The Reporting of Randomized Controlled Trials. Part 1

Abstract

Introduction. This paper is the first of two articles about the fundamental problem regarding the proper use of randomized controlled trials (RCT) in Italy in the research fields of nephrology and dialysis. The gold standard for measuring the effectiveness of an health care intervention is the RCT. Numerous RCTs show several methodological gaps, particularly evident in terms of the quality of trial reporting. Objective. To indicate a guideline for trial reporting that can be useful both to authors, for a proper and rigorous structuring and conduct of the trial, and readers, providing the methodological tools for a critical reading of any RCT. Materials and Methods. The reporting tool is the methodological standard ensuring the rigor of an RCT. The methodology used is that of analysing, in a concise but complete manner, the basic steps of a reporting that a trial must respect. Results. Compliance with a guideline of RCT reporting shows results that are unambiguous, clear, not manipulated or distorted, and produced by a sound and rigorous methodology in each stage of the RCT, thus allowing a proper understanding of the results and their possible generalization. Conclusions. The authors should systematically use the standard guidelines for the production of RCTs, respecting each indication, in order to ensure a useful and effective progress of the scientific knowledge, as well as the ethics and professionalism of the research. (nursing)