Neurourology and Urodynamics 30:69–74 (2011) Clinicians’ Views on the Feasibility of Surgical Randomized Trials in Urogynecology: Results of a Questionnaire Survey Evangelia Bakali, 1† Emma Pitchforth, 2‡ Douglas G. Tincello, 3∗ Sara Kenyon, 4§ Mark Slack, 5‖ Philip Toozs-Hobson, 6‖ Christopher Mayne, 1‖ David R. Jones, 7# and David Taylor 3∗∗ 1 University Hospitals of Leicester NHS Trust, Leicester, UK 2 LSE Health, London School of Economics and Political Science, London, UK 3 University of Leicester, Leicester, UK 4 School of Health & Population Studies, University of Birmingham, Birmingham, UK 5 Addenbrooke’s Hospital, University of Cambridge Foundation Hospital Trust, Cambridge, UK 6 Birmingham Women’s Hospital, Birmingham, UK 7 Department of Health Sciences, University of Leicester, Leicester, UK Aims: To survey the views of clinicians (urologists and gynecologists) about a proposed randomized surgical trial comparing two approaches for the treatment of women with urinary incontinence and vaginal prolapse. Methods: A questionnaire survey nested within a pilot randomized controlled trial of colposuspension versus anterior repair plus TVT (CARPET1) for women with incontinence and anterior vaginal prolapse. Members of the UK Continence Society, British Society of Urogynaecology, and International Continence Society were sent a single electronic mailing of semi- structured questionnaires containing closed and open questions and free text response boxes. Free text responses were analyzed using a thematic qualitative analysis. Results: One hundred fifty-seven questionnaires were returned, from a potential total of 400 from UK and 1,700 international respondents. Fifty-eight percent thought the trial ethical, 44% desirable, and 47% feasible. Thirty-three percent would recruit to the full study, and 22% would enroll themselves or their partner. Analysis of free text responses identified three themes impacting participation: issues of patient choice and consent; clinicians’ views of perceived benefit and complications of the two arms; and issues about the chosen trial design. Conclusions: This study highlights the difference between collective and individual equipoise and their impact upon surgical trials. Clinicians held strong views preventing them from regarding the study favorably. Difficulty with relinquishing control over choice of procedure appeared central. These findings support the growing evidence in favor of detailed qualitative pilot work for surgical trials. The role of expertise-based randomization deserves further consideration. Neurourol. Urodyn. 30:69–74, 2011. © 2010 Wiley-Liss, Inc. Key words: colposuspension; incontinence; methodology; pilot; prolapse; trial INTRODUCTION Randomized controlled trials (RCTs) are considered the high- est level of evidence for interventions in health care. However, completion of an RCT requires considerable additional effort from both patients and healthcare staff, which are recognized barriers to the successful completion of the study. 1 Surgical randomized trials have been less widely adopted because of additional difficulties with trial design, randomization, choice, and timing of outcome assessment. 2,3 Furthermore, evidence for cancer trials in particular suggest that both surgeons and patients will have preferences for or against certain interven- tions, leading to lack of recruitment, or withdrawal of consent following randomization. 4 We have recently completed a pilot study funded by the Medical Research Council to assess the feasibility of a larger RCT comparing abdominal colposuspension to vaginal prolapse surgery combined with insertion of tension-free vaginal tape (TVT) for women with coexisting prolapse and stress urinary incontinence (CARPET1). 5 The trial also included a patient pref- erence arm for women who did not wish to be randomized. Within this study, we surveyed the opinions members of rele- vant medical specialist societies who would have been asked to recruit to the larger study about the feasibility and design of our proposed RCT. METHODS CARPET1 was a pilot randomized trial with a patient prefer- ence arm comparing two approaches to the surgical correction Conflicts of interest: Dr. Tincello: Consultant-Ethicon; Speaker honorarium-Astellas; Trial participation-Ethicon Pfizer; Fellowship grant-Pfizer, Astellas; Research grant-Ethicon. Dr. Slack: Consultant-Pfizer, Astellas, Gynaecore; Trial participation- Relase; Research grant-Moulton Trust, Wellbeing Goraser. Dr. Toozs-Hobson: Speaker honorarium-Astellas, Pfizer; Trial participation-Pfizer. Dr. Mayne: Speaker honorarium-AMS, Ethicon, Astellas, Pfizer; Trial participation-AMS, Ethicon, Aller- gan. Dr. Jones: Trial participation and Research grant- NIHR. Additional Supporting Information may be found in the online version of this article. Contract grant sponsor: Medical Research Council; Contract grant number: 73379Contract grant sponsor: University Hospitals of Leicester NHS Trust. Linda Brubaker led the review process. † Academic Clinical Fellow in Obstetrics & Gynaecology. ‡ Jamsetji Tata Senior Research Fellow. § Senior Lecturer. ‖ Consultant Urogynaecologist. # Professor of Statistics. ∗∗ Professor of Obstetrics & Gynaecology. ∗ Correspondence to: Douglas G. Tincello, Senior Lecturer in Urogynaecol- ogy/Consultant Gynaecologist, Reproductive Science Section, CSMM, RKCSB, Leicester Royal Infirmary, PO Box 65, Leicester LE2 7LX, UK. E-mail: dgt4@le.ac.uk Received 8 February 2010; Accepted 8 April 2010 Published online 23 July 2010 in Wiley Online Library (wileyonlinelibrary.com). DOI 10.1002/nau.20943 © 2010 Wiley-Liss, Inc.