Recruitment methods in a clinical trial of provoked vulvodynia

Predictors of enrollment

Candi C. Bachour, Gloria A. Bachmann, David C. Foster, Jim Wan, Leslie A. Rawlinson, Candace Brown

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

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 < 0.001). There were no statistically significant differences in efficiency between recruitment methods (p = 0.11). Relative to clinician referral, black women were 13 times as likely to be enrolled through mass mailing (adjusted odds ratio 12.5, 95% confidence interval, 3.6-43.1) as white women. There were no differences in enrollment according to educational level, annual income, relationship status, age, menopausal status, or employment status and recruitment method. 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.

Original languageEnglish (US)
Pages (from-to)103-108
Number of pages6
JournalClinical Trials
Volume14
Issue number1
DOIs
StatePublished - Feb 1 2017

Fingerprint

Vulvodynia
Clinical Trials
Referral and Consultation
Community-Institutional Relations
Mass Media
Coitus
National Institutes of Health (U.S.)
Chronic Pain
Multicenter Studies

All Science Journal Classification (ASJC) codes

  • Pharmacology

Cite this

Recruitment methods in a clinical trial of provoked vulvodynia : Predictors of enrollment. / Bachour, Candi C.; Bachmann, Gloria A.; Foster, David C.; Wan, Jim; Rawlinson, Leslie A.; Brown, Candace.

In: Clinical Trials, Vol. 14, No. 1, 01.02.2017, p. 103-108.

Research output: Contribution to journalArticle

Bachour, Candi C. ; Bachmann, Gloria A. ; Foster, David C. ; Wan, Jim ; Rawlinson, Leslie A. ; Brown, Candace. / Recruitment methods in a clinical trial of provoked vulvodynia : Predictors of enrollment. In: Clinical Trials. 2017 ; Vol. 14, No. 1. pp. 103-108.
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abstract = "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 < 0.001). There were no statistically significant differences in efficiency between recruitment methods (p = 0.11). Relative to clinician referral, black women were 13 times as likely to be enrolled through mass mailing (adjusted odds ratio 12.5, 95{\%} confidence interval, 3.6-43.1) as white women. There were no differences in enrollment according to educational level, annual income, relationship status, age, menopausal status, or employment status and recruitment method. 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.",
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