Estudio médico legal de la Ley Orgánica de Regulación de la Eutanasia en España en comparación con el resto de los países que regulan la eutanasia y/o el suicidio asistido / Medico legal study of the organic law of the regulation of euthanasia in Spain compared to the rest of the countries that regulate euthanasia and / or assisted suicide

La regulación de la eutanasia ha sido objeto de debate desde hace años, desde los campos de la medicina, el derecho y la bioética, y por tanto de la medicina legal, en la que estas 3 disciplinas convergen. En los últimos 30 años hemos vivido un proceso de despenalización y regulación en diferentes países del mundo. Actualmente la eutanasia y/o el suicidio asistido están regulados en 7 países: Holanda, Bélgica, Luxemburgo, Canadá, Colombia, Nueva Zelanda y España, así como en 11 estados de EE. UU.: Oregón, Washington, Montana, Vermont, California, Colorado, Hawai, Maine, Nueva Jersey, Nuevo México y el Distrito Federal de Columbia/Washington D.C., y en 2 estados de Australia: Estado de Victoria y Australia Occidental. En este trabajo de revisión realizamos un estudio sobre los aspectos más importantes de la nueva Ley Orgánica de Regulación de la Eutanasia en España comparando con el resto de los países en los que también tienen la regularización de la eutanasia y/o el suicidio asistido. (AU)

The regulation of euthanasia has been the subject of debate for years, from the fields of Medicine, Law and Bioethics, and therefore of Legal Medicine, in which these three disciplines converge. In the last thirty years we have experienced a process of decriminalization and regulation in different countries of the world. Currently euthanasia and/or assisted suicide are regulated in 7 countries: Holland, Belgium, Luxembourg, Canada, Colombia, New Zealand and Spain, as well as in 11 US states: Oregon, Washington, Montana, Vermont, California, Colorado, Hawaii, Maine, New Jersey, New Mexico and the Federal District of Columbia / Washington D.C, and in 2 states of Australia: State of Victoria and Western Australia. In this review work we carry out a study on the most important aspects of the new law of the regulation of euthanasia in Spain compared to the rest of the countries in which they also have the regularization of euthanasia and / or assisted suicide. (AU)

[Caregivers and minors who are radicalised or at risk of becoming radicalised: legal benchmarks]. / Soignants et mineurs radicalisés ou en risque de le devenir : repères juridiques.

In an era where terrorism has become modernized and globalized, the international community and the French authorities remain cautious about an invisible, yet very present army, that of the "fighters in becoming ", whose indoctrination is privileged by the Islamic State: the minors. In these times of crisis, what legal apprehension can be brought to caregivers confronted with radicalised minor patients or undergoing radicalisation? Several limitations can be pointed out on this subject in the international response. Despite this, it is possible to give some guidance to caregivers confronted with situations of radicalized minors, or undergoing radicalisation, facing the dangers they represent for themselves and for society.

How Do We Combat Bogus Medicines in the Age of the COVID-19 Pandemic?

The COVID-19 pandemic has brought concurrent challenges. The increased incidence of fake and falsified product distribution is one of these problems with tremendous impact, especially in low- and middle-income countries. Up to a tenth of medicines including antibiotics and antimalarial drugs in the African market are considered falsified. Pandemics make this worse by creating an ecosystem of confusion, distraction, and vulnerability stemming from the pandemic as health systems become more stressed and the workload of individuals increased. These environments create opportunities for substandard and falsified medicines to be more easily introduced into the marketplace by unscrupulous operators. In this work we discuss some of the challenges with fake or falsified product distribution in the context of COVID-19 and proposed strategies to best manage this problem.

A contemporary medicolegal claims analysis of injuries related to neuraxial anesthesia between 2007 and 2016.

STUDY OBJECTIVE: To provide a contemporary medicolegal analysis of claims brought against anesthesia providers in the United States related to neuraxial blocks for surgery and obstetrics. DESIGN: In this retrospective analysis, we analyzed closed claims data from the Controlled Risk Insurance Company (CRICO) Comparative Benchmarking System (CBS) database between 2007 and 2016. SETTING: Closed claims from inpatient and outpatient settings related to neuraxial anesthesia for surgical procedures and obstetrics. PATIENTS: Forty-five claims were identified for analysis. These patients underwent a variety of surgical procedures, included both children and adults, and with ages ranging from 6 to 82. INTERVENTIONS: Patients receiving neuraxial anesthesia (spinals, epidurals) for surgery or obstetrics. MEASUREMENTS: Data collected includes patient demographics, alleged injury type/severity, surgical specialty, likely contributors to the alleged damaging event, and case outcome. Some of the data were drawn directly from coded variables in the CRICO database, and some were gathered from narrative case summaries. MAIN RESULTS: Settlement payments were made in 20% of claims. Reported adverse outcomes ranged from temporary minor to permanent major injuries. Most closed claims were classified as permanent minor injuries. The greatest number of claims involved residual weakness and radiculopathy resulting from epidurals. The largest contributing factor to these injuries was noted to be "Technical Knowledge/Performance" of the anesthesia provider followed by "Missing or Documentation Error." Over half of the claims arose from obstetric patients (31%) and patients undergoing orthopedic surgery (27%). CONCLUSIONS: Patients with pre-existing radiculopathy or comorbidities may warrant more thorough informed consent about the increased risk of injury. Additionally, prompt follow-up, monitoring, and documentation of post-operative symptoms, such as weakness or radiculopathy, are crucial for improving patient safety and satisfaction. More timely communication with the patient and the surgical team regarding residual neurologic symptoms is important for earlier diagnosis of injury.

Transplant community perceptions of the benefits and drawbacks of alternative quality metrics for regulation.

BACKGROUND: There is concern that the metrics currently used to regulate transplant centers, one-year patient and graft survival, may have adverse consequences including decreasing higher risk donor organ acceptance and transplant volume. This raises questions about whether alternative measures would be more appropriate. METHODS: We surveyed American Society of Transplant Surgeons (ASTS) and American Society of Transplantation (AST) members (n = 270) to characterize perceptions of several metrics that are used for regulation, are publicly reported, or have been suggested elsewhere, regarding their effectiveness, amenability to risk adjustment, and predicted effects on volume, mortality, and waitlist size. RESULTS: Respondents rated one-year patient and graft survival the most effective measure of quality of care (mean scores = 7.44, 7.31, respectively, out of 10) and most amenable to risk adjustment (mean scores = 6.26, 6.13, respectively). Most respondents believed alternative metrics would not impact their center's volume, waitlist size, or one-year transplant mortality. However, some did predict unintended consequences; for example, some believed using one-year waitlist mortality, one-year mortality of patients listed, or one-year mortality of patients referred for transplant would decrease the number of transplants performed (48.6%, 46.7%, and 48.3% of respondents, respectively). DISCUSSION: Despite previously published concerns with existing regulatory metrics, most participants did not believe any metrics would outperform one-year patient and graft survival.

A medicolegal analysis of malpractice claims involving anesthesiologists in the gastrointestinal endoscopy suite (2007-2016).

STUDY OBJECTIVE: Gastrointestinal endoscopy cases make up the largest portion of out of operating room malpractice claims involving anesthesiologists. To date, there has been no closed claims analysis specifically focusing on the claims from the endoscopy suite. We aim to identify associated case characteristics and contributing factors. DESIGN: Retrospective review of closed claims. SETTING: Multi-institutional setting of hospitals that submit data to the Controlled Risk Insurance Company (CRICO) Comparative Benchmarking System, a database representing approximately 30% of annual malpractice cases in the United States. PATIENTS: A total of 58 claims in the gastrointestinal endoscopy suite between January 1, 2007 and December 31, 2016. INTERVENTIONS: Gastrointestinal endoscopy procedures. MEASUREMENTS: We analyzed associated factors for each case as well as payments, and severity scores. MAIN RESULTS: There was a difference in the percent of cases that resulted in payment by procedure type, with 91% of endoscopic retrograde cholangiopancreatography (ERCP) cases resulting in payment compared with 37.5% of colonoscopy cases, 25% of combined esophagogastroduodenoscopy (EGD)/colonoscopy cases, 21.4% of EGD cases and 0.0% of endoscopic ultrasound cases (P = 0.0008). Oversedation was a possible contributing factor in 62.5% of cases. The mean payment for all claims involving anesthesiologists in the endoscopy suite was $99,754. CONCLUSIONS: There are differences in the rates of payment of malpractice claims between procedures. ERCPs made up a disproportionate percentage of the total amount paid to patients. While a significant percent of cases involved possible oversedation, these errors were compounded by other factors, such as failure to resuscitate or recognize the acute clinical change. With medically complex patients undergoing endoscopic procedures, it is critical to have well prepared anesthesia providers.

Development of indicators for a nationwide cross-sectoral quality assurance procedure for mental health care of patients with schizophrenia, schizotypal and delusional disorders in Germany.

PURPOSE: This paper describes the development of quality indicators for an external statutory and cross-sectoral quality assurance (QA) procedure in the context of the German health care system for adult patients suffering from schizophrenia, schizotypal and delusional disorders (F20-F29). METHODS: Indicators were developed by a modified RAND/UCLA Appropriateness Method with 1) the compilation of an indicator register based on a systematic literature search and analyses of health care claims data, 2) the selection of indicators by an expert panel that rated them for relevance and for feasibility regarding implementation. Indicators rated positive for both relevance and feasibility formed the final indicator set. RESULTS: 847 indicators were identified by different searches. Out of these, 56 were selected for the indicator register. During the formal consensus process the expert panel recommended another 45 indicators so that a total of 101 indicators needed to be considered by the panel. Of these, 27 indicators rated both relevant and feasible were included in the final set of indicators: this set included 4 indicators addressing structures, 19 indicators addressing processes and 4 indicators addressing outcomes. 17 indicators of the set will be reported by hospitals and 8 by psychiatric outpatient facilities. Two indicators considered to be cross-sectoral will be reported by both sectors. DISCUSSION: F20-F29 and its treatment show some specific features which so far have not been addressed by any procedure within the statutory QA program of the German health care system. These features include: Schizophrenia and related disorders a) are potentially chronic conditions, b) are mainly treated in outpatient settings, c) require a multi-professional treatment approach and d) are treated regionally in catchment areas. These specific features in combination with the peculiarities of some legal, political and organizational characteristics of the German health care system and its statutory QA program have strongly influenced the development of indicators. The result was a seemingly "imbalanced" set of indicators with a greater number of indicators for inpatient than for outpatient care despite the fact that clinical reality is otherwise. CONCLUSIONS: The circumstances of the German health care system that restricted the development of this cross-sectoral QA procedure addressing care for F20-F29 are also most likely to emerge with the development of cross-sectoral QA procedures for other (potentially) chronic conditions that are mainly treated in the outpatient setting by multi-professional teams or by networks of different providers. In order to be able to develop a QA procedure that mirrors the reality of service provision for (potentially) chronic diseases such as F20-F29 we need to explore further current and new data sources, diminish sectoral borders, and implement health care responsibility on the level of catchment areas.

Improvements to Benchmarks and Related Requirements Governing Hearing Aid-Compatible Mobile Handsets. Final rule.

The Commission adopts this Report and Order to implement a historic consensus proposal for ensuring that people with hearing loss have full access to innovative handsets.

Características, notación y sintaxis para el diseño de indicadores claves de proceso (KPI) en sistemas de adecuación de la demanda de laboratorio: el ejemplo de las recomendaciones de no hacer de AEBM-ML / Characteristics, function and syntax for the design of key performance indicators (KPI) in laboratory adjustment of the demand systems: The example of the “not to do” recommendations of the AEBM-ML

La Medicina del Laboratorio constituye un área de conocimiento multidisciplinar en continuo cambio, siendo responsabilidad de las sociedades científicas el compendiar y difundir los últimos avances científicos, así como proporcionar herramientas para su interpretación. El establecimiento de protocolos, guías y recomendaciones constituye una actividad esencial, pero estas acciones deben ir acompañadas de la definición de indicadores claves de procesos. Los indicadores claves de procesos permiten evaluar y hacer un seguimiento del correcto cumplimiento de los objetivos propuestos, así como actuar a modo de herramienta de mejora a través de la intercomparación entre laboratorios (benchmarking). La reciente publicación realizada por la Asociación Española de Biopatología Médica-Medicina del Laboratorio Decisiones inteligentes desde el laboratorio: de elegir sabiamente a no hacer constituye, en este sentido, un buen ejemplo. Elaborada en el seno del proyecto «Compromiso por la Calidad de las Sociedades Científicas en España» promovido por el Ministerio de Sanidad, Servicios Sociales e Igualdad, propone un total de 19 recomendaciones avaladas por un panel constituido por 26 expertos. Cada una de estas recomendaciones se acompaña de un conjunto de indicadores de proceso para evaluar el cumplimento y eficiencia de su implementación. Considerando como punto de partida la metodología y sistema de notación empleados en la citada monografía para el diseño de indicadores claves de procesos, constituye una guía de diseño útil para la evaluación de cualquier proceso de adecuación y uso efectivo del laboratorio (AU)

Laboratory Medicine is an area of multidisciplinary knowledge in continuous change. The scientific societies have the responsibility for summarising and disseminating the latest scientific advances, as well as providing tools for their interpretation. The establishment of protocols, guidelines and recommendations is an essential activity of these societies, but these actions must be accompanied by the definition of key performance indicators. The key performance indicators enable the objectives to be correctly fulfilled. Moreover, these indicators are an improvement tool based on the intercomparison between laboratories (benchmarking). Thus, the recent publication by the Spanish Medical Biopathology Society-Laboratory Medicine (Asociación Española de Biopatología Médica-Medicina del Laboratorio) entitled "Intelligent decisions since laboratory: from choose wisely till not to do" (Decisiones inteligentes desde el laboratorio: de elegir sabiamente a no hacer) is a good example. This publication, prepared within the framework of the "Commitment to Quality by the Spanish Scientific Societies" project, proposed by the Ministry of Health, makes 19 recommendations proposed by an expert panel of 26 laboratory professionals. Each recommendation includes several indicators to evaluate the compliance and effectiveness of their implementation. Taking the methodology and function used in the Spanish Medical Biopathology Association-Laboratory Medicine document for the design of key performance indicators as a basis, it becomes a useful guide for designing the evaluation of any adjustment process and its effective use in the laboratory (AU)

Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations--Revised Benchmark Rebasing Methodology, Facilitating Transition to Performance-Based Risk, and Administrative Finality of Financial Calculations. Final rule.

Under the Medicare Shared Savings Program (Shared Savings Program), providers of services and suppliers that participate in an Accountable Care Organization (ACO) continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. This final rule addresses changes to the Shared Savings Program, including: Modifications to the program's benchmarking methodology, when resetting (rebasing) the ACO's benchmark for a second or subsequent agreement period, to encourage ACOs' continued investment in care coordination and quality improvement; an alternative participation option to encourage ACOs to enter performance-based risk arrangements earlier in their participation under the program; and policies for reopening of payment determinations to make corrections after financial calculations have been performed and ACO shared savings and shared losses for a performance year have been determined.

Adapting Preclinical Benchmarks for First-in-Human Trials of Human Embryonic Stem Cell-Based Therapies.

UNLABELLED: : As research on human embryonic stem cell (hESC)-based therapies is moving from the laboratory to the clinic, there is an urgent need to assess when it can be ethically justified to make the step from preclinical studies to the first protocols involving human subjects. We examined existing regulatory frameworks stating preclinical requirements relevant to the move to first-in-human (FIH) trials and assessed how they may be applied in the context of hESC-based interventions to best protect research participants. Our findings show that some preclinical benchmarks require rethinking (i.e., identity, purity), while others need to be specified (i.e., potency, viability), owing to the distinctive dynamic heterogeneity of hESC-based products, which increases uncertainty and persistence of safety risks and allows for limited predictions of effects in vivo. Rethinking or adaptation of how to apply preclinical benchmarks in specific cases will be required repeatedly for different hESC-based products. This process would benefit from mutual learning if researchers included these components in the description of their methods in publications. SIGNIFICANCE: To design translational research with an eye to protecting human participants in early trials, researchers and regulators need to start their efforts at the preclinical stage. Existing regulatory frameworks for preclinical research, however, are not really adapted to this in the case of stem cell translational medicine. This article reviews existing regulatory frameworks for preclinical requirements and assesses how their underlying principles may best be applied in the context of human embryonic stem cell-based interventions for the therapy of Parkinson's disease. This research will help to address the question of when it is ethically justified to start first-in-human trials in stem cell translational medicine.

Benchmarking government action for obesity prevention--an innovative advocacy strategy.

BACKGROUND: Successful obesity prevention will require a leading role for governments, but internationally they have been slow to act. League tables of benchmark indicators of action can be a valuable advocacy and evaluation tool. OBJECTIVE: To develop a benchmarking tool for government action on obesity prevention, implement it across Australian jurisdictions and to publicly award the best and worst performers. DESIGN: A framework was developed which encompassed nine domains, reflecting best practice government action on obesity prevention: whole-of-government approaches; marketing restrictions; access to affordable, healthy food; school food and physical activity; food in public facilities; urban design and transport; leisure and local environments; health services, and; social marketing. A scoring system was used by non-government key informants to rate the performance of their government. National rankings were generated and the results were communicated to all Premiers/Chief Ministers, the media and the national obesity research and practice community. RESULTS: Evaluation of the initial tool in 2010 showed it to be feasible to implement and able to discriminate the better and worse performing governments. Evaluation of the rubric in 2011 confirmed this to be a robust and useful method. In relation to government action, the best performing governments were those with whole-of-government approaches, had extended common initiatives and demonstrated innovation and strong political will. CONCLUSION: This new benchmarking tool, the Obesity Action Award, has enabled identification of leading government action on obesity prevention and the key characteristics associated with their success. We recommend this tool for other multi-state/country comparisons.

Complying with state and federal regulations on essential drug benefits: implementing the Affordable Care Act.

OBJECTIVES: To examine health plan compliance with essential drug benefit regulations in California and Massachusetts and at the federal level. STUDY DESIGN: Health plan formulary review and analysis. METHODS: We analyzed formularies from the 3 largest small group plans in California and Massachusetts, including each state's benchmark plan. With respect to both federal and state regulations, for each health plan, we examined whether the drug was covered, the designated patient cost sharing tier of the drug, and which conditions of reimbursement were applied to the drug. RESULTS: Most drugs included in state and federal mandates are covered by both benchmark and non-benchmark plans. However, health plans are not fully compliant with state and federal regulations. Significant differences among plans relate more to cost sharing and conditions of reimbursement, such as prior authorization, step edits, and quantity limits, than to drug coverage. CONCLUSIONS/POLICY IMPLICATIONS: Because health plans in California and Massachusetts are not fully compliant with state and federal mandates, they will have to adjust their formularies to meet minimum requirements. State policy makers need to balance competing aims of comprehensiveness of coverage and drug affordability. They must consider: (1) choice of benchmark plan -choice of a more generous benchmark plan implies less leverage for negotiating lower prices; and (2) breadth of state mandates which, if they exceed federal mandates, must be paid for by the states.

[Quality of documentation of intraoperative and postoperative complications : improvement of documentation for a nationwide quality assurance program and comparison with routine data]. / Dokumentationsqualität intra- und postoperativer Komplikationen : Verbesserung der Dokumentation für die verpflichtende Qualitätssicherung und Vergleich mit DRG-Routinedaten.

INTRODUCTION: Complications after cholecystectomy are continuously documented in a nationwide database in Germany. Recent studies demonstrated a lack of reliability of these data. The aim of the study was to evaluate the impact of a control algorithm on documentation quality and the use of routine diagnosis coding as an additional validation instrument. METHODS: Completeness and correctness of the documentation of complications after cholecystectomy was compared over a time interval of 12 months before and after implementation of an algorithm for faster and more accurate documentation. Furthermore, the coding of all diagnoses was screened to identify intraoperative and postoperative complications. RESULTS AND DISCUSSION: The sensitivity of the documentation for complications improved from 46 % to 70 % (p = 0.05, specificity 98 % in both time intervals). A prolonged time interval of more than 6 weeks between patient discharge and documentation was associated with inferior data quality (incorrect documentation in 1.5 % versus 15 %, p < 0.05). The rate of case documentation within the 6 weeks after hospital discharge was clearly improved after implementation of the control algorithm. Sensitivity and specificity of screening for complications by evaluating routine diagnoses coding were 70 % and 85 %, respectively. The quality of documentation was improved by implementation of a simple memory algorithm.

[WINHO quality indicators for outpatient oncology care in Germany]. / WINHO-Qualitätsindikatoren für die ambulante onkologische Versorgung in Deutschland.

The aim of the WINHO indicators project is to describe and enhance the quality of outpatient oncology care in Germany with indicators. This paper deals with the development of a set of evidence- and consensus-based meaningful indicators to assess the quality of outpatient oncology care in Germany. These indicators are intended to be applied in assessments of quality of patient care in oncology practices, in quality reports and in peer-to-peer benchmarking. A set of 272 already existing indicators was identified through internet and literature searches. After redundancy reduction and addition of newly developed indicators for areas of ambulatory oncology care that were not yet covered, a preliminary set of 67 indicators was established. The further development of the indicator set was based on a modified version of the two-step RAND/UCLA expert evaluation method, which has been internationally established for developing quality indicator sets. The indicators were modified after the first round of ratings. After completing and assessing the second round of ratings, a set of 46 homogeneously positively rated quality indicators is now available for outpatient oncology care in Germany.

Beyond public health emergency legal preparedness: rethinking best practices.

The concept of public health legal preparedness grew out of the public health emergency preparedness movement, but was conceptualized more broadly to be utilized to achieve full public health legal preparedness for all types of public health threats. This article analyzes the need to refocus public health legal preparedness to include all areas of public health law and presents a new model for the fourth core element that will aid in the development of legal benchmarks so public health systems can more effectively work towards attaining public health legal preparedness in all areas of public health practice.

Implementing the Affordable Care Act: choosing an essential health benefits benchmark plan.

To improve the adequacy of private health insurance, the Affordable Care Act requires insurers to cover a minimum set of medical benefits, known as "essential health benefits." In implementing this requirement, states were asked to select a "benchmark plan" to serve as a reference point. This issue brief examines state action to select an essential health benefits benchmark plan and finds that 24 states and the District of Columbia selected a plan. All but five states will have a small-group plan as their benchmark. Each state, whether or not it made a benchmark selection, will have a set of essential health benefits that reflects local, employer-based health insurance coverage currently sold in the state. States adopted a variety of approaches to selecting a benchmark, including intergov­ernmental collaboration, stakeholder engagement, and research on benchmark options.