When Parents Request Nondisclosure: Rights of Adolescents to Access Their Health Information and Implications of the 21st Century Cures Act Final Rule.

AbstractDespite broad ethical consensus supporting developmentally appropriate disclosure of health information to older children and adolescents, cases in which parents and caregivers request nondisclosure continue to pose moral dilemmas for clinicians. State laws vary considerably regarding adolescents' rights to autonomy, privacy, and confidentiality, with many states not specifically addressing adolescents' right to their own healthcare information. The requirements of the 21st Century Cures Act have raised important ethical concerns for pediatricians and adolescent healthcare professionals regarding the protection of adolescent privacy and confidentiality, given requirements that chart notes and results be made readily available to patients via electronic portals. Less addressed have been the implications of the act for adolescents' access to their health information, since many healthcare systems' electronic portals are available to patients beginning at age 12, sometimes requiring that the patients themselves authorize their parents' access to the same information. In this article, we present a challenging case of protracted disagreement about an adolescent's right to honest information regarding his devastating prognosis. We then review the legal framework governing adolescents' rights to their own healthcare information, the limitations of ethics consultation to resolve such disputes, and the potential for the Cures Act's impact on electronic medical record systems to provide one form of resolution. We conclude that although parents in cases like the one presented here have the legal right to consent to medical treatment on their children's behalf, they do not have a corresponding right to direct the withholding of medical information from the patient.

A qualitative interview study to determine barriers and facilitators of implementing automated decision support tools for genomic data access.

Data access committees (DAC) gatekeep access to secured genomic and related health datasets yet are challenged to keep pace with the rising volume and complexity of data generation. Automated decision support (ADS) systems have been shown to support consistency, compliance, and coordination of data access review decisions. However, we lack understanding of how DAC members perceive the value add of ADS, if any, on the quality and effectiveness of their reviews. In this qualitative study, we report findings from 13 semi-structured interviews with DAC members from around the world to identify relevant barriers and facilitators to implementing ADS for genomic data access management. Participants generally supported pilot studies that test ADS performance, for example in cataloging data types, verifying user credentials and tagging datasets for use terms. Concerns related to over-automation, lack of human oversight, low prioritization, and misalignment with institutional missions tempered enthusiasm for ADS among the DAC members we engaged. Tensions for change in institutional settings within which DACs operated was a powerful motivator for why DAC members considered the implementation of ADS into their access workflows, as well as perceptions of the relative advantage of ADS over the status quo. Future research is needed to build the evidence base around the comparative effectiveness and decisional outcomes of institutions that do/not use ADS into their workflows.

Estado de la información médica y el consentimiento del paciente en cirugía ortopédica y traumatología en el Hospital Universitario de Burgos (periodo 2017-2018) / Status of medical information and patient consent in orthopedic surgery and traumatology at the University Hospital of Burgos (period 2017-2018)

Introducción: El principio de autonomía es la base del concepto de consentimiento informado. El consentimiento informado es un derecho del paciente que consiste en que este, previamente a que se efectúe la intervención médica en su cuerpo, debe expresar su conformidad que debe ir precedida de la debida información que le permite decidir según sus intereses. En este trabajo, nuestro objetivo fue conocer la situación de la información médica y del consentimiento informado del paciente en el Servicio de Traumatología y Cirugía Ortopédica del Hospital Universitario de Burgos.Material y métodosSe elaboró y distribuyó un cuestionario anónimo entre 647 pacientes de cirugía ortopédica y traumatología del Hospital Universitario de Burgos. Posteriormente, se realizó un estudio cuantitativo observacional descriptivo de corte transversal. Se estudió la asociación de las variables sociodemográficas con las respuestas a los ítems del cuestionario.ResultadosSolo el 28,9% de los pacientes conoce que la información es un derecho, pero la mayoría (97,3%) manifestaron la necesidad de recibir información sobre riesgos y complicaciones del tratamiento y consideran que la información no aumenta el miedo o ansiedad (63,4%). La mayoría afirmaron que fueron informados sobre la actuación asistencial (98,1%), comprendiendo las explicaciones recibidas (98,0%). El tiempo utilizado fue suficiente (73,7%). En general, la información recibida fue calificada como suficiente (89,8%).ConclusionesLos pacientes, en su mayoría, se sintieron informados y consideraron que el tiempo que el facultativo había tenido para ello era suficiente. (AU)

Introduction: The principle of autonomy is the basis of the informed consent concept. Informed consent is a patient´s right consisting in prior to the medical intervention being carried out on his body, he must express his agreement that it must be preceded by the proper information that allows him to decide according to his interests. In this work, our objective was to know the status of medical information and informed consent of the patient in the Traumatology and Orthopedic Surgery Service of the University Hospital of Burgos.Material and methodsAn anonymous questionnaire was prepared and distributed among 647 orthopedic surgery and trauma patients at the University Hospital of Burgos. Subsequently, a descriptive, cross-sectional, observational quantitative study was carried out. The association of sociodemographic variables with the responses to the questionnaire items was studied.ResultsOnly 28.9% of the patients know that information is a right, but the majority (97.3%) expressed the need to receive information on risks and complications of the treatment and consider that the information does not increase fear or anxiety (63.4%). The majority stated that they were informed about the care performance (98.1%), understanding the explanations received (98.0%). The time used was sufficient (73.7%). In general, the information received was rated as sufficient (89.8%).ConclusionsMost of the patients felt informed and considered that the time that the doctor had had for this was sufficient. (AU)

It is time for open access in clinical care.

A healthcare center widely sharing its internal guidelines on how to treat COVID-19 patients "just wasn't done." As the pandemic raged at a Boston hospital, the next generation of clinical leaders pushed for change.

Data sharing. Compartir datos de investigación, una práctica que todo investigador debería implementar en el proceso de investigación / Data sharing. Sharing research data, a practice that every researcher should implement in the research process

Introducción: Compartir datos es una práctica que beneficia y nutre a la ciencia abierta. La reutilización de datos sin procesar puede aportar nuevos resultados de investigación y otorga un segundo uso a los conjuntos de datos creados con otro fin, que además pueden servir como respaldo de los resultados de investigación. Objetivo: Exponer y actualizar los aspectos más importantes relacionados con el uso compartido de datos como parte del proceso de investigación. Material y Métodos: Se realizó un estudio bibliográfico que analiza y compila los principales aspectos que debe conocer un investigador que pretende compartir los datos de resultantes de sus investigaciones. Se empleó el análisis de contenido y el análisis documental clásico para la selección de documentos relevantes al estudio de la temática analizada. Desarrollo: Se establece una guía de repositorios de datos y buscadores de repositorios, donde se explican sus principales características. Se explica la importancia del papel de las revistas en el proceso de compartir datos de investigación y las tendencias internacionales de revistas científicas, así como los niveles de acceso a los set de datos de las investigaciones. Se abordan las ventajas de la aplicación de data sharing y su importancia. Conclusiones: Se ofrecen recomendaciones que se deben considerar para elegir repositorios cuando se pretende alojar datos de investigación(AU)

Introduction: Data sharing is a practice that benefits and nurtures open science movement. The reuse of raw data can provide new research results and give a second use to data sets created for another purpose, which can also serve as a support for research results. Objective: To present and update the most important aspects related to data sharing as part of the research process. Material and Methods: This is a bibliographic study that analyzes and compiles the main aspects that a researcher who intends to share the data resulting from his research should know. Content analysis and classic documentary analysis were used for the selection of documents relevant to the study on the subject analyzed. Development: A guide to data repositories and repository search engines is established, and its main characteristics are explained. The importance of the role of journals in the process of sharing research data, international trends in scientific journals, and the levels of access to research data sets, are explained. The advantages of the application of data sharing and its importance are discussed. Conclusions: Recommendations, which should be considered when choosing repositories to host research data, are offered(AU)

International primate neuroscience research regulation, public engagement and transparency opportunities.

Scientific excellence is a necessity for progress in biomedical research. As research becomes ever more international, establishing international collaborations will be key to advancing our scientific knowledge. Understanding the similarities in standards applied by different nations to animal research, and where the differences might lie, is crucial. Cultural differences and societal values will also contribute to these similarities and differences between countries and continents. Our overview is not comprehensive for all species, but rather focuses on non-human primate (NHP) research, involving New World marmosets and Old World macaques, conducted in countries where NHPs are involved in neuroimaging research. Here, an overview of the ethics and regulations is provided to help assess welfare standards amongst primate research institutions. A comparative examination of these standards was conducted to provide a basis for establishing a common set of standards for animal welfare. These criteria may serve to develop international guidelines, which can be managed by an International Animal Welfare and Use Committee (IAWUC). Internationally, scientists have a moral responsibility to ensure excellent care and welfare of their animals, which in turn, influences the quality of their research. When working with animal models, maintaining a high quality of care ("culture of care") and welfare is essential. The transparent promotion of this level of care and welfare, along with the results of the research and its impact, may reduce public concerns associated with animal experiments in neuroscience research.

Publicidad ilícita y salud: cerrar el círculo / Illicit advertising and health: Closing the circle / Publicitat il-lícita I salut: tancar el cercle

La regulación de la publicidad en algunos ámbitos de lo sanitario proporciona, más allá del nivel concreto de eficacia en su aplicación, naturalmente mutable y coyuntural, un marco coherente de protección que no se constata en otros campos. Este trabajo analiza la aplicabilidad de los criterios legales y jurisprudenciales de uno de ellos (el de publicidad de medicamentos) como complemento para la actuación frente a prácticas gravemente dañosas del interés público y de los derechos de los consumidores en otros como el de la publicidad de bebidas alcohólicas o de alimentos malsanos, muy necesitados de criterios jurídicos fundados con los que actuar para atajar la desprotección del consumidor y defender la salud pública

The regulation of advertising in some areas of health provides, beyond the specific level of effectiveness in its application, naturally mutable and conjunctural, a coherent framework of protection that is not found in other fields. This paper analyzes the applicability of legal and jurisprudential criteria of one of these areas (advertising of medicinal products) as a complement to action against practices that are seriously harmful to public interest and to consumer rights in other areas, such as the advertising of alcoholic beverages or unhealthy food, which are in great need of well-founded legal criteria with which to act to take action to tackle consumer protection and defend public health

La regulació de la publicitat en alguns àmbits del sanitari proporciona, més enllà del nivell concret d'eficàcia en la seva aplicació, naturalment mutable I conjuntural, un marc coherent de protecció que no es constata en altres camps. Aquest treball analitza l'aplicabilitat dels criteris legals I jurisprudencials d'un d'ells (el de publicitat de medicaments) com a complement per a l'actuació enfront de pràctiques greument danyoses de l'interès públic I dels drets dels consumidors en uns altres com el de la publicitat de begudes alcohòliques o d'aliments malsans, molt necessitats de criteris jurídics fundats amb els quals actuar per a atallar la desprotecció del consumidor I defensar la salut pública

Information Access and Use by Patients With Cancer and Their Friends and Family: Development of a Grounded Theory.

BACKGROUND: Information has been identified as a commonly unmet supportive care need for those living with cancer (ie, patients and their friends and family). The information needed to help individuals plan their lives around the consequences of cancer, such as the receipt of health care, is an example of an important informational need. A suitable theory to guide the development of interventions designed to meet this informational need has not been identified by the authors. OBJECTIVE: The aim of this study is to generate a grounded theory capable of guiding the development of interventions designed to assist those living with cancer in meeting their informational needs. METHODS: Classic grounded theory was used to analyze data collected through digitally recorded one-on-one audio interviews with 31 patients with cancer and 29 friends and family members. These interviews focused on how the participants had accessed and used information to plan their lives and what barriers they faced in obtaining and using this information. RESULTS: The theory that emerged consisted of 4 variables: personal projects, cancer as a source of disruption to personal projects, information as the process of accessing and interpreting cancer-related data (CRD) to inform action, and CRD quality as defined by accessibility, credibility, applicability, and framing. CRD quality as a moderator of personal project disruption by cancer is the core concept of this theory. CONCLUSIONS: Informational resources providing accessible, credible, applicable, and positively framed CRD are likely key to meeting the information needs of those affected by cancer. Web-based informational resources delivering high-quality CRD focused on assisting individuals living with cancer in maintaining and planning their personal projects are predicted to improve quality of life. Research is needed to develop and integrate resources informed by this theoretical framework into clinical practice.

Post-Coronavirus Disease 2019 Health Care and University: From Efficiency to Resilience.

After the initial emergency responses deployed to control the coronavirus disease 2019 (COVID-19) pandemic in the first half of 2020, we should now start thinking about long-term strategies and concepts for pandemic and disaster governance such as resilience. In this context, COVID-19 health care and education are especially important because they are essential public goods that determine what kind of a society we live in, during the pandemic and afterward. So for, the focus has been a tactical efficiency perspective that prioritized instrumental, logistical, or pragmatic aspects in planetary health and university education, with much less attention paid to social justice, history of inequity, and power asymmetries that affect the pandemic impacts in society. For a resilient COVID-19 response, we need to address not only medical, technical, and logistical challenges, but also the social disparities that are inherited from the prepandemic world that are negatively affecting the current pandemic outcomes.

SARS-Cov-2, el virus emergente que causa la pandemia de COVID-19 / SARS-CoV-2, the emerging virus behind the COVID-19 pandemic

Resumen La emergencia del nuevo SARS-CoV-2 - y el reconocimiento de la enfermedad que produce como pandemia - constituye el evento sanitario de mayor importancia en 2020. Debido a su reciente aparición y la inexistencia de medicamentos o vacunas seguras y eficaces, el manejo de casos y el control de brotes de la enfermedad se hace difícil. En esta revisión, se expone información sobre la pandemia, las características del virus, las manifestaciones clínicas de la enfermedad, su adecuado diagnóstico, las alternativas de tratamiento y las acciones que se ejecutan para su control (AU).

Abstract The emergency of the novel coronavirus, and the recognition of the disease it causes as a pandemic, constitute the main sanitary event in 2020. Because its recent discovery and the lack of safe and effective drugs or vaccines, the managing of cases and the control of the pandemic is problematic. In this review, the authors summarize the basic characteristics of the pathogen, the signs and symptoms of disease, and the diagnosis tools to identify presence of the virus. Furthermore, we also review the current knowledge on the treatment of infected cases as well as information about vaccine candidates. We highlight actions executed in Cuba to control the pandemic (AU).

Clinical and Technical Considerations of an Open Access Telehealth Network in South Carolina: Definition and Deployment.

BACKGROUND: Today, telehealth is experiencing exponential growth in utilization. Paralleling this trend is the growth in the telehealth industry, with sharp increases in the number of platforms, functionalities, and levels of integrations within both the electronic health record and other technical systems supporting health care. When a telehealth network is intended to be used across independent health care systems, an additional layer of complexity emerges. In the context of regionalized telehealth networks that are not within the same health care system, not only are technical interoperability challenges a practical barrier, but administrative, clinical, and competitive elements also quickly emerge, resulting in fragmented, siloed technologies. OBJECTIVE: The study aimed to describe a statewide approach to deploying an interoperable open access telehealth network across multiple health systems. METHODS: One promising solution to the abovementioned concerns is an open access telehealth network. In the field of telehealth, an open access network (OAN) can be defined as a network infrastructure that can be used by health care providers without a closed or proprietary platform, specific obligatory network, or service-specific telehealth technologies. This framework for the development of an OAN is grounded in practical examples of clinical programs that function in each stage of network maturity based on the experience of the South Carolina Telehealth Alliance (SCTA). The SCTA's experience details successes and challenges in an ongoing effort to achieve an OAN. The model describes an OAN in stages of collaborative maturity and provides insights into the technological, clinical, and administrative implications of making the collaboration possible. RESULTS: The four stages of an OAN are defined according to operational maturity, ranging from feasibility to demonstration of implementation. Each stage is associated with infrastructure and resource requirements and technical and clinical activities. In stage 1, technical standards are agreed upon, and the clinical programs are designed to utilize compliant technologies. In stage 2, collaboration is demonstrated through technical teams working together to address barriers, whereas clinical and administrative teams share best practices. In stage 3, a functional interoperable network is demonstrated with different institutions providing service through common telehealth end points at different patient care sites. In stage 4, clinical workflows are streamlined and standardized across institutions, and economies of scale are achieved through technical and administrative innovations. CONCLUSIONS: The approach to OAN development described provides a roadmap for achieving a functional telehealth network across independent health systems. The South Carolina experience reveals both successes and challenges in achieving this goal. The next steps toward the development of OANs include advocacy and ongoing engagement with the developers of telehealth technologies regarding their commitment to interoperability.

A systematic review of patient access to medical records in the acute setting: practicalities, perspectives and ethical consequences.

BACKGROUND: Internationally, patient access to notes is increasing. This has been driven by respect for patient autonomy, often recognised as a primary tenet of medical ethics: patients should be able to access their records to be fully engaged with their care. While research has been conducted on the impact of patient access to outpatient and primary care records and to patient portals, there is no such review looking at access to hospital medical records in real time, nor an ethical analysis of the issues involved in such a change in process. METHODS: This study employed a systematic review framework in two stems, to integrate literature identified from two searches: Medline, CINAHL and Scopus databases were conducted, (for (1) hospitalised patients, patient access to records and its effects on communication and trust within the doctor-patient relationship; and (2) patient access to medical records and the ethical implications identified). The qualitative and quantitative results of both searches were integrated and critically analysed. RESULTS: 3954 empirical and 4929 ethical studies were identified; 18 papers representing 16 studies were identified for review (12 empirical and 6 ethical). The review reveals a consensus that our current approach to giving information to patients - almost exclusively verbally - is insufficient; that patient access to notes is a welcome next step for patient-centred care, but that simply allowing full access, without explanation or summary, is also insufficient. Several ethical implications need to be considered: increased information could improve patient trust and knowledge but might transfer an (unwelcome) sense of responsibility to patients; doctors and patients have conflicting views on how much information should be shared and when; sharing written information might increase the already significant disparity in access to health care, and have unforeseen opportunity costs. The impact on medical practice of sharing notes in real time will also need to be evaluated. CONCLUSIONS: The review presents encouraging data to support patient access to medical notes. However, sharing information is a critical part of clinical practice; changing how it is done could have significant empirical and ethical impacts; any changes should be carefully evaluated.