Risk of Bias in Iranian Randomized Trials Included in Cochrane Reviews

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 de...

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Published inArchives of Iranian medicine Vol. 25; no. 6; pp. 375 - 382
Main Authors Kabir, Ali, Sofi-Mahmudi, Ahmad, Karimi Behnagh, Arman, Eidkhani, Vahid, Baradaran, Hamid Reza, Kabiri, Payam, Haghdoost, AliAkbar, Mesgarpour, Bita
Format Journal Article
LanguageEnglish
Published Iran Academy of Medical Sciences of I.R. Iran 01.06.2022
Subjects
Bias
Clinical trials
Evidence-based medicine
Humans
Iran
Medical research
Original
Randomized Controlled Trials as Topic
Research Design
Systematic review
Systematic Reviews as Topic
Iran
Systematic review
Iran
Evidence-based medicine
Randomized controlled trial
Cochrane
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Abstract 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.
AbstractList 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.
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). We searched "Iran" by selecting the "Search All Text" and "Review" fields in the 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. 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. 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.
Author Sofi-Mahmudi, Ahmad
Kabir, Ali
Haghdoost, AliAkbar
Eidkhani, Vahid
Baradaran, Hamid Reza
Mesgarpour, Bita
Kabiri, Payam
Karimi Behnagh, Arman
AuthorAffiliation 3 Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran 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
2 Cochrane Iran Associate Centre, National Institute for Medical Research Development (NIMAD), Tehran, Iran
4 Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran
1 Minimally Invasive Surgery Research Center, Iran University of Medical Sciences, Tehran, Iran
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Snippet Background: Among interventional studies, randomized controlled trials (RCTs) provide the highest level of evidence. However, RCTs can be susceptible to the...
Among interventional studies, randomized controlled trials (RCTs) provide the highest level of evidence. However, RCTs can be susceptible to the risk of bias...
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SubjectTerms Bias
Clinical trials
Evidence-based medicine
Humans
Iran
Medical research
Original
Randomized Controlled Trials as Topic
Research Design
Systematic review
Systematic Reviews as Topic
Title Risk of Bias in Iranian Randomized Trials Included in Cochrane Reviews
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