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J Caring Sci. 2025;14(1): 1-4.
doi: 10.34172/jcs.025.33575
  Abstract View: 46
  PDF Download: 41

Short Communication

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

Ehsan Sarbazi 1 ORCID logo, Homayoun Sadeghi-Bazargani 2* ORCID logo

1 Road Traffic Injury Research Center, Tabriz University of Medical Sciences, Tabriz, Iran
2 Department of Statistics and Epidemiology, Faculty of Health, Tabriz University of Medical Sciences, Tabriz, Iran
*Corresponding Author: Homayoun Sadeghi-Bazargani, Email: homayoun.bazargani@gmail.com

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was performed in international databases including PubMed, Google Scholar and hand-searches for published and unpublished literature from 2000 to 2021 and written in English.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.


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Submitted: 10 Jun 2024
Accepted: 02 Jul 2024
ePublished: 11 Feb 2025
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