Tutorial to plan and perform randomized clinical trials

Abstract

Objective: the aim of the present study was to present a tutorial for planning and performing randomized clinical trials. Materials and methods: an online search was performed on MEDLINE via PubMed. The following search strategy was used: “randomized controlled trial” [Publication Type] OR “randomized controlled trials as topic”[MeSH Terms] OR “randomized controlled trial”[All Fields]. A hand search was also performed. Results: the present tutorial presents and discusses topics of utmost importance for randomized clinical trials studies, as follows: importance of randomized clinical trials, methodological items (focused question, registration of the study protocol, eligibility criteria, outcomes of interest, data collection and data analysis, risk of bias), and methodological quality. The study design of randomized clinical trials features the lowest risk of bias to assess healthcare interventions. Conclusions: this tutorial offers a concise and practical description of important items regarding randomized clinical trials, which can be used by clinicians and researchers to better understand, plan, and perform randomized clinical trials