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

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.

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