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Published in: Trials 1/2018

Open Access 01-12-2018 | Research

Sex and cardiovascular disease status differences in attitudes and willingness to participate in clinical research studies/clinical trials

Authors: Thomas S. Gruca, Wesley J. Hottel, Janine Comstock, Anna Olson, Gary E. Rosenthal

Published in: Trials | Issue 1/2018

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Abstract

Background

While women are under-represented in research on cardiovascular disease (CVD), little is known about the attitudes of men and women with CVD regarding participation in clinical research studies/clinical trials.

Methods

Patients with CVD (and/or risk factors) and patients with other chronic conditions from Iowa were recruited from a commercial panel. An on-line survey assessed willingness to participate (WTP) and other attitudes towards aspects of clinical research studies.

Results

Based on 504 respondents, there were no differences in WTP in patients with CVD compared to patients with other chronic diseases. Across all respondents, men had 14% lower WTP (relative risk (RR) for men, 0.86, 95% CI, 0.72–1.02). Among patients with CVD, there was no significant difference in WTP between women (RR for women = 1) and men (RR for men, 0.96, 95% CI, 0.82–1.14).
There were no significant differences based on sex or CVD status for attitudes on randomization, blinding, side effects, conflict of interest, experimental treatments or willingness to talk to one’s physician. Women had more favorable attitudes about participants being treated like “guinea pigs” (RR for men, 0.84, 95% CI, 0.73–0.98) and clinical trials being associated with terminally ill patients (RR for men, 0.93, 95% CI, 0.86–1.00).

Conclusions

The findings reported here suggest that the observed lower levels of participation by women are due to factors other than a lower WTP or to women having more negative attitudes towards aspects of study participation. Patients with CVD have similar attitudes and WTP as patients with other chronic conditions.
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Literature
1.
go back to reference Heron M. Deaths: leading causes for 2013. National vital statistics reports. Hyattsville: National Center for Health Statistics; 2016. p. 65. Heron M. Deaths: leading causes for 2013. National vital statistics reports. Hyattsville: National Center for Health Statistics; 2016. p. 65.
2.
go back to reference Mosca L, Mochari-Greenberger H, Dolor RJ, Newby LK, Robb KJ. Twelve-year follow-up of American women’s awareness of cardiovascular disease risk and barriers to heart health. Circ Cardiovasc Qual Outcomes. 2010;3:120–7.CrossRefPubMedPubMedCentral Mosca L, Mochari-Greenberger H, Dolor RJ, Newby LK, Robb KJ. Twelve-year follow-up of American women’s awareness of cardiovascular disease risk and barriers to heart health. Circ Cardiovasc Qual Outcomes. 2010;3:120–7.CrossRefPubMedPubMedCentral
3.
go back to reference Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J, Writing Group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA. 2002;288:321–33.CrossRefPubMed Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J, Writing Group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA. 2002;288:321–33.CrossRefPubMed
4.
go back to reference Schulman SP, Thiemann DR, Ouyang P, et al. Effects of acute hormone therapy on recurrent ischemia in postmenopausal women with unstable angina. J Am Coll Cardiol. 2002;39:231–7.CrossRefPubMed Schulman SP, Thiemann DR, Ouyang P, et al. Effects of acute hormone therapy on recurrent ischemia in postmenopausal women with unstable angina. J Am Coll Cardiol. 2002;39:231–7.CrossRefPubMed
5.
go back to reference Ridker PM, Cook NR, Lee IM, et al. A randomized trial of low-dose aspirin in the primary prevention of cardiovascular disease in women. N Engl J Med. 2005;352:1293–304.CrossRefPubMed Ridker PM, Cook NR, Lee IM, et al. A randomized trial of low-dose aspirin in the primary prevention of cardiovascular disease in women. N Engl J Med. 2005;352:1293–304.CrossRefPubMed
6.
go back to reference Shen L, Melloni C. Representation of women in randomized clinical trials of cardiovascular disease prevention. Curr Cardiovasc Risk Rep. 2014;8:1–5.CrossRef Shen L, Melloni C. Representation of women in randomized clinical trials of cardiovascular disease prevention. Curr Cardiovasc Risk Rep. 2014;8:1–5.CrossRef
7.
go back to reference Mosca L, Benjamin EJ, Berra K, Bezanson JL, Dolor RJ, Lloyd-Jones DM, Newby LK, Pin˜a IL, Roger VL, Shaw LJ, Zhao D, Beckie TM, Bushnell C, D’Armiento J, Kris-Etherton PM, Fang J, Ganiats TG, Gomes AS, Gracia CR, Haan CK, Jackson EA, Judelson DR, Kelepouris E, Lavie CJ, Moore A, Nussmeier NA, Ofili E, Oparil S, Ouyang P, Pinn VW, Sherif K, Smith SC Jr, Sopko G, Chandra-Strobos N, Urbina EM, Vaccarino V, Wenger NK. Effectiveness-based guidelines for the prevention of cardiovascular disease in women—2011 update: a guideline from the American Heart Association. Circulation. 2011;123:1243–62.CrossRefPubMedPubMedCentral Mosca L, Benjamin EJ, Berra K, Bezanson JL, Dolor RJ, Lloyd-Jones DM, Newby LK, Pin˜a IL, Roger VL, Shaw LJ, Zhao D, Beckie TM, Bushnell C, D’Armiento J, Kris-Etherton PM, Fang J, Ganiats TG, Gomes AS, Gracia CR, Haan CK, Jackson EA, Judelson DR, Kelepouris E, Lavie CJ, Moore A, Nussmeier NA, Ofili E, Oparil S, Ouyang P, Pinn VW, Sherif K, Smith SC Jr, Sopko G, Chandra-Strobos N, Urbina EM, Vaccarino V, Wenger NK. Effectiveness-based guidelines for the prevention of cardiovascular disease in women—2011 update: a guideline from the American Heart Association. Circulation. 2011;123:1243–62.CrossRefPubMedPubMedCentral
8.
go back to reference U.S. Congress Public Law No. 103-43. National Institutes of Health Revitalization Act of 1993. 1993. U.S. Congress Public Law No. 103-43. National Institutes of Health Revitalization Act of 1993. 1993.
11.
go back to reference Sen Biswas M, Newby LK, Bastian LA, Peterson ED, Sugarman J. Who refuses enrollment in cardiac clinical trials? Clin Trials. 2007;4:258–63.CrossRefPubMed Sen Biswas M, Newby LK, Bastian LA, Peterson ED, Sugarman J. Who refuses enrollment in cardiac clinical trials? Clin Trials. 2007;4:258–63.CrossRefPubMed
15.
go back to reference Lee PY, Alexander KP, Hammill BG, Pasquali SK, Peterson ED. Representation of elderly persons and women in published randomized trials of acute coronary syndromes. JAMA. 2001;286:708–13.CrossRefPubMed Lee PY, Alexander KP, Hammill BG, Pasquali SK, Peterson ED. Representation of elderly persons and women in published randomized trials of acute coronary syndromes. JAMA. 2001;286:708–13.CrossRefPubMed
16.
go back to reference Johnson SM, Karvonen CA, Phelps CL, Nader S, Sanborn BM. Assessment of analysis by gender in the Cochrane reviews as related to treatment of cardiovascular disease. J Women’s Health (Larchmt). 2003;12:449–57.CrossRef Johnson SM, Karvonen CA, Phelps CL, Nader S, Sanborn BM. Assessment of analysis by gender in the Cochrane reviews as related to treatment of cardiovascular disease. J Women’s Health (Larchmt). 2003;12:449–57.CrossRef
17.
go back to reference Comis RL, Miller JD, Aldigé CR, Krebs L, Stoval E. Public attitudes toward participation in cancer clinical trials. J Clin Oncol. 2003;21:830–5.CrossRefPubMed Comis RL, Miller JD, Aldigé CR, Krebs L, Stoval E. Public attitudes toward participation in cancer clinical trials. J Clin Oncol. 2003;21:830–5.CrossRefPubMed
18.
go back to reference Sood A, Prasad K, Chhatwani L, Shinozaki E, Cha SS, Loehrer LL, Wahner-Roedler DL. Patients’ attitudes and preferences about participation and recruitment strategies in clinical trials. Mayo Clin Proc. 2009;84:243–7.CrossRefPubMedPubMedCentral Sood A, Prasad K, Chhatwani L, Shinozaki E, Cha SS, Loehrer LL, Wahner-Roedler DL. Patients’ attitudes and preferences about participation and recruitment strategies in clinical trials. Mayo Clin Proc. 2009;84:243–7.CrossRefPubMedPubMedCentral
19.
go back to reference Kraus SJ. Attitudes and the prediction of behavior: a meta-analysis of the empirical literature. Pers Soc Psychol B. 1995;21:58–75.CrossRef Kraus SJ. Attitudes and the prediction of behavior: a meta-analysis of the empirical literature. Pers Soc Psychol B. 1995;21:58–75.CrossRef
21.
go back to reference Ding EL, Powe NR, Manson JE, Sherber NS, Braunstein JB. Sex differences in perceived risks, distrust, and willingness to participate in clinical trials: a randomized study of cardiovascular prevention trials. Arch Intern Med. 2007;167:905–12.CrossRefPubMed Ding EL, Powe NR, Manson JE, Sherber NS, Braunstein JB. Sex differences in perceived risks, distrust, and willingness to participate in clinical trials: a randomized study of cardiovascular prevention trials. Arch Intern Med. 2007;167:905–12.CrossRefPubMed
22.
go back to reference Madsen SM, Mirza MR, Holm S, Hilsted KL, Kampmann K, Riis P. Attitudes towards clinical research amongst participants and nonparticipants. J Intern Med. 2002;251:156–68.CrossRefPubMed Madsen SM, Mirza MR, Holm S, Hilsted KL, Kampmann K, Riis P. Attitudes towards clinical research amongst participants and nonparticipants. J Intern Med. 2002;251:156–68.CrossRefPubMed
23.
go back to reference Featherstone K, Donovan JL. “Why don’t they just tell me straight, why allocate it?” The struggle to make sense of participating in a randomized controlled trial. Soc Sci Med. 2002;55(5):709–19.CrossRefPubMed Featherstone K, Donovan JL. “Why don’t they just tell me straight, why allocate it?” The struggle to make sense of participating in a randomized controlled trial. Soc Sci Med. 2002;55(5):709–19.CrossRefPubMed
24.
go back to reference Avis NE, Smith KW, Link CL, Hortobagyi GN, Rivera E. Factors associated with participation in breast cancer treatment clinical trials. J Clin Oncol. 2006;24:1860–7.CrossRefPubMed Avis NE, Smith KW, Link CL, Hortobagyi GN, Rivera E. Factors associated with participation in breast cancer treatment clinical trials. J Clin Oncol. 2006;24:1860–7.CrossRefPubMed
25.
go back to reference Madsen SM, Holm S, Riis P. Attitudes towards clinical research among cancer trial participants and non-participants: an interview study using a Grounded Theory approach. J Med Ethics. 2007;33(4):234–40.CrossRefPubMedPubMedCentral Madsen SM, Holm S, Riis P. Attitudes towards clinical research among cancer trial participants and non-participants: an interview study using a Grounded Theory approach. J Med Ethics. 2007;33(4):234–40.CrossRefPubMedPubMedCentral
26.
go back to reference Lovato LC, Hill K, Hertert S, Hunninghake DB, Probstfield JL. Recruitment for controlled clinical trials: literature summary and annotated bibliography. Control Clin Trials. 1997;18:328–52.CrossRefPubMed Lovato LC, Hill K, Hertert S, Hunninghake DB, Probstfield JL. Recruitment for controlled clinical trials: literature summary and annotated bibliography. Control Clin Trials. 1997;18:328–52.CrossRefPubMed
27.
go back to reference Treweek S, Mitchell E, Pitkethly M, Cook J, Kjeldstrøm M, Johansen M, Taskila TK, Sullivan F, Wilson S, Jackson C, Jones R, Lockhart P. Strategies to improve recruitment to randomized controlled trials. Cochrane Database Syst Rev. 2010;4:MR000013. Treweek S, Mitchell E, Pitkethly M, Cook J, Kjeldstrøm M, Johansen M, Taskila TK, Sullivan F, Wilson S, Jackson C, Jones R, Lockhart P. Strategies to improve recruitment to randomized controlled trials. Cochrane Database Syst Rev. 2010;4:MR000013.
31.
go back to reference Nguyen TT, Somkin CP, Ma Y, Fung L-C, Nguyen T. Participation of Asian-American women in cancer treatment research: a pilot study. J Natl Cancer Inst Monogr. 2005;35:102–5.CrossRef Nguyen TT, Somkin CP, Ma Y, Fung L-C, Nguyen T. Participation of Asian-American women in cancer treatment research: a pilot study. J Natl Cancer Inst Monogr. 2005;35:102–5.CrossRef
32.
go back to reference Zou G. A modified Poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004;159:702–6.CrossRefPubMed Zou G. A modified Poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004;159:702–6.CrossRefPubMed
34.
go back to reference Kruse RL, Koopman RJ, Wakefield BJ, Wakefield DS, Keplinger LE, Canfield SM, Mehr DR. Internet use by primary care patients: where is the digital divide? Fam Med. 2012;44(5):342–7.PubMed Kruse RL, Koopman RJ, Wakefield BJ, Wakefield DS, Keplinger LE, Canfield SM, Mehr DR. Internet use by primary care patients: where is the digital divide? Fam Med. 2012;44(5):342–7.PubMed
35.
go back to reference Craig BM, Hays RD, Pickard AS, Cella D, Revicki DA, Reeve BB. Comparison of US panel vendors for online surveys. Eysenbach G, ed. J Med Internet Res. 2013;15(11):e260.CrossRefPubMedPubMedCentral Craig BM, Hays RD, Pickard AS, Cella D, Revicki DA, Reeve BB. Comparison of US panel vendors for online surveys. Eysenbach G, ed. J Med Internet Res. 2013;15(11):e260.CrossRefPubMedPubMedCentral
36.
go back to reference Geller SE, Goldstein Adams M, Carnes M. Adherence to federal guidelines for reporting of sex and race/ethnicity in clinical trials. J Women's Health. 2006;15:1123–31.CrossRef Geller SE, Goldstein Adams M, Carnes M. Adherence to federal guidelines for reporting of sex and race/ethnicity in clinical trials. J Women's Health. 2006;15:1123–31.CrossRef
39.
go back to reference Lloyd-Williams F, Mair F, Shiels C, Hanratty B, Goldstein P, Beaton S, Capewell S, Lye M, Mcdonald R, Roberts C, Connelly D. Why are patients in clinical trials of heart failure not like those we see in everyday practice? J Clin Epidemiol. 2003;56(12):1157–62.CrossRefPubMed Lloyd-Williams F, Mair F, Shiels C, Hanratty B, Goldstein P, Beaton S, Capewell S, Lye M, Mcdonald R, Roberts C, Connelly D. Why are patients in clinical trials of heart failure not like those we see in everyday practice? J Clin Epidemiol. 2003;56(12):1157–62.CrossRefPubMed
40.
go back to reference McCann S, Campbell M, Entwistle V. Recruitment to clinical trials: a meta-ethnographic synthesis of studies of reasons for participation. J Health Serv Res Policy. 2013;18(4):233–41.CrossRefPubMed McCann S, Campbell M, Entwistle V. Recruitment to clinical trials: a meta-ethnographic synthesis of studies of reasons for participation. J Health Serv Res Policy. 2013;18(4):233–41.CrossRefPubMed
Metadata
Title
Sex and cardiovascular disease status differences in attitudes and willingness to participate in clinical research studies/clinical trials
Authors
Thomas S. Gruca
Wesley J. Hottel
Janine Comstock
Anna Olson
Gary E. Rosenthal
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2667-7

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