Recruitment in a Clinical Trial of Provoked Vulvodynia and Evaluation of Racial Differences [4Q]

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Abstract

INTRODUCTION:

Clinical trials for chronic pain conditions are often terminated due to low enrollment, and minority groups are often underrepresented. Enrollment of women with provoked vulvodynia (PVD) is particularly challenging due to reluctance in women and clinicians in discussing dyspareunia. We compared the effectiveness of different recruitment methods on eligibility, enrollment and randomization in women with this pain condition and evaluated racial differences.

METHODS:

Recruitment methods for this multicenter clinical trial included mass mailing, media and the health care system. Eligibility, enrollment and recruitment fractions were calculated for each recruitment method. Data are reported as percentages and were analyzed by chi-square and exact binomial test.

RESULTS:

Of 763 subjects screened, the overall eligibility fraction was 28.0%, enrollment fraction was 40.7% and recruitment fraction was 11.4%. Compared to media and the health care system, in this trial mass mailing resulted in the highest eligibility fraction (P=.001), enrollment fraction (P=.01) and recruitment fraction (P=.01). Black women had a higher enrollment fraction than white women (P=.02), with mass mailing remaining the most effective recruitment method in this cohort (P=<.0001).

CONCLUSION:

Recruitment of women with chronic gynecologic pain conditions is consistent with the challenges met in other pain trials. The development of more effective recruitment methods targeted at specific cohorts of women with chronic pain appears necessary for timely clinical trials' completion.

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