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Scientific evidence regularly guides policy decisions1, with behavioural science increasingly part of this process2. In April 2020, an influential paper3 proposed 19 policy recommendations (claims) detailing how evidence from behavioural science could contribute to efforts to reduce impacts and end the COVID-19 pandemic. Here we assess 747 pandemic-related research articles that empirically investigated those claims. We report the scale of evidence and whether evidence supports them to indicate applicability for policymaking. Two independent teams, involving 72 reviewers, found evidence for 18 of 19 claims, with both teams finding evidence supporting 16 (89%) of those 18 claims. The strongest evidence supported claims that anticipated culture, polarization and misinformation would be associated with policy effectiveness. Claims suggesting trusted leaders and positive social norms increased adherence to behavioural interventions also had strong empirical support, as did appealing to social consensus or bipartisan agreement. Targeted language in messaging yielded mixed effects and there were no effects for highlighting individual benefits or protecting others. No available evidence existed to assess any distinct differences in effects between using the terms physical distancing and social distancing. Analysis of 463 papers containing data showed generally large samples; 418 involved human participants with a mean of 16,848 (median of 1,699). That statistical power underscored improved suitability of behavioural science research for informing policy decisions. Furthermore, by implementing a standardized approach to evidence selection and synthesis, we amplify broader implications for advancing scientific evidence in policy formulation and prioritization.

IntroductionDrug overdoses have reached a historic milestone of over 100,000 deaths in a single year, 75,673 related to opioids. The acceleration in opioid-related deaths coupled with stark health inequities demands a close examination of opioid use disorder (OUD) treatment barriers and swift consideration of policy changes.DesignThe aim of this buprenorphine policy analysis is to summarize existing buprenorphine barriers and present policy solutions to improve access and actualize the contributions of Advanced Practice Registered Nurses (APRNs).MethodsThe policy analysis follows five sequential steps: (1) defining the problem, (2) identifying key stakeholders, (3) assessing the landscape of relevant policies, (4) describing viable policy options, and (5) making final recommendations.ResultsAlthough there are laudable efforts to improve buprenorphine access, such as the new buprenorphine guidelines issued in April 2021, without larger-scale changes to federal, state, and scope of practice laws, overdose rates will continue to rise. We recommend a multipronged policy approach to improve buprenorphine treatment access, including eliminating the DEA X waiver, improving OUD education, and adopting full practice authority for APRNs in all states.ConclusionIncremental change is no longer sufficient to address opioid overdose deaths. Bolder and coordinated policy action is possible and necessary to empower the full clinical workforce to apply evidence-based life-saving treatments for OUD. The critical contributions of nurses in advancing equitable access to OUD care are emphasized in the National Academy of Medicine's Report, Future of Nursing: Charting a Path to Achieve Health Equity. Nurses are named as instrumental in improving buprenorphine access. Policy changes that acknowledge and build on evidence-based treatment expansion strategies are sorely needed.Clinical relevanceOne of the most robust tools to combat opioid overdose deaths is buprenorphine, a partial opioid agonist, and gold standard medication treatment for OUD, but only 5% of the prescribing workforce possess the required Drug Enforcement Agency (DEA) X waiver. A growing body of evidence demonstrates that Advanced Practice Registered Nurses are accelerating the growth in waiver update and buprenorphine use, despite the considerable barriers and limitations described in this policy analysis.

Viruses have brought humanity many challenges: respiratory infection, cancer, neurological impairment and immunosuppression to name a few. Virology research over the last 60+ years has responded to reduce this disease burden with vaccines and antivirals. Despite this long history, the COVID-19 pandemic has brought unprecedented attention to the field of virology. Some of this attention is focused on concern about the safe conduct of research with human pathogens. A small but vocal group of individuals has seized upon these concerns - conflating legitimate questions about safely conducting virus-related research with uncertainties over the origins of SARS-CoV-2. The result has fueled public confusion and, in many instances, ill-informed condemnation of virology. With this article, we seek to promote a return to rational discourse. We explain the use of gain-of-function approaches in science, discuss the possible origins of SARS-CoV-2 and outline current regulatory structures that provide oversight for virological research in the United States. By offering our expertise, we - a broad group of working virologists - seek to aid policy makers in navigating these controversial issues. Balanced, evidence-based discourse is essential to addressing public concern while maintaining and expanding much-needed research in virology.

Understanding moral acceptability and willingness to use is crucial for informing policy.

THE PROBLEM: Most U.S. states lack a minimum age of juvenile legal jurisdiction, which leaves young children vulnerable to a harsh, punitive system that causes lifelong adverse health and social outcomes. However, partnership between academics, advocates, and policymakers can catalyze legislative change to set minimum ages. PURPOSE OF ARTICLE: We, an academic pediatrician and social worker, describe our stakeholder-policymaker-academic partnered research that led to the passage of California Senate Bill 439, which excludes children under age 12 from eligibility for juvenile legal prosecution. To stimulate future efforts, we also describe how the initial partnership led to a national coalition through which we are partnering with stakeholders across the United States to influence minimum age laws nationwide. KEY POINTS: Stakeholder-policymaker-academic partners can contribute synergistically in the research-to-policymaking process. CONCLUSIONS: Through a stakeholder-policymaker-academic partnership, we were able to influence the passage of a minimum age law for the juvenile legal system in California. Lessons learned in this collaboration can be applied by researchers across disciplines who wish to influence policy.

BackgroundCervical cancer is a major public health challenge in Africa. We analyzed the presence and content of policies for the primary, secondary and tertiary prevention of cervical cancer in Africa, to identify areas of opportunity for policy strengthening in the region most affected by cervical cancer globally.MethodsWe searched for publicly-available policy documents among countries in Africa. Using a data extraction form, we gathered data from these policies about key elements of primary, secondary and tertiary prevention approaches and activities based on World Health Organization (WHO) guidelines. We also contacted key stakeholders in each country to confirm these details. We summarized each country's policy details (summed score for each prevention stage and overall), and compared these scores across individual countries and groups of countries based on economic, policy and public health characteristics.ResultsMost countries had at least one policy addressing some aspect of cervical cancer prevention. Primary and secondary prevention were more commonly addressed, and certain details like age of vaccination, screening age/interval and method, were frequently mentioned in these policies.ConclusionCountries with high HIV burden and relatively more donor financing for health had more comprehensive cervical cancer policies; there was no apparent association with cervical cancer mortality, female representation in government, or economic indicators (poverty prevalence or income inequality).Policy summaryThere is room to improve cervical cancer policy comprehensiveness in Africa, and to bring these policies in line with evidence and expert recommendations. This analysis is timely given upcoming monitoring of the WHO Global Strategy to Accelerate the Elimination of Cervical Cancer as a Public Health Problem. These findings suggest some improvements in African cervical cancer policy, including increased inclusion of vaccination, but many topics remain under-specified. The influence of internal and external factors on policymaking should also be considered.

Background Evidence suggests intracerebral hemorrhage survivors have earlier recovery compared with ischemic stroke survivors. The Centers for Medicare and Medicaid Services prospective payment system instituted documentation rules for inpatient rehabilitation facilities (IRFs) in 2010, with the goal of optimizing patient selection. We investigated whether these requirements limited IRF and increased skilled nursing facility (SNF) use compared with home discharge. Methods and Results Intracerebral hemorrhage discharges to IRF, SNF, or home were estimated using GWTG (Get With The Guidelines) Stroke registry data between January 1, 2008, and December 31, 2015 (n=265 444). Binary hierarchical models determined associations between the 2010 Rule and discharge setting; subgroup analyses evaluated age, geographic region, and hospital type. From January 1, 2008, to December 31, 2009, 45.5% of patients with intracerebral hemorrhage had home discharge, 22.2% went to SNF, and 32.3% went to IRF. After January 1, 2010, there was a 1.06% absolute increase in home discharge, a 0.46% increase in SNF, and a 1.52% decline in IRF. The adjusted odds of IRF versus home discharge decreased 3% after 2010 (adjusted odds ratio [aOR], 0.97; 95% CI, 0.95-1.00). Lower odds of IRF versus home discharge were observed in people aged

Building ventilation systems must get much better

Implementation of prevention policies has often been impeded or delayed due to the lack of randomized controlled trials (RCTs) with hard clinical outcomes (eg, incident disease, mortality). Despite the prominent role of RCTs in health care, it may not always be feasible to conduct RCTs of public health interventions with hard outcomes due to logistical and ethical considerations. RCTs may also lack external validity and have limited generalizability. Currently, there is insufficient guidance for policymakers charged with establishing evidence-based policy to determine whether an RCT with hard outcomes is needed before policy recommendations. In this context, the purpose of this article is to assess, in a case study, the feasibility of conducting an RCT of the oft-cited issue of sodium reduction on cardiovascular outcomes and then propose a framework for decision-making, which includes an assessment of the feasibility of conducting an RCT with hard clinical outcomes when such trials are unavailable. We designed and assessed the feasibility of potential individual- and cluster-randomized trials of sodium reduction on cardiovascular outcomes. Based on our assumptions, a trial using any of the designs considered would require tens of thousands of participants and cost hundreds of millions of dollars, which is prohibitively expensive. Our estimates may be conservative given several key challenges, such as the unknown costs of sustaining a long-term difference in sodium intake, the effect of differential cotreatment with antihypertensive medications, and long lag time to clinical outcomes. Thus, it would be extraordinarily difficult to conduct such a trial, and despite the high costs, would still be at substantial risk for a spuriously null result. A robust framework, such as the one we developed, should be used to guide policymakers when establishing evidence-based public health interventions in the absence of trials with hard clinical outcomes.

Some environmental influences, including intentional interventions, have shown persistent effects on psychological characteristics and other socially important outcomes years and even decades later. At the same time, it is common to find that the effects of life events or interventions diminish and even disappear completely, a phenomenon known as fadeout. We review the evidence for persistence and fadeout, drawing primarily on evidence from educational interventions. We conclude that 1) fadeout is widespread, and often co-exists with persistence; 2) fadeout is a substantive phenomenon, not merely a measurement artefact; and 3) persistence depends on the types of skills targeted, the institutional constraints and opportunities within the social context, and complementarities between interventions and subsequent environmental affordances. We discuss the implications of these conclusions for research and policy.

The mass human and economic casualties wrought by the COVID-19 pandemic laid bare the deep inequities at the base of the disproportionate losses and suffering experienced by diverse U.S. populations. But the urgency and enormity of unmet needs requiring bold policy action also provided a unique opportunity to learn from and partner with community-based organizations that often are at the frontlines of such work. Following a review of Kingdon's model of the policy-making process, we illustrate how a partnership in a large California county navigated the streams in the policy-making process and used the window of opportunity provided by the pandemic to address a major public health problem: the incarceration of over 2 million people, disproportionately African American and Latinx, in overcrowded, unsafe jails, prisons, and detention centers. We highlight tactics and strategies used, challenges faced, and implications for health educators as policy advocates during and beyond the pandemic.

BackgroundThe United States HIV care workforce is shrinking, which could complicate service delivery to people living with HIV (PLWH). In this study, we examined the impact of practice transformations, defined as efficiencies in structures and delivery of care, on demonstration project sites within the Workforce Capacity Building Initiative, a Health Resources and Services Administration (HRSA) Ryan White HIV/AIDS Program Special Projects of National Significance (SPNS).Methods and findingsData were collected at 14 demonstration project sites in 7 states and the District of Columbia. Organizational assessments were completed at sites once before and 4 times after implementation. They captured 3 transformation approaches: maximizing the HIV care workforce (efforts to increase the number of existing healthcare workforce members involved in the care of PLWH), share-the-care (team-based care giving more responsibility to midlevel providers and staff), and enhancing client engagement in primary HIV care to reduce emergency and inpatient care (e.g., care coordination). We also obtained Ryan White HIV/AIDS Program Services Reports (RSRs) from sites for calendar years (CYs) 2014-2016, corresponding to before, during, and after transformation. The RSR include data on client retention in HIV care, prescription of antiretroviral therapy (ART), and viral suppression. We used generalized estimating equation (GEE) models to analyze changes among sites implementing each practice transformation approach. The demonstration projects had a mean of 18.5 prescribing providers (SD = 23.5). They reported data on more than 13,500 clients per year (mean = 969/site, SD = 1,351). Demographic characteristics remained similar over time. In 2014, a majority of clients were male (71% versus 28% female and 0.2% transgender), with a mean age of 47 (interquartile range [IQR] 37-54). Racial/ethnic characteristics (48% African American, 31% Hispanic/Latino, 14% white) and HIV risk varied (31% men who have sex with men; 31% heterosexual men and women; 7% injection drug use). A substantial minority was on Medicaid (41%). Across sites, there was significant uptake in practices consistent with maximizing the HIV care workforce (18% increase, p < 0.001), share-the-care (25% increase, p < 0.001), and facilitating patient engagement in HIV primary care (13% increase, p < 0.001). There were also significant improvements over time in retention in HIV care (adjusted odds ratio [aOR] = 1.03; 95% confidence interval [CI] 1.02-1.04; p < 0.001), ART prescription levels (aOR = 1.01; 95% CI 1.00-1.01; p < 0.001), and viral suppression (aOR = 1.03; 95% CI 1.02-1.04; p < 0.001). All outcomes improved at sites that implemented transformations to maximize the HIV care workforce or improve client engagement. At sites that implemented share-the-care practices, only retention in care and viral suppression outcomes improved. Study limitations included use of demonstration project sites funded by the Ryan White HIV/AIDS Program (RWHAP), which tend to have better HIV outcomes than other US clinics; varying practice transformation designs; lack of a true control condition; and a potential Hawthorne effect because site teams were aware of the evaluation.ConclusionsIn this study, we found that practice transformations are a potential strategy for addressing anticipated workforce challenges among those providing care to PLWH. They hold the promise of optimizing the use of personnel and ensuring the delivery of care to all in need while potentially enhancing HIV care continuum outcomes.

PurposeExome sequencing (ES) has the potential to improve management of congenital anomalies and neurodevelopmental disorders in fetuses, infants, and children. US payers are key stakeholders in patient access to ES. We examined how payers view insurance coverage and clinical utility of pediatric and prenatal ES.MethodsWe employed the framework approach of qualitative research to conduct this study. The study cohort represented 14 payers collectively covering 170,000,000 enrollees.ResultsSeventy-one percent of payers covered pediatric ES despite perceived insufficient evidence because they saw merit in available interventions or in ending the diagnostic odyssey. None covered prenatal ES, because they saw no merit. For pediatric ES, 50% agreed with expanded aspects of clinical utility (e.g., information utility), and 21% considered them sufficient for coverage. For prenatal ES, payers saw little utility until in utero interventions become available.ConclusionThe perceived merit of ES is becoming a factor in payers' coverage for serious diseases with available interventions, even when evidence is perceived insufficient. Payers' views on ES's clinical utility are expanding to include informational utility, aligning with the views of patients and other stakeholders. Our findings inform clinical research, patient advocacy, and policy-making, allowing them to be more relevant to payers.

Christian Lienhardt and colleagues discuss the importance of communication and coordination between regulators, researchers, and policy makers to ensure tuberculosis trials provide high-quality evidence for policy decisions.

In 2008, California enacted laws to restructure chemical policy and promote green chemistry. Ten years after the passage of California’s green chemistry laws, we assessed their performance through structured interviews with a sample of experts from government, academia, business, and the nonprofit sector. We combined the interviews with a scoping literature review to propose a new ten-point framework for evaluating the effectiveness of a chemical regulatory policy, and we assessed the performance of the California law against this framework. The California program performed well on transparency of the regulatory process; protecting vulnerable populations; placing the primary burden on the manufacturer; breadth of regulatory authority; and advancing the public right-to-know. Areas of weakness include unclear authority to require data on chemical use in products; an inefficient pace of implementation; and limited incentives for innovation. Promoting safer chemicals in products will require additional incentives to protect public health and the environment.

Transgender persons are at increased risk of victimization during incarceration and have unique health care needs. We convened a symposium of 27 key stakeholders to develop consensus on correctional policy, practice, and clinical care considerations for incarcerated transgender persons. Participants included formerly justice-involved transgender persons, correctional leaders, government authorities, academicians, advocates, health care providers, and expert consultants. Consensus considerations were developed in four areas: correctional practices that promote safety and respectful interactions with transgender inmates, training of correctional staff, health care delivery, and reentry to the community. Gaps in knowledge and practice in these four areas were also identified. A collaborative stakeholder model is an effective strategy to convene disparate groups who infrequently communicate with one another to help advance correctional policies and clinical care.

ObjectiveTo determine the impact of policy changes for pulse oximetry oxygen saturation (SpO2) alarm limits on neonatal mortality and morbidity among infants born very preterm.Study designThis was a retrospective cohort study of infants born very preterm in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Infants were classified based on treatment at a hospital with an SpO2 alarm policy change and study epoch (before vs after policy change). We used a generalized linear mixed model to determine the effect of hospital group and epoch on the primary outcomes of mortality and severe retinopathy of prematurity (ROP) and secondary outcomes of necrotizing enterocolitis, bronchopulmonary dysplasia, and any ROP.ResultsThere were 3809 infants in 10 hospitals with an SpO2 alarm policy change and 3685 infants in 9 hospitals without a policy change. The nature of most policy changes was to narrow the SpO2 alarm settings. Mortality was lower in hospitals without a policy change (aOR 0.63; 95% CI 0.50-0.80) but did not differ between epochs in policy change hospitals. The odds of bronchopulmonary dysplasia were greater for hospitals with a policy change (aOR 1.65; 95% CI 1.36-2.00) but did not differ for hospitals without a policy change. Severe ROP and necrotizing enterocolitis did not differ between epochs for either group. The adjusted odds of any ROP were lower in recent years in both hospital groups.ConclusionsChanging SpO2 alarm policies was not associated with reduced mortality or increased severe ROP among infants born very preterm.

Kidney disease is a global public health problem, affecting over 750 million persons worldwide. The burden of kidney disease varies substantially across the world, as does its detection and treatment. In many settings, rates of kidney disease and the provision of its care are defined by socio-economic, cultural, and political factors leading to significant disparities. World Kidney Day 2019 offers an opportunity to raise awareness of kidney disease and highlight disparities in its burden and current state of global capacity for prevention and management. Here, we highlight that many countries still lack access to basic diagnostics, a trained nephrology workforce, universal access to primary health care, and renal replacement therapies. We point to the need for strengthening basic infrastructure for kidney care services for early detection and management of acute kidney injury and chronic kidney disease across all countries and advocate for more pragmatic approaches to providing renal replacement therapies. Achieving universal health coverage worldwide by 2030 is one of the World Health Organization's Sustainable Development Goals. While universal health coverage may not include all elements of kidney care in all countries, understanding what is feasible and important for a country or region with a focus on reducing the burden and consequences of kidney disease would be an important step toward achieving kidney health equity.

Prostate-specific antigen (PSA)-based early detection for prostate cancer is the subject of intense debate. Implementation of organized prostate cancer screening has been challenging, in part because the PSA test is so amenable to opportunistic screening. To the extent that access to cancer screening tests increases in low- and middle-income countries (LMICs), there is an urgent need to thoughtfully evaluate existing and future cancer screening strategies to ensure benefit and control costs. We used Mexico's prostate cancer screening efforts to illustrate the challenges LMICs face. We provide five considerations for policymakers for a smarter approach and implementation of PSA-based screening.

BackgroundDespite the high burden of adverse adolescent sexual and reproductive health (SRH) outcomes, it has remained a low political priority in Kenya. We examined factors that have shaped the lack of current political prioritization of adolescent SRH service provision.MethodsWe used the Shiffman and Smith policy framework consisting of four categories-actor power, ideas, political contexts, and issue characteristics-to analyse factors that have shaped political prioritization of adolescent SRH. We undertook semi-structured interviews with 14 members of adolescent SRH networks between February and April 2019 at the national level and conducted thematic analysis of the interviews.FindingsSeveral factors hinder the attainment of political priority for adolescent SRH in Kenya. On actor power, the adolescent SRH community was diverse and united in adoption of international norms and policies, but lacked policy entrepreneurs to provide strong leadership, and policy windows were often missed. Regarding ideas, community members lacked consensus on a cohesive public positioning of the problem. On issue characteristics, the perception of adolescents as lacking political power made politicians reluctant to act on the existing data on the severity of adolescent SRH. There was also a lack of consensus on the nature of interventions to be implemented. Pertaining to political contexts, sectoral funding by donors and government treasury brought about tension within the different government ministries resulting in siloed approaches, lack of coordination and overall inefficiency. However, the SRH community has several strengths that augur well for future political support. These include the diverse multi-sectoral background of its members, commitment to improving adolescent SRH, and the potential to link with other health priorities such as maternal health and HIV/AIDS.ConclusionIn order to increase political attention to adolescent SRH in Kenya, there is an urgent need for policy actors to: 1) create a more cohesive community of advocates across sectors, 2) develop a clearer public positioning of adolescent SRH, 3) agree on a set of precise approaches that will resonate with the political system, and 4) identify and nurture policy entrepreneurs to facilitate the coupling of adolescent SRH with potential solutions when windows of opportunity arise.

Introduction"Treat All" - the treatment of all people with HIV, irrespective of disease stage or CD4 cell count - represents a paradigm shift in HIV care that has the potential to end AIDS as a public health threat. With accelerating implementation of Treat All in sub-Saharan Africa (SSA), there is a need for a focused agenda and research to identify and inform strategies for promoting timely uptake of HIV treatment, retention in care, and sustained viral suppression and addressing bottlenecks impeding implementation.MethodsThe Delphi approach was used to develop consensus around research priorities for Treat All implementation in SSA. Through an iterative process (June 2017 to March 2018), a set of research priorities was collectively formulated and refined by a technical working group and shared for review, deliberation and prioritization by more than 200 researchers, implementation experts, policy/decision-makers, and HIV community representatives in East, Central, Southern and West Africa.Results and discussionThe process resulted in a list of nine research priorities for generating evidence to guide Treat All policies, implementation strategies and monitoring efforts. These priorities highlight the need for increased focus on adolescents, men, and those with mental health and substance use disorders - groups that remain underserved in SSA and for whom more effective testing, linkage and care strategies need to be identified. The priorities also reflect consensus on the need to: (1) generate accurate national and sub-national estimates of the size of key populations and describe those who remain underserved along the HIV-care continuum; (2) characterize the timeliness of HIV care and short- and long-term HIV care continuum outcomes, as well as factors influencing timely achievement of these outcomes; (3) estimate the incidence and prevalence of HIV-drug resistance and regimen switching; and (4) identify cost-effective and affordable service delivery models and strategies to optimize uptake and minimize gaps, disparities, and losses along the HIV-care continuum, particularly among underserved populations.ConclusionsReflecting consensus among a broad group of experts, researchers, policy- and decision-makers, PLWH, and other stakeholders, the resulting research priorities highlight important evidence gaps that are relevant for ministries of health, funders, normative bodies and research networks.

ObjectivesWe sought the perspectives of lead public health officials working to improve health equity in the USA regarding the drivers of scientific evidence use, the supply of scientific evidence and the gap between their evidentiary needs and the available scientific evidence.DesignWe conducted 25 semistructured qualitative interviews (April 2017 to June 2017) with lead public health officials and their designees. All interviews were transcribed and thematically analysed.SettingPublic health departments from all geographical regions in the USA.ParticipantsParticipants included lead public health officials (20) and their designees (5) from public health departments that were either accredited or part of the Big Cities Health Coalition.ResultsMany respondents were using scientific evidence in the context of grant writing. Professional organisations and government agencies, rather than specific researchers or research journals, were the primary sources of scientific evidence. Respondents wanted to see more locally tailored cost-effectiveness research and often desired to participate in the planning phase of research projects. In addition to the scientific content recommendations, respondents felt the usefulness of scientific evidence could be improved by simplifying it and framing it for diverse audiences including elected officials and community stakeholders.ConclusionsRespondents are eager to use scientific evidence but also need to have it designed and packaged in ways that meet their needs.

This consensus statement voices the agreement of scientific stakeholders from regulatory agencies, academia and industry that a new framework needs adopting for assessment of chemicals with the potential to disrupt brain development. An increased prevalence of neurodevelopmental disorders in children has been observed that cannot solely be explained by genetics and recently pre- and postnatal exposure to environmental chemicals has been suspected as a causal factor. There is only very limited information on neurodevelopmental toxicity, leaving thousands of chemicals, that are present in the environment, with high uncertainty concerning their developmental neurotoxicity (DNT) potential. Closing this data gap with the current test guideline approach is not feasible, because the in vivo bioassays are far too resource-intensive concerning time, money and number of animals. A variety of in vitro methods are now available, that have the potential to close this data gap by permitting mode-of-action-based DNT testing employing human stem cells-derived neuronal/glial models. In vitro DNT data together with in silico approaches will in the future allow development of predictive models for DNT effects. The ultimate application goals of these new approach methods for DNT testing are their usage for different regulatory purposes.

BackgroundHeart failure (HF) is the leading cause of morbidity and mortality in the United States. Despite advancement in the management of HF, outcomes remain suboptimal, particularly among the uninsured. In 2014, the Affordable Care Act expanded Medicaid eligibility, and millions of low-income adults gained insurance. Little is known about Medicaid expansion's effect on inpatient HF care.Methods and resultsWe used the American Heart Association's Get With The Guidelines-Heart Failure registry to assess changes in inpatient care quality and outcomes among low-income patients (

Precision medicine is making an impact on patients, health care delivery systems, and research participants in ways that were only imagined fifteen years ago when the human genome was first sequenced. Discovery of disease-causing and drug-response genetic variants has accelerated, while adoption into clinical medicine has lagged. We define precision medicine and the stakeholder community required to enable its integration into research and health care. We explore the intersection of data science, analytics, and precision medicine in the formation of health systems that carry out research in the context of clinical care and that optimize the tools and information used to deliver improved patient outcomes. We provide examples of real-world impact and conclude with a policy and economic agenda necessary for the adoption of this new paradigm of health care both in the United States and globally.

Despite recent advances in HIV prevention and treatment, high HIV incidence persists among people who inject drugs (PWID). Difficult legal and political environments and lack of services for PWID likely contribute to high HIV incidence. Some advocates question whether any HIV prevention research is ethically justified in settings where healthcare system fails to provide basic services to PWID and where implementation of research findings is fraught with political barriers. Ethical challenges in research with PWID include concern about whether research evidence will be translated into practice; concerns that research might exacerbate background risks; and ethical challenges regarding the standard of HIV prevention in research. While these questions arise in other research settings, for research with PWID, these questions are especially controversial. This paper analyses four ethical questions in determining whether research could be ethically acceptable: (1) Can researchers ensure that research does not add to the burden of social harms and poor health experienced by PWID? (2) Should research be conducted in settings where it is uncertain whether research findings will be translated into practice? (3) When best practices in prevention and care are not locally available, what standard of care and prevention is ethically appropriate? (4) Does the conduct of research in settings with oppressive policies constitute complicity? We outline specific criteria to address these four ethical challenges. We also urge researchers to join the call to action for policy change to provide proven safe and effective HIV prevention and harm reduction interventions for PWID around the world.

Recent outbreaks of Ebola virus disease and Zika virus disease highlight the need for disseminating accurate predictions of emerging zoonotic viruses to national governments for disease surveillance and response. Although there are published maps for many emerging zoonotic viruses, it is unknown if there is agreement among different models or if they are concordant with national expert opinion. Therefore, we reviewed existing predictions for five high priority emerging zoonotic viruses with national experts in Cameroon to investigate these issues and determine how to make predictions more useful for national policymakers. Predictive maps relied primarily on environmental parameters and species distribution models. Rift Valley fever virus and Crimean-Congo hemorrhagic fever virus predictions differed from national expert opinion, potentially because of local livestock movements. Our findings reveal that involving national experts could elicit additional data to improve predictions of emerging pathogens as well as help repackage predictions for policymakers.

ObjectiveThe New York City's Thrive (ThriveNYC) and the Los Angeles County Health Neighborhood Initiative (HNI) are two local policies focused on addressing the social determinants of behavioral health as a preventive strategy for improving health service delivery. On January 29, 2016, leaders from both initiatives came together with a range of federal agencies in health care, public health, and policy research at the RAND Corporation in Arlington, Virginia. The goal of this advisory meeting was to share lessons learned, consider research and evaluation strategies, and create a dialogue between stakeholders and federal funders - all with the purpose to build momentum for policy innovation in behavioral health equity.MethodsThis article analyzes ethnographic notes taken during the meeting and in-depth interviews of 14 meeting participants through Kingdon's multiple streams theory of policy change.ResultsResults demonstrated that stakeholders shared a vision for behavioral health policy innovation focused on community engagement and social determinants of health. In addition, Kingdon's model highlighted that the problem, policy and politics streams needed to form a window of opportunity for policy change were coupled, enabling the possibility for behavioral health policy innovation.ConclusionsThe advisory meeting suggested that local policy makers, academics, and community members, together with federal agents, are working to implement behavioral health policy innovation.

BACKGROUND:Calls for evidence-informed public health policy, with implicit promises of greater program effectiveness, have intensified recently. The methods to produce such policies are not self-evident, requiring a conciliation of values and norms between policy-makers and evidence producers. In particular, the translation of uncertainty from empirical research findings, particularly issues of statistical variability and generalizability, is a persistent challenge because of the incremental nature of research and the iterative cycle of advancing knowledge and implementation. This paper aims to assess how the concept of uncertainty is considered and acknowledged in World Health Organization (WHO) policy recommendations and guidelines. METHODS:We selected four WHO policy statements published between 2008-2013 regarding maternal and child nutrient supplementation, infant feeding, heat action plans, and malaria control to represent topics with a spectrum of available evidence bases. Each of these four statements was analyzed using a novel framework to assess the treatment of statistical variability and generalizability. RESULTS:WHO currently provides substantial guidance on addressing statistical variability through GRADE (Grading of Recommendations Assessment, Development, and Evaluation) ratings for precision and consistency in their guideline documents. Accordingly, our analysis showed that policy-informing questions were addressed by systematic reviews and representations of statistical variability (eg, with numeric confidence intervals). In contrast, the presentation of contextual or "background" evidence regarding etiology or disease burden showed little consideration for this variability. Moreover, generalizability or "indirectness" was uniformly neglected, with little explicit consideration of study settings or subgroups. CONCLUSION:In this paper, we found that non-uniform treatment of statistical variability and generalizability factors that may contribute to uncertainty regarding recommendations were neglected, including the state of evidence informing background questions (prevalence, mechanisms, or burden or distributions of health problems) and little assessment of generalizability, alternate interventions, and additional outcomes not captured by systematic review. These other factors often form a basis for providing policy recommendations, particularly in the absence of a strong evidence base for intervention effects. Consequently, they should also be subject to stringent and systematic evaluation criteria. We suggest that more effort is needed to systematically acknowledge (1) when evidence is missing, conflicting, or equivocal, (2) what normative considerations were also employed, and (3) how additional evidence may be accrued.

BackgroundPreterm birth (PTB) is the leading cause of death in children under age five. Healthcare policy and other decision-making relevant to PTB may rely on obsolete, incomplete or inapplicable research evidence, leading to worsened outcomes. Appropriate knowledge transfer and exchange (KTE) strategies are an important component of efforts to reduce the global PTB burden. We sought to develop a 'landscape' analysis of KTE strategies currently used in PTB and related contexts, and to make recommendations for optimising programmatic implementation and for future research.MethodsIn the University of California, San Francisco's Preterm Birth Initiative, we convened a multidisciplinary working group and examined KTE frameworks. After selecting a widely-used, adaptable, theoretically-strong framework we reviewed the literature to identify evidence-based KTE strategies. We analysed KTE approaches focusing on key PTB stakeholders (individuals, families and communities, healthcare providers and policymakers). Guided by the framework, we articulated KTE approaches that would likely improve PTB outcomes. We further applied the KTE framework in developing recommendations.ResultsWe selected the Linking Research to Action framework. Searches identified 19 systematic reviews, including two 'reviews of reviews'. Twelve reviews provided evidence for KTE strategies in the context of maternal, neonatal and child health, though not PTB specifically; seven reviews provided 'cross-cutting' evidence that could likely be generalised to PTB contexts. For individuals, families and communities, potentially effective KTE strategies include community-based approaches, 'decision aids', regular discussions with providers and other strategies. For providers, KTE outcomes may be improved through local opinion leaders, electronic reminders, multifaceted strategies and other approaches. Policy decisions relevant to PTB may best be informed through the use of evidence briefs, deliberative dialogues, the SUPPORT tools for evidence-informed policymaking and other strategies. Our recommendations for research addressed knowledge gaps in regard to partner engagement, applicability and context, implementation strategy research, monitoring and evaluation, and infrastructure for sustainable KTE efforts.ConclusionsEvidence-based KTE, using strategies appropriate to each stakeholder group, is essential to any effort to improve health at the population level. PTB stakeholders should be fully engaged in KTE and programme planning from its earliest stages, and ideally before planning begins.

BackgroundMinority racial/ethnic pediatric populations and those living in poverty are at greater risk of exposure to trauma, development of mental health disorders, and school failure yet are less likely to have access to mental health services (MHS). School-based health centers (SBHCs) staffed with mental health providers may be one strategy for decreasing health care disparities.MethodsSecondary analysis of the cross-sectional School-Based Health Alliance Census School Year 2010-2011 Report was conducted. Descriptive statistics and chi-square analysis were used to describe differences between SBHCs with and without onsite MHS.ResultsA total of 70% of SBHCs offered MHS. SBHCs with more resources, more students, a longer history, and state funding were more likely to offer MHS, and geographic location had no impact on service availability.ConclusionReviewing SBHC characteristics that enable inclusion of MHS may help stakeholders expand this model of care to address exposure to chronic childhood trauma.

Mexico has experienced disproportionate drug-related harms given its role as a production and transit zone for illegal drugs destined primarily for the USA. In response, in 2009, the Mexican federal government passed legislation mandating pre-arrest diversion of drug-dependent individuals towards addiction treatment. However, this federal law was not specific about how the scale-up of the addiction treatment sector was to be operationalised. We therefore conducted in-depth qualitative interviews with key 'interactors' in fields affected by the federal legislation, including participants from the law enforcement, public health, addiction treatment, and governmental administration sectors. Among 19 participants from the municipal, state and federal levels were interviewed and multiple barriers to policy reform were identified. First, there is a lack of institutional expertise to implement the reform. Second, the operationalisation of the reform was not accompanied by a coordinated action plan. Third, the law is an unfunded mandate. Institutional barriers are likely hampering the implementation of Mexico's policy reform. Addressing the concerns expressed by interactors through the scale-up of services, the provision of increased training and education programmes for stakeholders and a coordinated action plan to operationalise the policy reform are likely needed to improve the policy reform process.

ContextDespite increasing interest in advance care planning (ACP) and previous ACP descriptions, a consensus definition does not yet exist to guide clinical, research, and policy initiatives.ObjectiveThe aim of this study was to develop a consensus definition of ACP for adults.MethodsWe convened a Delphi panel of multidisciplinary, international ACP experts consisting of 52 clinicians, researchers, and policy leaders from four countries and a patient/surrogate advisory committee. We conducted 10 rounds using a modified Delphi method and qualitatively analyzed panelists' input. Panelists identified several themes lacking consensus and iteratively discussed and developed a final consensus definition.ResultsPanelists identified several tensions concerning ACP concepts such as whether the definition should focus on conversations vs. written advance directives; patients' values vs. treatment preferences; current shared decision making vs. future medical decisions; and who should be included in the process. The panel achieved a final consensus one-sentence definition and accompanying goals statement: "Advance care planning is a process that supports adults at any age or stage of health in understanding and sharing their personal values, life goals, and preferences regarding future medical care. The goal of advance care planning is to help ensure that people receive medical care that is consistent with their values, goals and preferences during serious and chronic illness." The panel also described strategies to best support adults in ACP.ConclusionsA multidisciplinary Delphi panel developed a consensus definition for ACP for adults that can be used to inform implementation and measurement of ACP clinical, research, and policy initiatives.

Advocacy coalitions often play an important role in the state health policymaking process, yet little is known about their structure, composition, and behavior. In 2008, California became the first state to enact a menu labeling law. Using the advocacy coalition framework, we examine different facets of the coalitions involved in California's menu labeling policy debate. We use a qualitative research approach to identify coalition members and explore their expressed beliefs and policy arguments, resources, and strategies by analyzing legislative documents (n = 87) and newspaper articles (n = 78) produced between 1999 and 2009. Between 2003 and 2008, six menu labeling bills were introduced in the state's legislature. We found the issue received increasing media attention during this period. We identified two advocacy coalitions involved in the debate-a public health (PH) coalition and an industry coalition. State organizations acted as coalition leaders and participated for a longer duration than elected officials. The structure and composition of each coalition varied. PH coalition leadership and membership notably increased compared to the industry coalition. The PH coalition, led by nonprofit PH and health organizations, promoted a clear and consistent message around informed decision making. The industry coalition, led by a state restaurant association, responded with cost and implementation arguments. Each coalition used various resources and strategies to advance desired outcomes. PH coalition leaders were particularly effective at using resources and employing advocacy strategies, which included engaging state legislators as coalition members, using public opinion polls and information, and leveraging media resources to garner support. Policy precedence and a local policy push emerged as important policymaking strategies. Areas for future research on the state health policymaking process are discussed.

IntroductionResearchers advocating for evidence-informed policy have attempted to encourage policymakers to develop a greater understanding of research and researchers to develop a better understanding of the policymaking process. Our aim was to apply findings drawn from studies of the policymaking process, specifically the theory of policy windows, to identify strategies used to integrate evidence into policymaking and points in the policymaking process where evidence was more or less relevant.MethodsOur observational study relied on interviews conducted with 24 policymakers from the USA who had been trained to interpret scientific research in multiple iterations of an evidence-based workshop. Participants were asked to describe cases where they had been involved in making health policy and to provide examples in which research was used, either successfully or unsuccessfully. Interviews were transcribed, independently coded by multiple members of the study team and analysed for content using key words, concepts identified by participants and concepts arising from review of the texts.ResultsOur results suggest that policymakers who focused on health issues used multiple strategies to encourage evidence-informed policymaking. The respondents used a strict definition of what constituted evidence, and relied on their experience with research to discourage the use of less rigorous research. Their experience suggested that evidence was less useful in identifying problems, encouraging political action or ensuring feasibility and more useful in developing policy alternatives.ConclusionsPast research has suggested multiple strategies to increase the use of evidence in policymaking, including the development of rapid-response research and policy-oriented summaries of data. Our findings suggest that these strategies may be most relevant to the policymaking stream, which develops policy alternatives. In addition, we identify several strategies that policymakers and researchers can apply to encourage evidence-informed policymaking.

In February 2015, the United States Environmental Protection Agency (EPA) sponsored a workshop in Research Triangle Park, NC, USA to review the current state of the science one missions, air quality impacts, and health effects associated with exposures to ultrafine particles[1].[...].

The current study evaluated nurse delegation in home care, a pilot program introduced in 2007 in New Jersey to promote home care options for consumers needing assistance with medical/nursing tasks. Findings on readiness for the program, barriers and facilitating factors, experience with the program, and recommendations are summarized and presented. Methods included surveys and interviews with participants in nurse delegation, observations of planning and implementation meetings, and review meeting minutes. Major findings were no negative outcomes for consumers, improvements in quality of life and quality of care for consumers, high readiness and increasing satisfaction with experience in delegation, perception of nurse delegation in home care as a valued option, and the challenges of ensuring adequate staffing. Subsequent changes in regulation in New Jersey are underway, translating this research into policy. [Journal of Gerontological Nursing, 42(9), 7-15.].

The population health effect and cost-effectiveness of implementing intensive blood pressure goals in high-cardiovascular disease (CVD) risk adults have not been described. Using the CVD Policy Model, CVD events, treatment costs, quality-adjusted life years, and drug and monitoring costs were simulated over 2016 to 2026 for hypertensive patients aged 35 to 74 years. We projected the effectiveness and costs of hypertension treatment according to the 2003 Joint National Committee (JNC)-7 or 2014 JNC8 guidelines, and then for adults aged ≥50 years, we assessed the cost-effectiveness of adding an intensive goal of systolic blood pressure

Margaret McGregor and colleagues consider Bradford Hill's framework for examining causation in observational research for the association between nursing home care quality and for-profit ownership.

There is growing evidence that millions of adults have gained insurance coverage under the Affordable Care Act, but less is known about how access to and affordability of care may be changing. This study used data from the Health Reform Monitoring Survey to describe changes in access and affordability for nonelderly adults from September 2013, just prior to the first open enrollment period in the Marketplace, to March 2015, after the end of the second open enrollment period. Overall, we found strong improvements in access to care for all nonelderly adults and across income and state Medicaid expansion groups. We also found improvements in the affordability of care for all adults and for low- and moderate-income adults. Despite this progress, there were still large gaps in access and affordability in March 2015, particularly for low-income adults.

As Ebola has spread beyond West Africa, the challenges confronting health care systems with no experience in managing such patients are enormous. Not only is Ebola a significant threat to a population's health, it can infect the medical personnel trying to treat it. As such, it represents a major challenge to those in public health, emergency medical services (EMS), and acute care hospitals. Our academic medical center volunteered to become an Ebola Treatment Center as part of the US effort to manage the threat. We developed detailed policies and procedures for Ebola patient management at our university hospital. Both the EMS system and county public health made significant contributions during the development process. This article shares information about this process and the outcomes to inform other institutions facing similar challenges of preparing for an emerging threat with limited resources. The discussion includes information about management of (1) patients who arrive by ambulance with prior notification, (2) spontaneous walk-in patients, and (3) patients with confirmed Ebola who are interfacility transfers. Hospital management includes information about Ebola screening procedures, personal protective equipment selection and personnel training, erection of a tent outside the main facility, establishing an Ebola treatment unit inside the facility, and infectious waste and equipment management. Finally, several health policy considerations are presented.

More than three-quarters of a million (772,000) older Californians are among the "hidden poor"--older adults with incomes above the federal poverty line (FPL) but below a minimally decent standard of living as determined by the Elder Economic Security Standard™ Index (Elder Index) in 2011. This policy brief uses the most recent Elder Index calculations to document the wide discrepancy that exists between the FPL and the Elder Index. This study finds that the FPL significantly underestimates the number of economically insecure older adults who are unable to make ends meet. Yet, because many public assistance programs are aligned with the FPL, potentially hundreds of thousands of economically insecure older Californians are denied aid. The highest rates of the hidden poor among older adults are found among renters, Latinos, women, those who are raising grandchildren, and people in the oldest age groups. Raising the income and asset eligibility requirement thresholds for social support programs such as Supplemental Security Income (SSI), housing, health care, and food assistance would help California's older hidden poor make ends meet.

BackgroundNext-generation tumor sequencing (NGTS) panels, which include multiple established and novel targets across cancers, are emerging in oncology practice, but lack formal positive coverage by US payers. Lack of coverage may impact access and adoption. This study identified challenges of NGTS coverage by private payers.MethodsWe conducted semi-structured interviews with 14 NGTS experts on potential NGTS benefits, and with 10 major payers, representing more than 125,000,000 enrollees, on NGTS coverage considerations. We used the framework approach of qualitative research for study design and thematic analyses and simple frequencies to further describe findings.ResultsAll interviewed payers see potential NGTS benefits, but all noted challenges to formal coverage: 80% state that inherent features of NGTS do not fit the medical necessity definition required for coverage, 70% view NGTS as a bundle of targets versus comprehensive tumor characterization and may evaluate each target individually, and 70% express skepticism regarding new evidence methods proposed for NGTS. Fifty percent of payers expressed sufficient concerns about NGTS adoption and implementation that will preclude their ability to issue positive coverage policies.ConclusionsPayers perceive that NGTS holds significant promise but, in its current form, poses disruptive challenges to coverage policy frameworks. Proactive multidisciplinary efforts to define the direction for NGTS development, evidence generation, and incorporation into coverage policy are necessary to realize its promise and provide patient access. This study contributes to current literature, as possibly the first study to directly interview US payers on NGTS coverage and reimbursement.

Policymakers shape implementation and sustainment of evidence-based practices (EBPs), whether they are developing or responding to legislation and policies or negotiating public sector resource constraints. As part of a large mixed-method study, we conducted qualitative interviews with 24 policymakers involved in delivery of the same EBP in two U.S. states. We analyzed transcripts via open and focused coding techniques to identify the commonality, diversity, and complexity of implementation challenges; approaches to overcoming those challenges; and the importance of system-level contextual factors in ensuring successful implementation. Key findings centered on building support and leadership for EBPs; funding and contractual strategies; partnering with stakeholders; tackling challenges via proactive planning and problem solving; and the political, legal, and systemic pressures affecting EBP longevity. The policymaker perspectives offer guidance on nurturing system and organizational practice environments to achieve positive outcomes and for optimally addressing macro-level influences that bear upon the instantiation of EBPs in public sector child welfare systems.