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.

Compensation After Surgical Treatment for Hallux Valgus: A Review of 369 Claims to the Norwegian System of Patient Injury Compensation 2010-2020.

PURPOSE: The aim of the study is to identify the most common avoidable patient injuries related to hallux valgus surgery. METHODS: We assessed the claims reported to the Norwegian System of Patient Injury Compensation (NPE) following surgery for hallux valgus in light of hospital volume. Data from NPE was categorized according to age, sex, reason for claim, and reason for accepted/rejected claim. The institutions were grouped by catchment population into low volume (<150,000), middle volume (150,000-300,000), and high volume (>300,000) institutions. The effect of hospital volume on the likelihood of an accepted claim was estimated. RESULTS: NPE received 369 claims of which 173 (46.9%) were accepted. The main reason for accepted claims was recurrence of the deformity, wrong level osteotomy or insufficient fixation. A quarter of the claims were accepted because of lack of indication and one in 5 accepted claims was due to a postoperative infection. Patient treated at low-volume institutions had a higher fraction of accepted claims ( P < 0.01). The odds ratio for an accepted claim in the low volume hospitals was 5.8 (95% confidence interval 4.1-8.3) compared with the middle- and high-volume institutions. CONCLUSIONS: The likelihood of a treatment error that leads to compensation was higher in low-volume institutions. LEVEL OF EVIDENCE: Level II Prospective cohort study.

Injuries and deaths following Covid-19 vaccination: The ethical and legal case for compensation.

In April 2024, in a class action suit for compensation to families of persons suffering injury or death after vaccination with AstraZeneca's (AZ) Covid-19 vaccine [1], the manufacturer admitted in a UK court that the Oxford-AZ Covid-19 vaccine could cause a rare and potentially fatal blood clotting disorder ("thrombosis with thrombocytopenia syndrome" or TTS, which when triggered by a vaccine is called "vaccine induced thrombocytopenia and thrombosis, or VITT) [2]. The AZ Covid-19 vaccine is a chimpanzee adenovirus vectored vaccine encoding the SARS-CoV2 spike protein (ChAdOx1-S) marketed under the names Covishield and Vaxzevria.

Civil Monetary Penalties for EMTALA Violations Involving Minors, 2002-2023.

BACKGROUND AND OBJECTIVES: The Emergency Medical Treatment and Labor Act (EMTALA) is intended to prevent inadequate, delayed, or denied treatment of emergent conditions by emergency departments (EDs). EMTALA requirements pertain to patients of all ages presenting to dedicated EDs regardless of whether facilities have dedicated pediatric specialty services. This study aims to describe EMTALA-related civil monetary penalty (CMP) settlements involving minors. METHODS: Descriptions of all EMTALA-related CMPs occurring between 2002 and 2023 were obtained from the Office of the Inspector General web site and reviewed for involvement of minors (<18 years of age) using keywords in settlement summaries. Characteristics of settlements involving minors were described and compared with settlements not involving minors. RESULTS: Of 260 EMTALA-related CMPs, 38 (14.6%) involved minors. Most involved failure to provide a medical screening exam (MSE) (86.8%) and/or stabilizing treatment (52.6%). Seven (18.4%) involved pregnant minors. Eleven (28.9%) involved ED staff directing a patient (or guardian) to another facility, typically by private vehicle, and another involved 2 patients referred to on-campus outpatient clinics without an MSE. CONCLUSIONS: One in 7 CMPs related to EMTALA violations involved minors, and 1 in 5 of these minors was pregnant. One-third of CMPs involving minors included ED staff directing patients to proceed to another facility or on-campus clinic without MSE or stabilization. Findings suggest a need for providers to understand EMTALA-specific requirements for appropriate MSE, stabilization, and transfer, and for EDs at hospitals with limited pediatric services to implement policies for the evaluation of minors and protocols for transfer when indicated.

Loss of chance: the uncertainty of the event or the uncertainty of the conduct? Case Series and Medicolegal Considerations.

Background: The concept of damages for loss of chance originated in France in 1877 and was adapted to healthcare in 1962. In Italy, it was first introduced in healthcare liability in 2004, with Civil Court of Cassation decision No. 4400. Italian jurisprudence recognizes the loss of chance as an independent, legally and economically assessable damage, distinct from the actual outcome lost. The landmark St. Martin Judgments of 2019 further established that such damages can be claimed if they involve appreciable, serious, and consistent values. This requires proving a causal link between the conduct and the lost chance, based on established civil law criteria. Case report: 1) a 71-year-old man whose lung carcinoma was not diagnosed in time, leading to a significant reduction in survival chances. 2) a woman whose breast cancer diagnosis was delayed, resulting in a more advanced stage and decreased survival prospects. Discussion: In medical professional liability, the Supreme Court requires a high probability or certainty of causation for recognizing the causal link between wrongful conduct and damage. The assessment involves proving both the causal link and the reasonable probability of a lost opportunity's realization. Hypothetical damage is insufficient for compensation. Conclusions: The compensability of loss of chance relies on proving the causal link between the negligent act and the uncertain event, where the impact on the patient's non-pecuniary sphere is significant. Medicolegal practice faces challenges in distinguishing between causality and damage, which can lead to confusion between biological damage and damage from loss of opportunity.

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.

Psychiatric Illness and Clinical Negligence: When Can "Secondary Victims" Successfully Claim for Damages? Recent Developments from the United Kingdom.

On January 11, 2024, the United Kingdom (U.K.) Supreme Court rendered its judgment in Paul v Royal Wolverhampton NHS Trust, restricting the circumstances in which "secondary victims" can successfully claim for damages in clinical negligence cases. This ruling has provided welcome clarity regarding the scope of negligently caused "pure" psychiatric illness claims, but the judgment may well prove controversial. In this article, I trace the facts and opinion from the majority and also discuss an important dissenting opinion. I then reflect on what the ruling means for psychiatric illness claims by secondary victims, and more broadly on the implications for clinical negligence law. I suggest that while much-needed clarity has been injected in this area of the law, it is difficult, reading the majority of the Supreme Court's emphasis on the restricted scope of a medical practitioner's duty, to envision a scenario in which secondary victim could ever succeed in a clinical negligence context.

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.

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.

Reasons for malpractice claims after primary total hip arthroplasty in France: Insurance data from 240 claims from 2014 to 2017.

INTRODUCTION: Total hip arthroplasty (THA) is one of the most frequent orthopedic surgery procedures, and orthopedic surgeons are among the most frequently accused of malpractice by their patients. Identifying the main reasons for malpractice claims after THA is a prior condition to reducing their frequency. The quality of the preoperative risk information given to the patient by the surgeon is crucial for these purposes. Data specific to THA are sparse in France, and we therefore conducted a retrospective study (1) to determine whether the outcome of medico-legal expert appraisal correlated with the quality and traceability of preoperative information, and (2) to identify the most frequent grounds for complaint after primary THA. HYPOTHESIS: The quality of patient information partly determines expert appraisal. MATERIAL AND METHOD: A retrospective study was conducted based on data from the Branchet medical professional insurance agency for malpractice claims following THA over the period 2014-2017, with 240 complete files, for 125 women and 115 men. Data comprised: type of procedure, main grounds of complaint (complications), positive or negative expert appraisal, quality of preoperative patient information, amounts of compensation accorded and fees paid, and the practitioner's liability. We assessed correlations between information quality and liability. RESULTS: Surgical site infection and neurologic deficit were the two main grounds for malpractice claims. In the 240 files, cases for 106 operations (44.2%) were submitted to arbitration, 95 (39.6%) were brought to court, and 39 (16.2%) were settled out of court. The practitioner was held at least partly liable in 40 files (16.7%). Information to the patient was deemed imperfect or poor for 119 files (49.6%) and good in 121 (50.4%). Mean compensation was €30,940 (range, €0 to €198,100). In 27 of the 40 cases of liability (67.5%), the information to the patient was deemed imperfect or poor. Twenty-six of the 40 cases (65%) were settled out of court. In case of poor information, there was a significant risk for the practitioner to be held liable: 7.5 vs. 25% (p=0.003). DISCUSSION: The present study listed the main complications underlying malpractice claims after THA: infection, neurologic complications, and limb-length discrepancy. This should enable practitioners to improve patient information so as to reduce the rate of malpractice claims or at least decrease the practitioner's liability, as the study found a correlation between information quality and expert appraisal. LEVEL OF EVIDENCE: IV; retrospective study.

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.

A no-fault risk compensation approach for radiation risks incurred in space travel.

In this paper we recommend an appropriate compensation approach should be established for fatality and disabilities that may occur due to space radiation exposures of government or industry workers. A brief review of compensation approaches for nuclear energy and nuclear weapons development workers in the United States and other countries is described. We then summarize issues in the application of probability of causation calculation and provide examples of probability of causation (PC) calculations for missions to the International Space Station and Earth's moon or for Mars exploration. The main focus of this paper follows with a recommendation of a no-fault approach to compensation with the creation of appropriate insurance policies funded by employers to cover all disabilities or fatality, without requiring proof of causation or restriction to conditions that imply causation. Importantly we propose that the compensation described should be managed by recourse to private insurers.

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.

Compensation in Neonatal Clinical Trials: A Perspective.

Well conducted clinical trials are the mainstay for generating evidence on preferred treatments. In order to adequately protect the interests of the trial participants, the Central Licensing Authority of India has formulated guidelines to determine the quantum of compensation in cases of regulatory clinical trial related injury or death. However, these guidelines do not address the nuances of trials recruiting children aged under 16 years, within which, neonates are the most vulnerable population. Thus, there is a need for addressing this lacuna in the current guidelines. This article examines the challenges in determining the quantum of compensation in neonatal clinical trials using the current formula, which is a corollary to the challenges faced by the authors in procuring clinical trial insurance for the Probiotic supplementation for Prevention of Neonatal Sepsis (ProSPoNS) trial. Further, it suggests a template for a differential formula using birthweight of infants, which is one of the many important factors impacting neonatal mortality.

Exploring the Factors that Drive Clinical Negligence Claims: Stated Preferences of Those Who Have Experienced Unintended Harm.

BACKGROUND: Better understanding of the factors that influence patients to make a financial claim for compensation is required to inform policy decisions. This study aimed to assess the relative importance of factors that influence those who have experienced a patient safety incident (PSI) to make a claim for compensation. METHOD: Participants completed an online discrete choice experiment (DCE) involving 10 single profile tasks where they chose whether or not to file a claim. DCE data were modelled using logistic, mixed logit and latent class regressions; scenario analyses, external validity, and willingness to accept were also conducted. RESULTS: A total of 1029 participants in the United Kingdom responded to the survey. An appropriate apology and a satisfactory investigation reduced the likelihood of claiming. Respondents were more likely to claim if they could hold those responsible accountable, if the process was simple and straightforward, if the compensation amount was higher, if the likelihood of compensation was high or uncertain, if the time to receive a decision was quicker, and if they used the government compensation scheme. Men are more likely to claim for low impact PSIs. DISCUSSION AND CONCLUSIONS: The actions taken by the health service after a PSI, and people's perceptions about the probability of success and the size of potential reward, can influence whether a claim is made. Results show the importance of giving an appropriate apology and conducting a satisfactory investigation. This stresses the importance around how patients are treated after a PSI in influencing the clinical negligence claims that are made.

Litígios no Brasil: Ressarcimento do SUS

Em 21 de maio de 2019, a União, representada pela Advocacia Geral da União (AGU), ajuizou uma ação civil pública contra as maiores fabricantes de cigarro do país, visando o ressarcimento de gastos do Sistema Único de Saúde (SUS) com o tratamento de doenças atribuíveis ao tabagismo. Por meio dessa medida, a União busca reaver aos cofres públicos as despesas tidas com o tratamento de 26 doenças, nos últimos 5 anos, para as quais esteja cientificamente comprovado que a causa foi o consumo ou o contato com a fumaça do cigarro. A AGU também requer o pagamento de prestações periódicas pelos gastos que o sistema de saúde público terá no futuro com esses tratamentos e o pagamento de indenização por danos morais coletivos.

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.