Williams Barbara F, French John K, White Harvey D
Cardiovascular Research Unit, Green Lane Hospital, Auckland, New Zealand.
Lancet. 2003 Mar 15;361(9361):918-22. doi: 10.1016/s0140-6736(03)12773-0.
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.
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.
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.
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.
焦虑、恐惧、疼痛以及吗啡治疗可能会损害患者理解参与临床试验相关信息并给予知情同意的能力。我们旨在评估急性心肌梗死患者是否能够理解书面和口头信息，以及他们是否有能力自主给予参与临床试验的知情同意。
我们对新西兰和澳大利亚16家医院的399例急性心肌梗死患者进行了前瞻性研究，这些患者符合参与希鲁洛与早期再灌注或闭塞（HERO）-2试验的条件。我们评估了患者信息表的可读性、患者的教育程度、他们对同意过程的看法、对口头和书面信息的理解以及给予同意的能力。
患者信息表需要13年级（18岁）的教育水平才能理解，尽管345例患者中只有75例（22%）接受过中学以上教育。在给予或拒绝参与同意之前，346例患者中只有63例（18%）阅读了患者信息表。同意参与的患者比拒绝同意的患者更有可能报告对所提供信息有良好或部分理解（分别为272例[89%]对14例[70%]；p=0.009）。在对自主决策能力的评估中，145例患者中有75例（52%）被评为最低等级，26例（18%）没有同意的能力。
尽管HERO-2试验的同意过程符合临床试验的监管要求，但它并不适合大多数患者的需求。患者对所提供信息的理解以及他们自主给予同意的能力并不理想。
