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• Representatives of five expert panels came together to establish conceptual clarity and consensus for what social determinants of health mean for nursing. • We define the social determinants of health as having six key dimensions: economic stability, education access and quality (including health literacy), health care access and quality, neighborhood and the built environment, social and community context, and planetary conditions. • We provide a specific health policy example for each of the six key areas of the social determinants of health to illustrate how nurses can act to improve population health. • We underscore the crucial need to eliminate systematic and structural racism if equity in planetary health-related quality of life is to be attained. • Our conceptual framework addresses the particular importance of nursing actions at the individual, family, and population levels to promote health policies that advance health equity, anti-racism, and planetary health-related quality of life. The 2019-2020 American Academy of Nursing (Academy, 2019) policy priorities document states that "they have a clear and distinct focus on social determinants of health and uses this lens to advance policies and solutions within each of the three overarching priorities" This consensus paper seeks to establish conceptual clarity and consensus for what social determinants of health mean for nursing, with emphasis on examples of health policies that advance planetary health equity and improve planetary health-related quality of life. Volunteers from five Expert Panels of the Academy met via videoconference to determine roles and refine the focus of the paper. After the initial discussion, the first draft of the conceptual framework was written by the first three authors of the paper and, after discussion via videoconference with all the co-authors, successive drafts were developed and circulated for feedback. Consensus was reached when all authors indicated acceptance of what became the final version of the conceptual framework. A conceptual framework was developed that describes how the social determinants of health can be addressed through nursing roles and actions at the individual, family, and population levels with a particular focus on the role of health policy. The paper provides a specific health policy example for each of the six key areas of the social determinants of health to illustrate how nurses can act to improve population health. Nursing actions can support timely health policy changes that focus on upstream factors in the six key areas of the social determinants of health and thus improve population health. The urgent need to eliminate systematic and structural racism must be central to such policy change if equity in planetary health-related quality of life is to be attained. [ABSTRACT FROM AUTHOR]

Abstract This article presents the World Health Organization's (WHO) recommendations on the use of hepatitis B vaccines excerpted from the Hepatitis B vaccines: WHO position paper, July 2017 , published in the Weekly Epidemiological Record (Hepatitis B vaccines, 2017) [1]. This position paper replaces the May 2009 WHO position paper on hepatitis B vaccines (Hepatitis B vaccines, 2009) [2]. The position paper gives updated information on hepatitis B vaccines and their storage, transport and deployment. The recommendations concern the target groups for vaccination and the appropriate schedules. In particular, the recommendations stress the importance of vaccination of all infants at birth as the most effective intervention for the prevention of hepatitis B virus-associated disease worldwide. Footnotes to this paper provide a number of core references including references to grading tables that assess the quality of the scientific evidence, and to the evidence-to-recommendation table. In accordance with its mandate to provide guidance to Member States on health policy matters, WHO issues a series of regularly updated position papers on vaccines and combinations of vaccines against diseases that have an international public health impact. These papers are concerned primarily with the use of vaccines in large-scale immunization programmes; they summarize essential background information on diseases and vaccines, and conclude with WHO's current position on the use of vaccines in the global context. Recommendations on the use of hepatitis B vaccines were discussed by SAGE in October 2016; evidence presented at these meetings can be accessed at: http://www.who.int/immunization/sage/meetings/2016/October/presentations_background_docs/en/. [ABSTRACT FROM AUTHOR]

This article presents the World Health Organization's (WHO) recommendations on the use of dengue vaccine excerpted from the WHO position paper on dengue vaccine – September 2018, published in the Weekly Epidemiological Record [1]. This position paper replaces the July 2016 WHO position paper concerning the first licensed dengue vaccine, CYD-TDV [2]. The position paper presents new evidence that became available in November 2017. A retrospective analysis of data from clinical trials, using a new serological assay classified trial participants according to their dengue serostatus prior to receipt of the first vaccine dose. The analysis revealed an excess risk of severe dengue in seronegative vaccine recipients compared to seronegative non-vaccinated individuals, while confirming long-term protection in seropositive individuals [3]. The paper provides revised guidance on dengue vaccination strategies from a population health perspective. Footnotes to this paper provide a number of core references including references to grading tables that assess the quality of the scientific evidence, and to the evidence-to-recommendation table. In accordance with its mandate to provide guidance to Member States on health policy matters, WHO issues a series of regularly updated position papers on vaccines and combinations of vaccines against diseases that have an international public health impact. These papers are concerned primarily with the use of vaccines in large-scale immunization programmes; they summarize essential background information on diseases and vaccines, and conclude with WHO's current position on the use of vaccines in the global context. Recommendations on the use of dengue vaccine CYD-TDV were discussed by SAGE in April 2018; evidence presented at the meeting can be accessed at: http://www.who.int/immunization/sage/meetings/2018/april/presentations_background_docs/en/ [ABSTRACT FROM AUTHOR]

How the general public in Norway conceives being an older adult and the meaning of chronological age has changed over the last few decades. As narratives of aging may be identified in the Norwegian mass media and in the population at large, dominant narratives may also be identified in policy documents, such as government health policy papers. This article explores a narrative analytical framework based on stories, subtexts, and counterstories; it argues that such narratives are characterized as much by what is unsaid as by what is said, and as much by choice of words and word combinations as by explicit messages. Culture strongly influences the conception of a likely future (what will be) and an envisioned future (what ought to be) regarding aging and geriatric care in Norway, as expressed in the public policy papers. The public policy story is discussed as both a story continuously developing, where later health policy papers relate to and comment on earlier documents, and as a story characterized by a measure of cultural incoherence. Some recent government documents dealing with professional geriatric care will serve as material for a narrative analysis. [ABSTRACT FROM AUTHOR]

The terms consensus, guideline and position paper are sometimes employed as if they were interchangeable, but the purpose of such documents and the robustness of advice vary as the evidence base does not have the same depth in each. The Board of the European Cystic Fibrosis Society deemed it to be helpful to provide a short commentary on the definition of these terms, on their interconnections and on how ECFS considers them in documents endorsed by the society. [ABSTRACT FROM AUTHOR]

This article presents the World Health Organization's (WHO) recommendations for the use of vaccines against Bordetella pertussis from the WHO position paper on Pertussis vaccines: WHO position paper—August 2015, recently published in the Weekly Epidemiological Record (Pertussis vaccines: WHO position paper. Wkly Epidemiol Rec 2015;90(August(35)):433–60). This position paper summarizes the most recent developments in the field of pertussis disease and its prevention by vaccination. It includes the WHO position on the choice of Pertussis vaccine as well as on the use of additional strategies, particularly vaccination during pregnancy, for prevention of early infant mortality. This document replaces the first WHO position paper on vaccines against disease caused by Pertussis published in 2010 (Pertussis vaccines: WHO position paper. Wkly Epidemiol Rec 2010;85(October(40)):385–400) and incorporates the revised guidance on the choice of pertussis vaccines published in July 2014 (Pertussis vaccines: WHO position paper. Wkly Epidemiol Rec 2014;89(July(30)):337–44). Footnotes to this paper provide a number of core references. In accordance with its mandate to provide guidance to Member States on health policy matters, WHO issues a series of regularly updated position papers on vaccines and combinations of vaccines against diseases that have an international public health impact. These papers are concerned primarily with the use of vaccines in large-scale immunization programmes; they summarize essential background information on diseases and vaccines, and conclude with WHO's current position on the use of vaccines in the global context. This paper reflects the recommendations of WHO's Strategic Advisory Group of Experts (SAGE) on immunization. These recommendations were discussed by SAGE at its April 2014 and April 2015 meetings. The evidence presented at the meetings can be accessed at http://www.who.int/immunization/sage/previous/en/index.html . [ABSTRACT FROM AUTHOR]

This article presents the World Health Organization's (WHO) recommendations for the use of varicella and herpes zoster vaccination from the WHO position paper on varicella and herpes zoster vaccines – June 2014, published in the Weekly Epidemiological Record [1] . This position paper summarizes the WHO position on the use of varicella and herpes zoster vaccines. The current document replaces the position paper on the use of varicella vaccines published in 1998 [2] . Footnotes to this paper provide a number of core references. In accordance with its mandate to provide guidance to Member States on health policy matters, WHO issues a series of regularly updated position papers on vaccines and combinations of vaccines against diseases that have an international public health impact. These papers are concerned primarily with the use of vaccines in large-scale immunization programmes; they summarize essential background information on diseases and vaccines, and conclude with WHO's current position on the use of vaccines in the global context. This paper reflects the recommendations of WHO's Strategic Advisory Group of Experts (SAGE) on immunization. These recommendations were discussed by SAGE at its April 2014 meeting. Evidence presented at the meeting can be accessed at http://www.who.int/immunization/sage/previous/en/index.html . [ABSTRACT FROM AUTHOR]

This article presents the World Health Organization's (WHO) recommendations on the use of Japanese Encephalitis (JE) vaccines excerpted from the WHO position paper on Japanese Encephalitis vaccines recently published in the Weekly Epidemiological Record [1] . This updated position paper on JE vaccines replaces the 2006 position paper on this subject [2] ; it focuses on new information concerning the availability, safety, immunogenicity and effectiveness of JE vaccines and the duration of protection they confer. Recent data on global prevalence and burden of disease caused by JE and cost-effectiveness considerations regarding JE vaccination are also summarized. Footnotes to this paper provide a number of core references including references to grading tables that assess the quality of the scientific evidence. In accordance with its mandate to provide guidance to Member States on health policy matters, WHO issues a series of regularly updated position papers on vaccines and combinations of vaccines against diseases that have an international public health impact. These papers are concerned primarily with the use of vaccines in large-scale immunization programmes; they summarize essential background information on diseases and vaccines, and conclude with WHO's current position on the use of vaccines in the global context. This paper reflects the recommendations of WHO's Strategic Advisory Group of Experts (SAGE) on immunization. These recommendations were discussed by SAGE at its October 2014 meeting. Evidence presented at the meeting can be accessed at http://www.who.int/immunization/sage/previous/en/index.html . [ABSTRACT FROM AUTHOR]

This article presents the World Health Organization's (WHO) recommendations on the use of hepatitis E vaccine excerpted from the WHO position paper on hepatitis E vaccines – May 2015 recently published in the Weekly Epidemiological Record [1] . The current document is the first WHO position paper on hepatitis E vaccination and focuses primarily on the available evidence concerning the only hepatitis E vaccine that is currently licensed. The position paper gives consideration to the epidemiological features of the disease and assesses the use of the vaccine for public health benefits. Footnotes to this paper provide a number of core references including references to grading tables that assess the quality of the scientific evidence. In accordance with its mandate to provide guidance to Member States on health policy matters, WHO issues a series of regularly updated position papers on vaccines and combinations of vaccines against diseases that have an international public health impact. These papers are concerned primarily with the use of vaccines in large-scale immunization programmes; they summarize essential background information on diseases and vaccines, and conclude with WHO's current position on the use of vaccines in the global context. This paper reflects the recommendations of WHO's Strategic Advisory Group of Experts (SAGE) on immunization. These recommendations were discussed by SAGE at its October 2014 meeting. Evidence presented at the meeting can be accessed at http://www.who.int/immunization/sage/previous/en/index.html . [ABSTRACT FROM AUTHOR]

This article presents the World Health Organization's (WHO) recommendations for pain mitigation at the time of vaccination from the WHO position paper on reducing pain at the time of vaccination: WHO position paper—September 2015, recently published in the Weekly Epidemiological Record [1] . This position paper summarizes the evidence and integrates information pertaining to the reduction of pain, distress and fear during immunization across all age groups. In accordance with its mandate to provide guidance to Member States on health policy matters, WHO issues a series of regularly updated position papers on vaccines and combinations of vaccines against diseases that have an international public health impact, and on vaccination-related policy questions particularly concerning the use of vaccines in large-scale immunization programmes. They summarize essential background information and conclude with the current WHO position. This position paper addresses a cross-cutting issue which is relevant for all injectable vaccines and reflects the recommendations of WHO's Strategic Advisory Group of Experts (SAGE) on immunization. These recommendations were discussed by SAGE at its April 2015 meeting. The evidence presented at the meetings can be accessed at http://www.who.int/immunization/sage/previous/en/index.html . [ABSTRACT FROM AUTHOR]

Objective: In order to deliver good healthcare quality, it should explicitly be taken into account what patients value in healthcare. This study reviews qualitative studies in which patients express what they value. Based on this body of literature a preliminary taxonomy is designed.Methods: A systematic review of qualitative papers on what patients' value.Results: 22 studies out of a total of 3259 met the inclusion criteria. After critical appraisal, data extraction was carried out by two researchers independently and revealed values related to 1) the individual patient; 2) the expected behavior of professionals and 3) the interaction between patients and professionals. Seven key elements were recognized on the bases of content analysis; 1) uniqueness, 2) autonomy, 3) compassion, 4) professionalism, 5) responsiveness, 6) partnership and 7) empowerment.Conclusion: This study gives a rich insight into what patients value in various contexts and provides a promising taxonomy in line with patient centered based theories. The taxonomy needs further empirical research for a deeper insight and clarifaction in its elements.Practice Implications: This review and preliminary taxonomy contribute to the conceptualization of patient values as a bases for guidelines, policy and daily practice. [ABSTRACT FROM AUTHOR]

• Small doses of alcohol may or may not benefit cardiovascular disease (CVD). • Alcohol industry actors have been involved in review-level evidence, generating concerns. • Industry funding is not a major determinant of co-authorship in alcohol and CVD. • Conflicting findings on alcohol and CVD may be due to industry funding bias. • Progress in this area has implications for alcohol public health science and policy. Alcohol's effects on cardiovascular disease (CVD) are controversial. Alcohol industry actors have shown particular interest in this subject, and been extensively involved through research funding, and in other ways, generating concerns about bias, particularly in reviews. We conducted a co-authorship network analysis of the primary studies included within a previous co-authorship study of 60 systematic reviews on the impact of alcohol on CVD. Additionally, we examined the relationships between declared alcohol industry funding and network structure. There were 713 unique primary studies with 2832 authors published between 1969 and 2019 located within 229 co-authorship subnetworks. There was industry funding across subnetworks and approximately 8% of all papers declared industry funding. The largest subnetwork dominated, comprising 43% of all authors, with sparse evidence of substantial industry funding. The second largest subnetwork contained approximately 4% of all authors, with largely different industry funders involved. Harvard affiliated authors who at the review level formed co-authorship subnetworks with industry funded authors were seen at the primary study level to belong to the largest epidemiological subnetwork. A small number of key authors make extensive alcohol industry funding declarations. There was no straightforward relationship between co-authorship network formation and alcohol industry funding of epidemiological studies on alcohol and CVD. More fine-grained attention to patterns of alcohol industry funding and to key nodes may shed further light on how far industry funding may be responsible for conflicting findings on alcohol and CVD. [ABSTRACT FROM AUTHOR]

Complementing the well-established evidence base on health inequalities experienced by migrants, refugees and asylum seekers in the UK; we examined the extent to which their right to equal non-discriminatory access to health services (promotive, preventive, curative) was upheld during the COVID-19 pandemic. Arksey and O′Malley's scoping review framework. A comprehensive search was conducted on Medline, PubMed, and CINAHL using detailed MESH terms, for literature published between 01 January 2020 and 01 January 2024. The process was supported by a ten-page Google search and hand searching of reference lists. 42 records meeting the inclusion criteria were charted, coded inductively and analysed thematically in an integrated team-based approach. Dissonance between immigration regulation and health governance is illustrated in four themes: Health systems leveraged to (re)enforce the hostile environment; Dissonance between health rights on paper and in practice; Structural failures to overcome communication and digital exclusion; and COVID-19 vaccine (in)equity exacerbated fear, mistrust and exclusion. Migrants, refugees and asylum seekers encountered substantial individual, structural and policy-level barriers to accessing healthcare in the UK during COVID-19. Insecure immigration status, institutional mistrust, data-sharing and charging fears, communication challenges and digital exclusion impacted heavily on their ability to access healthcare in an equitable non-discriminatory manner. An inclusive and innovative health equity and rights-based responses reaching all migrants, refugees and asylum seekers are warranted if the National Health Service is to live up to its promise of ' leaving no one behind' in post-pandemic and future responses. [ABSTRACT FROM AUTHOR]

A persistent problem in cardiothoracic surgery, as in all of medicine, is when to offer or to withhold expensive technologies. The ethical requirement of balancing harms and benefits is often difficult to achieve. The use of LVADs is an example of such technologies, and when to offer it is explored in this paper. [ABSTRACT FROM AUTHOR]

• The pandemic pushed vaccine mandates to the forefront of global public health policy. • This special issue synthesises the findings of research in the field. • Scholars employ a range of methodologies to study speculative and real mandates. • Scholars study vaccine mandates at different stages of the policy cycle. • Scholars analyse mandates' impact on vaccine coverage rates and wider experiences. A workshop on mandatory vaccination was pitched to the World Public Health Congress in 2019 and the resultant special issue was pitched to Vaccine in 2020. During this project, the COVID-19 pandemic pushed vaccine policy to the forefront of global public health policy, and the imposition of vaccine mandates prompted a new wave of scholarship in the field. This introductory article employs the heuristic of Lasswell's (1956) policy cycle to synthesise the findings of the articles in the special issue. It considers the temporal lifetime of mandates and highlights findings regarding: the emergence of mandates as a policy option, public support and policy instrument design, what matters in the implementation of mandates, and what we can learn from evaluating them. The second half of the paper categorizes the included papers in terms of what aspects of mandates they study and the methods they employ to do so, in order to formulate a guide for future researchers of vaccine mandates. Scholars study either speculative or existing mandates – research can address several stages of the policy cycle or just one of them, ranging from attitudinal research to implementation studies and impact studies. Historical and contextual studies that take deep dives into a particular mandate are a much needed resource for studying emerging mandates, too, and scoping and framework- building work will undoubtedly be valuable in understanding and appreciating the wealth of knowledge production in this growing field. This special issue can serve as a roadmap for a consolidation of this interdisciplinary research agenda, and provide a helpful resource for decisionmakers at this historical juncture. [ABSTRACT FROM AUTHOR]

Despite the growing interest on the Russian-Ukrainian war and its repercussion on the children's health, there is no previous systematic review compiling the current evidence on this topic. This study conducted a rapid systematic review to investigate the current findings concerning the impact of the Ukraine war on the social and health aspects of the Ukrainian pediatric population. A rapid systematic review was conducted. PubMed, Scopus, CINAHL, PsycINFO, Web of Science, and Virtual Health Library (BVS Spain) were searched between February and April 2023. In addition, high-impact journals and institutions focused on pediatric health and human rights were also consulted. All relevant original articles, letters, editorials, and policy papers assessing the health and social repercussions of the war on Ukrainian children were included. From 134 publications matching the search criteria, 23 were included. These publications were categorized into three distinct domains: 'Public health challenges for the physical and mental health of children and adolescents', 'Lack of Healthcare resources and initiatives to mitigate suffering', and 'Policies, Government, and Children's rights'. Our findings revealed that the war is seriously impacting the life and the health of Ukrainian children, resulting in worse physical and mental health outcomes and perpetrating a deprived situation. To overcome such problems, several initiatives have been proposed by European and non-European countries, relying mostly on receiving refugees, providing mental health support, complementing lack of resources, and establishing policies to improve health care. It could help health professionals, policy makers, and governments to plan preventive, promotive, and therapeutic strategies for Ukrainian children. [ABSTRACT FROM AUTHOR]

The World Health Organisation's 2022 'blueprint for dementia research' highlights the need for more research into population-level risk reduction. However, definitions of population-level prevention vary, and application to dementia is challenging because of its multi-factorial aetiology and a maturing prevention evidence base. This paper compares and contrasts key concepts of 'population-level prevention' from the literature, explores related theoretical models and policy frameworks, and applies this to dementia risk reduction. We reach a proposed definition of population-level risk reduction of dementia, which focusses on the need to change societal conditions such that the population is less likely to develop modifiable risk factors known to be associated with dementia, without the need for high-agency behaviour change by individuals. This definition, alongside identified policy frameworks, can inform synthesis of existing evidence and help to co-ordinate the generation of new evidence. [ABSTRACT FROM AUTHOR]

• Alcohol policies that protect public health do not necessarily harm bars. • 'Sweetspot' policies are those which can improve public health without affecting hospitality businesses. • There is good evidence that increasing the price of shop-bought alcohol is a sweetspot policy. • Restricting remote/online alcohol sales is also a likely sweetspot policy. • Measures to shape or manage the night-time economy are less well supported by evidence. During COVID-19, hospitality businesses (e.g. bars, restaurants) were closed/restricted whilst off-sales of alcohol increased, with health consequences. Post-covid, governments face lobbying to support such businesses, but many health services remain under pressure. We appraised 'sweetspot' policy options: those with potential to benefit public services and health, whilst avoiding or minimising negative impact on the hospitality sector. We conducted rapid non-systematic evidence reviews using index papers, citation searches and team knowledge to summarise the literature relating to four possible 'sweetspot' policy areas: pricing interventions (9 systematic reviews (SR); 14 papers/reports); regulation of online sales (1 SR; 1 paper); place-shaping (2 SRs; 18 papers/reports); and violence reduction initiatives (9 SRs; 24 papers/reports); and led two expert workshops (n = 11). Interventions that raise the price of cheaper shop-bought alcohol appear promising as 'sweetspot' policies; any impact on hospitality is likely small and potentially positive. Restrictions on online sales such as speed or timing of delivery may reduce harm and diversion of consumption from on-trade to home settings. Place-shaping is not well-supported by evidence and experts were sceptical. Reduced late-night trading hours likely reduce violence; evidence of impact on hospitality is scant. Other violence reduction initiatives may modestly reduce harms whilst supporting hospitality, but require resources to deliver multiple measures simultaneously in partnership. Available evidence and expert views point to regulation of pricing and online sales as having greatest potential as 'sweetspot' alcohol policies, reducing alcohol harm whilst minimising negative impact on hospitality businesses. [ABSTRACT FROM AUTHOR]

• Childcare policy responses towards Covid-19 differed in European welfare states. • Policy responses cause informalization of childcare to different degrees. • Informalization of childcare is mainly connected with social risks for women. • Cultural and institutional differences help to understand varying policy responses. The closure of extra-familial childcare facilities by European governments in 2020 was an important part of interventions against the spread of the COVID-19 pandemic. One consequence was that childcare was provided by parents at home, mainly by women. As a result, women mainly experienced financial and employment risks related to this "informalization" of childcare. The childcare policies of European welfare states differ in the extent to which they include measures to reduce the social risks related to informalization. Against this backdrop, this paper asks: How should one understand cross-national differences in childcare policies during the pandemic? We are also particularly interested in the effects of childcare policies on the social risks connected with the informalization of childcare and what these mean for the gendered division of paid work and care. Differences in childcare policies during the pandemic are commonly explained in terms of the path dependence of such policies. Using the theoretical approach of "care arrangement," this article introduces a broader theoretical framework that considers the role of cultural and institutional factors for understanding the cross-national differences in childcare policies during the pandemic. We introduce the findings of a comparative empirical study of childcare policies in three European welfare states—Denmark, Germany and England—that represent different types of care arrangements. This paper uses policy and media documents, quantitative data on childcare and women's employment, cultural ideas and secondary analysis of empirical studies. We find that governments did not per se respond to the pandemic based on institutional path dependence regarding childcare policies, while the integration of culture into the theoretical framework allows for a more comprehensive understanding. [ABSTRACT FROM AUTHOR]

• Value system of a society is often shaped by its constitution, affecting how society perceives family. • Modern constitutional provisions on family implicitly lean towards traditional family forms. • The notion of Family Support is rarely expressly mentioned in constitutions of European countries. • Family Support is seen as a part of supervision authority or general duty of states to assist families. • More inclusive constitutional provisions with a constructive, rights-based approach are needed. This paper aims to explore the extent in which contemporary constitutional concepts of the family influence the recognition of the importance and the implementation of family support in European context. The authors start from the premise that constitutions lay the foundation for national legislation and policy, at the same time indicating a state's recognition of internationally agreed standards in a given field. Considering family support as a human right, the authors reflect on the meaning of constitutional protection vis a vis policies and practices of providing support to children and families and look into family related constitutional provisions of various European countries. Building upon the work of the European Family Support Network – COST Action 18123, the key elements of constitutional protection of families are identified, having a direct effect on the conceptualization and delivery of family support. In conclusion, considering the place and significance afforded to family support in national constitutions, the paper offers a classification of constitutions in that respect and evaluates the implications of constitutional regulation on family support policies. [ABSTRACT FROM AUTHOR]

The aim of this FEPSAC Position Statement is to summarize current knowledge about athletes' dual careers (DCs) in the European context and propose recommendations for future DC research, practice, and policy. Inspired by the European Union's Guidelines on Dual Careers of Athletes (European Commission, 2012), researchers, practitioners, and policy makers collaborated over the last decade to create the European DC discourse as a context-informed and negotiated body of DC knowledge. In this paper, we proceed from analyzing this body of knowledge using recent review papers and European DC psychological research projects to formulating seven postulates summarizing DC research findings on factors influencing athletes in their striving for DC excellence. These factors include (1) context, (2) pathways and transitions, (3) challenges, (4) resources and coping, (5) support and empowerment, (6) student–athletes' mental health, and (7) DC development environments. In the final section, we acknowledge the contributions of European DC discourse in serving athletes in their pursuit of DC excellence and European DC culture. We also provide a critical discussion on DC knowledge gaps and, on behalf of FEPSAC, offer recommendations for DC research, practice, and policy in Europe. • Role of FEPSAC and European Commission in promoting dual career topic is stressed. • Current knowledge on athletes' dual careers in the European context is summarized. • Pursuit of dual career excellence is supported by seven research-based postulates. • Recommendations for future dual career research, practice, and policy are provided. [ABSTRACT FROM AUTHOR]

Governments around the world responded to the COVID19 crisis (CVC) by aggressively deploying fiscal policy to boost health expenditure, income transfers and increased welfare payments, as well as wage subsidies to firms to retain employees to minimize short term unemployment. A fiscal response was in principle both necessary and timely, but the nature of the responses adopted by governments differed markedly around the world. After describing the global macroeconomic impact of the CVC and its effect on budget deficits and public debt levels, this paper critically evaluates the global fiscal response with reference to comparable historical episodes. The analysis suggests some fiscal responses were too expansive and of the wrong form. The paper then highlights the future macroeconomic risks arising from the highly elevated public debt levels the CVC has caused, concluding that fiscal consolidation rather than further fiscal 'stimulus' will be needed to address the parlous fiscal legacy of the crisis. [ABSTRACT FROM AUTHOR]

Child and maternal health, a key marker of overall health system performance, is a policy priority area by the World Health Organization and the United Nations, including the Sustainable Development Goals. Previous realist work has linked child and maternal health outcomes to globalization, political tradition, and the welfare state. It is important to explore the role of other key policy-related factors. This paper presents a realist synthesis, categorising policy instruments according to the established NATO model, to develop an explanatory model of how policy instruments impact child and maternal health outcomes. A systematic literature search was conducted to identify studies assessing the relationships between policy instruments and child and maternal health outcomes. Data were analysed using a realist framework. The first stage of the realist analysis process was to generate micro-theoretical initial programme theories for use in the theory adjudication process. Proposed theories were then adjudicated iteratively to produce a set of final programme theories. From a total of 43,415 unique records, 632 records proceeded to full-text screening and 138 papers were included in the review. Evidence from 132 studies was available to address this research question. Studies were published from 1995 to 2021; 76% assessed a single country, and 81% analysed data at the ecological level. Eighty-eight initial candidate programme theories were generated. Following theory adjudication, five final programme theories were supported. According to the NATO model, these were related to treasure, organisation, authority-treasure, and treasure-organisation instrument types. This paper presents a realist synthesis to develop an explanatory model of how policy instruments impact child and maternal health outcomes from a large, systematically identified international body of evidence. Five final programme theories were supported, showing how policy instruments play an important yet context-dependent role in influencing child and maternal health outcomes. • A realist synthesis was conducted. • Assessed relationship between policy instruments and child and maternal health. • Synthesis informed by 132 unique studies. • Five final programme theories were supported. • Impact of policy instruments was context-dependent. [ABSTRACT FROM AUTHOR]

Despite the strong evidence of prevention as a prime defence against the disease, the majority of cancer research investment continues to be made in basic science and clinical translational research. Little quantitative data is available to guide decisions on the choice of research priorities or the allocation of research resources. The primary aim of the mapping of the European cancer prevention research landscape presented in this paper is to provide the evidence-base to inform future investments in cancer research. Using bibliometric data to identify funders that are active in prevention research in Europe and in the world, we have identified that 14% of cancer research papers had a focus on prevention research and those were funded by 16% of all the European cancer research funders. An important finding of our study is the lack of research on primary prevention with primary prevention funders accounting for 25% of European cancer prevention funders, meaning that less than 4% of all European cancer research funders identified show an interest in primary prevention. An additional analysis revealed that 7% of European cancer prevention research papers are categorised as implementation projects, meaning that only 1% of all cancer research publications are implementation research in cancer prevention. This paper highlights that the narrow focus on biology and treatment in Europe needs to be widened to include such areas as primary prevention and secondary prevention and a larger concentration on implementation research. These data can help support a more policy-focused cancer research agenda for individual European governments and charitable and philanthropic organisations and stimulate joining efforts across Europe to create a more systematic and structured approach to cancer prevention. • 14% of European cancer research papers have a focus on prevention research. • Only 7% of those papers are categorised as implementation research. • 16% of all European cancer research funders show an interest in prevention research. • Less than 4% of them show an interest in primary prevention. • These data can help support more policy-focused cancer research agenda. [ABSTRACT FROM AUTHOR]

This paper examines factors associated with the likelihood of healthy ageing and the propensity to utilise health care resources for a rural community in South Africa and the associated policy implications. Our results suggest education exerts a positive influence, and its marginal impact is more prominent for females than males. Further, we show that better childhood health is associated with increased likelihood of ageing well. We also demonstrate an inverse relationship between health care utilisation and healthy ageing. The results presented here suggest that strategic policy investments across life courses in education and child-health fosters not only broader development goals but also enhances healthy ageing trajectories and improve the health and wellbeing of individuals across life stages. This study contributes to informing on the UN's healthy ageing global strategic agenda in the context of a poor rural region. [ABSTRACT FROM AUTHOR]

• The Dutch government opted for a COVID-19 herd immunity approach. • The initial response was moderate followed by a quick shift to mitigation. • Excess mortality was high, yet immunity remained low. • One region persisted with containment and showed much lower hospitalization rates. • Economic interventions prevented large scale lay-offs but are unsustainable. This paper describes the first months of the COVID-19 pandemic in the Netherlands, including policies to reduce the health-related and economic consequences. The Netherlands started with containment and shifted to mitigation within three weeks when implementing a 'mild' lockdown. The initial focus was to obtain herd immunity while preventing Intensive Care Units from getting overwhelmed. An in-depth analysis of available national and international COVID-19 data sources was conducted. Due to regional variation in COVID-19 hospitalization rates, this paper focuses on three distinct regions; the initial epicenter; the most northern provinces which – contrary to national policy – decided not to switch to mitigation; and the Bible Belt, as congregations of religious groups were initially excluded from the ban on group formation. On August 11th, 6,159 COVID-19 deaths were reported with at the peak an excess mortality Z-score of 21.7. As a result of the pandemic, the economy took a severe hit and is predicted to shrink 6.5% compared to projection. The hospitalization rates in the northern regions were over 70% lower compared to the rest of the country (18 versus 66 per 100,000 inhabitants). Differences between the Bible Belt and the rest of the country were hardly detectable. The Dutch have shown a way to effectively slow down transmission while allowing more personal and economic freedom than most other countries. Furthermore, the regional differences suggest that containment prevented a surge of infections in the northern provinces. The results should be interpreted with caution, due to the descriptive nature of this study. [ABSTRACT FROM AUTHOR]

To summarise the evidence on the impacts of gambling-related advertising that could lead to gambling-related harm, including impacts on vulnerable individuals and inequalities in the distribution of harms. An umbrella review of studies investigating the impact of gambling advertising. A review was undertaken of systematic reviews of qualitative, quantitative and mixed method studies reporting outcomes associated with gambling advertising and marketing. The search strategy included database searches (Web of Science, PsycInfo) and website searches. The quality of the included reviews was determined using A MeaSurement Tool to Assess systematic Reviews 2. 1024 papers were identified by database searches. Eight systematic reviews, including 74 unique studies, met inclusion criteria. Included studies, using quantitative and qualitative methods, consistently support the existence of a causal relationship between exposure to advertising of gambling products/brands and more positive attitudes to gambling, greater intentions to gamble and increased gambling activity at both individual and population level. There is evidence of a 'dose–response' effect; greater advertising exposure increases participation which leads to a greater risk of harm. There was more evidence for the impact on children and young people and for those already at risk from current gambling activity with those most vulnerable more likely to be influenced. Gambling advertising restrictions could reduce overall harm and mitigate the impact of advertising on gambling-related inequalities. Public health harm prevention strategies should include policies which limit exposure to advertising, particularly among children and vulnerable groups. [ABSTRACT FROM AUTHOR]

In 2019 the Australian government released a guiding document for maternity care: Woman-centred care strategic directions for Australian maternity services (WCC Strategy), with mixed responses from providers and consumers. The aims of this paper were to: examine reasons behind reported dissatisfaction, and compare the WCC Strategy against similar international strategies/plans. The four guiding values in the WCC strategy: safety, respect, choice, and access were used to facilitate comparisons and provide recommendations to governments/health services enacting the plan. Maternity plans published in English from comparable high-income countries were reviewed. Eight maternity strategies/plans from 2011 to 2021 were included. There is an admirable focus in the WCC Strategy on respectful care, postnatal care, and culturally appropriate maternity models. Significant gaps in support for continuity of midwifery care and place of birth options were notable, despite robust evidence supporting both. In addition, clarity around women's right to make decisions about their care was lacking or contradictory in the majority of the strategies/plans. Addressing hierarchical, structure-based obstacles to regulation, policy, planning, service delivery models and funding mechanisms may be necessary to overcome concerns and barriers to implementation. We observed that countries where midwifery is more strongly embedded and autonomous, have guidelines recommending greater contributions from midwives. Maternity strategy/plans should be based on the best available evidence, with consistent and complementary recommendations. Within this framework, priority should be given to women's preferences and choices, rather than the interests of organisations and individuals. [ABSTRACT FROM AUTHOR]

Many countries have imposed a set of non-pharmaceutical health policy interventions in an effort to slow the spread of the COVID-19 pandemic. The objective of this paper is to examine the effects of the interventions, drawing on evidence from the OECD countries. A special feature here is the mechanism that underlies the impact of the containment policies. To this end, a causal mediation analysis decomposing the total effect into a direct and an indirect effect is conducted. The key finding is a dual cause-effect channel. On the one hand, there is a direct effect of the non-pharmaceutical interventions on the various health variables. Beyond this, a quantitatively dominant indirect impact of non-pharmaceutical interventions operating via voluntary changes in social distancing is shown. [ABSTRACT FROM AUTHOR]

• This study applied a logistic growth model with parameters estimated by a non-linear least squares (NLS) method to daily new COVID-19 cases. • The model fitted time-series data exceedingly well for the whole of China, eleven selected Chinese provinces and municipalities, South Korea and Iran. • This study provided key estimates and a 95% confidence interval for parameters K , r, and P 0. • This study found that the growth rates of outbreaks differed between provinces in China and between South Korea and Iran. • As of March 13, 2020, this study's model suggested that countries such as the U.S.A., France, Italy, and Spain were still in the early stages of outbreaks. As the coronavirus disease 2019 (COVID-19) pandemic continues to proliferate globally, this paper shares the findings of modelling the outbreak in China at both provincial and national levels. This paper examines the applicability of the logistic growth model, with implications for the study of the COVID-19 pandemic and other infectious diseases. An NLS (Non-Linear Least Squares) method was employed to estimate the parameters of a differentiated logistic growth function using new daily COVID-19 cases in multiple regions in China and in other selected countries. The estimation was based upon training data from January 20, 2020 to March 13, 2020. A restriction test was subsequently implemented to examine whether a designated parameter was identical among regions or countries, and the diagnosis of residuals was also conducted. The model's goodness of fit was checked using testing data from March 14, 2020 to April 18, 2020. The model presented in this paper fitted time-series data exceedingly well for the whole of China, its eleven selected provinces and municipalities, and two other countries - South Korea and Iran - and provided estimates of key parameters. This study rejected the null hypothesis that the growth rates of outbreaks were the same among ten selected non-Hubei provinces in China, as well as between South Korea and Iran. The study found that the model did not provide reliable estimates for countries that were in the early stages of outbreaks. Furthermore, this study concured that the R 2 values might vary and mislead when compared between different portions of the same non-linear curve. In addition, the study identified the existence of heteroskedasticity and positive serial correlation within residuals in some provinces and countries. The findings suggest that there is potential for this model to contribute to better public health policy in combatting COVID-19. The model does so by providing a simple logistic framework for retrospectively analyzing outbreaks in regions that have already experienced a maximal proliferation in cases. Based upon statistical findings, this study also outlines certain challenges in modelling and their implications for the results. [ABSTRACT FROM AUTHOR]

This paper reviews the outbreaks of SARS and Covid-19 in Taiwan and their implications for public health and policy. SARS, a novel coronavirus that emerged in China in 2003, caused severe respiratory illness and spread rapidly across Asia, including Taiwan. Covid-19, another novel coronavirus that originated in China in 2019, posed a similar threat to Taiwan due to the high volume of cross-border travel. However, Taiwan learned from its experience with SARS and implemented timely and effective measures to contain the virus and protect its population. The paper draws on evidence from various sources, such as reviews, correspondence, and diaries, to examine how Taiwan responded to both epidemics. It highlights the role of the government, the health care system, the media, and the public in preventing and controlling the spread of infection. It also compares the economic and social impacts of SARS and Covid-19 on Taiwan and other countries. The paper argues that Taiwan's success in managing both epidemics demonstrates its maturity and competence in epidemic prevention and preparedness. It also suggests that Taiwan's model can serve as a reference for other countries facing similar challenges. The paper concludes by acknowledging the ongoing threat of emerging infectious diseases and calling for global cooperation and vigilance. [ABSTRACT FROM AUTHOR]

Objectives: Involvement of patients and medical professionals in assessment of relative effectiveness (relative effectiveness assessment) contributes to an efficient and effective health technology assessment (HTA) process and supports acceptance and implementation of the outcome. This study aimed to analyze stakeholder involvement in assessing relative effectiveness and how the parties involved value this collaboration.Methods: This is a document analysis of all drug assessments completed in 2019 (20) by the public HTA agency of The Netherlands, enriched with semistructured interviews with employees of the HTA agency (18) and representatives of patient (5) and medical (11) associations involved in these assessments. Data were analyzed, coded, and categorized.Results: In almost half of the assessments, there was no coordination with the medical associations at the start of the relative effectiveness assessment and no patient associations involved in this phase. During the assessment procedure, patient and medical associations were always asked to comment on the draft report. Nevertheless, the strict 5-day deadline that the HTA agency uses as a response period often hampered a proper response and involvement. According to interviewees of the HTA agency, this leads to a great diversity in the substantive quality of their input. Patient and medical associations indicated that the HTA agency relies too much on "paper knowledge," which leads to a (perceived) lack of alignment with clinical practice.Conclusions: The limited involvement results in a lack of coordination and mutual trust. Optimizing involvement of patients and medical professionals in HTA practice requires effort from all parties involved. Procedural adjustments and better coordination, especially at the start of the assessment, would probably improve cooperation. [ABSTRACT FROM AUTHOR]

Background: In response to the COVID-19 pandemic, many pharmacy-based or pharmacist-delivered services were introduced or amended to mitigate the pandemic's health and social impact. This happened within the context of pharmacists seeking more opportunities to increase their clinical responsibilities and play a larger role in primary care.Objective(s): To analyse the policymaking context and pharmacy responses to COVID-19 that enable or constrain the expansion of pharmacists' scope of practice.Methods: This study is a policy analysis of documentary data detailing changes in pharmacy policy in Australia, drawing on a "policy space analysis" framework to identify opportunities and constraints to policy reform. Data were collected from news for health professionals; federal/jurisdictional legislation and media releases; and guidelines and directives from government health departments and agencies. Changes to pharmacy practice were identified and classified according to type. For each change, potential opportunities and constraints for expanding pharmacists' scope of practice were identified.Results: Four categories of changes were identified: medicines limits/restrictions; alternatives to paper prescriptions; public health measures; and community pharmacist-delivered services. Opportunities from the pandemic response that could expand scope of practice include the potential permanence of temporary measures that increase pharmacists' responsibilities; remuneration to legitimise services; political acknowledgement of medicines safety and access as a priority; and government need to quickly address crises. Constraints include the potential permanence of temporary measures that restrict pharmacists' practice; negative perceptions of pharmacists from other clinicians; intra-professional disagreements regarding pharmacy-based services; and lack of pharmacist representation in institutional structures.Conclusions: This analysis demonstrates that the pandemic responses and policy context may facilitate expansion of pharmacists' scope of practice, and identifies possible avenues to do so; it also highlights constraints that need to be further addressed to achieve this goal. [ABSTRACT FROM AUTHOR]

There is a critical shortage of health professionals globally which is affecting the possibility of attaining universal health coverage. Developing countries in sub-Saharan Africa such as Ghana and Nigeria are disproportionately affected and the shortfall in health professionals is envisaged to worsen over the next decade. Countries have responded differently in addressing this shortage. To understand the differing response to the same policy issue in two countries that share similar characteristics in terms of geolocation, socioeconomic indices and disease burden, this paper offers a comparative policy analysis of the two countries using the 3-I framework and punctuated equilibrium theory as comparative policy analysis tools. The analysis identified the ideas, interests, and institutions at play and how they have led to different policy outcomes in both countries. The analysis also shows the interaction between subsystems, policy images and policy venues and how this interaction led to policy change, in the case of Ghana and lag in the case of Nigeria. Our findings show four critical areas in addressing health workforce shortages in both countries – a general approach to addressing the issue, welfare and remuneration, workforce autonomy and career progression, and financing for workforce improvement. For Ghana, there has been significant policy change including implementing strategies for increasing the production of health professionals and addressing remuneration and welfare issues. For Nigeria, there has been seems to be a lag in policy change. While the findings show that Ghana's approach has seemingly put them on a good path toward universal health coverage, applying any lessons should, however, be contextual, considering other country-level and health systems factors that are relevant to addressing health workforce shortages. • African countries bear the disproportionate burden of global health worker shortage. • Different countries in the region have had different policy responses to the issue. • Ghana's response has been strategic, positive, and leading them towards UHC. • Nigeria has witnessed policy stagnancy, encumbered by health systems politics. • To achieve UHC, health worker shortages need strategic context-based policy solutions. [ABSTRACT FROM AUTHOR]

• To sustain YPAR practices during the COVID-19 pandemic, adaptations were necessary. • Microsystem adaptations included addressing youth's basic and material needs. • Mesosystem adaptations entailed inclusive technology and attending to local changes. • Exosystem adaptations focused on modifying trainings for adult allies. • Macrosystem adaptations involved flexibility in deliverables and use of funding. Drawing upon illustrative examples from four diverse youth participatory action research (YPAR) projects that took place during the COVID-19 pandemic and racial justice uprisings, this paper showcases adaptations that were made to sustain YPAR practices and youth voice. Utilizing Bronfenbrenner's socio-ecological model as an organizing frame, we discuss how YPAR facilitators were responsive to youth and community needs within the micro-, meso-, exo-, and macrosystem. We addressed youth's material needs during periods of precarity and modified approaches for engaging adult allies, in recognition of their reduced capacity professionally and personally. While these adaptations were made in response to a rapidly shifting landscape during a specific historic period, they reflect lasting considerations for YPAR theory, practice, and policy. Opting for flexibility over fidelity and considering the realities present in multiple systems levels can help YPAR better meet the needs of youth and communities, especially during changing or challenging times. [ABSTRACT FROM AUTHOR]

The National Institute of Health (NIH) policy, Consideration of Sex as a Biological Variable (SABV) in NIH-funded Research (2015), focuses on the expectation that researchers account for the influence of SABV in vertebrate animal and human studies and provide a strong justification for single-sex investigations. When SABV is considered in the research design, data analyses, and reporting, the rigor and reproducibility of the research are elevated and inform best practices and precision health for all people. Additional recommendations include the appropriate use of terminology, integration into curricula, intersection with social determinants of health, and application of sex and gender equity guidelines when disseminating research. This paper is a "call to action" for nurse researchers to lean into and apply this policy's principles and our recommendations, from the bench to the bedside, to advance the equity and health of all people. • Omics-based clinical discoveries explain the influences of sex and gender on health and disease. • Despite consensus that sex and gender are distinct constructs, their use in research is unreliable. • Key recommendations to advance generation and dissemination of rigorous research are provided. • The SAGER guidelines promote the systematic reporting of sex and gender in research. [ABSTRACT FROM AUTHOR]

• The complex interconnectedness of climate change, energy demand, and health and long-term care poses current and future cascading challenges for the resilience of older people. • Key interconnections include a concern for the impact of frequent and intense weather events parallel to a global increase in life expectancy and social justice issues connected with strained resources and public infrastructure. • Comprehensive, targeted policies are needed on the national and global level that incentivize sustainable practices, enhance climate resilience, and support vulnerable populations in the Global South, and that mitigate the social justice implications of climate change for older adults. Challenges faced by many countries are energy insecurity, climate change, and the health and long-term care of growing numbers of older people. These challenges are increasingly intersecting with rising energy prices, aging populations, and an increased frequency and intensity of extreme climate events. This paper gives a deeper understanding of the current and predicted interconnections among these challenges through narrative-driven content and thematic analysis from workshops with a diverse group of international stakeholders from the Global North and Global South. Narratives emerged highlighting a complex nexus of interconnections and presenting critical action areas. Targeted local and global policies and interventions are needed to alleviate stress on health systems, encourage the integrated uptake of clean energy sources, and uphold social justice across all economies. Professionals can use this work to inform the design and implementation of effective interventions and increase the resilience of older adults by better preparing for systemic risks. [ABSTRACT FROM AUTHOR]

In November 2022, the anti-abortion advocacy group Alliance for Hippocratic Medicine filed a lawsuit against the U.S. Food and Drug Administration challenging the initial 2000 approval of mifepristone and its subsequent approvals, which removed unnecessary restrictions on its use, by disputing the medication's safety record. Such challenges relied on a study examining the incidence of emergency room visits following medication abortion with mifepristone and procedural abortion using Medicaid claims data from 1999–2015. In February 2024 that study was retracted by its publisher. In this paper, we analyzed the methods and presentations of the data used in the study. We drew upon commonly accepted principles in responsible epidemiologic and scientific research to evaluate the methods and presentations of the data and organized our findings into themes. We found multiple instances of methodological flaws, mischaracterizations, and obfuscations of data in this study, including use of a misleading research question and framing, analytic flaws, inappropriate use of an unvalidated proxy measure for outcomes of interest, and inappropriate and deceptive visualizations of data. In each instance, the resulting effect obfuscated and misrepresented the safety of medication abortion with mifepristone. The misrepresentation and exaggeration of data promoted and exacerbated misinterpretations about the study's findings, resulting in substantial harm before it was retracted. Recognizing that ongoing judicial proceedings threaten access to conventional reproductive health care in the United States, public health policies must be informed by scientific and medical literature that is comprehensive, methodologically sound, and absent any obfuscations or misrepresentations. Studnicki et al.'s study of emergency room visits after abortion misrepresented the safety of mifepristone with multiple instances of methodological flaws and obfuscations of data. While the study has now been retracted, it led to irrevocable harm, threatening access to medication abortion, which has an established safety record. [ABSTRACT FROM AUTHOR]

In healthcare institutions across the country, the role of poetry continues to emerge within the liminal spaces between the medical humanities and clinical care. While the field of narrative medicine is well-developed generally, formal review of the state of poetry as a healing modality is limited. Poetry in the medical humanities literature has often been described by its indefinability as much as by its impact on healing. The power of poetry in healthcare is thought to be multi-faceted and deserves to be explored further. Poetry can be medicine for both patient and clinician. "Poetic Medicine" is a modality that has been utilized for the healing of grief, loss, wounds of the psyche and spirit, and as a process for expanding resiliency in healthcare-applications that are particularly relevant to the practice of hospice and palliative medicine-for patient and clinician alike. While numerous approaches share common themes, current programs bringing poetry into healthcare have been operating largely in isolation from each other-with a lack of national consensus on definitions or structures of interventions. Such isolation is a major restriction to the study and growth of Poetic Medicine. While it is not known with certitude, the number of Poetic Medicine programs in healthcare in the United States appears to be growing. In this paper, we propose an initial framework to define the role and impact of poetry in healthcare and then describe two different, well-established Poetic Medicine programs in the United States. [ABSTRACT FROM AUTHOR]

Constructing simulation models can be a complex and time-consuming task, in particular if the models are constructed from scratch or if a general-purpose simulation modeling tool is used. In this paper, we propose a model construction framework, which aims to simplify the process of constructing discrete event simulation models for emergency medical service (EMS) policy analysis. The main building blocks used in the framework are a set of general activities that can be used to represent different EMS care chains modeled as flowcharts. The framework allows to build models only by specifying input data, including demographic and statistical data, and providing a care chain of activities and decisions. In a case study, we evaluated the framework by using it to construct a model for the simulation of the EMS activities related to acute stroke. Our evaluation shows that the predefined activities included in the framework are sufficient to build a simulation model for the rather complex case of acute stroke. [ABSTRACT FROM AUTHOR]

Childhood Immunization is one of the critical strategies to decrease infant morbidity and mortality due to infectious diseases, but primary immunization schedules for infants in most countries start at 2 months of age. Childhood vaccines therefore begin providing adequate protection later in life, leaving infants vulnerable to infectious diseases and creating an immunity gap that results in higher morbidity and mortality among younger infants. Maternal immunization, the practice of vaccinating individuals during pregnancy, reduces the risk of infant infection primarily through the transfer of protective maternal antibodies to the fetus during late pregnancy. Although much progress has been made in public health policies to support maternal immunization research, inclusion of pregnant individuals and children in clinical trials remains challenging. This has resulted in paucity of evidence regarding safety and effectiveness of vaccines to support licensure of products intended for use during pregnancy and lactation to prevent disease in the infant. In addition, although safeguards for clinical research in pregnancy are supportive, experimental vaccines, e.g., Respiratory Syncytial Viru s, are more complicated to study because data on safety, efficacy, and dosing are limited. This requires randomized controlled trials with safety monitoring for the mother, the fetus, and the infant with follow-up for at least 1 year or longer to assess long-term health outcomes that may be associated with peripartum vaccine exposure. The goal of this paper is to discuss the general regulatory considerations for clinical research to evaluate safety and effectiveness of vaccines administered during pregnancy to protect infants from disease. This could be useful to inform future vaccine trials. This discussion is not intended to provide agency guidance nor to articulate agency policy. [ABSTRACT FROM AUTHOR]