Department of Cardiology, Clinical Sciences, Lund University, Skane University Hospital, SE-221 85, Lund, Sweden.
Department of Cardiology, Norrland University Hospital, Umeå, Sweden.
Trials. 2020 Mar 6;21(1):246. doi: 10.1186/s13063-020-4147-0.
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.
我们旨在评估 VALIDATE-SWEDEHEART 试验的一个子研究中急性心肌梗死（AMI）患者的知情同意（IC）体验。原始试验比较了接受冠状动脉介入治疗的患者两种抗凝剂。ST 段抬高型心肌梗死患者在随机分组前需要进行见证的口头 IC，随后在经皮冠状动脉介入治疗后补充书面 IC。非 ST 段抬高型心肌梗死患者在进行血管造影前获得书面同意。
AMI 患者的 IC 过程存在争议。该人群的早期试验要求在随机分组前进行前瞻性同意。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研究甚少。
共纳入 414 名参加主要试验的患者，并向他们提出以下问题：（1）您是否记得被要求参加研究？（2）您对被要求参加研究的经历有何感受；您是否记得是积极的还是消极的？（3）您是否希望获得更多关于研究的信息？（4）您是否认为如果在稍后时间不告知您就将您纳入研究，这样会更好？
这些患者中有 94%记得被纳入；其中 85%的人对此有积极的体验，12%的人持中立态度，3%的人持消极态度。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。其中 5%的患者认为没有同意就纳入研究更好，27%的患者认为这并不重要。
在 AMI 的急性期要求患者进行口头 IC 是合理的。大多数患者对被要求参与研究感到满意，并了解自己被纳入了一项科学研究。此外，他们反对在随机分组和治疗后提供 IC。
VALIDATE-SWEDEHEART 欧洲联盟临床试验注册：2012-005260-10。ClinicalTrials.gov：NCT02311231。于 2014 年 12 月 8 日注册。
