Randomised Controlled Trials in Diabetes Research: A Pathway to Interpreting Published Results

Abstract

Although the importance of real-world evidence should not be underestimated, randomised controlled trials (RCTs) remain the gold standard for direct treatment comparisons. Over the last two decades, numerous publications have presented results of RCTs investigating the safety and efficacy of therapies for the treatment of type 2 diabetes, for example long-acting basal insulin analogues [1–14]. RCTs such as these use a robust design and methodology that aims to avoid confounders and determine differences between basal insulins. However, interpreting the results of RCTs and making judgements about the quality of evidence and how results may be applicable to diabetes management can be difficult for healthcare practitioners (HCPs) because of differing trial methodologies, analysis plans, and endpoints. There are guidelines for those developing publications that report the results of RCTs, such as the Consolidated Standards of Reporting Trials (CONSORT) guidelines [15], and readers are advised to familiarise themselves with these if possible. However, we have developed a checklist of points we consider most important when reading and interpreting RCT publications (Fig. 1). This checklist is based on CONSORT, other published literature, and our own experience, and may serve as useful guidance for HCPs. This article will discuss these key points in more detail, progressing through the sections of a typical RCT publication. Open in a separate window Fig. 1 Interpreting publications reporting results from randomised controlled trials (RCTs): a guidance checklist