1. Fakulteit Geneeskunde en Gesondheidswetenskappe

Faculty of Medicine and Health Sciences
An investigation into the health related quality of life
(HRQoL) and functional assessment of a cured
Pulmonary Tuberculosis (PTB) population in the
Breede Valley District: A Pilot Study
Presented by: Kurt Daniels (B.Sc UWC, M.Sc Stell)
Division of Physiotherapy
This Project was Funded by SURMEPI, Non Communicable
Diseases Grant and FIRRH

2. Map of Breede Valley Municipality
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3. 3
Background and Purpose
• Despite modern medicines advances, PTB
remains a major cause of death worldwide
• South Africa is burdened with one of the worse TB
epidemics in the world and has been flagged as 1
of 22 High Burden Regions
• Western Cape Incidence of 909/100000
• PTB has been identified as a risk factor for the
development of COPD
• Recent population based surveys has strongly
linked previous PTB with the development of
COPD

4. Background Continued…
Despite differences in etiology, both diseases could result in
pulmonary scarring
Many cases of COPD may be missed or wrongly diagnosed in
high burden countries
The World Health Organisation (WHO) defines health as “a
state of complete physical, mental and social “well-being”
and not only “the absence of disease or infirmity”
Current government strategies for PTB management:
 New case identification
 Microbiological markers
 Outcomes such as cured, treatment completed or
treatment failure/defaulted
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5. 5
Rationale
Patients have to deal
with more than just
the clinical symptoms.
Disease & Treatment
may have considerable
medical, social and
psychological
consequences

6. Rationale
• The clinical burden of the disease may
exist beyond the duration of the
treatment of the infection
• Characterization of the functional
capabilities of PTB patients post-
treatment and the impact of PTB on
their quality of life may identify a need
for more holistic management of
patients presenting with PTB that
extends beyond microbiological cure.
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7. Methods
• Study Design: Cross-sectional, quantitative, descriptive study
• Setting: Five primary health care facilities in the Breede Valley
sub-district of the Cape Winelands East District
• Ethical Considerations: Ethical approval for the study was
obtained from the Committee for Human Research at
Stellenbosch University (S12/06/186). All patients provided
written informed consent prior to participating in the study.
• Patient Recruitment: The names of adult patients (18yrs and
older) diagnosed with PTB, who had completed at least five
months of anti-tuberculosis treatment, were obtained from the
TB registers at the clinics from July 2012 up until August 2013.
Post bronchodilator lung function tests, health related quality of
life (SF-12 questionnaire) and six minute walk distance were
measured.
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8. Sample Size Calculation
• FEV1 and FEV1/FVC prevalence proportion ratios
based on Western Cape BOLD data
• The BOLD study data identified a prevalence of
obstructive airway disease in the Uitsig community
(Cape Town, Western Cape) of 22% and found an
association between airway obstruction and a previous
history of PTB.
• Using a primary outcome of COPD prevalence a
sample of 200 patients was deemed sufficient to detect
a chronic obstructive pulmonary disease (COPD)
prevalence of 15 % (95%CI 10%-20%).
• To inform the planning of a larger, observational study,
a pilot study was undertaken.
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9. Measurements and Procedures
Lung Function Measurements
• Post bronchodilator spirometry was performed using the
SpiroBank II and analyzed using the Win Spiro v4.4 software.
European Respiratory Society (Economic Community for
Coal and Steel) normal reference values were applied and
these were corrected for race (African decent).
Health Related Quality of Life (The BOLD Core
Questionnaire)
• The BOLD Core questionnaire was created from existing,
validated questionnaires
• Incorporates the SF-12v2
• The questionnaire has been validated in numerous BOLD
studies around the world.
Exercise Capacity - The Six Minute Walk Test (6MWT)
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10. Results
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11. 11
Total Names Obtained from
Registers June 2012 – June 2013
n= 328
Rawsonville
Clinic
n=35
Orchards
Clinic
n=16
De Doorns
Clinic
n=78
Worcester
Clinic
n=162
Touws Rivier
Clinic
n=33
Patients Not
Included
n=145
Reasons:
- No contact
number n=81
-Died n=8
- Moved
Away n=11
- Too sick
n=8
- Invalid
Address n=21
- Not
Interested
n=18
- Gang
Violence n=1
Patients Not
Included
n=11
Reasons:
- No Contact
number n= 11
Patients Not
Included
n=31
Reasons:
- No Contact
number n=25
- Number
does not exist
n=3
- Died n=1
- Moved
Away n=1
- Not
Interested
n=1
Patients Not
Included
n=59
Reasons:
- No Contact
Number n=59
Patients Not
Included
n=29
Reasons:
- No Contact
number n=24
- Number
does not exist
n=3
- Too sick
n=1
- Under age
n=1
Total Patients included in the study n=45
Spirometry n=44 6 MWT n=44 Health Related QoL n=45
Excluded: n=1
Patient did not understand spirometry
manoevre and results were not
repeatable to within 200ml
Excluded: n=1
Patient could not perform the test due to
unspecified illness at time of testing
affecting the patient’s ability to ambulate
Flow diagram of Patients included and excluded from the study

12. Population Demographics
Demographics Total n=45
Gender (male) % (n) 56% (n=25)
Age (years) (Mean ±SD) 39.88±10.20
Race % (n) Coloured = 93% (n=42)
Black = 7% (n=3)
Respiratory Conditions or Symptoms
Previously diagnosed with TB % (n)
Average number of times diagnosed with TB (n)
64.4% (n=29)
1.9 (n=29)
Previously Diagnosed Asthma/Bronchitis % (n) 20% (n=9)
Previously Diagnosed COPD % (n) 6.6% (n=3)
Hospitalized before age 10yrs due to Respiratory
complications % (n)
Breathing problems interfered with ADL’s % (n)
Usually cough without a cold % (n)
Usually cough up phlegm % (n)
Have had wheezing in the last 12 months % (n)
8% (n=4)
35.5% (n=16)
64.4% (n=29)
73.3% (n=33)
62.2% (n=28)
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13. Results of Lung Function Tests
• 44 patients data analysed,
 n=23 (52%) presented with normal lung function
 n=11 (25%) presented with a restrictive pattern
 n=9 (21%) presented with an obstructive pattern
and only n=1 (2%) presented with a mixed pattern
• No significant associations were identified
between respiratory symptoms of cough and FEV1
or between smoking or occupational dust
exposure and FEV1.
• Spirometry results did not statistically differ
between patients who identified themselves as
smokers and those who did not.
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14. Results of the 6MWT
• 42 patients data analysed
• Mean 6MWD was 294.05m ± 122.7m
• The 6MWD was significantly shorter for patients
who completed the 10m (n=27) course when
compared to patients completing the 20m course
(n=15) (p<0.001)
• Physiological measurements of oxygen saturation
(SPO2) and heart rate remained constant from
baseline to post-test measurements
• Patients perceptions of dyspnea (p<0.001) and
fatigue (p<0.001) changed from baseline to post-
test measurement .
• The 6MWD was not associated with age
(p=0.279; r= -0.167) or BMI (p=0.461; r= -0.113).
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15. Results of the HRQoL (SF-12v2) Scores
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16. Discussion
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17. Lung Function
• A little under half the population presented with airflow obstruction
• There is very little agreement in the literature as to what the dominant lung function
abnormality is in this population
• Godoy et al (2012) found obstruction as the most prevalent pattern at 39%6.
• Snider et al (1971) found 23% of the population with an obstructive pattern and 19% with
a mixed obstruction/restriction pattern
Six Minute Walk Test
• 6MWD was reduced in the present study.
• Studies by Sivaranjini et al (2010), Godoy et al (2012), Yoshida et al (2006) and Ando et
al (2003) all reported reduced 6-minute walk test distances (6MWD) in PTB patients.
• Sivaranjini et al (2010) recorded a mean (±SD) 6MWD of 285.79±79.81meters in males
and 245.5±73.11 meters in females.
Health Related Quality of Life
• The results of the present study suggest that PTB does negatively impact on patients
perceived HRQoL in both a physical and mental capacity.
• This is in agreement with a systematic review which concluded that patients perceptions
of their mental and physical health were affected after they were deemed as
microbiologically cured
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18. Challenges and
Suggestions for
Future Research
(Limitations)
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19. Tools and Outcome Measures
• Space limitations in the
primary care setting force
researchers to modify this
course length
• For this study:
 Course length was reduced
to 20m at clinics
 Course length was reduced
to 10m at patients homes
 Spirometry was done where
space was available
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20. Patient Reliability and Accessibility
 Researchers planned to recruit patients at the
clinics at their 5 month sputum sample
appointment.
 However, patients are not given a specific
time and date to return to the clinic
 Despite the great cooperation from the
nursing staff and community workers
Internal factors affecting patient recruitment:
 Accuracy of patient personal information
(Files)
 TB nurses method of communication with
patients
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21. Patient Recruitment Strategies
 External factors affecting patient recruitment :
 Weather
 Transport
 Distance to the clinic (Some patients had to
walk ±20km)
 Food (Some clinics would hand out bread with
medication. No bread = No show)
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22. Safety
 Certain areas could only be accessed at
specific times of the day
 Rioting and unrest in the area influenced
patients turning up for appointments or the
research team accessing certain areas
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23. Recommendations for Future Research
• Researchers should build on recruitment strategies with
the understanding that clinics handle patients differently
depending on their location (rural vs town), as well as the
patient load.
• To optimize patient recruitment, a trained research team
should be sent to all included clinics during data collection
• Farmers should be consulted during the project design
phase and permission obtained for patients to be
recruited at the farms rather than at their homes.
• Even though our questionnaire used for this project had
been previously translated into Afrikaans and validated in
a Cape Town community, many of the patients struggled
to understand the questionnaire.
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24. Conclusion
• The findings of this cross sectional pilot study
suggest that patients who have completed
anti-tuberculosis drug therapy and who are
deemed cured may suffer from impaired lung
function, a decreased exercise capacity and a
decreased quality of life.
• . Future studies should investigate whether or
not these patients would benefit from
pulmonary rehabilitation. The data reported in
this pilot study can inform the planning of a
larger observational study in the Overberg
region.
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25. References
• Boland/Overberg region annual health status report 2007/2008. 2012. [Online].
Available:
http://www.westerncape.gov.za/Text/2009/12/boland_overberg_region_07_08.
pdf
• Western cape 2011/2012 annual performance plan. 2012. [Online]. Available:
http://www.westerncape.gov.za/other/2011/3/health app 2011 2012.pdf
• Aggarwal, A., Gupta, D., Janmeja, A. & Jindal, S. 2013. Assessment of Health-
Related Quality of Life in Patients with Pulmonary Tuberculosis Under
Programme Conditions. International Journal of Tuberculosis and Lung
Disease, 17(7):947-53.
• Ando, M. 2003. The Effect of Pulmonary Rehabilitation in Patients with Post-
Tuberculosis Lung Disorder. Chest, 123(6):1988-95.
• Beekman, E. 2013. Course Length of 30m Versus 10m has a Significant
Influence on 6 Minute Walk Distance in Patients with COPD: An Experimental
Cross Over Study. Journal of Physiotherapy, 59169-76.
• Buist, A., Vollmer, M. & McBurnie, A. 2008. Worldwide Burden of COPD in
High- and Low-Income Countries.Part I.the Burden of Obstructive Lung
Disease (BOLD) Initiative. The International Journal of Tuberculosis and Lung
Disease, 12(7):703-708.
• Eisner, M. 2010. Influence of Anxiety on Health Outcomes in COPD. Thorax,
65229-34.
• Lemos, Larissa de Araujo, F., Alexsandra, R.G. & Elucir Gimeniz Galvao, Marli
Teresinha. 2012. Quality of Life Aspects of Patients with HIV/tuberculosis Co-25

26. QUESTIONS?
Thank You
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