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PURPOSE: The purpose of this study is to draw on the practical experience from the PROTECT BR case studies and make recommendations regarding the application of a number of methodologies and visual representations for benefit-risk assessment. METHODS: Eight case studies based on the benefit-risk balance of real medicines were used to test various methodologies that had been identified from the literature as having potential applications in benefit-risk assessment. Recommendations were drawn up based on the results of the case studies. RESULTS: A general pathway through the case studies was evident, with various classes of methodologies having roles to play at different stages. Descriptive and quantitative frameworks were widely used throughout to structure problems, with other methods such as metrics, estimation techniques and elicitation techniques providing ways to incorporate technical or numerical data from various sources. Similarly, tree diagrams and effects tables were universally adopted, with other visualisations available to suit specific methodologies or tasks as required. Every assessment was found to follow five broad stages: (i) Planning, (ii) Evidence gathering and data preparation, (iii) Analysis, (iv) Exploration and (v) Conclusion and dissemination. CONCLUSIONS: Adopting formal, structured approaches to benefit-risk assessment was feasible in real-world problems and facilitated clear, transparent decision-making. Prior to this work, no extensive practical application and appraisal of methodologies had been conducted using real-world case examples, leaving users with limited knowledge of their usefulness in the real world. The practical guidance provided here takes us one step closer to a harmonised approach to benefit-risk assessment from multiple perspectives.
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Sistemas de Notificação de Reações Adversas a Medicamentos , Apresentação de Dados , Farmacoepidemiologia/métodos , Medição de Risco/métodos , Sistemas de Notificação de Reações Adversas a Medicamentos/legislação & jurisprudência , Tomada de Decisões , Descoberta de Drogas , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Regulamentação Governamental , Farmacoepidemiologia/legislação & jurisprudência , Medição de Risco/legislação & jurisprudênciaRESUMO
BACKGROUND: The PROTECT Benefit-Risk group is dedicated to research in methods for continuous benefit-risk monitoring of medicines, including the presentation of the results, with a particular emphasis on graphical methods. METHODS: A comprehensive review was performed to identify visuals used for medical risk and benefit-risk communication. The identified visual displays were grouped into visual types, and each visual type was appraised based on five criteria: intended audience, intended message, knowledge required to understand the visual, unintentional messages that may be derived from the visual and missing information that may be needed to understand the visual. RESULTS: Sixty-six examples of visual formats were identified from the literature and classified into 14 visual types. We found that there is not one single visual format that is consistently superior to others for the communication of benefit-risk information. In addition, we found that most of the drawbacks found in the visual formats could be considered general to visual communication, although some appear more relevant to specific formats and should be considered when creating visuals for different audiences depending on the exact message to be communicated. CONCLUSION: We have arrived at recommendations for the use of visual displays for benefit-risk communication. The recommendation refers to the creation of visuals. We outline four criteria to determine audience-visual compatibility and consider these to be a key task in creating any visual. Next we propose specific visual formats of interest, to be explored further for their ability to address nine different types of benefit-risk analysis information.
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Sistemas de Notificação de Reações Adversas a Medicamentos , Apresentação de Dados , Farmacoepidemiologia/métodos , Medição de Risco/métodos , Sistemas de Notificação de Reações Adversas a Medicamentos/instrumentação , Comunicação , Tomada de Decisões , Farmacoepidemiologia/instrumentaçãoAssuntos
Inibidores da Angiogênese/efeitos adversos , Anticorpos Monoclonais Humanizados/efeitos adversos , Neovascularização de Coroide/tratamento farmacológico , Endoftalmite/induzido quimicamente , Oclusão da Artéria Retiniana/induzido quimicamente , Vasculite Retiniana/induzido quimicamente , Degeneração Macular Exsudativa/tratamento farmacológico , Endoftalmite/diagnóstico , Humanos , Injeções Intravítreas , Receptores de Fatores de Crescimento do Endotélio Vascular/uso terapêutico , Proteínas Recombinantes de Fusão/efeitos adversos , Proteínas Recombinantes de Fusão/uso terapêutico , Oclusão da Artéria Retiniana/diagnóstico , Vasculite Retiniana/diagnóstico , Fatores de RiscoRESUMO
The nucleosome is a fundamental structural and functional chromatin unit that affects nearly all DNA-templated events in eukaryotic genomes. It is also a biochemical substrate for higher order, cis-acting gene expression codes and the monomeric structural unit for chromatin packaging at multiple scales. To predict the nucleosome landscape of a model plant genome, we used a support vector machine computational algorithm trained on human chromatin to predict the nucleosome occupancy likelihood (NOL) across the maize (Zea mays) genome. Experimentally validated NOL plots provide a novel genomic annotation that highlights gene structures, repetitive elements, and chromosome-scale domains likely to reflect regional gene density. We established a new genome browser (http://www.genomaize.org) for viewing support vector machine-based NOL scores. This annotation provides sequence-based comprehensive coverage across the entire genome, including repetitive genomic regions typically excluded from experimental genomics data. We find that transposable elements often displayed family-specific NOL profiles that included distinct regions, especially near their termini, predicted to have strong affinities for nucleosomes. We examined transcription start site consensus NOL plots for maize gene sets and discovered that most maize genes display a typical +1 nucleosome positioning signal just downstream of the start site but not upstream. This overall lack of a -1 nucleosome positioning signal was also predicted by our method for Arabidopsis (Arabidopsis thaliana) genes and verified by additional analysis of previously published Arabidopsis MNase-Seq data, revealing a general feature of plant promoters. Our study advances plant chromatin research by defining the potential contribution of the DNA sequence to observed nucleosome positioning and provides an invariant baseline annotation against which other genomic data can be compared.
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Algoritmos , Montagem e Desmontagem da Cromatina , Modelos Genéticos , Nucleossomos/genética , Zea mays/genética , Arabidopsis/genética , Cromossomos de Plantas , Elementos de DNA Transponíveis , Variação Genética , Genoma Humano , Genoma de Planta , Humanos , Internet , Anotação de Sequência Molecular , Nucleossomos/metabolismo , Regiões Promotoras Genéticas , Reprodutibilidade dos Testes , Máquina de Vetores de SuporteRESUMO
[This corrects the article DOI: 10.3389/fpubh.2023.1195005.].
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Interventions to counter misinformation are often less effective for polarizing content on social media platforms. We sought to overcome this limitation by testing an identity-based intervention, which aims to promote accuracy by incorporating normative cues directly into the social media user interface. Across three pre-registered experiments in the US (N = 1709) and UK (N = 804), we found that crowdsourcing accuracy judgements by adding a Misleading count (next to the Like count) reduced participants' reported likelihood to share inaccurate information about partisan issues by 25% (compared with a control condition). The Misleading count was also more effective when it reflected in-group norms (from fellow Democrats/Republicans) compared with the norms of general users, though this effect was absent in a less politically polarized context (UK). Moreover, the normative intervention was roughly five times as effective as another popular misinformation intervention (i.e. the accuracy nudge reduced sharing misinformation by 5%). Extreme partisanship did not undermine the effectiveness of the intervention. Our results suggest that identity-based interventions based on the science of social norms can be more effective than identity-neutral alternatives to counter partisan misinformation in politically polarized contexts (e.g. the US). This article is part of the theme issue 'Social norm change: drivers and consequences'.
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Sinais (Psicologia) , Julgamento , Humanos , Probabilidade , Normas Sociais , ComunicaçãoRESUMO
Introduction: Human trafficking (HT) awareness campaigns can educate the public and specific professional figures about this crime and ways to prevent it. However, there currently remains a gap in terms of how to best frame such campaigns without stigmatizing groups of individuals or portraying victims in unrealistic ways. Methods: We conducted four focus groups with 22 experts in HT to explore their perspectives and opinions on current challenges in the framing of HT awareness campaigns in the United States. Focus groups were conducted via Zoom and transcribed verbatim. Two independent reviewers analyzed the transcripts to identify themes using an inductive approach. The results of the focus groups analysis were used to structure the guiding questions of a brainstorming technique named Nominal Group Technique (NGT). Fifteen of 22 experts that participated in the focus groups joined the in-person NGT with the intent of generating ideas and achieving consensus on target audiences, goals, and content of human trafficking awareness campaigns. At the end of the NGT participants ranked priority for actions in the development of HT awareness efforts in the United States. Results: During the NGT the experts provided a number of recommendations to improve HT awareness and to empower victims to reach for help. They pointed to the need for: awareness efforts that describe HT on a spectrum of human abuse and exploitation; training for professional figures about trauma-informed care and communication; and efforts that empower trafficked victims to seek support. They also pointed to the need to develop awareness efforts tailored to local needs in close collaborations with the community-based organizations that can champion their dissemination and be the primary point of access for victims seeking help.
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Objetivos , Tráfico de Pessoas , Humanos , Tráfico de Pessoas/prevenção & controle , Comunicação , Consenso , Grupos FocaisRESUMO
OBJECTIVE: To develop a conceptual theory to describe how financial strain affects women with young children to inform clinical care and research. DESIGN: Qualitative, grounded theory. SETTING: Participants were recruited from the waiting area of a pediatric clinic and an office of the Special Supplemental Nutrition Program for Women, Infants, and Children embedded within the largest safety-net academic medical center in New England. Participants were interviewed privately at the medical center or in the community. PARTICIPANTS: Twenty-six English-speaking women, mostly single and African American/Black, with at least one child 5 years old or younger, were sampled until thematic saturation was met. METHODS: We used grounded theory methodology to conduct in-depth, semistructured interviews with participants who indicated that they experienced financial strain. We analyzed the interview data using constant comparative analysis, revised the interview guide based on emerging themes, and developed a theoretical model. RESULTS: Five interrelated themes emerged and were developed into a theoretical model: Financial Strain Has Specific Characteristics and Common Triggers, Financial Strain Is Exacerbated by Inadequate Assistance and Results in Tradeoffs, Financial Strain Forces Parenting Modifications, Women Experience Self-Blame, and Women Experience Mental Health Effects. CONCLUSION: For women with young children, financial strain results in forced tradeoffs, compromised parenting practices, and self-blame, which contribute to significant mental health problems. These findings can inform woman-centered clinical practice and advocacy interventions. Women's health care providers should identify families experiencing financial strain, provide referrals to financial services, and join advocacy efforts to advance social policies that address the structural causes of poverty, such as increased minimum wage and paid family leave.
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Estresse Financeiro/complicações , Transtornos Mentais/diagnóstico , Poder Familiar/psicologia , Adulto , Pré-Escolar , Feminino , Estresse Financeiro/psicologia , Teoria Fundamentada , Humanos , Lactente , Entrevistas como Assunto/métodos , Transtornos Mentais/epidemiologia , New England , Poder Familiar/tendências , Pesquisa QualitativaRESUMO
Studies of category-specific disorders have suggested that categories of living and non-living things vary in the properties that are most salient to recognition. Studies of the object features generated by normal adults have also revealed different patterns of responses to different categories. These adult patterns are likely to originate in childhood, but there are few reports of children's verbal conceptions of objects, and none at present of objects from different categories. This paper investigates the development of object conceptions, in a large group of children, aged 3 years 7 months to 11 years 6 months, in response to 'What is a -- ?' questions directed to 72 objects, selected from two categories of living things (animals and fruit/vegetables) and two categories of artifacts (implements and vehicles). Proportions of perceptual-to-functional features provided by the children to living and non-living things varied with the range of features defined as functions, just as studies of adults have found. Apart from the distribution of superordinate responses, which were significantly more salient to living than to non-living categories, no other property separated the two categories. Only the category of implements could be distinguished from the other categories on the basis of the features generated. It is argued that the perceptual-functional theory of category-specific disorders receives little support from this study, but that in general the distribution of features generated by young children is similar to that produced by normal adults.
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Cognição , Formação de Conceito , Semântica , Adulto , Fatores Etários , Criança , Desenvolvimento Infantil , Pré-Escolar , Feminino , Humanos , Masculino , MemóriaAssuntos
Indústria Farmacêutica/métodos , Emprego/normas , Liderança , Psiquiatria/normas , Atenção à Saúde/normas , Indústria Farmacêutica/economia , Indústria Farmacêutica/ética , Emprego/ética , Humanos , Marketing de Serviços de Saúde/ética , Marketing de Serviços de Saúde/métodos , Marketing de Serviços de Saúde/normas , Preparações Farmacêuticas/economia , Preparações Farmacêuticas/provisão & distribuição , Psiquiatria/ética , Pesquisa/normas , Sociedades MédicasRESUMO
This paper reports an investigation into the age of acquisition of object names and object knowledge in a cross-sectional study of 288 children aged between 3 years 7 months and 11 years 6 months, comprising equal numbers of boys and girls. The objects belonged to four categories: animals, fruit and vegetables, implements, and vehicles. They were presented in three image types: line drawings, black-and-white photographs, and coloured photographs. In the knowledge test, five probe questions were asked for each object given the spoken name. Results showed that line drawings were more difficult to name than either black-and-white photographs or coloured photographs, which did not differ. The boys significantly out-performed the girls at naming and knowing, both overall and specifically for the category of vehicles. Naming and knowledge increased steadily with age but while young children below about 6 years 6 months showed an advantage to naming, older children showed an advantage to knowing. Similarly, age-of-acquisition measures for each item revealed a significant shift in the relationship between naming and knowing at around 80 months. We argue that differences in learning experience lead younger and older children to associate object names with different types of information, and we suggest that this difference probably accounts for the age-of-acquisition effects reported in adult object naming.
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Desenvolvimento da Linguagem , Rememoração Mental , Aprendizagem Verbal , Vocabulário , Criança , Pré-Escolar , Feminino , Humanos , Masculino , SemânticaRESUMO
A core difficulty in developmental dyslexia is the accurate specification and neural representation of speech. We argue that a likely perceptual cause of this difficulty is a deficit in the perceptual experience of rhythmic timing. Speech rhythm is one of the earliest cues used by infants to discriminate syllables and is determined principally by the acoustic structure of amplitude modulation at relatively low rates in the signal. We show significant differences between dyslexic and normally reading children, and between young early readers and normal developers, in amplitude envelope onset detection. We further show that individual differences in sensitivity to the shape of amplitude modulation account for 25% of the variance in reading and spelling acquisition even after controlling for individual differences in age, nonverbal IQ, and vocabulary. A possible causal explanation dependent on perceptual-center detection and the onset-rime representation of syllables is discussed.