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. TRIAL REGISTRATION VALIDATE-SWEDEHEART European Union Clinical Trials Register: 2012-005260-10. ClinicalTrials.gov: NCT02311231. Registered on 8 Dec 2014.

中文翻译：

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急性心肌梗死期间知情同意过程的患者体验：VALIDATE-SWEDEHEART 试验的子研究。

目的 我们旨在评估在 VALIDATE-SWEDEHEART 试验的子研究中急性心肌梗死 (AMI) 期间患者知情同意 (IC) 的体验。最初的试验在接受冠状动脉介入治疗的患者中比较了两种抗凝剂。ST 段抬高型心肌梗死患者在随机分组前需要见证口腔 IC，随后在经皮冠状动脉介入治疗后辅以书面 IC。对非 ST 段抬高型心肌梗死患者进行血管造影前获得了书面同意。背景 AMI 患者的 IC 过程尚有争议。在该人群中进行的早期试验需要在随机化之前获得前瞻性同意。几年前发表的一项试验使用了延迟同意，但对这一过程的患者体验的研究很少。方法 共有 414 名参加主要试验的患者被纳入并提出以下问题：（1）您记得被要求参加一项研究吗？(2) 您被邀请参加的经历如何；你记得它是积极的还是消极的？(3) 你想了解更多关于这项研究的信息吗？(4) 你认为如果你在以后才被通知的情况下被纳入研究会更好吗？结果 在这些患者中，94% 记得被纳入；其中 85% 的人对此持积极态度，12% 持中立态度，3% 持消极态度。关于更多信息，88% 的人不希望获得更多信息，68% 的人表示希望在纳入之前进行咨询。患者中，5% 的人认为在未经同意的情况下纳入研究会更好，27% 的人认为这不重要。结论 AMI急性期要求患者进行口头IC是合理的。大多数患者对被邀请参与并了解参加科学研究感到积极。此外，他们反对在随机化和治疗后提供 IC。试验注册验证 - SWEDEHEART 欧盟临床试验注册：2012-005260-10。ClinicalTrials.gov：NCT02311231。2014 年 12 月 8 日注册。此外，他们反对在随机化和治疗后提供 IC。试验注册验证 - SWEDEHEART 欧盟临床试验注册：2012-005260-10。ClinicalTrials.gov：NCT02311231。2014 年 12 月 8 日注册。此外，他们反对在随机化和治疗后提供 IC。试验注册验证 - SWEDEHEART 欧盟临床试验注册：2012-005260-10。ClinicalTrials.gov：NCT02311231。2014 年 12 月 8 日注册。