Butcher NJ, Monsour A, Mew EJ, et al. Guidelines for Reporting Outcomes in Trial Protocols: The SPIRIT-Outcomes 2022 Extension. JAMA. 2022;328(23):2345–2356. doi:10.1001/jama.2022.21243
Question What outcome-specific information should be included in a clinical trial protocol?
Findings Using an evidence-based and international consensus–based approach that applied methods from the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, 9 outcome-specific reporting items to be addressed in clinical trial protocols were identified.
Meaning Inclusion of these items in clinical trial protocols may enhance trial utility, replicability, and transparency and may help limit selective nonreporting of trial results.