title: A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse.
abstract: BACKGROUND
  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.
  
  
  METHODS
  We used methodological issues to classify and analyze the problems that arose in the feasibility study. Four centers participated with the aim of randomizing 50 women. Women were eligible if they had prolapse of any type, of stage I to IV, and had a pessary successfully fitted. Postal questionnaires were administered at baseline, 6 months, and 7 months post-randomization. After identifying problems arising within the pilot study we then sought to locate potential solutions that might minimize the trade-off between a subsequent explanatory versus pragmatic trial.
  
  
  RESULTS
  The feasibility study pointed to significant potential problems in relation to participant recruitment, features of the intervention, acceptability of the intervention to participants, and outcome measurement. Finding minimal evidence to support our decision-making regarding the transition from feasibility work to a trial, we developed a systematic process (A process for Decision-making after Pilot and feasibility Trials (ADePT)) which we subsequently used as a guide. The process sought to: 1) encourage the systematic identification and appraisal of problems and potential solutions; 2) improve the transparency of decision-making processes; and 3) reveal the tensions that exist between pragmatic and explanatory choices.
  
  
  CONCLUSIONS
  We have developed a process that may aid researchers in their attempt to identify the most appropriate solutions to problems identified within future pilot and feasibility RCTs. The process includes three key steps: a decision about the type of problem, the identification of all solutions (whether addressed within the intervention, trial design or clinical context), and a systematic appraisal of these solutions.
authors.affiliation: School of Nursing, Midwifery and Health, University of Stirling, Stirling FK9 4LA, Scotland. carol.bugge@stir.ac.uk.
authors.forename: Carol
authors.initials: C
authors.lastname: Bugge
authors.forename: Brian
authors.initials: B
authors.lastname: Williams
authors.forename: Suzanne
authors.initials: S
authors.lastname: Hagen
authors.forename: Janet
authors.initials: J
authors.lastname: Logan
authors.forename: Cathryn
authors.initials: C
authors.lastname: Glazener
authors.forename: Stewart
authors.initials: S
authors.lastname: Pringle
authors.forename: Lesley
authors.initials: L
authors.lastname: Sinclair
mesh_terms: D003131:Combined Modality Therapy; D019317:Evidence-Based Medicine; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D056887:Pelvic Organ Prolapse / Q000175:diagnosis / Q000628:therapy*; D010570:Pessaries / Q000009:adverse effects; D026741:Physical Therapy Modalities / Q000009:adverse effects; D010865:Pilot Projects; D012107:Research Design; D012606:Scotland; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome