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JAMA | Guidelines for Reporting Outcomes in Trial Protocols

Special Communication
December 13, 2022


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

Guidelines for Reporting Outcomes in Trial Protocols

The SPIRIT-Outcomes 2022 Extension

JAMA. 2022;328(23):2345-2356. doi:10.1001/jama.2022.21243

Key Points

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.

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