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骨科手术中知情同意的医学法律问题。

The medical-legal aspects of informed consent in orthopaedic surgery.

作者信息

Bhattacharyya Timothy, Yeon Howard, Harris Mitchel B

机构信息

Partners Orthopaedic Trauma Service, Massachusetts General Hospital, 35 Fruit Street, Yawkey 3600, Boston, MA 02114, USA.

出版信息

J Bone Joint Surg Am. 2005 Nov;87(11):2395-400. doi: 10.2106/JBJS.D.02877.

Abstract

BACKGROUND

Orthopaedic surgeons routinely obtain informed consent prior to surgery. Legally adequate informed consent requires a thorough discussion of treatment options and risks and proper documentation; however, there is little data to guide orthopaedic surgeons regarding effective methods of obtaining informed consent.

METHODS

We performed a closed claims analysis on malpractice claims involving an allegation of inadequate informed consent brought during a twenty-four-year period with two malpractice insurers. Relevant malpractice claims were reviewed, and data were abstracted. We then performed statistical analyses to identify factors that positively correlated with a successful defense.

RESULTS

We identified twenty-eight lawsuits that included a claim of inadequate informed consent. All of the cases involved elective orthopaedic surgical procedures; there were no emergent cases. Three cases involved a disputed surgical site; all three cases involved foot and ankle surgery and resulted in an indemnity payment. Documentation of appropriate informed consent in the office notes of the surgeon was associated with a decreased indemnity risk (p < 0.005). Obtaining the informed consent on the hospital ward or in the preoperative holding area was associated with an increased indemnity risk (p < 0.004). When informed consent was obtained in the office by the operating surgeon, the risk of malpractice payment was significantly decreased (p < 0.004).

CONCLUSIONS

Surgeons may be able to decrease the risk of a malpractice claim by obtaining informed consent in their offices, rather than in the preoperative holding area, and by documenting the informed consent discussion within their dictated office or operative notes.

摘要

背景

骨科医生在手术前通常会获取知情同意书。从法律角度而言,充分的知情同意需要对治疗方案和风险进行全面讨论并妥善记录;然而,几乎没有数据可指导骨科医生采用有效的知情同意获取方法。

方法

我们对两家医疗事故保险公司在24年期间受理的涉及知情同意不足指控的医疗事故索赔进行了结案索赔分析。对相关医疗事故索赔进行了审查,并提取了数据。然后我们进行统计分析,以确定与成功辩护呈正相关的因素。

结果

我们确定了28起诉讼,其中包括知情同意不足的索赔。所有病例均涉及择期骨科手术;无急诊病例。3起病例涉及手术部位争议;所有3起病例均涉及足踝手术,并导致了赔偿支付。外科医生办公室记录中有适当的知情同意记录与降低赔偿风险相关(p < 0.005)。在医院病房或术前等候区获取知情同意与赔偿风险增加相关(p < 0.004)。当由主刀医生在办公室获取知情同意时,医疗事故赔偿风险显著降低(p < 0.004)。

结论

外科医生可以通过在其办公室而非术前等候区获取知情同意,并在其口述的办公室或手术记录中记录知情同意讨论,来降低医疗事故索赔的风险。

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