The benefits and harms of open notes in mental health: A Delphi survey of international experts.

IMPORTANCE: As of April 5, 2021, as part of the 21st Century Cures Act, new federal rules in the U.S. mandate that providers offer patients access to their online clinical records. OBJECTIVE: To solicit the view of an international panel of experts on the effects on mental health patients, including possible benefits and harms, of accessing their clinical notes. DESIGN: An online 3-round Delphi poll. SETTING: Online. PARTICIPANTS: International experts identified as clinicians, chief medical information officers, patient advocates, and informaticians with extensive experience and/or research knowledge about patient access to mental health notes. MAIN OUTCOMES, AND MEASURES: An expert-generated consensus on the benefits and risks of sharing mental health notes with patients. RESULTS: A total of 70 of 92 (76%) experts from 6 countries responded to Round 1. A qualitative review of responses yielded 88 distinct items: 42 potential benefits, and 48 potential harms. A total of 56 of 70 (80%) experts responded to Round 2, and 52 of 56 (93%) responded to Round 3. Consensus was reached on 65 of 88 (74%) of survey items. There was consensus that offering online access to mental health notes could enhance patients' understanding about their diagnosis, care plan, and rationale for treatments, and that access could enhance patient recall and sense of empowerment. Experts also agreed that blocking mental health notes could lead to greater harms including increased feelings of stigmatization. However, panelists predicted there could be an increase in patients demanding changes to their clinical notes, and that mental health clinicians would be less detailed/accurate in documentation. CONCLUSIONS AND RELEVANCE: This iterative process of survey responses and ratings yielded consensus that there would be multiple benefits and few harms to patients from accessing their mental health notes. Questions remain about the impact of open notes on professional autonomy, and further empirical work into this practice innovation is warranted.

A Fit-for-Purpose Nutrient Profiling Model to Underpin Food and Nutrition Policies in South Africa.

South Africa (SA) is facing a rising prevalence of obesity and diet-related chronic diseases. The government is seeking to develop effective, evidence-based policy measures to address this. A well-designed, fit-for-purpose nutrient profiling model (NPM) can aid policy development. The aim of this study was to develop a fit-for-purpose NPM in SA. Steps included: (1) determining the purpose and target population; (2) selecting appropriate nutrients and other food components to include; (3) selecting a suitable NPM type, criteria and base; and (4) selecting appropriate numbers and thresholds. As part of the evaluation, the nutritional composition of packaged foods containing nutritional information (n = 6747) in the SA food supply chain was analyzed, a literature review was undertaken and various NPMs were evaluated. Our findings indicated that it is most appropriate to adapt an NPM and underpin regulation with a restrictive NPM that limits unhealthy food components. The Chile 2019 NPM was identified as suitable to adapt, and total sugar, saturated fat, sodium and non-sugar sweetener were identified as appropriate to restrict. This NPM has the potential to underpin restrictive policies, such as front-of-package labelling and child-directed marketing regulations in SA. These policies will support the fight against obesity and NCDs in the country.

Assessing the information quality and usability of My Health Record within a health literacy framework: What's changed since 2016?

BACKGROUND: This study examined the health literacy demands of My Health Record (MyHR) in the context of preparing for a government-announced opt-out system by repeating two studies of health information and usability conducted in 2016. OBJECTIVE: To examine whether Australia's MyHR meets the information and usability needs of people at risk of low health literacy and changes since 2016. METHOD: Content analysis: Informed by the 2016 methods and findings, measures of information quality, themes and target audiences were recorded and reported for each online consumer-facing health information resource. Heuristic evaluation: An evaluation of the MyHR and supporting information website was conducted using a predetermined checklist of usability criteria. A list of usability violations for both websites was identified. RESULTS: Total number of resources grew from 80 in 2016 to 233 in 2018. There was little change since 2016 to average readability levels, target audiences, presentation style, links between resources and usability of MyHR. Compared to 2016, this study demonstrated increases in resources from non-government organisations; video resources; translated resources; and resources with themes of privacy, security and post-registration use. CONCLUSION: This study identified some improvements in information quality since 2016, but gaps remain in information quality and usability which may negatively impact the ability for people with low health literacy to access and use MyHR. IMPLICATIONS: This study provides a framework for ongoing monitoring and evaluation of the suitability of MyHR for people at risk of low health literacy.

Problemas de información a los padres y tutores en la asistencia a urgencias en menores de 14 a 17 años por consumo de sustancias psicoactivas / Issues with information given to parents and guardians on medical care in the emergency department relating to minors aged from 14 to 17 years due to psychoactive substance

INTRODUCCIÓN: El cumplimiento de los deberes de la patria potestad exige a los padres y/o tutores estar informados de aquellos aspectos relevantes relacionados con la salud del menor. La legislación actual reconoce la autonomía a partir de los 16 años o menores emancipados. En este trabajo se analiza la información que reciben los padres o tutores legales de los menores mayores de 14 años que acuden a un servicio de urgencias hospitalario general de tercer nivel por intoxicación aguda por alcohol y otras drogas de abuso incluidos medicamentos como las benzodiacepinas si se consumen con fines recreativos. MATERIAL Y MÉTODOS: Se revisaron las historias clínicas de los menores atendidos en el servicio de urgencias de un hospital de tercer nivel durante los años 2016 y 2017 para conocer la información referida a los padres y se entrevistó a los médicos y enfermeros de dicho servicio para conocer la información que daban a los padres/tutores. RESULTADOS: En las historias clínicas en las que se citaba que el menor iba acompañado por amigos (11,5%), 5 de ellas (9,6%) no especificaban si se había realizado el aviso a padres/tutores. De las 26 historias clínicas (50%) en las que no había especificación del acompañamiento, en 22 (42,3%) tampoco existía especificación del aviso. Mientras que 28 de los 35 encuestados (80%) afirma avisar siempre que el menor no hubiera ido acompañado por sus padres o tutores. CONCLUSIONES: Se pone de manifiesto la existencia de una falta de información de tipo asistencial relativa al aviso a padres/tutores, así como una discrepancia entre los datos proporcionados por los médicos y enfermeros y los obtenidos en las historias clínicas

BACKGROUND: In accordance with parental legal duties, parents and guardians should be informed about health issues relevant to child health. Current Spanish legislation acknowledges autonomy from 16 years or emancipated minors. This study analyses the information given to the parents or legal guardians of minors over 14 years of age attending a tertiary-level general hospital emergency department on psychoactive substance intoxication (alcohol, cannabis, benzodiazepines). MATERIAL AND METHODS: The medical records of minors treated in the emergency department of a tertiary-level hospital, between 2016 and 2017, were reviewed. A survey of medical and nursing professionals from the emergency services was also conducted. RESULTS: Of the medical records that mentioned that the minor attended the emergency department with friends (11.5%), 5 (9.6%) did not specify if the parents or guardians were called. Of the 26 medical records (50%) in which there was no mention of whether if the minor attended alone or accompanied, 22 (42.3%) made no mention of informing parents. The study data show that 28 of the 35 respondents (80%) always notified if the minor had not been accompanied to the emergency department by a parent or guardian. CONCLUSIONS: There is lack of information relating to informing parents/guardians, as well as a discrepancy between the data provided by health professionals and the medical reports analysed

Cancer Warning Labels on Alcohol Containers: A Consumer's Right to Know, a Government's Responsibility to Inform, and an Industry's Power to Thwart.

OBJECTIVE: Although the World Health Organization (WHO) declared alcohol a Class 1 carcinogen 30 years ago, few governments have communicated this fact to the public. We illustrate how alcohol industry groups seek to keep their customers in the dark about alcohol-related cancer risks. In Canada, a federally funded scientific study examining the introduction of cancer warning labels on containers was shut down following industry interference. We show that the industry complaints about the study had no legal merit. Of 47 WHO member countries with alcohol warning labels, only South Korea requires cancer warnings on alcohol containers. However, industry complaints, supported by sympathetic governments, helped weaken the warning labels' implementation. Ireland has legislated for cancer warnings but faces continuing legal opposition expressed through regional and global bodies. Cancer societies and the public health community have failed to counter industry pressures to minimize consumer awareness of alcohol's cancer risks. Placing cancer warnings on alcohol containers could make a pivotal difference in motivating both drinkers to consume less and regulators to introduce more effective policies to reduce the serious harms of alcohol consumption.

Reported fire safety and first-aid amenities in Airbnb venues in 16 American cities.

Airbnb helps hosts rent all or part of their home to guests as an alternative to traditional hospitality settings. Airbnb venues are not uniformly regulated across the USA. This study quantified the reported prevalence of fire safety and first-aid amenities in Airbnb venues in the USA. The sample includes 120 691 venues in 16 US cities. Proportions of host-reported smoke and carbon monoxide (CO) detectors, fire extinguishers and first-aid kits were calculated. The proportion of venues that reportedly contained amenities are as follows: smoke detectors 80% (n=96 087), CO detectors 57.5% (n=69 346), fire extinguishers 42% (n=50 884) and first-aid kits 36% (n=43 497). Among this sample of Airbnb venues, safety deficiencies were noted. While most venues had smoke alarms, approximately 1/2 had CO alarms and less than 1/2 reported having a fire extinguishers or first-aid kits. Local and state governments or Airbnb must implement regulations compliant with current National Fire Protection Association fire safety standards.

Cuestionario/guía para la evaluación de proyectos de investigación con datos por un CEI / Questionnaire/guide for the evaluation of research projects with personal data by a Research Ethics Committee

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Comparing the eating out experiences of consumers seeking to avoid different food allergens.

BACKGROUND: Eating outside the home is challenging for consumers with food allergy (FA) and intolerance (FI) and lack of allergen information provision in eating out venues can lead to unnecessary restrictions. Following European legislation (2014) designed to improve allergen information provision, little is known about differences in information provision experienced by consumers seeking to avoid particular allergens, or how this impacts on their eating out experiences. This study compared the information provision that consumers with FA/FI to different allergens experience when eating out. METHODS: Using mixed methods, participants were recruited from across the UK and took part in self-report surveys or in-depth interviews. Surveys were completed by 232 participants avoiding either gluten (n = 66), nuts (peanuts/tree nuts) (n = 94), or milk (n = 74), and responses were subject to quantitative analyses. Interviews were carried out with 49 participants avoiding either gluten (n = 13), nuts (n = 14), milk (n = 13) or a combination of these allergens (n = 9), and analysed using the framework approach. RESULTS: Although general improvements in information provision following the legislation were reported, variations in provision between allergen groups led participants seeking to avoid milk to conclude that their dietary needs were less well-understood and seen as less important. These perceptions were reflected in a reluctance to involve eating out venue staff in deliberations about the potential for milk-free meal options. CONCLUSIONS: The provision of visual indicators of the presence of milk and of staff trained in allergen-awareness would improve the eating out experiences of consumers seeking to avoid milk. Medical professions can play a key role in encouraging these patients to pursue their right to make enquiries about allergens in order to avoid accidental milk ingestion when eating out.

Effects of posted point-of-sale warnings on alcohol consumption during pregnancy and on birth outcomes.

In 23 states and Washington D.C., alcohol retailers are required by law to post alcohol warning signs (AWS) that warn against the risks of drinking during pregnancy. Using the variation in the adoption of these laws across states and within states over time, I find a statistically significant reduction in prenatal alcohol use associated with AWS. I then use this plausibly exogenous change in drinking behavior to establish a causal link between prenatal alcohol exposure and birth outcomes. I find that AWS laws are associated with decreases in the odds of very low birth weight and very pre-term birth.

Aspectos médico-legales de la endoscopia digestiva. Congreso de la SEED. Zaragoza 2015 / No disponible

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Consentimiento informado en endoscopia digestiva: información para el paciente, protección para el endoscopista / No disponible

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El Consejo Consultivo de Pacientes de Cataluña: la voz directa del paciente en las políticas de salud en Cataluña / The Catalan Patient Council: the direct voice of the patient in health policies in Catalonia

El paso de un modelo asistencial más paternalista, centrado en la enfermedad y en la autoridad del profesional, hacia un modelo más participativo, centrado en los derechos y deberes de los pacientes informados, representa un cambio significativo en las políticas públicas de salud. Una forma de participación ciudadana muy extendida en nuestro país es el asociacionismo en torno a una enfermedad. La participación mediante las entidades es una herramienta pionera en el debate de las políticas de salud. El Gobierno de la Generalitat de Catalunya acordó impulsar el Plan estratégico de la participación del paciente en el sistema sanitario público. El Departament de Salut crea el Consejo Consultivo de Pacientes de Cataluña. Esta iniciativa es el órgano permanente de consulta y participación de los representantes de los pacientes en el sistema catalán de salud. El Consejo Consultivo de Pacientes de Cataluña ha nacido con la firme voluntad de situar al paciente en el centro del sistema y de hacerlo partícipe de las decisiones que le afectan. Este plan de participación del paciente se ha definido y elaborado de forma consensuada por parte de la administración y las entidades y son 8 las líneas aprobadas por el gobierno. El Consejo Consultivo de Pacientes de Cataluña ha mostrado ser un mecanismo eficaz para incrementar la participación activa de los pacientes en las políticas de salud y su relación con el sistema, pasando del monólogo al diálogo (AU)

The transition from a more paternalistic model of care focused on the disease and on the medical professional's authority towards a more participatory model cantered on the rights and duties of informed patients represents a significant change in public health policy. One of the most widespread methods of social participation in Catalonia today is the tendency to form associations around a particular disease. This kind of organizational participation is a pioneering tool in the debate around public health policy. The Government of the Generalitat de Catalunya undertook to promote the Strategic Plan of patient participation within the public health system. The Department of Health created the Patient Advisory Council of Catalonia (CCPC, as per the acronym in Catalan). This initiative constitutes a permanent consultative and participatory body for patient representatives in the Catalan healthcare system. The CCPC was set up with a solid determination to place the patient at the centre of the healthcare system, including them in the decision-making processes which directly affect them. This patient participation plan has defined and developed 8 different lines approved by the government, with consensus approval between regional government and the organisations. The CCPC has proven itself to be an effective tool for fostering active patient participation in health policy and its relationship with the system has evolved from that of a monologue to becoming the mechanism for dialogue it is today (AU)

The Experiences of State-Run Insurance Marketplaces That Use HealthCare.gov.

States have flexibility in implementing the Affordable Care Act's health insurance marketplaces and may choose to become more (or less) involved in marketplace operations over time. Interest in new implementation approaches has increased as states seek to ensure the long-term financial stability of their exchanges and exercise local control over marketplace oversight. This brief explores the experiences of four states--Idaho, Nevada, New Mexico, and Oregon--that established their own exchanges but have operated them with support from the federal HealthCare.gov eligibility and enrollment platform. Drawing on discussions with policymakers, insurers, and brokers, we examine how these supported state-run marketplaces perform their key functions. We find that this model may offer states the ability to maximize their influence over their insurance markets, while limiting the financial risk of running an exchange.

Can You Diagnose Me Now? A Proposal to Modify FDA's Regulation of Smartphone Mobile Health Applications with a Pre-Market Notification and Application Database System.

Mobile applications provide limitless possibilities for the future of medical care. Yet these changes have also created concerns about patient safety. Under the Federal Food, Drug, and Cosmetic Act (FDCA), the Food and Drug Administration (FDA) has the authority to regulate a much broader spectrum of products beyond traditional medical devices like stethoscopes or pacemakers. The regulatory question is not if FDA has the statutory. authority to regulate health-related software, but rather how it will exercise its regulatory authority. In September 2013, FDA published guidance on Mobile Medical Applications; in it, the Agency limited its oversight to a small subset of medical-related mobile applications, referred to as "mobile medical applications." For the guidance to be effective, FDA must continue to work directly with all actors--including innovators, doctors, and patients--as the market for mobile health applications continues to develop. This Article argues that FDA should adopt a two-step plan--a pre-market notification program and a mobile medical application database--to aid in the successful implementation of its 2013 guidance. By doing so, FDA will ensure that this burgeoning market can reach its fullest potential.