Archive \ Volume.8 2017 Issue 2

Quality of Methodological Reporting of Randomized Clinical Trials of Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors

Hadeel Alfahmi, Lina Aldawood, Bayan Baz, Mahmoud Elrggal, Hadeel Yahya Alsharif, Saad A. Alkahtani

Sodium-glucose cotransporter-2 (SGLT2) inhibitors are a new class of medicines approved recently for the treatment of type 2 diabetes. To improve the quality of randomized clinical trial (RCT) reports, the Consolidated Standards of Reporting Trials (CONSORT) statement for methodological features was created. For achieving our objective in this study, we assessed the quality of methodological reporting of RCTs of SGLT2 inhibitors according to the 2010 CONSORT statement. We reviewed and analyzed the methodology of SGLT2 inhibitors RCTs that were approved by the Food & Drug Administration (FDA). Of the 27 trials, participants, eligibility criteria, and additional analyses were reported in 100% of the trials. In addition, trial design, interventions, and statistical methods were reported in 96.3% of the trials. Outcomes were reported in 93.6% of the trials. Settings were reported in 85.2% of the trials. Blinding and sample size were reported in 66.7 and 59.3% of the trials, respectively. Sequence allocation and the type of randomization were reported in 63 and 74.1% of the trials, respectively. Besides those, a few methodological items were inadequate in the trials. Allocation concealment was inadequate in most of the trials. It was reported only in 11.1% of the trials. The majority of RCTs have high percentage adherence for more than half of the methodological items of the 2010 CONSORT statement.

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