A blueprint for success in real-world evidence: "glocal" approach to building capabilities and generating impactful evidence.

The past decade has seen the increasing influence and relevance of real-world data (RWD) and real-world evidence (RWE) in healthcare decision making. The value added by RWD/RWE has prompted the pharmaceutical industry to develop high performing systems and practices to harness the power of evidence generated at the global level. However, this worldwide transformation provides outstanding opportunities to support capability building within local affiliates and to impact key country-level stakeholders through resulting evidence. Therefore, we present an Evidence Blueprint Initiative, which links the global and local ("glocal") skills, and furthermore addresses the opportunities and gaps in evidence generation capabilities at the local level. Cross-functional experts were recruited at the local, regional, and global level to define best practices. A framework was developed to characterize the foundational expertise needed and to assess markets' existing capabilities. Subsequently, targeted roadmaps were developed and implemented to build capabilities in specific areas within each affiliate. The impact from the Blueprint is encouraging, resulting in improved local evidence plans, established evidence teams, enhanced RWD use and strategic implementation of patient centric science in local affiliates. The success of the Blueprint resides in empowering affiliates to realise their local evidence generation ambitions and to match them to their local context. It strengthens and expands the ties between various parts of the organisation and the external environment while building fit-for-future evidence capabilities from local affiliates.

Belief in vaccine myths and vaccine uptake in Utah during the COVID-19 pandemic.

Introduction: Since its emergence in December 2019, COVID-19 has caused millions of deaths worldwide. While vaccines are largely available in most places, including the United States (U.S.), vaccine uptake is lower than is desirable from a public health perspective. Objective: The objective of this paper is to examine belief in vaccine myths, including what individual and place characteristics underpin such beliefs, and uptake of vaccines - as well as the role of belief in myths in obtaining the COVID-19 vaccine. Methods: We use weighted survey data from an online panel of 529 Utah adult residents. Results: Sixty-nine percent of our sample was fully vaccinated at the time of taking the survey. We find that belief in vaccine myths varies among Utahns, with the highest percentage seeing the vaccines as unsafe because of their rapid development. Those who are older, are more religious (including members of The Church of Jesus Christ of Latter-day Saints), have less formal education, and are more conservative were more likely to have medium and/or higher levels of belief in vaccine myths. We find that belief in vaccine myths is associated with lower COVID-19 vaccine uptake, even when controlling for other factors. Conclusion: Understanding what drives vaccination uptake, including the role of belief in emerging vaccine myths, is important for public health measures in this and future outbreaks.

The social-ecological system of the Kenai River Fishery (Alaska, USA).

We present a collaboratively developed social-ecological model of the Kenai River Fishery. We developed the model through iterative interviews with stakeholders throughout the Kenai Peninsula using a novel participatory Fuzzy Cognitive Mapping process grounded in Ostrom's social-ecological systems framework. Individual social-ecological models, developed one-on-one with stakeholders, were combined into a single aggregated model representing the system's structure and function. We validated this aggregated model through subsequent interviews with stakeholders and focused literature reviews. The result is a model that can: 1) illustrate the breadth and interconnectedness of the Kenai River Fishery's social-ecological system; 2) be used to facilitate discussions around management of the fishery; and 3) be used to explore the components and interactions that move the system toward or away from sustainability. Using the model, we identify how the nature of salmon (migratory) and their habitat (large and unpredictable) leads to uncertainty about effective management strategies. This uncertainty, in addition to a large and diverse set of resource users, creates conflicting management goals that ultimately limit the governance system in making decisions that might increase the sustainability of the fishery.

Impacts of irrigation efficiency on water-dependent sectors are heavily controlled by region-specific institutions and infrastructures.

Farmers' investment in more efficient irrigation systems represents a primary adaptation strategy when confronting climate change. However, the regional benefits of these investments and their influence on the conflicting demands among different water dependent stakeholders for intensely irrigated regions remains an open question. Using the Pacific Northwest of the United States as an illustrative region of focus, we show that higher irrigation efficiency has diverse effects across stakeholders that are contingent on many local climatic, institutional and infrastructural factors such as the availability of water storage, the location of hydropower generators, and water rights. These complexities limit simple abstractions of irrigation efficiency as broader policy challenge and are central to its inclusion within the class of "wicked problems". Additionally, we argue that the widely used rebound effect concept, which implicitly discourages irrigation efficiency supporting policies, should not be assumed to fully capture the nuances of the complex suite of regional impacts that emerge from irrigation efficiency investments. Consequently, the evaluation of irrigation efficiency investments requires a broader framing across a diversity of perspectives. policies and actions that are pluralistic, context-specific, and closely engage various groups of stakeholders in the policymaking process.

Inequality amplifies the negative association between life expectancy and air pollution: A cross-national longitudinal study.

Ambient air pollution, in the form of fine particulate matter (PM2.5), poses serious population health risks. We estimate cross-national longitudinal models to test whether the negative relationship between life expectancy and PM2.5 concentration is larger in nations with higher levels of income inequality. The dependent variable is average life expectancy at birth, and the focal predictor variables include PM2.5 concentration, income inequality, and the two-way interaction between them. We also estimate the average marginal effects of PM2.5 concentration from low to high values of income inequality, and the predicted values of life expectancy from low to high values of PM2.5 concentration and income inequality. Results indicate that the negative relationship between life expectancy and PM2.5 concentration is larger in nations with higher levels of income inequality, and the reductions in predicted life expectancy are substantial when both PM2.5 concentration and income inequality are high. We suggest that the theoretical principles of Power, Proximity, and Physiology help explain our findings. This study underscores the importance in considering the multiplicative impacts of environmental conditions and socioeconomic factors in the modeling of population health.

The multiplicative impacts of working hours and fine particulate matter concentration on life expectancy: A longitudinal analysis of US States.

This study contributes to interdisciplinary research on the social and environmental determinants of population health, with a focus on the interaction between working hours and fine particulate matter (PM2.5) concentration. The authors estimate longitudinal models of the relationship between US state-level average life expectancy and both average working hours and PM2.5 concentration for the 2005-2014 period. Results obtained from two-way fixed effects models indicate that average life expectancy is negatively associated with both average working hours and fine particulate matter concentration. Findings also indicate clear moderating relationships: the negative association between life expectancy and working hours is amplified as PM2.5 concentration increases, and the negative relationship between life expectancy and fine particulate matter concentration is amplified when average working hours increase. The results of this study underscore the need for additional research on the multiplicative impacts of socioeconomic factors and environmental factors in the modeling of population health.

Adverse effects and treatment satisfaction among online users of four antidepressants.

Adverse effects (AEs) are an important factor in antidepressant treatment decision-making, though common AE profiles from clinical trial research highlight physical AEs to the neglect of emotional and behavioral AEs. First-hand accounts of antidepressant users on the Internet can supplement AE profiles with information gained from real-world treatment experiences. We examined online user reviews of two older (escitalopram; duloxetine) and two newer (vilazodone; vortioxetine) antidepressants for differences in their AE profiles and determined which categories of AEs were associated with users' satisfaction. A codebook of 60 physical, emotional, and behavioral AEs was used for line-by-line coding of effects reported among 3243 user reviews from three popular health websites. Emotional and behavioral effects were commonly reported (41%), followed by sleep (31.9%) and gastrointestinal (25.0%) effects. Specific AEs statistically significantly varied across drugs, creating potentially meaningful differences in AE profiles. Users of newer drugs more often reported emotional instability, while users of older drugs reported more emotional blunting. Emotional and behavioral AEs demonstrated moderate to substantial relationships with users' satisfaction, whereas gastrointestinal, metabolic, or sexual AEs were minimally related. More specific and systematic assessment of a broader range of AEs is needed in both research and practice.

Strategies for Working with Asian Americans in Mental Health: Community Members' Policy Perspectives and Recommendations.

This qualitative study used snowball sampling of individuals known to provide informal assistance to Asian American community members with their mental health problems in a locality in the South where there has been an exponential increase of the Asian American population. The major themes found include: (1) the existence of cultural, language, knowledge, and transportation barriers and the importance of policy in addressing them; (2) the impact of the model minority myth and the need for inclusive policymaking; and (3) the unique service and policy needs of immigrants. Findings demonstrate the importance and value of including diverse Asian American individuals in mental health policymaking efforts.

The Role of Healthcare Professionals in Encouraging Parents to See and Hold Their Stillborn Baby: A Meta-Synthesis of Qualitative Studies.

BACKGROUND: Globally, during 2013 there were three million recorded stillbirths. Where clinical guidelines exist some recommend that professionals do not encourage parental contact. The guidance is based on quantitative evidence that seeing and holding the baby is not beneficial for everyone, but has been challenged by bereaved parents' organisations. We aim to inform future guideline development through a synthesis of qualitative studies reporting data relevant to the research question; how does the approach of healthcare professionals to seeing and holding the baby following stillbirth impact parents views and experiences? METHODS/FINDINGS: Using a predetermined search strategy of PubMed and PsychINFO we identified robust qualitative studies reporting bereaved parental views and/or experiences relating to seeing and holding their stillborn baby (final search 24 February, 2014). Eligible studies were English language, reporting parental views, with gestational loss >20 weeks. Quality was independently assessed by three authors using a validated tool. We used meta-ethnographic techniques to identify key themes and a line of argument synthesis. We included 12 papers, representing the views of 333 parents (156 mothers, 150 fathers, and 27 couples) from six countries. The final themes were: "[Still]birth: Nature of care is paramount", "Real babies: Perfect beauties, monsters and spectres", and "Opportunity of a lifetime lost." Our line-of-argument synthesis highlights the contrast between all parents need to know their baby, with the time around birth being the only time memories can be made, and the variable ability that parents have to articulate their preferences at that time. Thus, we hypothesised that how health professionals approach contact between parents and their stillborn baby demands a degree of active management. An important limitation of this paper is all included studies originated from high income, westernised countries raising questions about the findings transferability to other cultural contexts. We do not offer new evidence to answer the question "Should parents see and hold their stillborn baby?", instead our findings advance understanding of how professionals can support parents to make appropriate decisions in a novel, highly charged and dynamic situation. CONCLUSIONS: Guidelines could be more specific in their recommendations regarding parental contact. The role of healthcare professionals in encouraging parents to see and hold their stillborn baby is paramount. Parental choice not to see their baby, apprehension, or uncertainty should be continuously revisited in the hours after birth as the opportunity for contact is fleeting and final.

Seeing and Holding Baby: Systematic Review of Clinical Management and Parental Outcomes After Stillbirth.

BACKGROUND: In 2009 there were an estimated 2.6 million stillbirths worldwide. In the United States, a 2007 systematic review found little consensus about professional behaviors perceived by parents to be most helpful or most distressing. In the United Kingdom, a bereaved parents' organization has highlighted discordance between parental views and clinical guidelines that recommend clinicians do not encourage parents to see and hold their baby. The objective of this review was to identify and synthesize available research reporting parental outcomes relating to seeing and holding. METHODS: We undertook a systematic review. We included studies of any design, reporting parental experiences and outcomes. Electronic searches (PubMed and PsychINFO) were conducted in January 2014. Three authors independently screened and assessed the quality of the studies before abstracting data and undertaking thematic analysis. RESULTS: We reviewed 741 records and included 23 studies (10 quantitative, 12 qualitative, and 1 mixed-method). Twenty-one studies suggested positive outcomes for parents who saw or held their baby. Increased psychological morbidity was associated with current pregnancy, choice not to see their baby, lack of time with their baby and/or insufficient mementos. Three themes were formulated "positive effects of contact within a traumatic life event," "importance of role of health professionals," and "impact on mothers and fathers: similarities and differences." CONCLUSIONS: Stillbirth is a risk factor for increased psychological morbidity. Parents seeing and holding their stillborn baby can be beneficial to their future well-being. Since 2007, there has been a proliferation of studies that challenge clinical guidelines recommending that clinicians do not encourage parental contact.

The changing effect of economic development on the consumption-based carbon intensity of well-being, 1990-2008.

Recent sustainability science research focuses on tradeoffs between human well-being and stress placed on the environment from fossil fuel consumption, a relationship known as the carbon intensity of well-being (CIWB). In this study we assess how the effect of economic development on consumption-based CIWB--a ratio of consumption-based carbon dioxide emissions to average life expectancy--changed from 1990 to 2008 for 69 nations throughout the world. We examine the effect of development on consumption-based CIWB for the overall sample as well as for smaller samples restricted to mostly high-income OECD nations, Non-OECD nations, and more nuanced regional samples of Non-OECD nations in Africa, Asia, and Latin America. We find that the effect of economic development on CIWB increased through time for the overall sample. However, analyses of the Non-OECD and OECD samples indicate that while the effect of development on CIWB increased from null to a moderate level for the Non-OECD nations, the effect of economic development was much larger, relatively stable through time, and more unsustainable for the OECD nations. Additional findings reveal important regional differences for Non-OECD nations. In the early 1990s, increased development led to a reduction in CIWB for Non-OECD nations in Africa, but in more recent years the relationship changed, becoming less sustainable. For the samples of Non-OECD nations in Asia and Latin America, we find that economic development increased consumption-based CIWB, and increasingly so throughout the 19 year period of study.

Self-directed care: participants' service utilization and outcomes.

OBJECTIVE: Self-directed care (SDC) is a mental health service delivery model in which participants budget the state dollars allotted for their care to purchase the goods and services they deem most appropriate for achieving their recovery goals. This study examines the demographic characteristics, service utilization patterns, and outcomes of individuals enrolled in the Florida Self-Directed Care (FloridaSDC) program, which is the oldest and most established SDC program in the United States for individuals diagnosed with a severe and persistent mental illness. METHOD: This is a naturalistic descriptive study in which demographic, service utilization, and outcome data (i.e., Functional Assessment Rating Scale (FARS) scores, days in the community, days worked, monthly income, discharge status) were collected from the clinical and fiscal records of 136 FloridaSDC participants. RESULTS: Key findings suggest that FloridaSDC participants had very little income and largely utilized their budgets to subsidize their living expenses. Though most participants did not work or earn income and very few left the program due to employment, participants' FARS scores improved modestly and nearly all participants remained in the community throughout the study period. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Participants' service purchases were rational given the poverty in which they live, and their outcomes did not suffer when they controlled decisions regarding their service needs. These findings highlight the utility and value of the personalized budgeting and individualized planning components of SDC. Findings also point to the need for practitioners to implement innovative strategies to enhance participants' employment readiness and supported employment opportunities. (PsycINFO Database Record

Individual environmental concern in the world polity: A multilevel analysis.

The authors assess the extent to which national-level integration in the world polity influences individual-level concern for the environment. While theoretically-derived propositions about such relationships have a deep history in comparative sociology, they-with few exceptions-remain untested. Consistent with past research, employed national-level measures of world polity integration include the relative presence of environmental international nongovernmental organizations (EINGOs) and the existence of environmental ministries. Results of multilevel analyses of individual-level environmental concern in 37 nations indicate that both forms of world polity integration increase the likelihood of individual-level environmental concern, net of other national-level factors and individual-level characteristics; although we find stronger support for the influence of EINGOs as a key variable indicating world polity connection. The findings provide unique support for world polity theory, suggesting that future research should consider how elements of world polity integration influence other forms of individual attitudes and behaviors. The results also highlight the importance in considering global and transnational factors when assessing the determinants of individual attitudes about the environment.

Measurement in abstinence education. Critique and recommendations.

The purpose of this article is to identify, assess, and offer solutions to common measurement errors found in sexual abstinence education evaluation. A critical review of the methodology of adolescent sexuality research was performed. "Gold standards" of their measurement strategy were derived and applied against 14 selected studies. Many of the articles reviewed had substantial limitations in their measurement strategies. However, several articles demonstrated excellence and serve as models for future efforts. Sexual abstinence education evaluation is plagued by the inherent weaknesses of self-report and health outcome measures. However, with careful adherence to the gold standards proposed, it is possible to limit the threat from these weaknesses, maximizing the benefit of self-report surveys and county-level health indicators.