A process for decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse

Carol Bugge, Brian Williams, Suzanne Hagen, Janet Logan, Cathryn Glazener, Jan Pringle, Lesley Sinclair

Research output: Contribution to journalArticle

Abstract

Current Medical Research Council (MRC) guidance on complex interventions advocates pilot trials and feasibility studies as part of a phased approach to the development, testing, and evaluation of healthcare interventions. In this paper we discuss the results of a recent feasibility study and pilot trial for a randomized controlled trial (RCT) of pelvic floor muscle training for prolapse (ClinicalTrials.gov: NCT01136889). The ways in which researchers decide to respond to the results of feasibility work may have significant repercussions for both the nature and degree of tension between internal and external validity in a definitive trial.
Original languageEnglish
Pages (from-to)1-13
Number of pages13
JournalTrials
Volume14
Issue number353
DOIs
Publication statusPublished - Oct 2013

Keywords

  • healthcare interventions
  • feasibility trials
  • pelvic floor muscle training

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