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Patient experience ...
Patient experience of the informed consent process during acute myocardial infarction : a sub-study of the VALIDATE-SWEDEHEART trial
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- Olsson, Anneli (author)
- Lund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital,Lund Univ, Skane Univ Hosp, Dept Cardiol, Clin Sci, SE-22185 Lund, Sweden
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- Ring, Camilla (author)
- Department of Cardiology, Norrland University Hospital, Umeå, Sweden,Norrland Univ Hosp, Dept Cardiol, Umea, Sweden
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- Josefsson, Johan (author)
- Department of Coronary Heart Disease, Örebro University Hospital, Örebro, Sweden,Orebro Univ Hosp, Dept Coronary Heart Dis, Orebro, Sweden
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- Eriksson, Annika (author)
- Department of Coronary Heart Disease, Örebro University Hospital, Örebro, Sweden,Orebro Univ Hosp, Dept Coronary Heart Dis, Orebro, Sweden
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- Rylance, Rebecca (author)
- Lund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital,Lund Univ, Skane Univ Hosp, Dept Cardiol, Clin Sci, SE-22185 Lund, Sweden
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- Fröbert, Ole, 1964- (author)
- Örebro universitet,Institutionen för medicinska vetenskaper,Department of Coronary Heart Disease, Örebro University Hospital, Örebro, Sweden,Orebro Univ Hosp, Dept Coronary Heart Dis, Orebro, Sweden
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- James, Stefan, 1964- (author)
- Uppsala universitet,Uppsala University,Kardiologi,Uppsala kliniska forskningscentrum (UCR)
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- Sparv, David (author)
- Lund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital,Lund Univ, Skane Univ Hosp, Dept Cardiol, Clin Sci, SE-22185 Lund, Sweden
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- Erlinge, David (author)
- Lund University,Lunds universitet,Molekylär kardiologi,Forskargrupper vid Lunds universitet,Molecular Cardiology,Lund University Research Groups,Skåne University Hospital,Lund Univ, Skane Univ Hosp, Dept Cardiol, Clin Sci, SE-22185 Lund, Sweden
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(creator_code:org_t)
- 2020-03-06
- 2020
- English.
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In: Trials. - : BMC. - 1745-6215. ; 21:1
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Abstract
Subject headings
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- 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: 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: 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: 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: 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Keyword
- Myocardial infarction
- Informed consent
- Informed consent
- Myocardial infarction
Publication and Content Type
- ref (subject category)
- art (subject category)
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Trials
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To the university's database
- By the author/editor
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Olsson, Anneli
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Ring, Camilla
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Josefsson, Johan
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Eriksson, Annika
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Rylance, Rebecca
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Fröbert, Ole, 19 ...
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James, Stefan, 1 ...
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Sparv, David
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Erlinge, David
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cardiac and Card ...
- Articles in the publication
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Trials
- By the university
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Örebro University
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Lund University
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Uppsala University