Skip to main content
Top
Published in: Journal of Bioethical Inquiry 1/2018

01-03-2018 | Original Research

Minority Veterans Are More Willing to Participate in Complex Studies Compared to Non-minorities

Authors: Leonardo Tamariz, Irene Kirolos, Fiorella Pendola, Erin N. Marcus, Olveen Carrasquillo, Jimmy Rivadeneira, Ana Palacio

Published in: Journal of Bioethical Inquiry | Issue 1/2018

Login to get access

Abstract

Background

Minorities are an underrepresented population in clinical trials. A potential explanation for this underrepresentation could be lack of willingness to participate. The aim of our study was to evaluate willingness to participate in different hypothetical clinical research scenarios and to evaluate the role that predictors (e.g. health literacy) could have on the willingness of minorities to participate in clinical research studies.

Methods

We conducted a mixed-methods study at the Miami VA Healthcare system and included primary care patients with hypertension. We measured willingness to participate as a survey of four clinical research scenarios that evaluated common study designs encountered in clinical research and that differed in degree of complexity. Our qualitative portion included comments about the scenarios.

Results

We included 123 patients with hypertension in our study. Of the entire sample, ninety-three patients were minorities. Seventy per cent of the minorities were willing to participate, compared to 60 per cent of the non-minorities. The odds ratio (OR) of willingness to participate in simple studies was 0.58; 95 per cent CI 0.18–1.88 p=0.37 and the OR of willingness to participate in complex studies was 5.8; 95 per cent CI 1.10–1.31 p=0.03. In complex studies, minorities with low health literacy cited obtaining benefits (47 per cent) as the most common reason to be willing to participate. Minorities who were not willing to participate, cited fear of unintended outcomes as the main reason.

Conclusions

Minorities were more likely to be willing to participate in complex studies compared to non-minorities. Low health literacy and therapeutic misconception are important mediators when considering willingness to participate in clinical research.
Literature
go back to reference Appelbaum, P.S., and C.W. Lidz. 2008. Twenty-five years of therapeutic misconception. The Hastings Center Report 38(2): 5–6; author re ply 6–7.PubMed Appelbaum, P.S., and C.W. Lidz. 2008. Twenty-five years of therapeutic misconception. The Hastings Center Report 38(2): 5–6; author re ply 6–7.PubMed
go back to reference Britton, A., M. McKee, N. Black, K. McPherson, C. Sanderson, and C. Bain. 1999. Threats to applicability of randomised trials: Exclusions and selective participation. Journal of Health Services Research & Policy 4(2): 112–121.CrossRef Britton, A., M. McKee, N. Black, K. McPherson, C. Sanderson, and C. Bain. 1999. Threats to applicability of randomised trials: Exclusions and selective participation. Journal of Health Services Research & Policy 4(2): 112–121.CrossRef
go back to reference Brody, H., and F.G. Miller. 2003. The clinician-investigator: Unavoidable but manageable tension. Kennedy Institute of Ethics Journal 13(4): 329–346.CrossRefPubMed Brody, H., and F.G. Miller. 2003. The clinician-investigator: Unavoidable but manageable tension. Kennedy Institute of Ethics Journal 13(4): 329–346.CrossRefPubMed
go back to reference Byrne, M.M., S.L. Tannenbaum, S. Gluck, J. Hurley, and M. Antoni. 2014. Participation in cancer clinical trials: Why are patients not participating? Medical Decision Making: An International Journal of the Society for Medical Decision Making 34(1): 116–126.CrossRef Byrne, M.M., S.L. Tannenbaum, S. Gluck, J. Hurley, and M. Antoni. 2014. Participation in cancer clinical trials: Why are patients not participating? Medical Decision Making: An International Journal of the Society for Medical Decision Making 34(1): 116–126.CrossRef
go back to reference Cohen, B.J., E.L. McGarvey, R.C. Pinkerton, and L. Kryzhanivska. 2004. Willingness and competence of depressed and schizophrenic inpatients to consent to research. The Journal of the American Academy of Psychiatry and the Law 32(2): 134–143.PubMed Cohen, B.J., E.L. McGarvey, R.C. Pinkerton, and L. Kryzhanivska. 2004. Willingness and competence of depressed and schizophrenic inpatients to consent to research. The Journal of the American Academy of Psychiatry and the Law 32(2): 134–143.PubMed
go back to reference George, S., N. Duran, and K. Norris. 2014. A systematic review of barriers and facilitators to minority research participation among African Americans, Latinos, Asian Americans, and Pacific Islanders. American Journal of Public Health 104(2): e16–31.CrossRefPubMedPubMedCentral George, S., N. Duran, and K. Norris. 2014. A systematic review of barriers and facilitators to minority research participation among African Americans, Latinos, Asian Americans, and Pacific Islanders. American Journal of Public Health 104(2): e16–31.CrossRefPubMedPubMedCentral
go back to reference Hussain-Gambles, M., K. Atkin, and B. Leese. 2004. Why ethnic minority groups are under-represented in clinical trials: A review of the literature. Health & Social Care in the Community 12(5): 382–388.CrossRef Hussain-Gambles, M., K. Atkin, and B. Leese. 2004. Why ethnic minority groups are under-represented in clinical trials: A review of the literature. Health & Social Care in the Community 12(5): 382–388.CrossRef
go back to reference Joffe, S., E.F. Cook, P.D. Cleary, J.W. Clark, and J.C. Weeks. 2001. Quality of informed consent in cancer clinical trials: A cross-sectional survey. Lancet 358(9295): 1772–1777.CrossRefPubMed Joffe, S., E.F. Cook, P.D. Cleary, J.W. Clark, and J.C. Weeks. 2001. Quality of informed consent in cancer clinical trials: A cross-sectional survey. Lancet 358(9295): 1772–1777.CrossRefPubMed
go back to reference Katz, R.V., B.L. Green, N.R. Kressin, C. Claudio, M.Q. Wang, and S.L. Russell. 2007. Willingness of minorities to participate in biomedical studies: Confirmatory findings from a follow-up study using the Tuskegee Legacy Project questionnaire. Journal of the National Medical Association 99(9): 1052–1060.PubMedPubMedCentral Katz, R.V., B.L. Green, N.R. Kressin, C. Claudio, M.Q. Wang, and S.L. Russell. 2007. Willingness of minorities to participate in biomedical studies: Confirmatory findings from a follow-up study using the Tuskegee Legacy Project questionnaire. Journal of the National Medical Association 99(9): 1052–1060.PubMedPubMedCentral
go back to reference Lavori, P.W., T.J. Wilt, and J. Sugarman. 2007. Quality assurance questionnaire for professionals fails to improve the quality of informed consent. Clinical Trials 4(6): 638–649.CrossRefPubMed Lavori, P.W., T.J. Wilt, and J. Sugarman. 2007. Quality assurance questionnaire for professionals fails to improve the quality of informed consent. Clinical Trials 4(6): 638–649.CrossRefPubMed
go back to reference Lidz, C.W., K. Albert, P. Appelbaum, L.B. Dunn, E. Overton, and E. Pivovarova. 2015. Why is therapeutic misconception so prevalent? Cambridge Quarterly of Healthcare Ethics 24(2): 231–241.CrossRefPubMed Lidz, C.W., K. Albert, P. Appelbaum, L.B. Dunn, E. Overton, and E. Pivovarova. 2015. Why is therapeutic misconception so prevalent? Cambridge Quarterly of Healthcare Ethics 24(2): 231–241.CrossRefPubMed
go back to reference Mounsey, L.A., F.C. Lin, I. Pursell, et al. 2017. Relation of household income to incidence of sudden unexpected death in Wake County, North Carolina. The American Journal of Cardiology 119(7): 1030–1035.CrossRefPubMed Mounsey, L.A., F.C. Lin, I. Pursell, et al. 2017. Relation of household income to incidence of sudden unexpected death in Wake County, North Carolina. The American Journal of Cardiology 119(7): 1030–1035.CrossRefPubMed
go back to reference Murthy, V.H., H.M. Krumholz, and C.P. Gross. 2004. Participation in cancer clinical trials: Race-, sex-, and age-based disparities. JAMA 291(22): 2720–2726.CrossRefPubMed Murthy, V.H., H.M. Krumholz, and C.P. Gross. 2004. Participation in cancer clinical trials: Race-, sex-, and age-based disparities. JAMA 291(22): 2720–2726.CrossRefPubMed
go back to reference Palacio, A.M., L.J. Tamariz, C. Uribe, et al. 2011. Can claims-based data be used to recruit black and Hispanic subjects into clinical trials? Health Services Research 47(2): 770–782.CrossRefPubMedPubMedCentral Palacio, A.M., L.J. Tamariz, C. Uribe, et al. 2011. Can claims-based data be used to recruit black and Hispanic subjects into clinical trials? Health Services Research 47(2): 770–782.CrossRefPubMedPubMedCentral
go back to reference Rodriguez, V., A.D. Andrade, R. Garcia-Retamero, et al. 2013. Health literacy, numeracy, and graphical literacy among veterans in primary care and their effect on shared decision making and trust in physicians. Journal of Health Communication 18(Suppl 1): 273–289.CrossRefPubMedPubMedCentral Rodriguez, V., A.D. Andrade, R. Garcia-Retamero, et al. 2013. Health literacy, numeracy, and graphical literacy among veterans in primary care and their effect on shared decision making and trust in physicians. Journal of Health Communication 18(Suppl 1): 273–289.CrossRefPubMedPubMedCentral
go back to reference Tamariz, L., A. Palacio, J. Denizard, Y. Schulman, and G. Contreras. 2015. The use of claims data algorithms to recruit eligible participants into clinical trials. The American Journal of Managed Care 21(2): e114–118.PubMed Tamariz, L., A. Palacio, J. Denizard, Y. Schulman, and G. Contreras. 2015. The use of claims data algorithms to recruit eligible participants into clinical trials. The American Journal of Managed Care 21(2): e114–118.PubMed
go back to reference Tamariz, L., A. Palacio, M. Robert, and E.N. Marcus. 2013. Improving the informed consent process for research subjects with low literacy: A systematic review. Journal of General Internal Medicine 28(1): 121–126.CrossRefPubMed Tamariz, L., A. Palacio, M. Robert, and E.N. Marcus. 2013. Improving the informed consent process for research subjects with low literacy: A systematic review. Journal of General Internal Medicine 28(1): 121–126.CrossRefPubMed
go back to reference Thong, I.S., M.Y. Foo, M.Y. Sum, et al. 2016. Therapeutic misconception in psychiatry research: A systematic review. Clinical Psychopharmacology and Neuroscience 14(1): 17–25. Thong, I.S., M.Y. Foo, M.Y. Sum, et al. 2016. Therapeutic misconception in psychiatry research: A systematic review. Clinical Psychopharmacology and Neuroscience 14(1): 17–25.
go back to reference Weiss, B.D., M.Z. Mays, W. Martz, et al. 2005. Quick assessment of literacy in primary care: The newest vital sign. Annals of Family Medicine 3(6): 514–522.CrossRefPubMedPubMedCentral Weiss, B.D., M.Z. Mays, W. Martz, et al. 2005. Quick assessment of literacy in primary care: The newest vital sign. Annals of Family Medicine 3(6): 514–522.CrossRefPubMedPubMedCentral
go back to reference Wendler, D., and C. Grady. 2008. What should research participants understand to understand they are participants in research? Bioethics 22(4): 203–208.CrossRefPubMed Wendler, D., and C. Grady. 2008. What should research participants understand to understand they are participants in research? Bioethics 22(4): 203–208.CrossRefPubMed
go back to reference Wendler, D., R. Kington, J. Madans, et al. 2006. Are racial and ethnic minorities less willing to participate in health research? PLoS Medicine 3(2): e19.CrossRefPubMed Wendler, D., R. Kington, J. Madans, et al. 2006. Are racial and ethnic minorities less willing to participate in health research? PLoS Medicine 3(2): e19.CrossRefPubMed
go back to reference Zuniga, M.L., E. Blanco, P. Martinez, S.A. Strathdee, and A.L. Gifford. 2007. Perceptions of barriers and facilitators to participation in clinical trials in HIV-positive Latinas: A pilot study. Journal of Women’s Health 16(9): 1322–1330.CrossRefPubMed Zuniga, M.L., E. Blanco, P. Martinez, S.A. Strathdee, and A.L. Gifford. 2007. Perceptions of barriers and facilitators to participation in clinical trials in HIV-positive Latinas: A pilot study. Journal of Women’s Health 16(9): 1322–1330.CrossRefPubMed
Metadata
Title
Minority Veterans Are More Willing to Participate in Complex Studies Compared to Non-minorities
Authors
Leonardo Tamariz
Irene Kirolos
Fiorella Pendola
Erin N. Marcus
Olveen Carrasquillo
Jimmy Rivadeneira
Ana Palacio
Publication date
01-03-2018
Publisher
Springer Singapore
Published in
Journal of Bioethical Inquiry / Issue 1/2018
Print ISSN: 1176-7529
Electronic ISSN: 1872-4353
DOI
https://doi.org/10.1007/s11673-017-9829-2

Other articles of this Issue 1/2018

Journal of Bioethical Inquiry 1/2018 Go to the issue