Abstract
BackgroundRecruitment 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.MethodsA 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.ResultsTwo 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.ConclusionsDespite 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.ISRCTN56495859 (registered on 12 February 2009); NCT00836459 (registered on 3 February 2009).
Highlights
Recruitment issues continue to impact a large number of trials
In this article we present a transparent examination of the recruitment experience from the Booster Study, which was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme and approved by Sheffield Research Ethics Committee
Overview of recruitment Two hundred eighty-two people were recruited into the Recruitment to the main intervention (RCT) over a period of 24 months (November 2009 to November 2011), which equated to 47 % of the recruitment target of 600 participants
Summary
Recruitment issues continue to impact a large number of trials. The purpose of this article is to build on the knowledge available to researchers on recruiting to community-based trials. Many randomised controlled trials (RCTs) suffer from poor recruitment. Up to two-thirds of research studies published in The Lancet and BMJ in 2000 and 2001 failed to meet recruitment targets or required an extension to do so [1]. Researchers examining studies funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme and the U.K. Medical Research Council (MRC) suggested that 31–55 % recruited to target and 45–54 % required an extension of some kind [2, 3]. Reducing the amount of studies which fail to recruit to time and target is critical
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