Neurosurgical Malpractice Litigation: A Systematic Review and Meta-Analysis.

BACKGROUND: Neurosurgery has 1 of the highest risks for medical malpractice claims. We reviewed the factors associated with neurosurgical malpractice claims and litigation in the United States and reported the outcomes through a systematic review of the literature. METHODS: We conducted a systematic review of the literature according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines using the Medline, Embase, Cochrane, PubMed, and Google Scholar databases. We sought to identify pertinent studies containing information about medical malpractice claims and outcomes involving neurosurgeons in the United States. RESULTS: We identified 15 retrospective studies spanning from 2002 to 2023 that reviewed over 7890 malpractice claims involving practicing neurosurgeons in the United States. Disparities were evident in neurosurgical litigation, with 474 cases linked to brain-related surgeries and a larger proportion, 1926 cases, tied to spine surgeries. The most commonly filed claims were intraprocedural errors (37.4%), delayed diagnoses (32.1%), and failure to treat (28.8%). Less frequently filed claims included misdiagnosis or choice of incorrect procedure (18.4%), occurrence of death (17.3%), test misinterpretation (14.4%), failure to appropriately refer patients for evaluation/treatment (14.3%), unnecessary surgical procedures (13.3%), and lack of informed consent (8.3%). The defendant was favored in 44.3% of claims, while in 31.3% of lawsuits were dropped, 17.7% of verdicts favored the plaintiff, and 16.6% reached an out of court settlement. Only 3.5% of lawsuits found both parties liable. CONCLUSION: Neurosurgery is a high-risk specialty with 1 of the highest rates of malpractice claims. Spine claims had a significantly higher rate of filed malpractice claims, while cranial malpractice claims were associated with higher litigation compensation. Predictably, spinal cord injuries play a crucial role in predicting litigation. Importantly, nonsurgical treatments are also a common source of liability in neurosurgical practice.

Malpractice litigation and spinal surgery in the National Health Service: a single tertiary-level centre perspective over 12 years.

INTRODUCTION: Medical malpractice litigation is a major concern for all spine surgeons. Our aim was to evaluate the incidence and burden of successful litigation relating to the management of spinal disorders over 12 years within a UK NHS tertiary-level spinal unit and compare these litigation costs with those of other specialties. METHODS: We obtained all data held by our claims department from its inception in January 2008 to December 2019. We also obtained costs for the total financial burden incurred by our Trust during this period. RESULTS: In total, there were 83 closed claims involving spinal pathologies. Over 80% of these comprised negligent surgery (n = 28, 34%), delay to diagnose/treat (n = 25, 30%) and negligent care (n = 18, 22%). The vast majority of claims were withdrawn without incurring any cost to the hospital (n = 59, 71%) and only 24 (29%) resulted in successful litigation for the claimant. The total cost of damages for these 24 successful claims was just over £8 million, including legal costs of £2.5 million, out of total litigation costs of £381 million over this period. DISCUSSION: Fewer than 30% of initial claims against a tertiary spinal surgical referral unit resulted in a successful financial outcome for the claimant. The total costs incurred were just over £8 million, with one-third apportioned to high legal costs, reflecting the complexity of resolving spinal litigation. Our entire legal expenses accounted for only 2% of the total legal bill paid by our hospital over a 12-year period.

Reducing Wrong-level Spinal Surgeries Through Root Cause Analyses: A 10-year Longitudinal Analysis of a Single Tertiary Institution's Iterative Policy Improvements.

MINI: This study is a comprehensive narrative of all wrong-level spine surgeries and prevention strategies employed at our institution between 2008 and 2019, and aims to provide a roadmap for developing a rigorous prevention protocol. We systematically track root cause analyses and policy changes to determine which prevention strategies are most effective.

Retrospective review. We aim to create a comprehensive narrative of all wrong-level spinal surgeries (WLSS) and subsequent prevention strategies employed at our institution and provide a roadmap for developing a rigorous prevention protocol. There is currently no published evidence-based protocol to prevent WLSS. Previous studies are limited to multi-institution surgeon surveys and opinion pieces; the impact of serial interventions to eliminate WLSS is lacking. No studies have longitudinally analyzed a single institution's serial root cause analyses (RCA) of individual WLSS cases and the stepwise impact of targeted interventions to reduce WLSS occurrence. We reviewed all wrong-site spine surgeries and prevention strategies employed at our institution between 2008 and 2019, and corresponding WLSS-related RCAs were collected from institutional records. We conducted a longitudinal analysis of these reports and tracked policy implementations that resulted along with the incidence of WLSS following each policy. Fifteen WLSS were identified with 13 corresponding RCAs of 21,179 spine surgeries between 2008 and 2019. Three policy categories emerged: imaging, operating room (OR) culture, and vertebral body marking. The salient changes from each category were: requiring two immovable vertebral markers (2013); requiring intraoperative radiographs with markers and retractors positioned (2014); open-ended questioning during spinal level verification by residents and fellows (2015); and requiring an impartial radiologist to have verbal contact with the operating surgeon intraoperatively to collaboratively discuss localization (2018). Each change resulted in WLSS incidence decline (five in 2014, three in 2015, 0 in 2019). Stepwise process improvement based on WLSS case review is necessary, as no one change in standard operating procedure effectively eliminated WLSS. Improvements in communication between OR staff, surgeon, and radiologist, as well as intraoperative imaging and marking optimization all contributed to improvements in WLSS rates. By focusing on lessons learned from RCAs using this methodology, institutions can iteratively improve rates of WLSS. Level of Evidence: 4.

Medical photography with a mobile phone: useful techniques, and what neurosurgeons need to know about HIPAA compliance.

Medical photographs are commonly employed to enhance education, research, and patient care throughout the neurosurgical discipline. Current mobile phone camera technology enables surgeons to quickly capture, document, and share a patient scenario with colleagues. Research demonstrates that patients generally view clinical photography favorably, and the practice has become an integral part of healthcare. Neurosurgeons in satellite locations often rely on residents to send photographs of diagnostic imaging studies, neurological examination findings, and postoperative wounds. Images are also frequently obtained for research purposes, teaching and learning operative techniques, lectures and presentations, comparing preoperative and postoperative outcomes, and patient education. However, image quality and technique are highly variable. Capturing and sharing photographs must be accompanied by an awareness of the legal ramifications of the Health Insurance Portability and Accountability Act (HIPAA). HIPAA compliance is straightforward when one is empowered with the knowledge of what constitutes a patient identifier in a photograph. Little has been published to describe means of improving the accuracy and educational value of medical photographs in neurosurgery. Therefore, in this paper, the authors present a brief discussion regarding four easily implemented photography skills every surgeon who uses his or her mobile phone for patient care should know: 1) provide context, 2) use appropriate lighting, 3) use appropriate dimensionality, and 4) manage distracting elements. Details of the HIPAA-related components of mobile phone photographs and patient-protected health information are also included.

Oversight and Ethical Regulation of Conflicts of Interest in Neurosurgery in the United States.

BACKGROUND: Developmental incentives are fundamental to surgical progress, yet financial and professional incentives inherently create conflicts of interest (COI). Understanding how to manage COI held by neurosurgeons, industry, hospitals, and journal editors, without thwarting progress and innovation is critical. OBJECTIVE: To present an overview of COI associated with innovation in neurosurgery, and review ways to manage these in an ethically sound manner. METHODS: A review of the literature was performed to assess conflicts of interest that affect neurosurgical innovation, and review ways to manage COI of various parties while adhering to ethical standards. RESULTS: COI are inherent to collaboration and innovation, and are therefore an unavoidable component of neurosurgery. The lack of a clear distinction between clinical practice and innovation, ability to use devices off-label, and unstandardized disclosure requirements create inconsistencies in the way that conflicts of interest are handled. Additionally, lack of requirements to compare innovation to the standard of care and inherent bias that affects study design and interpretation can have profound effects on the medical literature. Conflicts of interest can have both direct and downstream effects on neurosurgical practice, and it is possible to manage them while improving the quality of research and innovation. CONCLUSION: Conflicts of interest are inherent to surgical innovation, and can be handled in an ethically sound manner. Neurosurgeons, device companies, hospitals, and medical journals can take steps to proactively confront bias and ensure patient autonomy and safety. These steps can preserve public trust and ultimately improve evidence-based neurosurgical practice.

Information needs of patients in spine surgery: development of a question prompt list to guide informed consent consultations.

BACKGROUND CONTEXT: Informed consent is mandatory before surgery and fundamental in the physician-patient interaction. However, communication is sometimes suboptimal. PURPOSE: The objective was to develop a question prompt list (QPL) for patients undergoing spine surgery (spinal neurosurgery-QPL, "SN-QPL") to encourage them to acquire information during the informed consent consultation (ICC) and assess patients' information needs. STUDY DESIGN/SETTING: We conducted a prospective uncontrolled single center study in order to develop a QPL for patients undergoing spine surgery. PATIENT SAMPLE: Patients inclusion criteria were as follows: (1) planned spinal surgery, (2) age 18 to 80 years, (3) legal capacity, (4) ability to understand and respond to questionnaires, and (5) informed consent. OUTCOME MEASURES: We applied the following self-report measures: the developed preliminary QPL with regard to surgery topics and assessment of patients' information needs. METHODS: First, we performed a literature review, patient interviews, and two expert rounds. Subsequently, we validated a preliminary SN-QPL including 37 items before and after ICC with regard to importance of items and fulfillment of information needs in 118 patients. A principal component analysis followed by varimax rotation revealed the final SN-QPL. RESULTS: For the final version of the SN-QPL, 27 items with following four reliable subscales were derived with satisfactory internal consistency: (1) scale SN-QPL-C, "complications and possible postoperative deficits" (n  =  8 items, Cronbach α = 0.88); (2) scale SN-QPL-P, "prognosis and follow-up" (n = 8 items, Cronbach α = 0.86); (3) scale SN-QPL-I, "preoperative inpatient stay and organizational issues" (n = 5 items, Cronbach α = 0.75); and (4) scale SN-QPL-S: "safety of the surgical procedure" (with n = 6 items, Cronbach α = 0.84). The most unmet information needs were found in SN-QPL-P. The item with the greatest unmet information needs was "How much professional experience does my surgeon have?" CONCLUSIONS: Our SN-QPL was well-accepted and perceived as helpful by patients awaiting spinal surgeries. It seems to address meaningful items and questions. It could therefore be useful in optimizing pre- and postoperative satisfaction. Further, our study identified many unaddressed questions warranting communication interventions.

Malpractice Litigation in Brain Tumor Surgery: A 31-Year Analysis of Causative Factors in the United States from the Westlaw Database.

BACKGROUND: Medical malpractice litigation is an issue of major concern in neurosurgery, with 19.1% of neurosurgeons facing a claim annually. Neurosurgery possesses the greatest risk of malpractice of any specialty, likely owing to the complex clinical environment and disease severity. In the present study, we have characterized such litigation to determine the common factors that compel plaintiffs to file these claims. METHODS: WestLawNext, a prominent legal database, was used to identify all cases from 1985 to 2016 related to brain tumors. A total of 225 cases were identified, and each was analyzed for the cause of litigation (multiple causes were permitted). Because many had >1 ground for litigation, the reported percentages were based on the total counts of litigation rather than the number of cases. Additional information was collected from each case, including location, tumor type, and physician specialty. RESULTS: The cases were distributed across 36 states and U.S. territories: California (n = 42; 20%) and New York (n = 28; 13%) had the greatest number of cases. The top reasons for litigation were failure to diagnose (n = 109; 28%), failure to treat (n = 72; 18%), procedural error (n = 63; 16%), and failure to refer for diagnostic tests (n = 55; 14%). The most common diagnoses included pituitary adenoma (n = 26; 12%), acoustic neuroma (n = 27; 12%), and meningioma (n = 23; 10%). CONCLUSIONS: Malpractice litigation contributes to high overhead and physician burnout and escalates the cost of patient care. We found that benign brain tumors were the most common in litigation and that surgical issues accounted for only a small percentage.

Consent for post-operative visual loss in prone spinal surgery: aligning clinical practice with legal standards.

In March 2015, the Supreme Court's landmark ruling on the common law case of Montgomery vs Lanarkshire Health Board established the doctrine of informed patient consent, setting the legal standards that doctors should abide by. In this review, our primary aim has been to establish whether, despite the well-publicised implications of the ruling in the legal community, the medical profession has altered its practice. To do this, we reviewed the consenting methods applied by surgeons within our field of neurosurgery. We chose the rare, but disabling, material risk of prone spinal surgery: post-operative visual loss (POVL), as our tool for assessment. Departmental and national surveys both identified a common theme - the vast majority of doctors consenting patients for prone spinal surgery either do not consider POVL to be a serious material risk, or alternatively are not aware that current legal standards require them to ensure that patients are made aware of 'any' material risk involved in their treatment. In light of this finding, we discuss the legal implications of the Montgomery ruling, the current regulatory guidance available to support doctors, suggest some strategies to align clinical practice with the legal standards advocated by the ruling, and highlight some of the challenges surrounding the consent process given the legal framework in which we now practice.

Injury and Liability Associated With Spine Surgery.

BACKGROUND: Although spine surgery is associated with significant morbidity, the anesthesia liability profile for spine surgery is not known. We examined claims for spine procedures in the Anesthesia Closed Claims Project database to evaluate patterns of injury and liability. MATERIALS AND METHODS: A retrospective cohort study was performed. Inclusion criteria were anesthesia claims provided for surgical procedures in 2000 to 2014. We compared mechanisms of injury for cervical spine to thoracic or lumbar spine procedures using χ and the Fisher exact test. Univariate and multivariate logistic regression analyses were used to determine factors associated with permanent disabling injury in spine surgery claims. RESULTS: The 207 spine procedure (73% thoracic/lumbar; 27% cervical) claims comprised >10% of claims. Permanent disabling injuries to nerves, the spinal cord, and the eyes or visual pathways were more common with spine procedures than in nonspine procedures. Hemorrhage and positioning injuries were more common in thoracic/lumbar spine claims, whereas difficult intubation was more common in cervical spine claims. Multiple logistic regression demonstrated prone positioning (odds ratio=3.50; 95% confidence interval, 1.30-9.43) and surgical duration of ≥4 hours increased the odds of severe permanent injury in spine claims (odds ratio=2.73; 95% confidence interval, 1.11-6.72). CONCLUSIONS: Anesthesia claims related to spine surgery were associated with severe permanent disability primarily from nerve and eye injuries. Prone positioning and surgical duration of ≥4 hours were associated with permanent disabling injuries. Attention to positioning, resuscitation during blood loss, and reducing length of surgery may reduce these complications.

Trend of Malpractice Litigation against Neurosurgeons in Japan: An Analysis of Disclosed Database by Courts in Japan from 2001 through 2015.

Following the modern raising of public awareness, the numbers of malpractice litigation are increasing in the health care delivery system in Japan despite the extensive efforts of physicians. Authors reviewed the issues of litigation and the reasons for court decision from the healthcare-related negligence lawsuits in the past 15 years in Japan and investigated the cautionary points for reducing potential litigation. Healthcare-related negligence lawsuits between January 2001 and December 2015 were retrieved and sorted in each clinical field from the database in Courts in Japan and investigated on the proportional factors of the claims and court decisions in the neurosurgical field. During the period, 446 of healthcare-related court decisions including 41 against neurosurgeons (9.2%) were retrieved. Three of 41 decisions retrieved were decisions to retries for lower court decisions. In 38 claims against the neurosurgeons, 26 identified the negligence and 12 dismissed. In 26 decisions in favor of the plaintiffs, identified negligence in diagnosis in 4, clinical judgment in 3, technical skills in 5, clinical management in 7 and process of informed consent in 7. Five out of 18 decisions after 2006 were identified as negligence in an informed consent process, and additional one, who was mainly identified in inadequate technical skills also identified existing an inadequate informed consent process as a fundamental cause of litigation. Neurosurgeons are a higher risk group for malpractice litigation in Japan and adequate informed consent is important to reduce the risk of litigation.

Advances in surgery for movement disorders.

Movement disorder surgery has evolved throughout history as our knowledge of motor circuits and ways in which to manipulate them have expanded. Today, the positive impact on patient quality of life for a growing number of movement disorders such as Parkinson's disease is now well accepted and confirmed through several decades of randomized, controlled trials. Nevertheless, residual motor symptoms after movement disorder surgery such as deep brain stimulation and lack of a definitive cure for these conditions demand that advances continue to push the boundaries of the field and maximize its therapeutic potential. Similarly, advances in related fields - wireless technology, artificial intelligence, stem cell and gene therapy, neuroimaging, nanoscience, and minimally invasive surgery - mean that movement disorder surgery stands at a crossroads to benefit from unique combinations of all these developments. In this minireview, we outline some of these developments as well as evidence supporting topics of recent discussion and controversy in our field. Moving forward, expectations remain high that these improvements will come to encompass an even broader range of patients who might benefit from this therapy and decrease the burden of disease associated with these conditions. © 2016 International Parkinson and Movement Disorder Society.

Neurosurgery and Telemedicine in the United States: Assessment of the Risks and Opportunities.

BACKGROUND: Telemedicine has seen substantial growth in the past 20 years, related to technologic advancements and evolving reimbursement policies. The risks and opportunities of neurosurgical telemedicine are nuanced. METHODS: We reviewed general and peer-reviewed literature as it relates to telemedicine and neurosurgery, with particular attention to best practices, relevant state and federal policy conditions, economic evaluations, and prospective clinical studies. RESULTS: Despite technologic development, growing interest, and increasing reimbursement opportunities, telemedicine's utilization remains limited because of concerns regarding an apparent lack of need for telemedicine services, lack of widespread reimbursement, lack of interstate licensure reciprocity, lack of universal access to necessary technology, concerns about maintaining patient confidentiality, and concerns and limited precedent regarding liability issues. The Veterans Health Administration, a component of the U.S. Department of Veterans Affairs, represents a setting in which these concerns can be largely obviated and is a model for telemedicine best practices. Results from the VA demonstrate substantial cost savings and patient satisfaction with remote care for chronic neurologic conditions. Overall, the economic and clinical benefits of telemedicine will likely come from 1) diminished travel times and lost work time for patients; 2) remote consultation of subspecialty experts, such as neurosurgeons; and 3) remote consultation to assist with triage and care in time-sensitive scenarios, including acute stroke care and "teletrauma." CONCLUSIONS: Telemedicine is effective in many health care scenarios and will become more relevant to neurosurgical patient care. We favor proceeding with legislation to reduce barriers to telemedicine's growth.