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当知情同意出现问题时:医疗过失索赔和患者投诉的描述性研究。

When informed consent goes poorly: a descriptive study of medical negligence claims and patient complaints.

机构信息

Royal North Shore Hospital, Sydney, NSW, Australia.

出版信息

Med J Aust. 2011 Sep 19;195(6):340-4. doi: 10.5694/mja11.10379.

DOI:10.5694/mja11.10379
PMID:21929499
Abstract

OBJECTIVE

To describe the frequency, characteristics, and outcomes of medicolegal disputes over informed consent.

DESIGN AND SETTING

Retrospective review and analysis of negligence claims against doctors insured by Avant Mutual Group Limited and complaints lodged with the Office of the Health Services Commissioner of Victoria that alleged failures in the informed consent process and were adjudicated between 1 January 2002 and 31 December 2008.

MAIN OUTCOME MEASURES

Case frequency (by medical specialty), type of allegation, type of treatment.

RESULTS

A total of 481 cases alleged deficiencies in the informed consent process (218 of 1898 conciliated complaints [11.5%]; 263 of 7846 negligence claims [3.4%]). 57% of these cases were against surgeons. Plastic surgeons experienced dispute rates that were more than twice those of any other specialty or subspecialty group. 92% of cases (442/481) involved surgical procedures and 16% (77/481) involved cosmetic procedures. The primary allegation in 71% of cases was that the clinician failed to mention or properly explain risks of complications. Five treatment types - procedures on reproductive organs (12% of cases), procedures on facial features excluding eyes (12%), prescription medications (8%), eye surgery (7%) and breast surgery (7%) - accounted for 46% of all cases.

CONCLUSIONS

The typical dispute over informed consent involves an operation, often cosmetic, and allegations that a particular complication was not properly disclosed. With Australian courts now looking to patient preferences in setting legal standards of care for risk disclosure, medicolegal disputes provide valuable insights for targeting both quality improvement efforts and risk management activities.

摘要

目的

描述与知情同意相关的医疗法律纠纷的频率、特征和结果。

设计和设置

回顾性分析 2002 年 1 月 1 日至 2008 年 12 月 31 日期间,Avant Mutual Group Limited 承保的医生的疏忽索赔和维多利亚卫生服务专员办公室收到的投诉,这些投诉指控知情同意过程中的失误,并进行了裁决。

主要观察指标

按医疗专业划分的病例频率(共 481 例)、指控类型、治疗类型。

结果

共有 481 例病例指控知情同意过程存在缺陷(1898 例和解投诉中有 218 例[11.5%];7846 例疏忽索赔中有 263 例[3.4%])。其中 57%的病例来自外科医生。整形外科医生的争议率是其他任何专业或亚专业组的两倍多。92%的病例(442/481)涉及手术程序,16%(77/481)涉及美容程序。71%的病例的主要指控是临床医生未能提及或正确解释并发症的风险。五种治疗类型-生殖器官手术(占病例的 12%)、面部特征手术但不包括眼部(12%)、处方药物(8%)、眼部手术(7%)和乳房手术(7%)-占所有病例的 46%。

结论

典型的知情同意纠纷涉及手术,通常是美容手术,以及对特定并发症未得到适当披露的指控。随着澳大利亚法院现在在确定风险披露的护理法律标准时考虑患者的偏好,医疗法律纠纷为有针对性地开展质量改进工作和风险管理活动提供了宝贵的见解。

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