Abstract
Recruitment of participants into randomised controlled trials (RCTs) is critical for successful trial conduct. Although there have been two previous systematic reviews on related topics, the results (which identified specific interventions) were inconclusive and not generalizable. The aim of our study was to evaluate the relative effectiveness of recruitment strategies for participation in RCTs. A systematic review, using the PRISMA guideline for reporting of systematic reviews, that compared methods of recruiting individual study participants into an actual or mock RCT were included. We searched MEDLINE, Embase, The Cochrane Library, and reference lists of relevant studies. From over 16,000 titles or abstracts reviewed, 396 papers were retrieved and 37 studies were included, in which 18,812 of at least 59,354 people approached agreed to participate in a clinical RCT. Recruitment strategies were broadly divided into four groups: novel trial designs (eight studies), recruiter differences (eight studies), incentives (two studies), and provision of trial information (19 studies). Strategies that increased people's awareness of the health problem being studied (e.g., an interactive computer program [relative risk (RR) 1.48, 95% confidence interval (CI) 1.00-2.18], attendance at an education session [RR 1.14, 95% CI 1.01-1.28], addition of a health questionnaire [RR 1.37, 95% CI 1.14-1.66]), or a video about the health condition (RR 1.75, 95% CI 1.11-2.74), and also monetary incentives (RR1.39, 95% CI 1.13-1.64 to RR 1.53, 95% CI 1.28-1.84) improved recruitment. Increasing patients' understanding of the trial process, recruiter differences, and various methods of randomisation and consent design did not show a difference in recruitment. Consent rates were also higher for nonblinded trial design, but differential loss to follow up between groups may jeopardise the study findings. The study's main limitation was the necessity of modifying the search strategy with subsequent search updates because of changes in MEDLINE definitions. The abstracts of previous versions of this systematic review were published in 2002 and 2007. Recruitment strategies that focus on increasing potential participants' awareness of the health problem being studied, its potential impact on their health, and their engagement in the learning process appeared to increase recruitment to clinical studies. Further trials of recruitment strategies that target engaging participants to increase their awareness of the health problems being studied and the potential impact on their health may confirm this hypothesis. Please see later in the article for the Editors' Summary.
Highlights
The randomised controlled trial (RCT) provides the most reliable evidence for evaluating the effects of health care interventions [1,2], but the successful conduct of clinical randomised controlled trials (RCTs) is often hindered by recruitment difficulties [3]
Further trials of recruitment strategies that target engaging participants to increase their awareness of the health problems being studied and the potential impact on their health may confirm this hypothesis
Literature Search From 16,703 unique titles and abstracts, 396 articles were retrieved and 37 eligible publications identified (Figure 1). This total assessed recruitment outcomes in at least 59,354 people who were approached for clinical study participation, of whom 18,812 consented to participate (Table 1). (Not all studies identified the number of potential participants who were approached)
Summary
The randomised controlled trial (RCT) provides the most reliable evidence for evaluating the effects of health care interventions [1,2], but the successful conduct of clinical RCTs is often hindered by recruitment difficulties [3]. There have been two previous systematic reviews on strategies to enhance recruitment to research [9,10], they identified specific individual interventions These interventions could not be combined to offer useful general advice for recruitment for clinical RCTs. Recruitment of participants into randomised controlled trials (RCTs) is critical for successful trial conduct. In phase III trials, very large groups of patients (sometimes in excess of a thousand people) are randomly assigned to receive the new intervention or an established intervention or placebo (dummy intervention) These ‘‘randomized controlled trials’’ or ‘‘RCTs’’ provide the most reliable information about the effectiveness and safety of health care interventions
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