• Khalid S Alraddadi, Fayzah H Al-Adwani, Rajaa M Al-Raddadi, Sultan H Alamri, Iman K Ramadan, and Ahmad A Mirza.
• From the Department of Primary Health Care (Alraddadi, Al-Adwani), National Guard Health Affairs, King Saud bin Abdulaziz University for Health Sciences; from the Department of Community Medicine (Al-Raddadi, Ramadan), and from the Department of Family Medicine (Alamri), Faculty of Medicine, King Abdulaziz University; from the Department of Otolaryngology-Head and Neck Surgery (Mirza), Faculty of Medicine in Rabigh, King Abdulaziz University, Jeddah, Kingdom of Saudi Arabia; from the Department of Community Medicine (Ramadan), Faculty of Medicine, Al-Azhar University, Cairo, Egypt; and from the Department of Otolaryngology-Head and Neck Surgery (Mirza), Temerty Faculty of Medicine, University of Toronto, Toronto, Canada.
• Saudi Med J. 2023 Apr 1; 44 (4): 345354345-354.

ObjectivesTo describe variations in characteristics of randomized controlled trials conducted in the Gulf Cooperation Council (GCC) countries, and critically appraising the quality of design, conduct and analysis of the trials.MethodsWe carried out a systematically comprehensive electronic search of articles published between 1990 and 2018 and indexed in several databases: i) MEDLINE/PubMed, ii) EMBASE, iii) Cochrane Central Register of Controlled Trials (CENTRAL), iv) ClinicalTrials.gov, and v) World Health Organization International Clinical Trials Registry Platform. We summarized the overall risk of bias present in all analyzed studies using the Cochrane Collaboration risk of bias tool (CCRBT).ResultsA remarkable shift in numbers of publications from 2006 onwards was found. The largest number of publications were from Saudi Arabia and consisted of hospitals/clinics based studies. Lack of randomization was found in the majority of reports, and nearly three-fourth of the studies involved the use of intention-to-treat (ITT) principle. However, the proportion of adequately generated random sequence methods has increased yearly, and this increase accounted for a relatively large proportion over the latter half of the studied period (p<0.001), in contrast to the proportion of allocation concealment and blinding. Journal impact factor was significantly correlated with the quality of random sequence generation (r=0.145; p=0.014).ConclusionThe randomization methods have gained more attention over the last 3 decades. Secondly, Journal impact factor can serve as an indicator of randomization quality. To mitigate the large rate of overall high risk of bias in GCC studies, high-quality trials must be considered by ensuring adequate allocation concealment and blinding methods. PROSPERO No. ID: CRD42022310331.Copyright: © Saudi Medical Journal.

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