Meeting the challenges of recruitment to multicentre, community-based, lifestyle-change trials: a case study of the BeWEL trial
1 Health Services Research Unit, University of Aberdeen, Health Sciences Building, Foresterhill, Aberdeen AB25 2ZD, UK
2 Tayside Clinical Trials Unit, University of Dundee, Ninewells Hospital & Medical School, George Pirie Way, Dundee DD1 9SY, UK
3 Centre for Research into Cancer Prevention and Screening, Division of Cancer Research, Medical Research Institute, Level 7, Mailbox 7, University of Dundee, Ninewells Hospital and Medical School, Dundee DD1 9SY, UK
4 Directorate of Public Health, Dundee NHS, Tayside, UK
5 Institute for Social Marketing, University of Stirling and the Open University, Stirling FK9 4LA, UK
Trials 2013, 14:436 doi:10.1186/1745-6215-14-436Published: 18 December 2013
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.
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.
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.
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.
Current Controlled Trials ISRCTN53033856