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Recruiting to a large-scale physical activity randomised controlled trial : experiences with the gift of hindsight
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Copeland, Robert J., Horspool, Kimberley, Humphreys, Liam and Scott, Emma (2016) Recruiting to a large-scale physical activity randomised controlled trial : experiences with the gift of hindsight. Trials, 17 (1). pp. 1-12. 104. doi:10.1186/s13063-016-1229-0 ISSN 1745-6215.
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Official URL: http://dx.doi.org/10.1186/s13063-016-1229-0
Abstract
Background:
Recruitment issues continue to impact a large number of trials. Sharing recruitment information is vital to supporting researchers to accurately predict recruitment and to manage the risk of poor recruitment during study design and implementation. The purpose of this article is to build on the knowledge available to researchers on recruiting to community-based trials.
Methods:
A critical commentary of the recruitment challenges encountered during the Booster Study, a randomised controlled trial in which researchers investigated the effectiveness of a motivational interviewing style intervention on the maintenance of physical activity. An overview of recruitment is provided, as well as strategies employed to recruit prospective participants and possible barriers to recruitment.
Results:
Two hundred eighty-two people, 47 % of the original target, were recruited through mail-outs, with secondary recruitment pathways yielding no additional participants. The research team encountered problems with recontacting interested participants and providing study materials in non-English languages. A lower response rate to the mail-out and a greater number of non-contactable participants in the full study than in the pilot study resulted in a smaller pool of eligible participants from the brief intervention eligible for recruitment into the randomised controlled trial.
Conclusions:
Despite using widely accepted recruitment strategies and incorporating new recruitment tactics in response to challenges, the Booster Study investigators failed to randomise a sufficient number of participants. Recruitment in trials of community-based behavioural interventions may have different challenges than trials based on clinical or primary care pathways. Specific challenges posed by the complexity of the study design and problems with staffing and resources were exacerbated by the need to revise upwards the number of mailed invitations as a result of the pilot study. Researchers should ensure study design facilitates recruitment and consider the implications of changing recruitment on the operational aspects of the trial. Where possible, the impact of new strategies should be measured, and recruitment successes and challenges should be shared with those planning similar studies.
Item Type: | Journal Article | ||||||||
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Subjects: | R Medicine > RA Public aspects of medicine | ||||||||
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Social Science & Systems in Health (SSSH) |
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Library of Congress Subject Headings (LCSH): | Clinical trials -- Methodology | ||||||||
Journal or Publication Title: | Trials | ||||||||
Publisher: | Biomed Central | ||||||||
ISSN: | 1745-6215 | ||||||||
Official Date: | 24 February 2016 | ||||||||
Dates: |
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Volume: | 17 | ||||||||
Number: | 1 | ||||||||
Number of Pages: | 12 | ||||||||
Page Range: | pp. 1-12 | ||||||||
Article Number: | 104 | ||||||||
DOI: | 10.1186/s13063-016-1229-0 | ||||||||
Status: | Peer Reviewed | ||||||||
Publication Status: | Published | ||||||||
Access rights to Published version: | Open Access (Creative Commons) | ||||||||
Date of first compliant deposit: | 14 March 2016 | ||||||||
Date of first compliant Open Access: | 14 March 2016 | ||||||||
Funder: | National Institute for Health Research (Great Britain) (NIHR) |
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