Quality of life outcomes and patient-reported experiences in a randomised controlled trial for rifampicin-resistant TB (PRACTECAL-PRO): a mixed-methods study

SUMMARY BACKGROUND The TB-PRACTECAL clinical trial assessed 24-week, all-oral bedaquiline, pretomanid, and linezolid (BPaL)-based regimens for rifampicin-resistant TB against standard of care (SoC). The PRACTECAL-PRO sub-study evaluated changes in quality of life (QoL), among patients receiving investigational regimens versus SoC, and assessed patient experiences of the new treatments. METHODS We recruited participants from Belarus, Uzbekistan, and South Africa. Changes in QoL from baseline to 48 weeks were evaluated using the Short Form-12 (SF-12) and the St George’s Respiratory Questionnaire (SGRQ). Longitudinal analysis was conducted for all six domains of SF-12 and SGRQ. In-depth interviews provided narratives about patients’ experiences. RESULTS 137 patients participated in PRACTICAL-PRO. All trial arms showed improved SF-12 and SGRQ scores over 48 weeks. Proportional reduction in scores for SGRQ per month was higher in investigational than SoC groups’ Total score (13% vs. 4%), Impact (12% vs. 2%), Activity (14% vs. 7%), and Symptom (15% vs. 4%) domains, indicating quicker QoL improvement. Narratives indicated early treatment satisfaction and social acceptance, with wellbeing relying on family support, clinical contact, and counselling. CONCLUSION Patients receiving short, all-oral BPaL-based regimens show improvements across all measured QoL domains, a positive impact on personal relationships, and a return to productive life. TB trials should routinely include patient-reported outcomes.