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.

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.

Chemotherapy and Supportive Care Agents as Essential Medicines for Children With Cancer.

In resource-rich countries, 5-year survival rates for children with cancer approach 85%. This impressive statistic is largely the result of integrating research with clinical care. At the core of this endeavor are multiagent combination chemotherapy and supportive care agents (CASCA). Most CASCAs belong to the class of sterile injectable drugs, which make up the backbone of many proven and life-saving pediatric oncology regimens. There are few if any alternative agents available to treat most life-threatening childhood cancers. In the United States, shortages of CASCAs are now commonplace. The consequences of drug shortages are far reaching. Beyond the economic costs, these shortages directly affect patients' lives, and this is especially true for children with cancer. Drug shortages in general and shortages of CASCAs specifically result in increased medication errors, delayed administration of life-saving therapy, inferior outcomes, and patient deaths. One way to mitigate drug shortages is to adopt an essential medicines list and ensure that these medications remain in adequate supply at all times. We argue for creation of a CASCA-specific essential medicines list for childhood cancer and provide ethical and policy-based reasoning for this approach. We recognize that such a call has implications beyond pediatric cancer, in that children with other serious disease should have an equal claim to access to guaranteed evidence-based medicines. We provide these arguments as an example of what should be claimed for medical indications that are deemed essential to preserve life and function.

Encuesta a posgrados de pediatría sobre conocimiento y aplicación de los derechos de los niños y adolescentes en la práctica clínica / Survey of postgraduate pediatrics students on knowledge and application of children and adolescents rights in clinical practice / Pesquisa entre estudantes de pós-graduação em pediatria sobre conhecimento e aplicação dos direitos de crianças e adolescentes na prática clínica

La concepción de niñez y adolescencia es una construcción socio-histórica que ha evolucionado en el tiempo. En el paradigma actual se reconocen como sujetos de derecho. El cambio en el modelo de atención debe implicar prácticas basadas en este paradigma Objetivos: Describir el conocimiento de los médicos que cursan el posgrado de Pediatría sobre las normativas de derechos de los niños y adolescentes y conocer su percepción sobre la aplicación del enfoque de derechos en la práctica clínica. Metodología: encuesta anónima administrada por los investigadores o vía e-mail a estudiantes de posgrados de pediatría. Se exploran tres dimensiones: conocimiento de la existencia de normativas sobre derechos de niños y adolescentes y su utilización en la resolución de problemas en la práctica, y aplicación del enfoque de derechos en las prácticas clínicas de los encuestados y observada en otros integrantes del equipo de salud. Resultados: Se administraron 180 encuestas, respondieron 77 (43%). 97.4% refirieron conocer la existencia de alguna de las normativas, de estos 25.3% no las aplica en la resolución de problemas. La mayoría de los médicos refieran observar la vulneración de los derechos en su etapa de formación. Conclusiones: a pesar del conocimiento de existencia de normativas, existen dificultades para que las prácticas clínicas tengan un enfoque de derechos respetando a los niños, niñas y adolescentes como sujetos de derechos.

The conception of childhood and adolescence is a social and historical construction that has evolved over the time. In the current paradigm, they are recognized as subjects of rights. The change in the attention care model should imply practices based on this paradigm. Objectives: describe the knowledge of physicians enrolled in postgraduate pediatric courses on the rights of children and adolescents and know their perception on the application of the rights approach in clinical practice Methodology: anonymous survey administered by researchers or by email to postgraduate pediatrics students. Three categories are explored: knowledge of the existence of regulations on the rights of children and adolescents and their use in the resolution of problems in practice, application of the rights approach in the clinical practices of the respondents and observed in other members of the healthcare team. Results: 180 surveys were conducted, 77 responded (43%). Whereas 97.4% reported knowing the existence of some of the regulations, 25.3% do not apply them in the resolution of problems. Most physicians report that they observe the violation of rights in their training stages. Conclusions: despite knowledge of the existence of regulations, there are difficulties to effectively conduct a rights-based approach that respects children and adolescents as subjects of rights.

A concepção de infância e adolescência é uma construção sócio-histórica que evoluiu ao longo do tempo. No paradigma atual, crianças e adolescentes são reconhecidos como sujeitos de direitos. A mudança no modelo de cuidados deve implicar práticas baseadas nesse paradigma Objetivos: Descrever o conhecimento dos médicos matriculados no curso de pós-graduação pediátrica sobre os direitos das crianças e adolescentes e conhecer sua percepção da aplicação da abordagem de direitos humanos na prática clínica. Metodologia: Pesquisa anônima administrada por pesquisadores ou via e-mail aos estudantes do curso pós-graduação pediátrica. São exploradas três dimensões: conhecimento da existência de regulamentos sobre os direitos das crianças e adolescentes, seu uso na resolução de problemas na prática e aplicação da abordagem de direitos nas práticas clínicas dos entrevistados e dos outros membros da equipe de saúde. Resultados: foram realizadas 180 pesquisas, 77 responderam (43%). 97,4% relataram saber a existência de qualquer um dos regulamentos, destes 25,3% não os aplicam na resolução de problemas. A maioria dos médicos relata observar a violação dos direitos na fase de treinamento. Conclusões: Apesar do conhecimento da existência de regulamentos, há dificuldades para que as práticas clínicas tenham uma abordagem baseada em direitos respeitando crianças e adolescentes como sujeitos de direitos.

What is safety?: Miracles, benefit-risk assessments, and the "right to try".

Public discourse is full of quick solutions to health care problems like cancer and rare diseases. Among these is Right to Try legislation for experimental therapies. Right to Try legislation is based on the premise that all experimental agents in clinical trials are safe and guaranteed to produce miracles. Unfortunately, this notion is at odds with expert understanding, which indicates that the benefits and risks of drug products can only be understood together and evaluated incrementally and over time. The current manuscript examines why benefit to risk considerations, a lynchpin of the ethical conduct of clinical research since the Nuremberg Code, might be easily elided from public discourse. This paper considers guidelines for regulatory writing, which routinely separate discussions of effectiveness and safety, as a possible source for some confusion. The internationally-accepted ICH M4E (Common Technical Document) guideline published in 2016 now provides additional guidance for composing Benefits and Risks Conclusions, which weigh and consider effectiveness and safety together. Yet fundamental differences in understanding the "safety" of medicinal products continue to exist between experts in biomedicine, politicians, and healthcare activists. Examining differences in the understanding of "safety" between experts and non-experts also may help explain the source for flawed logic about the safety of investigational products in Right To Try narratives. No drug product is 100% safe. Continuing to weigh benefits and risks together is an important intellectual practice necessary to safeguard human health worldwide, and testing clinical safety is the only way to provide meaningful protections to patients. Science, not miracles, can ensure the protection of patients in clinical research as well as clinical practice. Weighing benefits and risks is an essential intellectual act that informs public health. Science, not miracles, can guide this work.

Consent and Assent in Pediatric Research: Whose Right Is It Anyway?

Although the right to health care is not written into the U.S. Constitution, moral and ethical tenets govern the delivery of optimal medical care universally and across the life continuum. Pertaining to children, in accordance with the Geneva Declaration of the Rights of the Child of 1924 and the United Nations Human Rights General Assembly adoption of the Rights of the Child in 1959, parents or guardians are responsible for the health and well-being of a child until age 18 years. Much consideration is needed regarding the anatomic, physiologic, emotional, and cognitive development of children when making decisions regarding their health care and, particularly, when enrolling them into research studies.
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Patient information in orthopedic and trauma surgery. Fundamental knowledge, legal aspects and practical recommendations.

Providing information to surgery patients is a form of health-care governed by clearly defined therapeutic and medicolegal rules, and in particular in France by the Act of March 4, 2002 and the Code of Good Practice. The patient's right to information is implemented in a face-to-face consultation, which should be fully codified, and in a specific clinical examination, followed by information regarding the affected organ, pathology, treatment options, possible surgery, and the preconditions, risks and results associated with the procedure. Information should be personalized and as complete as possible, communicating the state of knowledge as validated by scientific societies and medical institutions. State of the art technology (dedicated website, on-line information suites, etc.) is indispensable but needs to be mastered and to adhere to the guidelines of the Council of the National Order of Medicine. Information traceability, the retraction period and proof of content of the information are essential. A signed document delivered in an informative atmosphere optimizes the exercise. Patient information is an ethical and medicolegal obligation, but above all is the expression and demonstration of the health-care potential of the practitioner and our contribution to reducing the information gap, reinforcing the cement holding our society together.

NHS hospital complaints: are we still going round in circles?

In the second part of his two-part column John Tingle discusses the report published by the Patients Association on the state of the NHS Complaints system.

Estándares de Acreditación "derechos de pacientes": revisión y estado actual en Centros de Tratamiento en Drogadicción en Colombia / Accreditation standards concerning patients' rights: a review of the current state of affairs related to drug-addiction treatment centers in Colombia

Objetivos Caracterizar y referenciar estado actual del grupo estándares de acreditación "derechos de los pacientes" en muestra de instituciones de tratamiento en drogas de Colombia. Métodos Estudio de enfoque mixto, empírico de tipo descriptivo y hermenéutico; muestra piloto de 21 centros de tratamiento en drogas en las cuales se determina estado actual de los estándares de acreditación "derechos de los pacientes"; se evalúa posible relación o independencia de las variables categóricas mediante prueba exacta de Fisher con nivel de significancia de 0,05. En fase paralela se realiza revisión documental de referenciación. Resultados: Los Centros de tratamiento en drogas suministran información en mayor proporción a familiares (95 %) que a los pacientes (90 %) y menores de edad (81 %). Representan posibles barreras de acceso al tratamiento, ser portador o enfermo VIH (29 %), orientación sexual LGTB (14 %) y ser mujer (10 %); religión y raza no son condiciones para discriminación o barreras de atención. Existen estándares coincidentes en el grupo "derechos de los pacientes" en el sistema de acreditación Colombiano con The Joint Commission, pero esta última entidad acreditadora tiene desarrollos importantes en un manual específico aplicable a instituciones de tratamiento de adicción a drogas. Conclusiones Los centros evaluados en Colombia, muestran logros en el grupo de estándares para la acreditación derechos de los pacientes, pero estos estándares requieren revisión para su adaptación a los desarrollos internacionales y a la particularidad de la población adicta y de las instituciones de tratamiento.

Objective Characterizing and contrasting the current state of affairs concerning patients' rights-associated accreditation standards in a sample of drug-addiction treatment centers in Colombia. Methods This was mixed methodology research (i.e. descriptive and hermeneutic); a pilot sample of 21 drug-addiction treatment centers in Colombia was used for determining the current state of patients' rights accreditation standards. The possible relationship or independence between categorical variables was evaluated by using Fisher's exact test (0.05 significance level). A contrasting documentary review was made at the same time. Results Drug-addiction treatment centers provided more information for families (95 %) than patients (90 %) or minors (81 %). Possible barriers to gaining access for treatment were being HIV positive (29 %), being part of the LGTB population (14 %) and being female (10 %); religion and ethnicity were not seen as grounds for discrimination or treatment barriers. The patients' rights standards group coincided with Colombia´s accreditation system and Joint Commission standards; however, the latter accreditation entity has made significant progress regarding a specific manual for drug-addiction treatment centers. Conclusions The centers assessed in Colombia had made advances regarding accrediting patients' rights, but such standards require revision for being adapted to international developments and specific matters involved in treating addicts and the specific conditions for institutions dealing with such treatment.

Consentimiento informado / Informed consent

La presente contribución pone énfasis en la importancia del consentimiento informado en la práctica asistencial, sus fundamentos éticos y jurídicos, y al desarrollar la misma remarca aspectos bioéticos y médico-legales conjuntamente con las recientes normas legales que establecen obligaciones a los profesionales y derechos a los pacientes que no deben ignorarse.

In this review we emphasize the importance of the Informed Consent in clinical practice, its ethics and legal fundaments; explaining that we underline bioethic and medico-legal aspects together with the most recent legal regulations establishing obligations of the medical professionals and rights of the patient that can not be ignored.

[The trustworthy person: from the law to the real practice]. / La personne de confiance : de la loi à la réalité du terrain.

Since the 4th March 2002 law all hospital units should enable patients to designate a trustworthy person. The Institut Claudius Regaud Psycho-Social Oncology Unit has led an investigation into the understanding and the practical details use of this measure. The results demonstrate that the trustworthy person is well known. However its functions and responsibilities seem to be misunderstood. This raises the question of finding the most appropriate way of putting such a law into practice that would both suit and respect the patient's needs and wishes.

'Old' and 'new' institutions for persons with mental illness: treatment, punishment or preventive confinement?

Despite countless promises for a better life by national commissions, governments and the international community, there has evolved a vicious cycle of neglect, abandonment, indignity, cruel and inhuman treatment, and punishment of persons with mental illness. This shameful history of benign, and sometimes malignant, neglect of persons with mental illness is well understood, with the deep stigma and unredressed discrimination, the deplorable living conditions, and the physical and social barriers preventing their integration and full participation in society. The maltreatment of this vulnerable population has been reinforced by the hurtful stereotypes of incompetency and dangerousness. The belief that persons with mental illness are uniformly dangerous is an equally harmful myth. It provides policy makers with an ostensible justification to exercise control over persons with mental illness, even if they have not committed a violent offence. However, research demonstrates that the class of persons with most mental illnesses is no more dangerous than other populations, and that the vast majority of violence is committed by persons without mental illness. This article will show how this vulnerable population has been unconscionably treated. First, the gross violations of human rights that have occurred, and continue to occur, in 'old' psychiatric institutions will be examined. The deinstitutionalization movement, however, resulted in new places of confinement for this population, such as jails, prisons and homeless shelters. The second part of this paper will explore the new realities of criminal confinement of persons with mental illness. As we will see, incarceration of this vulnerable population in the criminal justice system has caused enormous suffering. If Dostoyevsky was correct that the 'degree of civilization... can be judged by entering its prisons', then by that measure, we are a deeply uncivilized society.