Guidelines for Reporting Outcomes in Trial Reports

Abstract

ImportanceClinicians, patients, and policy makers rely on published results from clinical trials to help make evidence-informed decisions. To critically evaluate and use trial results, readers require complete and transparent information regarding what was planned, done, and found. Specific and harmonized guidance as to what outcome-specific information should be reported in publications of clinical trials is needed to reduce deficient reporting practices that obscure issues with outcome selection, assessment, and analysis.ObjectiveTo develop harmonized, evidence- and consensus-based standards for reporting outcomes in clinical trial reports through integration with the Consolidated Standards of Reporting Trials (CONSORT) 2010 statement.Evidence ReviewUsing the Enhancing the Quality and Transparency of Health Research (EQUATOR) methodological framework, the CONSORT-Outcomes 2022 extension of the CONSORT 2010 statement was developed by (1) generation and evaluation of candidate outcome reporting items via consultation with experts and a scoping review of existing guidance for reporting trial outcomes (published within the 10 years prior to March 19, 2018) identified through expert solicitation, electronic database searches of MEDLINE and the Cochrane Methodology Register, gray literature searches, and reference list searches; (2) a 3-round international Delphi voting process (November 2018-February 2019) completed by 124 panelists from 22 countries to rate and identify additional items; and (3) an in-person consensus meeting (April 9-10, 2019) attended by 25 panelists to identify essential items for the reporting of outcomes in clinical trial reports.FindingsThe scoping review and consultation with experts identified 128 recommendations relevant to reporting outcomes in trial reports, the majority (83%) of which were not included in the CONSORT 2010 statement. All recommendations were consolidated into 64 items for Delphi voting; after the Delphi survey process, 30 items met criteria for further evaluation at the consensus meeting and possible inclusion in the CONSORT-Outcomes 2022 extension. The discussions during and after the consensus meeting yielded 17 items that elaborate on the CONSORT 2010 statement checklist items and are related to completely defining and justifying the trial outcomes, including how and when they were assessed (CONSORT 2010 statement checklist item 6a), defining and justifying the target difference between treatment groups during sample size calculations (CONSORT 2010 statement checklist item 7a), describing the statistical methods used to compare groups for the primary and secondary outcomes (CONSORT 2010 statement checklist item 12a), and describing the prespecified analyses and any outcome analyses not prespecified (CONSORT 2010 statement checklist item 18).Conclusions and RelevanceThis CONSORT-Outcomes 2022 extension of the CONSORT 2010 statement provides 17 outcome-specific items that should be addressed in all published clinical trial reports and may help increase trial utility, replicability, and transparency and may minimize the risk of selective nonreporting of trial results.

Guidelines for Reporting Outcomes in Trial Protocols

“…The SPIRIT-Outcomes 2022 extension provides evidence-and consensus-based guidance for reporting outcome-specific information in trial protocols, extending the SPIRIT 2013 statement checklist with 9 additional reporting items and harmonizing reporting recommendations with guidance from the CONSORT-Outcomes 2022 extension. 17 Alignment across these 2 extension guidelines creates a cohesive continuum of reporting from the trial protocol to the completed trial report that will facilitate both the researchers' production of the trial protocol and trial report and, importantly, enable assessment of researchers' adherence to the trial protocol.…”

“…To maximize the usefulness and effect of the SPIRIT-Outcomes 2022 extension, it can be used in conjunction with the CONSORT-Outcomes 2022 extension. 17 In addition, inclusion of SPIRIT-Outcomes 2022 extension checklist items in trial registry entries (eg, ClinicalTrials.gov) may increase implementation. Endorsement and implementation of the SPIRIT-Outcomes 2022 extension by publishers and editors for their authors could also increase uptake.…”

“…When other documents are available, the trial protocol should briefly describe or outline the checklist item components and refer to the separate documents such as the statistical analysis plan so that their existence, location, and accessibility are known. To maximize the usefulness and effect of the SPIRIT-Outcomes 2022 extension, it can be used in conjunction with the CONSORT-Outcomes 2022 extension . In addition, inclusion of SPIRIT-Outcomes 2022 extension checklist items in trial registry entries (eg, ClinicalTrials.gov) may increase implementation.…”

“…16 The development of the SPIRIT-Outcomes 2022 extension occurred in parallel with the Consolidated Standards of Reporting Trials (CONSORT)-Outcomes 2022 extension for clinical trial reports. 17…”

“…Specific guidance for the content of statistical analysis plans has been published . The development of the SPIRIT-Outcomes 2022 extension occurred in parallel with the Consolidated Standards of Reporting Trials (CONSORT)–Outcomes 2022 extension for clinical trial reports …”