Systematic review on the quality of randomized controlled trials from Saudi Arabia

Ahmad Mamoun Rajab,Abdulmalik Hamza,Roshdi Kotaiba Aldairi,Mohamad Mahmoud Alaloush,Juliann Saquib,Nazmus Saquib

doi:10.1016/j.conctc.2019.100441

Ahmad Mamoun Rajab, Abdulmalik Hamza + Show 4 more

Open Access

https://doi.org/10.1016/j.conctc.2019.100441

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Abstract

BackgroundThe quality of randomized controlled trials from Saudi Arabia is unknown since most are observational studies. ObjectiveTo determine (1) the quantity and quality of randomized controlled trials published from Saudi Arabia, and (2) whether significance of intervention effect varied by study quality. MethodsPubMed, SCOPUS, and Cochrane were searched with keywords for trials published from Saudi Arabia until February 2018. A total of 422 records were identified and screened, resulting in 61 eligible trials for analysis. Two researchers abstracted trial characteristics and assessed quality in seven domains (randomization, allocation concealment, blinding of assessors or participants, incomplete outcome data, selective reporting, and other sources of bias) using the Cochrane Collaboration Risk of Bias Tool. ResultsA majority of the trials (57%) were published during 2010–2018. High risk of bias was present for blinding (outcome: 13%; participants and personnel: 28%). Biases could not be assessed due to lack of information (unclear risk) in the domains of randomization (54%), allocation concealment (44%), and blinding of outcome assessment (57%). When all seven domains were considered together (summary risk of bias), 0% of the trials had low risk, 39% had high risk, and 61% had unclear risk of biases. A greater proportion of high-risk trials had significant intervention effect than unclear-risk trials (79% vs. 67%). ConclusionThe volume and quality of trials in Saudi Arabia was low. More high-quality randomized controlled trials are warranted to address chronic diseases.

Highlights

Randomized controlled trial (RCT) is the best design available in biomedical research [1]
We reported the risk of bias frequency for individual items of Cochrane Collaboration Risk of Bias Tool (CCRBT), and calculated a summary risk of bias with the following criteria: ‘low-risk trial’ if all domains were of low risk, ‘unclear-risk trial’ if all domains were of low or unclear risk, and ‘high-risk trial’ if one or more domain was of high risk
We found that 54% of the trial publications from Saudi Arabia did not provide details on random sequence generation to make an assessment of bias; this was comparable to the results of a Chinese study that reported two-thirds of its included trials failed to report details of randomization [35]

Summary

Introduction

Randomized controlled trial (RCT) is the best design available in biomedical research [1]. RCT can test a new drug, a lifestyle intervention, or a procedure [3,4] As a result, it has become the cornerstone of evidence-based medicine and is the source of most treatment guidelines [5]. The quality of randomized controlled trials from Saudi Arabia is unknown since most are observational studies. Objective: To determine (1) the quantity and quality of randomized controlled trials published from Saudi Arabia, and (2) whether significance of intervention effect varied by study quality. Two researchers abstracted trial characteristics and assessed quality in seven domains (randomization, allocation concealment, blinding of assessors or participants, incomplete outcome data, selective reporting, and other sources of bias) using the Cochrane Collaboration Risk of Bias Tool. More high-quality randomized controlled trials are warranted to address chronic diseases

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