Patient experience of the informed consent process during acute myocardial infarction: a sub-study of the VALIDATE-SWEDEHEART trial.
Acute Disease
Aged
Anticoagulants
/ therapeutic use
Female
Health Knowledge, Attitudes, Practice
Humans
Informed Consent
Male
Middle Aged
Patient Satisfaction
/ statistics & numerical data
Percutaneous Coronary Intervention
Randomized Controlled Trials as Topic
ST Elevation Myocardial Infarction
/ psychology
Informed consent
Myocardial infarction
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
06 Mar 2020
06 Mar 2020
Historique:
received:
04
10
2019
accepted:
06
02
2020
entrez:
8
3
2020
pubmed:
8
3
2020
medline:
29
12
2020
Statut:
epublish
Résumé
We aimed to assess the patient experience of informed consent (IC) during acute myocardial infarction (AMI) in a sub-study of the VALIDATE-SWEDEHEART trial. The original trial compared two anticoagulant agents in patients undergoing coronary intervention. A witnessed oral IC was required prior to randomization in patients with ST-segment elevation myocardial infarction, which was subsequently complemented with a written IC after percutaneous coronary intervention. Written consent was obtained before angiography in patients with non-ST-segment elevation myocardial infarction. The IC process in patients with AMI is under debate. Earlier trials in this population have required prospective consent before randomization. A trial published some years ago used deferred consent, but the patient experience of this process is poorly studied. A total of 414 patients who participated in the main trial were enrolled and asked the following questions: (1) Do you remember being asked to participate in a study? (2) How was your experience of being asked to participate; do you remember it being positive or negative? (3) Would you have liked more information about the study? (4) Do you think it would have been better if you were included in the study without being informed until a later time? Of these patients, 94% remembered being included; 85% of them experienced this positively, 12% were neutral and 3% negative. Regarding more information, 88% did not want further information, and 68% expressed that they wanted to be consulted before inclusion. Of the patients, 5% thought it would have been better to have study inclusion without consent, and 27% considered it of no importance. It is reasonable to ask patients for verbal IC in the acute phase of AMI. Most patients felt positively about being asked to participate and had knowledge of being enrolled in a scientific study. In addition they objected to providing IC after randomization and treatment. VALIDATE-SWEDEHEART European Union Clinical Trials Register: 2012-005260-10. ClinicalTrials.gov: NCT02311231. Registered on 8 Dec 2014.
Sections du résumé
OBJECTIVE
OBJECTIVE
We aimed to assess the patient experience of informed consent (IC) during acute myocardial infarction (AMI) in a sub-study of the VALIDATE-SWEDEHEART trial. The original trial compared two anticoagulant agents in patients undergoing coronary intervention. A witnessed oral IC was required prior to randomization in patients with ST-segment elevation myocardial infarction, which was subsequently complemented with a written IC after percutaneous coronary intervention. Written consent was obtained before angiography in patients with non-ST-segment elevation myocardial infarction.
BACKGROUND
BACKGROUND
The IC process in patients with AMI is under debate. Earlier trials in this population have required prospective consent before randomization. A trial published some years ago used deferred consent, but the patient experience of this process is poorly studied.
METHODS
METHODS
A total of 414 patients who participated in the main trial were enrolled and asked the following questions: (1) Do you remember being asked to participate in a study? (2) How was your experience of being asked to participate; do you remember it being positive or negative? (3) Would you have liked more information about the study? (4) Do you think it would have been better if you were included in the study without being informed until a later time?
RESULTS
RESULTS
Of these patients, 94% remembered being included; 85% of them experienced this positively, 12% were neutral and 3% negative. Regarding more information, 88% did not want further information, and 68% expressed that they wanted to be consulted before inclusion. Of the patients, 5% thought it would have been better to have study inclusion without consent, and 27% considered it of no importance.
CONCLUSION
CONCLUSIONS
It is reasonable to ask patients for verbal IC in the acute phase of AMI. Most patients felt positively about being asked to participate and had knowledge of being enrolled in a scientific study. In addition they objected to providing IC after randomization and treatment.
TRIAL REGISTRATION
BACKGROUND
VALIDATE-SWEDEHEART European Union Clinical Trials Register: 2012-005260-10. ClinicalTrials.gov: NCT02311231. Registered on 8 Dec 2014.
Identifiants
pubmed: 32143733
doi: 10.1186/s13063-020-4147-0
pii: 10.1186/s13063-020-4147-0
pmc: PMC7059267
doi:
Substances chimiques
Anticoagulants
0
Banques de données
ClinicalTrials.gov
['NCT02311231']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
246Références
Cook DJ, Blythe D, Rischbieth A, et al. Enrollment of intensive care unit patients into clinical studies: a trinational survey of researchers’ experiences, beliefs, and practices. Crit Care Med. 2008;36:2100–5.
doi: 10.1097/CCM.0b013e31817c00b0
World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310:2191–4.
doi: 10.1001/jama.2013.281053
Berger BJ. Minimum risk and HEAT-PPCI: innovative ideas for informed consent in emergency medical research. Ann Emerg Med. 2014;64:17A–9A.
doi: 10.1016/j.annemergmed.2014.10.007
Dickert NW, Fehr AE, Llanos A, Scicluna VM, Samady H. Patients’ views of consent for research enrollment during acute myocardial infarction. Acute Card Care. 2015;17:1–4.
doi: 10.3109/17482941.2014.994642
Zughaft D, Harnek J. A review of the role of nurses and technicians in ST-elevation myocardial infarction (STEMI). EuroIntervention. 2014;10(Suppl T):T83–6.
doi: 10.4244/EIJV10STA13
Smith HL. Myocardial infarction—case studies of ethics in the consent situation. Soc Sci Med. 1974;8:399–404.
doi: 10.1016/0037-7856(74)90125-5
Foex BA. Is informed consent possible in acute myocardial infarction? Heart. 2004;90:1237–8.
doi: 10.1136/hrt.2003.020255
Agard A, Herlitz J, Hermeren G. Obtaining informed consent from patients in the early phase of acute myocardial infarction: physicians’ experiences and attitudes. Heart. 2004;90:208–10.
doi: 10.1136/hrt.2003.021501
Gammelgaard A. Informed consent in acute myocardial infarction research. J Med Philos. 2004;29:417–34.
doi: 10.1080/03605310490503533
Agard A, Hermeren G, Herlitz J. 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? Heart. 2001;86:632–7.
doi: 10.1136/heart.86.6.632
Gammelgaard A, Mortensen OS, Rossel P, DANAMI-2 Investigators. Patients’ perceptions of informed consent in acute myocardial infarction research: a questionnaire based survey of the consent process in the DANAMI-2 trial. Heart. 2004;90:1124–8.
doi: 10.1136/hrt.2003.021931
MacKay CR, Torguson R, Waksman R. Delayed consent: will there be a shift in approach for US primary percutaneous coronary intervention trials? Lancet. 2015;386:714–6.
doi: 10.1016/S0140-6736(15)60077-0
Shaw D. HEAT-PPCI sheds light on consent in pragmatic trials. Lancet. 2014;384:1826–7.
doi: 10.1016/S0140-6736(14)61040-0
Dickert NW, Hendershot KA, Speight CD, Fehr AE. Patients’ views of consent in clinical trials for acute myocardial infarction: impact of trial design. J Med Ethics. 2017;43:524–9.
doi: 10.1136/medethics-2016-103866
Johnson LR, Siddaiah R. Use of deferred consent for enrolment in trials is fraught with problems. BMJ. 2015;351:h4609.
doi: 10.1136/bmj.h4609
Shahzad A, Kemp I, Mars C, et al. Unfractionated heparin versus bivalirudin in primary percutaneous coronary intervention (HEAT-PPCI): an open-label, single centre, randomised controlled trial. Lancet. 2014;384:1849-18.
Erlinge D, Omerovic E, Frobert O, et al. Bivalirudin versus heparin monotherapy in myocardial infarction. N Engl J Med. 2017;377:1132–42.
doi: 10.1056/NEJMoa1706443
Jernberg T, Attebring MF, Hambraeus K, et al. The Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART). Heart. 2010;96:1617–21.
doi: 10.1136/hrt.2010.198804
Erlinge D, Koul S, Eriksson P, et al. Bivalirudin versus heparin in non-ST and ST-segment elevation myocardial infarction—a registry-based randomized clinical trial in the SWEDEHEART registry (the VALIDATE-SWEDEHEART trial). Am Heart J. 2016;175:36–46.
doi: 10.1016/j.ahj.2016.02.007
Williams BF, French JK, White HD, HERO-2 investigators. Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent sub-study): a prospective observational study. Lancet. 2003;361:918–22.
doi: 10.1016/S0140-6736(03)12773-0
Andersen HR, Nielsen TT, Rasmussen K, et al. A comparison of coronary angioplasty with fibrinolytic therapy in acute myocardial infarction. N Engl J Med. 2003;349:733–42.
doi: 10.1056/NEJMoa025142
Williams BF, French JK, White HD. Is our method of obtaining consent appropriate for randomised controlled trials in acute myocardial infarction? N Z Med J. 1997;110:298–9.
pubmed: 9293286
Klein L, Moore J, Biros M. A 20-year review: the use of exception from informed consent and waiver of informed consent in emergency research. Acad Emerg Med. 2018;10:1169–77.
doi: 10.1111/acem.13438
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. https://eur-lex.europa.eu/eli/reg/2014/536/oj . Accessed 15 Dec 2019.
Dal-Ré R, Avendaño-Solà C, Bloechl-Daum B, de Boer A, Eriksson S, Fuhr U, et al. Low risk pragmatic trials do not always require participants’ informed consent. BMJ. 2019;364:l1092.
doi: 10.1136/bmj.l1092
Kahan BC, Rehal S, Cro S. Risk of selection bias in randomised trials. Trials. 2015;16:405.
doi: 10.1186/s13063-015-0920-x