Clinical and cost-effectiveness of pulmonary rehabilitation for people with post-tuberculosis lung disease in Uganda: a randomised controlled trial

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

RESEARCH QUESTION: Compared to usual care, does a 6-week PR programme 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 randomised controlled trial with blinded outcome assessments, comparing PR vs usual care (UC) for adults with PTLD in Kampala, Uganda. Participants were randomised (1:1) to receive either PR or UC, with assessments at 6-weeks post-intervention. The primary outcome was change in exercise capacity measured by the Incremental Shuttle Walk Test (ISWT). Secondary outcomes included HRQoL, respiratory symptoms, psychological well-being and cost-benefit analysis. A generalized linear mixed model (GLMM) 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 randomised, Mean±SD age was 43.3±15.2 years and 65 (57%) were male. The post-intervention improvement in mean ISWT in the PR group was significantly greater than in UC by 54.36m (95%CI 17.22 to 91.51; p=0.004). We also observed significant improvements in HRQoL in PR greater than UC; (CAT score [-3.6 (95%CI -6.7 to -0.39); p=0.015] and CCQ total [-0.37 (95%CI -0.68 to -0.06); p=0.004]). The EQ-VAS and QALYs marginally improved in the PR vs UC (3.98 [95%CI -2.05 to 10.02]; p=0.191) and 0.02 [95%CI -0.02 to 0.05], p=0.334), respectively. The average cost of PR was US$6,468/QALY gained, equating to US$20,000/QALY gained after adjusting for purchasing power (below NICE's cost-effectiveness threshold).

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