Sales Representatives in the Operating Room: Conflict of Interest or Clinical Support?

BACKGROUND: The Physician Payment Sunshine Act, which became federal law in January 2012, mandated that medical device manufacturers must disclose any financial support provided to individual physicians on a publicly available Web site. The law reflects increasing concern about physician-industry relationships. METHODS: The connection between surgeon and sales representative creates possibilities for both financial and non-financial conflicts of interest (COIs). Indeed, COIs may be inherent when a sales representative is motivated by profit while also serving a critical role in many surgeries. RESULTS: The potential benefits and risks for patients, who may not even be aware of the sales representative's presence in the operating room, must be considered. CONCLUSIONS: This paper adds to the national discussion about neurosurgical physician-industry conflicts of interests and the issues relative to sales representatives in the operating room.

Spine neurosurgeons facing the judicialization of their profession: disenchantment and alteration of daily practice-a qualitative study.

BACKGROUND: The judicialization of medicine can lead to professional disenchantment and defensive attitudes among surgeons. Some quantitative studies have investigated this topic in spine surgery, but none has provided direct thematic feedback from physicians. This qualitative study aimed to identify the impact of this phenomenon in the practice of spine neurosurgeons. METHODS: We proposed a qualitative study using grounded theory approach. Twenty-three purposively selected private neurosurgeons participated. Inclusion took place until data saturation was reached. Data were collected through individual interviews and analyzed thematically and independently by three researchers (an anthropologist, a psychiatrist, and a neurosurgeon). RESULTS: Data analysis identified five superordinate themes that were based on items that recurred in interviews: (1) private practice of spinal surgery (high-risk surgery based on frequent functional symptoms, in an unfavorable medicolegal context); (2) societal transformation of the doctor-patient relationship (new societal demands, impact of the internet and social network); (3) judicialization of spine surgery (surgeons' feelings about the frequency and motivation of the complaints they receive, and their own management of them); (4) coping strategies (identification and solutions for "at risk" situations and patients); and (5) professional disenchantment (impact of these events on surgeons' daily practice and career planning). Selected quotes of interviews were reported to support these findings. CONCLUSIONS: Our study highlights several elements that can alter the quality of care in a context of societal change and the judicialization of medicine. The alteration of the doctor-patient relationship and the permanent pressure of a possible complaint encourage surgeons to adopt defensive attitudes in order to minimize the risks of litigation and increased insurance premiums. These phenomena can affect the quality of care and the privacy of physicians to the extent that they may consider changing or interrupting their careers earlier.

Implementation of duty of candour within neurosurgery: a national survey and framework for improved application in clinical practice.

INTRODUCTION: Statutory duty of candour was introduced in November 2014 for NHS bodies in England. Contained within the regulation were definitions regarding the threshold for what constitutes a notifiable patient safety incident. However, it can be difficult to determine when the process should be implemented. The aim of this survey was to evaluate the interpretation of these definitions by British neurosurgeons. MATERIALS AND METHODS: All full (consultant) members of the Society of British Neurological Surgeons were electronically invited to participate in an online survey. Surgeons were presented with 15 cases and asked to decide in the case of each one whether they would trigger the process of duty of candour. Cases were stratified according to their likelihood and severity. RESULTS: In all, 106/357 (29.7%) members participated in the survey. Responses varied widely, with almost no members triggering the process of duty of candour in cases where adverse events were common (greater than 10% likelihood) and required only outpatient follow-up (7/106; 6.6%), and almost all members doing so in cases where adverse events were rare (less than 0.1% likelihood) and resulted in death (102/106; 96.2%). However, there was clear equipoise in triggering the process of duty of candour in cases where adverse events were uncommon (0.1-10% likelihood) and resulted in moderate harm (38/106; 35.8%), severe harm (57/106; 53.8%) or death (49/106; 46.2%). CONCLUSION: There is considerable nationwide variation in the interpretation of definitions regarding the threshold for duty of candour. To this end, we propose a framework for the improved application of duty of candour in clinical practice.

Canadian neurosurgeons' views on medical assistance in dying (MAID): a cross-sectional survey of Canadian Neurosurgical Society (CNSS) members.

BACKGROUND: The Supreme Court of Canada removed the prohibition on physicians assisting in patients dying on 6 February 2015. Bill C-14, legalising medical assistance in dying (MAID) in Canada, was subsequently passed by the House of Commons and the Senate on 17 June 2016. As this remains a divisive issue for physicians, the Canadian Neurosurgical Society (CNSS) has recently published a position statement on MAID. METHODS: We conducted a cross-sectional survey to understand the views and perceptions among CNSS members regarding MAID to inform its position statement on the issue. Data was collected from May to June 2016. RESULTS: Of the 300 active membes of the CNSS who recevied the survey, 89 respondents completed the survey, 71% of whom were attending neurosurgeons and 29% were neurosurgery residents. Most respondents,74.2%, supported the right of physicians to participate in MAID with 7.8% opposing. 37% had current patients in their practice fitting the criteria for MAID. 23.6% had been asked by patients to assist with MAID, but only 11% would consider personally providing it. 84% of neurosurgeons surveyed supported the physicians' right to conscientious objection to MAID while 21% thought attending surgeons should be removed from the inquiry and decision-making process. 43.8% agreed that the requirment to refer a patient to a MAID service should be mandatory. Glioblastoma multiforme (65%), quadriplegia/quadriparesis secondary to spinal tumour/trauma (54%) and Parkinson's disease (24%) were the most common suggested potential indications for MAID among the neurosurgical population. CONCLUSIONS: Our results demonstrate that most neurosurgeons in Canada are generally supportive of MAID in select patients. However, they also strongly support the physicians' right to conscientious objection.

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.

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.

Ethics and meningiomas: From prudence to obstinacy? The position of the neurosurgeon (for treatment or insurance purposes) in the case of complaints concerning post-operative clinical deterioration.

To treat or not to treat an asymptomatic or pauci-symptomatic benign meningioma, that is the question. And if treatment is necessary, what is the best technique: radical resection, sub-total resection or radiotherapy? This question is also pertinent for meningiomas of the skull base, posterior part of the sagittal sinus, anterior part of the foramen magnum and cerebellopontine angle. When the results of the treatment are good, the patient and the surgeon are satisfied. But when a new neurological deficit appears after the treatment, the patient is entitled to obtain compensation. What should be the position of the specialist medical assessor in this situation when the prognosis of these benign tumors is unknown? Is the preoperative information that is due to the patient complete, objective and sufficient? Is the therapeutic indication unquestionable? Is the technique irreproachable? For meningiomas, there is no "evidence-based medicine"; the therapeutic option is often based on the personal experience and/or the education of the surgeon and thus is, in fact, highly subjective.

Medical Malpractice Claims Following Incidental Durotomy Due to Spinal Surgery.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: Analyze medical malpractice verdicts and settlements associated with incidental durotomy. SUMMARY OF BACKGROUND DATA: Incidental durotomy is a common complication of spine surgery. Although most intraoperative dural tears are repaired without sequelae, persistent Cerebrospinal Fluid leak, infection, or neurological injury can yield adverse outcomes. The medicolegal implications of incidental durotomy are poorly understood. METHODS: Three separate, large legal databases were queried for cases involving incidental durotomy. Case, plaintiff, procedure, and outcome characteristics were analyzed. RESULTS: In total, 48 dural tear-related medical malpractice cases were analyzed. Most cases (56.3%) resulted in a ruling in favor of the defendant physician. Most cases alleged neurological deficits (86.7%). A large majority of cases without neurological sequelae had an outcome in favor of the defendant (83.3%). For cases involving a payment, the average amount was $2,757,298 in 2016 adjusted dollars. Additional surgery was required in 56.3% of cases, a delay in diagnosis/treatment of durotomy was present in 43.8%, and alleged improper durotomy repair was present in 22.9%. A favorable outcome for the plaintiff was more likely in cases with versus without alleged delay in diagnosis/treatment (61.9% vs. 29.6%, P = 0.025) and improper durotomy repair technique (72.7% vs. 35.1%, P = 0.040). Repeat surgery was not associated with favorable outcome for the plaintiff (42.8% cases with reoperation vs. 38.1% without, P = 0.486). CONCLUSION: This analysis of durotomy-associated closed malpractice claims after spine surgery is the largest yet conducted. Durotomy cannot always be considered an entirely benign event, and these findings have several direct implications for clinicians: late-presenting or dehiscent durotomy may be associated with adverse outcomes and subsequent risk of litigation, timely reoperation in the event of durotomy-related complications may not increase surgeon liability, and spine surgeons should be prepared to defend their choice of durotomy repair technique, should dehiscence occur. LEVEL OF EVIDENCE: 3.

Descriptive Analysis of State and Federal Spine Surgery Malpractice Litigation in the United States.

STUDY DESIGN: A retrospective review. OBJECTIVE: This study aimed to determine the factors associated with malpractice litigation in cases involving spine surgery in the United States. SUMMARY OF BACKGROUND DATA: Medical malpractice is of substantial interest to the medical community due to concerns of increased health care costs and medical decision-making for the sole purpose of reducing legal liability. METHODS: The Westlaw online legal database (Thomson Reuters, New York, NY) was searched for verdict and settlement reports pertaining to spine surgery from 2010 to 2015. Data were collected regarding type of procedure, patient age and gender, defendant specialty, outcome, award, alleged cause of malpractice, and factors involved in the plaintiff's decision to file. Initial search queried 187 cases, after which exclusion criteria were applied to eliminate duplicates and cases unrelated to spine surgery, yielding a total of 98 cases for analysis. RESULTS: The verdict was in favor of the defendant in 62 cases (63.3%). Neurosurgeons and orthopedic surgeons were the most common defendants in 29 (17.3%) and 40 (23.8%) of the cases, respectively. A perceived lack of informed consent was noted as a factor in 24 (24.4%) of the cases. A failure to diagnose or a failure to treat was noted in 31 (31.6%) and 32 (32.7%) cases, respectively. Median payments for plaintiff verdicts were nearly double those of settlements ($2,525,000 vs. $1,300,000). A greater incidence of plaintiff verdicts was noted in cases in which a failure to treat (P < 0.05) was cited, a patient death occurred (P < 0.05), or an emergent surgery had been performed (P < 0.01). CONCLUSION: Overall, physicians were not found liable in the majority of spine surgery malpractice cases queried. LEVEL OF EVIDENCE: 4.

Medical Malpractice in Neurosurgery: A Comprehensive Analysis.

BACKGROUND: Of all specialists, neurosurgeons have the highest probability of facing a medical malpractice claim. Here we report the first specialty-wide review of malpractice claims in neurosurgery performed using a well-established national online legal database. METHODS: The Westlaw legal research service (Thomson Reuters, Eagan, Minnesota, USA) was queried for jury verdicts and settlements related to neurosurgery and medical malpractice between 1985 and 2015. Case files were examined, and factors recorded included the age and sex of the patient, the state and year in which the verdict was reached, defendant specialties, award payouts, and alleged reasons for malpractice. Case files were sorted into neurosurgical subspecialties based on the nature of the condition and the type of treatment administered. RESULTS: A total of 516 cases were identified, and 343 cases were analyzed. A defendant's verdict was reached in 165 (48.1%) cases, and a plaintiff's verdict was reached in 93 (27.1%) cases. A settlement was reached in 81 cases (23.6%). The median payout for plaintiff's verdicts was $2,550,000 (range, $80,000-$216,849,187), and that for settlements was $1,300,000 (range, $100,000-$13,300,000). Procedural error (45.5%), a failure to diagnose (41.4%), or a failure to treat (42.9%) were the most commonly cited reasons for litigation. Neurosurgeons accounted for 21.1% of defendants. The median plaintiff award payout was highest for pediatric cases ($10,100,000). CONCLUSIONS: A defendant's verdict was reached in nearly one-half of the cases. In instances where a plaintiff's verdict was reached, large payouts were common, especially in pediatric and cerebrovascular cases. An emphasis on reducing procedural error, and making timely differential diagnoses, may reduce future litigation.

Defensive medicine among neurosurgeons in the Netherlands: a national survey.

OBJECTIVE: In defensive medicine, practice is motivated by legal rather than medical reasons. Previous studies have analyzed the correlation between perceived medico-legal risk and defensive behavior among neurosurgeons in the United States, Canada, and South Africa, but not yet in Europe. The aim of this study is to explore perceived liability burdens and self-reported defensive behaviors among neurosurgeons in the Netherlands and compare their practices with their non-European counterparts. METHODS: A survey was sent to 136 neurosurgeons. The survey included questions from several domains: surgeon characteristics, patient demographics, type of practice, surgeon liability profile, policy coverage, defensive practices, and perception of the liability environment. Survey responses were analyzed and summarized. RESULTS: Forty-five neurosurgeons filled out the questionnaire (response rate of 33.1%). Almost half (n = 20) reported paying less than 5% of their income to annual malpractice premiums. Nearly all respondents view their insurance premiums as a minor or no burden (n = 42) and are confident that in their coverage is sufficient (n = 41). Most neurosurgeons (n = 38) do not see patients as "potential lawsuits". CONCLUSIONS: Relative to their American peers, Dutch neurosurgeons view their insurance premiums as less burdensome, their patients as a smaller legal threat, and their practice as less risky in general. They are sued less often and engage in fewer defensive behaviors than their non-European counterparts. The medico-legal climate in the Netherlands may contribute to this difference.

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.

Health transformation project and defensive medicine practice among neurosurgeons in Turkey.

BACKGROUND: The term "Defensive" medicine was coined in the early 1970's and has been an important topic of scientific investigation and professional debate ever since. OBJECTIVE: The aim of this study was to investigate the characteristics of defensive medicine, its reasons, and the extent to which it is practiced in the Turkish health care system. This is the first national survey to study the practice of defensive medicine among neurosurgeons in Turkey. METHODS: The present cross-sectional study on defensive medicine assessed neurosurgeons registered at the Turkish Neurosurgical Society, who are actively working in various centers and hospitals within the Turkish health care system. A 40-question survey was adapted from existing measures described in the literature and was completed by a total of 404 neurosurgeons, representing 36.7% of the neurosurgeons registered at the Turkish Neurosurgical Society. RESULTS: Seventy-two percent of the participants in the current study reported practicing defensive medicine. This practice was mainly reported among inexperienced neurosurgeons (74.4%). Most were younger than 40 years of age (75.2%), working in state hospitals/universities (72.7%), and living in the Marmara region (38%). Respondents reported engaging in defensive medicine by avoiding high-risk surgery (62.6%), ordering additional imaging studies (60.9%) and laboratory tests (33.7%), and referring patients to consultants (31.2%). Most participants consider every patient as a potential threat in terms of a medical lawsuit (68.3%) and do not believe the courts can distinguish malpractice from complications (89.6%). CONCLUSION: Concerns and perceptions about medical liability lead neurosurgeons to practice defensive medicine. By avoiding high-risk surgery, ordering unnecessary diagnostic tests, and referring the patients to consultants, neurosurgeons try to minimize the risk of malpractice and protect themselves from legal risks, resulting in higher healthcare expenditure and longer treatment periods.