Significados atribuídos por mulheres com câncer de mama ao grupo de apoio / Meanings attributed by women with breast cancer to a support group / Significados atribuidos por las mujeres con cáncer de mama al grupo de apoyo

A sobrevivência ao câncer de mama é um problema de saúde pública que demanda serviços especializados com foco na reabilitação psicossocial. Entre as necessidades identificadas nesse contexto está o incentivo à adoção de estratégias de promoção de autocuidados pelas mulheres. Uma das estratégias adotadas consiste no grupo de apoio psicológico, que auxilia as pacientes a enfrentar a longa jornada do tratamento. Assim, o objetivo deste estudo é compreender os significados produzidos por mulheres com câncer de mama sobre sua participação em um grupo de apoio. Trata-se de um estudo qualitativo, descritivo e exploratório realizado com dez mulheres com câncer de mama usuárias de um serviço de reabilitação para mastectomizadas. Como referencial metodológico foi utilizada a Teoria Fundamentada nos Dados. A coleta de dados foi realizada por meio de entrevista aberta em profundidade e os conteúdos foram transcritos e codificados. A análise indutiva e o método de comparação constante foram aplicados nos processos de codificação aberta, axial e seletiva, que permitiram identificar três categorias nucleares: percepção das atividades realizadas no grupo, identificação de benefícios e barreiras do convívio no grupo e transformações decorrentes da participação. As participantes significaram sua presença no grupo como fonte de acolhimento, apoio, desenvolvimento de recursos pessoais e amizades, contribuindo para promover sua qualidade de sobrevida. Além dos potenciais benefícios, também foram identificadas barreiras que podem dificultar a adesão e continuidade da participação no grupo, o que sugere a necessidade de incorporar no cuidado um olhar para as dimensões subjetivas da saúde da mulher.(AU)

Surviving breast cancer is a public health problem and depends on services focused on psychosocial rehabilitation. Healthcare providers must encourage women to adopt strategies to promote their self-care. The psychological support group is a resource that helps women to face the long journey of treatment. This study aimed to understand the meanings women with breast cancer produced about their participation in a support group. This exploratory cross-sectional study was carried out with 10 women with breast cancer who use a rehabilitation service for mastectomized patients. Grounded Theory was used as a methodological reference. An open in-depth interview was applied for data collection. The contents were transcribed and coded. Inductive analysis and the constant comparison method were applied in the open, axial, and selective coding processes, which enabled the identification of three core categories: perception of the activities carried out in the group, identification of benefits and barriers of living in the group, and transformations resulting from participation. Participants denote their involvement with the group as a source of shelter, support, development of personal resources and friendships that helps promoting quality of life. Besides these potential benefits, participants also evinced barriers that can hinder adherence and continuity of participation in the group, suggesting the importance of incorporating a look at the subjective dimensions of women's health into care.(AU)

Sobrevivir al cáncer de mama es un problema de salud pública que depende de los servicios centrados en la rehabilitación psicosocial. Entre las necesidades identificadas en esta materia se encuentra el uso de estrategias para promover el autocuidado. Uno de los recursos que ayuda a afrontar el largo camino del tratamiento es el grupo de apoyo psicológico. El objetivo de este estudio es conocer los significados que producen las mujeres con cáncer de mama sobre su participación en un grupo de apoyo. Se trata de un estudio cualitativo, descriptivo y exploratorio, realizado con diez mujeres con cáncer de mama usuarias de un servicio de rehabilitación para mastectomizadas. Como referencia metodológica se utilizó la teoría fundamentada en los datos. Se aplicó una entrevista abierta en profundidad para la recogida de datos, cuyos contenidos fueron transcritos y codificados. El análisis inductivo y el método de comparación constante se aplicaron en los procesos de codificación abierta, axial y selectiva, lo que permitió identificar tres categorías centrales: percepción de las actividades realizadas en el grupo, identificación de los beneficios y las barreras de vivir en el grupo y transformaciones resultantes de la participación. Las mujeres denotan su participación en el grupo como una fuente de acogida, apoyo, desarrollo de recursos personales y amistades, que ayuda a promover la calidad de vida. Además de los beneficios potenciales, también se identificaron barreras que pueden dificultar la adherencia y continuidad de la participación en el grupo, lo que sugiere la necesidad de incorporar en la atención una mirada centrada en las dimensiones subjetivas de la salud de las mujeres.(AU)

Com Ciência e Com Respeito: episódio 14

Neste terceiro especial sobre a Cartilha dos Direitos dos Participantes de Pesquisa, vamos falar sobre o direito de decidir com tal liberdade, ou seja: com calma, sem constrangimentos e até mesmo sobre questões após a pesquisa.

Place de la tomodensitométrie dans la prise en charge des occlusions intestinales aigues à Dakar / Place of tomodensitometry in the management of acute intestinal occlusions in Dakar

ntroduction : L'occlusion intestinale aiguë (OIA) est un syndrome défini par l'arrêt du transit intestinal provoqué par un obstacle ou par une paralysie du péristaltisme intestinal. Il s'agit d'une urgence diagnostique et thérapeutique. Le scanner multibarrette a révolutionné la prise en charge de cette pathologie, car permettant de répondre aux différentes questions du chirurgien.Le but de notre étude était de décrire les aspects scanographiques des OIA, de déterminer les étiologies et de montrer la place de la TDM dans la prise en charge des OIA. Matériel et Méthode : Il s'agissait d'une étude rétrospective descriptive réalisée sur 05ans (Janvier 2010 à décembre 2015) portant sur 81 dossiers de patients colligés dans les services d'imagerie du CHU Aristide Le Dantec et de l'hôpital Principal. Les dossiers retenus sont ceux dont le diagnostic était établi à partir de la clinique, de l'imagerie et/ou non de la chirurgie. Résultats : Les occlusions mécaniques représentaient 94,4% (76 cas) et fonctionnelles 5.6% (05 cas). Elles étaient de type grêle dans 70% des cas et colique dans 30%. Les lésions élémentaires mises en évidence étaient : zone transitionnelle (36 patients), signe du fèces (28 patients), signe du bec (06 patients), signe du tourbillon (11 patients), signes de gravité (36 patients). Soixante-douze patients ont bénéficié d'une chirurgie et 04 patients d'un traitement médical. Le diagnostic préopératoire était confirmé par la chirurgie chez 68 patients. La chirurgie a redressé le diagnostic dans 04 cas. Les signes de gravité étaient confirmés à la chirurgie chez tous nos patients. Conclusion : La TDM occupe une place prépondérante dans le choix thérapeutique des OIA. Elle doit être demandée en première intention devant un syndrome occlusif

Introduction: Acute intestinal obstruction (AIO) is a syndrome defined by the cessation of intestinal transit caused by an obstacle or paralysis of intestinal peristalsis. It is a diagnostic and therapeutic emergency. The multi-bar CT scan has revolutionized the management of this pathology, as it allows the surgeon to answer different questions. The aim of our study was to describe the CT aspects of AIO, to determine the etiologies and to show the place of CT in the management of AIO. Material and Method: This was a retrospective descriptive study conducted over 5 years (January 2010 to December 2015) on 81 patient files collected in the imaging departments of the CHU Aristide Le Dantec and the Hôpital Principal. The files retained were those whose diagnosis was established from the clinic, imaging and/or not from surgery. Results: Mechanical occlusions represented 94.4% (76 cases) and functional occlusions 5.6% (05 cases). They were of the small bowel type in 70% of cases and colonic in 30%. The elementary lesions found were: transitional zone (36 patients), feces sign (28 patients), beak sign (06 patients), whirlpool sign (11 patients), signs of severity (36 patients). Seventytwo patients received surgery and 04 patients received medical treatment. The preoperative diagnosis was confirmed by surgery in 68 patients. Surgery corrected the diagnosis in 04 cases. Signs of severity were confirmed at surgery in all our patients. Conclusion: The CT scan has a major role in the therapeutic choice of AIO. It should be requested in first intention before an occlusive syndrome

El enfoque unificador disciplinar en el contexto de los cuidados paliativos / Approach to the unifying disciplinary approach in the context of palliative care / A abordagem disciplinar unificadora no contexto dos cuidados paliativos

Introducción: El cuidado paliativo se ha convertido en un desafío para los gobiernos por las repercusiones para pacientes, familias y sistemas de salud. La enfermería tiene un rol preponderante en ofrecer una práctica que dé respuesta a las necesidades de los pacientes en situación paliativa, es por este motivo que es necesario avanzar en el análisis de propuestas disciplinares, tal como la de Willis, Grace y Roy, quienes proponen un enfoque central unifi-cador para la disciplina de la enfermería. Metodología: Se realizó una revisión exploratoria a través de los siguientes descriptores: cuidado paliativo; enfoque unificador y disciplina de enfermería y sus dimensiones: humanización, significado, elección, calidad de vida y acom-pañamiento en el proceso de vivir y morir. Al respecto se utilizaron bases de datos, diccion-arios, libros de autores icónicos, y páginas de internet relacionadas con la salud en el periodo comprendido entre 2000 y 2020. Se privilegiaron como idiomas el español, el inglés y el por-tugués. Se analizaron 45 artículos. Resultados: Surgieron a partir de las categorías a priori, mencionadas anteriormente, las cuales hacen parte del enfoque unificador disciplinar y que a la vez permiten avanzar en la comprensión de cómo los cuidados paliativos se conciben como parte de ellas, lo que facilitó la reflexión y el avance en propuestas disciplinares desde un componente ontológico. Conclusión: La práctica de enfermería implica aspectos relaciona-dos con: la humanización, el significado, la elección, la calidad de vida y el acompañamiento en el proceso de vivir y morir. Estos aspectos se amplían desde una mirada epistemológica del cuidado, lo que facilita el avance en el entendimiento y en su aplicación. Es prioritario aplicar estos asuntos disciplinares en la práctica del cuidado paliativo, donde la interdisciplinariedad es una necesidad y una realidad

Introduction: Palliative care has become a challenge for governments due to the repercus-sions for patients, families and health systems. Nursing has a preponderant role in offering a practice that responds to the needs of patients in a palliative situation, it is for this reason that it is imperative to advance in the analysis of disciplinary proposals, including the one proposed by Willis, Grace and Roy, who propose a central unifying approach for the nursing discipline. Methodology: a thematic review was carried out through the descriptors: pallia-tive care, nursing discipline unifying approach, and its dimensions: humanization, meaning, choice, quality of life and accompaniment in the process of living and dying in databases dictionaries, books by iconic authors, and health-related internet pages from 2000 to 2020 in Spanish, English, and Portuguese, 45 articles were analyzed. Results: They were given from the a priori categories, mentioned above, which are part of the disciplinary unifying approach and at the same time allowed to advance in the understanding of how palliative care is conceived within them, managing to reflect and advance in disciplinary proposals from an ontological component. Conclusion: Nursing practice involves aspects of humanization, meaning, choice, quality of life and accompaniment in the process of living and dying. These aspects are expanded from an epistemological view of care, it will be possible to advance in the understanding and application of them. It is a necessity and a priority to apply these disciplinary issues in the practice of palliative care, where interdisciplinarity is a necessity and a reality

Introdução: Os cuidados paliativos se tornaram um desafio para os governos devido às re-percussões para os pacientes, famílias e sistemas de saúde. A enfermagem tem um papel pre-ponderante ao oferecer uma prática que responde às necessidades dos pacientes em situações paliativas, razão pela qual é necessário avançar na análise de propostas disciplinares, como a de Willis, Grace e Roy, que propõem uma abordagem unificadora central para a disciplina da enfermagem. Metodologia: foi realizada uma revisão exploratória utilizando os seguintes descritores: cuidados paliativos; abordagem unificadora e disciplina de enfermagem e suas dimensões: humanização, significado, escolha, qualidade de vida e acompanhamento no pro-cesso de vida e de morte. Foram utilizados bancos de dados, dicionários, livros de autores icônicos e páginas da Internet relacionadas à saúde no período entre 2000 e 2020. Os idiomas utilizados foram o espanhol, o inglês e o português. Quarenta e cinco artigos foram analisados. Resultados: estes emergiram das categorias a priori mencionadas acima, que fazem parte da abordagem disciplinar unificadora e ao mesmo tempo nos permitem avançar na compreensão de como os cuidados paliativos são concebidos como parte deles, o que facilitou a reflexão e o progresso nas propostas disciplinares a partir de um componente ontológico. Conclusão: a prática de enfermagem envolve aspectos relacionados a: humanização, significado, escolha, qualidade de vida e acompanhamento no processo de vida e de morte. Estes aspectos são expandidos a partir de uma visão epistemológica do cuidado, o que facilita o progresso na compreensão e aplicação. É uma prioridade aplicar estas questões disciplinares na prática dos cuidados paliativos, onde a interdisciplinaridade é uma necessidade e uma realidade

Did Access to Care Improve Since Passage of the Veterans Choice Act?: Differences Between Rural and Urban Veterans.

BACKGROUND: The 2014 Veterans Choice Program aimed to improve care access for Veterans through expanded availability of community care (CC). Increased access to CC could particularly benefit rural Veterans, who often face obstacles in obtaining medical care at the Veterans Health Administration (VHA). However, whether Veterans Choice Program improved timely access to care for this vulnerable population is understudied. OBJECTIVES: To examine wait times among rural and urban Veterans for 5 outpatient specialty care services representing the top requests for CC services among rural Veterans. RESEARCH DESIGN: Retrospective study using VHA and CC outpatient consult data from VHA's Corporate Data Warehouse in Fiscal Year (FY) 2015 (October 1, 2014 to September 30, 2015) and FY2018 (October 1, 2017 to September 30, 2018). SUBJECTS: All Veterans who received a new patient consult for physical therapy, cardiology, optometry, orthopedics, and/or dental services in VHA and/or CC. MEASURES: Wait time, care setting (VHA/CC), rural/urban status, sociodemographics, and comorbidities. RESULTS: Our sample included 1,112,876 Veterans. Between FY2015 and FY2018, mean wait times decreased for all services for both rural and urban Veterans; declines were greatest in VHA (eg, mean optometry wait times for rural Veterans in VHA vs. CC declined 8.3 vs. 6.4 d, respectively, P<0.0001). By FY2018, for both rural and urban Veterans, CC mean wait times for most services were longer than VHA wait times. CONCLUSIONS: Timely care access for all Veterans improved between FY15 and FY18, particularly in VHA. As expansion of CC continues under the MISSION Act, more research is needed to evaluate quality of care across VHA and CC and what role, if any, wait times play.

Rural Veterans' Experiences With Outpatient Care in the Veterans Health Administration Versus Community Care.

BACKGROUND: The 2014 Veterans Access, Choice and Accountability Act was intended to improve Veterans' access to timely health care by expanding their options to receive community care (CC) paid for by the Veterans Health Administration (VA). Although CC could particularly benefit rural Veterans, we know little about rural Veterans' experiences with CC. OBJECTIVE: The objective of this study was to compare rural Veterans' experiences with CC and VA outpatient health care services to those of urban Veterans and examine changes over time. RESEARCH DESIGN: Retrospective, cross-sectional study using data from the Survey of Healthcare Experiences of Patients (SHEP) and VA Corporate Data Warehouse. Subjects: All Veterans who responded to the SHEP survey in Fiscal Year (FY) 16 or FY19. MEASURES: Outcomes were 4 measures of care experience (Access, Communication, Coordination, and Provider Rating). Independent variables included care setting (CC/VA), rural/urban status, and demographic and clinical characteristics. RESULTS: Compared with urban Veterans, rural Veterans rated CC the same (for specialty care) or better (for primary care). Rural Veterans reported worse experiences in CC versus VA, except for specialty care Access. Rural Veterans' care experiences improved between FY16 and FY19 in both CC and VA, with greater improvements in CC. CONCLUSIONS: Rural Veterans' reported comparable or better experiences in CC compared with urban Veterans, but rural Veterans' CC experiences still lagged behind their experiences in VA for primary care. As growing numbers of Veterans use CC, VA should ensure that rural and urban Veterans' experiences with CC are at least comparable to their experiences with VA care.

Veterans' Use of Veterans Health Administration Primary Care in an Era of Expanding Choice.

BACKGROUND: The Veterans Choice Program (VCP), aimed at improving access to care, included expanded options for Veterans to receive primary care through community providers. OBJECTIVES: The objective of this study was to characterize and compare Veterans use of Veterans Health Administration (VA) primary care services at VA facilities and through a VA community care network (VA-CCN) provider. RESEARCH DESIGN: This was a retrospective, observational over fiscal years (FY) 2015-2018. SUBJECTS: Veterans receiving primary care services paid for by the VA. MEASURES: Veteran demographic, socioeconomic and clinical factors and use of VA primary care services under the VCP each year. RESULTS: There were 6.3 million Veterans with >54 million VA primary care visits, predominantly (98.5% of visits) at VA facility. The proportion of VA-CCN visits increased in absolute terms from 0.7% in 2015 to 2.6% in 2018. Among Veterans with any VA-CCN primary care, the proportion of VA-CCN visits increased from 22.6% to 55.3%. Logistic regression indicated that Veterans who were female, lived in rural areas, had a driving distance >40 miles, had health insurance or had a psychiatric/depression condition were more likely to receive VA-CCN primary care. Veterans who were older, identified as Black race, required to pay VA copayments, or had a higher Nosos score, were less likely to receive VA-CCN primary care. CONCLUSION: As the VA transitions from the VCP to MISSION and VA facilities gain experience under the new contracts, attention to factors that impact Veterans' use of primary care services in different settings are important to monitor to identify access barriers and to ensure Veterans' health care needs are met.

County-level Predictors of Growth in Community-based Primary Care Use Among Veterans.

BACKGROUND: The 2014 Choice Act expanded the Veterans Health Administration's (VA) capacity to purchase services for VA enrollees from community providers, yet little is known regarding the growth of Veterans' primary care use in community settings. OBJECTIVES: The aim was to measure county-level growth in VA community-based primary care (CBPC) penetration following the Choice Act and to assess whether CBPC penetration increased in rural counties with limited access to VA facilities. DATA AND SAMPLE: A total of 3132 counties from VA administrative data from 2015 to 2018, Area Health Resources Files, and County Health Rankings. ANALYSIS: We defined the county-level CBPC penetration rate as the proportion of VA-purchased primary care out of all VA-purchased primary care (ie, within and outside VA). We estimated county-level multivariate linear regression models to assess whether rurality and supply of primary care providers and health care facilities were significantly associated with CBPC growth. RESULTS: Nationally, CBPC penetration rates increased from 2.7% in 2015 to 7.3% in 2018. The rurality of the county was associated with a 2-3 percentage point (pp) increase in CBPC penetration growth (P<0.001). The presence of a VA facility was associated with a 1.7 pp decrease in CBPC penetration growth (P<0.001), while lower primary care provider supply was associated with a 0.6 pp increase in CBPC growth (P<0.001). CONCLUSION: CBPC as a proportion of all VA-purchased primary care was small but increased nearly 3-fold between 2015 and 2018. Greater increases in CBPC penetration were concentrated in rural counties and counties without a VA facility, suggesting that community care may enhance primary care access in rural areas with less VA presence.

Comparing Driving Miles for Department of Veterans Affairs-delivered Versus Department of Veterans Affairs-purchased Cataract Surgery.

BACKGROUND: The Veterans Choice Act of 2014 increased the number of Veterans eligible for Department of Veterans Affairs (VA)-purchased care delivered in non-VA community care (CC) facilities. Driving >40 miles from home to a VA facility is a key eligibility criterion for CC. It remains unclear whether this policy change improved geographical access by reducing drive distance for Veterans. OBJECTIVES: Describe the driving distance for Veterans receiving cataract surgery in VA and CC facilities, and if they visited the closest-to-home facility or if they drove to farther facilities. SUBJECTS: Veterans who had cataract surgery in federal fiscal year 2015. MEASURES: We calculated driving miles to the Closest VA and CC facilities that performed cataract surgeries, and to the location where Veterans received care. RESULTS: A total of 61,746 Veterans received 83,875 cataract surgeries. More than 50% of CC surgeries occurred farther than the Closest CC facility providing cataract surgery (median Closest CC facility 8.7 miles vs. Actual CC facility, 19.7 miles). Most (57%) Veterans receiving cataract surgery at a VA facility used the Closest VA facility (median Closest VA facility 28.1 miles vs. Actual VA facility at 31.2 miles). In all, 26.1% of CC procedures occurred in facilities farther away than the Closest VA facility. CONCLUSIONS: Although many Veterans drove farther than needed to get cataract surgery in CC, this was not true for obtaining care in the VA. Our findings suggest that there may be additional reasons, besides driving distance, that affect whether Veterans choose CC and, if they do, where they seek CC.

Eutanasia: ¿es esta la ley que necesitamos? / Euthanasia: is this the law we need?

La Ley de Eutanasia española introduce un nuevo derecho que se incorpora a la cartera de servicios del sistema sanitario, como una prestación cuya aplicación se garantiza en el plazo de 40 días. Desde la experiencia clínica se argumenta que, sin el derecho efectivo a unos cuidados paliativos de calidad, y con el actual déficit en las ayudas a la dependencia, esta ley puede ser un mensaje coactivo para aquellas personas especialmente frágiles y dependientes, que se sientan como una pesada carga para su familia y para la sociedad.Se razona de qué modo fundamentar el derecho a morir en la dignidad de la persona, puede tener repercusiones sociales inesperadas.El texto normativo muestra debilidades propias de una ley apresurada y sin apoyo de órganos consultivos. Hay cuestiones pendientes de aclarar en su aplicación dentro del contexto de la medicina de familia. Se concluye que esta nueva norma planteará más problemas de los que pretende resolver.(AU)

The Spanish Euthanasia Law introduces a new right that is added to the portfolio of services provided by the Spanish health system and whose application is guaranteed within a period of 40 days. From the perspective of clinical experience, it is argued that without the effective right to quality palliative care and given the current shortcomings in dependant care, this law may send a threatening message to particularly fragile and dependant individuals that will lead to them feeling like a burden to their families and society.It is reasoned that basing the right to die on the dignity of the individual may have unexpected social repercussions.The text of the law presents the flaws of having been written hastily and without the support of advisory entities. There are issues that require clarification with regard to the application of euthanasia within the context of general practice. The conclusion is that this new law will pose more problems of the type it aims to resolve.(AU)

O direito humano à liberdade e a prática abortiva brasileira / El derecho humano a la libertad y la práctica abortiva brasileña / The human right to liberty and Brazilian abortion practices

Abstract The aim of this paper is to justify women's right to abortion in the first trimester of pregnancy. Considering human rights as the protection of our normative agency or personhood, this paper will argue that human rights cannot be extended to human embryos and foetuses. In the first trimester of pregnancy, the moral status of the foetus is not sufficient to overcome the woman's right to the freedom to control her own body. There may be, however, moral considerations other than human rights that could restrict abortions after the first trimester of pregnancy. In order to protect human personhood and the most fundamentally accepted human rights - the rights to freedom, life, health and security of the body - countries like Brazil should decriminalize abortion in the first trimester of pregnancy and provide access to safe abortions through the public health care system.

Resumen El objetivo de este artículo es justificar el derecho de las mujeres a abortar en el primer trimestre de gestación. Si consideramos los Derechos Humanos como protección de nuestra agencia normativa o de nuestra personalidad, este artículo argumentará que los derechos humanos no pueden hacerse extensibles a los embriones y fetos humanos. En el primer trimestre de gestación, el estatus moral del feto no es suficiente para superar el derecho de las mujeres a la libertad de controlar sus propios cuerpos. Sin embargo, además de los derechos humanos pueden existir consideraciones morales que pueden impedir el aborto después del primer trimestre de gestación. Para proteger la personalidad humana y los derechos humanos más fundamentales aceptados - derecho a la libertad, a la vida, a la salud y a la seguridad del cuerpo - países como Brasil deberían despenalizar el aborto en el primer trimestre de gestación y brindar acceso a abortos seguros a través del sistema público de salud.

Resumo O objetivo deste artigo é justificar o direito das mulheres ao aborto no primeiro trimestre de gestação. Se os direitos humanos são definidos como proteções da nossa agência normativa ou personalidade, então não poderão ser atribuídos aos embriões e fetos humanos. No primeiro trimestre de gestação, o status moral do feto não restringe o direito das mulheres à liberdade de controlar seu próprio corpo. No entanto, outras considerações morais podem impedir o aborto após os três meses iniciais de gestação, tais como: viabilidade, senciência e interesses. Finalmente, o artigo defende que o Brasil deve descriminalizar o aborto no primeiro trimestre de gestação e proporcionar acesso a abortos seguros via sistema público de saúde para proteger os direitos humanos amplamente aceitos, tais como: o direito à liberdade, à vida, à saúde e à segurança corporal.

New clinical trials regulation in Spain: analysis of royal decree 1090/2015

The coming into force of Directive 2001/20/EC represented a step forward in harmonising clinical trial regulation in European countries, guaranteeing a uniform protection of subjects participating in clinical research across Europe. However, it led to a disproportionate increase in the bureaucratization, and thus, it became evident that procedures needed to be simplified without detriment to patient’s safety. Thus, Regulation 536/2014, that repealed Directive 2001/20/EC, with the aim of decreasing the growing bureaucratization and stimulating clinical research in Europe, established simplified procedures, such as regulating a common procedure for authorising trials in Europe, the institution of strict assessment timelines, or the definition of new concepts, such as «low-intervention clinical trial». The legal form of a Regulation allowed the norm to be directly applied to Member States without the need for transposition. By means of the new Royal Decree, the national legislation is adapted to make the application of the regulation feasible and it allows the development of the aspects that the Regulation leaves to national legislation. Both documents seek to stimulate clinical research with medicinal products to foster knowledge, facilitate transparency, and reinforce subjects’ safety. This will surely be the case, but with this revision, we will look at the novelties and key aspects that are most relevant to investigators and we will analyse the consequences for all parties involved in clinical research (AU)

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Autonomia da vontade do paciente e capacidade para consentir: uma reflexão sobre a coação irresistível / Autonomy of the patient’s will and capacity to consent: a reflection on the irresistible coercion

O presente trabalho pretende investigar a validade da manifestação de vontade do paciente, no momento em que o mesmo está influenciado pela dor e pelo sofrimento e necessita declarar se irá se submeter ou não a determinado tratamento. A pesquisa tem caráter interdisciplinar e se utiliza dos elementos da Teoria Geral do Direito Civil para a declaração de validade do negócio jurídico. A relação médico-paciente necessita de uma visão completa quanto aos elementos e requisitos que constituem sua validade na ordem jurídica. Como ponto de partida, analisa a relação do médico com os pacientes adeptos da religião Testemunha de Jeová para, em seguida, verificar os requisitos de validade da declaração de vontade. Investiga a manifestação da vontade como principal elemento do negócio jurídico para, no final, definir os conflitos que envolvem o estudo da autonomia da vontade e a dificuldade de solução dos casos concretos.

This paper aims to investigate the validity of the patient’s consent from the moment that he is influenced by pain and suffering and needs to declare that he will accept a particular treatment. The research is interdisciplinary and uses the general theory of civil law for the validity declaration of the legal business. The doctor-patient relationship requires a complete overview on the elements and requirements that are to be valid in law. As a starting point, this article analyzes the doctor’s relationship with Jehovah’s Witness religion, to check the validity requirements of the statement of intent. It investigates the expression of the will as the main element of the transaction to define at the end those conflicts involving the study of freedom of choice and the difficulty of resolution of cases in concrete.

What health plans do people prefer? The trade-off between premium and provider choice.

Within a healthcare system with managed competition, health insurers are expected to act as prudent buyers of care on behalf of their customers. To fulfil this role adequately, understanding consumer preferences for health plan characteristics is of vital importance. Little is known, however, about these preferences and how they vary across consumers. Using a discrete choice experiment (DCE) we quantified trade-offs between basic health plan characteristics and analysed whether there are differences in preferences according to age, health status and income. We selected four health plan characteristics to be included in the DCE: (i) the level of provider choice and associated level of reimbursement, (ii) the primary focus of provider contracting (price, quality, social responsibility), (iii) the level of service benefits, and (iv) the monthly premium. This selection was based on a literature study, expert interviews and focus group discussions. The DCE consisted of 17 choice sets, each comprising two hypothetical health plan alternatives. A representative sample (n = 533) of the Dutch adult population, based on age, gender and educational level, completed the online questionnaire during the annual open enrolment period for 2015. The final model with four latent classes showed that being able to choose a care provider freely was by far the most decisive characteristic for respondents aged over 45, those with chronic conditions, and those with a gross income over €3000/month. Monthly premium was the most important choice determinant for young, healthy, and lower income respondents. We conclude that it would be very unlikely for half of the sample to opt for health plans with restricted provider choice. However, a premium discount up to €15/month by restricted health plans might motivate especially younger, healthier, and less wealthy consumers to choose these plans.

Implementation of Choice from Participants' Perspectives: A Study of Community Mental Healthcare Reform in Sweden.

The aim of this study was to explore participants' experiences and opinions about a free-choice system in relation to policy objectives articulated by the national government and local authorities. A case study was conducted. Thirty-five informants participated. Qualitative interviews were undertaken. Results are discussed on how to address different dimensions of choice, not only where, but also what, by whom, how much, and when. They also concern how to design systems that in some ways ensure predictability and continuity to avoid unwanted harm caused by the unpredictability embedded in competitive choice systems. Finally, different aspects of quality need to be addressed.