Abstract
Objective: Multicenter randomized trials are required for pragmatic evaluations of health care interventions, but recruitment is difficult.
Systematic reviews failed to identify robust strategies to improve recruitment. We developed and evaluated a complex intervention to
increase levels of randomization and informed consent.
Study Design and Setting: The ProtecT (Prostate testing for cancer and Treatment) trial compares radical surgery, radical conformal
radiotherapy, and active monitoring for men aged 50e69 years with localized prostate cancer. The intervention was developed using qualitative
research methods (content, thematic and conversation analysis). Rates of randomization and immediate acceptance of allocation
were measured every 6 months to evaluate the impact of the intervention.
Results: The complex intervention comprised reviews of centers falling below study targets, training programmes, documents and
individually tailored feedback. Over 65% of eligible participants consented to randomization. Trial participants became increasingly well
informed as immediate acceptance of allocation rose from 65% to 81% between 2001 and 2005.
Conclusion: This complex intervention resulted in high levels of randomization and informed consent in a difficult trial. The generic
aspects of the intervention could be applied to other trials to maximize randomization and informed consent, and allow the mounting of
trials previously considered too difficult.
Translated title of the contribution | Development of a complex intervention improved randomisation and informed consent in a multi-centre randomised controlled trial |
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Original language | English |
Pages (from-to) | 29 - 36 |
Number of pages | 8 |
Journal | Journal of Clinical Epidemiology |
Volume | 62 |
DOIs | |
Publication status | Published - Jan 2009 |