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Open Access Research article

Questions asked and answered in pilot and feasibility randomized controlled trials

Milensu Shanyinde1, Ruth M Pickering1* and Mark Weatherall2

Author Affiliations

1 Primary Care and Population Sciences, University of Southampton, Southampton General Hospital, Tremona Road, Southampton, UK

2 School of Medicine and Health Sciences, University of Otago Wellington, Wellington, New Zealand

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BMC Medical Research Methodology 2011, 11:117  doi:10.1186/1471-2288-11-117

Published: 16 August 2011

Abstract

Background

In the last decade several authors have reviewed the features of pilot and feasibility studies and advised on the issues that should be addressed within them. We extend this literature by examining published pilot/feasibility trials that incorporate random allocation, examining their stated objectives, results presented and conclusions drawn, and comparing drug and non-drug trials.

Methods

A search of EMBASE and MEDLINE databases for 2000 to 2009 revealed 3652 papers that met our search criteria. A random sample of 50 was selected for detailed review.

Results

Most of the papers focused on efficacy: those reporting drug trials additionally addressed safety/toxicity; while those reporting non-drug trials additionally addressed methodological issues. In only 56% (95% confidence intervals 41% to 70%) were methodological issues discussed in substantial depth, 18% (95% confidence interval 9% to 30%) discussed future trials and only 12% (95% confidence interval 5% to 24%) of authors were actually conducting one.

Conclusions

Despite recent advice on topics that can appropriately be described as pilot or feasibility studies the large majority of recently published papers where authors have described their trial as a pilot or addressing feasibility do not primarily address methodological issues preparatory to planning a subsequent study, and this is particularly so for papers reporting drug trials. Many journals remain willing to accept the pilot/feasibility designation for a trial, possibly as an indication of inconclusive results or lack of adequate sample size.