Meeting the challenges of recruitment to multicentre, community-based, lifestyle-change trials: a case study of the BeWEL trial

Shaun Treweek, Erna Wilkie, Angela M Craigie, Stephen Caswell, Joyce Thompson, Robert J C Steele, Martine Stead, Annie S Anderson, BeWEL team

Research output: Contribution to journalArticle

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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.

TRIAL REGISTRATION: Current Controlled Trials ISRCTN53033856.

Original languageEnglish
Article number436
JournalTrials
Volume14
DOIs
Publication statusPublished - 2013

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National Health Programs
Life Style
Health Services Research
Research Personnel
Colonoscopy
Polyps
Early Detection of Cancer
Research
Telephone
Multicenter Studies
Colorectal Neoplasms
Body Weight
Diet
Costs and Cost Analysis

Keywords

  • colorectal cancer
  • multicentre trial
  • recruitment

Cite this

Meeting the challenges of recruitment to multicentre, community-based, lifestyle-change trials : a case study of the BeWEL trial. / Treweek, Shaun; Wilkie, Erna; Craigie, Angela M; Caswell, Stephen; Thompson, Joyce; Steele, Robert J C; Stead, Martine; Anderson, Annie S; BeWEL team.

In: Trials, Vol. 14, 436, 2013.

Research output: Contribution to journalArticle

Treweek, S, Wilkie, E, Craigie, AM, Caswell, S, Thompson, J, Steele, RJC, Stead, M, Anderson, AS & BeWEL team 2013, 'Meeting the challenges of recruitment to multicentre, community-based, lifestyle-change trials: a case study of the BeWEL trial', Trials, vol. 14, 436. https://doi.org/10.1186/1745-6215-14-436
Treweek, Shaun ; Wilkie, Erna ; Craigie, Angela M ; Caswell, Stephen ; Thompson, Joyce ; Steele, Robert J C ; Stead, Martine ; Anderson, Annie S ; BeWEL team. / Meeting the challenges of recruitment to multicentre, community-based, lifestyle-change trials : a case study of the BeWEL trial. In: Trials. 2013 ; Vol. 14.
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N2 - 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.TRIAL REGISTRATION: Current Controlled Trials ISRCTN53033856.

AB - 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.TRIAL REGISTRATION: Current Controlled Trials ISRCTN53033856.

KW - colorectal cancer

KW - multicentre trial

KW - recruitment

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