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)

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Abstract

Background and Objective: Recruitment to randomized trials is often difficult, but few studies have investigated interventions to improve recruitment. In a randomized trial nested within a trial of treatments for localized prostate cancer, we investigated the comparative effectiveness and cost-effectiveness of nurses and surgeons in recruiting patients.

Methods: Men with localized prostate cancer were randomized to see a nurse or urologic surgeon for an “information appointment” in which they were asked to consent to the ProtecT treatment trial comparing surgery, radiotherapy, and active monitoring. Analysis was conducted by intention to treat using chi-square with 95% confidence intervals for proportions and differences between groups. An economic evaluation was performed using the duration of appointments and grade of recruitment staff.

Results: Case-finding identified 167 men with localized prostate cancer. One hundred fifty (90%) took part in the recruitment trial. There was a 4.0% difference between nurses and surgeons in recruitment rates (67% nurses, 71% urologists, 95% CI −10.8% to +18.8%, P = .60). Cost-minimization analysis showed that nurses spent longer times with patients but surgeon costs were higher and nurses often supported surgeon-led clinics.

Conclusion: Nurses were as effective and more cost-effective recruiters than urologic surgeons. This suggests an increased role for nurses in recruiting patients to randomized trials.

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 (Prostate testing for cancer and Treatment) 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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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.

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