Health Statistics Group Seminar

Pilot/feasibility studies are an essential part of trial preparation, particularly for the planning of complex interventions. However recent research has shown that pilot/feasibility studies suffer from publication bias and a lack of clarity in the objectives and methodological focus. Those of us who sit on panels for funding bodies have also noticed frequent misunderstandings about the purpose of pilot/feasibility studies when these are part of a funding application; opportunities to answer important research questions at the piloting/feasibility stage may be lost and as a result full trials may be less efficient, interventions may be less effective, and trials may run into serious problems with conduct and recruitment that could have been anticipated and allowed for with proper piloting.

There is currently a great deal of interest in this area. Over the past two years the group has been developing reporting guidelines for pilot/feasibility studies via a series of meetings, and a large Delphi study, and  will be conducting a consensus meeting later in 2014.

In the course of this work the group has grappled with, amongst other things, the definition of pilot/feasibility studies and how to ensure such a study is well done. The seminar will briefly describe this work and the work of others in this area, the debate about definitions, and some do's and don'ts of pilot/feasibility studies.

Sandra is a Professor of Biostatistics at Queen Mary University of London. Since 2007 she has been joint lead (with Chris Griffiths) of the Centre for Primary Care and Public Health. She is also director of the Pragmatic Clinical Trials Unit housed within the Centre and joint lead for the Barts and The London arm of the Research Design Service.

Sandra was instrumental in setting up the Royal Statistical Society Primary Health Care Study Group in 2002. Her main research interests are cluster randomised trials and complex interventions, particularly in primary care. She has published a number of key papers and a recent book on cluster randomised trials. In addition to her methodological research she has responsibility for the statistical design and analysis aspects of a large number of collaborative research projects mostly concerned with the management of chronic conditions. Many of these projects use a cluster randomised trial design.

For further information, please contact Cath Williams (c.e.o.williams@exeter.ac.uk, 01392 726055).