4 Many journals now require that reports of RCTs conform to the recommendations in the CONSORT statement. An explanation and elaboration of the rationale for the checklist items are provided in an accompanying article. These items are evidence based when possible. 3 The statement comprises a checklist of essential items that should be included in reports of RCTs and a diagram to document the flow of participants through the trial from before group assignment through to the final analysis. To attempt to address this issue, the Consolidated Standards of Reporting Trials (CONSORT) statement was developed and includes a set of recommendations for the reporting of RCTs. Inadequate reporting of randomised controlled trials (RCTs) is associated with bias in the estimation of treatment effects 1 2 it also impairs the critical appraisal of the quality of randomised trials, which is important when assessing the validity of the results of the individual trial and when conducting systematic reviews. The use of the CONSORT extension to crossover trials will improve reporting of randomised crossover trials The Consolidated Standards of Reporting Trials (CONSORT) statement provides a minimum set of 25 items to be reported with rationale and exemplars for all randomised trialsĬONSORT extension to crossover trials extends 14 items of the CONSORT statement Examples of good reporting and evidence based rationale for CONSORT crossover checklist items are provided. The CONSORT 2010 checklist is revised for crossover designs, and introduces a modified flowchart and baseline table to enhance transparency. We present the CONSORT extension to randomised crossover trials, which aims to facilitate better reporting of crossover trials. However, the reporting of crossover trials has been variable and incomplete, which hinders their use in clinical decision making and by future researchers. They are a useful and efficient design because participants act as their own control. Crossover trials are a particular type of trial for chronic conditions in which participants are randomised to a sequence of interventions. The primary focus of the statement was on parallel group trials with two treatment groups. The Consolidated Standards of Reporting Trials (CONSORT) statement was developed to improve the reporting of randomised controlled trials. The lack of transparent reporting impedes readers from judging the reliability and validity of trial findings, prevents researchers from extracting information for systematic reviews, and results in research waste. Evidence shows the quality of reporting of randomised controlled trials is not optimal.
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