The new reporting obligation for Respiratory Syncytial Virus (RSV) in Germany - a critical view.

Background: In summer 2023, mandatory reporting of respiratory syncytial virus (RSV) by name was introduced in Germany. The stated objectives were: to improve the database to prevent overburdening of the healthcare system, to implement targeted, early investigation and action by local health authorities to prevent further spread, and to assess vaccines after the expected approval of RSV vaccination. Methods: These objectives are examined against the background of data from mandatory reporting of RSV in the German federal state of Saxony, which has been required since 2002, and the data from the ARE (acute respiratory diseases) survey in Germany, considering the basic legal requirements and options of the Infection Protection Act, the requirements of the EU Commission for the collection of data on infectious diseases and the recommendations by experts of the European Centre for Disease Prevention and Control (ECDC), the options for individual or general preventive measures by the health authorities and previous experience with the evaluation options of the reported data (especially regarding the effectiveness of vaccinations). Results and discussion: An extrapolation of the previously reported data from Saxony to the whole of Germany shows that over 100,000 reports per year must be expected (more than the reports of both rota and noroviruses together). Neither the requirements of the EU Commission nor the views of an expert group of the ECDC recommend mandatory RSV reporting. Mandatory reporting by name is also not appropriate from a legal perspective. A sentinel, which is also better suited to assessing vaccinations, would be more appropriate to avoid unnecessarily overburdening the health authorities. In addition, initial experience with wastewater sentinels for RSV has shown that they may be used to record local and regional RSV infections - albeit without information on the severity of the disease and thus the burden on the healthcare system.Against this background, mandatory reporting of RSV does not appear to be appropriate. Instead, the existing sentinels should be continued and further expanded, possibly supplemented by RSV wastewater monitoring.

[Hot weather and health risks in the focus of the Hessian health authorities : Inspection and consultation of residential care and nursing facilities since 2004]. / Hitzeschutz im Fokus der hessischen Betreuungs- und Pflegeaufsicht : Beratung und Prüfung stationärer Einrichtungen seit dem Jahr 2004.

BACKGROUND AND AIMS: Heat extremes are associated with considerable health risks, especially for vulnerable groups. To counteract these risks, public health policy calls for protective measures to be linked to heat warnings. Such links do not generally exist in Germany, with the exception of the heat inspections and consultations carried out by the Hessian health authorities since 2004. The aims of this work were to identify the structures and processes of the Hessian heat inspections and heat consultations and to derive findings for acute response to heat in residential care and nursing facilities. METHODS: We conducted 14 qualitative, semi-structured interviews with experts from the Hessian health authorities as well as with managers of residential care and nursing facilities. The analysis of the interview protocols was carried out using content-structuring qualitative content analysis. In addition, documents from the supervisory authority were analyzed. RESULTS: Every year, up to 370 heat inspections are carried out in the approximately 2500 inpatient facilities in Hesse. They are either integrated into already planned inspections or carried out separately; they focus on preventive and acute measures. In principle, heat protection can be easily integrated into the daily routine of residential health facilities. High staff turnover and lack of resources pose challenges. DISCUSSION: Inspections and consultations on heat management raise awareness of hot weather health risks and support the establishment of preventive measures. The Hessian system is a suitable orientation for other federal states.

Evaluation of mpox contact tracing activities and data collection in EU/EEA countries during the 2022 multicountry outbreak in nonendemic countries.

To control human-to-human mpox transmission during the 2022 outbreak, European Union (EU)/European Economic Area (EEA) countries conducted case investigation and contact tracing (CT). We aimed to provide an overview of CT activities, describe CT data collection practices, and identify related facilitators, barriers, and potential opportunities for improvement. Between April 03, 2023 and May 12, 2023, a survey was distributed to CT stakeholders in 30 EU/EEA countries, asking about mpox CT activities and data collection and requesting to rank enablers, barriers, and improvements for CT on a five-point Likert scale. The 139 respondents from 27 countries indicated having performed case investigations (96%, n = 133), backward CT (88%, n = 122), forward CT (87%, n = 121), and follow-up on contacts' outcomes (77%, n = 107). Sixty percent (n = 80/134) used standardized data collection forms and 73% (n = 91/124) used databases. The highest-rated enablers were clear guidelines (mean = 3.9), quick access to laboratory results (3.6), and sufficient expertise (3.6). Highly rated barriers were inability to contact contacts (3.0) or cases (2.5) and lack of staff (2.4). The most needed improvements were availability of staff (3.5), expertise on affected populations (3.4) and data reporting tools and systems (3.3). To improve CT of mpox and diseases with similar transmission patterns, EU/EEA countries should increase workforce capacity in public and sexual health, offer training on CT operations and communication with affected communities, and use common CT data collection tools and systems.

Food-borne botulism outbreak during the Rugby World Cup linked to marinated sardines in Bordeaux, France, September 2023.

In September 2023, a botulism outbreak affecting 15 individuals occurred in Bordeaux, France, during the Rugby World Cup. We report on eight individuals from four different countries on two continents admitted to the intensive care unit at our hospital, where six required invasive mechanical ventilation. Cases reported consuming locally produced canned sardines at a restaurant. This report highlights the importance of rapid, worldwide alerts from health authorities to prevent severe consequences of such outbreaks, particularly during events attracting international visitors.

REIN: a tool at the service of health authorities / REIN : un outil au service des administrations sanitaires

On the occasion of the 20th anniversary of the REIN (French Renal Epidemiology and Information Network), a summary work on the contributions of the national French ESKD register was carried out. On the issue of its link with health authorities, the following key messages were retained. One of the purposes of REIN is to contribute to a better understanding about patient management and its evolution, and thus to be called upon to develop health strategies aimed at improving the prevention and treatment of chronic renal failure. Indeed, the planning of the supply and the evaluation of the treatment are important issues for the public health decision-makers who must have the relevant indicators and tools to help them in their decision-making and follow-up processes. REIN is clearly identified as a source of information by institutional partners, as is shown by the various requests made by the Regional health agencies (ARS), the French National Authority for Health (HAS) and the General Directorate for Healthcare Services (DGOS), as well as other health authorities. It allows estimating the needs of the population within the framework of decree nos. 2002-1197 and 2002-1198 of September 2002 relating to the treatment of chronic renal failure by renal dialysis. The recent possibility of probabilistic matching of REIN data with the data from the National Healthcare Data System (SNDS) for a pseudonymised individual allows for more detailed studies on the different care pathways, as well as evaluating the impact of the different actions or experiments that are set up, with the help of detailed clinical information from the REIN and, among other things, the expenses reimbursed by the Health Insurance.

À l'occasion des 20 ans du REIN (Réseau Epidémiologie et Information en Néphrologie), un travail de synthèse sur les apports du registre a été mené. Sur la question de ses liens avec les administrations sanitaires, les messages clés suivants ont été retenus. Une des finalités de REIN est de contribuer à mieux connaître la prise en charge des patients et de ses évolutions et ainsi être sollicité pour l'élaboration de stratégies sanitaires visant à améliorer la prévention et la prise en charge de l'insuffisance rénale chronique. En effet, la planification de l'offre et l'évaluation de la prise en charge sont des enjeux importants pour les décideurs en santé publique qui doivent disposer d'indicateurs et d'outils pertinents pour les aider dans leur décision avec leur suivi. REIN est clairement identifié comme source d'information par les partenaires institutionnels comme en témoignent les diverses sollicitations faites par les agences régionales de santé (ARS), la Haute Autorité de santé (HAS) ou la Direction générale de l'offre de soins (DGOS) mais également d'autres administrations sanitaires. Il permet d'estimer les besoins de la population dans le cadre des décrets nos 2002-1197 et 2002-1198 septembre 2002 relatifs au traitement de l'insuffisance rénale chronique par la pratique de l'épuration extrarénale. La récente possibilité d'appariement probabiliste des données de REIN aux données du Système national des données de santé (SNDS) pour un même individu pseudonymisé permet des études plus fines sur les différents parcours de soins, mais aussi d'évaluer l'impact des différentes actions ou expérimentations mises en place, avec l'aide des informations cliniques détaillées du REIN et, entre autres, les dépenses remboursées par l'Assurance maladie.

Walking the talk in digital transformation of regulatory review.

Cloud-based regulatory platforms have the potential to substantially transform how regulatory submissions are developed, transmitted, and reviewed across the full life cycle of drug development. The benefits of cloud-based submission and review include accelerating critical therapies to patients in need globally and efficiency gains for both drug developers and regulators. The key challenge is turning the theoretical promise of cloud-based regulatory platforms into reality to further the application of technology in the regulatory processes. In this publication we outline regulatory policy journeys needed to effect the changes in the external environment that would allow for use of a cloud-based technology, discuss the prerequisites to successfully navigate the policy journeys, and elaborate on future possibilities when adoption of cloud-based regulatory technologies is achieved.

How did Chinese public health authorities promote COVID-19 vaccination on social media? A content analysis of the vaccination promotion posts.

Objective: Drawing upon the health belief model, this study aims to analyze the message characteristics of coronavirus disease 2019 (COVID-19) vaccination promotion messages posted by influential Chinese public health institutions and how those characteristics affect audiences' participative engagement on Weibo, which is a popular social media site in China. Methods: Two Chinese phrases for the COVID-19 vaccine were adopted as search terms to retrieve qualified posts on Weibo from 1 December 2019 to 18 March 2023. A total of 2546 posts by the top nine most impactful public health institutions were retained for quantitative content analysis. Message characteristics derived from the health belief model and participative engagement indicators were coded by the authors. Results: Among health belief model constructs, the collective-oriented constructs (i.e., benefits, cues to action, and susceptibility) appeared in almost half of the posts, while the individual-oriented constructs (i.e., barriers, self-efficacy, and severity) were mentioned less. Moreover, negative binomial regression models revealed that collective-oriented constructs and self-efficacy facilitated engagement, while other constructs played impeding roles. Conclusions: Appearances and functions of the health belief model's constructs in the COVID-19 vaccination promotion context are closely associated with China's collectivistic culture. Furthermore, constructs conforming to people's psychological traits are likely to promote public engagement and may facilitate vaccination behavior.

Trustworthiness Over Time on Twitter: Three Critical Periods for the Norwegian Health Authorities and Political Leadership During the COVID-19 Pandemic.

Public health authorities and political leaders need to come across as trustworthy in their handling of a crisis like the COVID-19 pandemic. There is, however, little knowledge about how the affordances and dynamics of social media influence perceptions of trustworthiness, especially during a protracted crisis. In this article, we study how Twitter users were discussing the trustworthiness of the Norwegian health authorities and political leadership throughout three periods of partial lockdown during the COVID-19 pandemic. Across all the periods, there was a substantial number of positive comments, but these were outweighed by negative ones. Ability was clearly the most discussed factor for trustworthiness, and many users offered up their lay expertise. Discussions of integrity and benevolence were less frequent and mostly negative when they occurred. An increase in negative comments during the last period might be read as an expression of fatigue, and there was a noted dissatisfaction with the ability of the political leadership. Taken together, the study suggests Twitter to be an arena where users are exposed to arguments and counterarguments in negotiations over ability in particular. Such discussions can intensify as a crisis drags on and are important to grasp for health authorities and political leadership alike. Thus, the study sheds light on the contribution that a socio-technical platform like Twitter makes to the discursive formation of trustworthiness over time, which in turn might function to strengthen or erode public trust in public authorities and political leadership.

A Structured Benefit-Risk Assessment Operating Model for Investigational Medicinal Products in the Pharmaceutical Industry.

Robust and transparent formal benefit-risk (BR) analyses for medicinal products represent a means to better understand the appropriate use of medicinal products, and to maximize their value to prescribers and patients. Despite regulatory and social imperatives to conduct structured BR (sBR) assessments, and the availability of a plethora of methodological tools, there exists large variability in the uptake and execution of sBR assessments among pharmaceutical companies. As such, in this paper we present an sBR assessment framework developed and implemented within a large global pharmaceutical company that aims to guide the systematic assessment of BR across the continuum of drug development activities, from first-time-in-human studies through to regulatory submission. We define and emphasize the concepts of Key Clinical Benefits and Key Safety Risks as the foundation for BR analysis. Furthermore, we define and foundationally employ the concepts of sBR and a Core Company BR position as the key elements for our BR framework. We outline 3 simple stages for how to perform the fundamentals of an sBR analysis, along with an emphasis on the weighting of Key Clinical Benefits and Key Safety Risks, and a focus on any surrounding uncertainties. Additionally, we clarify existing definitions to differentiate descriptive, semi-quantitative, and fully quantitative BR methodologies. By presenting our framework, we wish to stimulate productive conversation between industry peers and health authorities regarding best practice in the BR field. This paper may also help facilitate the pragmatic implementation of sBR methodologies for organizations without an established framework for such assessments.

Safety Surveillance During Drug Development: Comparative Evaluation of Existing Regulations.

Drug safety monitoring is essential for developing efficient and safe treatments. It starts with preclinical toxicology studies and continues with the observation and analysis of potentially harmful effects in humans throughout the whole drug life cycle. Safety surveillance during the clinical phase is of paramount importance for protecting the health of clinical trial (CT) participants at a period when relatively little is known about the drug safety profile, and for reassuring that detected risks are minimized when the product obtains marketing approval. This review aimed to investigate current safety surveillance methods during drug development worldwide, in order to identify potential gaps and opportunities for amelioration. To this end, international guidelines, standards, and local legislations about CTs were reviewed and compared. Our review revealed common strategies, mainly in alignment with international guidelines, especially concerning the systematic collection, assessment, and expedition of adverse events by investigators and sponsors and the preparation of periodic aggregate safety reports by sponsors, as a means to inform health authorities (HAs) about the evolving benefit-risk balance of the investigational product. Inconsistencies in safety surveillance mainly concerned local expedited reporting requirements. Significant gaps were identified in the methodologies for aggregate analyses and the responsibilities of HAs. Addressing the regulatory discrepancies and harmonizing the safety surveillance processes at a global level would increase the usability of safety data accumulated by clinical studies worldwide, thus enabling and hopefully accelerating the development of safe and efficient drug therapies.

Governing by commissioning services - Implementing alcohol screening and brief interventions in hospital settings in Norway.

Norwegian health services have undergone marked logistical changes in organization and funding over recent decades. One significant change was the new public management-inspired commissioner's document, first issued in 2013 by the Norwegian Ministry of Health and Care Services, to establish medical and surgical departments' identification of patients with underlying substance abuse problems (Ministry of Health and Care Services, 2013). Herein, we investigate how multiple stakeholders and actors, who bear responsibility in regional and local health trusts, have responded to the commissioned services to establish routines for identifying alcohol and substance abuse problems among patients admitted to medical and surgical wards. First, an extensive literature search was conducted. Second, we conducted qualitative interviews with informants who have responsibility for applying the commissioner's document in regional health authorities and local hospitals. The study results demonstrate that responsible actors at all levels take establishing alcohol routines seriously, and that hospitals' self-assessment of their achievements on internal goals indicate that they have made satisfactory progress. Nevertheless, improvement is needed to meet the goal of discussing alcohol use with all patients admitted to medical and surgical wards within local health trusts. Recommendations for the next steps, based on these findings, include further research and training priorities.

Leveraging the regulatory framework to facilitate drug development in Parkinson's disease.

There is an exigent need for disease-modifying and symptomatic treatment approaches for Parkinson's disease. A better understanding of Parkinson's disease pathophysiology and new insights in genetics has opened exciting new venues for pharmacological treatment targets. There are, however, many challenges on the path from discovery to drug approval. These challenges revolve around appropriate endpoint selection, the lack of accurate biomarkers, challenges with diagnostic accuracy, and other challenges commonly encountered by drug developers. The regulatory health authorities, however, have provided tools to provide guidance for drug development and to assist with these challenges. The main goal of the Critical Path for Parkinson's Consortium, a nonprofit public-private partnership part of the Critical Path Institute, is to advance these so-called drug development tools for Parkinson's disease trials. The focus of this chapter will be on how the health regulators' tools were successfully leveraged to facilitate drug development in Parkinson's disease and other neurodegenerative diseases.

[Bavarian online database for corona screening tests-development and use of a digital solution in the pandemic]. / Bayerisches Meldeportal für Corona-Reihenuntersuchungen ­ Entwicklung und Einsatz einer digitalen Lösung in der Pandemie.

During the SARS-CoV­2 pandemic, various data had to be collected to support political decisions for pandemic preparedness and response. Nevertheless, using analogue tools like paper and pencil as well as sending files with media discontinuity that have to be merged later are not useful and can hardly provide usable data in real time. With the selected system architecture, the Bavarian Online Database for Corona Screening Tests (BayCoRei) is a central, Bavaria-wide, consistent digital solution that is agile and easy to use. BayCoRei uses established technical components and interfaces. Apart from this, the support of the individual stakeholders (e.g., health authorities, service providers, and district governments) plays a decisive role in the success of the solution. The present article describes BayCoRei and two other online databases as examples that comprise the technology and architecture that have proven to be (rapidly) deployable and points out the gap between intention and reality regarding pandemic management.

NAFLD and NASH biomarker qualification in the LITMUS consortium - Lessons learned.

Biomarkers have the potential to accelerate drug development, as early indicators of improved clinical response, to improve patient safety, and for personalised medicine. However, few have been approved through the biomarker qualification pathways of the regulatory agencies. This paper outlines how biomarkers can accelerate drug development, and reviews the lessons learned by the EU IMI2-funded LITMUS consortium, which has had several interactions with regulatory agencies in both the US and EU regarding biomarker qualification in patients with non-alcoholic fatty liver disease and non-alcoholic steatohepatitis. Sharing knowledge of such interactions with the scientific community is of paramount importance to increase the chances of qualification of relevant biomarkers that may accelerate drug development, and thereby help patients, across disease indications. A qualified biomarker enables a decision to be made that all understand and support in a common framework.

Racism in public health services: A research agenda.

Despite racism and its impact on health inequities being increasingly studied in health care settings, racism in public health services has so far been neglected in public health research. Studying racism in public health services provides many opportunities to explore the relationship between racism and health protection. We identify several research themes to be explored on (1) non-stigmatizing and community-driven risk communication, (2) surveillance by public health authorities of racialized minority groups, (3) racism experiences in everyday interactions with public health authorities, (4) legal consequences of encounters with public health authorities and (5) public health infrastructure, structural racism and the intersectionality of marginalization. Tackling these research themes will help to start building an evidence base on how racism interferes with equitable health protection and how to dismantle it.

The Outcome- or Cost-Effectiveness Analysis of LUS-Based Care or CXR-Based Care of Neonatal Lung Diseases: The Clinical Practice Evidence from a Level â ¢ NICU in China.

OBJECTIVE: To compare the effect of managing neonatal lung disease with lung ultrasound (LUS) or chest X-ray (CXR) monitoring on health outcomes and cost-effectiveness. METHODS: The data obtained from the NICU of the Beijing Chaoyang District Maternal and Child Healthcare Hospital were used as the study group, as LUS has completely replaced CXR in managing newborn lung disease in the hospital for the past 5 years. The primary outcomes of this study were the misdiagnosis rate of respiratory distress syndrome (RDS), the using status of mechanical ventilation, the incidence rate of bronchopulmonary dysplasia (BPD) and the survival rate in hospitalized infants. The secondary outcomes included the use pulmonary surfactant (PS), and the mortality rate of severe diseases (such as pneumothorax, pulmonary hemorrhage and RDS, etc.). RESULTS: Managing neonatal lung disease with LUS monitoring may enable the following effects: The frequency of ventilator use reducing by 40.2%; the duration of mechanical ventilation reducing by 67.5%; and the frequency of ventilator weaning failure being totally avoided. A misdiagnosis rate of 30% for RDS was also avoided. The dosage of PS was significantly reduced by 50% to 75%. No BPD occurred in the LUS-based care group for 5 years. The fatality rates of RDS, pneumothorax and pulmonary hemorrhage decreased by 100%. The poor prognosis rate of VLBW infants decreased by 85%, and the total mortality rate of hospitalized infants decreased by 90%. Therefore, the cost of LUS-based care was inevitably saved. CONCLUSIONS: Diagnosing and managing neonatal lung diseases with LUS monitoring have significant benefits, and this technology should be widely promoted and applied around the world.

The Utility of an Online Forward Triage Tool During the SARS-CoV-2 Pandemic: Health Care Provider and Health Authority Perspectives.

Introduction: The SARS CoV-2 pandemic poses major challenges not only to patients but also to health care professionals and policy-makers, with rapidly changing, sometimes complex, recommendations, and guidelines to the population. Online forward triage tools (OFTT) got a major boost from the pandemic as they helped with the implementation and monitoring of recommendations. Methods: A multiphase mixed method sequential explanatory study design was employed. Quantitative data were collected first and informed the qualitative interview guides. Video interviews were held with key informants (health care providers and health authorities) between 2 September and 10 December 2020. Audio-recordings were transcribed verbatim, coded thematically and compared with patient perspectives (framework). Objectives: To explore the perspectives of health care providers and authorities in Canton Bern on the utility of a COVID-19 OFTT, as well as elicit recommendations for telehealth in future. Results: The following themes emerged; (i) accessibility (ii) health system burden reduction (iii) utility in preventing onward transmission (iv) utility in allaying fear and anxiety (v) medical decision-making utility (vi) utility as information source (vii) utility in planning and systems thinking. The health care providers and health authorities further provided insights on potential barriers and facilitators of telehealth in future. Conclusion: Similar to patients, health care providers acknowledge the potential and utility of the COVID-19 OFTT particularly as an information source and in reducing the health system burden. Data privacy, doctor-patient relationship, resistance to change, regulatory, and mandate issues, and lack of systems thinking were revealed as barriers to COVID-19 OFTT utility.

[Approval of CoronaVac in Brazil and Chile: some lessons on vaccine regulatory challengesA aprovação da CoronaVac no Brasil e no Chile: algumas lições sobre os desafios regulatórios de vacinas]. / La aprobación de CoronaVac en Brasil y Chile: algunas lecciones sobre los retos regulatorios de vacunas.

This analysis compares and systematizes some of the milestones (between December 2020 and October 2021) in the approval by Brazil and Chile of the CoronaVac vaccine made by the Chinese laboratory Sinovac, with regard to how the efficacy and immunogenicity of the vaccine was determined. To this end, a comprehensive analysis was conducted of official public documentation of the vaccine's approval in both countries; likewise, relevant technical articles on the subject, as well as dissemination and discussion in the media were considered. In both cases, a wide range of private and public actors expressed clearly competing interests in the measurement and dissemination of figures on the vaccine's efficacy. This reveals the challenges that middle-income countries face-and will continue to face-when certifying the quality of products in a pandemic period, and the need to institutionally strengthen regulatory authorities to ensure a sound and accurate evaluation of vaccine quality, in terms of safety and efficiency.

Esta análise compara e sistematiza alguns marcos da aprovação, no Brasil e no Chile, da vacina CoronaVac, do laboratório chinês Sinovac, de dezembro de 2020 a outubro de 2021, especificamente sobre como sua eficácia e imunogenicidade foram fundamentadas. Para tanto, foi realizada uma análise exaustiva da documentação pública oficial sobre a aprovação da vacina em ambos os países. Da mesma forma, foram considerados artigos técnicos pertinentes sobre o assunto, e divulgações e discussões realizadas na mídia. Em ambos os casos, uma disputa de interesses de uma ampla gama de atores privados e públicos em torno da medição e divulgação dos números referentes à eficácia foi claramente expressa. Isso permite visualizar os enormes desafios que os países de renda média enfrentam e enfrentarão para certificar a qualidade dos produtos em um contexto epidemiológico de pandemia e a necessidade de fortalecer institucionalmente as autoridades reguladoras para viabilizar uma avaliação íntegra e acertada da qualidade das vacinas em relação a sua segurança e eficiência.

Face masks on Instagram: an analysis of public health authorities' guidance toward prevention.

Instagram (IG) has been used as a health promotion tool by national and international sanitary authorities to tackle COVID-19. The profile of the World Health Organization (WHO) on IG contributed to spread and update information on the new coronavirus prevention This study focus attention on a non-pharmaceutical control measure (face mask in the community) and discusses the adaptation of health authorities from Portugal and Brazil to WHO guidelines on this topic, and how they passed them to citizens. A content analysis of posts from WHO, Portuguese National Health Service (NHS), and the Brazilian Ministry of Health (MH) profiles on IG was carried out, in the first 100 days of the pandemic. The sample is composed of 65 posts - WHO (12), NHS (36) and, MH (17). NHS highlights masks in 8,8% of posts and MH in 3,3%. WHO guidelines followed scientific evidence and prioritized the surgical masks, while NHS and MH adapted the guidelines to regional scenarios (community transmission and difficulty to social distancing) and produced information on non-surgical masks. NHS recommends the use of certified non-surgical masks. MH diverged from WHO guidelines and advised cloth masks. NHS has adopted the preventive approach and the use of celebrities to stress the importance of following its guidelines. MH adopted an institutional approach to encourage adherence to the instructions. Both profiles offered incomplete content on the production, use, disposal, and maintenance of masks.