Do vaccines cause epilepsy? Review of cases in the National Vaccine Injury Compensation Program.

OBJECTIVE: The National Childhood Vaccine Injury Act of 1986 created the National Vaccine Injury Compensation Program (VICP), a no-fault alternative to the traditional tort system. Since 1988, the total compensation paid exceeds $5 billion. Although epilepsy is one of the leading reasons for filing a claim, there has been no review of the process and validity of the legal outcomes given current medical information. The objectives were to review the evolution of the VICP program in regard to vaccine-related epilepsy and assess the rationale behind decisions made by the court. METHODS: Publicly available cases involving epilepsy claims in the VICP were searched through Westlaw and the US Court of Federal Claims websites. All published reports were reviewed for petitioner's theories supporting vaccine-induced epilepsy, respondent's counterarguments, the final decision regarding compensation, and the rationale underlying these decisions. The primary goal was to determine which factors went into decisions regarding whether vaccines caused epilepsy. RESULTS: Since the first epilepsy case in 1989, there have been many changes in the program, including the removal of residual seizure disorder as a vaccine-related injury, publication of the Althen prongs, release of the acellular form of pertussis, and recognition that in genetic conditions the underlying genetic abnormality rather than the immunization causes epilepsy. We identified 532 unique cases with epilepsy: 105 with infantile spasms and 427 with epilepsy without infantile spasms. The petitioners' experts often espoused outdated, erroneous causation theories that lacked an acceptable medical or scientific foundation and were frequently criticized by the court. SIGNIFICANCE: Despite the lack of epidemiological or mechanistic evidence indicating that childhood vaccines covered by the VICP result in or aggravate epilepsy, these cases continue to be adjudicated. After 35 years of intense litigation, it is time to reconsider whether epilepsy should continue to be a compensable vaccine-induced injury.

Cumulative incidence of cardiac surgery associated with exposure to benfluorex: A retrospective analysis based on compensation claims data.

Data on retrospective compensation claims for injuries caused by pharmaceutical drugs are prone to selection and reporting biases. Nevertheless, this case study of the antidiabetic drug benfluorex shows that such data can be used to estimate the cumulative incidence of drug-related injury, and to provide insights into its epidemiology. To this end, we develop a modelling framework for under-reporting of retrospective claims for compensation arising from drug damage. The model involves a longitudinal component related to attrition of cases over time, and a cross-sectional component related to incomplete reporting. We apply this model to cardiac valve surgery necessitated by exposure to benfluorex. Benfluorex was marketed in France between 1976 and 2009, when it was withdrawn because it caused valvular heart disease. A scandal erupted in 2010 over the scale of the damage caused by the drug. Since then, no further estimates of cumulative incidence have been published, though thousands of claims for compensation have been processed. The analysis combines compensation claims data and sociological survey data on benfluorex users, together with data on benfluorex sales and duration of treatment. We find a threshold of toxicity at about 6 months' exposure, and that at least 1690 individuals (95% CI 1290 to 2320) needed heart surgery to replace or repair valves damaged by exposure to benfluorex in France: a cumulative incidence of 3.68 per 10,000 (95% CI 2.68 to 5.34) benfluorex users or 3.22 per 10,000 (95% CI 2.48 to 4.39) person-years at risk above the exposure threshold. While these findings are tentative, they are consistent with those obtained previously using very different methods.

Obstetric claims in Finland 2012-2022-A nationwide patient insurance registry study.

INTRODUCTION: Maternal and infant mortality rates in Finland are among the lowest in the world, yet preventable obstetric injuries occur every year. The aim of this study was to describe obstetric claims, their compensation rates, and temporal trends of claims reported to the Patient Insurance center. MATERIAL AND METHODS: A nationwide, register-based study was conducted. Data consisted of obstetric claims reported to the Patient Insurance Center between 2012 and 2022. Data analyzed included the year of injury, compensation criteria, maternal age, birth hospital, delivery method, reported causes of injury, and maternal or neonatal injury. The data were analyzed with descriptive statistics and logistic regression models. RESULTS: A total of n = 849 obstetric claims were filed during the study period, of which n = 224 (26.4%) received compensation. The rate of claims was 0.15%, and the rate of compensation was 0.04% in relation to the total volume of births during the period. Substandard care was the most common (97.3%) criterion for compensation. There was a curvilinear increase in the claims rate and a linear increase in compensation rates from 2013 to 2019. More claims were filed and compensated for cesarean and vacuum-assisted deliveries than for unassisted vaginal deliveries. Delayed delivery (18.7%) and surgical technique failure (10.9%) were the most reported causes of injuries. Retained surgical bodies were the induced cause of injury with the highest rate of compensated claims (86.7%). The most common maternal injury was infection (17.9%) and pain (11.7%). Among neonatal injuries, severe (19.2%) and mild asphyxia (16.6%) were the most frequent. Burn injuries (93.3%) and fetal or neonatal death (60.5%) had the highest rate of compensated claims. CONCLUSIONS: The study provided new information on substandard care and injuries in obstetric care in Finland. An increasing trend in claims and compensation rates was found. Identifying contributors to substandard care that lead to fetal asphyxia is important for improving obstetric safety. Further analysis of the association of claims and compensation rates with operative deliveries is needed to determine their causality. Frequent review of obstetric claims would be useful in providing more recent data on substandard care and preventable injuries.

What guidance exists to support patient partner compensation practices? A scoping review of available policies and guidelines.

BACKGROUND: An integral aspect of patient engagement in research, also known as patient and public involvement, is appropriately recognising patient partners for their contributions through compensation (e.g., coauthorship, honoraria). Despite known benefits to compensating patient partners, our previous work suggested compensation is rarely reported and researchers perceive a lack of guidance on this issue. To address this gap, we identified and summarised available guidance and policy documents for patient partner compensation. METHODS: We conducted this scoping review in accordance with methods suggested by the JBI. We searched the grey literature (Google, Google Scholar) in March 2022 and Overton (an international database of policy documents) in April 2022. We included articles, guidance or policy documents regarding the compensation of patient partners for their research contributions. Two reviewers independently extracted and synthesised document characteristics and recommendations. RESULTS: We identified 65 guidance or policy documents. Most documents were published in Canada (57%, n = 37) or the United Kingdom (26%, n = 17). The most common recommended methods of nonfinancial compensation were offering training opportunities to patient partners (40%, n = 26) and facilitating patient partner attendance at conferences (38%, n = 25). The majority of guidance documents (95%) suggested financially compensating (i.e., offering something of monetary value) patient partners for their research contributions. Across guidance documents, the recommended monetary value of financial compensation was relatively consistent and associated with the role played by patient partners and/or specific engagement activities. For instance, the median monetary value for obtaining patient partner feedback (i.e., consultation) was $19/h (USD) (range of $12-$50/h). We identified several documents that guide the compensation of specific populations, including youth and Indigenous peoples. CONCLUSION: Multiple publicly available resources exist to guide researchers, patient partners and institutions in developing tailored patient partner compensation strategies. Our findings challenge the perception that a lack of guidance hinders patient partner financial compensation. Future efforts should prioritise the effective implementation of these compensation strategies to ensure that patient partners are appropriately recognised. PATIENT OR PUBLIC CONTRIBUTIONS: The patient partner coauthor informed protocol development, identified data items, and interpreted findings.

Patient partner perspectives on compensation: Insights from the Canadian Patient Partner Survey.

INTRODUCTION: There is a growing role for patients, family members and caregivers as consultants, collaborators and partners in health system settings in Canada. However, compensation for this role is not systematized. When offered, it varies in both type (e.g., one-time honorarium, salary) and amount. Further, broad-based views of patient partners on compensation are still unknown. We aimed to describe the types and frequency of compensation patient partners have been offered and their attitudes towards compensation. METHODS: This study uses data from the Canadian Patient Partner Study (CPPS) survey. The survey gathered the experiences and perspectives of those who self-identified as patient partners working across the Canadian health system. Three questions were about compensation, asking what types of compensation participants had been offered, if they had ever refused compensation, and whether they felt adequately compensated. The latter two questions included open-text comments in addition to menu-based and scaled response options. Basic frequencies were performed for all questions and open-text comments were analyzed through inductive qualitative content analysis. RESULTS: A total of 603 individuals participated in the CPPS survey. Most respondents were never or rarely offered salary (81%), honorarium (64%), gift cards (80%) or material gifts (93%) while half were offered conference registration and expenses at least sometimes. A total of 129 (26%) of 499 respondents reported refusing compensation. Of 511 respondents, half felt adequately compensated always or often, and half only sometimes, rarely or never. Open-text comments revealed positive, ambivalent and negative attitudes towards compensation. Attitudes were framed by perceptions about their role, sentiments of giving back to the health system, feelings of acknowledgement, practical considerations, values of fairness and equity and accountability relationships. CONCLUSIONS: Our findings confirm that compensation is not standardized in Canada. Half of survey respondents routinely feel inadequately compensated. Patient partners have diverse views of what constitutes adequate compensation inclusive of personal considerations such as a preference for volunteering, and broader concerns such as promoting equity in patient partnership. Organizations should attempt to ensure that compensation practices are clear, transparent and attentive to patient partners' unique contexts. PATIENT CONTRIBUTION: Two patient partners are members of the CPPS research team and have been fully engaged in all study phases from project conception to knowledge translation. They are co-authors of this manuscript. The survey was co-designed and pilot tested with patient partners and survey participants were patient partners.

Risk management and empirical study of the doctor-patient relationship: based on 1790 litigation cases of medical damage liability disputes in China.

BACKGROUND: Compensation for medical damage liability disputes (CMDLD) seriously hinders the healthy development of hospitals and undermines the harmony of the doctor-patient relationships (DPR). Risk management in the DPR has become an urgent issue of the day. The study aims to provide a comprehensive description of CMDLD in China and explore its influencing factors, and make corresponding recommendations for the management of risks in the DPR. METHODS: This study extracted data from the China Judgment Online - the official judicial search website with the most comprehensive coverage. Statistical analysis of 1,790 litigation cases of medical damage liability disputes (COMDLD) available from 2015 to 2021. RESULTS: COMDLD generally tended to increase with the year and was unevenly distributed by regions; the compensation rate was 52.46%, the median compensation was 134,900 yuan and the maximum was 2,234,666 yuan; the results of the single factor analysis showed that there were statistically significant differences between the compensation for different years, regions, treatment attributes, and trial procedures (P < 0.05); the correlation analysis showed that types of hospitals were significantly negatively associated with regions (R=-0.082, P < 0.05); trial procedures were significantly negatively correlated with years (R=-0.484, P < 0.001); compensat- ion was significantly positively correlated with years, regions, and treatment attributes (R = 0.098-0.294, P < 0.001) and negatively correlated with trial procedures (R=-0.090, P < 0.01); regression analysis showed that years, treatment attributes, and regions were the main factors affecting the CMDLD (P < 0.05). CONCLUSIONS: Years, regions, treatment attributes, and trial procedures affect the outcome of CMDLD. This paper further puts forward relevant suggestions and countermeasures for the governance of doctor-patient risks based on the empirical results. Including rational allocation of medical resources to narrow the differences between regions; promoting the expansion and sinking of high-quality resources to improve the level of medical services in hospitals at all levels; and developing a third-party negotiation mechanism for medical disputes to reduce the cost of medical litigation.

COVID-19 Vaccine Injury Compensation Program: Lessons Learned From a Review of 10 Implementing Countries.

National vaccine injury compensation serves as a crucial and significant safety net for individuals affected by government-recommended vaccines during a pandemic, contributing to the community's overall safety. In the Republic of Korea, compensation for adverse events resulting from coronavirus disease 2019 (COVID-19) vaccinations has been provided through the National Vaccine Injury Compensation Program introduced in 1995. However, there have been limitations with these measures during the COVID-19 pandemic owing to strict criteria for substantiating causality between the vaccine and injury, its nontransparent process of determining whether to compensate, and the compensation amount that is not practically calculated. This article reviewed the Vaccine Injury Compensation Programs in 10 major countries to present implications for improving the Korean system. Expanding the scope of national accountability is essential to compensate for the consequences of adhering to national policies during public health crises. Therefore, valuable insight can be obtained from examining the systems in Germany, Japan, and Taiwan, which have implemented more relaxed criteria for determining causality in compensation cases; Thailand's system, which provides the mandatory payment of preliminary compensation for damage caused by vaccination; systems in Germany, France, and Japan, which offer compensation for vaccine injuries from a practical perspective; and systems in France and the United Kingdom, which have a process allowing the assessment records to be shared with the claimants. Furthermore, a dedicated agency for vaccine injury compensation, as seen in France, the United Kingdom, and Australia, is necessary to enhance the efficiency of the Korean system.

The Claims of Biospecimen Donors to Credit and Compensation.

The biorights movement argues that current treatment of biospecimen donors is unfair. To evaluate this claim, the present Science & Society article identifies the standards used to determine credit and compensation in research, and applies them to donors. This analysis suggests most donors deserve credit and, contrary to current practice, some deserve compensation.

Plaintiff aims in medical negligence disputes: limitations of an adversarial system.

The adversarial nature of medical negligence litigation is subject to frequent criticism by the media, patient advocates, and scholars. In Ireland, reform of the medical negligence dynamic is often mooted, particularly in response to the high financial costs of this type of litigation; however, change in this area has been slow. Recently, the Irish courts have dealt with a number of high-profile, medical negligence disputes, including claims for those affected by the CervicalCheck controversy, which involved the failure to disclose the results of a retrospective audit to women who had developed cervical cancer. These cases have again highlighted the shortcomings of an adversarial system. This article explores the limitations of the tort system in the context of plaintiff aims in medical negligence disputes, drawing on empirical findings (qualitative interviews with patient support groups and barristers), and the literature. In doing so, the article argues that while financial compensation is necessary and appropriate in cases of medical negligence, the current system fails to recognise the often emotional nature of these claims, and the wider needs and aims of litigants involved in these disputes.

Jury verdicts, outcomes, and tort reform features of malpractice cases involving thoracic outlet syndrome.

OBJECTIVE/BACKGROUND: Thoracic outlet syndrome (TOS) is most often referred to vascular surgeons. However, there is a lack of understanding of the malpractice cases involving TOS. The goal of this study is to better understand the medicolegal landscape related to the care of TOS. METHODS: The Westlaw Edge AI-powered proprietary system was retrospectively reviewed for malpractice cases involving TOS. A Boolean search strategy was used to identify target cases under the case category of "Jury Verdicts & Settlements" for all state and federal jurisdictions from 1970 to September 2020. The settled case was described but not included in the statistical analysis. Descriptive statistics were used to report our findings, and when appropriate. The P ≤ .05 decision rule was established a priori as the null hypothesis rejection criterion to determine associations between jury verdicts outcomes and state's tort reform status. RESULTS: In this study, 39 cases were identified and met the study's inclusion criteria from the entire Westlaw Edge database. Among plaintiffs who disclosed age and/or gender, median age was 35.0 years with a female majority (67.6%). Cases involving TOS were noted to be steadily decreasing since the mid-1990s. The cases were unevenly spread across 18 states, with the highest number of cases (14, 35.9%) from California and the second highest (4, 10.3%) from Pennsylvania. A similar uneven distribution was seen among U.S. census regions, in which the West had the highest cases (39.5%). The study revealed that more cases were brought to trials in tort reform states (26, 68.4%) than in non-tort reform states (12, 31.6%). A total of 24 of 39 (61.5%) plaintiffs had one specific claim, which resulted in their economic and noneconomic damages. Negligent operation and treatment complication represented an overwhelming majority of claims brought by 38 of 39 plaintiffs (97.4%). Misdiagnosis and lack of informed consent were both brought nine times (23.1%) by the group. Intraoperative nerve injury (20 patients, 51.3%) was the most commonly reported complication. Excluding one case with a settlement of $965,000, 30 of 38 (78.9%) cases went to trials and received defense verdicts. Eight cases (20.5%) were found in favor of plaintiffs with a median payout of $725,581. CONCLUSIONS: This study highlighted higher than average payouts to plaintiffs and risk factors that may result in malpractice lawsuits for surgeons undertaking TOS treatment. Future studies are needed to further clarify the relationships between tort reform and outcomes of malpractice cases involving TOS.

Ureteric injuries during hysterectomy-A Norwegian retrospective study of occurrence and claims for compensation over an 11-year period.

INTRODUCTION: Ureteric injury is a rare but serious, iatrogenic complication of hysterectomy. The risk depends on indication for surgery, predisposing risk factors, and peroperative conditions. Our aims were to evaluate and learn from compensation claims to The Norwegian System of Patient Injury Compensation (NPE) for ureteric injury occurring during hysterectomies to predict risk factors, time of identification, symptoms, and consequences, and to relate these cases to injuries registered in The Norwegian Patient Registry. MATERIAL AND METHODS: A retrospective study of ureteric injuries occurring during hysterectomies, reported to NPE and the Norwegian Patient Registry from 2009 through 2019. RESULTS: During the study period, 53 096 hysterectomies were registered in The Norwegian Patient Registry, of which ureteric injury was documented in 643 (1.2%). More ureteric injuries were registered in large hospital trusts than in small trusts (1.3% vs. 0.7%, p < 0.05). NPE received 69 claims due to ureteric injury occurring during hysterectomy, comprising 11% of all injuries in the study period. Compensation was approved for 15%. Women who claimed compensation were younger (48.1 ± 8.9 years vs. 55.1 ± 13.6 years, p < 0.01), more likely to have had a benign diagnosis (89.9% vs. 52.1%, p < 0.01), and more likely to have had the ureteric injury recognized after discharge (58.0% vs. 33.0%, p < 0.001) compared with non-complainants. Identification of the ureters during the hysterectomy was documented in 30% of the NPE patient files. Additional information for the NPE cases included the following. The most common symptoms of unidentified injury were pain (77%), fever (12%), urinary leakage (13%), and anuria (8%). Re-operation was necessary in 77% of the cases, and 10% of the women lost one kidney. Long-term consequences after repair, such as loss of a kidney or persistent pain, were seen in 17%. No women died because of the injury. CONCLUSIONS: The incidence of ureteric injury occurring during hysterectomy in Norway was 1.2%; 11% involved a claim for compensation, and 15% of these had their case approved. Most ureteric injuries were not recognized during the hysterectomy. Documentation of peroperative identification of the ureters during hysterectomy was often missing. Vigilance to pain as a postoperative symptom of peroperative unrecognized ureteric injury may result in earlier diagnosis and treatment.

Compensation claims following anterior cruciate ligament injuries reported to the patient insurance company in Sweden in 2005-2014.

Background and purpose - Patients in the Swedish healthcare system are insured against avoidable adverse events via Landstingens Ömsesidiga Försäkringsbolag (LÖF). We assessed the reasons for compensation claims reported to LÖF following an ACL injury. Patients and methods - We searched the LÖF database for compensation claims related to ACL injuries reported in 2005-2014, and cross-matched claims with the Swedish National Knee Ligament Register. We then performed a review of the medical records. Results - We identified 530 eligible claims in 2005-2014. 352 (66%) claims were accepted by LÖF and 178 claims were rejected. Accepted claims corresponded to fewer than 1% of ACL surgeries performed in the same period. The most common reasons for an accepted claim were postoperative septic arthritis followed by suboptimal surgery and delay in diagnosis and treatment. Interpretation - There are different reasons for accepting a compensation claim following an ACL injury, which represents different treatment errors that can be avoided.

Association between industry payments and prescriptions of long-acting insulin: An observational study with propensity score matching.

BACKGROUND: The rapidly increased spending on insulin is a major public health issue in the United States. Industry marketing might be one of the upstream determinants of physicians' prescription of long-acting insulin-the most commonly used and costly type of insulin, but the evidence is lacking. We therefore aimed to investigate the association between industry payments to physicians and subsequent prescriptions of long-acting insulin. METHODS AND FINDINGS: Using the databases of Open Payments and Medicare Part D, we examined the association between the receipt of industry payments for long-acting insulin in 2016 and (1) the number of claims; (2) the costs paid for all claims; and (3) the costs per claim of long-acting insulin in 2017. We also examined the association between the receipt of payments and the change in these outcomes from 2016 to 2017. We employed propensity score matching to adjust for the physician-level characteristics (sex, years in practice, specialty, and medical school attended). Among 145,587 eligible physicians treating Medicare beneficiaries, 51,851 physicians received industry payments for long-acting insulin worth $22.3 million. In the propensity score-matched analysis including 102,590 physicians, we found that physicians who received the payments prescribed a higher number of claims (adjusted difference, 57.8; 95% CI, 55.8 to 59.7), higher costs for total claims (adjusted difference, +$22,111; 95% CI, $21,387 to $22,836), and higher costs per claim (adjusted difference, +$71.1; 95% CI, $69.0 to $73.2) of long-acting insulin, compared with physicians who did not receive the payments. The association was also found for changes in these outcomes from 2016 to 2017. Limitations to our study include limited generalizability, confounding, and possible reverse causation. CONCLUSIONS: Industry marketing payments to physicians for long-acting insulin were associated with the physicians' prescriptions and costs of long-acting insulin in the subsequent year. Future research is needed to assess whether policy interventions on physician-industry financial relationships will help to ensure appropriate prescriptions and limit overall costs of this essential drug for diabetes care.

Does physician compensation for declaration of involuntary status increase the likelihood of involuntary admission? A population-level cross-sectional linked administrative database study.

BACKGROUND: There is substantial variability in involuntary psychiatric admission rates across countries and sub-regions within countries that are not fully explained by patient-level factors. We sought to examine whether in a government-funded health care system, physician payments for filling forms related to an involuntary psychiatric hospitalization were associated with the likelihood of an involuntary admission. METHODS: This is a population-based, cross-sectional study in Ontario, Canada of all adult psychiatric inpatients in Ontario (2009-2015, n = 122 851). We examined the association between the proportion of standardized forms for involuntary admissions that were financially compensated and the odds of a patient being involuntarily admitted. We controlled for socio-demographic characteristics, clinical severity, past-health care system utilization and system resource factors. RESULTS: Involuntary admission rates increased from the lowest (Q1, 70.8%) to the highest (Q5, 81.4%) emergency department (ED) quintiles of payment, with the odds of involuntary admission in Q5 being nearly significantly higher than the odds of involuntary admission in Q1 after adjustment (aOR 1.73, 95% CI 0.99-3.01). With payment proportion measured as a continuous variable, the odds of involuntary admission increased by 1.14 (95% CI 1.03-1.27) for each 10% absolute increase in the proportion of financially compensated forms at that ED. CONCLUSIONS: We found that involuntary admission was more likely to occur at EDs with increasing likelihood of financial compensation for invoking involuntary status. This highlights the need to better understand how physician compensation relates to the ethical balance between the right to safety and autonomy for some of the world's most vulnerable patients.

Inequality in the last resort: how medical appraisal affects malpractice litigations in China.

BACKGROUND: Medical malpractice litigations affect the practices of patient safety. However, medical malpractice litigations involve highly specialized knowledge. Thus, medical appraisal is usually essential in the ascertainment of responsibility and judicial decision-making. China's judicial system is characterized by a dual-mode of medical appraisal resulting from two parallel appraisal agencies: judicial appraisal institutions and medical associations. This paper examines whether or not and how choices of different medical appraisal agencies affect malpractice lawsuit results in China. METHODS: We collected and sampled a total of 2557 verdicts pertaining to medical disputes from "China Judgements Online" in 2014. We used an ordinary least square regression model and a mediating effect regression model to analyze to what extent and how different choices between two medical appraisal agencies affect malpractice litigations. RESULTS: (1) Almost 81.55% (2082) of litigants resorted to medical malpractice appraisals in China in 2014. Among 2070 cases with appraisal results accepted by the court, 60.10% of the litigants chose judicial appraisal institutions (1244), as opposed to medical associations (826). (2) Among 2557 cases, 2306 (90.18%) claimed compensation and 1919 (83.22%) were awarded compensation by the courts. The proportion of compensation paid in a case is 48% on average. (3) Appraisal agencies matter in the investigation of medical errors, which in turn affects the proportion of compensation paid in a case. (4) Choosing judicial appraisal institutions will raise the proportion of compensation paid by about 10% on average. CONCLUSIONS: Different choices between appraisal institutions affect malpractice litigations in China. As the last resort for remedying medical malpractice, medical appraisals in the judicial system could be a source of inequality in China's medical litigation outcomes.

Clinical Negligence Claims Against Vascular Surgery in the United Kingdom: An Observational Study.

BACKGROUND: Claims for clinical negligence awarded to patients and their families are on the increase. The annual "cost of harm" is approximately £7-9 billion in the United Kingdom. In 2017, the National Health Service (NHS) resolution service reported that they mediated more claims than in their entire history. Vascular surgery is a specialty with a disproportionately higher number of claims for clinical negligence. The aim of this observational study was to review the trends of clinical negligence claims in vascular surgery within the United Kingdom. The costs and the primary cause for the complaint were evaluated. METHODS: A retrospective observational study was performed. Clinical negligence claims in vascular surgery between the financial years of April 2005/2006 to April 2018/2019 were requested from NHS resolution under the Freedom of Information Act. Data were provided on November 8, 2019. All data were anonymized, and any categories containing fewer than five claims were removed to protect the identity of claimants. RESULTS: Over the 13-year period, 1,189 claims in vascular surgery were identified, with the annual mean (range) being 91 (20-134) claims per year. Of 1,189 claims, 875 (74%) are closed with payments made to the claimants. The mean annual total payment was £10,015,373. Delay in treatment was the most common cause for litigation claims in vascular surgery with 157 closed claims costing £33,255,248 over the 13-year period. Lower limb amputation was the most common primary injury claim with 140 closed cases but had a larger financial cost at £64,155,969. CONCLUSIONS: Clinical negligence claims in vascular surgery within the United Kingdom have been increasing steadily over the last 13 years and with a changing claims culture is expected to continue. The most common cause for claims with damages paid was delay in treatment, and lower limb amputation was the most common injury suffered. Improved consent, better communication with patients, and a higher surgical skill level could significantly reduce the number of future claims.

Stopping exploitation: Properly remunerating healthcare workers for risk in the COVID-19 pandemic.

We argue that we should provide extra payment not only for extra time worked but also for the extra risks healthcare workers (and those working in healthcare settings) incur while caring for COVID-19 patients-and more generally when caring for patients poses them at significantly higher risks than normal. We argue that the extra payment is warranted regardless of whether healthcare workers have a professional obligation to provide such risky healthcare. Payment for risk would meet four essential ethical requirements. First, assuming healthcare workers do not have a professional obligation to take on themselves the risks, payments in the form of incentives would preserve autonomy in deciding what risks to take on oneself. Second, even assuming that healthcare workers do have a professional obligation to take on themselves the risks, payments for risk would create fair working conditions by avoiding exploitation. Third, payments for risk would make it more likely that public healthcare systems can discharge their institutional responsibility to provide healthcare in circumstances where healthcare workers may otherwise (perhaps legitimately) opt out. Fourth, payments for risk would guarantee an efficient healthcare system in pandemic situations. Finally, we address two likely objections that some might raise against our proposal, particularly with regard to incentives, namely that such payments or incentives can themselves be coercive and that they represent a form of undue inducement.

Correlation between compensated patient claims and 30-day mortality.

OBJECTIVE: To test if compensation claims from patients (reported to the Norwegian System of Patient Injury Compensation) are correlated with the existing quality indicator of 30-day mortality (based on data from Norwegian Patient Registry). This correlation has not been previously evaluated. DESIGN: The association between patient claims and 30-day mortality at hospital trust level was assessed by the Pearson correlation coefficient. SETTING: The Norwegian System of Patient Injury Compensation is a governmental agency under the Ministry of Health and Care Services and deals with patient-reported complaints about incorrect treatment in the public and private healthcare services. Patient-reported claims may be an indicator of healthcare quality, as 30-day mortality. PARTICIPANTS: All 19 Norwegian hospital trusts. INTERVENTIONS: : None. MAIN OUTCOME MEASURE: Patient claims rates, 30-day mortality and Pearson correlation coefficient. RESULTS: Both number of deaths within 30 days and number of claims have declined over time. High correlation (0.77, P < 0.001) was found between number of deaths within 30 days and the total number of claims. In addition, an even stronger association was found with approved claims, with a correlation coefficient of 0.83 (P < 0.001). Moreover, adjusted 30-day mortality was significantly correlated with the patient-claim rate using number of bed-days as denominator, but not when using number of discharges. CONCLUSIONS: The results from the present study indicate an association between compensation claims from patients and 30-day mortality, suggesting that both parameters reflect the latent quality of care for the hospital trusts, but they may capture different aspects of care.

Healthcare inequality in compensation claims concerning acute hospital services: a Danish register-based study.

OBJECTIVE: Although citizens' equal right to acute healthcare of appropriate quality is an oft-cited goal for modern societies, healthcare disparities may persist. We aimed to investigate inequality in compensation claims and compensation payments regarding acute healthcare services. DESIGN AND SETTING: We conducted a cross-sectional study of compensation claim patterns using the Danish Patient Compensation Association (DPCA) registries. PARTICIPANTS, INTERVENTIONS AND MAIN OUTCOME MEASURES: We used register data on all cases managed by DPCA relating to acute hospital healthcare for adults (aged > 18 years) from 2007 to 2017. RESULTS: In total, the DPCA had 5556 compensation claims for injuries caused by acute care services during the years 2007-2017. Age group of 50-64 years (odds ratio (OR) = 1.37 compared with those aged 18-49 years; P < 0.001), marriage (OR = 1.14; P < 0.001), higher income (OR = 1.55; P < 0.001) and Danish origin (OR = 1.49; P < 0.001) were statistically associated with higher odds for filing a compensation claim; men (OR = 0.83; P < 0.001) and those with many co-morbidities were much less represented (OR = 0.24; P < 0.001). Male gender (OR = 1.25; P < 0.001) and higher age (OR = 2.55 (80+ years); P < 0.001) were associated with higher odds for a compensation award. Failed diagnosis was also more often at stake in men (OR = 1.38; P < 0.001) and in patients aged 50-64 years (OR = 1.17; P < 0.001) but occurred less often in patients with multiple morbidities (OR = 0.68; P < 0.001). CONCLUSIONS: Findings from our Danish material suggest some inequality in compensation claims and compensation payments regarding acute healthcare services.

Postoperative pain and infection are the most frequent reasons for legal action after knee arthroscopy: a 5-year review based on two private insurance French companies after arthroscopy.

PURPOSE: The objective of this study was to determine the reasons for complaints and describe the judicial means upstream of France's courts following arthroscopy. METHODS: This is a retrospective observational study including all compensation records related to arthroscopic surgery, collected from the two leading French insurance organizations: MACSF and Branchet companies, from 2014 to 2018. Three medical experts performed the protocol and analysis. RESULTS: Finally, 247 procedures were included. The most common motives were: the appearance or persistence of pain (43.7%), postoperative infection (29.1%), technical errors (10.5%), nerve damage (5.7%), arterial lesions (2.8%), side errors (2.4%). Knee arthroscopies were more at risk of legal action for infection (p = 0.0006), and for disappointing results or persistent pain (p = 0.001). The first recourse was the conciliation and compensation commission (CCI) in 136 cases (55.1%), the civil court (TGI) in 88 cases (35.6%) and amicable settlement in 23 cases (9.3%). The mean time between surgery and the complaint was 32.8 ± 25.7 months, and was shorter in the case of an amicable procedure (p < 0.001). The lawsuit's mean duration was 15.6 ± 11.2 months, but longer in case of civil proceedings (p < 0.0001). The experts found no negligence in 81.8% of cases (n = 202). Infections were the leading cause of recourse to the conciliation and compensation commission (p < 0.0001), while technical errors were the main reason for complaints settled in an amicable procedure (p = 0.035). It was found more proven negligence in case of amicable procedures (p < 0.0001). The mean amount of compensation was 60,968.45€. No significant difference could be found regarding the median values of compensation between the reason of complaint. The amount of compensation was higher in civil court proceedings than in any others (p = 0.02). CONCLUSION: The main reasons for arthroscopy litigation in France are reported in this study, specifying how they are managed upstream of possible legal proceedings. The knee is the main joint involved. Patient information, close follow-up associated with early and appropriate management of complications are the main ways to reduce complaints. LEVEL OF EVIDENCE: IV.