National Academy of Medicine – 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.

While the world continues to respond to the COVID-19 pandemic, novel influenza viruses persist as a constant pandemic threat. The global response to COVID-19 has pushed the boundaries on what is possible for rapid pandemic response in several areas, including vaccine research, development, manufacturing, equitable distribution, allocation, and administration. If well understood and sufficiently adapted, these actions could be applied to future pandemic and seasonal influenza vaccine preparedness efforts. However, developing and delivering these more effective vaccines to meet the demand goes beyond simply technical challenges and includes issues across governance, financing, research, supply chain, and public engagement.

To address these challenges, the National Academies of Sciences, Engineering, and Medicine convened a virtual public workshop in May of 2021 to discuss the emerging evidence on unprecedented actions related to COVID-19 that could inform and advance pandemic and seasonal influenza vaccine preparedness efforts and subsequent response. This Proceedings of a Workshop provides a high-level summary of the presentations and discussions that occurred during the workshop.

Genome editing is a powerful new tool for making precise alterations to an organism''s genetic material. Recent scientific advances have made genome editing more efficient, precise, and flexible than ever before. These advances have spurred an explosion of interest from around the globe in the possible ways in which genome editing can improve human health. The speed at which these technologies are being developed and applied has led many policymakers and stakeholders to express concern about whether appropriate systems are in place to govern these technologies and how and when the public should be engaged in these decisions.

Human Genome Editing considers important questions about the human application of genome editing including: balancing potential benefits with unintended risks, governing the use of genome editing, incorporating societal values into clinical applications and policy decisions, and respecting the inevitable differences across nations and cultures that will shape how and whether to use these new technologies. This report proposes criteria for heritable germline editing, provides conclusions on the crucial need for public education and engagement, and presents 7 general principles for the governance of human genome editing.

With unprecedented global aging, societies must undertake all-of-society efforts to maximize the benefits and minimize the burdens of aging populations. The Global Roadmap for Healthy Longevity (Global Roadmap) describes a realistic vision of healthy longevity that could be achieved by 2050. The vision includes full inclusion of people of all ages, regardless of health or functional status, in all aspects of society and societies characterized by social cohesion and equity.

To achieve the vision, Global Roadmap recommends changes that need to be made to health systems, social infrastructure, physical environments, education, work, and retirement. In some cases, the recommended changes benefit older people most directly, but when older people thrive, people of all ages benefit. If taken up, the recommendations of this report can support individuals of all ages in all corners of the globe to live long, meaningful, and purpose-driven lives by 2050.

Patient-centered, high-quality health care relies on the well-being, health, and safety of health care clinicians. However, alarmingly high rates of clinician burnout in the United States are detrimental to the quality of care being provided, harmful to individuals in the workforce, and costly. It is important to take a systemic approach to address burnout that focuses on the structure, organization, and culture of health care.

Taking Action Against Clinician Burnout: A Systems Approach to Professional Well-Being builds upon two groundbreaking reports from the past twenty years, To Err Is Human: Building a Safer Health System and Crossing the Quality Chasm: A New Health System for the 21st Century, which both called attention to the issues around patient safety and quality of care. This report explores the extent, consequences, and contributing factors of clinician burnout and provides a framework for a systems approach to clinician burnout and professional well-being, a research agenda to advance clinician well-being, and recommendations for the field.

Heritable human genome editing - making changes to the genetic material of eggs, sperm, or any cells that lead to their development, including the cells of early embryos, and establishing a pregnancy - raises not only scientific and medical considerations but also a host of ethical, moral, and societal issues. Human embryos whose genomes have been edited should not be used to create a pregnancy until it is established that precise genomic changes can be made reliably and without introducing undesired changes - criteria that have not yet been met, says Heritable Human Genome Editing.

From an international commission of the U.S. National Academy of Medicine, U.S. National Academy of Sciences, and the U.K.''s Royal Society, the report considers potential benefits, harms, and uncertainties associated with genome editing technologies and defines a translational pathway from rigorous preclinical research to initial clinical uses, should a country decide to permit such uses. The report specifies stringent preclinical and clinical requirements for establishing safety and efficacy, and for undertaking long-term monitoring of outcomes. Extensive national and international dialogue is needed before any country decides whether to permit clinical use of this technology, according to the report, which identifies essential elements of national and international scientific governance and oversight.

The decade ahead will test the nation''s nearly 4 million nurses in new and complex ways. Nurses live and work at the intersection of health, education, and communities. Nurses work in a wide array of settings and practice at a range of professional levels. They are often the first and most frequent line of contact with people of all backgrounds and experiences seeking care and they represent the largest of the health care professions.

A nation cannot fully thrive until everyone - no matter who they are, where they live, or how much money they make - can live their healthiest possible life, and helping people live their healthiest life is and has always been the essential role of nurses. Nurses have a critical role to play in achieving the goal of health equity, but they need robust education, supportive work environments, and autonomy. Accordingly, at the request of the Robert Wood Johnson Foundation, on behalf of the National Academy of Medicine, an ad hoc committee under the auspices of the National Academies of Sciences, Engineering, and Medicine conducted a study aimed at envisioning and charting a path forward for the nursing profession to help reduce inequities in people''s ability to achieve their full health potential. The ultimate goal is the achievement of health equity in the United States built on strengthened nursing capacity and expertise. By leveraging these attributes, nursing will help to create and contribute comprehensively to equitable public health and health care systems that are designed to work for everyone.

The Future of Nursing 2020-2030: Charting a Path to Achieve Health Equity explores how nurses can work to reduce health disparities and promote equity, while keeping costs at bay, utilizing technology, and maintaining patient and family-focused care into 2030. This work builds on the foundation set out by The Future of Nursing: Leading Change, Advancing Health (2011) report.

In mid-2022, the United States has lost more than 1 million people to the COVID-19 pandemic. We have been real-time witnesses to scores of heroic responses to the disease, death, inequity, and economic strife unleashed by the virus, but have also experienced the consequences of poor pandemic preparedness and long-standing structural failures in our health system.

For decades, the U.S. health system has fallen far short of its potential to support and improve individual and population health. The COVID-19 pandemic has presented death and devastation—but also an unprecedented opportunity to truly transform U.S. health, health care, and health delivery.

To capitalize on this opportunity, the National Academy of Medicine gathered field leaders from across all of the major health system sectors to assess how each sector has responded to the pandemic and the opportunities that exist for health system transformation. The opportunity is now to capitalize on the hard-won lessons of COVID-19 and build a health care system that centers patients, families, and communities; cares for clinicians; supports care systems, public health, and biomedical research to perform at the best of their abilities; applies innovations from digital health and quality, safety, and standards organizations; and encourages health care payers and health product manufacturers and innovators to produce products that benefit all.

In the United States, 54% of nurses and physicians, 60% of medical students and residents, and 61% of pharmacists have symptoms of burnout. Burnout is a long-standing issue and a fundamental barrier to professional well-being. It was further exacerbated by the COVID-19 pandemic. Health workers who find joy, fulfillment, and meaning in their work can engage on a deeper level with their patients, who are at the heart of health care. Thus, a thriving workforce is essential for delivering safe, high-quality, patient-centered care.

The National Plan for Health Workforce Well-Being is intended to inspire collective action that focuses on changes needed across the health system and at the organizational level to improve the well-being of the health workforce. As a nation, we must redesign how health is delivered so that human connection is strengthened, health equity is achieved, and trust is restored. The National Plan''s vision is that patients are cared for by a health workforce that is thriving in an environment that fosters their well-being as they improve population health, enhance the care experience, reduce costs, and advance health equity; therefore, achieving the "quintuple aim."

Together, we can create a health system in which care is delivered joyfully and with meaning, by a committed team of all who work to advance health, in partnership with engaged patients and communities.

Sharing health data and information across stakeholder groups is the bedrock of a learning health system. As data and information are increasingly combined across various sources, their generative value to transform health, health care, and health equity increases significantly. Health data have proven their centrality in guiding action to change the course of individual and population health, if properly stewarded and used.

In the context of the COVID-19 pandemic, both data and a lack of data illuminated profound shortcomings that affected health care and health equity. Yet, a silver lining of the pandemic was a surge in collaboration among data holders in public health, health care, and technology firms, suggesting that an evolution in health data sharing is visible and tangible.

This Special Publication features some of these novel data-sharing collaborations, and has been developed to provide practical context and implementation guidance that is critical to advancing the lessons learned identified in its parent NAM Special Publication, Health Data Sharing: Building a Foundation of Stakeholder Trust. The focus of this publication is to identify and describe exemplar groups to dispel the myth that sharing health data more broadly is impossible and illuminate the innovative approaches that are being taken to make progress in the current environment. It also serves as a resource for those waiting in the wings, showing how barriers were addressed and harvesting lessons and insights from those on the front lines.

In the meantime, knowledge is already available to foster better health care and health outcomes. The examples described in this volume suggest how intentional attention to health data sharing can enable unparalleled advances, securing a healthier and more equitable future for all.

The United States is in the midst of an urgent and complex opioid crisis. To address how education and training can more effectively respond to this crisis, we must have a better understanding of problems in practice—or professional practice gaps—for health professionals and teams in practice. A coordinated response requires identifying and addressing professional practice gaps (PPGs) related to pain management, opioid use disorder, and other substance use disorder (SUD) care, as well as integrating evidence-based best practices into health professional education and training curricula across the continuum from undergraduate training into post-graduate continuing education This Special Publication presents two information-gathering efforts to assess persisting PPGs pertaining to pain management and SUD care and to better understand the current health professional education environment: the first is a comprehensive literature review, and the second is a survey of the regulatory landscape.

The results underscore the need to collaboratively develop a harmonized interprofessional, person- and family-centered approach for the continuum of health professions education to more effectively address the opioid crisis.

In this Special Publication, the Health Professional Education and Training Workgroup of the National Academy of Medicine''s Action Collaborative on Countering the U.S. Opioid Epidemic identified five action-oriented priorities to support this goal:

With due effort and support, these approaches will amplify effective practices while harmonizing and improving the environment for health care professionals to best serve the needs of their patients and communities.

In response to a growing national awareness that the development and use of new diagnostic, therapeutic, and preventive interventions had been occurring at a quickening pace—one far outstripping the evidence necessary to make informed decisions about their comparative advantage—the Patient-Centered Outcomes Research Institute (PCORI) was established in 2010 as part of the Affordable Care Act legislation. PCORI is guided by the imperative to help patients, families, clinicians, and other health care stakeholders make better informed health care decisions and improve care and outcomes. To inform the next steps in its organizational strategy, PCORI enlisted the National Academy of Medicine (NAM) to leverage its deep experience in convening experts on matters of significant national importance, including its long-standing thought leadership role in the realization of a learning health system. The NAM formed a multi-stakeholder workgroup and held two virtual convenings with the objective of engaging with patients, clinicians, health system leaders, researchers, and other stakeholders from the broader health community to identify and discuss high-priority emerging issues in health, health care, and biomedical science and technology. The key messages from these meetings are outlined in the Special Publication Priorities on the Health Horizon: Informing PCORI''s Strategic Plan.

Given the breadth of the domains considered in the Priorities on the Health Horizon meetings—emerging technologies, social and environmental factors, optimizing value, and infrastructure—a formidable set of pressing health and health care research needs were reviewed and discussed. In addition, certain fundamental strategic priorities emerged as basic and critical to progress in the field: (1) the need to reorient research perspectives and activities to patient and family priorities and values, and in particular, those conditions that drive inequities; (2) the need to foster strategic learning partnerships across groups, organizations, and sectors; and (3) the need to build the continuous learning infrastructure to produce new insights at the pace and scale necessary for health and health care improvement.

Moving forward, building the capacity to continuously improve learning and sharing throughout the system will entail stakeholders working together as seamlessly as possible. The NAM and PCORI worked together to facilitate an expansive dialogue with key stakeholders and engender trust through a focus on shared commitments to progress on improving health for all Americans in the decade ahead.

The effective use of data is foundational to the concept of a learning health system—one that leverages and shares data to learn from every patient experience, and feeds the results back to clinicians, patients and families, and health care executives to transform health, health care, and health equity. More than ever, the American health care system is in a position to harness new technologies and new data sources to improve individual and population health.

Learning health systems are driven by multiple stakeholders—patients, clinicians and clinical teams, health care organizations, academic institutions, government, industry, and payers. Each stakeholder group has its own sources of data, its own priorities, and its own goals and needs with respect to sharing that data. However, in America''s current health system, these stakeholders operate in silos without a clear understanding of the motivations and priorities of other groups. The three stakeholder working groups that served as the authors of this Special Publication identified many cultural, ethical, regulatory, and financial barriers to greater data sharing, linkage, and use. What emerged was the foundational role of trust in achieving the full vision of a learning health system.

This Special Publication outlines a number of potentially valuable policy changes and actions that will help drive toward effective, efficient, and ethical data sharing, including more compelling and widespread communication efforts to improve awareness, understanding, and participation in data sharing. Achieving the vision of a learning health system will require eliminating the artificial boundaries that exist today among patient care, health system improvement, and research. Breaking down these barriers will require an unrelenting commitment across multiple stakeholders toward a shared goal of better, more equitable health.

We can improve together by sharing and using data in ways that produce trust and respect. Patients and families deserve nothing less.

The emergence of artificial intelligence (AI) in health care offers unprecedented opportunities to improve patient and clinical team outcomes, reduce costs, and impact population health. While there have been a number of promising examples of AI applications in health care, it is imperative to proceed with caution or risk the potential of user disillusionment, another AI winter, or further exacerbation of existing health- and technology-driven disparities.

This Special Publication synthesizes current knowledge to offer a reference document for relevant health care stakeholders. It outlines the current and near-term AI solutions; highlights the challenges, limitations, and best practices for AI development, adoption, and maintenance; offers an overview of the legal and regulatory landscape for AI tools designed for health care application; prioritizes the need for equity, inclusion, and a human rights lens for this work; and outlines key considerations for moving forward.

AI is poised to make transformative and disruptive advances in health care, but it is prudent to balance the need for thoughtful, inclusive health care AI that plans for and actively manages and reduces potential unintended consequences, while not yielding to marketing hype and profit motives.

Evidence-based medicine arose from a clear need and represents a major advance in the science of clinical decision making. Despite broad acceptance of evidence-based medicine, however, a fundamental issue remains unresolved: evidence is derived from groups of people, yet medical decisions are made by and for individuals. Despite persistent assertions from clinicians that determining the best therapy for each patient is a more complicated endeavor than just picking the best treatment on average, traditional approaches have been overly reliant on the average effects estimated from the outcomes of clinical trials.

This Special Publication is based on a workshop, held by the National Academy of Medicine, that considered patient and stakeholder perspectives on the importance of understanding heterogeneous treatment effects (HTE) and best practices for implementing clinical programs that take HTE into account. For evidence to be more applicable to individual patients, we need to combine methods for strong causal inference (first and foremost, randomization) with methods for prediction that permit inferences about which particular patients are likely to benefit and which are not. Better population-based outcomes will only be realized when we understand more completely how to treat patients as the unique individuals they are.

Health services research is "the multidisciplinary field of scientific investigation that studies how social factors, financing systems, organizational structures and processes, health technologies, and personal behaviors affect access to health care and the quality and cost of health care." Since the 1960s, health services research has provided the foundation for progress, effectiveness, and value in health care. Ironically, at a time in which appreciation has never been higher for both the need and potential from health services research, the political and financial support for sustenance and growth appear to be weakening.

With funding support from AcademyHealth, the American Association of Colleges of Nursing, the American Board of Family Medicine, the American Society of Anesthesiologists, the Association of American Medical Colleges, the Federation of American Hospitals, and the Robert Wood Johnson Foundation, this National Academy of Medicine Special Publication identifies the range of issues that health services research must consider, address, and potentially overcome to transform the field to meet the needs of a 21st-century health care system. These issues are broad, multidisciplinary, and will require a coordinated effort to address—as well as dedicated and sustainable funding. Federal support for health services research has never been more critical. Now is a critical time for the field to articulate its priorities, demonstrate its utility, and transform to meet the needs of a 21st-century health care system. The physical and financial health of the nation is at stake.

Realizing the promise of digital technology will depend on the ability to share information across time and space from multiple devices, sources, systems, and organizations. The major barrier to progress is not technical; rather, it is in the failure of organizational demand and purchasing requirements. In contrast to many other industries, the purchasers of health care technologies have not marshaled their purchasing power to drive interoperability as a key requirement. Better procurement practices, supported by compatible interoperability platforms and architecture, will allow for better, safer patient care; reduced administrative workload for clinicians; protection from cybersecurity attacks; and significant financial savings across multiple markets.

With funding support from the Gordon and Betty Moore Foundation, this National Academy of Medicine Special Publication represents a multi-stakeholder exploration of the path toward achieving large-scale interoperability through strategic acquisition of health information technology solutions and devices. In this publication, data exchanges over three environments are identified as critical to achieving interoperability: facility-to-facility (macro-tier); intra-facility (meso-tier); and at point-of-care (micro-tier). The publication further identifies the key characteristics of information exchange involved in health and health care, the nature of the requirements for functional interoperability in care processes, the mapping of those requirements into prevailing contracting practices, the specification of the steps necessary to achieve system-wide interoperability, and the proposal of a roadmap for using procurement specifications to engage those steps. The publication concludes with a series of checklists to be used by health care organizations and other stakeholders to accelerate progress in achieving system-wide interoperability.

To advance insights and perspectives on how to better manage the care of the high-need patient population, the National Academy of Medicine, with guidance from an expert planning committee, was tasked with convening three workshops held between July 2015 and October 2016. The resulting special publication, Effective Care for High-Need Patients: Opportunities for Improving Outcomes, Value, and Health, summarizes the presentations, discussions, and relevant literature.

There is no question that opioid use disorder has become the fastest growing, serious, and far-reaching public health crisis facing our nation today. The growing and unprecedented opioid epidemic is a critical issue for public health and medical care throughout the country. Provisional estimates suggest that nearly 65,000 Americans died from a drug overdose in 2016, a 21% increase from the previous year and at a level higher than occurred during the peak years for deaths from HIV infection and automobile fatalities.

Nearly half of opioid overdose deaths are related to medications obtained legally by prescription, sparking deep concern among leaders in the health care sector. The need is clear for clinicians, as the "gatekeepers" of opioid prescriptions, and as the front line in facilitating access to treatment for addiction, to work together with state and community leaders to reduce the impact of opioid misuse on American communities.

At the request of the National Governors Association, the National Academy of Medicine convened a group of experts and field leaders to explore clinicians'' roles in addressing opioid misuse and addiction. The resulting Special Publication is informed by, and builds on, initiatives and guidelines that have been stewarded by various stakeholder organizations providing leadership in addressing these issues. In the midst of evolving understanding of and experience in pain management and substance abuse, the authors offer to clinicians a set of axioms applicable both to responsible, appropriate opioid prescribing practices, and to recognition and treatment of substance use disorder. Also underscored are actions that clinicians can take to improve their skills and effectiveness in the face of the growing need, including leadership engagement to ensure that communities have the resources and tools that clinicians require to fulfill their responsibilities.