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Reference: Shanyinde, M, Pickering, RM and Weatherall, M, (2011). Questions asked and answered in pilot and feasibility randomized controlled trials. BMC medical research methodology, 11 (1), 117.Citable link to this page:

 

Questions asked and answered in pilot and feasibility randomized controlled trials.

Abstract: BACKGROUND: In the last decade several authors have reviewed the features of pilot and feasibility studies and advised on the issues that should be addressed within them. We extend this literature by examining published pilot/feasibility trials that incorporate random allocation, examining their stated objectives, results presented and conclusions drawn, and comparing drug and non-drug trials. METHODS: A search of EMBASE and MEDLINE databases for 2000 to 2009 revealed 3652 papers that met our search criteria. A random sample of 50 was selected for detailed review. RESULTS: Most of the papers focused on efficacy: those reporting drug trials additionally addressed safety/toxicity; while those reporting non-drug trials additionally addressed methodological issues. In only 56% (95% confidence intervals 41% to 70%) were methodological issues discussed in substantial depth, 18% (95% confidence interval 9% to 30%) discussed future trials and only 12% (95% confidence interval 5% to 24%) of authors were actually conducting one. CONCLUSIONS: Despite recent advice on topics that can appropriately be described as pilot or feasibility studies the large majority of recently published papers where authors have described their trial as a pilot or addressing feasibility do not primarily address methodological issues preparatory to planning a subsequent study, and this is particularly so for papers reporting drug trials. Many journals remain willing to accept the pilot/feasibility designation for a trial, possibly as an indication of inconclusive results or lack of adequate sample size.

Peer Review status:Peer reviewedPublication status:PublishedVersion:Publisher's versionNotes:© 2011 Shanyinde 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.

Bibliographic Details

Publisher: BioMed Central Ltd.

Publisher Website: http://www.biomedcentral.com/

Journal: BMC medical research methodologysee more from them

Publication Website: http://www.biomedcentral.com/bmcmedresmethodol/

Issue Date: 2011

pages:117Identifiers

Urn: uuid:fa16221f-891b-4fec-8892-3da8987c8098

Source identifier: 262417

Eissn: 1471-2288

Doi: https://doi.org/10.1186/1471-2288-11-117

Issn: 1471-2288 Item Description

Type: Journal article;

Language: eng

Version: Publisher's versionKeywords: Humans Drug Toxicity Feasibility Studies Pilot Projects Drug Evaluation Randomized Controlled Trials as Topic Tiny URL: pubs:262417

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Author: Shanyinde, M - institutionUniversity of Oxford Oxford, MSD, Primary Care Health Sciences - - - Pickering, RM - - - Weatherall, M

Source: https://ora.ox.ac.uk/objects/uuid:fa16221f-891b-4fec-8892-3da8987c8098



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