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; Stewart 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, Stewart Pringle, Lesley Sinclair

Applied Health Sciences

Research output: Contribution to journal › Article › peer-review

102 Citations (Scopus)

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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
Article number	353
Number of pages	13
Journal	Trials
Volume	14
DOIs	https://doi.org/10.1186/1745-6215-14-353
Publication status	Published - 25 Oct 2013

Keywords

complex intervention
pilot trial
feasibility study
methodology
pelvic organ

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10.1186/1745-6215-14-353Licence: CC BY

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© 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, 463 KBLicence: CC BY

Cite this

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AU - Bugge, Carol

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AU - Hagen, Suzanne

AU - Logan, Janet

AU - Glazener, Cathryn

AU - Pringle, Stewart

AU - Sinclair, Lesley

PY - 2013/10/25

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AB - 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.

KW - complex intervention

KW - pilot trial

KW - feasibility study

KW - methodology

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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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