New CONSORT 2010 extension for pilot and feasibility trials

The CONSORT 2010 statement is a set of evidence-based guidelines summarising the minimum essential information to include in reports of randomised clinical trials (RCTs). Adherence to the CONSORT guidelines is said to improve the quality of RCT reporting. In a blog post on BioMed Central, Gillian Lancaster highlights the publication of a new extension to the CONSORT guidelines, aimed specifically at pilot and feasibility trials.

The number of studies described as pilot and feasibility trials is increasing, but the reporting of such trials is often considered inadequate. Whereas full RCTs aim to test the efficacy or effectiveness of an intervention, the aim of a pilot or feasibility study is to assess the feasibility of an RCT itself. The CONSORT 2010 extension to randomised pilot and feasibility trials acknowledges this distinction and offers guidance specific to reporting of pilot and feasibility studies. The extension comprises a 26-item checklist, an additional checklist for abstracts, and a template for presenting the flow of patients through the trial. It is hoped that use of the extension will improve the transparency and reporting of pilot and feasibility studies, and thereby help to reduce wastage in research.

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Summary by Louisa Lyon, DPhil from Aspire Scientific.