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

William Levack · Julia Patrick Engkasan · Allen Walter Heinemann · Stefano Négrini

19 citations0/0 files storedAmerican Journal of Physical Medicine & Rehabilitation

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Meta-analysis and systematic reviews Statistical Methods in Clinical Trials Clinical practice guidelines implementation

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.

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References

2010CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials 2014Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide 2010CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials 1996Improving the quality of reporting of randomized controlled trials. The CONSORT statement 1996Improving the Quality of Reporting of Randomized Controlled Trials 2016CONSORT 2010 statement: extension to randomised pilot and feasibility trials 2008Improving the reporting of pragmatic trials: an extension of the CONSORT statement 2004Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement

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2019In Search of Solutions for Evidence Generation in Rehabilitation 2022Selection, Confounding, and Attrition Biases in Randomized Controlled Trials of Rehabilitation Interventions 2020Cochrane Rehabilitation: 2019 annual report 2021Tools to Assess the Risk of Bias and Reporting Quality of Randomized Controlled Trials in Rehabilitation

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