Aspectos médico-legales del consentimiento informado en cirugía ortopédica.(I)

1 Partners Orthopaedic Trauma Service, Massachusetts General Hospital, 35 Fruit Street, Yawkey 3600, Boston, MA 02114. E-mail address for T. Bhattacharyya: tbhattacharyya@partners.org

2 Department of Orthopaedic Surgery, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115

Investigation performed at Medical Professional Mutual Insurance Company (ProMutual), and Risk Management Foundation, Boston, Massachusetts

The authors did not receive grants or outside funding in support of their research or preparation of this manuscript. They did not receive payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the authors are affiliated or associated.

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.