Clinicians' views on the feasibility of surgical randomized trials in urogynecology: Results of a questionnaire survey§

Authors


  • Linda Brubaker led the review process.

  • 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, Allergan. Dr. Jones: Trial participation and Research grant- NIHR.

  • §

    Linda Brubaker led the review process.

Abstract

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.

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