pecause'thEly'are smi3ll'white tablets. When
used for attacks they'ai:e usually taken 8 at-a-time, once in the morning,
lf'the patient reoeivéd predalsone todáy,.entet the nurtlber'of'tirnês.itdsto be
taken each day, the number oftabtets.át atime and the ri.umber of days it will
be taken for.
IntêrViewer: 1)10 the patient receh;:ë,any;Prediiisonetiltilets,to taKe;hoiné today?
No,'or:tiines to-be NO. onabletsJo,be· ·No:pfdays to be
ti;{keneaêhdé\t . ,taken ê8ëh.Urrie taken.Ior
187 I- -,E-S-----------r-. -,---i=1.""ii8""+=I':.::;· ~:L---+.=18:.;;.9::;.,;J-S==='----i=49"'O=-r=[''-o-----i
Y X
NO ...... go to.the next. question (top of:page 16)
If the, patient is tJsing prednis;~l\1e).~tbQme Oh:a regular basls, enter the
nurrioer of tïmes, ins to beêt~Ren el:lcn'day. and the number of tablets .to be
take.nat,a'timé: Ybu;iNillr,lote',tli!at-youiare nbfrequiredto enter-the.duraticn-of
th.e.dOOfS.t3:.Qecausietthé:l?~tientU!~es' it regularlY at home, it is.usually taken
ellery day,
Interviewer:.Is':Ih'e,pfil'éntusing\PredriiSónê'táblels\al honiê'ón';~I';e9(jla(básis(ïi1isime.aris'daIIYor·alrhost every .dlliij?
247 I-_- ~N""o'--'. o:;-f"".time.::,o.::s· :,::ts:::k:·.:e::':eon:a"".".':<:::,I:1d:á..::L...·Y I-"IN:_::o,:;C_,!f;_::I::,:áb::;;!e::.:;ts::."::::.ak:::;e,,,n.;:::e:::,:ác:.:,:h.;:::ti:_::ni=-e---l
.YES X ..2118J j I249I ,
NO,. _,. go·tb,the next question (16p·OfP!lgetS)
A'rltib'iotics .(Page ;1ifJr~,!uestion~,1,91 ,,,"22(7)
A~pin y01.1'fo!10w'tht3:~an'Je,'Ï~lo~edort3;:ê;1,~;wthieth'inh~l,ers arid ·the'pr~dr,Ji:sone,
fir~Wasking' at:i.otit:aritibidficS~reÓei,Yed'tpda,y'~nd'then about-those "that theY
are·.\:lsing'.n'9liVCIfhPrnê~', RéiTleri1be~t ,th~Fp?iJjents.might nót.·re~li:Zethatthe
packet of:tab,lets ih'their hands-isra» antibiotic; rather compare the medication
th~y have with that onthe- chart.
·it:moxi(jillin·(A;.rnoxci"cil"lin)
TradE! name; Beté;lmox, Arrioxi.1
This is ,avery eommoniy,',u~eq áritipibtic e$peciallyfor ·respiratory tract
itifeCtións .($ii1usitisetc), It cptne,s' ih:2,)sftéhgths, '250 and 50'(), Both are
purple and blue capl;iOles,buf the 500 is;twicéthé,size qfthe250.
Anio-*jcillirj>/c(~.Ytlli;frli,ë;'~cid(A,'móx~i:.;qilclih Fclav-u-Ian"ic acid)
Trade name: Bio-AmokSiklav; Al!gmentin
A2S0
This is used less commonly for respiratory tract infections. It come's in a
bottle.
Cotrimoxazole (CO:..tr-icmox~a-zdle)
Trade name: Cozole, 'l3actrim
This is used, for r;~sp,lrat0rytract infections but also for P?itientswith HIV.
When taken evecy:(lay ltprevents some .of the infections ,pepple·with
HIV/AIDS gêta~:tlt1!~,r ihmillJne ~ystern becomes. prÓ·g.r.ês:sivëlYw~a.ker.
It comes in a:b~i.s1~~;8~S.~:-P' atients,pftenkl\lOw exa$tIMf,~~~~t\~?y~~~an/vv.hen
y<:ius'~Y.'~t~~or;(EHDstjr:)':fpiW..•:.Q(5n't e~nfq~~itVJith Qtt\lér'r:r~Jy~~iQrt~which
com~: in 1:>1i~,t:$r<paqk~(~~i:]~ciallyparacetamol which has,~rs,irr\ilar apJ'i)ear:ance
(large roumlwhit~ tiiblét):.
DOJfYc¥cline.(!Dox..:y~cy.;cline)
Tradé nap:'\e : D0*,y.êlih.
Can be used for many dlffêrenttypes oflnfectiorrs some ofth'ern respiratory
(bronchitis). Patients with damaged lungs sometimes ge.t very frequent
inféctlons and us'eDoxycycline ev.ery day to prevent-these. .
Erthrornycih ~Ery-thr0-ri1y-cin)
Trade na-me, Rl;jbintycin
Used"for re.spiratory::tr;áct infections·especially in, patie.ntswAo.are állergicto
pe.niG_illin. RUbiÏT1yéih ta:bJët$'are hard to miss - they are aneon pinkl .
Flue/oXa.cillin (Fh.J~clox-a"cil-lin)
Tr(ld~ n~me; FlciXapen
A.form of penicillin used,for infections in the ear and of the skin. Smallish
capsules:
Fluc.o.nazQ/e (Flu:,con.,a~zole)
Trade name: Oifh.lcan
USedU()r'fun,g~nlntêCtionsJike thr.ushbothofthemoutl:l and of-the vagina.
Flucoh~tóle is: lJ$U~l!yres~rvedforPlatjerij's with, HIV as they get v,ery Dad
thruSh of'the fëodpipe Whi€h can ptevent then from swallowing. Often
patients withHIWÁIDStake this every day. It 'comes' in a plastic bottle and
th'e táb.lets' are pink and ,$qu'arish id shap~,
Peni~illill \IK (Pen~i-:GiI~linVK)
Trade name: BetáperL .
This has a, ve.ry<long namewhibh, is abit ola mouthful
(pher1.oxytt1éthylj::>éniGilliri) $0 .i.!H~alleqPen VK tor short.
Usedfor a Wide range ohnfectibns bLit:rhbstfrequeritly tor tonsillitis anC!
pneumohla.
Once again you will need to indicate whether the patient has received the
medicatlen or not, how m$ny til'J.les it is 10 be taken each day, the number of
tablets at a time ahdthe'duratiop of ttle,c:owrse., .
Yo,uwilll1otice thatfor ':qntibiqtiC$, ,tl1átYQU are using noW" y,ouWill netneeëto
fill in cletails of-the course duratlon; as these are usually taken everyday.
The. PDA Willask-you.tó il'lcli~te YES orNO tdé.a'c,h .olthese antibiotics in
turn, If youirrdieate YES. itwill automatica'lIy skip to the questions about no.
of tlmes per day, duration pt course. etc.
A2S1
ANTIBIOTICS RECEIVED. TODAY (Interviewer. Check ALL that apply)
No. oftlmes to be No'ót No. of days to be
taken each day lilbleis/capsules to taken for
beitaken each. time . (Duration of course)
192 Amoxicillin 250mg capsules
(Betamox 250) 193 194 195
196 Amoxicillin 500mg capsules(Betamox 500) X 197 3 198 1 199 5
200 Arncxicillin/clavulanic acid tablets(Blo-Amoksiklav) 201 202 203
OtherMedication (Page 16, Questions 22B --.229, P'aqe; fB.Questions 2:r8
..,.2·79)" ..
This-asks about 'avatietyofother medications,commom[y use<:fforrespiratory
probl~iT1s. Follo.wtli'i:l~prq~e'di.Jteas·P,efq"r~.,q~t t!1is~iill'E~yOl'J.'qiilyh~d .
indicate whether'the items.are '''received t0day" or,i'that you are using;new".
We de net requlrémáté q~tail~d.irif()rmati9ri for-the.se. The. items ar,e
displayed. iri the visll.ál ai<:l~o:lëtei:dingto whether they are tablets, nasal sprays
ete, but listed in alphabetical order.
The items appear inasingle listen the PDA You must check all the items
that apply.
Acetic Ac;d·Eard;'dps
used-to dry out leaKing ears.
Bec/omethaso.ne Nasa/$pray (Be- clo-me-tha-sone)
Ttaqe name: Be91ate
This is used\ferthe·treatment ef hayféver and "sinus". It Gemes it a little
brown.glass bottlé.
ChJ.orpheniraminé GChlór-phe"ni-ra-mine),
Traqe'R'ame:,.AJI~m~x
This is a' antl:;h'jsfamine used:forallergies, hayfever and sometimes the itch ef
eczema. It'c:omé,$:á.s:small'yellbw'faole'ts:
Eiltllapril,(Ena~la~pril)
TraQe names: Rer*:ec, Hypa~
This is a blood pressure medication. The reason that we want-to know about
iris that it.causes.a t[óubl~.solile cqugh as áslde-effect. It comes in a' blister
("tin-fóil") pack with the days of the week.writterr en the packaging. .
Mist£J(pecto.tant'(Mist Ex"pec"tb-rC!nt)
Trade name: same
Thls is cough mixture.
Nystatin suspension ~Ny"sta-tin)
Trade names: Nystaëid, Óé!nsJat
This is a suspension for thrash'in the mouth. It comes with a-little dr0pper for
patients to-suck up a ml at a time. This isthen dropped into. the mouth and
rinsed around.
Oxynietazo/iné.N;J~arSpray (Oxy"i:néta~zo-line)
A252
Trade name: Drixine
This is a decongestant nasal spray used mainly for patients with sinusitis.
Paracetamol (Pa-ra-ce-ta-mol)
Trade names: Painamol, Panado
This is the most common painkiller in primary care.
Paracetamol/codeine (Pa-ra-ce-ta-moll co-deine)
Trade names :Painamol Plus, Betacod, Dolorol forte
This is slightly stronger than paracetamol alone and commonly used in
primary care.
Sa/butamol (Sal-but-a-mol)
Trade name: Venteze
This is the same as the reliever inhaler but in tablet form. Venteze tablets are
easy to recognize as they are lilac in colour.
Theophylline (The-oph-yl-line)
Trade name: Nuelin SA
This is a medication used for asthma and emphysema.
OTHER MEDICATION RECEIVED TODAY (Interviewer: Check ALL that apply)
VISITS TO OTHER HEALTH CARE PROVIDERS IN THE LAST 3 MONTHS
Pages 19 - 28: Questions 280 - 486
This is laid out almost exactly as it appears in the baseline questionnaire and
so I will not go into detailed explanations here.
Remember that there is provision for you to enter 5 visits to health care
providers (HCPs) other than the clinic (you are conducting the interview in) in
the 3 month interval between interviews. You must therefore prioritise "big"
visits like hospital admissions as these are very costly. If a patient has been
to a pharmacy 5 times and admitted to the nearby hospital once, be sure to
document the hospital admission and rather leave out one of the pharmacy
visits. Other 'big" items may include visits to a traditional healer (where
patients may spend a few days). If there are any visit to HCPs where the
patient has had to spend a few days be sure to document the details for these
visits.
A253
As before each visit is recorded over 2 pages.
Thé tirnefnarne is .particularly important and' shOuld qe ~~plélitl~a C\gain to the
patient. It includes an events between the 2 interviéws·Jwm the moment the
patient left the first interview to the moment they stepped into the follow-up
interview.
Be aware that HCP visits may fall at these outer limj\s>óf tne'@rmonthperiodof
interest. For example a sick patient may have, gp,ne dir~:Stlyi.fi:orn,the baseline
interview to. ho~pitaL .That aClmis~ion must .b,~r,e~ro~ëLih thé follOW-Up
questionnaire. Anotlier patient may.'.have vi~~e:d; él rjriv.ate,tfQdtor on the
m0rnil'lg of-the follow-up interview. That visit must bé'd0êqnienteo here,
Unlike the baseline questionnaire, you wiILbe:;asked td: ent~rOthe.total number
cif visits to élll other health care proVi!,jéfS J:jesid~s the clinic bêfbre eritering the
details foreach visit.
280 Haveyou bëëtito áriotlier'hiiiiltWcare.provlder beSldes'tIlis,clinic' inthe las(3 months after our first interview?
YES Ix
NO I
28·1 How 'maf1y:llines"haYe YOu'.beenjo.an O,tliër'h~alth,care p'rqil,l~er'bifsléles:tI\is' cllnic'iri'thei'asf3' montnsioifter' our first
hiterviêW1
Intervievioer: Enter number below: Then enter details for the visits:
z
CAREGIVER COSTS IN THE LAST 3 MONTHS
Page 29: Questions 487 - 502
This 'section. attempts' tb ca.pturé I$st. work or opportunity.to Work ofp~opJe
who care for·the patient at home during the ,3 month interval between thé 2
intër'"i~Ws. ..
Tb date approximately .90% :otthe corqP.létéd: interviews reflect-that the patient
does h'ave a (j)i'!regiy~r. aJ home. Pléá~I:!;:erlsl:lr~ that this person is caring for
th.e .:patie,nt ,bf3~"ldtj.~ of poor .h~til,6and not because of .other reasons.
Pe.o[!l.le viho are fulfUling ;usu~l·fi:!mily rdlës (like. mothers; who look after
husbands and' chiléfren): and .;vno are' 119t.SR(i)cifti::aïlylooking after the, patient
because of lllness are not eenslsered oareqivers for the purpose of this
interview. Likewis.e family or' friends Who. ~e!p .9ut dtjrió.g busy Of stressfl;J1
times (like, fuheral,s, exams. efe) but ndt because of illness are also not
consider.ed caregivérs.
Remember that,you want to. capturecarer time, not.companion time (which is
papture'd ungér trav~1 t«the ciii'lic' or qther'H~P visits). Ofte,n this can be
diffi~u'Jt to tease out .as the same' person is both carel" and C.!ihie/HCP
companion. fry to understand how much' Clays they devote to visits to the
cliniczóther HOP and how m~ny days they deyóte to carii)g .fi:>fthe patient at
home. This time should only be capture,d ifthe oarer is missing their usual
activity (work; schoot, lookin!lfor work) tore are for the. patient-at home.
A254
Remember that patients aften have more than one Cê;I_fi§§iverl;i.mit the patient
to the person who spends ,the mest-time lboking. áfte.rthé :patient.
ECONOMIC IMPACT OF ILLNESS
Pages 30,- 31: Questions 503 - 523
The employment questions are repeated at follow-up since many people are
employed seasonally and economic circumstances (and therefore the impact
otillness on them) tend-to ohanqeoften in ourcemraumttes.
You may need to explaih this to patients Who appear td be: losing interest
towards the 'end of tlrë interview 'and are irritatéd that you are asking them the
same questions as' at :baseline.
Remember that you may (>nly .choose ()ne option to descnbe employment
status. Choose the option that "best" described the patient's employment
status.
Only enter the number ef gays ¥!JJéll:)lete work/;l;Iftend sqhool/loOk for' work
becfluse Qf iIIneS$, nOtfoT al1)l ether reason. Dër not eount days oh annual
leave, days away to attend funerals, stud\lleave etc.
The questionnaire instructs the interviewer to cor:mpl'ete question 51:6 (income
last in the. last ,3 months) for aU péltiepts who indiGélte that they receive an
income (employed, self"'.emRIQye(:,i'),. You do not need to collest this
infQrrn.êtiQp, fr9rn, pl;lt!~nt~~.\¥hgb~; ) r,lqt ingiG~te that they receive an income
g~pê.hdeht on tHe, aliii1f,y to V\ib~k ,(unem,pJo¥ed\ :studenUi:eamer, receiving
gránt/pension, Qthe~;). FQf. tbes.e ul1'em,ployed (non';io.come generating)
p;ahents' skipte, q,\:I.e'stion$21 (I.<i),sat:jo~in ttle, lilIst3 m,ontns?);' .
Both empló~ed and LJhémple~e(j patients (he. aU patients) should be asked
whether they have lost a jsb. in the 3 rnOrltm interval between the 2 interview,
and ,if.yes, how, much they used te earn when, still employed, Again We only
want to knOw,about Jobs that have. been kist as 'a resylt of any iIInfiJss (not
just respiratory illnes.se$). You will nee.d tp prpbe tb~epatil'iln.t and investigate
why tOeY lost to JQbto eo.SIJre lOgt ;itVJ~s Ipst Cl,S á rteS'l;JIJ olillhess arid not for
dther reasons (re,trenchrnent, p00f perforri'lêinee, rnóved t~wns ete),
Tnis section ends wilh th~ Same qu~stLQ{1:;ap.opt what the household did to
cope-with any medical costs incurre,q by the .patient (if any). The dlfference is
that at baseline t.he question 'a.s~ed about the last year; at follow-up the
questien only cefers te the 3 month interval between the. 2, interviews. Be sure
tb emphasise this te-the ,patient
Ag;:ïiri, you l1J;ay n:ee:dt()~in:dit'afe NotAp.pn~atlle '(the las]. 9ptien on the, paper
version; the '!;N" button in the low~r I,eftscreen orth~ 'pDA?'if the patient did not
incur any medical costs d.uring the 3 rnC?n}h p'êripd. Kêep your thinking taps
on here - patients whe. report visits' to priijat~. doctors, traditional healers,
pharmacies ete must g.et the money from somewhere!
A255
:.HI\C : :':,., : ; " :,,';.'
~,I?,"a'g3e,1:"Questi_qn,s~,52~.~526",,~ , ,- ~, , :,,, ,
Again the sensitive questibns ,~b'ol,JtHIV have been left to the end of the
questionnaire to enable you to have established a ré:lpport with the patient by
this time, and so as not to compromise the rest of the questionnaire,
Remember to reassure the patient that we are not interested in the result of
any HIV tests that might or might not have had, only whether the health
services are offering counselling and, testing. Treat all responses with a
neutral expression (even if patients confess to being HIV positive) and you will
gain their trust.
Please note that even if a patient chooses to disclose hi,slhef HIV status to
yO,U, you may not drsctese it to anyone else (inplud:ing y0ur colleagues)
without hislher permission. This survey is unlike clinieal practi'ce where health
professionals might have to disclose a patient's HIV status to a colleague
(provided the patient has .given his/her consent for this) in order to ensure
effective care is provided to that patient. As. a researcher you have no
requirernent to share 'this inforrnatieá with allyone. Respect the privacy of
patients who disclose their status tQ Vdu; ihis indicative of the trust you gained
as a good interviewer. Don't share this private information with others.
Note that the time-fr;ame'lj; the 3' rn'oritlJjnt~rval between the 2 questionnaires.
The questlon "Have ya.,u,j;)J;f§n',te$*é·~'fQr,HiWin the past?" is omitted as it has
already l)een askéd in the::tiléjl$eJine,quéstionnaire.
PATIENT SATISFACTION WITH SERVICES PROVIDED AT THE CLINIC
Pages 32 - 33: Questions 527 - 547
The fitst 18 q,iJesti0l1S are from a questionnaire called the Consultation
Satisfaction @Ui!is'tionnairewhich is' used to rate satisfastton with General
Praetitieners in Britain. It has been Widely tested {tt 12 000 interviews) and
has been transtated into .other langUêges (él'lthough this' is the first time it has
been translated into Sothel), It has also. been used to rate the care provided
by nurse practitioners.
Do not tell the nurse that you are asking patients to rate their satisfaction with
the care provided by 'the nurses at the c;lihic.. You will immediately create a
negative-and critical environment in Which youwillfindit difficult to workl
At the same time, it,.is yOl,lr task tq esta.b!i'sh eX;:.lctly how satisfied patients
really are with the care the nurses provide at the dfnlc. In order to do this
'successfully you need to ensure that the nurses d9'ri't' feel "put on the spot"
(do not tell them that this forms part, of file TntelNiew, ensure privacy when
interviewing patients) and ensure that the irifofima,Hon you receive from the
patient remains extremely confideritii:l.I. Rét1$'s9fe the patient that all
comments will remain confidential ah~:W,ilkr;lë>t/bé:$hï~·r.e,w<i!tihtne clinic staff in
any way. It fbl.IOWsthat yoU rntlst hC5JsbQW',Q(dTs'O\-f~:asny'dfthe responses
with the clinic staff. Db nol indiCate Y0utcll~$'é3.H~fáêt,iqn,Wi.tmclinic services in
any way. Remertiper'you are there as, é:l':sCi~,rlfjfiG'Q~~~~~rtC; il record what the
patients repert. Becoming involve,d in tfuë·"q.iimipc,det:)~te :sfÉÏps you of your
A256
observer status and compromises your reports. Doeurnent poor service
delivery but don't discuss it!
The Consultation .Satisfaction Questionnaire (CSQ) asks patients to reflect
back on a single consultation, their last consultation with the clinic nurse
whether it be the moming of the follow-up interview, the eonsoltation on the
day of the baseline interview (if the patient has not beert baCk.to the clinic at
all in the last 3 moKtms;);;qr:at, some time between these 2 days. The patient
should reflect on tl;li$.:::,gP.8S!4l,lcïH9fj,t.tefore;3tternptiqg to.a.nswer any of the
questions. ·T<J~e.':tiifi~'1t~Nig~f~~li$h'1~;:.t,the patl~,nt:is ihipkiflg back to one
particular consultation, ,ahdi;llia'f_fi,is]he lasttime they saw the- nurse.
The layout of t~e qt!estions ih'oul(j áls.o be explained to the patient before
starting. Tell th~ .p:atient that you are going to. read them a number of
statements de·sJ)r:i.~im:tgheir las]. COrlsliIlta.tiQnwith the clinic nurse. You are
then going to ask 4hem to, rate haw l~ey feel about the statement ~ whether
they ~gr:ee, str0'ngN agree. disagr.ee" strongly disagree or feel neutral (This is
known as a Likert ;Scáleii,nd is used to assess many'forrns of satisfaction from
consumer services to h~'aitlilcaré). Ëxplaïh, the concept "neutral" to the patient;
that you have no feeling.s .either waY.
Then read each stateme~t 0ne. by one to We patient, ano asked them to rate
how they feel on the scale. AllbW the, patient time id think. Some of the
questions may appear repetitive, This is deliberate and improves the
reliability of the' questionnaire. Click on the chosen category on the PDA or
mark the box with an X
GlI5qgr~-~---"-"r--~~ro~g,ydisagree
The .second last question asks the p,atiel'lt to compare the quality of care now
proy;Ïqeq by the n!:H$.escitthe clibiq wilh~th.e'G13reprovided 3 rnonths,ago at the
time of th,e bas~line, interview. This i~'a!')qther transition assessment, This
time we are asses$ing the quality ofGarce.inot the patient's health status.
Rernerrrber these transitiph assê's'smëhfs requlre intellectual gymnastics and
are usually time COhsuming.
During the survey yQlI,rna'y.b~p'Qrne".êW,are thê3t PC!tiel)ts .often tolerate very
poor ql,lality of seP{iGe:s' éllJ'd f;I:t~:,lril~ot~tMo t cornplair:L This is particljlarly
prevalent in imp,Qy~ri$h~'~; eQr.t)IJ;i,i!!,l\lit!~s wh~:He peQ~le receive free servlees
like primar;y healthG~re·(":á;bad;~grWi!!l,~ is better than ne service at all"). This
m"!y pr,ever:lt. pati~Mts,·lf:qfnj~eim~,'·e,riti)'t:!ly henest about their satisfaction with
services, This .is riej'lpgliberc;i'te diiihol1esty' but rather because patients don't
want.to appearuIlgrafêfuL
Often ithelps jfYP,u,~8.P.~i:lhh0t{\tg:p~.,~~e9r\din~~the.d~,t~il~·ofWh~tthey have to
say... Thi:S,.is, {life :r~á$~ri,Ag'.'~;~bi~~( th~'!ê3st\2 ,c'luëstiqlils (Nvrmper of .positive
points raised, ,~urnP'er..<;ifi.ri~~At,i~~'J'?,'" .;:r.~.!~~dY)ou rmust\fiïl:iysieally appear
to have stqPP:e(;l~re,dwrqin:~r}Whêt0t8~tP, • q};Qá$:Jo Sáy ~'borjtJh:e servies at the
clinic. Putihe .'.qLJ~S~!Ohn~iÏ'ébr";Pb~~;a6w:ri"tHepen"qr stylusawa.y and ask the
A2S?
patient whether they have any other comments or thoughts about the care
they receive at the clinic. Leam this question off by heart; do not read it off
the questionnaire or PDA. The patient must not know that you will record
what they have to say.
Reserved patients may at this point really open up to you and let you know
what he/she really thinks of the care at the clinic. Don't write anything down
while the patient is speaking. Instead mentally count up the number of
positive things the patient relates, as well as the number of negatives (we call
the negative whinge-counting). After you have said goodbye and thank you to
the patient enter the number of positive points and the number of negative
points. The picture obtained from the Consultation Satisfaction Questionnaire
and from your positive and negative point counts may well be very different.
We will let you know at the end of the survey.
END OF FOLLOW-UP QUESTIONNAIRE
v - UFS
A258 BLOE FO TEIN
ANNEX17
May 2003 re-interview questionnaire
A259
ANNEX9
FREE STATE LUNG HEALTH SURVEY
RE.INTERViEWING QUESTIONS',FOR MAY 2003
1. Question 19:
Eng!ish: For how lorig, have you been coughing? (days, weeks, months years)
Sotho: Ke nako e kae 0 kgohlola?
Afrikaans: Hoe lank hoes jy al?
Zulu: Sekuylslkhatht esingakanani ukhwehlela?
~hosa: , Kudala kangakanani Likhohlela?
Origipal Response.. , ,..Re-lnterviewinq
response: , ..
Reasontor
Difference: , " , ".., .
Corrective
Action: , , .
2. Question 232:
English: How .do you usually,travél.to'lhis •c. linic?
sotho: o II.w.aet~~ tlo tI~ ki'! ~hg kJiïii~i[,1g?·
Afrikaans: Hoe kom jtge.woonlik QY hierdie kliniek?
Zulu: Ujwayele ukuhamba· ng!!ni uma uza kulomtholarnpilo?
.Xhosa: Udla ngokufika/ngokuzei njani kli[ekliniki?
O'r:iginal.Response: Re-interViewing
response: .. , , , , ,., .
Reason for
Difference: , , ' '" .
Corrective Action: •
• • • • • • • "" ••••••.•• ' •••• " ••••••• " ••••••••••••••• :' " •• ', ','.' ',' 'Co .. " " ••• ,0 ': ' ••• _', _ .. ! ._••• _.•' •• ',' •• , ••• ,',: , •.• ~'.' ••••••••••• :'
EMgli~h: Have you been-to .another health care provider I;i.e~idl!s this «linie Jn the last 3
mOnths'?
Soiho: Na okilewaya sepakeng:se seng sa-bophele bo.ntleIe kliniking. ena
dikgWéding tS"e.3 tse fé_til~n9? .
Afrikaans: Was,jy gedurende die afgelope':tmaandeby'n ander
gesohdheid~Qr'gvo,orsieheribe.halw~ hier,die·klinifi.k?
Zutu: LJke;yoiayá i<w.enYe ind~woyrf~tnpi!6~lJle~inyarig~reiiMtathu ezendlule
ngaphandle kwalorntholampilo' (klihikhi)?
Xhosa: Ihg1;lQaIiki:lona elinYe,!tik:O,l~ii:;liripiIO·LJblJkhe'wa.y.ákLJIÓ kwezinyang1;l zinlathu
zlqithlleyo?
Oriqinal.Response: " ." , Re-inte"riiieWing response:
Reason forDifferenc~:
; .: ;.; ' ;,; - "..;.' ; ' ' ; - .
C;Of[El,ctive
Action: , . , ; .
4. Question 469:
English: HêS t!irjyóne· (irjch,ldipQ f~njiJYotJri~hds)109ked·a:fter you ijl home. because of
any illness 'in -the lasi'3. months?
A260
Sótho: Na ho na le molho (ho keny~lI~tswa ba lelapa le metswaUe) ya neng ao
hlokomela lapeng ka lebaka la i:lo~ula ho. itseng dikgweofngtse 3 tse fetileng?
Afrikaans: Het enigeiemand (insluitende familie of vriendê) jou die afgelope 3 maande
tuis versorg, as gevolg van enige.siekle?
Zulu: Ingabe ubêkliona llmuntu (urhriper;ii noma lJrhngaHi) ooekukunakela ekhaya
ngenxa yokwguia kwakho ,kulezinyangaezint;lthuiezendlule?
Xhosa: Ihgaba iJkhQ'riaurnritu ~k",sapho n'ez.ihlobo)QYew~~lJkhathalela okanye waku
jOhga usekhayent ngexana lengulo, noba y~yiphina. kWezinyangazintathu
ziqithileyo?
Original Response:", """""""""""" ". ,,,,,.,, .. " .Re-interviewlng
response: " ,.. ,.. "." ".". '."
Reason for Difference:
',' • • • • • •••••••• ' • • • • •• _. " • • '.' ',' " • • • • • • • • • • • • 0,,' • • • • • • • • • _, •• '0 •••••••• 0', " • ,_, • • • _, • • •••• , • '.' •• _ •••••••• ": • • • • • • ._. • • • • ~ • • • • ••••••••• " .' •••••
Gorreclive Action:
••• '. ',' ',' •• ". " ••••••• : ••• ,', • '•• ; •••• ,' _"~. ;"0"',- ._ .;. ', ,', .- _,;. •• '••••• ' .~•••• '. " •• "," •• ,' •• _,' •••••.•••••.••••••••••••••••.•••••••••
5. Ent~t Que$tion. number cïfyour .cl1oice:
Original Response: Re-interview.iAg response:
Réaso.Ï1for Qifférence:
Corr:edlve,Actibri:
, ,', ••••••• ' •• _, 0'0 " ••• ', ,_,', ••• ,' ••••• , •.•••• _ _. _,' .' ••••• 0" " •• ', ••••••• ,' •.•••••• '-.' ••• ',' •••• '•• ', ••••• ,' •••• , !:•••••••••••••••••••••• ~•••••
...-.- ' ;
A261
ANNEXI8
PALSA project flow chart
A262
PALSA PROJECT FLOW CHART
Consultations between FS DOH, MRC. UCT,
UFS, WHO ete
1999-2001
Responsibility- Dr. Litlhakanyane, Dr.
Zwaresntein, Prof. Bachmann
Local adaptation of WHO Guidelines
May 2002
Responsibility- Dr. R. English, Prof. Bateman, Dr.
Zwarenstein, prof ..Bachmann
Piloting of PAL~A i.nter:vention ma,terials, that is
guidelines, aoaëernic deté!iling training anc! desk
blotter.
November- 2002
Responsibility- Dr: R. English, Dr. L Fairall
Piloting of draft I, II and III ofLHS Baseline
questionnaire
Nov-Dec 2002
Responsibillty- Mr ..B. Majara
Production of'PALSA intervention materials
January -200'3
Responsibility- Dr. L. Fairall, Dr. A. Bheeki, m. R
English,
Training .ofPALSAtrainers
Fel:iruar'y.200.3
Resp6.ns.ipilit'y- Dr:.R EQ9!is,Ji,.l)r, L. Fairall, Elr.
A. Bheeki, Mrs. P: Mayérs, Mr. B. Maj~ra,
Mrs. A. Petérs
Quality.checks of PALSA trainers in non-trial
cliniës
Commencement of PALSAtraining:.in
intervention clinics March to April 2003
Responsibility- Mrs. P. l\IIayers
Beginning of.April2003
Responsibility- Dr. L. Fairall, ML B. Majara,
Old, C::::',6 t:,.p.in.o''''~ rTQ .(',.Y'"',.rlj ....~+~.~·_~.,
Recruitment & training .o. f Lung. HealthiSurVéY·
(LHS)fiéla .wéirKers
End óf Aprin~o9~
Responsibiiity- ProfDingie, Dr. L. Faii'aU, Mr. B.
Majara, Ega, Christo
Recruitmentó! COHORT
Oommencement of Baseline interviews
Beginnihg of May 2003 '.
Responsibility- Dr. L. Fairall, B. Majara
A263
Continuation of PALS A intervention clinics
training
July2003 Pilotinq.ef the Follow-up questionnaire
Responsibility- Dr. L. Fairall, Mr. B. Majara,
PAlSA trainers Mid July 2003
Résponsibility- B. Majara
Training of. LHs field workers on Flu
questionnaire
End ofJ.uly 2003
Résponsibility- Dr. L. Fainall, Mr. B. Majara
Continuation of Baseline interviews and
Gemmencernent of FlU interviews
August2,003.
Responsibility- Dr. L. Fakall, IIiIr. B. Majata
Corilpletign,.Qf!dati'J tollec:tion
November 2063
Responsibiiity~ Dr. L. Féjiréill, M.r. B. Majé:jra
D.ata c0din~/cléáning/ah<!lysis
Dec'03 to !"!'iD '(')4 .' . .
ResponSibiiity- .pr0f· S:aG~r:nênJr,.Prof, Joqbert,
Dr. ZWarehSleih, Dr. Féijrali, Mr; Mêjara
Presentation Of trialresultslO stákeholders
Mar 'Q4 to Jl,lly '04 . .
RespoMiI?ilj~y;. Prgf.'Satem,ann, Prqf: ~achmarfn,
Dr. ZWé!rehsf~in, Di'. English, Dr. F~ifá.li; Mr:
Majara,.Mrs. Peters
Thesis reports/articles writing
Mar '04- Nay '04
Responsibility" Or. English, Dr. Faifáll, :Mr.
Majara . ..
A264