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 The vast majority of claims were withdrawn without incurring any cost to the hospital (n = 59, 71%) and only 24 (29%) resulted in successful litigation for the claimant.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.

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.

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.

The effect of duty hour regulations on outcomes of neurological surgery in training hospitals in the United States: duty hour regulations and patient outcomes.

OBJECT: The effects of sleep deprivation on performance have been well documented and have led to changes in duty hour regulation. New York State implemented stricter duty hours in 1989 after sleep deprivation among residents was thought to have contributed to a patient's death. The goal of this study was to determine if increased regulation of resident duty hours results in measurable changes in patient outcomes. METHODS: Using the Nationwide Inpatient Sample (NIS), patients undergoing neurosurgical procedures at hospitals with neurosurgery training programs were identified and screened for in-hospital complications, in-hospital procedures, discharge disposition, and in-hospital mortality. Comparisons in the above outcomes were made between New York hospitals and non-New York hospitals before and after the Accreditation Council for Graduate Medical Education (ACGME) regulations were put into effect in 2003. RESULTS: Analysis of discharge disposition demonstrated that 81.9% of patients in the New York group 2000-2002 were discharged to home compared with 84.1% in the non-New York group 2000-2002 (p = 0.6, adjusted multivariate analysis). In-hospital mortality did not significantly differ (p = 0.7). After the regulations were implemented, there was a nonsignificant decrease in patients discharged to home in the non-New York group: 84.1% of patients in the 2000-2002 group compared with 81.5% in the 2004-2006 group (p = 0.6). In-hospital mortality did not significantly change (p = 0.9). In New York there was no significant change in patient outcomes with the implementation of the regulations; 81.9% of patients in the 2000-2002 group were discharged to home compared with 78.0% in the 2004-2006 group (p = 0.3). In-hospital mortality did not significantly change (p = 0.4). After the regulations were in place, analysis of discharge disposition demonstrated that 81.5% of patients in the non-New York group 2004-2006 were discharged to home compared with 78.0% in the New York group 2004-2006 (p = 0.01). In-hospital mortality was not significantly different (p = 0.3). CONCLUSIONS: Regulation of resident duty hours has not resulted in significant changes in outcomes among neurosurgical patients.

Worse outcomes for patients undergoing brain tumor and cerebrovascular procedures following the ACGME resident duty-hour restrictions.

OBJECT: On July 1, 2003, the Accreditation Council for Graduate Medical Education (ACGME) implemented duty-hour restrictions for resident physicians due to concerns for patient and resident safety. Though duty-hour restrictions have increased resident quality of life, studies have shown mixed results with respect to patient outcomes. In this study, the authors have evaluated the effect of duty-hour restrictions on morbidity, mortality, length of stay, and charges in patients who underwent brain tumor and cerebrovascular procedures. METHODS: The Nationwide Inpatient Sample was used to evaluate the effect of duty-hour restrictions on complications, mortality, length of stay, and charges by comparing the pre-reform (2000-2002) and post-reform (2005-2008) periods. Outcomes were compared between nonteaching and teaching hospitals using a difference-in-differences (DID) method. RESULTS: A total of 90,648 patients were included in the analysis. The overall complication rate was 11.7%, with the rates not significantly differing between the pre- and post-duty hour eras (p = 0.26). Examination of hospital teaching status revealed that complication rates decreased in nonteaching hospitals (12.1% vs 10.4%, p = 0.0004) and remained stable in teaching institutions (11.8% vs 11.9%, p = 0.73) in the post-reform era. Multivariate analysis demonstrated a significantly higher complication risk in teaching institutions (OR 1.33 [95% CI 1.11-1.59], p = 0.0022), with no significant change in nonteaching hospitals (OR 1.11 [95% CI 0.91-1.37], p = 0.31). A DID analysis to compare the magnitude in change between teaching and nonteaching institutions revealed that teaching hospitals had a significantly greater increase in complications during the post-reform era than nonteaching hospitals (p = 0.040). The overall mortality rate was 3.0%, with a significant decrease occurring in the post-reform era in both nonteaching (5.0% vs 3.2%, p < 0.0001) and teaching (3.2% vs 2.3%, p < 0.0001) hospitals. DID analysis to compare the changes in mortality between groups did not reveal a significant difference (p = 0.40). The mean length of stay for all patients was 8.7 days, with hospital stay decreasing from 9.2 days to 8.3 days in the post-reform era (p < 0.0001). The DID analysis revealed a greater length of stay decrease in nonteaching hospitals than teaching institutions, which approached significance (p = 0.055). Patient charges significantly increased in the post-reform era for all patients, increasing from $70,900 to $96,100 (p < 0.0001). The DID analysis did not reveal a significant difference between the changes in charges between teaching and nonteaching hospitals (p = 0.17). CONCLUSIONS: The implementation of duty-hour restrictions correlated with an increased risk of postoperative complications for patients undergoing brain tumor and cerebrovascular neurosurgical procedures. Duty-hour reform may therefore be associated with worse patient outcomes, contrary to its intended purpose. Due to the critical condition of many neurosurgical patients, this patient population is most sensitive and likely to be negatively affected by proposed future increased restrictions.

A nine-year review of medicolegal claims in neurosurgery.

INTRODUCTION: Neurosurgery remains among the highest malpractice risk specialties. This study aimed to identify areas in neurosurgery associated with litigation, attendant causes and costs. METHODS: Retrospective analysis was conducted of 42 closed litigation cases treated by neurosurgeons at one hospital between March 2004 and March 2013. Data included clinical event, timing and reason for claim, operative course and legal outcome. RESULTS: Twenty-nine claims were defended out of court and twelve were settled out of court. One case required court attendance and was defended. Of the 42 claims, 28, 13 and 1 related to spinal (0.3% of caseload), cranial (0.1% of caseload) and peripheral nerve (0.07% of caseload) surgery respectively. The most common causes of claims were faulty surgical technique (43%), delayed diagnosis/misdiagnosis (17%), lack of information (14%) and delayed treatment (12%), with a likelihood of success of 39%, 29%, 17% and 20% respectively. The highest median payouts were for claims against faulty surgical technique (£230,000) and delayed diagnosis/misdiagnosis (£212,650). The mean delay between clinical event and claim was 664 days. CONCLUSIONS: Spinal surgery carries the highest litigation risk versus cranial and peripheral nerve surgery. Claims are most commonly against faulty surgical technique and delayed diagnosis/misdiagnosis, which have the highest success rates and payouts. In spinal surgery, the most common cause of claims is faulty surgical technique. In cranial surgery, the most common cause is lack of information. Claims may occur years after the clinical event, necessitating thorough contemporaneous documentation for adequate future defence. We emphasise thorough patient consultation and meticulous surgical technique to minimise litigation in neurosurgical practice.

Causes and outcomes of cauda equina syndrome in medico-legal practice: a single neurosurgical experience of 40 consecutive cases.

BACKGROUND: This is a unique report of 40 patients litigating in relation to the management of a cauda equina syndrome (CES), with prospective data collection. METHODS: Patients were seen and examined; medical records and radiological imaging were reviewed. The following data were collected prospectively: age; sex; the level of cauda equina (CE) compression; the pathology causing the compression; the clinical picture at first presentation; the causes of any iatrogenic injury; possible breaches of duty of care and the responsible discipline; recovery of bladder control; return to work. FINDINGS: There were possible breaches of duty of care for 39 patients initially, and for 69 patients overall. Twenty-eight patients presented with compressive degenerative pathologies (mainly central disc prolapses); all 28 had deteriorated to the point of bladder paralysis (complete CES (CESR)) at the time of treatment. Twenty-six (93%) had voluntary bladder control at presentation. Long-term bladder paralysis was probably avoidable in over 90% of patients. Eleven patients had iatrogenic injuries: all had long-term bladder paralysis. Thirty-four patients had bladder paralysis (CESR) at the point of decompressive surgery. Recovery of bladder function occurred in only seven patients (21%), i.e. long-term bladder outcomes were poor. Only 22% of patients returned to work. CONCLUSION: In this highly selected group of patients whose CES was not managed in an appropriate/standard fashion, 93% of patients had long-term bladder, bowel and sexual dysfunction that was probably avoidable. Mismanagement of patients with iatrogenic injuries was associated with a universally poor outcome.

History of spine surgery in the ancient and medieval worlds.

There is a paucity of surviving texts from ancient and medieval times that can shed light on the early development of spine surgery. Nevertheless, the author reviews many of the available books and fragments and discusses early developments in the field of spine surgery from the point of view of physicians' personalities, general themes, and actual surgical practices. For purposes of an overview and to highlight changing trends in spine surgery, he divides the paper into four eras of medicine: 1) Egyptian and Babylonian; 2) Greek and early Byzantine; 3) Arabic; and 4) medieval.

It is easier to confuse a jury than convince a judge: the crisis in medical malpractice.

STUDY DESIGN: A study of cervical spine malpractice cases was conducted. Identifying tort reform models may help to resolve a crisis in medical malpractice. OBJECTIVE: To identify tort reform models that may help to resolve a crisis in medical malpractice. SUMMARY OF BACKGROUND DATA: Medical malpractice faces a crisis. Insurance rates are exorbitant, yet many injured patients go uncompensated. Physicians practice defensive medicine for fear of suits, and society pays the price. METHODS: Using, 36 malpractice cases involving cervical spine surgery were identified: 20 from California ($250,000 cap on pain and suffering) and 16 from New York ("the sky's the limit"). Queries included who sued, who was sued, who won, who lost, and why? Six different tort reform models also were identified and explored. RESULTS: Common bases for suits included failure to diagnose and treatment (56%), lack of informed consent (64%), new neurologic deficits (64%), and pain and suffering (72%). All of the six plaintiff verdicts (average, $4.42 million) and four of the nine settlements (average, $1.6 million) involving surgery that resulted in new postoperative quadriplegia appeared to be appropriate. However, the author could discern "no fault" in cases five defendants had settled, and the surgeons did not deserve to lose. On the other hand, the author found "fault" in five defense verdicts rendered to three newly quadriplegic patients and two with new postoperative root injuries. These patients deserved monetary awards, but received no compensation whatsoever. There currently are two models that would work better than the system in place in most states. These include the American Medical Association National Specialty Societies Medical Liability Project with the Alternative Dispute Resolution Model (SSMLP), and the Selective No Fault Models. Among the advantages shared by one or more of these models is their ability to reimburse injured patients while eliminating physician liability, to use malpractice panels rather than trials, and to put a cap on damages. CONCLUSIONS: To solve the medical malpractice crisis, Congress, the individual states, or both should adopt tort reform. Two tort reform models compensating injured patients and eliminating physician liability appear to be not only effective but also fair to all concerned parties.