El documento de voluntades anticipadas. Comparativa de la legislación actual en el marco de la Unión Europea / Advance Directives. Comparison of current legislation within the European Union

La Ley 41/2002, de 14 de noviembre, básica reguladora de la autonomía del paciente da valor legal vinculante a las voluntades anticipadas (VA) en España. Sin embargo, la situación en cada país de la Unión Europea es distinta y desconocida para la mayoría del personal sanitario. Para conocer esas diferencias, se realizó una recogida y estudio de las distintas legislaciones en materia de derechos del paciente, y se estableció una comparativa actualizada de las características que cada país otorga a las VA. De los 28 países de la Unión Europea, 15 han desarrollado legislación específica en materia de VA, y le otorgan carácter vinculante el 86% si se utiliza la formulación escrita. Siete países exigen formalización del documento de voluntades anticipadas (DVA) ante notario, testigos o ante representantes de la Administración. La figura del representante se contempla en 11 países. En 3 países existe un registro de VA, mientras que en el resto el DVA solo se incluye en la historia clínica. En 5 países se exige la revisión periódica del documento, que pierde validez pasado este periodo de vigencia. Todas las legislaciones prevén modificaciones y la revocación de las VA. El contenido de las VA suele referirse al rechazo de medidas de soporte y limitación de tratamiento, aunque las solicitudes de tratamiento específico se contemplan como orientativas. La legislación sobre VA en la Unión Europea es muy diversa, con múltiples connotaciones específicas en cada país. Sería deseable una legislación más homogénea, divulgada y aplicada, de acuerdo con la sociedad actual. (AU)

Advance Directives (AD) have been legally binding in Spain since the publication of Act 41/2002, of 14th November, which regulates patients’ rights to autonomy and obligations concerning clinical information and recording clinical information. However, the situation in each country of the European Union remains heterogeneous and unknown to most health care professionals. By collecting and studying the legislation on patients’ rights in European Union countries we have made an updated comparison of the different features of AD in each country.Only 15 of the 28 European Union Countries have developed specific rules on AD which makes them legally binding in 86% of cases if they are written. A formal Advance Directive signed before a notary, a civil officer or a witness, is required in only 7 countries. The designation of a patient's attorney for health matters is regulated in 11 of the countries. There is an AD Register in 3 countries, whereas in the other countries it is only included in the medical record. Regular revision of an advance directive document, to maintain its validity, is required in five countries. All legislations provide for amendments and the revocation of AD, as they forbid unlawful actions. Rejection of routine supportive measures and treatment limitation are the main content of AD, although specific treatment applications are viewed as guidance. There seem to be many differences between laws concerning AD among the European Union Countries. A more homogeneous legislation, publicized and applied within the wider social consensus, would be desirable. (AU)

Placebo in new Covid-19 vaccine trials: data quality prioritised over participants' rights.

The WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation makes recommendations on the use of placebo controlled trials in ongoing and future Covid-19 vaccine research. These recommendations unequivocally prioritise data quality over participants' rights and safety. Participants in trials of vaccines which have received emergency use listing or authorisation would be refused available vaccines. Placebo-controlled trials that would be impossible to conduct in rich countries would be permitted in poor countries. If these suggestions are implemented, the major beneficiary will be the vaccine industry.

Trials for second generation Covid-19 vaccines: Revisiting the debate over placebo use in developing country clinical trials.

This article compares the current debate over the use of placebos in developing country clinical trials of second generation Covid-19 vaccines with the debates over previous paradigmatic cases raising similar issues. Compared to the earlier zidovudine and Surfaxin trials, Covid-19 vaccine trials are likely to confer lower risk to placebo groups and to offer a greater number and variety of alternative study designs. However, turning to the developing world to conduct studies that would be unacceptable in developed countries, simply on the ground that Covid-19 vaccines are generally unavailable in developing countries, is not ethically justifiable. This is so whether the justification is rooted in total absence of vaccine in a given country or in developing country vaccine prioritisation practices, because at root both derive from economic, not scientific conditions. However, the advent of variants that may create genuine uncertainty as to comparator vaccine effectiveness could justify a placebo control, depending on vaccine characteristics, variant prevalence, the degree of variant resistance, and the acceptability of immune-bridging studies. These factors must be considered together in the necessary case-by-case assessment of the ethical justification for any proposed trial.

Unblinding in Randomized Controlled Trials: A Research Ethics Case.

A pregnant woman was enrolled in a double-blind randomized controlled trial (RCT) in which participants were randomized to a placebo or a drug being tested to prevent a hypertensive complication. After completing the trial, the research participant insisted on being told which drug she received to prepare for a future pregnancy. This case highlights an element of RCT procedure that has received minimal attention-whether to unblind study participants at the end of their participation. Given that unblinding is not standard practice for nonserious adverse events, what actions are justifiable for the investigators to take? To synthesize the information about this case, we used the CASES model, created by the National Center for Ethics in Health Care to analyze ethics cases. Ethical principles that guide research emphasize communication with participants and the importance of reducing harm within the constraints of the scientific goals. Participants may value knowing which drug they received for future health care decision-making. We review information about the benefits and harms of unblinding.

Do pré-natal ao parto: um estudo transversal sobre a influência do acompanhante nas boas práticas obstétricas no Sistema Único de Saúde em Santa Catarina, 2019 / Desde la atención prenatal hasta el parto: un estudio transversal sobre la influencia del acompañante en las buenas prácticas obstétricas el Sistema Único de Salud en Santa Catarina, Brasil, 2019 / From prenatal care to childbirth: a cross-sectional study on the influence of a companion on good obstetric practices in the Brazilian National Health System in Santa Catarina State, 2019

Objetivo: Analisar a associação da presença de acompanhante no pré-natal e parto com a qualidade da assistência recebida por usuárias do Sistema Único de Saúde (SUS). Métodos Estudo transversal com puérperas que realizaram pré-natal e parto pelo SUS em Santa Catarina, Brasil, em 2019, entrevistadas em até 48 horas após o parto. Estimaram-se as razões de prevalências mediante regressão de Poisson. Resultados Entrevistaram-se 3.580 puérperas. No pré-natal, a presença de acompanhante associou-se positivamente ao recebimento de orientações pelos profissionais da saúde (RP=1,27 - IC95% 1,08;1,50) e à construção do plano de parto (RP=1,51 - IC95% 1,15;1,97). No parto, a presença de acompanhante associou-se ao maior recebimento de analgesia (RP=2,89 - IC95% 1,40;5,97), manobra não farmacológica para alívio da dor (RP=1,96 - IC95% 1,44;2,65), escolha da posição para o parto (RP=1,63 - IC95% 1,24;2,16) e menor probabilidade de ser amarrada (RP=0,47 - IC95% 0,35;0,63). Conclusão A presença de acompanhante no pré-natal e parto mostrou-se associada à melhor qualidade da assistência.

Objetivo: Analizar la asociación entre presencia de acompañante durante atención prenatal y parto con la calidad de atención que reciben las usuarias del Sistema Único de Salud (SUS). Métodos Estudio transversal con puérperas que recibieron atención prenatal y parto por el SUS en Santa Catarina, Brasil, en 2019, entrevistadas hasta 48 horas posparto. Las razones de prevalencia se estimaron mediante la regresión de Poisson. Resultados Se entrevistaron 3,580 puérperas. En la atención prenatal, la presencia de acompañante se asoció positivamente a recibir orientación de los profesionales de salud (RP=1,27 - IC95% 1,08; 1,50) y la construcción del plan de parto (RP=1,51 - IC95% 1,15; 1,97). En el momento del parto, se asoció con mayor recepción de analgesia (RP=2,89 - IC95% 1,40;5,97), maniobras no-farmacológicas para alivio del dolor (RP=1,96 - IC95% 1,44;2,65), elección de la posición para el parto (RP=1,63 - IC95% 1,24;2,16) y menor probabilidad de estar atada (RP=0,47 - IC95% 0,35;0,63). Conclusión La presencia de acompañante en la atención prenatal y el parto se asoció con una mejor calidad de la atención.

Objective: To analyze association between presence of a companion during prenatal consultations and childbirth and quality of care received by puerperal women using the Brazilian National Health System (SUS). Methods This was a cross-sectional study with puerperal women who underwent prenatal care and delivery on the SUS in Santa Catarina State, Brazil, in 2019, and who were interviewed within 48 hours postpartum. Prevalence ratios were estimated using Poisson regression. Results 3,580 puerperal women were interviewed. In prenatal care, presence of a companion was positively associated with receiving guidance from health professionals (PR=1.27 - 95%CI 1.08;1.50) and building a birth plan (PR=1.51 - 95%CI 1.15;1.97). At delivery, presence of a companion was associated with greater receipt of analgesics (PR=2.89 - 95%CI 1.40;5.97), non-pharmacological pain relief management (PR=1.96 - 95%CI 1.44;2.65), choice of position for delivery (PR=1.63 - 95%CI 1.24;2.16) and less likelihood of being strapped down (PR=0.47 - 95%CI 0.35;0.63). Conclusion Presence of a companion during prenatal care and delivery was associated with better quality of care.

Déficits sociales en las normativas y documentos relativos a la autodeterminación clínica del paciente: una mirada desde el trabajo social sanitario / Social deficits in the regulations and documents relating to clinical self-determination of the patient: A look from the social health work

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Primary health care, the Declaration of Astana and COVID-19.

Four decades after the Declaration of Alma-Ata, its vision of health for all and strategy of primary health care are still an inspiration to many people. In this article we evaluate the current status of primary health care in the era of the Declaration of Astana, the sustainable development goals, universal health coverage and the coronavirus disease 2019 pandemic. We consider how best to guide greater application of the primary health care strategy, reflecting on tensions that remain between the political vision of primary health care and its implementation in countries. We also consider what is required to support countries to realize the aspirations of primary health care, arguing that national needs and action must dominate over global preoccupations. Changing contexts and realities need to be accommodated. A clear distinction is needed between primary health care as an inspirational vision and set of values for health development, and primary health care as policy and implementation space. To achieve this vision, political action is required. Stakeholders beyond the health sector will often need to lead, which is challenging because the concept of primary health care is poorly understood by other sectors. Efforts on primary health care as policy and implementation space might focus explicitly on primary care and the frontline of service delivery with clear links and support to complementary work on social determinants and building healthy societies. Such efforts can be partial but important implementation solutions to contribute to the much bigger political vision of primary health care.

Quarante ans après la Déclaration d'Alma-Ata, sa vision en matière de santé universelle et sa stratégie de soins de santé primaires demeurent une inspiration pour de nombreuses personnes. Dans cet article, nous évaluons l'état actuel des soins de santé primaires à l'ère de la Déclaration d'Astana, des objectifs de développement durable, de la couverture maladie universelle et de la pandémie de maladie à coronavirus 2019 (COVID-19). Nous tentons de déterminer quel est le meilleur moyen de favoriser une application plus vaste de la stratégie de soins de santé primaires, en tenant compte des tensions qui subsistent entre la vision politique des soins de santé primaires et leur mise en œuvre dans les différents pays. Nous identifions également les éléments qui aident les pays à concrétiser les aspirations liées aux soins de santé primaires, et affirmons que les besoins et actions à l'échelle nationale doivent primer sur les préoccupations internationales. L'évolution des contextes et des réalités doit être prise en considération. Il est impératif d'opérer une nette distinction entre les soins de santé primaires comme source d'inspiration et ensemble de valeurs guidant le développement sanitaire d'une part, et comme espace politique et de mise en œuvre de l'autre. Pour y parvenir, des actes politiques sont indispensables. Des intervenants n'appartenant pas au secteur de la santé devront souvent prendre l'initiative, ce qui représente un défi car le concept des soins de santé primaires suscite l'incompréhension dans les autres secteurs. Les efforts en matière d'espace politique et de mise en œuvre pourraient se concentrer explicitement sur les soins de santé primaires et la première ligne des prestations de service, avec des liens clairement établis et un soutien aux travaux complémentaires consacrés aux déterminants sociaux et à la création d'une société saine. De tels efforts peuvent offrir des solutions partielles mais essentielles à l'élaboration d'une vision politique bien plus large des soins de santé primaires.

Cuatro décadas después de la Declaración de Almá Atá, su visión de la salud para todos y su estrategia de atención primaria de salud siguen siendo una inspiración para muchas personas. En este artículo se evalúa el estado actual de la atención primaria de salud en la era de la Declaración de Astaná, los objetivos de desarrollo sostenible, la cobertura sanitaria universal y la pandemia de la enfermedad por coronavirus de 2019. Se analiza la mejor manera de orientar una mayor aplicación de la estrategia de atención primaria de salud al estudiar las tensiones que subsisten entre la visión política de la atención primaria de salud y su aplicación en los países. También se analiza lo que se requiere para ayudar a los países a materializar las aspiraciones de la atención primaria de salud al argumentar que las necesidades y las medidas nacionales deben prevalecer sobre las preocupaciones mundiales. Se deben tener en cuenta los contextos y las realidades cambiantes. Hay que establecer una clara diferencia entre la atención primaria de salud como visión inspiradora y conjunto de valores para el desarrollo de la salud, y la atención primaria de salud como entorno normativo y de aplicación. Por consiguiente, se requiere la adopción de medidas políticas para hacer realidad esta visión. Con frecuencia, las partes interesadas que no pertenecen al sector sanitario tendrán que tomar la iniciativa, lo que supone un reto porque el concepto de atención primaria de salud no se comprende bien en otros sectores. Los esfuerzos relacionados con la atención primaria como entorno normativo y de aplicación se podrían centrar de manera explícita en la atención primaria y en la prestación de servicios de primera línea a través de vínculos claros y el apoyo a la labor complementaria sobre los determinantes sociales y la construcción de sociedades sanas. Esos esfuerzos pueden ser soluciones parciales pero importantes de aplicación para contribuir a la visión política mucho más amplia de la atención primaria de salud.

An audit tool for relicensing inspection for private hospitals in eThekwini district, South Africa.

BACKGROUND: South Africa is moving towards National Health Insurance (NHI), which aims to provide access to universal health coverage for all South Africans. The NHI will only accredit and contract eligible health facilities that meet nationally approved quality standards in the public and private sector. Detailed tools for measuring compliance with the National Core Standards (NCS) and Batho Pele principles have been developed and implemented in the public sector. To date and since its implementation in the public sector, very little is known about the national audit tool and the method used to evaluate quality and patient safety standards in private hospitals in eThekwini district. OBJECTIVE: The aim of the study was to develop an audit tool for relicensing inspection of private hospitals in eThekwini district based on the clinical domains of the NCS and Batho Pele principles. METHODOLOGY: An exploratory sequential mixed method research design was used with a qualitative first phase involving 24 nurse managers through purposive sampling. This was followed by a quantitative phase in which a structured questionnaire was administered to 270 nurses who were randomly sampled for the study from 4 hospitals. RESULTS: The results revealed that the NCS and the Batho Pele principles are not fully implemented or evaluated in the selected hospitals in eThekwini district. CONCLUSION: These findings were significant and denoted the need for a standardised clinical audit tool for private hospitals in eThekwini district.

A Matter of Justice: "Fat" Is Not Necessarily a Bad Word.

This essay argues that the discrimination that fat patients face is an issue of health justice. Insofar as this is the case, bioethicists and health care providers should not only care about it but also work to dismantle the systematic, institutional, social, and individual factors that are contributing to it to ensure that fat patients receive high-quality health care, free of stigma and discrimination. The essay discusses a variety of ways in which fat patients are discriminated against and considers the false assumptions that fuel such discrimination. It concludes by considering the structural and social issues that contribute to fatness and pushes health care providers to abandon the assumption that being fat is an individual moral failing. Ultimately, the paper argues, "fat" is not necessarily a bad word, nor one that health care providers should avoid.

The therapeutic proportionality standard: a new content for the best interests standard / El estándar de proporcionalidad terapéutica: Un nuevo contenido para el mejor interes estándar

The standard of the patient's best interests is the main bioethical standard used in the decision-making process that involves incompetent patients (i.e. neonatology, pediatric patients and incompetent adults). This standard has been widely criticized as being self-destructive, individualistic, vague, unknown, dangerous and open to abuse. With the purpose of defending it, several reforms of this standard have been proposed, especially in the pediatric field. We propose a redefinition of the standard based on two concepts: 1) medical futility as a negative criterion, and 2) the principle of proportionality as a positive criterion. Our work includes a new relationship between concepts in classical moral theology (i.e. ordinary / extraordinary; proportionate / disproportionate) applied to the bioethics of life-sustaining treatments for incompetent patients

El estándar del mejor interés del paciente es el único estándar bioético utilizado en los procesos de decisión de tratamientos en enfermos no competentes (neonatología, pediatría y adultos no competentes). Este estándar ha sido ampliamente criticado por autodestructivo, individualista, vago, desconocido, peligroso y abierto a abusos. Para defender el estándar se han propuesto varias reformulaciones especialmente en el ámbito pediátrico. Nosotros proponemos una redefinición del estándar basada en dos conceptos: 1) el de futilidad médica como criterio negativo, y 2) el principio de proporcionalidad como criterio positivo. Nuestro trabajo incluye una nueva relación entre los conceptos de la teología moral clásica (ordinario / extraordinario; proporcionado / desproporcionado) aplicados a la bioética de los tratamientos de soporte vital en pacientes no competentes

Developing a Patient Charter for People Living With Conditions, Diseases, or Traumas Involving the Skin [Formula: see text].

BACKGROUND: Studies have shown disparities in the perception of skin disease burden between patients and physicians, with patients often feeling that the severity, emotional impact, and social repercussions of their skin condition are underestimated. Although physician's professional behavior is guided by documents such as the Hippocratic Oath, there are no patient-driven principles to guide healthcare interactions involving skin concerns. OBJECTIVE: To develop a concise and practical charter for patients based on their perceptions of unmet needs with the goals of helping patients express their needs and exercise their rights to accessing and utilizing the healthcare system for conditions, diseases, or traumas involving the skin. METHODS: An initial literature review examined healthcare delivery concerns of patients with skin conditions. Results were used to draft a charter that was reviewed by a Canadian patient focus group representing various skin condition advocacy groups. A revised charter was reviewed by Canadian dermatologists before being formally approved by the Canadian Skin Patient Alliance Board and endorsed by the Canadian Dermatology Association. RESULTS: The Patient Charter comprises 8 principles for providing and receiving professional services for the skin in the healthcare setting. CONCLUSIONS: This Patient Charter provides direct insights into patient priorities and will be used as an educational and advocacy tool in healthcare, occupational, and social settings. The intended goal is for the Patient Charter to empower patients and to educate health professions, government, industry, and society at large. Accordingly, the charter will be disseminated through print materials, informational videos, and social media campaigns.

Humanizing birth in Tanzania: a qualitative study on the (mis) treatment of women during childbirth from the perspective of mothers and fathers.

BACKGROUND: While there has been a trend for greater number of women to deliver at health facilities across Tanzania, mothers and their family members continue to face mistreatment with respectful maternity care during childbirth being violated. The objective of this study was to describe the experience of mothers and fathers in relation to (mis) treatment during childbirth in Tanzania. METHODS: Using a qualitative descriptive design, 12 semi-structured interviews and four focus group discussions were held with mothers and fathers who were attending a postnatal clinic in the Lake Zone region of Tanzania. Mothers' age ranged from 20 to 45 years whereas fathers' age ranged from 25 to 60 years. Data were analyzed using a priori coding based on Bohren's et al. typology of the mistreatment of women during childbirth. RESULTS: Mothers reported facing mistreatment and disrespectful maternity care through verbal abuse (harsh or rude language and judgmental or accusatory comments), failure to meet professional standards of care (refused pain relief, unconsented surgical operations, neglect, abandonment or long delays, and skilled attendant absent at time of delivery), poor rapport between women and providers (poor communication, lack of supportive care, denied husbands presence at birth, denied mobility, denied safe traditional practices, no respect for their preferred birth positions), and health system conditions and constraints (poor physical condition of facilities, supply constraints, bribery and extortion, unclear fee structures). Despite some poor care, some mothers also reported positive birthing experiences and respectful maternity care by having a skilled attendant assistance at delivery, having good communication from nurses, receiving supportive care from nurses and privacy during delivery. CONCLUSION: Despite the increasing number of deliveries occurring in the hospital, there continue to be challenges in providing respectful maternity care. Humanizing birth care in Tanzania continues to have a long way to go, however, there is evidence that changes are occurring as mothers notice and report positive changes in delivery care practices.

Innovative Practice, Clinical Research, and the Ethical Advancement of Medicine.

Innovative practice occurs when a clinician provides something new, untested, or nonstandard to a patient in the course of clinical care, rather than as part of a research study. Commentators have noted that patients engaged in innovative practice are at significant risk of suffering harm, exploitation, or autonomy violations. By creating a pathway for harmful or nonbeneficial interventions to spread within medical practice without being subjected to rigorous scientific evaluation, innovative practice poses similar risks to the wider community of patients and society as a whole. Given these concerns, how should we control and oversee innovative practice, and in particular, how should we coordinate innovative practice and clinical research? In this article, I argue that an ethical approach overseeing innovative practice must encourage the early transition to rigorous clinical research without delaying or deferring the development of beneficial innovations or violating the autonomy rights of clinicians and their patients.

Protecting privacy to protect mental health: the new ethical imperative.

Confidentiality is a central bioethical principle governing the provider-patient relationship. Dating back to Hippocrates, new laws have interpreted it for the age of precision medicine and electronic medical records. This is where the discussion of privacy and technology often ends in the scientific health literature when Internet-related technologies have made privacy a much more complex challenge with broad psychological and clinical implications. Beyond the recognised moral duty to protect patients' health information, clinicians should now advocate a basic right to privacy as a means to safeguard psychological health. The article reviews empirical research into the functions of privacy, the implications for psychological development and the resigned sentiment taking hold regarding the ability to control personal data. The article concludes with a call for legislative, educational and research steps to readjust the equilibrium between the individual and 'Big Data'.