Original ArticleDevelopment of a complex intervention improved randomization and informed consent in a randomized controlled trial
Section snippets
Background
Pragmatic multicenter randomized controlled trials are widely acknowledged as the design of choice for evaluating the effectiveness of health care interventions in a range of settings applicable to real-life health systems. Recruitment difficulties have been identified as a major cause of trials failing to start, being abandoned, or requiring additional support to reach (often revised) target sample sizes [1], [2], [3], but strategies to improve recruitment to trials remain few and of limited
The ProtecT study
The ProtecT (Prostate testing for cancer and Treatment) trial compares radical surgery, radical conformal radiotherapy, and active monitoring in men aged 50–69 years with localized prostate cancer in nine clinical centers in the UK [9]. Ethical approval was obtained from a multicenter research ethics committee. A feasibility study was undertaken in three centers in 1999–2001 with a nested trial of recruitment strategies [7] and integrated qualitative research [9]. The qualitative research
Results
The timing and constituents of the complex intervention are shown with the rates of randomization and immediate acceptance of allocation calculated each year from 2001 to 2007 (Fig. 1). The rate of immediate acceptance of allocation rose from 66% in 2002 to 71% in 2003, following center reviews, training and publication of document one (Fig. 1). This rise continued and increased to 78% in 2005, following intensified training and the publication of document two, in 2004. The rate of
Discussion
Multicenter trials are complex to mount and require considerable investment, but they often fail to recruit at the speed and to the level originally anticipated [1], [2], [3], [4], [5], [8]. Systematic reviews have identified many barriers but few robust interventions to improve recruitment [1], [4], [5], [6], [8]. The implementation of the complex intervention in the ProtecT study led to a marked increase in the rate of immediate acceptance of allocation over time (from 65% to 81%) with the
Acknowledgments
Contributions: F.C.H., J.L.D. and D.E.N. are PIs of the ProtecT trial; J.A.L. is the ProtecT trial co-ordinator; E.S. provided support and training for nurse-recruiters; D.G., P.P. and P.B. are lead clinical center investigators; T.P. is the lead statistician. J.L.D. devised the idea for this paper, led and carried out the qualitative research with L.B. and the Quartet team (see below). All authors contributed to the writing of the paper. J.L.D. is the guarantor.
Funding: The ProtecT study is
References (19)
- et al.
Patterns of patient enrollment in randomized controlled trials
J Clin Epidemiol
(2001) - et al.
Barriers to participation in randomised controlled trials: a systematic review
J Clin Epidemiol
(1999) - et al.
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)
J Clin Epidemiol
(2003) - et al.
What is participatory research?
Soc Sci Med
(1995) - et al.
Why don't they just tell me straight, why allocate it?” The struggle to make sense of participating in a randomised controlled trial
Soc Sci Med
(2002) - et al.
Perceptions of equipoise are crucial to trial participation: a qualitative study of men in the ProtecT Study
Controlled Clin Trials
(2003) - et al.
Factors that limit the quality, number and progress of randomised controlled trials
Health Technol Assess
(1999) - et al.
Recruitment experience in clinical trials: literature summary and annotated bibliography
Control Clin Trials
(1987) - et al.
Recruitment for controlled clinical trials: literature summary and annotated bibliography
Control Clin Trials
(1997)
Cited by (127)
Optimizing Informed Consent in Cancer Clinical Trials
2023, Seminars in Radiation OncologyFactors associated with trial recruitment, preferences, and treatments received were elucidated in a comprehensive cohort study
2019, Journal of Clinical EpidemiologyTreatment preference and recruitment to pediatric RCTs: A systematic review
2019, Contemporary Clinical Trials CommunicationsThe QuinteT Recruitment Intervention supported five randomized trials to recruit to target: a mixed-methods evaluation
2019, Journal of Clinical Epidemiology