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. 2025 Feb 11;14(1):1-4.
doi: 10.34172/jcs.025.33575. eCollection 2025 Feb.

Is CONSORT a Risk of Bias Tool for Experimental Studies: A Big Misunderstanding

Ehsan Sarbazi  1 , Homayoun Sadeghi-Bazargani  2
Affiliations

Is CONSORT a Risk of Bias Tool for Experimental Studies: A Big Misunderstanding

Ehsan Sarbazi et al. J Caring Sci. .

Abstract

Introduction: In order to avoid bias in systematic reviews (SRs), the accuracy in selection of risk of bias (RoB) assessment tools is essential to obtain highest level of evidence for evidence-based decision making in health care. We aimed to review how 'CONSORT statement', as a reporting quality of randomized controlled trials, has been misused in recent SRs as a ROB tool.

Methods: A mini-review was performed in international databases including PubMed, Google Scholar and hand-searches for published and unpublished literature from 2000 to 2021 and written in English. The following keywords: risk of bias, "Consolidated Standards of Reporting Trials", CONSORT, "systematic review" were used. Citations were screened and those meeting our inclusion criteria were retained.

Results: A total of 11 SRs were identified that misused CONSORT as a ROB tool, four of which were used only CONSORT as ROB tool. Different authentic magazines from various countries were recognized.

Conclusion: The CONSORT statement aims to increase clarity and consistency of transparency of reporting in randomized controlled trials. It is quite essential to draw the attention of SR researchers, journal editors/reviewers as well as the reading audience to the fact that CONSORT statement CONSORT statement is not a ROB tool.

Keywords: CONSORT; Clinical trials; Epidemiologic methods; Quality of reporting; Systematic reviews.

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Conflict of interest statement

The authors declare no conflict of interest.

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