A Review of CONSORT Guidelines About Comparison Groups With a Focused Discussion on Implications for Rehabilitation Clinical Trials

Abstract

Objective We examined and appraised the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement and its extension from the perspective of the reporting of comparison groups (ie, interventions or control conditions against which an experimental intervention is compared) in clinical trials on rehabilitation topics. Design We downloaded the CONSORT 2010 Statement and all endorsed and unofficial extensions reported on the CONSORT and EQUATOR Web sites. We extracted all statements on the selection, design, delivery, or interpretation of data from comparison groups in clinical trials. We discussed preliminary findings during the Cochrane Rehabilitation Methodology Meeting in Kobe and then further by email before finalizing results. Results We identified 23 standards reported across the CONSORT 2010 Statement and 10 extensions. Overall, these standards address many, but not all, issues related to reporting of comparison groups in rehabilitation trials. Conclusions We recommend that additional standards be created for the selection of types of comparisons, choices around reporting of “usual care,” reporting of intended “mechanisms of control,” and reporting a rationale for the hypothesized superiority of one intervention over another when superiority trial design are used. Rehabilitation research would benefit from development of a specific checklist and guidelines to help researchers make best use of existing extensions.