The Reporting of Randomized Controlled Trials. Part II

Abstract

In our previous article, published on this journal, we analyzed the structure of an RCT in the sections of the title, abstract, introduction, objectives or hypotheses, methods, design, patients, settings, interventions, outcomes, sample size, randomization, and statistical methods. In this second article we will conclude our analysis on RCT reporting with the results section: the flow chart of the patients recruited, dates and recruitment period, demographic and clinical characteristics, results for the outcome, and results for the adverse effects and reactions. In the discussion section: the limits of the trial, generalizability of the results, comparison of the results, registration of the trail and, finally, the financial aspect of the trial. (nursing)