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

摘要

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.