The CONSORT statement instructions for reporting randomized clinical trials

Abstract

Clinical strategies and decision making in health care should be supported by the best available scientific evidence not only on intuition neither on previous clinical experience. Randomized controlled trials (RCT) are considered the gold standard for the assessment of interventions efficacy but inadequate report difficulties their interpretation and identification of eventual bias. A group of scientists and editors developed the CONSORT Statement to improve the quality of reporting of RCTs. The CONSORT statement comprises a checklist of essential items that should be included in reports of RCTs and a diagram for documenting the flow of participants through a trial. Nowadays, the CONSORT are translated to several languages and it has been modified to attend different study designs. The present document intended to improve the comprehension of CONSORT recommendations and to spread its use on Portuguese language through a brief discussion of main aspects from the revised version of CONSORT statement.