Skip to main content

Advertisement

SpringerLink
Log in

Factors associated with refusal or acceptance of older patients (≥ 65 years) to provide consent to participate in clinical research in cardiology: a qualitative study

  • Original Article
  • Published:
Aging Clinical and Experimental Research Aims and scope Submit manuscript

Abstract

Background

Clinical research is an essential step in the successful translation of knowledge from basic research into concrete clinical applications, yet many people are reluctant to provide consent when actually approached to actively participate in clinical trials.

Aims

We investigated the factors that influence older patient’s (≥ 65 years) decisions to accept or refuse to participate in a prospective randomized clinical trial in secondary prevention after acute coronary syndrome.

Methods

Qualitative approach based on individual semi-structured interviews with patients who were approached for consent to participate in a currently ongoing clinical trial was adopted. Patients were interviewed after the consent process (8 accepted; 8 refused the trial). Interviews were analysed using grounded theory methodology.

Results

Sixteen patients aged ≥ 65 years participated. The main concept to emerge from these interviews is that the actual trial itself does not appear to be the primary determinant in the decision to participate in clinical research. Rather, patients’ decisions to participate (or not) in clinical research appear to be primarily determined by their capacity to deal with the current health event that has disrupted their life, and by their available mental and physical resources.

Discussion and conclusion

Older patients display varying levels of engagement in their own health, ranging from low engagement with high trust in the medical profession, to high engagement mirrored by distrust of the medical profession. Structural conditions, such as personal benefit from trial participation, or logistic barriers to participation, seem to affect both accepters and refusers in the same manner.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

Availability of data

Selected data are available from the corresponding author on reasonable request. For the purposes of privacy, interview transcripts are confidential and cannot be made available.

References

  1. Burns KE, Magyarody N, Jiang D et al (2013) Attitudes and views of the general public towards research participation. Intern Med J 43:531–540. https://doi.org/10.1111/j.1445-5994.2011.02433.x

    Article  CAS  PubMed  Google Scholar 

  2. Ellis PM (2000) Attitudes towards and participation in randomised clinical trials in oncology: a review of the literature. Ann Oncol 11:939–945

    Article  CAS  Google Scholar 

  3. Ohmann C, Deimling A (2004) Attitude towards clinical trials: results of a survey of persons interested in research. Inflamm Res 53:S142–S147. https://doi.org/10.1007/s00011-004-0353-6

    Article  CAS  PubMed  Google Scholar 

  4. Shenoy P, Harugeri A (2015) Elderly patients’ participation in clinical trials. Perspect Clin Res 6:184–189. https://doi.org/10.4103/2229-3485.167099

    Article  PubMed  PubMed Central  Google Scholar 

  5. Kazmierska J (2012) Do we protect or discriminate? Representation of senior adults in clinical trials. Rep Pract Oncol Radiother 18:6–10. https://doi.org/10.1016/j.rpor.2012.08.006

    Article  PubMed  PubMed Central  Google Scholar 

  6. Vitale C, Fini M, Spoletini I et al (2017) Under-representation of elderly and women in clinical trials. Int J Cardiol 232:216–221. https://doi.org/10.1016/j.ijcard.2017.01.018

    Article  PubMed  Google Scholar 

  7. Konrat C, Boutron I, Trinquart L et al (2012) Underrepresentation of elderly people in randomised controlled trials. The example of trials of 4 widely prescribed drugs. PLoS One 7:e33559. https://doi.org/10.1371/journal.pone.0033559

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  8. Harter P, du Bois A, Schade-Brittinger C et al (2005) Non-enrolment of ovarian cancer patients in clinical trials: reasons and background. Ann Oncol 16:1801–1805. https://doi.org/10.1093/annonc/mdi367

    Article  CAS  PubMed  Google Scholar 

  9. Jenkins V, Fallowfield L (2000) Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy. Br J Cancer 82:1783–1788. https://doi.org/10.1054/bjoc.2000.1142

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  10. Baggstrom MQ, Waqar SN, Sezhiyan AK et al (2011) Barriers to enrollment in non-small cell lung cancer therapeutic clinical trials. J Thorac Oncol 6:98–102. https://doi.org/10.1097/JTO.0b013e3181fb50d8

    Article  PubMed  Google Scholar 

  11. Du W, Gadgeel SM, Simon MS (2006) Predictors of enrollment in lung cancer clinical trials. Cancer 106:420–425. https://doi.org/10.1002/cncr.21638

    Article  PubMed  Google Scholar 

  12. Grunfeld E, Zitzelsberger L, Coristine M et al (2002) Barriers and facilitators to enrollment in cancer clinical trials: qualitative study of the perspectives of clinical research associates. Cancer 95:1577–1583. https://doi.org/10.1002/cncr.10862

    Article  PubMed  Google Scholar 

  13. Jenkins V, Farewell V, Farewell D et al (2013) Drivers and barriers to patient participation in RCTs. Br J Cancer 108:1402–1407. https://doi.org/10.1038/bjc.2013.113

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  14. Martin SS, Ou FS, Newby LK et al (2013) Patient- and trial-specific barriers to participation in cardiovascular randomized clinical trials. J Am Coll Cardiol 61:762–769. https://doi.org/10.1016/j.jacc.2012.10.046

    Article  PubMed  Google Scholar 

  15. Robinson SB, Ashley M, Haynes MA (1996) Attitude of African-Americans regarding prostate cancer clinical trials. J Community Health 21:77–87

    Article  CAS  Google Scholar 

  16. Ross S, Grant A, Counsell C et al (1999) Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol 52:1143–1156

    Article  CAS  Google Scholar 

  17. Spaar A, Frey M, Turk A et al (2009) Recruitment barriers in a randomized controlled trial from the physicians’ perspective: a postal survey. BMC Med Res Methodol 9:14. https://doi.org/10.1186/1471-2288-9-14

    Article  PubMed  PubMed Central  Google Scholar 

  18. Dickert NW, Fehr AE, Llanos A et al (2015) Patients’ views of consent for research enrollment during acute myocardial infarction. Acute Card Care 17:1–4. https://doi.org/10.3109/17482941.2014.994642

    Article  PubMed  Google Scholar 

  19. Dickert NW, Miller FG (2015) Involving patients in enrolment decisions for acute myocardial infarction trials. BMJ 351:h3791. https://doi.org/10.1136/bmj.h3791

    Article  PubMed  PubMed Central  Google Scholar 

  20. Kerkhoff LA, Butler J, Kelkar AA et al (2016) Trends in consent for clinical trials in cardiovascular disease. J Am Heart Assoc. https://doi.org/10.1161/JAHA.116.003582

    Article  PubMed  PubMed Central  Google Scholar 

  21. Ibanez B, Castellano JM, Fuster V (2019) Polypill strategy at the heart of cardiovascular secondary prevention. Heart 105:9–10. https://doi.org/10.1136/heartjnl-2018-313464

    Article  PubMed  Google Scholar 

  22. Castellano JM, Bueno H, Fuster V (2015) The cardiovascular polypill: clinical data and ongoing studies. Int J Cardiol 201:S8–S14. https://doi.org/10.1016/S0167-5273(15)31027-5

    Article  PubMed  Google Scholar 

  23. Glaser BG (1998) Doing grounded theory: issues and discussions. Sociology Press, Mill Valley

    Google Scholar 

  24. Appelbaum PS, Roth LH, Lidz C (1982) The therapeutic misconception: informed consent in psychiatric research. Int J Law Psychiatry 5:319–329

    Article  CAS  Google Scholar 

  25. Henderson GE, Churchill LR, Davis AM et al (2007) Clinical trials and medical care: defining the therapeutic misconception. PLoS Med 4:e324. https://doi.org/10.1371/journal.pmed.0040324

    Article  PubMed  PubMed Central  Google Scholar 

  26. Lidz CW, Appelbaum PS (2002) The therapeutic misconception: problems and solutions. Med Care 40:V55–V63. https://doi.org/10.1097/01.MLR.0000023956.25813.18

    Article  PubMed  Google Scholar 

  27. Auerbach SM (2001) Do patients want control over their own health care? A review of measures, findings, and research issues. J Health Psychol 6:191–203. https://doi.org/10.1177/135910530100600208

    Article  CAS  PubMed  Google Scholar 

  28. Stiggelbout AM, Molewijk AC, Otten W et al (2008) The impact of individualized evidence-based decision support on aneurysm patients’ decision making, ideals of autonomy, and quality of life. Med Decis Mak 28:751–762. https://doi.org/10.1177/0272989X08321680

    Article  Google Scholar 

  29. Behrendt C, Golz T, Roesler C et al (2011) What do our patients understand about their trial participation? Assessing patients’ understanding of their informed consent consultation about randomised clinical trials. J Med Ethics 37:74–80. https://doi.org/10.1136/jme.2010.035485

    Article  CAS  PubMed  Google Scholar 

  30. Jenkins V, Leach L, Fallowfield L et al (2002) Describing randomisation: patients’ and the public’s preferences compared with clinicians’ practice. Br J Cancer 87:854–858. https://doi.org/10.1038/sj.bjc.6600527

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  31. Jepson M, Elliott D, Conefrey C et al (2018) An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment. J Clin Epidemiol 99:75–83. https://doi.org/10.1016/j.jclinepi.2018.02.018

    Article  PubMed  PubMed Central  Google Scholar 

  32. Krieger JL, Neil JM, Strekalova YA et al (2017) Linguistic strategies for improving informed consent in clinical trials among low health literacy patients. J Natl Cancer Inst. https://doi.org/10.1093/jnci/djw233

    Article  PubMed  Google Scholar 

Download references

Acknowledgements

The authors are grateful to Helen Scott, Ph.D. (UK) (http://www.groundedtheoryonline.com/) for assistance with the coding and grounded theory process.

Funding

This study received financial support from Research Unit EA3920 “Prognostic markers and factors of regulation in cardiac and vascular diseases” (Director: Prof. Siamak Davani) of the University of Burgundy Franche-Comté.

Author information

Authors and Affiliations

  1. Department of Cardiology, University Hospital Jean Minjoz, EA3920, University of Franche-Comté, 3 Boulevard Fleming, 25000, Besançon, France

    Fiona Ecarnot & Nicolas Meneveau

  2. Unité de Soutien Méthodologique à la Recherche - Délégation à la Recherche Clinique et à l’Innovation, François Mitterand University Hospital, Dijon, France

    Nicolas Meunier-Beillard

  3. Department of Intensive Care, François Mitterrand University Hospital, 14 rue Paul Gaffarel, Dijon, France

    Nicolas Meunier-Beillard & Jean-Pierre Quenot

  4. INSERM CIC 1432, Clinical Epidemiology, University of Burgundy, Dijon, France

    Nicolas Meunier-Beillard & Jean-Pierre Quenot

  5. Lipness Team, INSERM Research Center LNC-UMR1231 and LabExLipSTIC, University of Burgundy, Dijon, France

    Jean-Pierre Quenot

Authors
  1. Fiona Ecarnot
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Nicolas Meunier-Beillard
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Jean-Pierre Quenot
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Nicolas Meneveau
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

FE, NMB, JPQ contributed to study conception and design. FE and NM performed data collection. All authors contributed to analysis of the data and drafting of the manuscript. All authors approved the final manuscript for publication.

Corresponding author

Correspondence to Fiona Ecarnot.

Ethics declarations

Conflict of interest

The authors declare that they have no competing interests.

Statement of human and animal rights

This study was approved by the Ethics Committee of the University Hospital of Besancon (CPP Est II) on January 17, 2017, under the number 16/17.

Informed consent

All patients provided oral consent to participate in the study. The need for written informed consent was waived in the absence of any intervention.

Additional information

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Ecarnot, F., Meunier-Beillard, N., Quenot, JP. et al. Factors associated with refusal or acceptance of older patients (≥ 65 years) to provide consent to participate in clinical research in cardiology: a qualitative study. Aging Clin Exp Res 32, 133–140 (2020). https://doi.org/10.1007/s40520-019-01172-z

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40520-019-01172-z

Keywords

Search

Navigation