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.

Defining laboratory medicine, or squaring the circle?

In the August 2020 issue of Clinical Chemistry and Laboratory Medicine, Giuseppe Lippi and Mario Plebani proposed a definition of laboratory medicine, which ends with this sentence: "The results of these measurements are translated into actionable information for improving the care and/or maintaining the wellness of both a single individual and an entire population". Nevertheless, the selfishness of individuals may, sometimes, jeopardize the interest of whole populations. The virtue of justice being within the reach of the entire human community more than of single individuals, the final sentence in the definition proposed by Giuseppe Lippi and Mario Plebani, should therefore, in our view, be rewritten, less selfishly, for example like this: "For a given investment, these measurements are preferably made when they bring as much beneficence, and non-maleficence, as possible to the whole population".

Challenges in clinical trials for children and young people.

There is a well-known knowledge gap regarding the efficacy and safety of medicines in children of all ages and children are often treated with medicines off-label. Children are thus deprived of treatment based on the same quality of information that guides treatment in adults. The knowledge gap regarding efficacy and safety of medicines in children has been acknowledged by authorities and is reflected in legislation both in North America and in the European Union. Recent reports on the effects of legislation indicates that paediatric clinical trials remain a challenge.Paediatric clinical trials are needed in the entire developmental age spectrum and are especially needed in certain therapy areas. Paediatric clinical trials have special features compared with trials in adults, and these need to be taken into account. These special features include scientific issues related to small samples and heterogeneity, the consent/assent procedure, the need for age-appropriate study information, specific outcomes and safety issues related to development and maturation. Competence in paediatric clinical trials is required in both designing, planning, co-ordinating and organising paediatric clinical trials, as well as research infrastructure and networks to increase power and disseminate information and expert advice. Strengthening of paediatric clinical research is essential to facilitate generating the data that will let children enjoy new medical advances in a similar manner as adults.

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.

Large randomized controlled trials in infertility.

As the first paper in this series of Views and Reviews on randomized controlled trials (RCTs), we aim to provide the basics of RCTs in infertility research. In this paper, we discuss the need and ethical considerations of large trials in infertility research and important aspects to guarantee the quality of a trial, including protocols, registrations and monitoring, issues of study design and analysis, and reporting standards. Because most of the treatment effects we would like to study represent relatively small signal-to-noise ratios, large RCTs are required to provide sufficient power to answer these questions. Trial protocols, registrations, and monitoring facilitate the transparency of conduct, analysis, and reporting of the trial. Issues of trial design and analysis, such as nonblinding and misuse of the denominators, are common in published trials in this area and could be further improved. Finally, following the current reporting standard facilitates complete and transparent reporting, critical appraisal, and interpretation.

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.

Do à la carte menus serve infertility patients? The ethics and regulation of in vitro fertility add-ons.

Add-on treatments are the new black. They are provided (most frequently, sold) to patients undergoing in vitro fertilization on the premise that they will improve the chances of having a baby. However, the regulation of add-ons is consistently minimal, meaning that they are introduced into routine practice before they have been shown to improve the live birth rate. Debate on the adequacy of this light-touch approach rages. Defenders argue that demands for a rigorous approval process are paternalistic, as this would delay access to promising treatments. Critics respond that promising treatments may turn out to have adverse effects on patients and their offspring, contradicting the clinician's responsibility to do no harm. Some add-ons, including earlier versions of preimplantation genetic testing for aneuploidy, might even reduce the live birth rate, raising the prospect of desperate patients paying more to worsen their chances. Informed consent represents a solution in principle, but in practice there is a clear tension between impartial information and direct-to-consumer advertising. Because the effects of a treatment cannot be known until it has been robustly evaluated, we argue that strong evidence should be required before add-ons are introduced to the clinic. In the meantime, there is an imperative to identify methods for communicating the associated risks and uncertainties of add-ons to prospective patients.

How Moral Case Deliberation Supports Good Clinical Decision Making.

In clinical decision making, facts are presented and discussed, preferably in the context of both evidence-based medicine and patients' values. Because clinicians' values also have a role in determining the best courses of action, we argue that reflecting on both patients' and professionals' values fosters good clinical decision making, particularly in situations of moral uncertainty. Moral case deliberation, a form of clinical ethics support, can help elucidate stakeholders' values and how they influence interpretation of facts. This article demonstrates how this approach can help clarify values and contribute to good clinical decision making through a case example.