Ethics of Implementing US Preventive Services Task Force Recommendations for Childhood Obesity.

Childhood obesity represents a serious and growing concern for the United States. Its negative consequences for health and well-being can be far-reaching, devastating, and intergenerational. In 2017, the US Preventive Services Task Force (USPSTF) issued a grade B recommendation for screening children and adolescents for obesity and offering or referring to comprehensive, intensive behavioral interventions as indicated. However, many communities in the United States have limited access to such interventions. The USPSTF's mission is to review and grade research evidence for clinical preventive services and does not include cost or population-based operationalization and implementation logistics considerations for its recommendations. Yet implementing recommendations without considering cost and operationalization may lead to equity and access challenges. These are essential considerations, but oversight of the implementation of these recommendations is not standardized or assigned to any one agency or organization. As such, a central ethical feature inherent to the implementation of USPSTF recommendations calls for stakeholder collaborations to take on the next step beyond the establishment of evidence-based recommendations: to ensure the ethical application of such guidelines across diverse populations. Furthermore, the screening-intervention relationship inherent to this USPSTF recommendation raises ethical concerns regarding US societal norms surrounding obesity, particularly when contrasted against other screening-intervention modalities. More efforts, such as increased incentives or expansion of clinical services in low-resource areas, should be taken to facilitate this recommended intervention by expanding access to childhood obesity interventions to fulfill ethical responsibilities to equity and to ensure the right to open futures for children.

Medicalización de la vida y daño poblacional: revisión bibliográfica no sistematizada / Medicalization of life and population damage: non-systematic bibliographic review

La práctica de la medicina se encuentra atravesando una crisis, en la cual muchas de las prácticas médicas que se realizan son de poco valor y con frecuencia generan daño a las personas. Se presenta una revisión bibliográfica no sistematizada en la que se analizan en conjunto los diversos factores que contribuyen al desarrollo de excesos médicos y a los daños que estos generan. Consideramos que su conocimiento puede contribuir a mejorar la calidad de los cuidados que se ofrecen a nuestros pacientes. (AU)

The practice of medicine is going through a crisis, in which many of the medical practices that are carried out are of little value and often cause harm to people. An unsystematic bibliographic review is presented in which various factors that contribute to the development of medical excesses are analyzed. Their knowledge can contribute to improving the quality of medical care offered to our patients. (AU)

Navigating Ethical Practices in the Era of High Cost Hematology.

PURPOSE OF REVIEW: In this review article, we will highlight ethical issues faced by hematologists due to a growing constellation of expensive diagnostics and therapeutics in hematology. We outline the important issues surrounding this topic including stakeholders, cost considerations, and various ethical challenges surrounding access to care, communication about costs, and individual vs. societal responsibilities. We review available tools to navigate these ethical themes and offer potential solutions. RECENT FINDINGS: We identified several gaps in the literature on the topic of ethical issues in hematology treatment and supplement by non-hematological cancer and general medical literature. We propose proactive solutions to address these problems to include cost transparency, utilization of evidence-based decision making tools, application of the four quadrant approach to ethical care, and advanced systems-based practice curriculum for physician trainees.

The New 2019 Institutional Review Board Common Rule Update: Implications for Plastic Surgery Research.

Clinical research remains at the forefront of academic practice and evidence-based medicine. Unfortunately, history has shown that human subjects are vulnerable to experimentation without regard for their own dignity and informed decision-making. Subsequently, it is vital for research institutes to uphold safeguards and ethical conscientiousness toward human subjects. The establishment of federal regulations and the development of institutional review boards have set guidance on these processes. On January 21, 2019, final revisions to the Federal Policy for the Protection of Human Subjects (the "Common Rule") went into effect. The purpose of this article is to review changes to the Common Rule and discuss their impact on plastic surgery research.

Stem cells in aesthetic dermatology: bioethical and professional obligations.

Recently, stem cells in aesthetics have attracted increased attention, especially as they have become a popular trend that is being mass-marketed to consumers on the Internet and social media. Unfortunately, studies have shown this marketing to be misleading as it portrays many purported benefits of stem cells that have yet to be proven in the limited studies that are available. It is important for clinicians to understand the evidence and marketing behind any new trends, especially in the fast-paced world of aesthetics, where treatments often outpace current medical understanding. As clinicians, we have bioethical and professional obligations to educate ourselves on current trends, ensure adequate patient safety, and advocate for continued consumer education.

Formats of responsibility: elective surgery in the era of evidence-based medicine.

This article illustrates what pragmatic sociology refers to as investments in form, by examining the formats created and used by a group of surgeons to determine when elective surgery for pelvic floor disorders could be responsibly undertaken. Drawing upon ethnographic observations of surgical consultations at an academic medical centre in Canada, we show how two specific formats - that the patient is sufficiently bothered and the patient accepts the risks of surgery - allow for justifiable action in conditions of uncertainty and contingency and in light of the demands of dominant imperatives in medicine and health care, especially evidence-based medicine (EBM). We argue that an analytic of justification is necessary for understanding when and how surgery is offered and elected for, and for considering how surgical consultations might be improved.

Alternative facts and morcellation.

PURPOSE OF REVIEW: Since the recent black-box warning regarding the use of electromechanical morcellation, there has been a hesitancy to utilize the product and even to perform other types of morcellation by gynecologists. Unfortunately, this Food and Drug Administration action and the continued public criticisms of this procedure are grounded in poor data and faulty reasoning. To truly perform informed consent to patients considering procedures involving morcellation, a thorough review of the facts, not alternative facts, must be communicated. RECENT FINDINGS: Misrepresentation of the ethics surrounding this procedure, the role of informed consent and the risks and benefits as determined by evidence-based medicine have led to confusion and poor public policy. Today's evidence suggests that the procedure is indeed ethical when full disclosure of the risks and benefits is presented via informed consent. Risks of the procedure have been exaggerated significantly, and little attention has been paid to the risks of denying morcellation procedures to patients. Attempts to condemn gynecologists as acting contrary to established surgical principles do not coincide with facts. SUMMARY: Morcellation is a controversial technique which undoubtedly has a role as well as limitations. To appropriately determine if the procedure is indicated and acceptable to the patient, full disclosure of the best available evidence is necessary.

Análise bioética do uso de protocolos clínicos de oncologia em adolescentes / Bioethical analysis of the use of clinical oncologic protocols in adolescents

Os protocolos clínicos são recomendações normativas atreladas a várias abordagens terapêuticas que tomaram por bases os estudos que têm a medicina baseada em evidências para compor as suas estruturações. Nesse contexto, os protocolos clínicos em adultos são utilizados em várias especialidades médicas, notadamente na oncologia, com conflitos bioéticos descritos ao longo de sua história e aplicação. Apesar das limitações inerentes às suas bases de estruturação, os protocolos clínicos têm suas utilidades defendidas incorporadas à prática médica, como meios para justificar as ações trazendo-os até o campo da relação médico-paciente na tomada de decisão. O câncer infanto-juvenil é considerado raro, sendo necessário a reunião de centros nacionais e internacionais em prol da padronização de protocolos clínicos específicos. Há conflitos relacionados ao uso dos protocolos clínicos de primeira linha, atrelados a situações de vulnerabilidade causadas pelo contexto social de desigualdades que os adolescentes e seus pais vivem. Nesse cenário, o impacto do câncer restringe ainda mais o exercício da autonomia desses adolescentes, numa fase de desenvolvimento de suas capacidades para sua sobrevida no futuro. Esse estudo tem por objetivo a análise bioética na aplicação de protocolos clínicos de primeira escolha em adolescentes com tumores sólidos numa unidade hospitalar de oncologia pediátrica, tendo como referências nacionais e internacionais de livros, web sites e artigos científicos em revistas especializadas nos últimos cinco anos. O método utilizado foi qualitativo por meio de entrevistas semiestruturadas de oito oncologistas pediátricos, dezesseis pais e cinco adolescentes de idades entre 14 a 17 anos. Os resultados encontrados evidenciam conflitos na aplicação dos protocolos clínicos que limitam o exercício da autonomia de todos os participantes, e que nos adolescentes é agravado pelo impacto e tratamento da doença associados a desigualdade social que vivenciam e que compromete sua perspectiva de sobrevida com qualidade de vida e desenvolvimento do cuidado de si

Clinical protocols are normative recommendations tied to various therapeutic approaches that have taken the basis of studies that have evidence-based medicine to compose their structures. In this context, clinical protocols in adults are used in several medical specialties, notably in oncology with bioethical conflicts described throughout its history and application. Despite the inherent limitations of their structuring bases, the clinical protocols remain with their incorporated uses incorporated into medical practice, as means to justify the actions bringing them to the field of the doctor-patient relationship in the decision-making. Childhood and adolescent cancer is considered rare, and it is necessary to gather national and international centers for the standardization of specific clinical protocols. There are conflicts related to the use of first-line clinical protocols, linked to situations of vulnerability caused by the social context of inequalities that adolescents and their parents live. In this scenario, the impact of cancer further restricts the exercise of autonomy of these adolescents, in a phase of developing their capacities for their survival in the future. This study has as its objective the bioethical analysis in the application of clinical protocols of first choice in adolescents with solid tumors in the hospital unit of pediatric oncology, with national and international reference books, web sites and scientific articles in specialized journals in the last 5 years. The method used was qualitative semi-structured interviews of eight pediatric oncologists, sixteen parents and five adolescents from ages 14 to 17 years. The results highlight conflicts in the application of clinical protocols that limit the exercise of autonomy of all participants, and that in adolescents is compounded by the impact and treatment of the disease associated with social inequality experience and which compromises your prospect of survival with the quality of life and developing the care of themselves

From evidence-based to hope-based medicine? Ethical aspects on conditional market authorization of and early access to new cancer drugs.

There is a strong patient demand for early access to potentially beneficial cancer drugs. In line with this authorization agencies like the European Medicines Agency are providing drugs with conditional market authorisation based on positive interim analyses. This implies that drugs are used with insecure evidence of efficacy and adverse side-effects. Several authors have pointed to ethical problems with such a system but up to date no indepth ethical analysis of this system is found which is the aim of this article. Drawing of the four generally accepted principles of medical ethics: beneficence, nonmaleficence, respect for autonomy and justice the ethical pros and cons of conditional market authorisation are analysed. From the perspective of beneficence and non-maleficence it is found that the main problem is not risk of adverse side-effects to patients, but rather risk of less beneficial outcomes than what can be expected which could change incentives for patients' choice of treatment. This is also related to the extent to which patients might make an autonomous choice, especially taking into account problematic psychological attitudes and biases in medical decision-making. However, the main problem is related to justice and an equitable distribution of scarce health-care resources given the opportunity cost of drugs treatment. When using resources on cancer treatments which later might be found to be less efficacious than was first expected, other patients (in and outside the cancer field) are deprived of potentially more beneficial treatments even though their needs might be equally or more severe. At the same time, demanding more evidence has an ethical cost to patients in terms of depriving them of potential benefits in terms of reduced mortality and morbidity. In order to handle these ethical conflicts further research and analyses are required and it is suggested that pricing strategies and information requirements are alternatives to be further explored.

From protection to entitlement: selecting research subjects for early phase clinical trials involving breakthrough therapies.

Our goals are to (1) set forth and defend a multiprinciple system for selecting individuals who meet trial eligibility criteria to participate in early phase clinical trials testing chimeric antigen receptor (CAR T-cell) for acute lymphoblastic leukaemia when demand for participation exceeds spaces available in a trial; (2) show the relevance of these selection criteria to other breakthrough experimental therapies; (3) argue that distinct distributive justice criteria apply to breakthrough experimental therapies, standard research and healthcare and (4) argue that as evidence of benefit increases, the emphasis of justice in research shifts from protecting subjects from harm to ensuring fair access to benefits.

Asbestos: Socio-legal and Scientific Controversies and Unsound Science in the Context of the Worldwide Asbestos Tragedy - Lessons to be Learned.

Eight to fifteen per cent of lung cancer cases and nearly all mesothelioma cases are caused by asbestos. Problems in compensation issues ensue from strict legal requirements for eligibility and regulations of the statutory accident insurance institution pertaining to eligibility for occupational disease benefits. The latter include the unscientific requirement for set numbers of asbestos bodies or fibers to be found in lung tissue in order to "prove" disease causation if lung specimen are available. Although the validity of such evidence has been discredited by independent scientists, it is still used as evidence by an influential US pathology department. Frequently, epidemiological evidence regarding causal relationships and exposure histories is also often being ignored by insurance-affiliated medical experts.Similar misleading arguments are currently being used in newly industrialized countries where white asbestos - which is carcinogenic and fibrogenic like other asbestos types - is efficiently promoted as being less harmful. As a result, asbestos use is increasing in some of these countries. Behind the worldwide asbestos tragedy, a well-designed strategy orchestrated by certain transnational or multinational industrial interest groups can be perceived.Beyond the asbestos tragedy their covert plan is motivated by economic interests and discounts the ensuing damage to health and the impact of the diseases they create on public health systems.

Guidelines or gospels?

In the interest of advancing evidenced-based medicine, enthusiasm for clinical practice guidelines has skyrocketed. They have a genuine impact on clinical practice and are frequently referenced in the literature. Their construction is complex and labor intensive, and has significant limitations given the necessary process as well as the data available. There has been less focus on their appropriate clinical application as dictated by these inherent limitations. It is worthwhile taking a step back and considering how we know what we think we know based on statistical analysis of biomedical data sets and the real implications of those population data for making predictions about the individual patient we encounter in the clinic. These data as used to establish guidelines for care should be the foundation and starting point for our thoughtful recommendations and decision making, not the final word. The importance of nuance in clinical judgment remains even in this "evidence-based" world.

Survival after Perioperative Cardiopulmonary Resuscitation: Providing an Evidence Base for Ethical Management of Do-not-resuscitate Orders.

Automatic suspension of do-not-resuscitate (DNR) orders during general anesthesia does not sufficiently address a patient's right to self-determination and is a practice still observed among anesthesiologists today. To provide an evidence base for ethical management of DNR orders during anesthesia and surgery, the authors performed a systematic review of the literature to quantify the survival after perioperative cardiopulmonary resuscitation (CPR). Results show that the probability of surviving perioperative CPR ranged from 32.0 to 55.7% when measured within the first 24 h after arrest with a neurologically favorable outcome expectancy between 45.3 and 66.8% at follow-up, which suggests a viable survival of approximately 25%. Because CPR generally proves successful in less than 15% of out-of-hospital cardiac arrests, the altered outcome probabilities that the conditions in the operating room bring on warrant reevaluation of DNR orders during the perioperative period. By preoperatively communicating the evidence to patients, they can make better informed decisions while reducing the level of moral distress that anesthesiologists may experience when certain patients decide to retain their DNR orders.