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

<bold>Background:</bold> A significant number of TB survivors continue to experience chronic respiratory symptoms due to post-tuberculosis lung disease (PTLD), but has no known effective treatment, with no previous fully powered trials of pulmonary rehabilitation (PR) in PTLD. <bold>Objective:</bold> To assess the effectiveness of a 6-week supervised PR programme on exercise capacity and economic outcomes among adults in Uganda living with PTLD. <bold>Methods:</bold> Randomised (1:1) controlled trial with blinded outcome measures, comparing PR versus usual care (UC) for patients with PTLD in Kampala, Uganda. The primary outcome was change in walking distance measured by the Incremental Shuttle Walk Test (ISWT) from baseline to the end of 6-week PR. Secondary outcomes (EQ-5D-5L, cost-benefit) were compared between the PR and UC arms from baseline to 6-week follow-up. Both intention-to-treat (ITT) and per-protocol analyses were conducted. <bold>Results:</bold> 114 participants with PTLD were randomised (aged 43.3±15.2 years, 57% male). Both ITT and per protocol analyses showed that walking distance in the PR arm improved significantly more than UC at 6 weeks follow-up with a difference in difference of means of 50.7±17.9 m, p=0.005 and 49.2±18.4 m p=0.008 respectively. The EQ visual analogue scale in PR improved significantly more than UC with a difference in means between two the groups of 13.7±3.3 (p=0.001). PR arm QALY scores increased, increasing the between-group difference QALY score by 0.01 QALYs ([95%CI -0.02-0.04], p=0.470). This implies an average cost of PR of US$8485/QALY gained. <bold>Conclusion:</bold> Our 6-week PR programme is both clinically effective and cost-effective for PTLD in Uganda