Recruitment and Retention of Healthy, Postmenopausal Women of African and European Ancestry: Results from a Dietary Intervention with Repeated Biospecimen Collections

Susan E McCann, Elisa M Rodriguez, Deborah Erwin, Song Yao, David Tritchler, Meredith A J Hullar, Tracey O'Connor, Johanna W Lampe, Susan E McCann, Elisa M Rodriguez, Deborah Erwin, Song Yao, David Tritchler, Meredith A J Hullar, Tracey O'Connor, Johanna W Lampe

Abstract

Recruitment of minority participants to clinical trials, especially studies without therapeutic intent, has been historically challenging. This study describes barriers to and successes of recruitment and retention strategies to dietary studies. A flaxseed study was conducted in healthy, postmenopausal women of African ancestry (AA) and European ancestry (EA) to assess associations between gut microbial community composition and host metabolism (NCT01698294). To ensure equitable participation by AA and EA women, multiple forms of recruitment were utilized, including advertisements, posters, e-mail, word of mouth, and community outreach. Successful recruitment and retention of AA women to the intervention depended upon the specific methods used. AA women compared with EA women were more likely to respond to direct recruitment and community-based methods, rather than general advertisements. However, once women expressed interest, similar rates of consent were observed for AA and EA women (AA and EA: 51.6% vs. 55.7%, respectively; P > 0.05), supporting the willingness of minority populations to participate in clinical research. Retention, however, was lower among AA compared with EA women (AA and EA: 57.6% vs. 80.9%, respectively; P < 0.01), which may be related to multiple factors, including health reasons, intolerance to flaxseed, noncompliance with study requirements, time constraints, and nonspecified personal reasons. This study confirms the utility of direct community-based strategies for recruitment of diverse populations into nontherapeutic dietary intervention studies. The methods used successfully identified eligible women who expressed willingness to consent to the trial and were able to achieve >70% of recruitment goals for AA women. Future efforts are warranted to improve retention to complex studies. This trial was registered at www.clinicaltrials.gov as NCT01698294.

Keywords: African ancestry; European ancestry; dietary interventions; recruitment; retention.

© The Author(s) 2022. Published by Oxford University Press on behalf of the American Society for Nutrition.

Figures

FIGURE 1
FIGURE 1
CONSORT diagram for disposition of attempts to contact women interested in participating in a flaxseed intervention study. *Excluding 14 women ineligible because of race not EA or AA. AA, African ancestry; CONSORT, Consolidated Standards of Reporting Trials; EA, European ancestry.

References

    1. Oh SS, Galanter J, Thakur N, Pino-Yanes M, Barcelo NE, White MJ, de Bruin DM, Greenblatt RM, Bibbins-Domingo K, Wu AHet al. . Diversity in clinical and biomedical research: a promise yet to be fulfilled. PLoS Med. 2015;12(12):e1001918.
    1. US Congress. National Institutes of Health Revitalization Act of 1993: Act to Amend the Public Health Service Act to Revise and Extend the Programs of the National Institutes of Health, and for Other Purposes. Public Law 103-43; (1993).
    1. National Insitutes of Health . [Internet]. Available from:.
    1. Kurt A, Kincaid H, Semler L, Jacoby JL, Johnson MB, Careyva BA, Stello B, Friel T, Smulian JC, Knouse MC. Impact of race versus education and race versus income on patients' motivation to participate in clinical trials. J Racial Ethn Health Disparities. 2018;5(5):1042–51.
    1. Nicholson LM, Schwirian PM, Groner JA. Recruitment and retention strategies in clinical studies with low-income and minority populations: progress from 2004-2014. Contemp Clin Trials. 2015;45(Pt A):34–40.
    1. Hagiwara N, Berry-Bobovski L, Francis C, Ramsey L, Chapman RA, Albrecht TL. Unexpected findings in the exploration of African American underrepresentation in biospecimen collection and biobanks. J Cancer Educ. 2014;29(3):580–7.
    1. Rodriguez EM, Saad-Harfouche FG, Miller A, Mahoney MC, Ambrosone CB, Morrison CD, Underwood WR, Erwin DO. Engaging diverse populations in biospecimen donation: results from the Hoy y Manana study. J Comm Genet. 2016;7(4):271–7.
    1. Rodriguez EM, Torres ET, Erwin DO. Awareness and interest in biospecimen donation for cancer research: views from gatekeepers and prospective participants in the Latino community. J Comm Genet. 2013;4(4):461–8.
    1. Bevel M, Babatunde OA, Heiney SP, Brandt HM, Wirth MD, Hurley TG, Khan S, Johnson H, Wineglass CM, Warren TYet al. . Sistas Inspiring Sistas Through Activity and Support (SISTAS): study design and demographics of participants. Ethn Dis. 2018;28(2):75–84.
    1. Sharpe PA, Stucker J, Wilcox S, Liese AD, Bell BA. Recruitment and retention for the evaluation of a healthy food initiative in economically disadvantaged, majority African American communities. Fam Community Health. 2021;44(1):43–51.
    1. Erwin DO, Moysich K, Kiviniemi MT, Saad-Harfouche FG, Davis W, Clark-Hargrave N, Ciupak GL, Ambrosone CB, Walker C. Community-based partnership to identify keys to biospecimen research participation. J Cancer Educ. 2013;28(1):43–51.
    1. Chang H, Yao S, Tritchler D, Hullar MA, Lampe JW, Thompson LU, McCann SE. Genetic variation in steroid and xenobiotic metabolizing pathways and enterolactone excretion before and after flaxseed intervention in African American and European American women. Cancer Epidemiol Biomarkers Prev. 2019;28(2):265–74.
    1. Patel SN, Staples JN, Garcia C, Chatfield L, Ferriss JS, Duska L. Are ethnic and racial minority women less likely to participate in clinical trials?. Gynecol Oncol. 2020;157(2):323–8.
    1. Linden HM, Reisch LM, Hart A Jr, Harrington MA, Nakano C, Jackson JC, Elmore JG. Attitudes toward participation in breast cancer randomized clinical trials in the African American community: a focus group study. Cancer Nurs. 2007;30(4):261–9.
    1. Shelton RC, Brotzman LE, Johnson D, Erwin D. Trust and mistrust in shaping adaptation and de-implementation in the context of changing screening guidelines. Ethn Dis. 2021;31(1):119–32.
    1. Ochs-Balcom HM, Rodriguez EM, Erwin DO. Establishing a community partnership to optimize recruitment of African American pedigrees for a genetic epidemiology study. J Comm Genet. 2011;2(4):223–31.
    1. Erves JC, Mayo-Gamble TL, Malin-Fair A, Boyer A, Joosten Y, Vaughn YC, Sherden L, Luther P, Miller S, Wilkins CH. Needs, priorities, and recommendations for engaging underrepresented populations in clinical research: a community perspective. J Comm Health. 2017;42(3):472–80.
    1. Michaels M, Weiss ES, Guidry JA, Blakeney N, Swords L, Gibbs B, Yeun S, Rytkonen B, Goodman R, Jarama SLet al. . The promise of community-based advocacy and education efforts for increasing cancer clinical trials accrual. J Cancer Educ. 2012;27(1):67–74.

Source: PubMed

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