Structure and content of a trial report Consort

The importance with which randomized controlled trials (RCTs) are held has meant that many of the leading medical journals not only undertake routine statistical review, but also apply specific checklists for the reporting of clinical trials. This was formalized, in 1996 [1] (updated in 2001 [2]), by the publication of the 'Consolidated standards of reporting trials' (CONSORT) statement (see also http://www.consort-statement.org). This statement includes a checklist of twenty-one items, mainly related to the description of the methods and results, and the discussion section of a randomized trial, which the CONSORT group has deemed essential in order to evaluate the 'internal and external validity' of a trial report. Table 10.1 shows the key items included in the CONSORT checklist together with a brief descriptor. Some journals ask for a table such as this to be submitted with a trial report, with the descriptor column replaced by one indicating the page of the report on which each item appears. CONSORT further recommends the inclusion of a flow diagram which follows the group of patients considered for, and randomized and analysed, in the trial, detailing the reasons for patients failing to be included at any stage (see Fig. 10.1).

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