Arch Iran Med. 2022;25(6): 375-382.
doi: 10.34172/aim.2022.61

Scopus ID: 85134841352
  Abstract View: 570
  PDF Download: 390

Original Article

Risk of Bias in Iranian Randomized Trials Included in Cochrane Reviews

Ali Kabir 1,2 ORCID logo, Ahmad Sofi-Mahmudi 2 ORCID logo, Arman Karimi Behnagh 1 ORCID logo, Vahid Eidkhani 1 ORCID logo, Hamid Reza Baradaran 3,2 ORCID logo, Payam Kabiri 4,2 ORCID logo, AliAkbar Haghdoost 5,2 ORCID logo, Bita Mesgarpour 2* ORCID logo

1 Minimally Invasive Surgery Research Center, Iran University of Medical Sciences, Tehran, Iran
2 Cochrane Iran Associate Centre, National Institute for Medical Research Development (NIMAD), Tehran, Iran
3 Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences, Tehran, Iran
4 Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
5 Social Determinants of Health Research Centre, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran
*Corresponding Author: Corresponding Author: Bita Mesgarpour, PharmD, MPH, PhD; Address: 21, West Fatemi St., National Institute for Medical Research Development (NIMAD), Tehran, Iran. Email: , Email: mesgarpour@research.ac.ir


Background: Among interventional studies, randomized controlled trials (RCTs) provide the highest level of evidence. However, RCTs can be susceptible to the risk of bias (RoB). Systematic reviews can be performed to appraise RoB in the included articles using evaluative tools. This study aimed to describe the main characteristics and focus on the RoB of RCTs conducted in Iran and included in Cochrane Reviews (CRs).

Methods: We searched “Iran” by selecting the “Search All Text” and “Review” fields in the Cochrane Database of Systematic Reviews within Ovid. CRs that included the RCTs conducted in Iran were retrieved. A trial was selected only if it was included in CRs, described as a controlled clinical trial, involved human subjects and CR authors assessed its RoB. The trials were characterized by investigating the relevant articles and the table “Characteristics of included studies” in each CR. The RoB was investigated by collecting the review authors’ judgments based on RoB assessment tables in the CRs.

Results: Out of 1166 Iranian RCTs included by 571 CRs, low RoB was found in 44.9% for random sequence generation, 20.8% for allocation concealment, 32.3% for blinding of participants/personnel, 36.5% for blinding of outcome assessors, 56.3% for incomplete outcome data, 41.3% for selective outcome reporting and 53.8% for other sources of bias.

Conclusion: The RoB in Iranian RCTs was found to be mostly high or unclear. While this is similar to the global situation, it is recommended that the methodological quality of conducting and reporting RCTs be addressed in Iran.

Cite this article as: Kabir A, Sofi-Mahmudi A, Karimi Behnagh A, Eidkhani V, Baradaran HR, Kabiri P, et al. Risk of bias in iranian randomized trials included in cochrane reviews. Arch Iran Med. 2022;25(6):375-382. doi: 10.34172/aim.2022.61
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Submitted: 30 Jan 2021
Revision: 10 Jun 2021
Accepted: 15 Sep 2021
ePublished: 01 Jun 2022
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