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.

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.

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.

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.

Public support for graphic health warning labels in the U.S.

BACKGROUND: In 2009, the U.S. Food and Drug Administration was required to mandate that graphic health warning labels be placed on cigarette packages and advertisements. PURPOSE: To assess public support in the U.S. for graphic health warning labels from 2007 to 2012. METHODS: Data from 17,498 respondents from 13 waves of the National Adult Tobacco Survey, a list-assisted random-digit-dial survey, were used. Overall support for graphic health warning labels, as well as support by smoking status, and by sociodemographics and smoker characteristics are estimated. Analyses were conducted in 2014. RESULTS: Since 2007, a majority of the public overall has been in favor of labels. Support increased significantly among the public overall and among non-smokers from 2007 through 2009 (p<0.001), after which it remained flat. Among smokers, support levels increased from 2007 through 2011 (p<0.001), but decreased significantly from 2011 through 2012 (p<0.001). Support was high regardless of smoking status, although among smokers, support varied by level of smoking, interest in quitting, and whether labels were seen as an important reason to quit. Support varied by sociodemographic characteristics, particularly among smokers. Younger, less-affluent, and less-educated smokers supported labels at higher levels than their counterparts. CONCLUSIONS: A majority of U.S. residents support graphic health warning labels for cigarette packs, though support among smokers declined after 2011.