The CONSORT extension for pragmatic trials builds upon the existing CONSORT checklist and gives specific guidance for 8 of the 22 checklist items in relation to pragmatic trials. For each of the eight items the standard CONSORT text and additional guidance, an example of good reporting for the item, and an explanation of the issues are presented. Importantly, these suggestions should be seen as additional to the general guidance in the main CONSORT explanatory paper and where relevant, other CONSORT guidance.
Pragmatic trials are designed to measure effectiveness; that is whether an intervention works when used in usual conditions of care. To ensure applicability (also called generalisability) in a wide range of usual care settings, pragmatic trials should, so far as possible, include in the trial the kinds of participants to whom the intervention will be applied in the real world, once its effectiveness is established. The need for purchasers, providers and recipients of health care to use evidence from trials in policy decisions has increased the focus on pragmatic trials, however, poor reporting can reduce their usefulness.
The main CONSORT flow diagram should be used.
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Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D for the CONSORT and Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008; 337;a2390. PMID: 19001484