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. 2001 Dec;86(6):632–637. doi: 10.1136/heart.86.6.632

Patients' experiences of intervention trials on the treatment of myocardial infarction: is it time to adjust the informed consent procedure to the patient's capacity?

A Agard 1, G Hermeren 1, J Herlitz 1
PMCID: PMC1730006  PMID: 11711455

Abstract

OBJECTIVE—To investigate how patients included in trials on treatment in the early phase of acute myocardial infarction experience the consent procedure.
DESIGN—A combined qualitative and quantitative interview concerning the patients' knowledge of the trial, their feelings about being asked to participate, and their attitudes towards the consent procedure.
SETTING—Tertiary referral centre.
PATIENTS—31 patients who had given written informed consent for their participation in randomised intervention trials of acute myocardial infarction.
RESULTS—The patients interviewed had only fragmentary knowledge about the trial they were involved in. Most considered that reading and signing a consent form was an unwanted or unnecessary procedure. Instead, they would have preferred to have been given concise verbal information about the study. Most were willing to allow a physician to decide for them in the event of their being too ill to be asked about their participation.
CONCLUSIONS—Patients who are asked to participate in intervention trials in the early phase of acute myocardial infarction often appear to lack sufficient knowledge to reach an autonomous choice. There were problems and disadvantages associated with the process of obtaining written informed consent in this particular situation, especially regarding the need for the patient to sign a consent form during the acute phase of the disease.


Keywords: informed consent; clinical trial; acute myocardial infarction; patient attitudes

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Selected References

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  1. Bean W. B. Masquerades of myocardial infarction. Lancet. 1977 May 14;1(8020):1044–1046. doi: 10.1016/s0140-6736(77)91271-5. [DOI] [PubMed] [Google Scholar]
  2. Biros M. H., Lewis R. J., Olson C. M., Runge J. W., Cummins R. O., Fost N. Informed consent in emergency research. Consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers. JAMA. 1995 Apr 26;273(16):1283–1287. doi: 10.1001/jama.273.16.1283. [DOI] [PubMed] [Google Scholar]
  3. Boisjolie C. R., Sharkey S. W., Cannon C. P., Brunette D., Haugland J. M., Thatcher J. L., Henry T. D. Impact of a thrombolysis research trial on time to treatment for acute myocardial infarction in the emergency department. Am J Cardiol. 1995 Aug 15;76(5):396–398. doi: 10.1016/s0002-9149(99)80108-8. [DOI] [PubMed] [Google Scholar]
  4. Britten N. Qualitative interviews in medical research. BMJ. 1995 Jul 22;311(6999):251–253. doi: 10.1136/bmj.311.6999.251. [DOI] [PMC free article] [PubMed] [Google Scholar]
  5. Grim P. S., Singer P. A., Gramelspacher G. P., Feldman T., Childers R. W., Siegler M. Informed consent in emergency research. Prehospital thrombolytic therapy for acute myocardial infarction. JAMA. 1989 Jul 14;262(2):252–255. [PubMed] [Google Scholar]
  6. Kannel W. B., Abbott R. D. Incidence and prognosis of unrecognized myocardial infarction. An update on the Framingham study. N Engl J Med. 1984 Nov 1;311(18):1144–1147. doi: 10.1056/NEJM198411013111802. [DOI] [PubMed] [Google Scholar]
  7. Katz J. The Nuremberg Code and the Nuremberg Trial. A reappraisal. JAMA. 1996 Nov 27;276(20):1662–1666. [PubMed] [Google Scholar]
  8. Kremers M. S., Whisnant D. R., Lowder L. S., Gregg L. Initial experience using the Food and Drug administration guidelines for emergency research without consent. Ann Emerg Med. 1999 Feb;33(2):224–229. doi: 10.1016/s0196-0644(99)70399-9. [DOI] [PubMed] [Google Scholar]
  9. Kucia A. M., Horowitz J. D. Is informed consent to clinical trials an "upside selective" process in acute coronary syndromes? Am Heart J. 2000 Jul;140(1):94–97. doi: 10.1067/mhj.2000.106625. [DOI] [PubMed] [Google Scholar]
  10. Levine R. J. Research in emergency situations. The role of deferred consent. JAMA. 1995 Apr 26;273(16):1300–1302. [PubMed] [Google Scholar]
  11. Mays N., Pope C. Rigour and qualitative research. BMJ. 1995 Jul 8;311(6997):109–112. doi: 10.1136/bmj.311.6997.109. [DOI] [PMC free article] [PubMed] [Google Scholar]
  12. Nilstun T. Nya forskningsetiska riktlinjer från CIOMS. Föredömlig avvägning autonomi-nytta-rättvisa. Lakartidningen. 1994 Jan 19;91(3):157-8, 161. [PubMed] [Google Scholar]
  13. Ockene I. S., Miner J., Shannon T. A., Gore J. M., Weiner B. H., Ball S. P. The consent process in the Thrombolysis in Myocardial Infarction (TIMI--phase I) trial. Clin Res. 1991 Feb;39(1):13–17. [PubMed] [Google Scholar]
  14. Passamani E. R., Weisfeldt M. L. 31st Bethesda Conference. Emergency Cardiac Care. Task force 3: Special aspects of research conduct in the emergency setting: Waiver of informed consent. J Am Coll Cardiol. 2000 Mar 15;35(4):862–880. [PubMed] [Google Scholar]
  15. Smith H. L. Myocardial infarction--Case studies of ethics in the consent situation. Soc Sci Med. 1974 Jul;8(7):399–404. doi: 10.1016/0037-7856(74)90125-5. [DOI] [PubMed] [Google Scholar]
  16. Spivey W. H., Abramson N. S., Iserson K. V., MacKay C. R., Cohen M. P. Informed consent for biomedical research in acute care medicine. Ann Emerg Med. 1991 Nov;20(11):1251–1265. doi: 10.1016/s0196-0644(05)81484-2. [DOI] [PubMed] [Google Scholar]
  17. Williams B. F., French J. K., White H. D. Is our method of obtaining consent appropriate for randomised controlled trials in acute myocardial infarction? N Z Med J. 1997 Aug 8;110(1049):298–299. [PubMed] [Google Scholar]
  18. Yuval R., Halon D. A., Merdler A., Khader N., Karkabi B., Uziel K., Lewis B. S. Patient comprehension and reaction to participating in a double-blind randomized clinical trial (ISIS-4) in acute myocardial infarction. Arch Intern Med. 2000 Apr 24;160(8):1142–1146. doi: 10.1001/archinte.160.8.1142. [DOI] [PubMed] [Google Scholar]

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