Who can best recruit to randomized trials?: Randomized trial comparing surgeons and nurses recruiting patients to a trial of treatments for localized prostate cancer (the ProtecT study)☆
Introduction
Recruitment to randomized trials is often slower and more selective than intended, potentially threatening the power and external validity of trials [1] and leading to longer (and more expensive) recruitment periods [2], [3], [4]. Systematic reviews have identified a number of barriers to participation by clinicians and patients [5], [6], but have concluded that there has been little evaluation of strategies to overcome these problems [6].
Articles have described lessons to be learned from recruitment difficulties in major trials [7], [8], [9], [10], but only two randomized trials of interventions to improve recruitment appear to have been undertaken. In these trials, various strategies to obtain informed consent were attempted, and although patients were reported to be significantly better informed in one trial [11], in neither trial was any increase in recruitment achieved [11], [12].
Little research seems to have investigated who might be the most effective and cost-effective recruiters. It is generally accepted that doctors should recruit, although they have been reported to have “individual” methods [13], and studies have documented that they often perceive considerable difficulties in reconciling the different roles of clinician and recruiter [14], [15]. It has been suggested that nurses could play a greater role in recruitment [16], although one trial including supplementary consent by a nurse did not improve recruitment [11]. We sought to investigate, in a randomized trial, whether nurses or urologic surgeons would be the most effective and cost-effective recruiters of patients invited to participate in a trial of treatments for localized prostate cancer.
Section snippets
Methods
The randomized trial of recruitment was nested within the ProtecT (state sting for ancer and reatment) study [17]. This involved a program of case-finding to identify men with localized prostate cancer. Briefly, men aged 50–69 years in GP practices in three study areas were invited to attend a 30-minute prostate check clinic appointment where they saw trained nurse-researchers who provided them with information about the implications of having a prostate-specific antigen (PSA) test, the
Findings
Case-finding identified 167 men with localized prostate cancer between 1999 and 2001. The majority (n = 150, 90%) consented to randomization between the nurse and urologist for the recruitment trial (Fig. 1). Of the 75 randomized to a nurse, 50 (67%) were recruited to the treatment trial, compared with 53 (71%) of the 75 who were randomized to a urologist. This difference in recruitment rates of 4.0% (95% confidence interval −10.8% to +18.8%) was not statistically significant (P = .60). The
Discussion
This randomized trial showed that nurses were as effective and more cost-effective recruiters than urologic surgeons in this study. The differences in recruitment between the two groups were much less than between the centers. Although nurses spent longer times with patients, they incurred lower costs than surgeons and thus were less expensive overall. Time costs of surgeons in this study were based on their annual salaries because of the central remuneration of the UK NHS. In other health
Acknowledgements
The ProtecT feasibility study was funded by the UK NHS Research and Development Health Technology Assessment Programme. Further funding to support the study came from the MRC Health Services Research Collaboration and the South West NHS Research and Development Directorate. The Department of Social Medicine at the University of Bristol is the lead centre of the MRC Health Services Research Collaboration.
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2018, Contemporary Clinical Trials CommunicationsCitation Excerpt :Incentivizing staff (providing funds for enrolling patients) has been shown to improve patient recruitment [33]. Using nurses instead of surgeons (physicians) to perform recruitment has not evidenced any difference in outcomes; however, cost savings have been realized [35,40] which may be important in supporting recruitment and retention, or other aspects of the clinical trial, indirectly. Patient recruitment and retention is affected negatively when patients are concerned about being assigned to a control group rather than receiving active study drug.
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2017, Contemporary Clinical Trials CommunicationsCitation Excerpt :In this study, we investigate such associations. In a broad sense, it shares this aim with many earlier studies (e.g. Refs. [1,4,6,8,14,16,17,19,22]). Note, however, that there exist considerable heterogeneity between these studies in terms of e.g. medical context, methodology, the operationalization of ‘recruitment performance’, and the results, making it far from clear which factors should be used for the purpose of an operational risk classification.
Stepwise strategies to successfully recruit diabetes patients in a large research study in Mexican population
2017, Primary Care DiabetesCitation Excerpt :Having a specifically-designated space within the clinic with our own trained personnel facilitated recruitment and measurement procedures. Nurses proved to be ideal recruiters [32]. In the end, trust may be the most important underlying variable in recruiting [33].
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2014, Journal of Clinical EpidemiologyCitation Excerpt :The quest for evidence was a powerful imperative for these doctors, but they struggled intellectually and emotionally with aspects of equipoise. One solution might be that recruitment could instead be undertaken by nurses, who have been shown to be as effective as doctors [35], or research staff, who might be able to present the RCT more neutrally without clinical responsibility. These suggestions require further research, although there is evidence that nurses' perceptions of their roles can also conflict with recruitment to RCTs, perhaps even more so than doctors [28,36].
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ProtecT Study Group: John Anderson, Miranda Benney, Lucy Brindle, Sally Burton, Daniel Dedman, Ingrid Emmerson, Cath Ferguson, Stephen Frankel, John Goepel, Louise Goodwin, John Graham, David Gunnell, Christine Hardy, Helen Harris, Barbara Hattrick, Peter Holding, David Jewell, Clare Kennedy, Sue Kilner, Peter Kirkbride, Hing Leung, Teresa Mewes, Jon Oxley, Ian Pedley, Andrew Robinson, Mary Robinson, Liz Salter, Mark Sidaway, Carol Torrington, Lyn Wilkinson, Andrea Wilson.