Clinicians, patients, and policy-makers rely on published results from clinical trials to help inform evidence-based decision-making. To be able to critically evaluate and use the results of trials, readers require complete and transparent information with respect to what was planned, what was done, and what was found. Complete reporting of the investigated trial outcomes enables reproducibility of results, knowledge synthesis efforts, and prevents outcome switching and other reporting biases – ultimately helping to facilitate uptake of trial results into clinical practice. The CONSORT (Consolidated Standards of Reporting Trials) 2010 statement provides guidance on what information to include in reports of randomized controlled trials (RCTs), including general guidance on how to report trial outcomes, and has been extended to cover patient-reported outcomes. There remains no standard evidence-based guidance that is applicable to all outcome types, disease areas, and populations for trial reports; issues of missing or poorly reported information with respect to trial outcomes remain common in the published medical literature.
In collaboration with members of the CONSORT group, we have extended the current CONSORT statement to develop an international, evidence- and consensus-based guidance for reporting outcomes in published trial reports, called CONSORT-Outcomes. The CONSORT-Outcomes reporting extension provides recommendations for outcome-specific information that should be addressed and included in published clinical trial reports. Use and implementation of CONSORT-Outcomes by trial authors, peer reviewers, journals, and other end users promises to help enhance trial utility, reproducibility, and minimize the risk of selective reporting.
The evidence synthesis, Delphi study, and international consensus meeting have been completed. The checklists have been finalized (available on request). The CONSORT-Outcomes Statement and Explanation and Elaboration document will be published in Q2 2021.
Updated February 2021