A Gammelgaard1, O S Mortensen, P Rossel. 1. Department of Medical Philosophy and Clinical Theory, Institute of Public Health, Building 22.3, University of Copenhagen, Blegdamsvej 3, 2200 Copenhagen N., Denmark. a.gammelgaard@medphil.ku.dk
Abstract
OBJECTIVE: To analyse how patients in the acute phase of a myocardial infarct experience the informed consent procedure of a clinical trial. DESIGN: A questionnaire based follow up survey including patients who gave informed consent as well as patients who did not consent to the trial. PATIENTS: 103 patients who gave informed consent and 78 who did not consent to the second Danish acute myocardial infarction trial (DANAMI-2). RESULTS: 76% of the trial participants and 63% of the non-participants agreed or mostly agreed that they felt able to make a decision about whether or not to participate in the trial; 50% of the trial participants and 34% of the non-participants found it acceptable that patients in their situation have to make such a decision. Only 28% of the trial participants and 7% of the non-participants read the information sheet before they made the decision. CONCLUSIONS: Informed consent should be sought in acute myocardial infarction trials despite the emergency situation and the medical condition of the patients. Patients' self assessed ability to make a decision should be explicitly addressed during the informed consent process and patients should not be pressurised into decision making. Physicians and research ethics committees should focus specifically on improving the oral information.
OBJECTIVE: To analyse how patients in the acute phase of a myocardial infarct experience the informed consent procedure of a clinical trial. DESIGN: A questionnaire based follow up survey including patients who gave informed consent as well as patients who did not consent to the trial. PATIENTS: 103 patients who gave informed consent and 78 who did not consent to the second Danish acute myocardial infarction trial (DANAMI-2). RESULTS: 76% of the trial participants and 63% of the non-participants agreed or mostly agreed that they felt able to make a decision about whether or not to participate in the trial; 50% of the trial participants and 34% of the non-participants found it acceptable that patients in their situation have to make such a decision. Only 28% of the trial participants and 7% of the non-participants read the information sheet before they made the decision. CONCLUSIONS: Informed consent should be sought in acute myocardial infarction trials despite the emergency situation and the medical condition of the patients. Patients' self assessed ability to make a decision should be explicitly addressed during the informed consent process and patients should not be pressurised into decision making. Physicians and research ethics committees should focus specifically on improving the oral information.
Entities:
Keywords:
Biomedical and Behavioral Research; Empirical Approach
Authors: Henning R Andersen; Torsten T Nielsen; Klaus Rasmussen; Leif Thuesen; Henning Kelbaek; Per Thayssen; Ulrik Abildgaard; Flemming Pedersen; Jan K Madsen; Peer Grande; Anton B Villadsen; Lars R Krusell; Torben Haghfelt; Preben Lomholt; Steen E Husted; Else Vigholt; Henrik K Kjaergard; Leif Spange Mortensen Journal: N Engl J Med Date: 2003-08-21 Impact factor: 91.245
Authors: Judith E Arnetz; Ulrika Winblad; Anna T Höglund; Bertil Lindahl; Kalle Spångberg; Lars Wallentin; Yun Wang; Joel Ager; Bengt B Arnetz Journal: Health Expect Date: 2010-06-23 Impact factor: 3.377
Authors: Neal W Dickert; David Wendler; Chandan M Devireddy; Sara F Goldkind; Yi-An Ko; Candace D Speight; Scott Yh Kim Journal: Clin Trials Date: 2018-10-03 Impact factor: 2.486
Authors: Michael C Soule; Eleanor E Beale; Laura Suarez; Scott R Beach; Carol A Mastromauro; Christopher M Celano; Shannon V Moore; Jeff C Huffman Journal: Soc Work Health Care Date: 2016-03-02
Authors: Piotr Iwanowski; Andrzej Budaj; Anna Członkowska; Wojciech Wasek; Beata Kozłowska-Boszko; Urszula Oledzka; Wojciech Masełbas Journal: Trials Date: 2008-07-21 Impact factor: 2.279