Recruitment methods in a clinical trial of provoked vulvodynia: Predictors of enrollment

Autor: Candi C. Bachour, Jim Y. Wan, Candace Brown, Leslie A. Rawlinson, David C. Foster, Gloria Bachmann
Rok vydání: 2016
Předmět:
Zdroj: Clinical Trials. 14:103-108
ISSN: 1740-7753
1740-7745
DOI: 10.1177/1740774516663461
Popis: Background: Successful recruitment in clinical trials for chronic pain conditions is challenging, especially in women with provoked vulvodynia due to reluctance in discussing pain associated with sexual intercourse. The most successful recruitment methods and the characteristics of women reached with these methods are unknown. Objective: To compare the effectiveness and efficiency of four recruitment methods and to determine socioeconomic predictors for successful enrollment in a National Institutes of Health–sponsored multicenter clinical trial evaluating a gabapentin intervention in women with provoked vulvodynia. Methods: Recruitment methods utilized mass mailing, media, clinician referrals and community outreach. Effectiveness (number of participants enrolled) and efficiency (proportion screened who enrolled) were determined. Socioeconomic variables including race, educational level, annual household income, relationship status, age, menopausal status and employment status were also evaluated regarding which recruitment strategies were best at targeting specific cohorts. Results: Of 868 potential study participants, 219 were enrolled. The most effective recruitment method in enrolling participants was mass mailing ( p Conclusion: In this clinical trial, mass mailing was the most effective recruitment method. Race of participants enrolled in a provoked vulvodynia trial was related to the recruitment method.
Databáze: OpenAIRE