RESUMO
Food and nonalcoholic beverage marketing is implicated in poor diet and obesity in children. The rapid growth and proliferation of digital marketing has resulted in dramatic changes to advertising practices and children's exposure. The constantly evolving and data-driven nature of digital food marketing presents substantial challenges for researchers seeking to quantify the impact on children and for policymakers tasked with designing and implementing restrictive policies. We outline the latest evidence on children's experience of the contemporary digital food marketing ecosystem, conceptual frameworks guiding digital food marketing research, the impact of digital food marketing on dietary outcomes, and the methods used to determine impact, and we consider the key research and policy challenges and priorities for the field. Recent methodological and policy developments represent opportunities to apply novel and innovative solutions to address this complex issue, which could drive meaningful improvements in children's dietary health.
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Bebidas , Marketing , Humanos , Criança , Marketing/métodos , Alimentos , Política Nutricional , Indústria Alimentícia , Dieta , Obesidade Infantil/prevenção & controleRESUMO
We analyze the transition from innovative ideas to final marketed products. This transition occurs through two synergetic supply chains for innovation and products. Basic concepts are developed, tested, upscaled, and introduced to commercial use in the innovation supply chain. Then, the products are produced and delivered to the consumer through the product supply chain. We argue that product markets trace their birth to product innovations. These markets tend to start as noncompetitive, which rewards innovators. Credit access and risk determine the reliance on contracting and product diffusion over space and time. The innovation and product supply chains are encouraged and facilitated by public policies, such as support for research and education, intellectual property rights protection, low barriers to trade, science-based regulation, and well-functioning capital markets. We argue for multidisciplinary research incorporating knowledge from economics, business, and engineering to better understand the evolution of innovative companies and supply chains. This understanding will help the development of policies to address challenges of climate change and food security among others.
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Recursos NaturaisRESUMO
BACKGROUND & AIMS: Chronic liver disease (CLD) causes 1.8% of all deaths in Europe, many of them from liver cancer. We estimated the impact of several policy interventions in France, the Netherlands, and Romania. METHODS: We used a validated microsimulation model to assess seven different policy scenarios in 2022-2030: a minimum unit price (MUP) of alcohol of 0.70 or 1, a volumetric alcohol tax, a sugar-sweetened beverage (SSB) tax, food marketing restrictions, plus two different combinations of these policies compared against current policies (the 'inaction' scenario). RESULTS: All policies reduced the burden of CLD and liver cancer. The largest impact was observed for a MUP of 1, which by 2030 would reduce the cumulative incidence of CLD by between 7.1% to 7.3% in France, the Netherlands, and Romania compared with inaction. For liver cancer, the corresponding reductions in cumulative incidence were between 4.8% to 5.8%. Implementing a package containing a MUP of 0.70, a volumetric alcohol tax, and an SSB tax would reduce the cumulative incidence of CLD by between 4.29% to 4.71% and of liver cancer by between 3.47% to 3.95% in France, the Netherlands, and Romania. The total predicted reduction in healthcare costs by 2030 was greatest with the 1 MUP scenario, with a reduction for liver cancer costs of 8.18M and 612.49M in the Netherlands and France, respectively. CONCLUSIONS: Policy measures tackling primary risk factors for CLD and liver cancer, such as the implementation of a MUP of 1 and/or a MUP of 0.70 plus SSB tax could markedly reduce the number of Europeans with CLD or liver cancer. IMPACT AND IMPLICATIONS: Policymakers must be aware that alcohol and obesity are the two leading risk factors for chronic liver disease and liver cancer in Europe and both are expected to increase in the future if no policy interventions are made. This study assessed the potential of different public health policy measures to mitigate the impact of alcohol consumption and obesity on the general population in three European countries: France, the Netherlands, and Romania. The findings support introducing a 1 minimum unit price for alcohol to reduce the burden of chronic liver disease. In addition, the study shows the importance of targeting multiple drivers of alcohol consumption and obesogenic products simultaneously via a harmonized fiscal policy framework, to complement efforts being made within health systems. These findings should encourage policymakers to introduce such policy measures across Europe to reduce the burden of liver disease. The modeling methods used in this study can assist in structuring similar modeling in other regions to expand on this study's findings.
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Doenças do Sistema Digestório , Neoplasias Hepáticas , Humanos , Impostos , Consumo de Bebidas Alcoólicas/efeitos adversos , Consumo de Bebidas Alcoólicas/epidemiologia , Consumo de Bebidas Alcoólicas/prevenção & controle , Obesidade/epidemiologia , Obesidade/prevenção & controle , Etanol , Políticas , Custos de Cuidados de Saúde , Neoplasias Hepáticas/epidemiologia , Neoplasias Hepáticas/etiologia , Neoplasias Hepáticas/prevenção & controleRESUMO
BACKGROUND: Cell and gene therapy products (CGTPs) often receive accelerated approvals, lacking comprehensive long-term safety and efficacy data, which can raise significant safety concerns. This research aims to study the post-marketing surveillance (PMS) of CGTPs in the European Union (EU), the United States (US), Japan, South Korea, and China, to offer insights for the development of a secure and standardized post-marketing regulatory framework for CGTPs. METHODS: Related regulations and the implementation effect of PMS for approved CGTPs were studied searching PubMed, CNKI, and the official websites of the European Medicines Agency, the US Food and Drug Administration, Japan's Pharmaceuticals and Medical Device Agency, South Korea's Ministry of Food and Drug Safety, and the National Medical Products Administration of China. RESULTS: Compared to those in China, the guidelines of PMS for CGTPs in the EU, the US, Japan, and South Korea was more comprehensive. Notably, the EU had dedicated regulations and supporting guidelines of PMS. Of the 26 CGTPs approved in the EU, 88% were under additional monitoring, 38% received conditional marketing authorization, and 12% were authorized under exceptional circumstances, with 77% designated as orphan drugs. The US had released 34 guidelines specifically for CGTPs which, forming the foundation of post-marketing risk management. Among the 27 CGTPs approved in the US, 22% were required to perform risk evaluation and mitigation strategies, 37% added black box warnings in the package inserts, 63% mandated to post-marketing requirements, and 15% subject to post-marketing commitments. In Japan, stringent supervision measures encompassing all-case surveillance (79%) and re-examination (53%) were applied to the 19 approved CGTPs, with 21% approved through conditional and time-limited approval. The PMS for CGTPs in South Korea, mainly included PSUR, re-examination, and re-evaluation. China had introduced several relevant regulations, which consisted of general statements and lacked detailed guidance. CONCLUSIONS: This study demonstrates that the regulatory policies of PMS for CGTPs in the EU, the US, Japan, and South Korea were comprehensive. The implementation of PMS for CGTPs in the EU, the US, and Japan was well developed. This knowledge holds valuable insights for China's future learning and development in this field.
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União Europeia , Terapia Genética , Vigilância de Produtos Comercializados , China , Estados Unidos , Humanos , Japão , Terapia Genética/legislação & jurisprudência , República da Coreia , Terapia Baseada em Transplante de Células e Tecidos/métodosRESUMO
Fifteen years ago, public health experts urged industry, governments, and advocates to take action to dramatically improve the unhealthy food-marketing environment surrounding children in order to address the global childhood obesity crisis. Since then, research has confirmed that food marketing to children has far-reaching negative effects on their diets and health, takes advantage of adolescent vulnerabilities, and contributes to health disparities. In addition, digital marketing has profoundly changed young people's engagement with brands. Moreover, reliance on industry self-regulation as a solution has proven ineffective. Government-led policies have been more successful, but they remain limited in scope and challenging to adopt and implement. New approaches are necessary to increase public and policy maker awareness that food marketing is more than a nuisance, that it threatens the long-term health of children and adolescents worldwide, and that meaningful governmental action is urgently required to curtail industry's negative impact on young people's well-being.
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Indústria Alimentícia , Marketing , Obesidade Infantil , Saúde Pública , Humanos , Obesidade Infantil/prevenção & controle , Criança , AdolescenteRESUMO
Gene therapy is a fast-growing field showing great potential to treat genetic diseases and cancer. With accelerating gene therapy development and approval, their environment risk assessment (ERA) becomes increasingly important. An ERA is an assessment of the risks to human health and the environment upon exposure to a medicinal product as the result of its release during clinical development or after entering the market. Because ERA is an important component of regulatory submission, drug developers must perform a robust assessment to ensure the safety of unintended persons, animal, plants, microorganisms and environment at large. Global regulations on gene therapy ERA continue to evolve. Gene therapy ERAs are carried out according to general principles as provided in regulatory guidelines for application of clinical trials and marketing authorizations. The current review intends to summarize regulations and content requirements on gene therapy ERA in European Union, the USA and Japan. The approved gene therapy products by EMA and US Food and Drug Administration are analyzed for the critical aspects of their ERAs to provide the current status and practice of gene therapy ERAs by drug developers. For this purpose, the main contents of these gene therapy ERAs are summarized. Critical safety factors of gene therapy ERAs are described. With more experience and knowledge to be accumulated, gene therapy ERAs are expected to be less challenging with commonly used viral vectors.
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Terapia Genética , Terapia Genética/métodos , Terapia Genética/efeitos adversos , Humanos , Medição de Risco , Animais , Estados Unidos , União EuropeiaRESUMO
BACKGROUND: Emicizumab is used as a subcutaneous prophylaxis for prevention of bleeding episodes in patients with haemophilia A (HA) with and without inhibitors. While low bleeding rates were observed in clinical trials, patients still experience breakthrough bleeds (BTBs) with emicizumab in the real-world. Current guidelines recommend use of recombinant activated factor VII (rFVIIa) for treatment of BTBs in patients with inhibitors. Due to thrombotic events observed in the HAVEN 1 study, activated prothrombin complex concentrate (aPCC) should be used with caution. OBJECTIVES: The objective of this review is to identify and discuss real-world data on the frequency of BTBs and the safety of concomitant rFVIIa use in patients with inhibitors on emicizumab prophylaxis. METHODS: A search of the following databases was conducted on 15 July 2022: BIOSIS Previews® , Current Contents Search® , Embase® , MEDLINE® . Search terms included 'real world', 'haemophilia A', and 'emicizumab'. RESULTS AND CONCLUSIONS: Eleven relevant publications were identified (seven original research articles and four congress abstracts). The frequency of BTBs specifically for HA patients with inhibitors was described in three publications with 5%-56% patients on emicizumab reporting ≥1 bleeding episode. Treatment of these BTBs appeared to be managed according to relevant guidelines. Importantly, no thrombotic complications occurred during concomitant rFVIIa use. Due to the nature of real-world studies, direct comparison of the results between studies is limited. However, real-world data show that BTBs in inhibitor patients during emicizumab prophylaxis can be safely treated with rFVIIa.
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Anticorpos Biespecíficos , Anticorpos Monoclonais Humanizados , Hemofilia A , Trombose , Humanos , Fator VIIa/uso terapêutico , Hemofilia A/tratamento farmacológico , Hemorragia/prevenção & controle , Fator VIII/uso terapêutico , Anticorpos Biespecíficos/uso terapêutico , Trombose/complicações , Proteínas RecombinantesRESUMO
BACKGROUND: Previous community-wide physical activity trials have been criticized for methodological limitations, lack of population-level changes, and insufficient reach among underserved communities. Social marketing is an effective technique for community-wide behavior change and can coincide with principles of community-based participatory research (CBPR). PURPOSE: A systematic scoping review of community-wide interventions (system-level) targeting physical activity and/or weight loss was conducted to (i) describe and critically discuss how social marketing strategies are implemented; (ii) identify which populations have been targeted, including underserved communities; (iii) evaluate the use of CBPR frameworks; (iv) assess retention rates; and (v) identify gaps in the literature and formulate future recommendations. METHODS: Eligible studies included those that: aimed to improve physical activity and/or weight loss on a community-wide level, used social marketing strategies, and were published between 2007 and 2022. RESULTS: Approximately 56% of the studies reported a positive impact on physical activity. All studies described social marketing details in alignment with the five principles of social marketing (product, promotion, place, price, and people). Only two studies explicitly identified CBPR as a guiding framework, but most studies used one (k = 8, 32%) or two (k = 12, 48%) community engagement strategies. Few studies included at least 50% representation of African American (k = 2) or Hispanic (k = 3) participants. CONCLUSIONS: This review highlights key gaps in the literature (e.g., lack of fully-developed CBPR frameworks, reach among underserved communities, randomized designs, use of theory), highlights examples of successful interventions, and opportunities for refining community-wide interventions using social marketing strategies.
The purpose of this study was to conduct a systematic scoping review of community-wide interventions targeting physical activity and/or weight loss to describe how social marketing strategies have been implemented, identify which populations have been targeted, evaluate the use of Community-Based Participatory Research (CBPR) frameworks, assess retention rates and identify gaps in the literature and formulate future recommendations. Over half of the studies reported a positive impact on physical activity. All studies described social marketing details in alignment with the five principles of social marketing (product, promotion, place, price, and people). Only two studies explicitly identified CBPR as a guiding framework, but most studies used one or two community engagement strategies. Few studies included at least 50% representation of African American or Hispanic participants. Many of the programs provided health information on the benefits of being active (e.g., educational lessons), behavioral strategies (e.g., walking with friends and family), or opportunities to increase walking and physical activity (e.g., community activities, walking clubs, maps for walking or biking, gardening). A number of the programs also addressed environmental facilitators for walking such as utilizing signage for stair use, accessing parks, or participating in community walking groups. Overall this review highlights key gaps in the literature (e.g., lack of fully-developed CBPR frameworks, reach among underserved communities, randomized designs, use of theory), and highlights examples of successful interventions, and opportunities for refining community-wide interventions using social marketing strategies.
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Pesquisa Participativa Baseada na Comunidade , Exercício Físico , Marketing Social , Humanos , Promoção da Saúde/métodosRESUMO
BACKGROUND: Little is known about the influence of e-cigarette marketing features on the antecedents of e-cigarette use. PURPOSE: Using an eye-tracking experiment, we examined visual attention to common features in e-cigarette ads and its associations with positive e-cigarette perceptions among young adults. METHODS: Young adults (ages 18-29) who smoke cigarettes (n = 40) or do not use tobacco (n = 71) viewed 30 e-cigarette ads on a computer screen. Eye-tracking technology measured dwell time (fixation duration) and entry time (time to first fixation) for 14 pre-defined ad features. Participants then completed a survey about perceptions of e-cigarettes shown in the ads. We used regression models to examine the associations between ad features and standardized attention metrics among all participants and by tobacco-use status and person-aggregated standardized attention for each ad feature and positive e-cigarette perceptions. RESULTS: Dwell time was the longest for smoker-targeted claims, positive experience claims, and price promotions. Entry time was the shortest for multiple flavor descriptions, nicotine warnings, and people. Those who do not use tobacco had a longer dwell time for minor sales restrictions and longer entry time for purchasing information than those who smoke. Longer dwell time for multiple flavor descriptions was associated with e-cigarette appeal. A shorter entry time for fruit flavor description was associated with positive e-cigarette-use expectancies. CONCLUSIONS: Young adults allocated attention differently to various e-cigarette ad features, and such viewing patterns were largely similar by tobacco-use statuses. Multiple or fruit flavors may be the features that contribute to the positive influence of e-cigarette marketing among young adults.
E-cigarette marketing exposure is associated with e-cigarette use among young adults. However, little is known about the influence of e-cigarette marketing features among this population. This study used eye-tracking technology to objectively measure dwell time and entry time for 14 pre-defined e-cigarette ad features. Young adults (ages 1829) who smoke cigarettes (n = 40) or do not use tobacco (n = 71) viewed 30 e-cigarette ads on a computer screen and completed an online survey about positive e-cigarette perceptions. The study found that dwell time was the longest for smoker-targeted claims, positive experience claims, and price promotions. Entry time was the shortest for multiple flavor descriptions, nicotine warnings, and people. Those who do not use tobacco had a longer dwell time for minor sales restrictions and longer entry time for purchasing information than those who smoke. Longer dwell time for multiple flavor descriptions was associated with e-cigarette appeal. A shorter entry time for fruit flavor description was associated with positive e-cigarette-use expectancies. The results suggest that young adults allocated attention differently to various e-cigarette ad features, and such viewing patterns were largely similar by tobacco-use statuses. Multiple or fruit flavors may be the features that contribute to the positive influence of e-cigarette marketing among young adults.
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Publicidade , Atenção , Sistemas Eletrônicos de Liberação de Nicotina , Tecnologia de Rastreamento Ocular , Humanos , Adulto Jovem , Masculino , Feminino , Adulto , Adolescente , Vaping/psicologiaRESUMO
BACKGROUND: The retail market for toddler-specific packaged foods is growing. Many of these products are ultra-processed and high in nutrients of concern for health, yet marketed in ways that may make them appear wholesome. This study aims to assess parents' responses to claims on unhealthy, ultra-processed toddler food products and test whether removing such claims promotes more accurate product perceptions and healthier product preferences. METHODS: Parents of toddlers aged 12 to < 36 months (N = 838) were recruited for an online experiment testing four on-pack claim conditions: control (no claim); 'contains "good" ingredient'; 'free from "bad" ingredient'; and unregulated 'child-related' claim. Participants were randomly assigned to one condition, then viewed images of toddler food products that varied in nutrition content and the claims displayed. Participants completed tasks assessing product preferences (unhealthy product displaying claim vs. a healthier option with no claim, across four food categories (banana bars, strawberry snacks, blueberry yogurt snacks and veggie snacks)), purchase intentions and product perceptions. Poisson regression (count variable) and linear regression (continuous outcomes) analyses were employed to test for mean differences by marketing claim conditions. RESULTS: For the overall sample, brief exposure to 'free from "bad" ingredient' claims increased participant's intentions to purchase unhealthy food products for their toddlers, but there was no clear evidence that 'contains "good" ingredient' claims and 'child-related' claims significantly impacted parent's preferences, purchase intentions and perceptions of toddler foods. However, certain claims influenced particular parent subgroups. Notably, parents with three or more children chose more unhealthy products when these products displayed 'contains "good" ingredient' or 'free from "bad" ingredient' claims; the latter claims also promoted stronger purchase intentions and enhanced product perceptions among this subgroup. CONCLUSIONS: Findings indicate that 'free from "bad" ingredient' claims on unhealthy toddler foods are of most concern, as they boost the appeal of these products to parents. 'Contains "good" ingredient' claims and 'child-related' claims showed limited effects in this study. Considering available evidence, we recommend claims should not be permitted on child-oriented foods, as they may promote inaccurate product perceptions and unhealthy product choices by parents, that can detract from their children's diets and health.
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Comportamento do Consumidor , Rotulagem de Alimentos , Preferências Alimentares , Marketing , Pais , Adulto , Pré-Escolar , Feminino , Humanos , Lactente , Masculino , Comportamento de Escolha , Preferências Alimentares/psicologia , Alimentos Infantis , Intenção , Marketing/métodos , Valor Nutritivo , Pais/psicologia , Percepção , LanchesRESUMO
BACKGROUND: Marketing of unhealthy foods to children on digital media significantly impacts their dietary preferences and contributes to diet-related noncommunicable diseases. Canadian children spend a significant amount of time on digital devices and are frequently exposed to unhealthy food marketing on social media, including by influencers with celebrity status who endorse products. This study aimed to examine the frequency, healthfulness, and power of unhealthy food marketing in posts by influencers popular with Canadian children on YouTube, Instagram and TikTok. METHODS: The top 9 influencers popular amongst Canadian children aged 10-12 years were identified from the 2021 International Food Policy Study Youth Survey. A total of 2,232 Instagram, YouTube and TikTok posts made by these influencers between June 1st 2021 and May 31st 2022 were examined for instances of food marketing. Food products/brands were identified and frequencies were calculated for the number of posts promoting food products/brands, posts promoting products/brands classified as less healthy according to Health Canada's Nutrient Profile Model (2018) and marketing techniques utilized. RESULTS: YouTube had the highest average rate of food marketing instances per post, at a rate of 1 food marketing instance every 0.7 posts, while TikTok and Instagram had instances every 10.2 posts and 19.3 posts, respectively. Overall, fast food restaurants was the most promoted food category (21%), followed by regular soft drinks (13%), snacks (11%), candy and chocolate (11%) and water (8%). The most frequently used marketing techniques were appeals to fun/cool (37%), the use of songs or music (28%) and the product being consumed (25%). In terms of healthfulness, 83% of the products/brands (87% of brands and 82% of products) promoted were classified as less healthy. CONCLUSIONS: Social media influencers play a substantial role in promoting unhealthy food products to children, primarily fast food items. Given the significant impact of such marketing on children, there is a need for ongoing government-led monitoring, and it is crucial to include social media and influencer marketing in marketing restrictions targeting children in Canada to safeguard this vulnerable demographic.
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Mídias Sociais , Criança , Adolescente , Humanos , Internet , Canadá , Alimentos , Bebidas , Marketing/métodos , Fast FoodsRESUMO
Numerous research methodologies have been used to examine food environments. Existing reviews synthesizing food environment measures have examined a limited number of domains or settings and none have specifically targeted Canada. This rapid review aimed to 1) map research methodologies and measures that have been used to assess food environments; 2) examine what food environment dimensions and equity related-factors have been assessed; and 3) identify research gaps and priorities to guide future research. A systematic search of primary articles evaluating the Canadian food environment in a real-world setting was conducted. Publications in English or French published in peer-reviewed journals between January 1 2010 and June 17 2021 and indexed in Web of Science, CAB Abstracts and Ovid MEDLINE were considered. The search strategy adapted an internationally-adopted food environment monitoring framework covering 7 domains (Food Marketing; Labelling; Prices; Provision; Composition; Retail; and Trade and Investment). The final sample included 220 articles. Overall, Trade and Investment (1%, n = 2), Labelling (7%, n = 15) and, to a lesser extent, Prices (14%, n = 30) were the least studied domains in Canada. Among Provision articles, healthcare (2%, n = 1) settings were underrepresented compared to school (67%, n = 28) and recreation and sport (24%, n = 10) settings, as was the food service industry (14%, n = 6) compared to grocery stores (86%, n = 36) in the Composition domain. The study identified a vast selection of measures employed in Canada overall and within single domains. Equity-related factors were only examined in half of articles (n = 108), mostly related to Retail (n = 81). A number of gaps remain that prevent a holistic and systems-level analysis of food environments in Canada. As Canada continues to implement policies to improve the quality of food environments in order to improve dietary patterns, targeted research to address identified gaps and harmonize methods across studies will help evaluate policy impact over time.
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Abastecimento de Alimentos , Canadá , Humanos , Rotulagem de Alimentos/métodos , Comércio , Meio Ambiente , Marketing/métodos , AlimentosRESUMO
As cannabis legalization expands and online marketing intensifies, this study examines whether online social cues can amplify youth-targeted cannabis advertising and whether cannabis warning labels (CWLs) can counteract these influences. A U.S. online sample of 970 adolescents and 1776 young adults susceptible to cannabis use were recruited from Qualtrics in summer 2022. Each participant was randomly assigned to one of the 3 (CWLs: none vs. textual vs. pictorial) by 3 (comments: none vs. anti-cannabis vs. pro-cannabis) conditions in an online experiment. Participants were exposed to three online marketing posts promoting marijuana edibles (randomly selected from a large pool, N = 1260), each with either no warning label, a textual warning, or a pictorial warning (text and picture), and with either five comments (pro- or anti-cannabis in valence) or none. Results showed that among adolescents, pro-cannabis comments increased product appeal (vs. anti-cannabis comments: b = 0.18, p = .025; vs. no comments: b = 0.21, p = .021), and did so more than young adults. For adolescents, only pictorial warnings reduced product appeal (b = -0.20, p = .028). For young adults, both pictorial (b = -0.18, p = .002) and textual warnings (b = -0.12, p = .029) reduced product appeal. Furthermore, both textual (adolescents: b = -0.20, p = .004; young adults: b = -0.15, p = .005) and pictorial (adolescents: b = -0.30, p < .001; young adults: b = -0.18, p = .001) warnings reduced cannabis use intentions. Findings support requiring enhanced CWLs accompany online marketing ads.
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Cannabis , Produtos do Tabaco , Humanos , Adolescente , Adulto Jovem , Cannabis/efeitos adversos , Rotulagem de Produtos/métodos , Marketing , Intenção , PublicidadeRESUMO
OBJECTIVES: This study aimed to provide an overview of analytical methods in scientific literature for comparing uncontrolled medicine trials with external controls from individual patient data real-world data (IPD-RWD) and to compare these methods with recommendations made in guidelines from European regulatory and health technology assessment (HTA) organizations and with their evaluations described in assessment reports. METHODS: A systematic literature review (until March 1, 2023) in PubMed and Connected Papers was performed to identify analytical methods for comparing uncontrolled trials with external controls from IPD-RWD. These methods were compared descriptively with methods recommended in method guidelines and encountered in assessment reports of the European Medicines Agency (2015-2020) and 4 European HTA organizations (2015-2023). RESULTS: Thirty-four identified scientific articles described analytical methods for comparing uncontrolled trial data with IPD-RWD-based external controls. The various methods covered controlling for confounding and/or dependent censoring, correction for missing data, and analytical comparative modeling methods. Seven guidelines also focused on research design, RWD quality, and transparency aspects, and 4 of those recommended analytical methods for comparisons with IPD-RWD. The methods discussed in regulatory (n = 15) and HTA (n = 35) assessment reports were often based on aggregate data and lacked transparency owing to the few details provided. CONCLUSIONS: Literature and guidelines suggest a methodological approach to comparing uncontrolled trials with external controls from IPD-RWD similar to target trial emulation, using state-of-the-art methods. External controls supporting regulatory and HTA decision making were rarely in line with this approach. Twelve recommendations are proposed to improve the quality and acceptability of these methods.
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Latino/a/x sexual minority men (SMM) and transgender women remain disproportionately impacted by HIV, with higher HIV incidence and lower uptake of pre-exposure prophylaxis (PrEP) than their non-Hispanic White peers. Disparities in PrEP uptake among Latino/a/x populations have been found to be due to structural, social, and personal barriers. Social marketing interventions have been shown to effectively address barriers and increase PrEP uptake in other populations, and thus offer potential as a tool to increase PrEP uptake for Latino/a/x populations. The PrEPárate campaign was developed through community based participatory research and ran from April to September 2022 in Cook County, Illinois. We conducted a mixed methods evaluation through surveys (N = 515) and semi-structured interviews with survey participants and community partners (N = 14). We examined cross-sectional associations of campaign exposure with PrEP awareness and uptake in adjusted multivariable regression models. We used rapid qualitative methods to analyze interviews and assess implementation outcomes following the RE-AIM framework. The campaign reached over 118,000 people on social media, with additional reach over public transit and local events. PrEPárate exposure was associated with increased PrEP awareness (aOR = 5.23; 95% CI [2.58, 10.63]) and PrEP uptake (aOR = 1.69; 95% CI [1.09, 2.62]). Survey respondents expressed that the campaign name, visuals, ambassadors, and distribution were effective in engaging the target audience. Community partners felt the campaign was implemented with fidelity to the original vision and identified future directions for PrEPárate. Social marketing campaigns, anchored in community engagement, may be an effective strategy to increase PrEP awareness and uptake among underserved Latino/a/x populations.
RESUMEN: Los hombres de minorías sexuales y las mujeres transgénero latinos siguen siendo desproporcionadamente afectados por el VIH, con una incidencia de VIH más alta y un menor uso de la Profilaxis Pre-Exposición (PrEP) que sus pares blancos no hispanos. Se ha encontrado que las disparidades en la adopción de PrEP entre las poblaciones latinas se deben a barreras estructurales, sociales y personales. Las intervenciones de mercadeo social han demostrado ser efectivas para eliminar los obstáculos e incrementar el uso de PrEP en otras poblaciones, y por lo tanto son una potencial herramienta para aumentar el uso de PrEP en las poblaciones latinas. La campaña PrEPárate fue desarrollada a través de investigación participativa basada en la comunidad, y se llevó a cabo desde abril hasta septiembre de 2022 en el Condado de Cook, Illinois. Realizamos una evaluación de métodos mixtos a través de encuestas (N = 515) y entrevistas semiestructuradas con participantes de la encuesta y socios comunitarios (N = 14). Se examinaron las asociaciones transversales de la exposición a la campaña con la consciencia y el uso de PrEP en modelos de regresión multivariable ajustados. Utilizamos métodos cualitativos rápidos para analizar entrevistas y evaluar los resultados de la implementación usando el marco RE-AIM. La campaña alcanzó a más de 118,000 personas en redes sociales, con un alcance adicional en el transporte público y eventos locales. La exposición a PrEPárate se asoció con un aumento en la consciencia de PrEP (aOR = 5.23; IC del 95% [2.58, 10.63]) y el uso de PrEP (aOR = 1.69; IC del 95% [1.09, 2.62]). Las participantes de la encuesta expresaron que el nombre de la campaña, las visuales, los embajadores, y la distribución fueron eficaces para atraer al público. Los socios comunitarios sintieron que la campaña se implementó con fidelidad a la visión original e identificaron direcciones futuras para PrEPárate. Las campañas de mercadeo social, basados en el aporte de la comunidad, pueden ser una estrategia efectiva para aumentar la consciencia y el uso de PrEP entre las poblaciones latinas desatendidas.
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Celebrities can generate substantial attention and influence public interest in species. Using a large-scale examination of publicly available data, we assessed whether species across 6 taxonomic groups received more page views on Wikipedia when the species was named after a celebrity than when it was not. We conducted our analysis for 4 increasingly strict thresholds of how many average daily Wikipedia page views a celebrity had (1, 10, 100, or 1000 views). Overall, we found a high probability (0.96-0.98) that species named after celebrities had more page views than their closest relatives that were not named after celebrities, irrespective of the celebrity threshold. The multiplicative effect on species' page views was larger but more uncertain as celebrity page-view thresholds increased. The range for thresholds of 1 to 1000 was 1.08 (95% credible interval [CI] 1.00-1.18) to 1.76 (95% CI 0.96-2.80), respectively. The hierarchical estimates for the taxa tended to be positive. The strongest effects were for invertebrates, followed by amphibians, reptiles, fish, and mammals, whereas the weakest effect was for birds at lower page-view thresholds. Our results suggest that naming species after celebrities could be particularly significant for those belonging to taxonomic groups that are generally less popular than others (e.g., invertebrates). Celebrities may further influence the effectiveness of this marketing strategy, depending on their likability and connection to the species named after them. Eponyms may serve as a reminder of the disproportionate power dynamics between populations and some namesakes' untenable actions. However, they also provide an opportunity to recognize remarkable individuals and promote equity, inclusivity, and diversity in taxonomic practice. We encourage taxonomists to examine whether naming threatened species after celebrities could affect conservation support, especially for species that are otherwise typically overlooked by the public.
Impacto sobre la atención virtual de una especie si lleva el nombre de una celebridad Resumen Las celebridades pueden generar atención considerable e influir sobre el interés público por las especies. Usamos un análisis a gran escala de datos con disponibilidad pública para evaluar si las especies de seis grupos taxonómicos recibían más visitas en Wikipedia cuando el nombre de la especie provenía del de una celebridad que cuando no. Realizamos nuestro análisis en cuatro umbrales cada vez más estrictos de cuántas visitas diarias en promedio tenía la página de Wikipedia de una celebridad (1, 10, 100 or 1000 visitas). En general, descubrimos una probabilidad alta (0.960.98) de que las especies con nombres de celebridades tuvieran más visitas que sus parientes más cercanos que no tenían un nombre así, sin importar el umbral de la celebridad. El efecto multiplicativo sobre las visitas a la página de la especie fue mayor pero más incierto si incrementaba el umbral de visitas de la celebridad. El rango para los umbrales de 1 a 1000 fue de 1.08 (95% intervalo creíble [IC] 1.001.18) a 1.76 (95% IC 0.962.80) respectivamente. Los estimados jerárquicos para los taxones tuvieron una tendencia positiva. Los efectos más fuertes se presentaron en los invertebrados, seguidos de los anfibios, reptiles, peces y mamíferos, mientras que el efecto más débil fue para las aves en los umbrales de menor número de visitas. Nuestros resultados sugieren que nombrar a una especie con el nombre de una celebridad podría ser particularmente importante para aquellas que pertenecen a grupos taxonómicos que generalmente suelen ser menos populares que otros (invertebrados). Las celebridades podrían influir todavía más en la efectividad de esta estrategia de marketing, dependiendo de su popularidad y la conexión con la especie que lleva su nombre. Los epónimos pueden funcionar como recordatorios de las dinámicas disparejas de poder entre las poblaciones y las acciones indefendibles de algunos homónimos. Sin embargo, los epónimos también proporcionan la oportunidad para reconocer individuos destacados y promover la equidad, inclusividad y diversidad en la práctica taxonómica. Alentamos a que los taxónomos analicen si nombrar a una especie amenazada con el nombre de una celebridad podría afectar el apoyo a su conservación, especialmente para las especies que de otra manera suelen ser ignoradas por el público.
Assuntos
Conservação dos Recursos Naturais , Espécies em Perigo de Extinção , Animais , Invertebrados , Mamíferos , AtençãoRESUMO
Communities have a strong role in protecting biodiversity. In addition to participation in restoration, a range of actions in the public or private sphere may support biodiversity. Despite this, there is a lack of clarity about what actions should be prioritized for behavior change campaigns. We developed and applied a method to prioritize community actions for biodiversity conservation that incorporates an expert-based assessment of impact and a community-informed measure of the likelihood of uptake. In stage 1, experts (n = 143) completed a survey that quantified the relative impact of actions based on best-worst scaling of perceived impact. In stage 2, surveyed community members (n = 3200) ranked the likelihood of adopting actions based on the ease or difficulty of performing each action, and the opportunity for change based on the proportion of respondents not yet engaging in each behavior. Experts gave the following actions the highest ranking for impact: voting for the environment (first), participating in restoration in ecological priority areas (second), and purchasing and protecting remnant bushland (third). When considering the disciplinary background and institutional background of experts, voting and participating in restoration activities remained in the upper ranked options. However, there was some divergence between these groups. For example, reducing beef consumption was ranked third by university-based experts but ranked 28th by experts based in state government. Overall, community members ranked the following behaviors as most likely to be adopted: following quarantine laws (first), reducing plastic use (second), and managing pets (third). Top likelihood ranking of actions was minimally affected by community characteristics (nature relatedness, gender, location). Integrating these findings, the action ranked most favorably for impact, likelihood, and opportunity was participating in restoration. Choosing actions for behavior change campaigns requires consideration of the entire social-ecological system-from social factors that enable or constrain adoption to the ecological impact of actions across relevant social and ecological contexts.
Inducción de perspectivas diversas para priorizar las acciones comunitarias a favor de la conservación de la biodiversidad Las comunidades juegan un papel importante en la protección de la biodiversidad. Además de participar en la restauración, existe una gama de acciones públicas y privadas que pueden ayudar a la biodiversidad. A pesar de esto, no está claro cuáles acciones deben priorizarse en las campañas de cambio conductual. Desarrollamos y aplicamos un método para priorizar las acciones comunitarias a favor de la conservación de la biodiversidad que incorpora la evaluación por experto del impacto y la medida comunitaria de la probabilidad de captación. En la fase 1, los expertos (n = 143) completaron una encuesta que cuantificó el impacto relativo de las acciones con base en una escala mejorpeor del impacto percibido. En la fase 2, los miembros de la comunidad (n = 3200) clasificaron la probabilidad del éxito de las acciones con base en la proporción de respondientes que todavía no participan en cada comportamiento. Los expertos otorgaron la clasificación más alta para el impacto a las siguientes acciones: votar por el ambiente (primero), participar en la restauración de áreas ecológicas prioritarias (segundo) y adquirir y proteger matorrales remanentes (tercero). Cuando consideramos la formación disciplinaria e institucional de los expertos, la votación y la participación en las actividades de restauración permanecieron en las opciones con clasificación más alta; sin embargo, existió una divergencia entre estos grupos. Por ejemplo, los expertos de las universidades clasificaron en tercero la reducción del consumo de carne de res, pero los expertos del gobierno estatal lo clasificaron en vigésimo octavo. En general, los miembros de la comunidad clasificaron los siguientes comportamientos como los más probables de ser adoptados: seguir las normas de cuarentena (primero), reducir el uso de plásticos (segundo) y el manejo de mascotas (tercero). Las características comunitarias (relación con la naturaleza, género, ubicación) afectaron en lo mínimo a la clasificación más alta de probabilidad de las acciones. Al integrar estos resultados, la acción mejor clasificada en cuanto a impacto, probabilidad y oportunidad fue la participación en la restauración. La selección de acciones para las campañas de cambio conductual requiere que se considere todo el sistema socio ecológico desde los factores sociales que permiten o restringen la conservación hasta las acciones de impacto ecológico relevantes en los contextos sociales y ecológicos.
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BACKGROUND: Tofacitinib is an oral Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We aimed to identify the safety and effectiveness of tofacitinib in patients with UC in routine clinical settings in Korea. METHODS: This open-label, observational, prospective, post-marketing surveillance study was conducted at 22 hospitals in the Republic of Korea. Patients with moderate to severe active UC who received tofacitinib were included and followed up for up to 52 weeks. Tofacitinib was administered at a dosage of 10 mg twice daily for at least 8 weeks, followed by 5 or 10 mg twice daily at the investigator's discretion based on clinical evaluation according to the approved Korean label. Safety including adverse events (AEs) and effectiveness including clinical remission, clinical response, and endoscopic mucosal healing were evaluated. Safety analysis set was defined as all patients registered for this study who received at least one dose of tofacitinib according to the approved Korean label and followed up for safety data. Effectiveness analysis set included patients in the safety analysis set who were evaluated for overall effectiveness assessment and excluded patients who had received tofacitinib less than 8 weeks. RESULTS: A total of 110 patients were enrolled, of whom 106 patients were included in the safety population. The median duration of treatment was 370 days and the treatment duration ranged from 16 to 684 days for the safety population. AEs occurred in 42 patients (39.6%). Serious AEs (SAEs) occurred in 7 patients (6.6%) and of them, there were 2 cases of serious infections. These serious infections were reported as Adverse Event of Special Interest (AESI) in this study and no other AESI were reported. There were no cases of death during the study period. Clinical remission rates were 40.0%, 46.7%, 57.6%, and 55.1% at 8, 16, 24, and 52 weeks, and clinical response rates were 77.8%, 87.9%, 56.6%, and 81.4% at each visit, respectively. Endoscopic mucosal healing rates were 58.7% at 16 weeks and 46.2% at 52 weeks. CONCLUSION: Tofacitinib was effective in Korean patients with moderate to severe active UC and the safety findings were consistent with the known safety profile of tofacitinib. This study confirmed the safety and effectiveness of tofacitinib in Korean patients with moderate to severe active UC in routine clinical settings. TRIAL REGISTRATION: This study is registered in the ClinicalTrials.gov under the identifier NCT04071405, registered on 28 August 2019.
Assuntos
Colite Ulcerativa , Piperidinas , Vigilância de Produtos Comercializados , Pirimidinas , Humanos , Pirimidinas/efeitos adversos , Pirimidinas/uso terapêutico , Pirimidinas/administração & dosagem , Piperidinas/efeitos adversos , Piperidinas/uso terapêutico , Piperidinas/administração & dosagem , Colite Ulcerativa/tratamento farmacológico , Masculino , Feminino , Adulto , Estudos Prospectivos , Pessoa de Meia-Idade , República da Coreia , Pirróis/efeitos adversos , Pirróis/uso terapêutico , Pirróis/administração & dosagem , Resultado do Tratamento , Inibidores de Janus Quinases/efeitos adversos , Inibidores de Janus Quinases/uso terapêutico , Inibidores de Janus Quinases/administração & dosagem , Idoso , Inibidores de Proteínas Quinases/efeitos adversos , Inibidores de Proteínas Quinases/uso terapêutico , Inibidores de Proteínas Quinases/administração & dosagem , Adulto Jovem , Indução de RemissãoRESUMO
BACKGROUND: Trastuzumab-deruxtecan (T-DXd) was approved for the treatment of HER2-positive patients with advanced gastric cancer in Japan based on the results of the DESTINY-Gastric01 trial. This study aimed to collect real-world data and evaluate the effectiveness and safety of T-DXd. METHODS: Patients aged ≥ 20 years at the start of T-DXd administration with a histopathologically confirmed diagnosis of HER2-positive unresectable advanced or recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma that had worsened after chemotherapy were enrolled in this retrospective cohort study. Key outcomes included T-DXd treatment status, overall survival (OS), real-world progression-free survival (rwPFS), time to treatment failure (TTF), objective response rate and frequency of grade ≥ 3 adverse events (AEs). RESULTS: Of the 312 patients included in the analysis, 75.3% were male, the median (range) age was 70.0 (27.0-89.0) years, 12.2% had an ECOG PS ≥ 2, 43.3% had ascites and the initial T-DXd dose was > 5.4- ≤ 6.4 mg/kg in 78.2% of patients. The median (95% confidence interval) OS, rwPFS and TTF (months) was 8.9 (8.0-11.0), 4.6 (4.0-5.1) and 3.9 (3.4-4.2), respectively. The response rate was 42.9% in patients with a target lesion. In total, 48.4% of patients experienced a grade ≥ 3 AE, 2.6% experienced grade 5 AEs and 60.9% experienced AEs leading to T-DXd dose adjustments (reduction: 36.9%, interruption: 34.0% or discontinuation: 23.7%). No new safety signals were detected. CONCLUSIONS: T-DXd was effective and had a manageable safety profile as a third- or later-line treatment for patients with HER2-positive gastric or GEJ cancer in Japanese clinical practice. CLINICAL TRIAL REGISTRATION: UMIN000049032.
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INTRODUCTION: E-cigarette industry's marketing and social media efforts have promoted adolescent vaping. We developed and pilot-tested an anti-vaping media literary program - MediaSense. METHODS: In addition to employing the Community-Based Participatory Research approach for program development, we applied a prospective, interventional, and single-arm design to assess the impact of MediaSense among students from five middle and high schools. Data were collected through REDCap surveys administered before and after the intervention. We performed generalized linear mixed models and median analysis to evaluate changes in vaping media literacy (i.e., Authors and Audiences [vAA], Messages and Meanings [vMM], and Representation and Reality [vRR]), knowledge, harm perception, and susceptibility to e-cigarette use before and after the intervention. RESULTS: A total of 384 students aged 11-18 years completed the pre-post survey assessment. After the intervention, students exhibited significantly improved vaping media literacy across all three domains (vAA,fold change [FC]=150%, p<0.0001; vMM, FC=143%, p<0.0001; vRR, FC=133%, p=0.0007). The intervention was associated with a reduction of vaping susceptibility (adjusted odds ratio [AOR]=0.7, p=0.04) and improvement in harm perception (AOR=1.6, p=0.009), knowledge of flavored e-cigarettes (AOR=4.4, p<0.0001) and Tobacco 21 policy (AOR=6.2, p<0.0001). Further mediation analysis unveiled the pathway of the intervention on reduction of vaping susceptibility through media literacy (ßindirect=-0.03, p=0.003) and harm perception enhancement (ßindirect=-0.02, p=0.03). CONCLUSION: The MediaSense program showed promise in vaping prevention among adolescents by reducing vaping susceptibility. Comprehensive vaping media literacy education, especially interventions aimed at decoding misleading marketing information and addressing emerging marketing themes, provides valuable evidence in curbing adolescent vaping. IMPLICATIONS: MediaSense (Media Education for Sensible Evaluation and Nurturing Substance-free Experiences) represents a promising e-cigarette education program designed for adolescent vaping prevention. The findings of this study highlight the positive impact of the program on media literacy, harm perception, and knowledge of tobacco control policies.