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Context Providers can help clients achieve their personal reproductive goals by providing high-quality, client-centered contraceptive counseling. Given the individualized nature of contraceptive decision making, provider attention to clients’ preferences for counseling interactions can enhance client centeredness. The objective of this systematic review was to summarize the evidence on what preferences clients have for the contraceptive counseling they receive. Evidence acquisition This systematic review is part of an update to a prior review series to inform contraceptive counseling in clinical settings. Sixteen electronic bibliographic databases were searched for studies related to client preferences for contraceptive counseling published in the U.S. or similar settings from March 2011 through November 2016. Because studies on client preferences were not included in the prior review series, a limited search was conducted for earlier research published from October 1992 through February 2011. Evidence synthesis In total, 26 articles met inclusion criteria, including 17 from the search of literature published March 2011 or later and nine from the search of literature from October 1992 through February 2011. Nineteen articles included results about client preferences for information received during counseling, 13 articles included results about preferences for the decision-making process, 13 articles included results about preferences for the relationship between providers and clients, and 11 articles included results about preferences for the context in which contraceptive counseling is delivered. Conclusions Evidence from the mostly small, qualitative studies included in this review describes preferences for the contraceptive counseling interaction. Provider attention to these preferences may improve the quality of family planning care; future research is needed to explore interventions designed to meet preferences. Theme information This article is part of a theme issue entitled Updating the Systematic Reviews Used to Develop the U.S. Recommendations for Providing Quality Family Planning Services, which is sponsored by the Office of Population Affairs, U.S. Department of Health and Human Services.

Context The objective of this systematic review was to update a prior review and summarize the evidence (newly identified and cumulative) on the impact of contraceptive counseling provided in clinical settings. Evidence acquisition Multiple databases, including PubMed, were searched during 2016–2017 for articles published from March 1, 2011, to November 30, 2016. Evidence synthesis The search strategy identified 24,953 articles; ten studies met inclusion criteria. Two of three new studies that examined contraceptive counseling interventions (i.e., enhanced models to standard of care) among adolescents and young adults found a statistically significant positive impact on at least one outcome of interest. Five of seven new studies that examined contraceptive counseling, in general, or specific counseling interventions or aspects of counseling (e.g., personalization) among adults or mixed populations (adults and adolescents) found a statistically significant positive impact on at least one outcome of interest. In combination with the initial review, six of nine studies among adolescents and young adults and 16 of 23 studies among adults or mixed populations found a statistically significant positive impact of counseling on at least one outcome of interest. Conclusions Overall, evidence supports the utility of contraceptive counseling, in general, and specific interventions or aspects of counseling. Promising components of contraceptive counseling were identified. The following would strengthen the evidence base: improved documentation of counseling content and processes, increased attention to the relationships between client experiences and behavioral outcomes, and examining the comparative effectiveness of different counseling approaches to identify those that are most effective. Theme information This article is part of a theme issue entitled Updating the Systematic Reviews Used to Develop the U.S. Recommendations for Providing Quality Family Planning Services, which is sponsored by the Office of Population Affairs, U.S. Department of Health and Human Services.

Context Educational interventions can help individuals increase their knowledge of available contraceptive methods, enabling them to make informed decisions and use contraception correctly. This review updates a previous review of contraceptive education. Evidence acquisition Multiple databases were searched for articles published March 2011–November 2016. Primary outcomes were knowledge, participation in and satisfaction/comfort with decision making, attitudes toward contraception, and selection of more effective methods. Secondary outcomes included contraceptive behaviors and pregnancy. Excluded articles described interventions that had no comparison group, could not be conducted feasibly in a clinic setting, or were conducted outside the U.S. or similar country. Evidence synthesis A total of 24,953 articles were identified. Combined with the original review, 37 articles met inclusion criteria and described 31 studies implementing a range of educational approaches (interactive tools, written materials, audio/videotapes, and text messages), with and without healthcare provider feedback, for a total of 36 independent interventions. Of the 31 interventions for which knowledge was assessed, 28 had a positive effect. Fewer were assessed for their effect on attitudes toward contraception, selection of more effective methods, contraceptive behaviors, or pregnancy—although increased knowledge was found to mediate additional outcomes (positive attitudes toward contraception and contraceptive continuation). Conclusions This systematic review is consistent with evidence from the broader healthcare field in suggesting that a range of interventions can increase knowledge. Future studies should assess what aspects are most effective, the benefits of including provider feedback, and the extent to which educational interventions can facilitate behavior change and attainment of reproductive health goals. Theme information This article is part of a theme issue entitled Updating the Systematic Reviews Used to Develop the U.S. Recommendations for Providing Quality Family Planning Services, which is sponsored by the Office of Population Affairs, U.S. Department of Health and Human Services.

Criticism of the Centers for Disease Control and Prevention (CDC) and its efforts to put forth recommendations and data based on core public health practice and principles is contrary to the realities of the work that the CDC has done on preparedness in past decades In 2001, the CDC funded a project intended to facilitate the development of an integrated national system of Academic Centers for Public Health Preparedness (CPHPs) to train frontline public health professionals who respond to bioterrorist incidents and other emerging infectious diseases Nineteen CPHPs were funded until the program was discontinued in August 2010 and replaced by 14 Preparedness and Emergency Response Learning Centers, whose funding ended in 2018 2 CPHPs worked to identify core principles for public health preparedness and response, strategies for local and state data collection, and curricula and best practices for educating the public health and first responder workforce

Background The gender pay gap in the United States (US) has narrowed over the last several decades, with the female/male earnings ratio in the US increased from about 60% before the 1980s to about 79% by 2014. However, the gender pay gap among the healthcare workforce persists. The objective of this study is to estimate the gender pay gap in the US federal governmental public health workforce during 2010–2018. Methods We used an administrative dataset including annual pay rates and job characteristics of employees of the US Department of Health and Human Services. Employees’ gender was classified based on first names. Regression analyses were used to estimate the gender pay gap using the predicted gender. Results Female employees of the DHHS earned about 13% less than men in 2010, and 9.2% less in 2018. Occupation, pay plan, and location explained more than half of the gender pay gap. Controlling for job grade further reduces the gap. The unexplained portion of the gender pay gap in 2018 was between 1.0 and 3.5%. Female employees had a slight advantage in terms of pay increase over the study period. Conclusions While the gender pay gap has narrowed within the last two decades, the pay gap between female and male employees in the federal governmental public health workforce persists and warrants continuing attention and research. Continued efforts should be implemented to reduce the gender pay gap among the health workforce.

This article describes the origins and drafting of the Belmont Report by members of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

The Belmont Report has provided a useful and virtually universal framework for protecting human subjects from research abuses. However, it provides little to no guidance on the substance of human research. In an environment where major decisions concerning health-care access, funding, and regulation hinge on human research, this omission leaves downstream users of human research virtually unprotected and with few tools or frameworks to protect against a variety of practices that compromise the social value of human research. This essay advocates for the addition of a fourth principle to the Belmont three: "scientific integrity." Such a principle would seek to train human research on important social objectives while maximizing the accessibility, credibility, and generalizability of findings.

Essential but Undefined Safety-net hospitals provide essential care to patients regardless of their insurance coverage, financial circumstances, or immigration status, and they often operate with t...

Bridging the Gap at Warp Speed In addition to its goal of delivering safe and effective vaccines quickly, Operation Warp Speed aims to combat Covid-19 by improving the use of existing therapies and...

Policy Lessons from Our Covid Experience As the U.S. economy reopens, it’s important to assess how we can be better prepared to stave off such enormous economic losses during the next Covid-19 wave...

The American response to the pandemic involves a prominent volume of federal resources, especially for developing and acquiring products for internal use, such as diagnostics or vaccines. Investment mechanisms and historical aspects justify this expenditure. Thus, the social construction of nationalism in American society hinders access to health technologies. The review of such aspects shows how the United States (U.S.) secured a large number of potential products, ensuring excessive local production. This unilateral foreign policy has influenced other countries or regional blocs and undermined global cooperation and solidarity, affecting the collective health of several nations.A resposta americana à pandemia envolve um proeminente volume de recursos federais, em especial destinados ao desenvolvimento e aquisição de produtos no uso interno, como diagnósticos ou vacinas. As justificativas para esse desembolso se baseiam em mecanismos de investimentos e aspectos históricos. Assim, a construção social do nacionalismo na formação na sociedade americana prejudica o acesso a tecnologias em saúde. A revisão desses aspectos demonstra como os Estados Unidos (EUA) garantiram compra de grande quantitativo de produtos em potencial, inclusive assegurando excessiva produção local. Essa política externa unilateral tem influenciado outros países ou blocos regionais e prejudicado a cooperação e a solidariedade global com impacto na saúde coletiva de diversas nações.

Medicaid is uniquely equipped to serve low-income populations. We identify four features that form the “soul” of Medicaid, explain how the administration is testing them, and explore challenges in accountability contributing to this struggle. We highlight the work of watchdogs acting to protect Medicaid and conclude with considerations for future health reform.

Background Healthcare systems and public health agencies use different methods to measure the impact of substance use (SU) on population health. We studied the ability of systems to accurately capture data on drug use-associated infective endocarditis (DUA-IE). Methods We conducted a retrospective analysis of patients with IE discharge diagnosis from an academic medical center, 2011–2017, comparing data from hospital Electronic Health Record (EHR) to State Uniform Hospital Discharge Data Set (UHDDS). To identify SU we developed a composite measure. Results EHR identified 472 IE discharges (430 of these were captured in UHDDS); 406 (86.0%) were correctly coded based on chart review. IE discharges increased from 57 to 92 (62%) from 2012 to 2017. Hospitalizations for the subset of DUA-IE identified by any measure of SU increased from 10 to 54 (440%). Discharge diagnosis coding identified 128 (60.7%) of total DUA-IE hospitalizations. The composite measure identified an additional 65 (30.8%) DUA-IE hospitalizations and chart review an additional 18 (8.5%). Conclusions The failure of discharge diagnosis coding to identify DUA-IE in 40% of hospitalizations demonstrates the need for better systems to capture the impact of SU. Collaborative data sharing could help improve surveillance responsiveness to address an emerging public health crises.

A foreshadowing of changes for other populations and nursing specialties?

Objective-This report describes regional differences in the specific drugs most frequently involved in drug overdose deaths in the United States in 2017. Methods-Data from the 2017 National Vital Statistics System-Mortality files were linked to electronic files containing literal text information from death certificates. Drug overdose deaths were identified using International Classification of Diseases, 10th Revision underlying cause-of-death codes X40-X44, X60-X64, X85, and Y10-Y14. Drug mentions were identified using established methods for searching the literal text from death certificates. Deaths were assigned to 1 of 10 U.S. Department of Health and Human Services (HHS) regions based on the decedent's state of residence. The number and age-adjusted death rate was determined for the 10 drugs most frequently involved in drug overdose deaths in 2017, both nationally and for each HHS region. Deaths involving more than one drug were counted in all relevant drug categories (i.e., the same death could be counted in more than one drug category). Results-Among drug overdose deaths in 2017 that mentioned at least 1 specific drug on the death certificate, the 10 drugs most frequently involved included fentanyl, heroin, cocaine, methamphetamine, alprazolam, oxycodone, morphine, methadone, hydrocodone, and diphenhydramine. Regionally, 6 drugs (alprazolam, cocaine, fentanyl, heroin, methadone, and oxycodone) were found among the 10 most frequently involved drugs in all 10 HHS regions, although the relative ranking varied by region. Age-adjusted rates of drug overdose deaths involving fentanyl or deaths involving cocaine were higher in the regions east of the Mississippi River, while age-adjusted rates for drug overdose deaths involving methamphetamine were higher in the West. The regional patterns observed did not change after adjustment for differences in the specificity of drug reporting. Conclusions-The drugs most frequently involved in drug overdose deaths in 2017 varied by HHS region. Understanding the regional differences can help inform local prevention and policy efforts.

Public health needs up-to-date information for surveillance and response. As healthcare application programming interfaces become widely available, a novel data gathering mechanism could provide public health with critical information in a timely fashion to respond to a fast-moving epidemic. In this article, we extrapolate from our experiences using a Fast Healthcare Interoperability Resource-based architecture for infectious disease surveillance for sexually transmitted diseases to its application to gather case information for an outbreak. One of the challenges with a fast-moving outbreak is to accurately assess its demand on healthcare resources, since information specific to comorbidities is often not available. These comorbidities are often associated with poor prognosis and higher resource utilization. If the comorbidity data and other clinical information were readily available to public health workers, they could better address community disruption and manage healthcare resources. The use of FHIR resources available through application programming and filtered through tools such as described herein will give public health the flexibility needed to investigate rapidly emerging disease while protecting patient privacy.

Donor lung allocation in the United States focuses on decreasing waitlist mortality and improving recipient outcomes. The implementation of allocation policy to match deceased donor lungs to waitlisted patients occurs through a unique partnership between government and private organizations, namely the Organ Procurement and Transplantation Network under the Department of Health and Human Services and the United Network for Organ Sharing. In 2005, the donor lung allocation algorithm shifted towards the prioritization of medical urgency of waitlisted patients instead of time accrued on the waitlist. This led to the Lung Allocation Score, which weighs over a dozen clinical variables to predict a one-year estimate of survival benefit, and is used to prioritize waitlisted patients. In 2017 the use of local allocation boundaries was eliminated in favor of a 250 nautical mile radius from the donor hospital as the first unit of distance used in allocation. The next upcoming iteration of donor allocation policy is expected to use a continuous distribution algorithm where all geographic boundaries are eliminated. There are additional opportunities to improve donor lung allocation, such as for patients with high antibody titers with access to a limited number of donors..

Recent coronavirus disease 2019 (COVID-19) events have presented challenges to health care systems worldwide. Air medical movement of individuals with potential infectious disease poses unique challenges and threats to crews and receiving personnel. The US Department of Health and Human Services air medical evacuation teams of the National Disaster Medical System directly supported 39 flights, moving over 2,000 individuals. Infection control precautions focused on source and engineering controls, personal protective equipment, safe work practices to limit contamination, and containment of the area of potential contamination. Source control to limit transmission distance was used by requiring all passengers to wear masks (surgical masks for persons under investigation and N95 for known positives). Engineering controls used plastic sheeting to segregate and treat patients who developed symptoms while airborne. Crews used Tyvek (Dupont Richmond, VA) suits with booties and a hood, a double layer of gloves, and either a powered air-purifying respirator or an N95 mask with a face shield. For those outside the 6-ft range, an N95 mask and gloves were worn. Safe work practices were used, which included mandatory aircraft surface decontamination, airflow exchanges, and designated lavatories. Although most patients transported were stable, to the best of our knowledge, this represents the largest repatriation of potentially contagious patients in history without infection of any transporting US Department of Health and Human Services air medical evacuation crews.

Current treatments for patients with HIV are not only effective at controlling viral replication but are also associated with a more favorable adverse reaction profile, may often be taken once daily, and are increasingly available in combination single-tablet regimens. This article provides an overview and prescribing considerations for several primary drugs currently recommended by the US Department of Health and Human Services.

In his State of the Union Address on February 5, 2019, President Donald J. Trump announced his administration’s goal to end the domestic HIV epidemic. Following the announcement of the Ending the HIV Epidemic: A Plan for America initiative, the president proposed $291 million in new funding for the fiscal year 2020 Department of Health and Human Services (HHS) budget to implement a new initiative to reduce the number of new HIV infections by 75% in the next five years (2025) and by 90% in the next 10 years (2030). This is in addition to the $20 billion the US government already spends each year, domestically, for HIV prevention and care. With this initiative, HHS recognizes that the time to end the HIV epidemic is now: we have the right data, the right biomedical and behavioral tools, and the right leadership. With the new resources, the goal is achievable. This article outlines how this initiative will be accomplished through the implementation of four fundamental strategies that will be tailored by local communities on the basis of their own needs and strengths.

Earlier this year, the U.S. Department of Health and Human Services announced its intent to strengthen enforcement of legal protections for health care providers' conscience rights. It proposed regulations that would give the DHHS Office of Civil Rights greater authority to ensure that recipients of federal funding comply with federal conscience laws. This recent development creates an opportunity for scholars and policy-makers to revisit the perennial debate about whether and how law should protect health care providers' rights of conscience. Arguments about who should be protected, what actions should be protected, and whether there should be any limitations on the exercise of conscience rights have brought us no closer to a resolution. However, there is one remaining avenue for analysis that has, surprisingly, received very little attention-the question of how providers are protected, and from what consequences. Existing U.S. conscience laws immunize health care providers from a wide range of adverse consequences-including civil liability, criminal prosecution, administrative penalties, adverse action by employers, and discrimination by private actors, among others. However, academic and public policy debates rarely acknowledge the breadth of these protections. It is essential to disentangle this network of possible protections.

This study uses Department of Health and Human Services data to analyze surveillance of electronic health records for patient safety issues to identify those with a potential for patient harm, and the frequency of these issues.

OBJECTIVE To analyze changes in intracytoplasmic sperm injection (ICSI) utilization, indications, and outcomes across U.S. regions. METHODS We conducted a retrospective cohort study. Data sets for 2000-2014 were obtained from the Centers for Disease Control and Prevention. Clinics with 100 or greater fresh, nondonor cycles were grouped by 10 nationally recognized Department of Health and Human Services (DHHS) regions and were compared for use of ICSI, frequency of male factor infertility, preimplantation genetic therapies, pregnancy, and live birth rates per cycle among fresh in vitro fertilization cycles in women younger than 35 years of age. RESULTS Nationwide ICSI utilization increased 52% (46.3±6.1% to 70.0±7.1%) from 2000 to 2014, whereas pregnancy and live birth rates per cycle modestly increased by 8.5% (39.2±3.8% to 42.5±2.5%) and 7.6% (34.4±3.6% to 37±2.6%), respectively, showing a positive correlation (r=0.78, P

According to Secretary Azar of Health and Human Services, implementing international reference pricing (IPI) in Medicare Part B will have minimal impacts. He has stated, "These savings, while substantial for American patients and taxpayers, cannot possibly pull out more than 1 percent of RD." As companies traditionally spend 20% of free cash flow on RD, we have measured the IPI impact according to industry standard metrics. The potential negative impacts of the international reference pricing plan, as it is currently structured, are numerous. Companies are likely to avoid developing Medicare Bart B physician-administered drugs in the future if it comes to fruition. Further, if distributing in any of the included countries in the benchmarking exercise that traditionally have prices far below that of the United States has the impact of creating lower US prices where the industry currently derives more than 80% of their global profit, companies will simply not seek market access in those benchmarked countries and patients in those countries will not receive the medicines they need. The idea that companies will be able to unilaterally raise prices in Europe defies logic and practice. Many countries in the EU have been threatening IP rights under the TRIPS clauses of the WTO for several years because of their belief that pharmaceutical pricing is unacceptably high right now, without the IPI. Harnessing real-world evidence would allow for increased competition by faster time to market. One wonders why an approach encompassing the improved time to market was not considered, as the reference pricing proposal as it stands now, ultimately, will reduce RD budgets, impair the overall investment climate, and deprive patients the new medicines.

Since the inception of gene synthesis technologies, there have been concerns about possible misuse. Using gene synthesis, pathogens-particularly small viruses-may be assembled "from scratch" in the laboratory, evading the regulatory regimes many nations have in place to control unauthorized access to dangerous pathogens. Progress has been made to reduce these risks. In 2010, the US Department of Health and Human Services (HHS) published guidance for commercial gene synthesis providers that included sequence screening of the orders and customer screening. The industry-led International Gene Synthesis Consortium (IGSC) was formed in 2009 to share sequence and customer screening methods, and it now includes the major international gene synthesis providers among its members. Since the 2010 HHS Guidance was released, however, there have been changes in gene synthesis technologies and market conditions that have reduced the efficacy of these biosecurity protections, leading to questions about whether the 2010 HHS Guidance should be updated, what changes could make it more effective, and what other international governance efforts could be undertaken to reduce the risks of misuse of gene synthesis products. This article describes these conditions and recommends actions that governments should take to reduce these risks and engage other nations involved in gene synthesis research.

Background Expert groups have recommended ongoing monitoring of the public health workforce to determine its ability to execute designated objectives. Resource- and time-intensive surveys have been a primary data source to monitor the workforce. We evaluated an administrative data source containing US Department of Health and Human Services (HHS) aggregate federal civil service workforce-related data to determine its potential as a workforce surveillance system for this component of the workforce. Methods We accessed FedScope, a publicly available online database containing federal administrative civilian HHS personnel data. Using established guidelines for evaluating surveillance systems and identified workforce characteristics, we evaluated FedScope attributes for workforce surveillance purposes. Results We determined FedScope to be a simple, highly accepted, flexible, stable, and timely system to support analyses of federal civil service workforce-related data. Data can be easily accessed, analyzed, and monitored for changes across years and draw conclusions about the workforce. FedScope data can be used to calculate demographics (eg, sex, race or ethnicity, age group, and education level), employment characteristics (ie, supervisory status, work schedule, and appointment type), retirement projections, and characterize the federal workforce into standard occupational categories. Conclusions This study indicates that an administrative data source containing HHS personnel data can function as a workforce surveillance system valuable to researchers, public health leaders, and decision makers interested in the federal civil service public health workforce. Using administrative data for workforce development is a model that can be applicable to federal and nonfederal public health agencies and ultimately support improvements in public health.

In vitro chemical safety testing methods offer the potential for efficient and economical tools to provide relevant assessments of human health risk. To realize this potential, methods are needed to relate in vitro effects to in vivo responses, i.e., in vitro to in vivo extrapolation (IVIVE). Currently available IVIVE approaches need to be refined before they can be utilized for regulatory decision-making. To explore the capabilities and limitations of IVIVE within this context, the U.S. Environmental Protection Agency Office of Research and Development and the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods co-organized a workshop and webinar series. Here, we integrate content from the webinars and workshop to discuss activities and resources that would promote inclusion of IVIVE in regulatory decision-making. We discuss properties of models that successfully generate predictions of in vivo doses from effective in vitro concentration, including the experimental systems that provide input parameters for these models, areas of success, and areas for improvement to reduce model uncertainty. Finally, we provide case studies on the uses of IVIVE in safety assessments, which highlight the respective differences, information requirements, and outcomes across various approaches when applied for decision-making.

The new 2018 edition of the Physical Activity Guidelines for Americans (PAGA18) released by the U.S. Department of Health and Human Services [1] and directly informed by the 779-page 2018 Physical Activity Guidelines Advisory Committee Scientific Report [2] will undoubtedly change how we promote and research physical activity (PA). For the first time, PAGA18 include new insights on the role of a single session of PA for cognitive function and brain health, suggesting that the scientific evidence supporting PA benefits on cognitive function and brain health has matured. In addition, considering the difficulty in initiating and adhering to a long-term exercise program, cognitive function benefits from a single bout may provide a new approach to promote exercise for people who are not ready yet to adopt and adhere to an ongoing habitual exercise routine...

Toppling the Ethical Balance A new rule from the U.S. Department of Health and Human Services creates a wide-ranging right to refuse to provide health care services. If it goes into effect, patient...

Background The Philadelphia Ujima Coalition for a Healthier Community (Philadelphia Ujima) promotes health improvement of girls, women, and their families using a gender framework and community-based participatory research approach to addressing gender-based disparities. Institutional policies developed through community-based participatory research approaches are integral to sustaining gender-integrated health-promotion programs and necessary for reducing gender health inequities. This paper describes the results of a policy analysis of the Philadelphia Ujima coalition partner sites and highlights two case studies. Methods The policy analysis used a document review and key informant interview transcripts to explore 1) processes that community, faith, and academic organizations engaged in a community participatory process used to develop policies or institutional changes, 2) types of policy changes developed, and 3) initial outcomes and impact of the policy changes on the target population. Results Fifteen policies were developed as a result of the funding from the U.S. Department of Health and Human Services Office on Women's Health. Policy changes included 1) healthy food options guidance, 2) leadership training on sexual and relationship violence, and 3) curricula and programming inclusion and expansion of a sex and gender focus in high school and medical school. Conclusions Organizational practice changes and policies can be activated through individual-level interventions using a community participatory approach. This approach empowers communities to play an integral role in creating health-promoting policies.

“It is not the critic who counts; not the man who points out how the strong man stumbles, or where the doer of deeds could have done them better. The credit belongs to the man who is actually in the arena, whose face is marred by dust and sweat and blood; who strives valiantly; who errs, who comes