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Pragmatic Clinical Trials Unit

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Pilot and Feasibility Studies

The number of pilot and feasibility studies in the literature is increasing, but they are often poorly reported. Our research into pilot and feasibility studies aims to improve the conduct and reporting of such studies. Our methodological work in this area is listed below. The group leading this work has also facilitated a number of workshops on conducting pilot and feasibility studies. We also have collaborations with others working on pilot and feasibility studies both in the UK and Canada.

Specific topics of our work include: 

  • A framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial 
  • A CONSORT extension for pilot and feasibility trials 
  • A systematic review of the reporting quality of pilot and feasibility cluster randomised trials 
  • A simulation study to see how large a pilot study for a cluster randomised trial should be
  • A website designed to support those conducting pilot and feasibility studies and those carrying out methodological research on these types of studies https://pilotandfeasibilitystudies.qmul.ac.uk/

 References to our published papers :

  • Campbell M.J., Lancaster G.A., Eldridge S.M.. A randomised controlled trial is not a pilot trial simply because it uses a surrogate endpoint. Pilot and feasibility studies. 2018 Dec;4(1):130
  • Chan C.L., Leyrat C., Eldridge S.E., Quality of reporting of pilot and feasibility cluster randomised trials: a systematic review. BMJ Open. 2017;7(11)
  • Eldridge S.M., Costelloe C.E., Kahan B.C., Lancaster G.A., Kerry S.M., How big should the pilot study for my cluster randomised trial be? Statistical methods in medical research. 2015
  • Eldridge S.M., Lancaster G.A., Campbell M.J., Thabane L., Hopewell S., Coleman C.L., Bond C.M., Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS ONE. 2016; 11(3)
  • Eldridge S.M.Chan C.L., Campbell M.J., Bond C.M., Hopewell S., Thabane L., Lancaster G.A., CONSORT 2010 statement: extension to randomised pilot and feasibility trials BMJ 2016; 355 doi: https://doi.org/10.1136/bmj.i5239 (Published 24 October 2016)Cite this as: BMJ 2016;355:i5239
  • Eldridge S., Chan C., Campbell M., Bond C., Hopewell S., Thabane L., Lancaster G.A. CONSORT Statement: extension to randomised pilot and feasibility trials. Pilot and Feasibility Studies 2016, 2:64. DOI 10.1186/s40814-016-0105-8 (dual publication).
  • Thabane L., Hopewell S., Lancaster G.A., Bond C., Coleman C., Campbell M., Eldridge S. Methods and Processes for Development of a CONSORT Extension for Reporting Pilot Randomized Controlled Trials. Pilot and Feasibility Studies 2016, 2:25. DOI 10.1186/s40814-016-0065-z.
  • Eldridge SE., Kerry S. Chapter 4 Pilot and feasibility studies. In Eldridge S.E. and Kerry S. A practical guide to cluster randomised trials in health services research. Chichester: John Wiley & Sons, 2012.

 

 

 

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