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 StudyPresented by: Kurt Daniels (B.Sc UWC, M.Sc Stell)

Division of Physiotherapy

This Project was Funded by SURMEPI, Non Communicable Diseases Grant and FIRRH

Map of Breede Valley Municipality

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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

Background Continued…Despite differences in etiology, both diseases could

result in pulmonary scarringMany cases of COPD may be missed or wrongly

diagnosed in high burden countriesThe 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/defaulted4

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Rationale

Patients have to deal with more than just the clinical symptoms.

Disease & Treatment may have considerable medical, social and psychological consequences

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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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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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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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)9

Results

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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=145Reasons:- 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=11Reasons:- No Contact number n= 11

Patients Not Included n=31Reasons:- 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=59Reasons:- No Contact Number n=59

Patients Not Included n=29Reasons: - 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=1Patient did not understand spirometry manoevre and results were not repeatable to within 200ml

Excluded: n=1Patient 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

Population DemographicsDemographics 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)12

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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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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Results of the HRQoL (SF-12v2) Scores

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Discussion

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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 patternSix 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 cured17

Challenges and Suggestions for Future Research

(Limitations)

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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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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

DOTS vs no DOTS

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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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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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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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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.24

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-Infection. Acta Paulista De Enfermagem, 25(1):41-7.

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QUESTIONS?Thank You

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