Recruitment of Women With Provoked Vestibulodynia in a Clinical Trial [41

Abstract

INTRODUCTION: Although there is an increasing body of evidence regarding successful recruitment in clinical trials, limited data are available on the influence of gender, ethnicity, or specific gynecologic conditions. Recruiting women with provoked vestibulodynia is particularly challenging owing to reluctance in discussing dyspareunia. Recruitment methods for patients with provoked vestibulodynia were analyzed for efficacy, cost, and ethnicity preferences. METHODS: Recruitment included mass mailing (mailing house, utilities company), media (web site development, Facebook, Craigslist, newspaper advertisements, flyers, newsletters), community outreach (presentations, community events), and the health care system (clinician letters, clinic patients, registry). Data were analyzed by χ2, ANOVA, and a logistic model. RESULTS: Among 503 inquiries, 134 patients were eligible (26.6%) and 58 (11.5%) were randomized. Patients recruited through the health care system were significantly more likely to be eligible (38%) than those recruited through mass mailing (25%) or the media (20%) (P<.003). Neither recruitment method (P=.64) nor ethnicity (P=.19) had any effect on randomization, and there were no interaction effects between recruitment method and ethnicity (P=.96). Community outreach appears ineffective. Cost per randomized patient was $525, $527, and $17 for mass mailing, media, and health care system, respectively. CONCLUSION: The health care system is the most efficient and cost-effective recruitment method; it does not lead to more randomized patients or reach more minority women with provoked vestibulodynia. Specific methods for improving randomization rates and increasing minority enrollment are needed.