Clinical Effectiveness and Cost-Effectiveness of Pulmonary Rehabilitation for People in Uganda With Post-TB Lung Disease: A Randomized Controlled Trial.

BACKGROUND

Post-TB lung disease (PTLD) causes significant disability in survivors of TB. Pulmonary rehabilitation (PR) may offer effective disease management but lacks high-quality evidence in this underrepresented population.

RESEARCH QUESTION: Compared with usual care, does a 6-week PR program improve exercise capacity and health-related quality of life (HRQoL) cost-effectively in adults living with post-TB lung disease?

STUDY DESIGN AND

METHODS

We conducted a single-center randomized controlled trial with blinded outcome assessments, comparing PR vs usual care (UC) for adults in Kampala, Uganda with PTLD. Participants were randomized (1:1) to receive either PR or UC, with assessments at 6 weeks postintervention. The primary outcome was change in exercise capacity measured by the Incremental Shuttle Walk Test. Secondary outcomes included HRQoL, respiratory symptoms, psychological well-being, and cost-benefit analysis. A generalized linear mixed model was used for the primary efficacy analysis (intention-to-treat) and a difference-in-differences analysis for secondary outcomes (modified intention-to-treat).

RESULTS

Between November 2020 and September 2022, 178 adults with PTLD were assessed for eligibility and 114 were randomized (mean age ± SD, 43.3 ± 15.2 years; 65 [57%] were male). The postintervention improvement in mean Incremental Shuttle Walk Test in the PR group was significantly greater than in the UC group, by 54.36 m (95% CI, 17.22-91.51 m; P = .004). We also observed significant improvements in HRQoL in PR compared with UC: COPD Assessment Test score, -3.6 (95% CI, -6.7 to -0.39; P = .015); and Clinical COPD Questionnaire total, -0.37 (95% CI, -0.68 to -0.06; P = .004). The EuroQol Visual Analog Scale and quality-adjusted life-years (QALYs) marginally improved in the PR group vs the UC group: 3.98 (95% CI, -2.05 to 10.02; P = .191) and 0.02 (95% CI, -0.02 to 0.05; P = .334), respectively. The average cost of PR was $6,468/QALY gained, equating to $20,000/QALY gained after adjusting for purchasing power (below the National Institute for Health and Care Excellence cost-effectiveness threshold).

INTERPRETATION: In adults with PTLD, a 6-week PR program elicited clinically and statistically significant improvements in exercise capacity and HRQoL compared with UC, and was cost-effective.

CLINICAL TRIAL REGISTRATION: ISRCTN Clinical Trial Registry; No.: ISRCTN18256843; URL: isrctn.com.