Protocol for the development of a Core Outcome Set (COS) for reporting outcomes of clinical trials of anti-tuberculosis treatment in adults with pulmonary tuberculosis

BACKGROUND: The global burden of tuberculosis (TB) remains high, and treatment of both drug-susceptible and drug-resistant diseases is complex and prolonged. International clinical trial networks and public-private partnerships are beginning to deliver advances in TB treatment, and collaborative data-sharing efforts are being promoted to improve the transparency and scrutiny of the evidence used in formulating treatment guidelines and public health policies. Empirical studies have identified variability in the selection and reporting of clinical trial outcomes in historical and recent phase III trial reports and protocols in TB. This variability could affect the synthesis of evidence and interpretation by practitioners, regulators, and policymakers. METHODS AND ANALYSIS: A comprehensive list of outcomes used in phase III treatment trials of pulmonary TB in adults, grouped according to key domains, will be identified from systematic reviews of published trials and trial protocols. A systematic review of qualitative evidence will inform outcomes important to people diagnosed with TB. Consensus will be sought from an international panel of participants representing key stakeholder groups using a multi-stage Delphi process. The final COS identified from the Delphi survey will be ratified at an online consensus meeting and approved by the SSC. The process will be conducted according to the Core Outcome Set-STAndards for Development (COS-STAD) guidance and with the support of the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. DISCUSSION: A COS implemented in the TB trials community that reflects the outcomes most important to stakeholders would help ensure that important evidence is translated rapidly, clearly, and effectively into practice to maximise patient benefit. TRIAL REGISTRATION: The study has been registered with the COMET database of core outcome sets (study 2195, registered October 2022).