Dataset Information

Allegations of Failure to Obtain Informed Consent in Spinal Surgery Medical Malpractice Claims.

ABSTRACT:

Importance

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.

Objective

To investigate the failure to obtain informed consent as an allegation in medical malpractice claims for patients undergoing a spinal procedure.

Design, setting, and participants

In this retrospective cohort study, a national medicolegal database was searched for malpractice claim cases related to spinal surgery for all years available (ie, January 1, 1980, through December 31, 2015).

Main outcomes and measures

Failure to obtain informed consent and associated medical malpractice case verdict.

Results

A total of 233 patients (117 [50.4%] male and 116 [49.8%] female; 80 with no informed consent allegation and 153 who cited lack of informed consent) who underwent spinal surgery and filed a malpractice claim were studied (mean [SD] age, 47.1 [13.1] years in the total group, 45.8 [12.9] years in the control group, and 47.9 [13.3] years in the informed consent group). Median interval between year of surgery and year of verdict was 5.4 years (interquartile range, 4-7 years). The most common informed consent allegations were failure to explain risks and adverse effects of surgery (52 [30.4%]) and failure to explain alternative treatment options (17 [9.9%]). In bivariate analysis, patients in the control group were more likely to require additional surgery (45 [56.3%] vs 53 [34.6%], P?=?.002) and have more permanent injuries compared with the informed consent group (46 [57.5%] vs 63 [42.0%], P?=?.03). On multivariable regression analysis, permanent injuries were more often associated with indemnity payment after a plaintiff verdict (odds ratio [OR], 3.12; 95% CI, 1.46-6.65; P?=?.003) or a settlement (OR, 6.26; 95% CI, 1.06-36.70; P?=?.04). Informed consent allegations were significantly associated with less severe (temporary or emotional) injury (OR, 0.52; 95% CI, 0.28-0.97; P?=?.04). In addition, allegations of informed consent were found to be predictive of a defense verdict vs a plaintiff ruling (OR, 0.41; 95% CI, 0.17-0.98; P?=?.046) or settlement (OR, 0.01; 95% CI, 0.001-0.15; P?Conclusions and relevanceLack of informed consent is an important cause of 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. The findings of this study can therefore help to improve preoperative discussions to protect spinal surgeons from malpractice claims and ensure that patients are better informed.

SUBMITTER: Grauberger J

PROVIDER: S-EPMC5831424 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Publications

Allegations of Failure to Obtain Informed Consent in Spinal Surgery Medical Malpractice Claims.

Grauberger Jennifer J Kerezoudis Panagiotis P Choudhry Asad J AJ Alvi Mohammed Ali MA Nassr Ahmad A Currier Bradford B Bydon Mohamad M

JAMA surgery 20170621 6

<h4>Importance</h4>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.<h4>Objective</h4>To investigate the failure to obtain informed consent as an allegation in medical malpractice claims for patients undergoing a spinal procedure.<h4>Design, setting, and participants</h4 ...[more]

PMID: 28445561

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Project description:BackgroundThe success of newly introduced surgical techniques is generally primarily assessed by surgical outcome measures. However, data on medical liability should concomitantly be used to evaluate provided care as they give a unique insight into substandard care from patient's point of view. The aim of this study was to analyze the number and type of medical claims after laparoscopic gynecologic procedures since the introduction of advanced laparoscopy two decades ago. Secondly, our objective was to identify trends and/or risk factors associated with these claims.MethodsTo identify the claims, we searched the databases of the two largest medical liability mutual insurance companies in The Netherlands (MediRisk and Centramed), covering together 96% of the Dutch hospitals. All claims related to laparoscopic gynecologic surgery and filed between 1993 and 2015 were included.ResultsA total of 133 claims met our inclusion criteria, of which 54 were accepted claims (41%) and 79 rejected (59%). The number of claims remained relatively constant over time. The majority of claims were filed for visceral and/or vascular injuries (82%), specifically to the bowel (40%) and ureters (20%). More than one-third of the injuries were entry related (38%) and 77% of the claims were filed after non-advanced procedures. A delay in diagnosing injuries was the primary reason for financial compensation (33%). The median sum paid to patients was €12,000 (500-848,689). In 90 claims, an attorney was defending the patient (83% for the accepted claims; 57% for the rejected claims).ConclusionThe number of claims remained relatively constant during the study period. Most claims were provoked by bowel and ureter injuries. Delay in recognizing injuries was the most encountered reason for granting financial compensation. Entering the abdominal cavity during laparoscopy continues to be a potential dangerous step. As a result, gynecologists are recommended to thoroughly counsel patients undergoing any laparoscopic procedure, even regarding the risk of entry-related injuries.

Project description:To examine characteristics of medical malpractice claims involving radiation oncologists closed during a 10-year period.Malpractice claims filed against radiation oncologists from 2003 to 2012 collected by a nationwide liability insurance trade association were analyzed. Outcomes included the nature of claims and indemnity payments, including associated presenting diagnoses, procedures, alleged medical errors, and injury severity. We compared the likelihood of a claim resulting in payment in relation to injury severity categories (death as referent) using binomial logistic regression.There were 362 closed claims involving radiation oncology, 102 (28%) of which were paid, resulting in $38 million in indemnity payments. The most common alleged errors included "improper performance" (38% of closed claims, 18% were paid; 29% [$11 million] of total indemnity), "errors in diagnosis" (25% of closed claims, 46% were paid; 44% [$17 million] of total indemnity), and "no medical misadventure" (14% of closed claims, 8% were paid; less than 1% [$148,000] of total indemnity). Another physician was named in 32% of claims, and consent issues/breach of contract were cited in 18%. Claims for injury resulting in death represented 39% of closed claims and 25% of total indemnity. "Improper performance" was the primary alleged error associated with injury resulting in death. Compared with claims involving death, major temporary injury (odds ratio [OR] 2.8, 95% confidence interval [CI] 1.29-5.85, P=.009), significant permanent injury (OR 3.1, 95% CI 1.48-6.46, P=.003), and major permanent injury (OR 5.5, 95% CI 1.89-16.15, P=.002) had a higher likelihood of a claim resulting in indemnity payment.Improper performance was the most common alleged malpractice error. Claims involving significant or major injury were more likely to be paid than those involving death. Insights into the nature of liability claims against radiation oncologists may help direct efforts to improve quality of care and minimize the risk of being sued.

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Project description:BackgroundObtaining adequate informed consent from trauma patients is challenging and time-consuming. Healthcare providers must communicate complicated medical information to enable patients to make informed decisions. This study aimed to explore the challenges of obtaining valid consent and methods of improving the quality of the informed consent process for surgical procedures in trauma patients.MethodsWe conducted a systematic review of relevant English-language full-text original articles retrieved from PubMed (1961-August 2018) that had experimental or observational study design and involved adult trauma patients. Studies involving informed consent in clinical or research trials were excluded. Titles and abstracts of searched articles were reviewed and relevant data were extracted with a structured form. Results were synthesized with a narrative approach.ResultsA total of 2044 articles were identified in the initial search. Only eight studies were included in the review for narrative synthesis. Six studies involved orthopedic surgeries, one involved nasal bone surgeries, and one involved trauma-related limb debridement. Only one study was conducted in an emergency department. Information recall was poor for trauma patients. Risk recall and comprehension were greater when written or video information was provided than when information was provided only verbally. Patient satisfaction was also greater when both written and verbal information were provided than when verbal information alone was provided; patients who received video information were more satisfied than patients who received written or verbal information.ConclusionsMany articles have been published on the subject of informed consent, but very few of these have focused on trauma patients. More empirical evidence is needed to support the success of informed consent for trauma patients in the emergency department, especially within the necessarily very limited time frame. To improve the informed consent process for trauma patients, developing a structured and standardized informed consent process may be necessary and achievable; its effectiveness would require evaluation. Adequately educating and training healthcare providers to deliver structured, comprehensive information to trauma patients is crucial. Institutions should give top priority to ensuring patient-centered health care and improved quality of care for trauma patients.

Dataset Information

Allegations of Failure to Obtain Informed Consent in Spinal Surgery Medical Malpractice Claims.

Importance

Objective

Design, setting, and participants

Main outcomes and measures

Results

Publications

Allegations of Failure to Obtain Informed Consent in Spinal Surgery Medical Malpractice Claims.

Similar Datasets

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