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知情同意——为何其目标未能完全实现?

Informed consent -- why are its goals imperfectly realized?

作者信息

Cassileth B R, Zupkis R V, Sutton-Smith K, March V

出版信息

N Engl J Med. 1980 Apr 17;302(16):896-900. doi: 10.1056/NEJM198004173021605.

Abstract

We explored reasons for the failure of patients to recall major portions of the information on consent forms and in oral explanations about consent. Within one day of signing consent forms for chemotherapy, radiation therapy, or surgery, 200 cancer patients completed a test of their recall of the material in the consent explanation and filled out a questionnaire regarding their opinions of its purpose, content, and implications. Only 60 per cent understood the purpose and nature of the procedure, and only 55 per cent correctly listed even one major risk or complication. We found that three factors were related to inadequate recall: education, medical status, and the care with which patients thought they had read their consent forms before signing. Only 40 per cent of the patients had read the form "carefully." Most believed that consent forms were meant to "protect the physician's rights." Although most thought that consent forms were necessary and comprehensible and that they contained worthwhile information, the legalistic connotations of the forms appeared to lead to cursory reading and inadequate recall.

摘要

我们探究了患者无法回忆起同意书上大部分信息以及口头同意解释内容的原因。在签署化疗、放疗或手术同意书后的一天内,200名癌症患者完成了一项关于他们对同意书解释内容回忆情况的测试,并填写了一份关于他们对同意书目的、内容及影响看法的问卷。只有60%的患者理解了手术的目的和性质,只有55%的患者能正确列出哪怕一项主要风险或并发症。我们发现有三个因素与回忆不充分有关:教育程度、医疗状况以及患者认为自己在签署同意书前阅读时的认真程度。只有40%的患者“认真”阅读了同意书。大多数患者认为同意书旨在“保护医生的权益”。尽管大多数患者认为同意书是必要且易懂的,并且包含有价值的信息,但同意书的法律内涵似乎导致了患者走马观花式的阅读和回忆不充分。

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