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Patient experience of the informed consent process during acute myocardial infarction : A sub-study of the VALIDATE-SWEDEHEART trial

Olsson, Anneli LU orcid ; Ring, Camilla ; Josefsson, Johan ; Eriksson, Annika ; Rylance, Rebecca LU ; Fröbert, Ole ; James, Stefan ; Sparv, David LU and Erlinge, David LU orcid (2020) In Trials 21(1).
Abstract

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... (More)

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. 

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author
; ; ; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Informed consent, Myocardial infarction
in
Trials
volume
21
issue
1
article number
246
publisher
BioMed Central (BMC)
external identifiers
  • pmid:32143733
  • scopus:85081253081
ISSN
1745-6215
DOI
10.1186/s13063-020-4147-0
language
English
LU publication?
yes
id
ce5f5cf8-1836-4640-af66-012cf711771c
date added to LUP
2020-04-01 15:25:48
date last changed
2024-06-13 14:18:04
@article{ce5f5cf8-1836-4640-af66-012cf711771c,
  abstract     = {{<p>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. </p>}},
  author       = {{Olsson, Anneli and Ring, Camilla and Josefsson, Johan and Eriksson, Annika and Rylance, Rebecca and Fröbert, Ole and James, Stefan and Sparv, David and Erlinge, David}},
  issn         = {{1745-6215}},
  keywords     = {{Informed consent; Myocardial infarction}},
  language     = {{eng}},
  month        = {{03}},
  number       = {{1}},
  publisher    = {{BioMed Central (BMC)}},
  series       = {{Trials}},
  title        = {{Patient experience of the informed consent process during acute myocardial infarction : A sub-study of the VALIDATE-SWEDEHEART trial}},
  url          = {{http://dx.doi.org/10.1186/s13063-020-4147-0}},
  doi          = {{10.1186/s13063-020-4147-0}},
  volume       = {{21}},
  year         = {{2020}},
}