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

doi:10.1186/1745-6215-14-353

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

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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 language	English
Pages (from-to)	1-13
Number of pages	13
Journal	Trials
Volume	14
Issue number	353
DOIs	https://doi.org/10.1186/1745-6215-14-353
Publication status	Published - Oct 2013

Keywords

healthcare interventions
feasibility trials
pelvic floor muscle training

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10.1186/1745-6215-14-353

Bugge, C. (2013) A process for decision-making after Pilot and feasibility trials (ADePT)
© 2013 Bugge et al.; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Final published version, 636 KBLicence: CC BY

Cite this

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AU - Glazener, Cathryn

AU - Pringle, Jan

AU - Sinclair, Lesley

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ER -

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

Keywords

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