Global landscape analysis of no-fault compensation programmes for vaccine injuries: A review and survey of implementing countries.

To update the landscape analysis of vaccine injuries no-fault compensation programmes, we conducted a scoping review and a survey of World Health Organization Member States. We describe the characteristics of existing no-fault compensation systems during 2018 based on six common programme elements. No-fault compensation systems for vaccine injuries have been developed in a few high-income countries for more than 50 years. Twenty-five jurisdictions were identified with no-fault compensation programmes, of which two were recently implemented in a low- and a lower-middle-income country. The no-fault compensation programmes in most jurisdictions are implemented at the central or federal government level and are government funded. Eligibility criteria for vaccine injury compensation vary considerably across the evaluated programmes. Notably, most programmes cover injuries arising from vaccines that are registered in the country and are recommended by authorities for routine use in children, pregnant women, adults (e.g. influenza vaccines) and for special indications. A claim process is initiated once the injured party or their legal representative files for compensation with a special administrative body in most programmes. All no-fault compensation programmes reviewed require standard of proof showing a causal association between vaccination and injury. Once a final decision has been reached, claimants are compensated with either: lump-sums; amounts calculated based on medical care costs and expenses, loss of earnings or earning capacity; or monetary compensation calculated based on pain and suffering, emotional distress, permanent impairment or loss of function; or combination of those. In most jurisdictions, vaccine injury claimants have the right to seek damages either through civil litigation or from a compensation scheme but not both simultaneously. Data from this report provide an empirical basis on which global guidance for implementing such schemes could be developed.

Medico-legal claims in bariatric surgery in France between 2010 and 2015.

PURPOSE OF THE STUDY: The practice of bariatric surgery has multiplied 3.5 times in France in the last ten years. The purpose of the study is to analyze medico-legal claims in this area in order to identify lessons to improve patient care. PATIENTS AND METHODS: Two visceral surgeons analyzed 358 independent claim files. Age, gender, socio-economic origin, body mass index, surgical history, depression, smoking, anticoagulants, and pre-operative assessment of patients were recorded. The operative indication, the type and date of occurrence of the event, the existence and causes of intra-operative incidents, re-interventions, inter-hospital transfers and deaths were noted. Any anomaly of care, whether noted by the expert or the court, was considered a fault. RESULTS: The types of bariatric procedures included sleeve gastrectomy in 52.1% of cases and gastric bypass in 33.2% of cases. A third of patients (31.2%) had a history of previous abdominal surgery. The main complications were anastomotic leak (48.6%), followed by vomiting, wounds of neighboring organs, and infections. Fault was found in 30.4% of cases: for delay of care (36.8%), surgical clumsiness or ineptitude (15.5%), incorrect indications, lack of patient information. In 6.4% of cases, metabolic deficiencies with encephalopathy developed. CONCLUSION: The indications of the French High Authority of Health [Haute autorité de santé (HAS)] must be respected and intra-operative difficulties should not be underestimated in patients who have undergone previous surgery. Post-operatively, clinical signs of severity take precedence over complementary examinations, even when negative. Close monitoring is necessary to quickly detect complications that occur outside the facility, whether it is a surgical complication or vitamin deficiency.

Effect of an Integrated Payment System on the Direct Economic Burden and Readmission of Rural Cerebral Infarction Inpatients: Evidence from Anhui, China.

Rural China is piloting an integrated payment system, which prepays a budget to a medical alliance rather than a single hospital. This study aims to evaluate the effect of this reform on the direct economic burden and readmission rates of cerebral infarction inpatients. The settlement records of 78,494 cerebral infarction inpatients were obtained from the New Rural Cooperative Medical Scheme (NRCMS) database in Dingyuan and Funan Counties in the Anhui Province. The direct economic burden was estimated by total costs, out-of-pocket expenditures, the out-of-pocket ratio, and the compensation ratio of the NRCMS. Generalized additive models and multivariable linear/logistic regression were applied to measure the changes of the dependent variables along with the year. Within the county, the total costs positively correlated to the year (ß = 313.10 in 2015; 163.06 in 2016). The out-of-pocket expenditures, out-of-pocket ratios, and the length-of-stay positively correlated to the year in 2015 (ß = 105.10, 0.01, and 0.18 respectively), and negatively correlated to the year in 2016 (ß = -58.40, -0.03, and -0.30, respectively). The odds ratios of the readmission rates were less than one within the county (0.70 in 2015; 0.53 in 2016). The integrated payment system in the Anhui Province has considerably reduced the direct economic burden for the rural cerebral infarction inpatients, and the readmission rate has decreased within the county. Inpatients' health outcomes should be given further attention, and the long-term effect of this reform model awaits further evaluation.

A Contemporary Medicolegal Analysis of Outpatient Interventional Pain Procedures: 2009-2016.

BACKGROUND: Closed malpractice claim studies allow a review of rare but often severe complications, yielding useful insight into improving patient safety and decreasing practitioner liability. METHODS: This retrospective observational study of pain medicine malpractice claims utilizes the Controlled Risk Insurance Company Comparative Benchmarking System database, which contains nearly 400,000 malpractice claims drawn from >400 academic and community medical centers. The Controlled Risk Insurance Company Comparative Benchmarking System database was queried for January 1, 2009 through December 31, 2016, for cases with pain medicine as the primary service. Cases involving outpatient interventional pain management were identified. Controlled Risk Insurance Company-coded data fields and the narrative summaries were reviewed by the study authors. RESULTS: A total of 126 closed claims were identified. Forty-one claims resulted in payments to the plaintiffs, with a median payment of $175,000 (range, $2600-$2,950,000). Lumbar interlaminar epidural steroid injections were the most common procedures associated with claims (n = 34), followed by cervical interlaminar epidural steroid injections (n = 31) and trigger point injections (n = 13). The most common alleged injuring events were an improper performance of a procedure (n = 38); alleged nonsterile technique (n = 17); unintentional dural puncture (n = 13); needle misdirected to the spinal cord (n = 11); and needle misdirected to the lung (n = 10). The most common alleged outcomes were worsening pain (n = 26); spinal cord infarct (n = 16); epidural hematoma (n = 9); soft-tissue infection (n = 9); postdural puncture headache (n = 9); and pneumothorax (n = 9). According to the Controlled Risk Insurance Company proprietary contributing factor system, perceived deficits in technical skill were present in 83% of claims. CONCLUSIONS: Epidural steroid injections are among the most commonly performed interventional pain procedures and, while a familiar procedure to pain management practitioners, may result in significant neurological injury. Trigger point injections, while generally considered safe, may result in pneumothorax or injury to other deep structures. Ultimately, the efforts to minimize practitioner liability and patient harm, like the claims themselves, will be multifactorial. Best outcomes will likely come from continued robust training in procedural skills, attention paid to published best practice recommendations, documentation that includes an inclusive consent discussion, and thoughtful patient selection. Limitations for this study are that closed claim data do not cover all complications that occur and skew toward more severe complications. In addition, the data from Controlled Risk Insurance Company Comparative Benchmarking System cannot be independently verified.

Undisclosed conflicts of interest among biomedical textbook authors.

BACKGROUND: Textbooks are a formative resource for health care providers during their education and are also an enduring reference for pathophysiology and treatment. Unlike the primary literature and clinical guidelines, biomedical textbook authors do not typically disclose potential financial conflicts of interest (pCoIs). The objective of this study was to evaluate whether the authors of textbooks used in the training of physicians, pharmacists, and dentists had appreciable undisclosed pCoIs in the form of patents or compensation received from pharmaceutical or biotechnology companies. METHODS: The most recent editions of six medical textbooks, Harrison's Principles of Internal Medicine (HarPIM), Katzung and Trevor's Basic and Clinical Pharmacology (KatBCP), the American Osteopathic Association's Foundations of Osteopathic Medicine (AOAFOM), Remington: The Science and Practice of Pharmacy (RemSPP), Koda-Kimble and Young's Applied Therapeutics (KKYAT), and Yagiela's Pharmacology and Therapeutics for Dentistry (YagPTD), were selected after consulting biomedical educators for evaluation. Author names (N = 1,152, 29.2% female) were submitted to databases to examine patents (Google Scholar) and compensation (ProPublica's Dollars for Docs [PDD]). RESULTS: Authors were listed as inventors on 677 patents (maximum/author = 23), with three-quarters (74.9%) to HarPIM authors. Females were significantly underrepresented among patent holders. The PDD 2009-2013 database revealed receipt of US$13.2 million, the majority to (83.9%) to HarPIM. The maximum compensation per author was $869,413. The PDD 2014 database identified receipt of $6.8 million, with 50.4% of eligible authors receiving compensation. The maximum compensation received by a single author was $560,021. Cardiovascular authors were most likely to have a PDD entry and neurologic disorders authors were least likely. CONCLUSION: An appreciable subset of biomedical authors have patents and have received remuneration from medical product companies and this information is not disclosed to readers. These findings indicate that full transparency of financial pCoI should become a standard practice among the authors of biomedical educational materials.

Susceptibility Weighted Imaging of the Cervical Spinal Cord with Compensation of Respiratory-Induced Artifact

PURPOSE: The objective of this study was to obtain improved susceptibility weighted images (SWI) of the cervical spinal cord using respiratory-induced artifact compensation. MATERIALS AND METHODS: The artifact from B0 fluctuations by respiration could be compensated using a double navigator echo approach. The two navigators were inserted in an SWI sequence before and after the image readouts. The B0 fluctuation was measured by each navigator echoes, and the inverse of the fluctuation was applied to eliminate the artifact from fluctuation. The degree of compensation was quantified using a quality index (QI) term for compensated imaging using each navigator. Also, the effect of compensation was analyzed according to the position of the spinal cord using QI values. RESULTS: Compensation using navigator echo gave the improved visualization of SWI in cervical spinal cord compared to non-compensated images. Before compensation, images were influenced by artificial noise from motion in both the superior (QI = 0.031) and inferior (QI = 0.043) regions. In most parts of the superior regions, the second navigator resulted in better quality (QI = 0.024, P < 0.01) compared to the first navigator, but in the inferior regions the first navigator showed better quality (QI = 0.033, P < 0.01) after correction. CONCLUSION: Motion compensation using a double navigator method can increase the improvement of the SWI in the cervical spinal cord. The proposed method makes SWI a useful tool for the diagnosis of spinal cord injury by reducing respiratory-induced artifact.

An aggravated return-to-work case of organic solvent induced chronic toxic encephalopathy

BACKGROUND: Organic solvent-induced chronic toxic encephalopathy (CTE) is known as a non-progressive disorder that does not progress after diagnosis. The authors present a case those symptoms worsened after continued exposure to organic solvent after returning to work. Because such a case has not been reported in South Korea to the best of our knowledge, we intend to report this case along with literature review. CASE PRESENTATION: A 59-year-old man, who performed painting job at a large shipyard for 20 years, was receiving hospital treatment mainly for depression. During the inpatient treatment, severe cognitive impairment was identified, and he visited the occupational and environmental medicine outpatient clinic for assessing work relatedness. In 1984, at the age of 27, he began performing touch-up and spray painting as a shipyard painter. Before that he had not been exposure to any neurotoxic substances. In 2001, at the age of 44, after 15 years of exposure to mixed solvents including toluene, xylene and others, he was diagnosed with CTE International Solvent Workshop (ISW) type 2A. After 7 years of sick leave, he returned to work in 2006. And he repeated return-to-work and sick leave in the same job due to worsening of depressive symptoms. He had worked four times (2006–2010, 2011–2011, 2011–2011, 2016–2017) for a total of 5 years as a shipyard painter after first compensation. During the return-to-work period, the mean values of the mixed solvent index ranged from 0.57 to 2.15, and except for a one semiannual period, all mean values were above the standard value of 1. We excluded other diseases that can cause cognitive impairment like central nervous system diseases, brain injury, psychological diseases and metabolic diseases with physical examinations, laboratory tests, and brain image analysis. And finally, throughout neuropsychological tests, an overall deterioration in cognitive function was identified compared to 2002, and the deterioration types was similar to that often shown in the case of CTE; thus a diagnosis of CTE (ISW) type 3 was made. CONCLUSION: This case is showing that CTE can go on with continued exposure to mixed solvents. Appropriate “fitness to work” should be taken to prevent disease deterioration especially for the sick leave workers.

Mesothelioma in Australia: a review.

The incidence of malignant mesothelioma in Australia is among the highest in the world as a result of widespread use of asbestos by industry and in construction throughout the 20th century. The risk of developing malignant mesothelioma after asbestos exposure is dose-related; a transient, low dose exposure confers a correspondingly very low risk of disease. Malignant mesothelioma is a heterogeneous disease, partly explaining the limited role of biomarkers in screening and diagnosis. The prognosis remains poor, and early advice on medico-legal compensation and a collaborative team approach to managing malignant mesothelioma are both essential. Chemotherapy can have a modest treatment effect in some people. New therapies, such as immunotherapy, do not yet have a defined role in the treatment of malignant mesothelioma. As treatment options for malignant mesothelioma are limited and no cure is available, there is no established role for early detection or screening of at risk populations. A multidisciplinary approach to caring for patients with malignant mesothelioma and their carers is vital.

Healthy Dining Out in Diabetic Patients / 임상당뇨병

Dining out can be difficult for diabetics whose dietary choices are limited compared to healthy people. However, it is almost impossible to eat only at home in modern society, so it is essential to learn and practice how to eat well. As mentioned above, the nutrition labeling system is being applied and extended not only to processed foods, but also to restaurants, and there are many restaurants that present calories and major nutrients of their food options, although the nutrient names can differ depending on location. Therefore, diabetes patients can enjoy eating out if they can check the nutritional information, decide a menu to suit their nutritional needs, and limit the amount of food eaten. For sugar reduction, it is important to limit added sugars, particularly by selecting proper beverages. It should not be forgotten that sodium intake is easy to fall into the temptation to eat sugars as a compensation for salty taste and can cause complications such as hypertension. Also, it is advisable for diabetics to visit restaurants offering low-salt options.

No fault compensation in perinatal medicine in Japan-from results for 8 years

No fault compensation in perinatal medicine has been established to provide aid to patients in the event of disability due to a medical accident during delivery and to strive to resolve disputes quickly that contributes to reduce medical malpractice suit in the field of perinatal medicine. Furthermore, this system is aimed to establish a mechanism that achieves higher quality of obstetric care by analyzing the causes of accidents. This system is operated by Japan Council for Quality Health Care and 99.9% of childbirth facilities in Japan registered with this compensation system. Compensation system has two major functions including compensation and cause analysis and recurrence prevention based on cases. Compensation eligibility is reviewed in the Review Committee at the organization in Japan Council for Quality Health Care and currently 1,717 cases are judged as eligible cases out of 2,250 since 2009. The cause of each eligible case is analyzed in the Cause Analysis Committee one by one. The Cause Analysis Committee has 7 independent subcommittee and each subcommittee members are consistent of obstetricians, neonatologists, pediatricians, midwives and lawyers. Original cause analysis report is sent to childbirth facility and patient's family. Questionnaire survey demonstrated that 73% of childbirth facilities and 65% of patient family were satisfied with the cause analysis report. The number of medical lawsuit in obstetrics and gynecology is significantly decreased compared to those in all medical departments since the compensation system was introduced suggesting that these cause analysis reports may contribute the decrease in medical lawsuits. The major purpose of the Recurrence Prevention Committee is striving to prevent future cases of cerebral palsy and to improve the quality of obstetric care. To accomplish the purpose, the committee routinely collect information from individual cases and analyze quantitatively and epidemiologically. Furthermore the committee choose subject from cases to discuss for future prevention and provide wide public disclosure of the information with recommendation. The committee issued 6 reports until now and these reports have been distributed to childbirth facilities, perinatal medicine-related scientific society and administrative agencies.

Why Has It Taken So Long to Address the Problems Created by Uranium Mining in the Navajo Nation?

Following the start of uranium mining after World War II, progress toward addressing the hazards it created for workers and nearby communities was slow, taking many decades. This essay asks why it took so long and suggests several factors that might have contributed.

The Claims Management Committees trial: experience of an Italian hospital of the National Health System.

INTRODUCTION: In Italy, health care is mainly financed by earmarked central and regional taxes, with regions receiving their allocated share of resources from the National Health Fund. The Council of the Tuscany Region in 2009 began an experimentation aimed to enforce the extrajudicial conciliation. The Council established the Claims Management Committees (CMC) for civil liability in the Tuscan Health Service. The CMC trial provides that the damages are compensated directly by the hospital, removing the cost of liability insurance. The aim of this study is to collect and compare the liability-insurance-period and the CMC trial-period. MATERIALS AND METHODS: Data were derived from the management claims database of the Health Directorate of the Careggi Hospital in Florence between 2006 and 2012. Two main periods are considered for the comparison of data: 2006-2007-2008 during the insurance management and 2010-2011-2012 during the CMC trial. RESULTS: During the insurance management period, the total expenditure was equal to the €14,846,334.44 paid in the 3-year period. The total expenditure during the CMC trial 3-years period was equal to €7.076.370,75. Under the CMC management, we observed a marked decrease in the recourse to legal action in the face of a substantial maintenance of the number of claims opened for each year. The CMC trial showed a greater speed in setting claims for damages. DISCUSSION AND CONCLUSIONS: Under CMC management, a greater and more diligent efficiency is matched by a lower economic outlay. The use of the direct management of damage compensation may be an important tool for risk management, thus guaranteeing the recourse to targeted and appropriate interventions.