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Addressing the reporting of pilot and feasibility trials with a brand new CONSORT extension

02/11/2016

The insights gained from pilot and feasibility studies for informing the design of definitive studies cannot be contested and recent drives to reduce waste in research has pushed the advantages of conducting and reporting these studies into wider focus. Here, Gillian Lancaster, Editor-in-Chief of Pilot and Feasibility Studies and co-author of the CONSORT 2010 extension to randomised pilot and feasibility trials discusses the importance of this CONSORT extension and what it will mean for the reporting of pilot and feasibility trials.

The culmination of work that started with a question at a Society for Academic Primary Care conference workshop on pilot and feasibility studies in 2011 has finally come to fruition.The CONSORT extension to randomised pilot and feasibility trials provides reporting guidelines which should be welcomed with open arms by any journal wanting to include well-structured reporting of pilot and feasibility trials that are in preparation for a future definitive RCT.

“… should be welcomed with open arms by any journal wanting to include well-structured reporting of pilot and feasibility trials that are in preparation for a future definitive RCT.”

Previous research (see here, here and here) has shown that pilot and feasibility studies are often of poor quality and not well reported. The new guidelines will help authors to identify the pertinent information to report from their pilot work focusing on feasibility objectives and outcomes, and help to align this work within the wider context of preparing for a future definitive trial.

The 26-item checklist retains some of the standard CONSORT items, but most have been adapted to focus on pilot and feasibility work. Other items have been removed and some new items added. In the publication a template is provided for a CONSORT flowchart for these studies and a separate checklist for the abstract for a randomised pilot or feasibility trial – with worked examples.

Within the journal Pilot and Feasibility Studies, we continually strive to emphasise that the aims and objectives of pilot and feasibility studies are not the same as for a definitive RCT, which tests effectiveness or efficacy of an intervention. Adoption of these guidelines will be a standard requirement of the journal to ensure feasibility objectives are clearly specified and appropriately addressed in submitted papers for publication.

Pilot and feasibility studies address the uncertainties that need to be clarified, as well as the processes and procedures that need to be tried out, before the future definitive trial can be fully planned. Any methodological changes made along the way should also be reported as this is useful information to share with other researchers. The new guidelines will ensure transparent reporting of all the relevant issues.

“I for one am very excited at the prospect of adopting the guidelines for Pilot and Feasibility Studies and the impact they will have on the journal.”

The 2010 CONSORT statement is designed to improve the transparency and quality of reporting definitive RCTs. A recent BioMed Central blog by Larissa Shamseer stresses the importance of endorsement and adherence to these guidelines.

I believe that endorsement and adherence to this extension to the CONSORT statement will result in improvements in the quality of reporting of randomised pilot and feasibility trials. After all the guidelines have been constructed following a methodologically rigorous process (see here and here) and arrived at by consensus of experts in the field!

I for one am very excited at the prospect of adopting the guidelines for Pilot and Feasibility Studies and the impact they will have on the journal.

Gillian’s article originally appeared on the BioMed Central blog network on 27 October 2016.

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