Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): a prospective observational study
Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): a prospective observational study
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DOI：
10.1016/s0140-6736(03)12773-0
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发表时间：
2003-03-15
期刊：
影响因子：
168.9
通讯作者：
White, HD
中科院分区：
文献类型：
--
作者：
Williams, BF;French, JK;White, HD
背景焦虑、恐惧、疼痛和吗啡治疗可能会损害患者理解临床试验信息和知情同意的能力。我们的目的是评估急性心肌梗死患者是否可以理解的书面和口头信息，他们是否有能力给予自主知情同意参加临床试验。方法我们前瞻性研究了399例急性心肌梗死患者在16家医院在新西兰和澳大利亚谁有资格参加的水蛭和早期再灌注或闭塞（HERO）-2试验。我们评估了患者信息表的可读性，患者的教育状况，他们的意见的同意过程中，理解的口头和书面信息，并有能力给予consent.Findings患者信息表需要一年13（18岁）的教育水平的理解，虽然只有75 345例（22%）已超过中学教育。只有63/346（18%）读患者。在同意或拒绝参与之前提供信息表。同意的患者比拒绝同意的患者更有可能报告对所提供信息的良好或部分理解（分别为272 [89%] vs 14 [70%]; p=0.009）。在自主决策能力的评估中，145人中有75人（52%）被评为最低等级，26人（18%）不能同意。解释虽然HERO-2的同意过程符合临床试验的监管要求，但它不适合大多数患者的需求。患者对所提供信息的理解和自主同意的能力低于最佳水平。
Background Anxiety, fear, pain, and treatment with morphine might compromise the ability of patients to comprehend information about, and give informed consent for, participation in clinical trials. We aimed to assess whether patients with acute myocardial infarction could understand written and verbal information and whether they were competent to give autonomous informed consent to participate in a clinical trial.Methods We prospectively studied 399 patients with acute myocardial infarction in 16 hospitals in New Zealand and Australia who were eligible for participation in the Hirulog and Early Reperfusion or Occlusion (HERO)-2 trial. We assessed readability of patient information sheets, patients' educational status, their views of the consent process, comprehension of verbal and written information, and competence to give consent.Findings The patient information sheet needed a year 13 (age 18) educational level for comprehension, although only 75 of 345 patients (22%) had been educated beyond secondary school. Only 63 of 346 (18%) read the patient. information sheet before giving or refusing consent to participate. Patients who gave consent were more likely to report good or partial comprehension of the information provided than were those who refused consent (272 [89%] vs 14 [70%], respectively; p=0.009). In an assessment of competence to make an autonomous decision, 75 of 145 (52%) were ranked at the lowest grade and 26 (18%) were not competent to consent.Interpretation Although the consent process for HERO-2 met regulatory requirements for clinical trials, it was inappropriate for the needs of most patients. The patients' comprehension of the information provided and their competence to autonomously give consent was less than optimum.