Abstract

Abstract INTRODUCTION Predictive factors associated with increased risk of medical malpractice litigation have been identified including severity of injury, physician sex and error in diagnosis. However, there is a paucity of literature investigating informed consent in spinal surgery malpractice. Our objective was to highlight the failure to obtain informed consent as an allegation in medical malpractice claims for patients undergoing spine-surgery. METHODS This was a retrospective case-control study using a national medico-legal database westlaw next. We identified a total of 233 patients (80 with no informed consent allegation, 153 who cited lack of informed consent) who underwent spinal surgery and filed a malpractice claim were studied. RESULTS >The most common informed consent allegations were failure to explain risks/side effects of surgery (30.4%) and failure to explain alternative treatment options (9.9%). In bivariate analysis, patients in the control group were more likely to require additional surgery (56.3% vs 34.6%, P = 0.002) and suffer from more permanent injuries compared to the informed consent group (P = 0.033). On multivariable regression analysis, permanent injuries were more often associated with indemnity payment following a plaintiff verdict (OR 3.12, 95% CI 1.46 - 6.65, P = 0.003) or a settlement (OR 6.26, 95% CI 1.06 - 36.70, P = 0.042). Informed consent allegations were significantly associated with less severe (temporary/emotional) injury (OR 0.52, 95% CI 0.28 - 0.97, P = 0.043). Additionally, allegations of informed consent were found to be predictive of a defense verdict versus a plaintiff ruling (OR 0.41, 95% CI 0.17 - 0.98, P = 0.046) or settlement (OR 0.01, 95% CI 0.001 - 0.15, P < 0.001). CONCLUSION Lack of informed consent is an important cause for medical malpractice litigation. Although associated with a lower rate of indemnity payments, malpractice lawsuits including informed consent allegations still present a time, money, and reputation toll for physicians

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