- The CONSORT-Outcomes 2022 Extension adds 17 outcome-specific items to improve reporting of randomised clinical trials.
The original Consolidated Standards of Reporting Trials (CONSORT) 2010 statement details the items that should be included when reporting the results of randomised clinical trials (RCT). However, trial outcomes are still often inconsistently or incompletely reported. To address this need, details of an extension to CONSORT that outlines the essential outcome-specific information applicable to all outcome types, populations, and trial designs, CONSORT-Outcomes 2022, have been published in JAMA.
In addition to the original 25-item CONSORT checklist, the CONSORT-Outcomes 2022 Extension includes 17 new outcome-specific items that should be reported for all RCTs:
- The rationale for selecting the domain of the primary outcome
- for each outcome, a description of the measurement variable, analysis metric (eg, change from baseline), aggregation method, and the assessment time point
- if applicable, a definition and rationale for the minimal important change for the primary outcome
- the cut-off values used if continuous outcome data were analysed as categorical data
- for assessments performed at multiple time points, the time points used for the outcome analysis
- definitions of all individual components of composite outcomes
- identification of outcomes not prespecified in the trial protocol or registry
- description of the study instruments used to evaluate the outcome, their reliability, validity, and responsiveness in a similar population
- description of the person who assessed the outcome and qualifications or training necessary to administer the study instruments
- description of processes used to ensure the quality of outcome data during and after data collection, or inclusion of a statement on where this is available
- definition and justification of the target difference between treatment groups
- description of methods used to account for multiplicity in the analysis or interpretation of the primary and secondary outcomes
- description and rationale for outcome data exclusion criteria for any outcome, or a statement that no outcome data were excluded
- description of methods used to handle and evaluate missing data
- definition of the outcome analysis population in relation to trial protocol nonadherence
- inclusion of results for all prespecified outcome analyses or a statement where these results are available
- justification for performing any analyses that were not prespecified.
The authors of the extension believe the inclusion of these items in all RCT reports will help to further enhance the value, reproducibility, and transparency of RCTs and reduce the problem of selective reporting of trial results.
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