Antibiotic Use in Hospital Urinary Tract Infections After FDA Regulation.

BACKGROUND: The FDA issued a "black box" warning regarding risks of fluoroquinolones in 2008 with updates in 2011, 2013, and 2016. OBJECTIVE: To examine antimicrobial use in hospital-treated UTIs from 2000 to 2020. DESIGN: Cross-sectional study with interrupted time series analysis. PARTICIPANTS: Patient encounters with a diagnosis of UTI from January 2000 to March 2020, excluding diagnoses of renal abscess, chronic cystitis, and infection of the gastrointestinal tract, lungs, or prostate. MAIN MEASURES: Monthly use of fluoroquinolone and non-fluoroquinolone antibiotics were assessed. Fluoroquinolone resistance was assessed in available cultures. Interrupted time series analysis examined level and trend changes of antimicrobial use with each FDA label change. KEY RESULTS: A total of 9,950,790 patient encounters were included. From July 2008 to March 2020, fluoroquinolone use declined from 61.7% to 11.7%, with similar negative trends observed in inpatients and outpatients, age ≥ 60 and < 60 years, males and females, patients with and without pyelonephritis, and across physician specialties. Ceftriaxone use increased from 26.4% encounters in July 2008 to 63.6% of encounters in March 2020. Among encounters with available culture data, fluoroquinolone resistance declined by 28.9% from 2009 to 2020. On interrupted time series analysis, the July 2008 FDA warning was associated with a trend change (-0.32%, < 0.001) and level change (-5.02%, p < 0.001) in monthly fluoroquinolone use. CONCLUSIONS: During this era of "black box" warnings, there was a decline in fluoroquinolone use for hospital-treated UTI with a concomitant decline in fluoroquinolone resistance and rise in ceftriaxone use. Efforts to restrict use of a medication class may lead to compensatory increases in use of a single alternative agent with changes in antimicrobial resistance profiles.

Research on government regulation methods for the spatial layout of retail pharmacies: practice in Shanghai, China.

BACKGROUND: In China, retail pharmacies are critical sources for obtaining medications and play a vital role in residents' daily access to drugs and treatment of common illnesses. Effectively guiding the placement of these pharmacies in areas of need through government regulation is crucial for enhancing medication access. In this study, we used population and retail pharmacy spatial distribution data from Shanghai to design guidance and supplementary methods for optimizing the spatial layout of retail pharmacies and medical insurance designated pharmacies based on regional characteristics. METHODS: Population distribution, road traffic network, administrative division and retail pharmacy data from Shanghai in 2018 were collected from relevant government departments. ArcGIS 10.3 was used to map the retail pharmacies and population distribution. Based on the spatial distribution of population and the service standards of pharmacies, service circles with insufficient pharmacies were identified, and supplementary methods for retail pharmacies and medical insurance designated pharmacies were developed. RESULTS: In 2018, Shanghai had 3009 retail pharmacies, each serving an average of 6412 residents. The city was divided into 2188 basic pharmaceutical service circles, each within a 15-minute walking distance. The results indicated that there were 1387 service circles without any pharmacies, 151 of which had populations exceeding 5000. Additionally, 356 service circles had pharmacies but lacked medical insurance designated ones. After supplementation, 841 retail pharmacies were planned to be added in residential areas. Compared with before, the coverage area and population served of the pharmacies increased significantly. CONCLUSIONS: This study mapped the spatial distribution of population and retail pharmacies in Shanghai, and designed government guidance and supplementary methods for optimizing the layout of retail pharmacies. The findings offer valuable insights for government agencies in low- and middle-income countries to improve the spatial distribution of retail pharmacies.

The relationship between trust in federal oversight of vaccine safety and willingness to participate in COVID-19 clinical trials: a repeated measures study of Philadelphia residents (September 2021 - March 2023).

BACKGROUND: The Coronavirus Disease 2019 (COVID-19) pandemic precipitated an urgent need for clinical trials to discover safe and efficacious treatments. We examined how COVID-19 experiences, clinical trial awareness, and trust in the vaccine safety process were associated with willingness to participate in COVID-19 clinical trials. The objective was to investigate the relationship between trust in federal oversight of vaccine safety and willingness to participate in clinical trials for COVID-19 treatment across four distinct time points over an 18-month period during the COVID-19 pandemic. METHODS: We used four waves of data collected from September 2021 to March 2023 among 582 Philadelphia residents (with a missing data rate of 0.9%). Generalized estimating equations estimated the association between willingness to participate in COVID-19 clinical trials and participants' trust in the federal government's oversight of COVID-19 vaccine safety, COVID-19-related variables (COVID-19 related health challenges, history of COVID-19 infection), awareness of clinical trials and how to enroll in them, and sociodemographic characteristics (age, race/ethnicity, sexual orientation, gender, parental status, education, and insurance). RESULTS: On average, willingness to participate in a COVID-19 clinical trial was positively associated with greater trust in the federal government's oversight of vaccine safety [ß = 0.34, 95% confidence interval (CI): 0.15-0.53], having COVID-19 (ß = 0.40, 95% CI: 0.08-0.73), awareness of clinical trials (ß = 0.38, 95% CI: 0.04-0.73), and knowledge of how to enroll (ß = 0.83, 95% CI: 0.44-1.23). Among sociodemographic characteristics, race/ethnicity (p = 0.001) and gender (p = 0.018) were identified as predictors for COVID-19 trial willingness. CONCLUSION: Willingness to participate in clinical trials may be bolstered by strengthening the public's trust in the federal government's role within vaccine safety oversight, increasing the perceived relevance of clinical trials to individuals' health and well-being, and offering tailored information to educate diverse communities about ongoing trials and how to enroll in them.

How external and agency characteristics are related to coordination in homecare - findings of the national multicenter, cross-sectional SPOTnat study.

BACKGROUND: Homecare client services are often distributed across several interdependent healthcare providers, making proper care coordination essential. However, as studies exploring care coordination in the homecare setting are scarce, serious knowledge gaps exist regarding how various factors influence coordination in this care sector. To fill such gaps, this study's central aim was to explore how external factors (i.e., financial and regulatory mechanisms) and homecare agency characteristics (i.e., work environment, workforce, and client characteristics) are related to care coordination in homecare. METHODS: This analysis was part of a national multicentre, cross-sectional study in the Swiss homecare setting that included a stratified random sample of 88 Swiss homecare agencies. Data were collected between January and September 2021 through agency and employee questionnaires. Using our newly developed care coordination framework, COORA, we modelled our variables to assess the relevant components of care coordination on the structural, process, and outcome levels. We conducted both descriptive and multilevel regression analyses-with the latter adjusting for dependencies within agencies-to explore which key factors are associated with coordination. RESULTS: The final sample size consisted of 1450 employees of 71 homecare agencies. We found that one explicit coordination mechanism ("communication and information exchange" (beta = 0.10, p <.001)) and four implicit coordination mechanisms-"knowledge of the health system" (beta = -0.07, p <.01), "role clarity" (beta = 0.07, p <.001), "mutual respect and trust" (beta = 0.07, p <.001), and "accountability, predictability, common perspective" (beta = 0.19, p <.001)-were significantly positively associated with employee-perceived coordination. We also found that the effects of agency characteristics and external factors were mediated through coordination processes. CONCLUSION: Implicit coordination mechanisms, which enable and enhance team communication, require closer examination. While developing strategies to strengthen implicit mechanisms, the involvement of the entire care team is vital to create structures (i.e., explicit mechanisms) that enable communication and information exchange. Appropriate coordination processes seem to mitigate the association between staffing and coordination. This suggests that they support coordination even when workload and overtime are higher.

How regulatory frameworks drive differences in home-care agencies: Results from a national multicenter cross-sectional study in Switzerland.

INTRODUCTION: The sustainability and rising costs of the health-care system are of concern. Although health-care reforms impact various areas of care, there is only limited evidence on how regulations affect home-care agencies and health-care delivery. OBJECTIVES: The primary aim was to explore different financial and regulatory mechanisms and how they drive differences in the organizational structures, processes, and work environment of home-care agencies. DESIGN AND METHODS: We used data from a national multicenter cross-sectional study of Swiss home care that included a random sample of 88 home-care agencies with a total of 3223 employees. Data was collected in 2021 through agency and personnel questionnaires including geographic characteristics, financial and regulatory mechanisms, service provision, financing, work environment, resources and time allocation, and personnel recruitment. We first conducted a cluster analysis to build agency groups with similar financial and regulatory mechanisms. We then performed Fisher's exact, ANOVA, and Kruskal-Wallis tests to determine group differences in organizational structures, processes, and work environments. Finally, we performed a lasso regression to determine which variables were predictive for the groups. RESULTS: Four agency groups were built, differing in view of financial and regulatory mechanisms and we found differences in the range and amount of services provided, with regard to employment conditions and cost structures. DISCUSSION: The most prominent differences were found between agency groups with versus agency groups without a service obligation. Financial incentives must be well aligned with the goal of achieving and maintaining financially sustainable, accessible, and high-quality home care.

[Securing the implantable medical device circuit]. / Arrêté du 8 septembre 2021 : sécurisation du circuit des dispositifs médicaux implantables.

OBJECTIVES: The decree concerning quality management of implantable medical device circuits came into force in healthcare establishments on 26 May 2022. The aim of this project is to assess the level of safety of this circuit within the pharmacy, in order to improve it and bring it into line with this future regulation. METHODS: A grid for compliance with the decree was drawn up, enabling compliance rates to be calculated. A second grid was drawn up in accordance with internal procedures. All these criteria were audited in pairs. Priority areas for improvement were identified and working groups were formed. The action plan was monitored by the Steering Committee. Control audits ensure the implementation and relevance of the action plan, as well as the effective securing of the circuit. RESULTS: The rate of circuit compliance with the decree rose from 58% (initial audits) to 72% (control audits). Over a period of 18 months, six workgroups were set to implement improvement measures allowing to ensure regulatory compliance and circuit security. Obstacles (equipment, IT) nevertheless hindered the presence of the unique identifier for medical devices at every stages of the circuit. CONCLUSIONS: This cross-functional project was carried out in "project mode", thanks to the involvement of field staff. It will be pursued at hospital level by the person in charge of the quality management system.

Design, implementation, and inferential issues associated with clinical trials that rely on data in electronic medical records: a narrative review.

Real world evidence is now accepted by authorities charged with assessing the benefits and harms of new therapies. Clinical trials based on real world evidence are much less expensive than randomized clinical trials that do not rely on "real world evidence" such as contained in electronic health records (EHR). Consequently, we can expect an increase in the number of reports of these types of trials, which we identify here as 'EHR-sourced trials.' 'In this selected literature review, we discuss the various designs and the ethical issues they raise. EHR-sourced trials have the potential to improve/increase common data elements and other aspects of the EHR and related systems. Caution is advised, however, in drawing causal inferences about the relationships among EHR variables. Nevertheless, we anticipate that EHR-CTs will play a central role in answering research and regulatory questions.

Mapping and analysis of laws influencing built environments for walking and cycling in Australia.

BACKGROUND: Physical inactivity is a significant public health concern, with limited signs of improvement despite a global commitment to achieving the World Health Organization's target of 15% reduction by 2030. A systems approach is required to tackle this issue, involving the creation of environments that are conducive to physical activity. Laws represent an important tool for regulating the built environment for physical activity, are a mechanism for systems change, and have the capacity to reorient the goals and rules of a system. However, they are understudied and potentially underutilised for physical activity. Scientific legal mapping is a first step towards understanding how laws could impact the built environment to facilitate greater population physical activity. METHOD: We conducted a legal assessment of state and territory laws in Australia, to systematically characterise how they address built environment considerations with specific relevance to walking and cycling. An interdisciplinary team of researchers with public health, law and urban planning expertise was formed to complete the multistage process. Key steps included a systematic search of laws using a combination of original legal research, consultation of secondary sources, and review and verification by an urban planning expert; development of a coding scheme; and completion of coding and quality control procedures. RESULTS: Most jurisdictions in Australia do not currently embed objectives in primary legislation that would promote physical activity and support an integrated approach to land use and transport planning that encourages active and sustainable lifestyles. Only two jurisdictions addressed the large majority of evidence-based standards that promote active living. Of the standards addressed in law, few fully met evidence-based recommendations. While most jurisdictions legislated responsibility for enforcement of planning law, few legislated obligations for monitoring implementation. CONCLUSION: Increasing physical activity is a systems issue, requiring actions across multiple sectors. An in-depth examination of the legal environment is an important step towards understanding and influencing the existing physical activity system, why it may not be generating desired outcomes, and potential opportunities for improvement. Our findings reveal opportunities where laws could be strengthened to promote more active environments. Updating this dataset periodically will generate longitudinal data that could be used to evaluate the impact of these laws on the built environment and physical activity behaviours.

Dynamic HTA for digital health solutions: opportunities and challenges for patient-centered evaluation.

OBJECTIVES: Germany's 2019 Digital Healthcare Act (Digitale-Versorgung-Gesetz, or DVG) created a number of opportunities for the digital transformation of the healthcare delivery system. Key among these was the creation of a reimbursement pathway for patient-centered digital health applications (digitale Gesundheitsanwendungen, or DiGA). Worldwide, this is the first structured pathway for "prescribable" health applications at scale. As of October 10, 2023, 49 DiGA were listed in the official directory maintained by Germany's Federal Institute for Drugs and Medical Devices (BfArM); these are prescribable by physicians and psychotherapists and reimbursed by the German statutory health insurance system for all its 73 million beneficiaries. Looking ahead, a major challenge facing DiGA manufacturers will be the generation of the evidence required for ongoing price negotiations and reimbursement. Current health technology assessment (HTA) methods will need to be adapted for DiGA. METHODS: We describe the core issues that distinguish HTA in this setting: (i) explicit allowance for more flexible research designs, (ii) the nature of initial evidence generation, which can be delivered (in its final form) up to one year after becoming reimbursable, and (iii) the dynamic nature of both product development and product evaluation. We present the digital health applications in the German DiGA scheme as a case study and highlight the role of RWE in the successful evaluation of DiGA on an ongoing basis. RESULTS: When a DiGA is likely to be updated and assessed regularly, full-scale RCTs are infeasible; we therefore make the case for using real-world data and real-world evidence (RWE) for dynamic HTAs. CONCLUSIONS: Continous evaluation using RWD is a regulatory innovation that can help improve the quality of DiGAs on the market.

Mediating and spatial spillover effects of public participation in environmental pollution governance mediated via traditional and new media.

A systematic study of public participation (Pub) in environmental pollution control can facilitate collaborative governance based on multiple factors, and promote the modernization of national governance. Based on the data of 30 Chinese provinces from 2011 to 2020, this study empirically analyzed the mechanism of Pub in environmental pollution governance. Based on multiple channels, a dynamic spatial panel Durbin model and an intermediary effect model were constructed. The main results are as follows: (1) Pub based on environmental letters and visits have no significant impact on local pollution reduction, while the Baidu search index of environmental pollution has the greatest effect on emission reduction, followed by environmental protection strategies based on the National People's Congress (NPC) and microblogging. (2) Pub not only has a direct positive impact on environmental control through its positive externality but also indirectly reduces environmental treatment by enhancing the intensity of environmental regulation. (3) Pub has a significant spatial spillover effect on environmental control based on geographical attenuation. Excluding environmental legislation, the direct spatial spillover effects of Pub under the networked platform and traditional channels are only significant within 1200 km and 1000 km, respectively, which decrease with increasing geographic distance within this range. When the environmental regulations are considered, the spatial spillover effects of suggestions proposed by NPC and the Chinese People's Political Consultative Conference (CPPCC) are significant within 800 km, while the attenuation boundary of Internet complaints, Baidu index, and microblogging public opinion is 1000 km. (4) The impact of Pub on environmental governance varies significantly among regions. Compared with central and western regions, the eastern region showed more effective pollution reduction based on Pub.

How does government regulation shape residents' green consumption behavior? A multi-agent simulation considering environmental values and social interaction.

Green consumption is an inevitable choice to alleviate environmental pressure and promote sustainable development. Residents' green consumption behavior decisions are influenced by a combination of external government regulation and internal consumer psychological factors. This study incorporated regret theory and environmental values into a multi-agent model to simulate residents' green consumption behavior under various government regulation scenarios. The results show that in the absence of government regulation, residents have little motivation to actively choose green consumption. In terms of a single policy, government subsidy is more conducive to promoting green consumption behavior than government penalty, and the evolutionary trend of group decision making becomes more stable with increased policy intensity. However, neither of the two single regulatory policies can fully promote residents' environmentally conscious consumption decisions. Therefore, a combination of "carrots" (government subsidy) and "sticks" (government penalty) is required to motivate a significant increase in the number of residents who choose green consumption behavior. In addition, the intensity of social interaction between residents is found to influence the stability of behavioral evolution, with higher intensity (i.e., more neighbors) resulting in greater fluctuations in group behavior but driving more residents toward green consumption. These findings can provide a theoretical reference for policy formulation of green consumption behavior.

Paramedic use and understanding of their professional code of conduct.

BACKGROUND: Paramedicine is a newly regulated profession in Australia and with the introduction of regulation in 2018 for this profession came increased responsibilities - including the introduction of a professional code of conduct. Several countries now have regulation of paramedicine and associated professional codes to guide ethical and professional behaviour. Despite this, there has been no published research into paramedic understanding and use of their professional codes. OBJECTIVES: To explore Australian paramedics' use and understanding of their professional code of conduct. Research design: This study used a qualitative descriptive design, underpinned by hermeneutic theory. Reflexive thematic analysis was used to analyse the interview data and identify Australian paramedic perceptions surrounding the use of their code of conduct. RESULTS: 11 Registered Paramedics from several states and territories were interviewed. Participants were invited to interview by advertisement on social media and the Australasian College of Paramedicine Web site. Participants had varied professional backgrounds including clinical work, education providers and policymakers/managers. Four themes were identified as follows: Theme 1 - 'You don't know, what you can't know'; Theme 2 - 'I don't need the code - the code is for others'; Theme 3 - 'It's about time'; Theme 4 - 'Navigating the new profession'. Ethical considerations: Ethics approval was granted by the Monash University Human Research Ethics Committee (MUHREC) Project ID: 28921. All participants provided informed consent. CONCLUSIONS: The results of this study suggest that paramedics' knowledge and use of their code is limited, and participants appeared to mostly rely instead on 'common sense' morals. Participants did appear to want to understand the broad concepts of the code more and have this better integrated into the profession. The code was also interpreted as important to the paramedic profession and its new professional status, helping to legitimise it as a health profession in Australia.

Evaluating the influence of static management on individuals' oral health.

PURPOSE: This study aimed to evaluate the effect of static management on individuals' oral health-related quality of life (OHRQoL) according to the dynamic zero-COVID policy in China. METHODS: The digital questionnaire conducted with three sub-questionnaires was sent to 700 patients who accepted treatment at the Department of Stomatology, 363 Hospital. Data on demographic characteristics, the Oral Health Impact Profile-14 and willingness to invest in oral health were collected from the 658 completed questionnaires. According to the state of individuals' lives, participants were divided into two groups: a static management group (Group 1) and a nonstatic management group (Group 2). The scores of the Oral Health Impact Profile-14 and willingness to invest in oral health were compared between these two groups using IBM SPSS Statistics. RESULTS: The results showed that individuals undergoing static management reported better OHRQoL. Meanwhile, they also presented lower willingness to invest money and dental visits in oral health. Furthermore, according to the results of the logistic regression analysis, aging acts as a negative correlation factor for the OHRQoL of people undergoing static management, while the willingness to invest money and dental visits in oral health is defined as a positive predictor for OHRQoL. CONCLUSION: Static management effects the OHRQoL of individuals. Aging and WTIOH in money and dental visits are related the individuals' OHRQoL during static management.

The cost of privatisation to the profession: Media representation of audiology in Australia.

PURPOSE: To investigate how the profession of audiology was represented in the media in Australia and how the increased privatisation of the profession may have shaped this representation. METHODS: A systematic search of English language media records was conducted from 1 January 2000 to 17 July 2020 using ANZ News Stream, TV News, Google News and INFORMIT. Twenty-four of 1056 originally identified articles were retained. The findings were extracted and synthesised. RESULTS: Context and content analyses were preformed, revealing a predominantly negative portrayal of Audiology as a profession in 21 (87.5%) of 24 articles. Predominant themes included: sales driven by incentives; predatory strategies and malpractice; non-regulation and privatisation of the hearing care industry; and conflict of interest. CONCLUSIONS: The media was found to highlight consumer mistrust in the profession in recent years. Increased regulation of the profession of audiology is recommended to protect the population against exploitative practices and to renew faith in the profession by the public.

Effect on Antimicrobial Resistance of a Policy Restricting Over-the-Counter Antimicrobial Sales in a Large Metropolitan Area, São Paulo, Brazil.

Although restricting over-the-counter (OTC) antimicrobial drug sales is recommended globally, no data track its effect on antimicrobial resistance (AMR) in bacteria. We evaluated the effect of a national policy restricting OTC antimicrobial sales, put in place in November 2010, on AMR in a metropolitan region of São Paulo, Brazil. We reviewed associations between antimicrobial sales from private pharmacies and AMR in 404,558 Escherichia coli and 5,797 Streptococcus pneumoniae isolates using a dynamic regression model based on a Bayesian approach. After policy implementation, a substantial drop in AMR in both bacterial species followed decreased amoxicillin and trimethoprim/sulfamethoxazole sales. Conversely, increased ciprofloxacin sales were associated with increased ciprofloxacin resistance, and extended spectrum ß-lactamases-positive E. coli isolates and azithromycin sales increases after 2013 were associated with increased erythromycin resistance in S. pneumoniae isolates. These findings suggest that restricting OTC antimicrobial sales may influence patterns of AMR, but multifaceted approaches are needed to avoid unintended consequences.

Changes in telepsychiatry regulations during the COVID-19 pandemic: 17 countries and regions' approaches to an evolving healthcare landscape.

BACKGROUND: During the COVID-19 pandemic, the use of telemedicine as a way to reduce COVID-19 infections was noted and consequently deregulated. However, the degree of telemedicine regulation varies from country to country, which may alter the widespread use of telemedicine. This study aimed to clarify the telepsychiatry regulations for each collaborating country/region before and during the COVID-19 pandemic. METHODS: We used snowball sampling within a global network of international telepsychiatry experts. Thirty collaborators from 17 different countries/regions responded to a questionnaire on barriers to the use and implementation of telepsychiatric care, including policy factors such as regulations and reimbursement at the end of 2019 and as of May 2020. RESULTS: Thirteen of 17 regions reported a relaxation of regulations due to the pandemic; consequently, all regions surveyed stated that telepsychiatry was now possible within their public healthcare systems. In some regions, restrictions on prescription medications allowed via telepsychiatry were eased, but in 11 of the 17 regions, there were still restrictions on prescribing medications via telepsychiatry. Lower insurance reimbursement amounts for telepsychiatry consultations v. in-person consultations were reevaluated in four regions, and consequently, in 15 regions telepsychiatry services were reimbursed at the same rate (or higher) than in-person consultations during the COVID-19 pandemic. CONCLUSIONS: Our results confirm that, due to COVID-19, the majority of countries surveyed are altering telemedicine regulations that had previously restricted the spread of telemedicine. These findings provide information that could guide future policy and regulatory decisions, which facilitate greater scale and spread of telepsychiatry globally.

The Effect of Biosimilar Prescription Targets for Erythropoiesis-Stimulating Agents on the Prescribing Behavior of Physicians in Germany.

OBJECTIVES: This study aimed to aid decision makers by analyzing the impact of introducing biosimilar prescription targets on physician prescribing behavior in the prescription of biologic erythropoiesis-stimulating agents in Germany. METHODS: We combined secondary data of regional level biosimilar prescription targets and secondary data of routinely collected claims data of dispensed prescriptions by physicians operating within the statutory health insurance system in ambulatory care across 7 German regions from 2009 to 2015. Two-way fixed-effects regression analysis was used to identify the average treatment effect of introducing biosimilar prescription targets at the physician level. The main outcome of interest was the share of biosimilar prescriptions on all prescriptions within the substance group. We compared 6 regions that introduced biosimilar prescription targets with 1 region without any prescription target policy. RESULTS: Introducing biosimilar prescription targets increased the average share of biosimilars between 6 percentage points (P < .05) in Hamburg and up to 20 percentage points (P < .001) in Saxony-Anhalt. Stratification of specialists by prescription volume and adoption status indicated heterogeneous effects. We identified similar but higher effects for high-volume prescribers. Disentangling of effects with regard to the composition of biosimilar share suggested that the increase in biosimilar share was driven by increased biosimilar use accompanied by a nonsignificant decrease in original biologics prescriptions. CONCLUSIONS: Prescription targets to alter physician prescribing behavior meet their intended goals by increasing biosimilar share. Physicians partly responded to the policy by decreasing overall prescriptions of the target substance. Prescription targets might be a useful tool, but decision makers need to consider all aspects of potential responses.

Artificial intelligence in medico-dental diagnostics of the face: a narrative review of opportunities and challenges.

OBJECTIVES: This review aims to share the current developments of artificial intelligence (AI) solutions in the field of medico-dental diagnostics of the face. The primary focus of this review is to present the applicability of artificial neural networks (ANN) to interpret medical images, together with the associated opportunities, obstacles, and ethico-legal concerns. MATERIAL AND METHODS: Narrative literature review. RESULTS: Narrative literature review. CONCLUSION: Curated facial images are widely available and easily accessible and are as such particularly suitable big data for ANN training. New AI solutions have the potential to change contemporary dentistry by optimizing existing processes and enriching dental care with the introduction of new tools for assessment or treatment planning. The analyses of health-related big data may also contribute to revolutionize personalized medicine through the detection of previously unknown associations. In regard to facial images, advances in medico-dental AI-based diagnostics include software solutions for the detection and classification of pathologies, for rating attractiveness and for the prediction of age or gender. In order for an ANN to be suitable for medical diagnostics of the face, the arising challenges regarding computation and management of the software are discussed, with special emphasis on the use of non-medical big data for ANN training. The legal and ethical ramifications of feeding patients' facial images to a neural network for diagnostic purposes are related to patient consent, data privacy, data security, liability, and intellectual property. Current ethico-legal regulation practices seem incapable of addressing all concerns and ensuring accountability. CLINICAL SIGNIFICANCE: While this review confirms the many benefits derived from AI solutions used for the diagnosis of medical images, it highlights the evident lack of regulatory oversight, the urgent need to establish licensing protocols, and the imperative to investigate the moral quality of new norms set with the implementation of AI applications in medico-dental diagnostics.

Moving in the right direction: tobacco packaging and labeling in the Americas.

Objectives: To assess the adoption of tobacco packaging and labeling policies based on the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC)'s Article 11 guidelines, in the WHO Region of the Americas (AMRO). Methods: We reviewed tobacco control laws in AMRO from the Campaign for Tobacco-Free Kids' Tobacco Control Laws database. We analyzed four sub-policy areas for smoked and smokeless tobacco products: 1) health warning labels (HWLs), 2) constituents and emissions (C&Es), 3) misleading tobacco packaging and labeling, and 4) standardized "plain" packaging. Results: Of 35 countries in AMRO, 31 have tobacco packaging and labeling laws. Twenty-six countries require pictorial HWLs, 24 require warnings printed on at least 50% of the front and back of the packs, and 24 rotate a single or multiple (from 2 to 16) warnings within a specified period (from 5 up to 24 months). Only 21 countries require descriptive messages on toxic C&Es information. Twenty-seven countries ban brand descriptors with references to implied harm reduction (e.g., "light"), 24 ban figures, colors, and other signs, but only 13 prohibit emission yields printed on the packs. Only Canada and Uruguay have adopted standardized tobacco packaging while Uruguay also requires a single presentation (one brand variant) per brand family. Conclusion: Many countries in AMRO have made good progress in adopting multiple, rotating, large pictorial HWLs and banning misleading brand descriptors. However, there needs to be greater attention on other tobacco packaging and labeling provisions with a focus on implementing standardized tobacco packaging.

Overcoming tobacco industry opposition to standardized packaging in the Americas.

Countries in the Region of the Americas have been slow to adopt standardized packaging of tobacco products. The objectives of this analysis are to report on the progress made in adopting such packaging in countries in the Region, review known tobacco industry strategies for opposing these policies and discuss the resources available to academics, advocates and policy-makers who might be interested in advancing the use of standardized packaging in the Region. Of the 23 countries worldwide that have fully adopted standardized packaging laws, only 2 are in the Region (Canada and Uruguay). Six other countries (Brazil, Chile, Costa Rica, Ecuador, Mexico and Panama) have tried to introduce standardized packaging through draft bills, all of which have been delayed or withdrawn. There are indications that the tobacco industry has used its playbook of arguments to oppose the policy in those countries, including allegations that standardized packaging breaches national laws and international treaties protecting intellectual property, alongside threats of litigation. It is possible that these threats and allegations may have had a greater effect in the Region because of the lengthy (6 years) and costly (legal fees of US$ 10 million) international investment arbitration brought by Philip Morris International against Uruguay's strong tobacco packaging laws. However, all of the industry's arguments have been debunked, and national courts and international legal forums have upheld standardized packaging as a lawful policy. Governments in the Region of the Americas should follow the examples of Canada and Uruguay and reject the industry's false arguments and litigation threats. This analysis discusses some of the financial and technical resources that can assist them.

Los países de la Región de las Américas han tardado en adoptar el empaquetado estandarizado de los productos de tabaco. Los objetivos de este análisis son informar sobre el progreso realizado en la adopción de dicho empaquetado en los países de la Región, revisar las estrategias conocidas de la industria tabacalera para oponerse a estas políticas y abordar los recursos disponibles para la comunidad académica, los defensores de la causa y los responsables de formular las políticas que podrían estar interesados en fomentar el uso del empaquetado estandarizado en la Región. De los 23 países de todo el mundo que han adoptado plenamente leyes sobre el empaquetado estandarizado, solo dos se encuentran en la Región (Canadá y Uruguay). Otros seis países (Brasil, Chile, Costa Rica, Ecuador, México y Panamá) han tratado de introducir empaquetados estandarizados mediante proyectos de ley, los cuales han enfrentado demoras o han sido retirados. En esos países hay indicios de que la industria tabacalera ha recurrido a una cartilla de argumentos para oponerse a esta política, como acusaciones de que los empaquetados estandarizados violan las leyes nacionales y los tratados internacionales que protegen la propiedad intelectual, además de amenazas de litigios. Es posible que estas amenazas y alegatos hayan tenido un mayor efecto en la Región debido al largo (6 años) y costoso (costos legales de US$ 10 millones) arbitraje internacional en el ámbito de las inversiones presentado por Philip Morris International contra las fuertes leyes de empaquetado de tabaco de Uruguay. Sin embargo, todos los argumentos de la industria han sido desacreditados, y los tribunales nacionales y los foros jurídicos internacionales han defendido el empaquetado estandarizado como una política legal. Los gobiernos de la Región de las Américas deben seguir los ejemplos de Canadá y Uruguay y rechazar los argumentos falsos y las amenazas de litigio de la industria. En este análisis se examinan algunos de los recursos financieros y técnicos que pueden ayudarlos.

Os países da Região das Américas têm sido lentos em adotar embalagens padronizadas para produtos de tabaco. Os objetivos desta análise são: informar acerca do progresso feito na adoção de tais embalagens nos países da região; revisar as estratégias conhecidas da indústria do tabaco para se opor a essas políticas; e discutir os recursos disponíveis para acadêmicos, defensores e formuladores de políticas que possam estar interessados em avançar no uso de embalagens padronizadas na região. Dos 23 países do mundo que adotaram leis obrigando o uso de embalagens totalmente padronizadas, apenas 2 estão na região (Canadá e Uruguai). Seis outros países (Brasil, Chile, Costa Rica, Equador, México e Panamá) tentaram introduzir embalagens padronizadas por meio de projetos de lei, os quais foram todos adiados ou retirados. Há indícios de que a indústria do tabaco usou seus argumentos habituais ­ incluindo alegações de que embalagens padronizadas violam leis nacionais e tratados internacionais de proteção à propriedade intelectual, além de ameaças de litígio ­ para se opor às políticas nesses países. É possível que essas ameaças e alegações tenham tido um efeito maior na região devido ao longo (6 anos) e dispendioso (US$ 10 milhões em honorários advocatícios) processo de arbitragem internacional iniciado pela Philip Morris International contra as fortes leis de embalagem de produtos de tabaco do Uruguai. Porém, todos os argumentos da indústria foram desmascarados e tanto os tribunais nacionais como fóruns jurídicos internacionais decidiram em favor da embalagem padronizada como política legal. Os governos da Região das Américas deveriam seguir os exemplos do Canadá e do Uruguai e rejeitar os argumentos falsos e as ameaças de litígio da indústria. Esta análise discute alguns recursos financeiros e técnicos que podem ajudá-los.