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© 2002 American Public Health Association
RESEARCH AND PRACTICE |
Juliet L. Rogers is with the University of Michigan, Ann Arbor.
Correspondence: Requests for reprints should be sent to Juliet L. Rogers, MPH, University of Michigan Health System, Co-Director, National Center of Excellence in Women's Health, 300 N Ingalls, Room NI4D21, Ann Arbor, MI 48109-0475 (e-mail: roxann{at}umich.edu).
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INTRODUCTION |
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 TOP INTRODUCTION METHODSRESULTSDISCUSSIONReferences |
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Low recruitment rates of women into clinical trials are attributed to logistical challenges such as raising awareness of trials, creating lay-friendly information about trial participation, and connecting willing participants with investigators. In response to these challenges, the University of Michigan Health System's National Center of Excellence in Women's Health and Center for Clinical Investigation and Therapeutics created the Women's Health Registry to enroll women into a searchable database that allows identification and prescreening of women interested in research participation. Institutional review board–approved investigators submit study details, including eligibility criteria, and the registry team generates contact information for prescreened women who have consented to be contacted by investigators. Although systems designed elsewhere assist investigators in identifying eligible patients for specific trials,1,2 the registry takes a broader approach by storing contact and health history information for women interested in being prescreened and contacted for participation in projects whenever they meet criteria.
In a pilot of the database (June 2000–January 2001), 654 women completed a multipage questionnaire capturing demographic and personal health information. Word-of-mouth and on-site publicity was used to inform women of the project, in addition to a 2-week print and radio campaign in local communities (within 30 miles) that surround the University of Michigan. Predictably, the pilot campaign disproportionately enrolled participants who were White (92%), had higher education or advanced degrees (86%), and had health insurance (93%).
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METHODS |
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TOPINTRODUCTIONMETHODSRESULTSDISCUSSIONReferences |
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In the interest of increasing the participation of women of color, the Women's Health Registry team launched a second publicity campaign in May 2001 specifically targeting African American women. The campaign's "call to action" posters were placed on local public buses (within 10 miles of Ann Arbor, Mich); in Detroit, Mich, newspapers (serving Detroit and surrounding suburbs); and in newspapers of 3 local communities with majority non-White populations. The advertisements featured an African American woman and a large header reading, "Give us some of your time and we'll give it back to future generations." The text highlighted the historical underrepresentation of African American women in clinical research that defines medical treatment and protocols and encouraged women to enroll in the registry database via a toll-free number or secure Web site.
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RESULTS |
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TOPINTRODUCTIONMETHODSRESULTSDISCUSSIONReferences |
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The "Give us some of your time" campaign enrolled 525 women aged 18 or older living in Michigan and was successful in meeting its goal of increasing the non-White enrollment. The non-White enrollment increased from 8.00% of the total pilot sample enrollment to 14.48% in the "Give us some of your time" sample.
The new sample was analyzed for significant differences in demographics and questionnaire responses (19 categories of questions, including information on more than 120 health conditions) by race/ethnicity. Highly significant differences (P 
.001, Pearson 
2 test) between White and non-White women enrolled during the new campaign were found in 2 categories: perceived health status (P = .001) and health insurance coverage (P .001). Statistically significant differences in prevalence of diabetes between the 2 groups also were found (P = .03, Pearson 2 test). No differences were detected between White and non-White enrollees in education level; employment status; marital status; Internet access; or prevalence of heart, gastrointestinal, liver, kidney, bladder, or endocrine conditions, neurological disorders, mental health concerns, cancer, hormone replacement therapy use, physical or sexual abuse, sexual assault, or eating disorders. Enrollment characteristics by race/ethnicity are summarized in Table 1
.
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DISCUSSION |
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TOPINTRODUCTIONMETHODSRESULTSDISCUSSIONReferences |
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The "Give us some of your time" campaign targeted geographic areas and social outlets selected for their racially/ethnically and socially diverse populations. The only major difference between the enrollment sample from this campaign and that from the previous campaign targeting higher-socioeconomicstatus areas was in the proportional representation of non-White women. Differences in education, community health, employment status, and prevalence of violence between targeted communities did not translate into significant differences between total sample populations from each campaign. Also noteworthy was that the sample from the new campaign had few significant differences by race/ethnicity in demographic characteristics or prevalence of illness. This finding could prompt the conclusion that it is the product, and not the approach, that elicits action in people—educated, employed, and insured people of all racial/ethnic backgrounds. More plausibly, these results reflect the persistent strength of disincentives to participate in research. Lack of time, lack of transportation or child care, language barriers, lack of trust, intimidation,3,4 and other well-known factors may overpower any efforts to increase participation of women through greater awareness of participation opportunities.
The response to the registry publicity campaign focusing on African American women is promising. Screening and enrollment into clinical trials of participants who joined the registry during the campaign are in the early stages. Thus, data on differences in enrollment in trials (vs enrollment in the registry) by race/ethnicity are unavailable at this time but will be the focus of future analyses.
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Acknowledgments |
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The University of Michigan Health System Women's Health Program is a designated National Center of Excellence in Women's Health (contract 282-97-0071) funded by the Office on Women's Health, Public Health Service, US Department of Health and Human Services.
The University of Michigan Health System Women's Health Registry Lead Team that developed the enrollment campaign described in this paper included Juliet L. Rogers, MPH, Judith Birk, JD, Timothy R. B. Johnson, MD, Valerie Castle, MD, Wendy Kwan, MS, and Kristal Kingsley, BA. The development of publicity and advertising materials was managed by Nancy Pascaris, University of Michigan Health System Office of Planning and Marketing.
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Footnotes |
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Peer Reviewed
Accepted for publication November 12, 2001.
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References |
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TOPINTRODUCTIONMETHODSRESULTSDISCUSSIONReferences |
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1. Ohno-Machado L, Wang SJ, Mar P, Boxwala AA. Decision support for clinical trial eligibility determination in breast cancer. In: Proceedings of the American Medical Informatics Association Annual Symposium; Washington, DC; November 6–10, 1999:34–344.
2. Newcomb PA, Love RR, Phillips JL, Buckmaster BJ. Using a population-based cancer registry for recruitment in a pilot cancer control study. Prev Med.1990;19:61–65.[Medline]
3. Freedman TG. Why don't they come to Pike Street and ask us? Black American women's health concerns. Soc Sci Med.1998;47:941–947.
4. Brown BA, Long HL, Gould T, Weitz T, Milliken N. A conceptual model for the recruitment of diverse women into research studies. J Womens Health Gender-Based Med.2000;9:625–632.[Medline]
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