Please use this identifier to cite or link to this item: http://hdl.handle.net/1893/19485
Appears in Collections:Faculty of Health Sciences and Sport Journal Articles
Peer Review Status: Refereed
Title: Meeting the challenges of recruitment to multicentre, community-based, lifestyle-change trials: a case study of the BeWEL trial
Authors: Treweek, Shaun
Wilkie, Erna
Craigie, Angela
Caswell, Stephen
Thompson, Joyce
Steele, Robert
Stead, Martine
Anderson, Annie S
Contact Email: martine.stead@stir.ac.uk
Keywords: Colorectal cancer
Multicentre trial
Recruitment
Issue Date: 18-Dec-2013
Publisher: BioMed Central Ltd
Citation: Treweek S, Wilkie E, Craigie A, Caswell S, Thompson J, Steele R, Stead M & Anderson AS (2013) Meeting the challenges of recruitment to multicentre, community-based, lifestyle-change trials: a case study of the BeWEL trial, Trials, 14, Art. No.: 436.
Abstract: Background: Recruiting participants to multicentre, community-based trials is a challenge. This case study describes how this challenge was met for the BeWEL trial, which evaluated the impact of a diet and physical activity intervention on body weight in people who had had pre-cancerous bowel polyps. Methods: The BeWEL trial was a community-based trial, involving centres linked to the Scottish National Health Service (NHS) colorectal cancer screening programme. BeWEL had a recruitment target of 316 and its primary recruitment route was the colonoscopy clinics of the Scottish Bowel Screening Programme. Results: BeWEL exceeded its recruitment target but needed a 6-month no-cost extension from the funder to achieve this. The major causes of delay were lower consent rates (49% as opposed to 70% estimated from earlier work), the time taken for NHS research and development department approvals and the inclusion of two additional sites to increase recruitment, for which there were substantial bureaucratic delays. A range of specific interventions to increase recruitment, for example, telephone reminders and a shorter participant information leaflet, helped to increase the proportion of eligible individuals consenting and being randomized. Conclusions: Recruitment to multicentre trials is a challenge but can be successfully achieved with a committed team. In a UK context, NHS research and development approval can be a substantial source of delay. Investigators should be cautious when estimating consent rates. If consent rates are less than expected, qualitative analysis might be beneficial, to try and identify the reason. Finally, investigators should select trial sites on the basis of a formal assessment of a site's past performance and the likelihood of success in the trial being planned.
Type: Journal Article
URI: http://hdl.handle.net/1893/19485
DOI Link: http://dx.doi.org/10.1186/1745-6215-14-436
Rights: © 2013 Treweek 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.
Affiliation: University of Aberdeen
Beatson West of Scotland Cancer Centre
University of Dundee
University of Dundee
NHS Tayside
University of Dundee
Institute for Social Marketing
University of Dundee

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