An urgent call to raise the bar in oncology.

Important breakthroughs in medical treatments have improved outcomes for patients suffering from several types of cancer. However, many oncological treatments approved by regulatory agencies are of low value and do not contribute significantly to cancer mortality reduction, but lead to unrealistic patient expectations and push even affluent societies to unsustainable health care costs. Several factors that contribute to approvals of low-value oncology treatments are addressed, including issues with clinical trials, bias in reporting, regulatory agency shortcomings and drug pricing. With the COVID-19 pandemic enforcing the elimination of low-value interventions in all fields of medicine, efforts should urgently be made by all involved in cancer care to select only high-value and sustainable interventions. Transformation of medical education, improvement in clinical trial design, quality, conduct and reporting, strict adherence to scientific norms by regulatory agencies and use of value-based scales can all contribute to raising the bar for oncology drug approvals and influence drug pricing and availability.

Ethical challenges in nephrology: a call for action.

The American Society of Nephrology, the European Renal Association-European Dialysis and Transplant Association and the International Society of Nephrology Joint Working Group on Ethical Issues in Nephrology have identified ten broad areas of ethical concern as priority challenges that require collaborative action. Here, we describe these challenges - equity in access to kidney failure care, avoiding futile dialysis, reducing dialysis costs, shared decision-making in kidney failure care, living donor risk evaluation and decision-making, priority setting in kidney disease prevention and care, the ethical implications of genetic kidney diseases, responsible advocacy for kidney health and management of conflicts of interest - with the aim of highlighting the need for ethical analysis of specific issues, as well as for the development of tools and training to support clinicians who treat patients with kidney disease in practising ethically and contributing to ethical policy-making.

Efectos de la afiliación al Seguro Social General en el Gasto de Bolsillo en Salud de los hogares. Ecuador 2014 / Effects of affiliation to General Social Security on household out-of-pocket health spending. Ecuador 2014

Introducción: La seguridad social se fundamenta en la entrega oportuna de servicios de salud, evitando la falta de protección y el empobrecimiento de las familias que se asocia de manera directa con excesivos gastos de bolsillo. Objetivo: Estimar el efecto que tiene la afiliación al Seguro Social General (SSG) en el Gasto de Bolsillo en Salud (GBS) en los hogares ecuatorianos para el año 2014. Metodología: El efecto se estimó mediante el análisis estadístico Propensity Score Matching y utilizando el programa Stata, sobre una muestra de 22,364 observaciones, de las cuales 7,509 son tratadas ­ hogares afiliados al SSG ­ y 14,855 son de control ­ hogares sin ningún tipo de afiliación ­, datos tomados de la encuesta de Condiciones de Vida realizada por el INEC para el año 2014. Como variable de resultado se utilizó a los gastos de bolsillo y como variable de tratamiento a los hogares en los que al menos, el jefe del hogar este afiliado al Seguro Social General. Resultados: Se encontró un efecto positivo entre la condición de afiliados al SSG y el GBS de los hogares, el afiliado tiene una propensión a realizar mayores gastos privados en salud que el no afiliado, incrementándose aún más si el jefe del hogar es de sexo masculino. Para los dos sexos, la similitud es únicamente en la covariable ingresos, sin embargo, cuando el jefe de hogar es de sexo femenino, las covariables significativas se incrementan. Conclusiones: Los afiliados al SSG muestran un incremento en los GBS lo que significaría una falta de protección financiera a pesar de los aportes mensuales realizados a la seguridad social.

Introduction: Social security is based on the timely delivery of health services, avoiding the lack of protection and impoverishment of families that is directly associated with excessive health expenditures. Objective: To estimate the effect that the General Social Security (SSG) affiliation has on Pocket Health Expenditure (GBS) in Ecuadorian households for the year 2014. Methodology: The effect was estimated using the Propensity Score Matching method and using the Stata program, on a sample of 22,364 observations, and only 7,509 are treated - SSG affiliated households - and 14,855 are control - households without any affiliation - data were taken from the Life Conditions survey conducted by the INEC for the year 2014. Health expenditures was used as result variable and households in which at least the head of the household is affiliated to General Social Security was used as treatment variable. Results: A positive effect was found between the condition of members of the SSG and the GBS of the households, the affiliate has a propensity to make higher private health expenses than the unaffiliated, increasing even more if the head of the household is male. For both sexes, the similarity is only in the income covariate, however, when the head of the household is female, the significant covariates increase. Conclusions: The members of the SSG show an increase in the GBS which would mean a lack of financial protection despite the monthly contributions made to social security.

Healthcare Rationing Cutoffs and Sorites Indeterminacy.

Rationing is an unavoidable mechanism for reining in healthcare costs. It entails establishing cutoff points that distinguish between what is and is not offered or available to patients. When the resource to be distributed is defined by vague and indeterminate terms such as "beneficial," "effective," or even "futile," the ability to draw meaningful boundary lines that are both ethically and medically sound is problematic. In this article, I draw a parallel between the challenges posed by this problem and the ancient Greek philosophical conundrum known as the "sorites paradox." I argue, like the paradox, that the dilemma is unsolvable by conventional means of logical analysis. However, I propose another approach that may offer a practical solution that could be applicable to real-life situations in which cutoffs must be decided (such as rationing).

Ethics of the Physician's Role in Health-Care Cost Control: AOA Critical Issues.

The United States health-care expenditure is rising precipitously. The Congressional Budget Office has estimated that, in 2025, at our current rate of increased spending, 25% of the gross domestic product will be allocated to health care. Our per-capita spending on health care also far exceeds that of any other industrialized country. Health-care costs must be addressed if our country is to remain competitive in the global marketplace and to maintain its financial solvency. If unchecked, the uncontrolled rise in health-care expenditures will not only affect our capacity to provide our patients with high-quality care but also threaten the ability of our nation to compete economically on the global stage. This is not hyperbole but fiscal reality.As physicians, we are becoming increasingly familiar with the economics impacting health-care policy. Thus, we are in a unique position to control the cost of health care. This includes an increased reliance on creating and adhering to evidence-based guidelines. We can do this and still continue to respect the primacy of patient welfare and the right of patients to act in their own self-interest. However, as evidenced by the use of high-volume centers of excellence, each strategy adapted to control costs must be vetted and must be monitored for its unintended ethical consequences.The solution to this complex problem must involve the input of all of the health-care stakeholders, including the patients, payers, and providers. Physicians ought to play a role in designing and executing a remedy. After all, we are the ones who best understand medicine and whose moral obligation is to the welfare of our patients.

Gestión de las peticiones de NT-proBNP y procalcitonina mediante reglas computarizadas basadas en criterios clínicos / NT-proBNP and procalcitonin request management using computerized rules based on clinical criteria

Introducción: El péptido natriurético cerebral y su fragmento aminoterminal (NT-proBNP) se secretan en respuesta al incremento de la presión arterial y sobrecarga de volumen. Presenta un elevado valor predictivo negativo para el diagnostico de la insuficiencia cardiaca, correlacionándose con su grado de severidad. La procalcitonina es un biomarcador que aumenta su concentración en el plasma de pacientes sépticos, y permite diferenciar infecciones bacterianas frente a otras etiologías, siendo su concentración proporcional a la gravedad de la sepsis. Ambos biomarcadores presentan un elevado precio, que no hace aconsejable su uso indiscriminado. En el presente trabajo hemos propuesto un protocolo de petición para los 2 biomarcadores, basado en los criterios clínicos, con el fin de filtrar adecuadamente las peticiones a través del sistema informático del laboratorio (SIL). Método: Se diseñaron volantes de petición basados en la guía de la insuficiencia cardiaca de la European Society of Cardiology, para el NT-proBNP y en la guía de la Society of Critical Care Medicine para procalcitonina, puntuándose cada uno de los ítems considerados. Mediante reglas informáticas se excluyeron las peticiones cuya puntuación fuese inferior a un determinado valor. Para ambos biomarcadores se excluyeron aquellas peticiones que no procedían de los servicios clínicos implicados. Resultados: Se solicitaron un total de 140 peticiones para el NT-proBNP y 339 para la procalcitonina. Para la procalcitonina se excluyeron 32 peticiones (4,42%) y para el NT-proBNP 4 peticiones (9,43%). Conclusiones: El diseño de una petición específica para NT-proBNP y procalcitonina es una herramienta eficaz para controlar el gasto (AU)

Background: Type B natriuretic peptide and its N-terminal fragment (NT-proBNP) are secreted in response to an increase in blood pressure and volume overload. NT-proBNP shows a high negative predictive value for heart failure and correlates with the level of severity. Procalcitonin is a biomarker over-expressed in septic patients, which enables bacterial infections to be distinguished from other etiologies, as its concentration is proportional to sepsis severity. Both biomarkers are expensive, thus its indiscriminate use is not advisable. A request protocol based on clinical criteria is presented for both biomarkers, in order to filter the requests using the laboratory informatics system (LIS). Methods: The request forms were designed following the heart failure guidelines of European Society of Cardiology for NT-proBNP, and the guidelines of Society of Critical Care Medicine for procalcitonin, giving a score for each item. Using computerized rules, requests with a score lower than a specific cut-off value were excluded. In addition requests from clinical departments not involved in critical patient care were rejected. Results: A total of 140 requests were received for NT-proBNP, with 339 for procalcitonin. Of these 32 (9.43%) were rejected for procalcitonin, and 4 (2.8%) for NT-proBNP. It can be concluded that the design of a specific request form for NT-proBNP and procalcitonin is an efficient tool for the cost management (AU)

[Healthcare occupations are "different"]. / Gesundheitsberufe sind "anders"

Healthcare requires careful coordination of several occupations. In order to attain the best possible result, including effectiveness and cost-efficiency, the specific expertise of each of these occupations must be clearly defined. Healthcare occupations, physicians and nurses, are indeed professions as opposed to mere "jobs". They are concerned with living but ill human beings and not with things. Reliance on a personal capacity of judgment is a decisive aspect of professions. Healthcare professionals perform best if they are granted specific independence relative to their work.

[Today's jobs in the healthcare sector are comparable to other professions]. / Gesundheitsberufe sind heute Berufe wie andere auch.

By applying current standards of job descriptions and performance profiles in the healthcare sector, this article focuses on the issue whether there are fundamental differences between physicians and other healthcare professionals compared to other professions. There are special requirements for physicians, such as a university degree, but the same also holds true for other professions. The increasing economization of the healthcare sector in recent years has led to a situation where differences in the standards for healthcare professionals when compared to other occupations are no longer apparent. Medical directors at university hospitals also have to conform to standards that are applied to executive managers in other businesses. Besides the obvious professional skills, communication with patients and collaborators, knowledge of economics and leadership competence are also mandatory. This does not exclude the impression that physicians and nurses subjectively see in their profession more than just a job but truly a vocation.

[Surgery and the zeitgeist: what happened to ethics and moral?]. / Chirurgie und Zeitgeist: Wo bleiben Ethik und Moral?

Ethical and moral topics have always been an integral part of surgery. The rapid progress of highly advanced medicine has induced public discussions about medico-ethical problems as well as respective legislation. Interdisciplinary ethical committees, appointed by political as well as professional associations, have published guidelines concerning current ethical topics. However, what about the doctor's attitude and the influence of the ever changing "Zeitgeist"? With the surplus of unproven health information on the web, modern information technologies have changed the doctor-patient relationship. Active leadership of the doctor is still required. For the benefit of the patient the physician should confront increasing economic pressures and the requirements of higher performance levels with competence. Indications have to be based on the results of valid quality controls. Special moral standards should be applied for working within the surgical community and for the pursuit of a career in academic surgery. By strengthening mutual respect and the community spirit surgery will remain attractive for aspiring young doctors.

The moral psychology of rationing among physicians: the role of harm and fairness intuitions in physician objections to cost-effectiveness and cost-containment.

INTRODUCTION: Physicians vary in their moral judgments about health care costs. Social intuitionism posits that moral judgments arise from gut instincts, called "moral foundations." The objective of this study was to determine if "harm" and "fairness" intuitions can explain physicians' judgments about cost-containment in U.S. health care and using cost-effectiveness data in practice, as well as the relative importance of those intuitions compared to "purity", "authority" and "ingroup" in cost-related judgments. METHODS: We mailed an 8-page survey to a random sample of 2000 practicing U.S. physicians. The survey included the MFQ30 and items assessing agreement/disagreement with cost-containment and degree of objection to using cost-effectiveness data to guide care. We used t-tests for pairwise subscale mean comparisons and logistic regression to assess associations with agreement with cost-containment and objection to using cost-effectiveness analysis to guide care. RESULTS: 1032 of 1895 physicians (54%) responded. Most (67%) supported cost-containment, while 54% expressed a strong or moderate objection to the use of cost-effectiveness data in clinical decisions. Physicians who strongly objected to the use of cost-effectiveness data had similar scores in all five of the foundations (all p-values > 0.05). Agreement with cost-containment was associated with higher mean "harm" (3.6) and "fairness" (3.5) intuitions compared to "in-group" (2.8), "authority" (3.0), and "purity" (2.4) (p < 0.05). In multivariate models adjusted for age, sex, region, and specialty, both "harm" and "fairness" were significantly associated with judgments about cost-containment (OR = 1.2 [1.0-1.5]; OR = 1.7 [1.4-2.1], respectively) but were not associated with degree of objection to cost-effectiveness (OR = 1.2 [1.0-1.4]; OR = 0.9 [0.7-1.0]). CONCLUSIONS: Moral intuitions shed light on variation in physician judgments about cost issues in health care.

[Shared governance and reasonableness as ethical contributions to health policy]. / La gobernanza compartida y la razonabilidad como aportaciones éticas a la política sanitaria.

Health is one of the fundamental human rights. Recognizing it as a right means that the State has an obligation to ensure a minimum level of opportunities is maintained, and to restore it when lost. This minimum level may not be covered in periods of economic crisis, such as the one we are currently experiencing.Managed care, focused on economic questions, emerged after the crisis of 1973 in order to help make clinical decisions based on economic factors. In practice, the result of managed care was to turn economic cost control into an end in itself while forgetting about equity; something for which it has been challenged from an ethical perspective. Since then, many authors have attempted to reconcile efficiency and equity in health management, but the debate remains open.In this article, and basing our approach on the theories of P. Ruger and Norman Daniels, we argue that shared health governance and accountability for reasonableness can offer significant ethical contributions in the process of achieving an efficient and fair health system. In the model we propose, citizens, professionals and health institutions all play an active role in capacity building in the field of health. These capacities are related to healthy lifestyles, accessible and transparent information, the promotion of self-care, the acquisition of knowledge, skills and appropriate attitudes, leadership based on values and co-responsibility to achieve set goals in a reasonable way. If we develop these capacities, we will have used the current economic crisis as an opportunity for improving ethical practice in the field of health.

Justice and fairness: a critical element in U.S. health system reform.

The case for U.S. health system reform aimed at achieving wider insurance coverage in the population and disciplining the growth of costs is fundamentally a moral case, grounded in two principles: (1) a principle of social justice, the Just Sharing of the costs of illness, and (2) a related principle of fairness, the Prevention of Free-Riding. These principles generate an argument for universal access to basic care when applied to two existing facts: the phenomenon of "market failure" in health insurance and, in the U.S., the existing legal guarantee of access to emergency care. The principles are widely shared in U.S. moral culture by conservatives and liberals alike. Similarly, across the political spectrum, the fact of market failure is not contested (though it is sometimes ignored), and the guarantee of access to emergency care is rarely challenged. The conclusion generated by the principles is not only that insurance for a basic minimum of care should be mandatory but that the scope of that care should be lean, efficient, and constrained in its cost.

Different labs.

In this case a young dentist has signed onto a managed care plan that has several attractive features. Eventually, however, he notices that he makes little or no net revenue for some of the work that he does. A colleague recommends that he use different labs for different patients, with labs matched to each patient's dental plan and coverage. Offshore labs are used for managed care patients. Three knowledgeable experts comment on the case, two with many years of private practice experience, two who are dental educators holding master's degrees in philosophy and bioethics.

Rationing just medical care.

U.S. politicians and policymakers have been preoccupied with how to pay for health care. Hardly any thought has been given to what should be paid for--as though health care is a commodity that needs no examination--or what health outcomes should receive priority in a just society, i.e., rationing. I present a rationing proposal, consistent with U.S. culture and traditions, that deals not with "health care," the terminology used in the current debate, but with the more modest and limited topic of medical care. Integral to this rationing proposal--which allows scope to individual choice and at the same time recognizes the interdependence of the individual and society--is a definition of a "decent minimum," the basic package of medical treatments everyone should have access to in a just society. I apply it to a specific example, diabetes mellitus, and track it through a person's life span.