Guiding principles for pragmatic randomised trials of tuberculosis treatments.

Pragmatic randomized tuberculosis treatment trials can be designed using PRECIS-2 to balance real-world generalisability with participant safety and data reliability across routine care settings.

• Why it matters: Evidence is needed on effectiveness, safety, and tolerability of new tuberculosis treatments in routine practice, to better inform practice guidelines and support uptake.
• What they did: The Review lays out guiding principles for pragmatic trials, covering eligibility, recruitment, care organisation, adherence support, outcomes, follow-up, primary analysis, data collection, and monitoring using the PRECIS-2 framework.
• The result: Applying these principles should improve real-world evidence generation and facilitate global implementation of effective tuberculosis treatments, including considerations for individually and cluster-randomised designs.

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