Within a week or so following the meeting, a draft report was circulated to the entire group for further refinement. This process was continued until we felt the report accurately represented what had gone on during the meeting. The checklist consists of 21 items that pertain mainly to the methods, results, and discussion of an RCT report and identify key pieces of information necessary to evaluate the internal and external validity of the report. Appropriate adjustments will need to be made in reports of trials with a larger number of groups or trials using a different design. One possible interpretation is that some trials with inadequate reporting of allocation concealment actually had faulty randomization, and faulty randomization allowed the introduction of bias.
Title Identify the study as a randomized trial.
Introduction Identify the study as a randomized trial. Planned interventions and their timing. Describe protocol deviations from the study as planned, together with the reasons. State general interpretation of the data in light of the totality of the available evidence. The format we favor includes a combination of 5 new subheadings in the text of the trial report and the use of the checklist during the journal submission process.