Health and Medicine Division – författare

The global response to COVID-19 has demonstrated the importance of vigilance and preparedness for infectious diseases, particularly influenza. There is a need for more effective influenza vaccines and modern manufacturing technologies that are adaptable and scalable to meet demand during a pandemic. The rapid development of COVID-19 vaccines has demonstrated what is possible with extensive data sharing, researchers who have the necessary resources and novel technologies to conduct and apply their research, rolling review by regulators, and public-private partnerships. As demonstrated throughout the response to COVID-19, the process of research and development of novel vaccines can be significantly optimized when stakeholders are provided with the resources and technologies needed to support their response.

Vaccine Research and Development to Advance Pandemic and Seasonal Influenza Preparedness and Response focuses on how to leverage the knowledge gained from the COVID-19 pandemic to optimize vaccine research and development (R&D) to support the prevention and control of seasonal and pandemic influenza. The committee''s findings address four dimensions of vaccine R&D: (1) basic and translational science, (2) clinical science, (3) manufacturing science, and (4) regulatory science.

The COVID-19 pandemic has challenged the world''s preparedness for a respiratory virus event. While the world has been combating COVID-19, seasonal and pandemic influenza remain imminent global health threats. Non-vaccine public health control measures can combat emerging and ongoing influenza outbreaks by mitigating viral spread.

Public Health Lessons for Non-Vaccine Influenza Interventions examines provides conclusions and recommendations from an expert committee on how to leverage the knowledge gained from the COVID-19 pandemic to optimize the use of public health interventions other than vaccines to decrease the toll of future seasonal and potentially pandemic influenza. It considers the effectiveness of public health efforts such as use of masks and indoor spacing, use of treatments such as monoclonal antibodies, and public health communication campaigns.

The COVID-19 pandemic has laid bare the fragility of the global system of preparedness and response to pandemics and the fragmentation of our research and development ecosystem. The pandemic has provided a disruptive moment to advance new norms and frameworks for influenza. It also has demonstrated how innovative global public-private partnerships and coordination mechanisms can lead to rapid successes in viral vaccine research, manufacturing, and risk pooling.

Countering the Pandemic Threat Through Global Coordination on Vaccines identifies ways to strengthen pandemic and seasonal influenza global coordination, partnerships, and financing. This report presents seven overarching recommendations for how the urgent influenza threat should be conceptualized and prioritized within the global pandemic preparedness and response agenda in the future.

Influenza viruses, both seasonal and pandemic, have the potential to disrupt the health and well-being of populations around the world. The global response to the COVID-19 pandemic and prior public health emergencies of international concern illustrate the importance of global preparedness and coordination among governments, academia, scientists, policy makers, nongovernmental organizations, the private sector, and the public to address the threat of pandemic influenza. These health emergencies have revealed opportunities to enhance global vaccine infrastructure, manufacturing, distribution, and administration.

Globally Resilient Supply Chains for Seasonal and Pandemic Influenza Vaccines outlines key findings and recommendations to bolster vaccine distribution, manufacturing, and supply chains for future seasonal and pandemic influenza events. This report addresses the challenges of manufacturing and distributing vaccines for both seasonal and pandemic influenza, highlighting the critical components of vaccine manufacturing and distribution and offering recommendations that would address gaps in the current global vaccine infrastructure.

Digital health encompasses a broad array of tools and strategies with the goals of advancing research, increasing health care access and quality, and making care more personalized. It encompasses health content, digital health interventions, and digital applications, such as communication tools connecting patients and clinicians (e.g., secure email in the patient portal, text, chat, video visit), remote monitoring tools, clinical decision support tools, and systems for exchanging health information. Patient-facing tools, tools for clinicians, and systems to facilitate research and care improvement are all part of this diverse landscape, and each raises unique opportunities and potential challenges.

To examine key policy issues for the effective and safe development, implementation, and use of digital health technologies in oncology research and care, the National Cancer Policy Forum of the National Academies of Sciences, Engineering, and Medicine held a virtual workshop in collaboration with the Forum on Cyber Resilience. The workshop, Opportunities and Challenges for Using Digital Health Applications in Oncology, held on July 13-14, 2020, convened a broad group of experts, including clinicians and researchers; patient advocates; and representatives of federal agencies, health professional societies, health care organizations, insurers, and the pharmaceutical and health technology industries. Many workshop speakers found the opportunities presented by digital health tools to be particularly compelling for oncology; however, capitalizing on these opportunities necessitates careful attention to the design, implementation, and use of digital health technologies. This publication summarizes the presentations and discussions from the workshop.

Investment and innovation in drug research and development (R&D) for highly prevalent chronic diseases has stalled in recent decades, despite half of all Americans living with at least one chronic disease. As a result, prevalent chronic diseases are producing immense health care costs as well as preventable suffering and death. On February 22, March 2, and March 8, 2021, the National Academies of Sciences, Engineering, and Medicine, convened a workshop to discuss barriers to innovation in this space and examine strategies and incentives to support equitable, person-centered drug R&D for prevalent chronic diseases.

The Food Forum of the National Academies of Sciences, Engineering, and Medicine convened a virtual workshop, Challenges and Opportunities for Precision and Personalized Nutrition, on August 10-12, 2021. The workshop explored potential challenges and opportunities in the application of precision and personalized nutrition approaches to optimize dietary guidance and improve nutritional status. Workshops presenters discussed current precision and personalized nutrition research methodologies, limitations in data and design, adapting technologies for utilization, and policy and regulatory challenges. This Proceedings of a Workshop summarizes the presentations and discussions of the workshop.

A planning committee convened by the Forum on Microbial Threats of the National Academies of Sciences, Engineering, and Medicine held a virtual workshop on February 23-25, 2021, titled Systematizing the One Health Approach in Preparedness and Response Efforts for Infectious Disease Outbreaks. The workshop gave particular consideration to research opportunities, multisectoral collaboration mechanisms, community-engagement strategies, educational opportunities, and policies that speakers have found effective in implementing the core capacities and interventions of One Health principles to strengthen national health systems and enhance global health security. This Proceedings of a Workshop summarizes the presentations and discussions of the workshop.

To explore issues related to community-driven power-building efforts to improve population health, the Roundtable on Population Health Improvement of the National Academies of Sciences, Engineering, and Medicine hosted a virtual public workshop, "Community Power in Population Health Improvement", on January 28 and 29, 2021. Participants discussed the different components and dimensions of community-led action around different population health improvement topics such as education, transportation, environmental health, healthy eating, and active living, among others. This Proceedings of a Workshop summarizes the presentations and discussion of the workshop.

The United States faces an alarmingly high rate of maternal morbidity and mortality, distinguishing it from other high-income countries that have achieved decreases in these rates in recent years. U.S. maternal morbidity and mortality rates are disproportionate across racial, ethnic, socioeconomic, and geographic groups. Statistics on maternal health outcomes reveal that there are challenges to protecting both the lives and future health of birthing people and their children.

Recognizing the urgency of this growing problem, the National Academies Board on Population Health and Public Health Practice convened a 2-day virtual workshop, Advancing Maternal Health Equity and Reducing Maternal Mortality. The workshop examined the current state of maternal health in the United States and explored the factors needed to help communities and health care systems become more effective in reducing maternal morbidity and mortality and improving health outcomes through the fourth trimester. This publication summarizes the presentations and discussions of the workshop.

Student wellbeing is foundational to academic success. One recent survey of postsecondary educators found that nearly 80 percent believed emotional wellbeing is a "very" or "extremely" important factor in student success. Studies have found the dropout rates for students with a diagnosed mental health problem range from 43 percent to as high as 86 percent. While dealing with stress is a normal part of life, for some students, stress can adversely affect their physical, emotional, and psychological health, particularly given that adolescence and early adulthood are when most mental illnesses are first manifested. In addition to students who may develop mental health challenges during their time in postsecondary education, many students arrive on campus with a mental health problem or having experienced significant trauma in their lives, which can also negatively affect physical, emotional, and psychological wellbeing.

The nation''s institutions of higher education are seeing increasing levels of mental illness, substance use and other forms of emotional distress among their students. Some of the problematic trends have been ongoing for decades. Some have been exacerbated by the COVID-19 pandemic and resulting economic consequences. Some are the result of long-festering systemic racism in almost every sphere of American life that are becoming more widely acknowledged throughout society and must, at last, be addressed.

Mental Health, Substance Use, and Wellbeing in Higher Education lays out a variety of possible strategies and approaches to meet increasing demand for mental health and substance use services, based on the available evidence on the nature of the issues and what works in various situations. The recommendations of this report will support the delivery of mental health and wellness services by the nation''s institutions of higher education.

New technologies and improved understanding of the genesis and progression of various cancers have added to the enthusiasm for potential new strategies to improve screening and early detection of cancer. Research is also under way to evaluate refinements in current screening approaches, including determining optimal screening intervals, the ages at which screening should begin and end, as well as more specific estimates of the potential risks and benefits of screening for certain populations, such as racial and ethnic minority populations and people who have elevated risk for specific cancers. However, there remain significant challenges to developing, validating, and effectively implementing new cancer screening approaches. Guidelines for screening issued by different organizations vary considerably with no clear way of deciding which guidelines are most trustworthy. There is also a need to improve access to high-quality cancer screening and follow-up care, particularly in low-resource communities and among populations who are underserved or have numerous barriers to receiving care.

To examine the challenges and opportunities related to improving current approaches to cancer screening, as well as the evidence base for novel cancer screening methods, the National Cancer Policy Forum held a workshop, Advancing Progress in the Development and Implementation of Effective, High-Quality Cancer Screening, on March 2-3, 2020, in Washington, DC. This workshop convened a broad range of experts, including clinicians, researchers, statisticians, and patient advocates, as well as representatives of health care organizations, academic medical centers, insurers, and federal agencies. This publication summarizes the presentations and discussions of the workshop and highlights suggestions from individual participants regarding how to improve cancer screening.

Regenerative medicine products, which are intended to repair or replace damaged cells or tissues in the body, include a range of therapeutic approaches such as cell- and gene-based therapies, engineered tissues, and non-biologic constructs. The current approach to characterizing the quality of a regenerative medicine product and the manufacturing process often involves measuring as many endpoints as possible, but this approach has proved to be inadequate and unsustainable.

The Forum on Regenerative Medicine of the National Academies of Sciences, Engineering, and Medicine convened experts across disciplines for a 2-day virtual public workshop to explore systems thinking approaches and how they may be applied to support the identification of relevant quality attributes that can help in the optimization of manufacturing and streamline regulatory processes for regenerative medicine. A broad array of stakeholders, including data scientists, physical scientists, industry researchers, regulatory officials, clinicians, and patient representatives, discussed new advances in data acquisition, data analysis and theoretical frameworks, and how systems approaches can be applied to the development of regenerative medicine products that can address the unmet needs of patients. This publication summarizes the presentation and discussion of the workshop.

Millions of people are living with dementia in the United States and globally. To live well with dementia, people need care, services, and supports that reflect their values and preferences, build on their strengths and abilities, promote well-being, and address needs that evolve as cognitive impairment deepens.

Persons living with dementia co-manage their care with or rely on the support of a wide range of care partners and caregivers, including spouses, other family members and friends, and direct care workers in homes or residential care settings. While dementia care has improved since the 1970s, many individuals still lack access to high-quality care and are not living as well as they might. Disadvantaged groups, especially racial and ethnic minorities, still face challenges in access to care, services, and supports, due to deep and persistent inequities.

Meeting the Challenge of Caring for Persons Living with Dementia and Their Care Partners and Caregivers: A Way Forward examines the complex body of evidence on dementia care and informs decision making about which interventions are ready to be broadly disseminated and implemented. It also offers a blueprint to guide future research using rigorous, cutting-edge methods that are inclusive, equitable, and yield critical information for real-world implementation, toward the ultimate goal of better supporting persons living with dementia and their care partners and caregivers in living as well as possible.

To explore various aspects of faculty development, the Global Forum on Innovation in Health Professional Education of the National Academies of Sciences, Engineering, and Medicine held a virtual workshop in August 2020 titled Health Professions Faculty for the Future. At the workshop, presenters provided examples of how educators are using effective teaching strategies and of practices in health professional education. This publication summarizes the presentation and discussion of the workshop.

The Office of the Assistant Secretary for Planning and Evaluation (ASPE), in partnership with other agencies and divisions of the United States Department of Health and Human Services, coordinates a portfolio of projects that build data capacity for conducting patient-centered outcomes research (PCOR). PCOR focuses on producing scientific evidence on the effectiveness of prevention and treatment options to inform the health care decisions of patients, families, and health care providers, taking into consideration the preferences, values, and questions patients face when making health care choices.

ASPE asked the National Academies to appoint a consensus study committee to identify issues critical to the continued development of the data infrastructure for PCOR. The committee''s work will contribute to ASPE''s development of a strategic plan that will guide their work related to PCOR data capacity over the next decade.

As part of its information gathering activities, the committee organized three workshops to collect input from stakeholders on the PCOR data infrastructure. This report, the first in a series of three interim reports, summarizes the discussion and committee conclusions from the first workshop, focused on looking ahead at data user needs over the next decade. The workshop included representatives of patient groups with a wide reach and researchers with broad research interests as well as an understanding of the PCOR infrastructure.

Overwhelming evidence exists that exposure to outdoor fine particulate matter (PM2.5) is associated with a range of short-term and chronic health impacts, including asthma exacerbation, acute and chronic bronchitis, heart attacks, increased susceptibility to respiratory infections, and premature death, with the burden of these health effects falling more heavily on underserved and marginalized communities. Although less studied to date, indoor exposure to PM2.5 is also gaining attention as a potential source of adverse health effects, particularly given that Americans spend 90 percent of their lives indoors and indoor PM2.5 levels can exceed outdoor levels.

To better understand the sources of indoor PM2.5, the possible health effects of exposure to indoor PM2.5, and engineering approaches and interventions to reduce those exposure risks, the National Academies of Sciences, Engineering, and Medicine convened a virtual workshop, Indoor Exposure to Fine Particulate Matter and Practical Mitigation Approaches, on April 14, 21, and 28, 2021. The workshop focused on exposures that occur in residential and school buildings and on existing and practical mitigation technologies and approaches. This publication summarizes the presentation and discussion of the workshop.

The U.S. Social Security Administration (SSA) administers programs that provide disability benefits. Once SSA establishes the presence of a severe impairment, it determines whether the impairment meets the criteria in the Listing of Impairments (Listings) that qualify a candidate for disability benefits.

The current Listings that address hearing loss treated with cochlear implantation contain criteria that evaluate hearing ability through a speech recognition test called the Hearing in Noise Test (HINT). Since its development in 1994, the HINT has been widely used to measure cochlear implant candidacy and postoperative outcomes. However, the test characteristics, the state of cochlear implant technology, and the environment that made the HINT a common choice of assessment in 1994 are different in 2021. The HINT has several limitations in its characteristics and deviation from its intended use.

At the request of SSA, the National Academies of Sciences, Engineering, and Medicine convened a consensus study committee to identify and recommend generalized testing procedures and criteria for evaluating the level of functional hearing ability needed to make a disability determination in adults and children after cochlear implantation. The committee''s report, Evaluating Hearing Loss for Individuals with Cochlear Implants, details and supports its findings, conclusions, and recommendations based on published evidence and professional judgment.

Accumulating evidence gathered over the past three decades has demonstrated a biological basis for differences between men and women with respect to clinical features and treatment responses to several neuropsychiatric, neurodevelopmental, and neurodegenerative disorders. Dramatic sex differences have also been identified in the brain transcriptomes of individuals with multiple brain disorders, including depression, posttraumatic stress disorder, and autism. The brain transcriptome includes all of the messenger RNA as well as the non-protein-coding RNA molecules expressed in brain tissue and thus represents gene activity. To explore these sex-based transcriptomic differences further, the National Academies of Sciences, Engineering, and Medicine''s Forum on Neuroscience and Nervous System Disorders hosted a workshop on September 23, 2020, titled Sex Differences in Brain Disorders: Emerging Transcriptomic Evidence and Implications for Therapeutic Development. The workshop brought together a broad spectrum of stakeholders to share cutting-edge emerging evidence, discuss challenges, and identify future opportunities and potential directions. This publication summarizes the presentation and discussion of the workshop.

The Roundtable on Population Health Improvement of the National Academies of Sciences, Engineering, and Medicine hosted a public workshop on September 19, 2019 titled Models for Population Health Improvement by Health Care Systems and Partners: Tensions and Promise on the Path Upstream. The term upstream refers to the higher levels of action to improve health. Medical services act downstream (i.e., at the patient level) in improving population health, while such activities as screening and referring to social and human services (e.g., for housing, food assistance) are situated midstream, and the work of changing laws, policies, and regulations (e.g., toward affordable housing, expanding healthy food access) to improve the community conditions for health represents upstream action.

The workshop explored the growing attention on population health, from health care delivery and health insurance organizations to the social determinants of health and their individual-level manifestation as health-related social needs, such as patients'' needs. The workshop showcased collaborative population health improvement efforts, each of which included one or more health systems. This publication summarizes the presentations and discussions from the workshop.

Substance use disorder (SUD) and opioid use disorder are significant public health threats that affect millions of Americans each year. To help address overdose deaths and lack of access to treatment, the Comprehensive Addiction and Recovery Act (CARA) was signed into law on July 22, 2016. CARA is extensive legislation intended to address many facets of the opioid epidemic, including prevention, treatment, recovery, law enforcement, criminal justice reform, and overdose reversal. It authorizes more than $181 million each year in new funding to fight the opioid epidemic and it requires the implementation of programs and services across the United States to address SUD and recovery.

Following the passage of CARA, the Departments of Education, Health and Human Services (HHS), and Labor, along with the 2018 Related Agencies Appropriations Act, included appropriations for a study of the Substance Abuse and Mental Health Services Administration (SAMHSA) components in CARA, to be conducted by the National Academies of Sciences, Engineering, and Medicine. In response to this charge, the National Academies formed an ad hoc committee to review outcomes achieved by four programs funded by SAMHSA through CARA: State Pilot Grant Program for Treatment for Pregnant and Postpartum Women (PPW-PLT), Building Communities of Recovery (BCOR), Improving Access to Overdose Treatment (OD Treatment Access), and First Responders (FR-CARA). The committee''s review is designed to result in three reports over 5 years. This report, the second in the series, reviews reported outcomes and metrics to assess progress toward achieving program goals.

The evolution of health care is expanding the possibilities for integration of clinical research into the continuum of clinical care; new approaches are enabling the collection of data in real-world settings; and new modalities, such as digital health technologies and artificial intelligence applications, are being leveraged to overcome challenges and advance clinical research. At the same time, the clinical research enterprise is strained by rising costs, varying global regulatory and economic landscapes, increasing complexity of clinical trials, barriers to recruitment and retention of research participants, and a clinical research workforce that is under tremendous demands.

Looking ahead to 2030, the Forum on Drug Discovery, Development, and Translation of the National Academies of Sciences, Engineering, and Medicine convened a public workshop for stakeholders from across the drug research and development life cycle to reflect on the lessons learned over the past 10 years and consider opportunities for the future. The workshop was designed to consider goals and priority action items that could advance the vision of a 2030 clinical trials enterprise that is more efficient, effective, person-centered, inclusive, and integrated into the health care delivery system so that outcomes and experiences for all stakeholders are improved. This Proceedings of a Workshop summarizes the presentations and discussions that took place during the four-part virtual public workshop held on January 26, February 9, March 24, and May 11, 2021.