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知情同意:患者理解多少?

Informed consent: how much does the patient understand?

作者信息

Bergler J H, Pennington A C, Metcalfe M, Freis E D

出版信息

Clin Pharmacol Ther. 1980 Apr;27(4):435-40. doi: 10.1038/clpt.1980.60.

DOI:10.1038/clpt.1980.60
PMID:6987027
Abstract

Comprehension and recall of the information contained in the informed consent statement was tested in clinically hypertensive patients entering a controlled trial comparing hydrochlorothiazide and propranolol. The consent statement was the primary vehicle for conveying the information to the patient. The average of correct answers to a multiple-choice quiz was 71.6% at 2 hr and 61.2% at 3 mo after the consent procedure. The effectiveness of recall did not correlate with level of education. Patients exhibited greater comprehension of the action of the drugs than of their side effects. Nearly all patients indicated their belief that they would receive the best possible care. While 95% wanted to be informed about the trial, 75% stated they would have given their consent even without this information.

摘要

在一项比较氢氯噻嗪和普萘洛尔的对照试验中,对纳入研究的临床高血压患者测试了他们对知情同意书中所含信息的理解和记忆。同意书是向患者传达信息的主要载体。在同意程序后的2小时,多项选择题测验的平均正确答案率为71.6%,3个月时为61.2%。记忆效果与教育程度无关。患者对药物作用的理解比对其副作用的理解更好。几乎所有患者都表示相信他们会得到尽可能好的治疗。虽然95%的患者希望了解试验情况,但75%的患者表示,即使没有这些信息,他们也会同意参加试验。

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