Complete reporting of trial outcomes in protocols for randomized controlled trials is important for obtaining ethical and regulatory approvals, ensuring the trial team conducts the trial consistently, and ultimately, helps to provide transparency of methods and facilitating the interpretation of the subsequent trial results. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) reporting guideline published in 2013 provides guidance on what information to include in a trial protocol, including general guidance on how to report trial outcomes, and has recently been extended to cover patient-reported outcomes. There remains no standard evidence-based reporting guideline for trial outcomes that is applicable to all outcome types, disease areas, and populations for trial protocols, however, and issues of missing or poorly reported information with respect to trial outcome selection, definition, measurement, and analyses remain.
In collaboration with members of the SPIRIT group, we have extended the current SPIRIT statement to develop an international, evidence- and consensus-based guideline for reporting outcome-specific information in trial protocols, called SPIRIT-Outcomes. The SPIRIT-Outcomes reporting extension provides recommendations for outcome-specific information that should be addressed in trial protocols. Use and implementation of SPIRIT-Outcomes by protocol authors, ethics review boards, regulators, peer reviewers and journals promises to help enhance trial utility, reproducibility, and minimize the risk of selective reporting in trial reports.
The evidence synthesis, Delphi study, and international consensus meeting have been completed. The checklists have been finalized and are available here. The SPIRIT-Outcomes Statement and Explanation and Elaboration document has been published and is now available:
Guidelines for Reporting Outcomes in Trial Protocols: The SPIRIT-Outcomes 2022 Extension
Details about the evidence synthesis process can be found here.
Details about the protocol can be found here.
Updated May 2023
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