Background: Recruiting and retaining participants for clinical trials, particularly women and ethnic minorities, are challenging. Few studies, however, examine gender and ethnic differences in research processes. Such information is important for findings to adequately represent the available population.
Objective: The study aim was to examine study recruitment processes (referral, eligibility, consent/enrollment) and study retention (completion) for gender and ethnic differences.
Methods: A descriptive comparative analysis of data from 2 randomized clinical trials focused on cancer outpatients with pain and/or fatigue. A computerized ResearchTracking software allowed documentation of recruitment and retention effort outcomes.
Results: Among the 1464 referred patients, 612 (42%) were eligible for study participation. Lack of ongoing care at the study settings and lack of English skills were the main reasons for ineligibility. There were no gender differences in consent/enrollment or completion rates. Ethnic minority patients were represented proportionally to the available population (13%) and were equally willing to consent/enroll and complete both studies as their white counterparts, if they were eligible.
Conclusions: Specific strategies to target language eligibility barriers are necessary to increase minority participation.
Implications for Practice: Future studies could include audio-aided tools in their native language to help recruit patients with limited English skills, if the study tools can be validly translated into other languages and are equivalent to English versions. Efforts to educate and garner support of providers could improve enrollment of patients in cancer studies, especially in studies of audio- or video-recorded patient-provider interaction.
Author Affiliations: Nursing Department, Taipei Medical University-Shuang Ho Hospital, New Taipei City, Taiwan, Republic of China (Dr Huang); College of Nursing, Department of BiobehavioralHealth Science, University of Illinois at Chicago (Drs Ezenwa andWilkie);Nursing Consult, LLC, Seattle, Washington (Dr Judge).
This research was made possible by grants 2RO1 CA62477 and 1RO1 CA81918 from the National Institutes of Health, National Cancer Institute.
Two authors (Drs Wilkie and Judge) are owners of a company that has no relationship to the research reported in this article. The other authors have no conflicts related to the research reported in this article.
The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.
Correspondence: Diana J. Wilkie, PhD, RN, FAAN, College of Nursing,Department of Biobehavioral Health Science (MC 802), University of Illinois at Chicago, 845 South Damen Ave, Room 660, Chicago, IL 60612 ( email@example.com).
Accepted for publication July 2, 2012.