In September 2015, the National Academies of Sciences, Engineering, and Medicine hosted a workshop to explore the basic and translational research needs for population health science, and to discuss specific research priorities and actions to foster population health improvement. The workshop was designed to provide frameworks for understanding population health research and its role in shaping and having an effect on population health, identify individual and institutional facilitators and challenges regarding the production, communication, and use of research for population health improvement, and identify key areas for future research critical to the advancement of population health improvement. This publication summarizes the presentations and discussions from the workshop.
The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already legally on the market (called a predicate), in which case the device does not need to go through the premarket approval (PMA) process. As part of its assessment of the FDA's premarket clearance process for medical devices, the Institute of Medicine (IOM) held a workshop on July 28, 2010 to discuss how medical devices are monitored for safety after they are available to consumers. Its primary focus was on monitoring the safety of marketed medical devices, including FDA's postmarket surveillance activities, analysis of safety concerns that resulted in medical device recalls, and non-FDA sources of adverse-event information. Public Health Effectiveness of the FDA 501(K) Clearance Process summarizes the views of the workshop participants.
Health systems and assets are a large part of the critical infrastructure of any community and are vital not only for the safety and well-being of its citizens, but also for the economic vitality, quality of life, and livelihood of the entire community. As part of its ongoing mission to foster dialogue among stakeholders and to confront the challenges inherent in ensuring the nation's health security, the Institute of Medicine (IOM) Forum on Medical and Public Health Preparedness for Catastrophic Events sponsored a town hall session at the 2012 Public Health Preparedness Summit. This event took place February 21-24 in Anaheim, California. In this session sponsored by the IOM, the focus of discussion was sustaining health care delivery beyond the initial response to a disaster and facilitating the full long-term recovery of the local health care delivery systems. Many elements required for recovery are also fundamental to the day-to-day operations of these systems. Investing in improved health care delivery systems, both financially and through collaborative capacity building, can enhance economic development and growth before a disaster, and also prove instrumental in sustaining services and recovering after a disaster. Post-Incident Recovery Considerations of the Health Care Service Delivery Infrastructure serves as a summary of the session and explains the value of regional capacity building; the importance of interagency, intergovernmental, and public-private collaboration; and the significant role that health care coalitions can play in ensuring resilient communities and national health security.
Biological differences between the sexes influence not only individual health but also public health, biomedical research, and health care. The Institute of Medicine held a workshop March 8-9, 2010, to discuss sex differences and their implications for translational neuroscience research, which bridges the gap between scientific discovery and application.
Problems contacting emergency services and delayed assistance are not unusual when incidents occur in rural areas, and the consequences can be devastating, particularly with mass casualty incidents. The IOM's Forum on Medical and Public Health Preparedness for Catastrophic Events held a workshop to examine the current capabilities of emergency response systems and the future opportunities to improve mass casualty response in rural communities.
During public health emergencies such as pandemic influenza outbreaks or terrorist attacks, effective vaccines, drugs, diagnostics, and other medical countermeasures are essential to protecting national security and the public's well-being. The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE)-a partnership among federal, state, and local governments; industry; and academia-is at the forefront of the effort to develop and manufacture these countermeasures. However, despite the PHEMCE's many successes, there are still serious challenges to overcome. Government-funded medical research is not always focused on countermeasures for the most serious potential threats, and it is difficult to engage pharmaceutical and biotechnology companies to develop and manufacture medical countermeasures that have a limited commercial market. At the request of the Secretary of the U.S. Department of Health and Human Services and the Assistant Secretary for Preparedness and Response, the IOM held a workshop February 22-24, 2010, to address challenges facing the PHEMCE. Workshop participants discussed federal policies and procedures affecting the research, development, and approval of medical countermeasures and explored opportunities to improve the process and protect Americans' safety and health.
During public health emergencies (PHEs) involving chemical, biological, radiological, or nuclear threats or emerging infectious diseases, medical countermeasures (MCMs) (e.g., drugs, vaccines, devices) may need to be dispensed or administered to affected populations to help mitigate the human health impact of the threat. The optimal MCMs determined for use during an emergency might be U.S. Food and Drug Administration (FDA) approved but used in unapproved ways (e.g., in a new age group or against a new agent); FDA approved using animal models because human efficacy testing is not ethical or feasible; or not yet FDA approved for any indication. As part of the United States' scientific and research preparedness enterprise, there is an imperative to go "beyond the last mile" of MCM dispensing and administration to build and maintain a national capability to monitor and assess the use of MCMs (e.g., safety, compliance, clinical benefit) after they have been dispensed during PHEs. To further the discussion on this need, the Board on Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine hosted a 2-day public workshop, Building a National Capability to Monitor and Assess Medical Countermeasure Use in Response to Public Health Emergencies. The workshop, sponsored by FDA, was held on June 6â€"7, 2017, in Washington, DC. Workshop participants discussed the roles and efforts of the federal government and of relevant stakeholders with an interest in building and maintaining a national PHE MCM active monitoring and assessment capability. This publication summarizes the presentations and discussions from the workshop.
Health literacy is the degree to which one can understand and make decisions based on health information. Nearly 90 million adults in the United States have limited health literacy. While poor health literacy spans all demographics, rates of low health literacy are disproportionately higher among those with lower socioeconomic status, limited education, or limited English proficiency, as well as among the elderly and individuals with mental or physical disabilities. Studies have shown that there is a correlation between low health literacy and poor health outcomes. In 2010, President Obama signed the Affordable Care Act designed to extend access to health care coverage to millions of Americans who have been previously uninsured. Many of the newly eligible individuals who should benefit most from the ACA, however, are least prepared to realize those benefits as a result of low health literacy. They will face significant challenges understanding what coverage they are eligible for under the ACA, making informed choices about the best options for themselves and their families, and completing the enrollment process. Health Literacy Implications for Health Care Reform explores opportunities to advance health literacy in association with the implementation of health care reform. The report focuses on building partnerships to advance the field of health literacy by translating research findings into practical strategies for implementation, and on educating the public, press, and policymakers regarding issues of health literacy.
On February 5, 2015, the Institute of Medicine Roundtable on Population Health Improvement hosted a workshop to explore the relationship between public health and health care, including opportunities, challenges, and practical lessons. The workshop was convened in partnership with the Association of State and Territorial Health Officials (ASTHO)-Supported Primary Care and Public Health Collaborative. Organized in response to the 2012 IOM report Primary Care and Public Health: Exploring Integration to Improve Population Health, this workshop focused on current issues at the interface of public health and health care, including opportunities presented by and lessons learned from the Centers for Medicaid and Medicare Services State Innovation Models program. The workshop featured presentations on several dimensions of the public health-health care relationship. Collaboration Between Health Care and Public Health summarizes the presentations and discussion of the event.
Spread, Scale, and Sustainability in Population Health is the summary of a workshop convened by the Institute of Medicine's Roundtable on Population Health Improvement in December 2014 to discuss the spread, scale, and sustainability of practices, models, and interventions for improving health in a variety of inter-organizational and geographical contexts. This report explores how users measure whether their strategies of spread and scale have been effective and discusses how to increase the focus on spread and scale in population health.
Ten years after the sequencing of the human genome, scientists have developed genetic tests that can predict a person's response to certain drugs, estimate the risk of developing Alzheimer's disease, and make other predictions based on known links between genes and diseases. However, genetic tests have yet to become a routine part of medical care, in part because there is not enough evidence to show they help improve patients' health. The Institute of Medicine (IOM) held a workshop to explore how researchers can gather better evidence more efficiently on the clinical utility of genetic tests. Generating Evidence for Genomic Diagnostic Test Development compares the evidence that is required for decisions regarding clearance, use, and reimbursement, to the evidence that is currently generated. The report also addresses innovative and efficient ways to generate high-quality evidence, as well as barriers to generating this evidence. Generating Evidence for Genomic Diagnostic Test Development contains information that will be of great value to regulators and policymakers, payers, health-care providers, researchers, funders, and evidence-based review groups.
Genomic applications are being integrated into a broad range of clinical and research activities at health care systems across the United States. This trend can be attributed to a variety of factors, including the declining cost of genome sequencing and the potential for improving health outcomes and cutting the costs of care. The goals of these genomics-based programs may be to identify individuals with clinically actionable variants as a way of preventing disease, providing diagnoses for patients with rare diseases, and advancing research on genetic contributions to health and disease. Of particular interest are genomics- based screening programs, which will, in this publication, be clinical screening programs that examine genes or variants in unselected populations in order to identify individuals who are at an increased risk for a particular health concern (e.g., diseases, adverse drug outcomes) and who might benefit from clinical interventions. On November 1, 2017, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop to explore the challenges and opportunities associated with integrating genomics-based screening programs into health care systems. This workshop was developed as a way to explore the challenges and opportunities associated with integrating genomics-based programs in health care systems in the areas of evidence collection, sustainability, data sharing, infrastructure, and equity of access. This publication summarizes the presentations and discussions from the workshop.
On February 26, 2020, the Board on Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine hosted a 1-day public workshop in Washington, DC, to examine current and emerging bioethical issues that might arise in the context of biomedical research and to consider research topics in bioethics that could benefit from further attention. The scope of bioethical issues in research is broad, but this workshop focused on issues related to the development and use of digital technologies, artificial intelligence, and machine learning in research and clinical practice; issues emerging as nontraditional approaches to health research become more widespread; the role of bioethics in addressing racial and structural inequalities in health; and enhancing the capacity and diversity of the bioethics workforce. This publication summarizes the presentations and discussions from the workshop.
In 2013 the Institute of Medicine (IOM) Roundtable on Population Health Improvement organized a workshop to discuss opportunities to foster a health in all policies approach in non-health sectors such as housing, transportation, defense, education, and others. Much of the discussion focused on public-sector organizations, and roundtable members saw the need for further discussion of the role of the private sector, both as stakeholder and partner. On June 4, 2015, the roundtable convened a follow-up workshop focused on applying a health lens to the role and potential of businesses in improving economic well-being and community health outcomes. Participants explored what businesses can offer the movement to improve population health and areas of potential, as well as models for how businesses can impact the determinants of health, and developed a platform for discussing how to promote and support health in all business practices, policies, and investments. This report summarizes the presentations and discussions from the workshop.
Whether or not the United States has safe and effective medical countermeasures-such as vaccines, drugs, and diagnostic tools-available for use during a disaster can mean the difference between life and death for many Americans. The Food and Drug Administration (FDA) and the scientific community at large could benefit from improved scientific tools and analytic techniques to undertake the complex scientific evaluation and decision making needed to make essential medical countermeasures available. At the request of FDA, the Institute of Medicine (IOM) held a workshop to examine methods to improve the development, evaluation, approval, and regulation of medical countermeasures. During public health emergencies such as influenza or chemical, biological, radiological/nuclear (CBRN) attacks, safe and effective vaccines, treatments, and other medical countermeasures are essential to protecting national security and the well being of the public. Advancing Regulatory Science for Medical Countermeasure Development examines current medical countermeasures, and investigates the future of research and development in this area. Convened on March 29-30, 2011, this workshop identified regulatory science tools and methods that are available or under development, as well as major gaps in currently available regulatory science tools. Advancing Regulatory Science for Medical Countermeasure Development is a valuable resource for federal agencies including the Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), the Department of Defense (DoD), as well as health professionals, and public and private health organizations.
As information technology becomes an integral part of health care, it is important to collect and analyze data in a way that makes the information understandable and useful. Informatics tools-which help collect, organize, and analyze data-are essential to biomedical and health research and development. The field of cancer research is facing an overwhelming deluge of data, heightening the national urgency to find solutions to support and sustain the cancer informatics ecosystem. There is a particular need to integrate research and clinical data to facilitate personalized medicine approaches to cancer prevention and treatment-for example, tailoring treatment based on an individual patient's genetic makeup as well as that of the tumor-and to allow for more rapid learning from patient experiences. To further examine informatics needs and challenges for 21st century biomedical research, the IOM's National Cancer Policy Forum held a workshop February 27-28, 2012. The workshop was designed to raise awareness of the critical and urgent importance of the challenges, gaps and opportunities in informatics; to frame the issues surrounding the development of an integrated system of cancer informatics for acceleration of research; and to discuss solutions for transformation of the cancer informatics enterprise. Informatics Needs and Challenges in Cancer Research: Workshop Summary summarizes the workshop.
With the advent of genome-wide association studies, numerous associations between specific gene loci and complex diseases have been identified-for breast cancer, coronary artery disease, and asthma, for example. This rapidly advancing field of genomics has stirred great interest in "personalized" health care from both the public and private sectors. The hope is that using genomic information in clinical care will lead to reduced health care costs and improved health outcomes as therapies are tailored to the genetic susceptibilities of patients. A variety of genetically based health care innovations have already reached the marketplace, but information about the clinical use of these treatments and diagnostics is limited. Currently data do not provide information about how a genomic test impacts clinical care and patient health outcomes-other approaches are needed to garner such information. This volume summarizes a workshop to address central questions related to the development of systems to evaluate clinical use of health care innovations that stem from genome-based research: What are the practical realities of creating such systems? What different models could be used? What are the strengths and weaknesses of each model? How effectively can such systems address questions about health outcomes?
Socioeconomic conditions are known to be major determinants of health at all stages of life, from pregnancy through childhood and adulthood. "Life-course epidemiology" has added a further dimension to the understanding of the social determinants of health by showing an association between early-life socioeconomic conditions and adult health-related behaviors, morbidity, and mortality. Sensitive and critical periods of development, such as the prenatal period and early childhood, present significant opportunities to influence lifelong health. Yet simply intervening in the health system is insufficient to influence health early in the life course. Community-level approaches to affect key determinants of health are also critical. Many of these issues were raised in the 1995 National Academies book, Children's Health, the Nation's Wealth. The present volume builds upon this earlier book with presentations and examples from the field. Focusing on Children's Health describes the evidence linking early childhood life conditions and adult health; discusses the contribution of the early life course to observed racial and ethnic disparities in health; and highlights successful models that engage both community factors and health care to affect life course development.
Knowing one's genetic disposition to a variety of diseases, including common chronic diseases, can benefit both the individual and society at large. The IOM's Roundtable on Translating Genomic-Based Research for Health held a workshop on March 22, 2010, to bring together diverse perspectives on the value of genetic testing, and to discuss its use in clinical practice.
The process for developing new drug and biologic products is extraordinarily expensive and time-consuming. Although large pharmaceutical companies may be able to afford the cost of development because they can expect a large return on investment, organizations developing drugs to treat rare and neglected diseases are unable to rely on such returns. On June 23, 2008, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held a public workshop, "Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies," which sought to explore new and innovative strategies for developing drugs for rare and neglected diseases.
Nearly 5.3 million Americans are living with Alzheimer's disease, and 26.6 million people are affected worldwide. The Alzheimer's Disease Neuroimaging Initiative (ADNI), a public-private partnership, provides a publicly available, international database of clinical and imaging data to foster research and collaboration on Alzheimer's research worldwide. The Institute of Medicine held a workshop on July 12, 2010, to explore opportunities to use information from and partnerships formed because of ADNI to continue to improve the understanding and treatment of Alzheimer's disease.
Those involved in the drug development process face challenges of efficiency and overall sustainability due in part to high research costs, lengthy development timelines, and late-stage drug failures. Novel clinical trial designs that enroll participants based on their genetics represent a potentially disruptive change that could improve patient outcomes, reduce costs associated with drug development, and further realize the goals of precision medicine. On March 8, 2017, the Forum on Drug Discovery, Development, and Translation and the Roundtable on Genomics and Precision Health of the National Academies of Sciences, Engineering, and Medicine hosted the workshop Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development. Participants examined successes, challenges, and possible best practices for effectively using genetic information in the design and implementation of clinical trials to support the development of precision medicines, including exploring the potential advantages and disadvantages of such trials across a variety of disease areas. This publication summarizes the presentations and discussions from the workshop.
Scientific advances during the last decade now indicate that Alzheimer's disease is a continuous, progressive cognitive disease, most likely beginning many years before dementia is apparent. To discuss the next steps in validating new diagnostic guidelines for Alzheimer's disease, the IOM Forum on Neuroscience and Nervous System Disorders hosted a public workshop session at the Alzheimer's Association International Conference.
Since the 2014 Ebola outbreak many public- and private-sector leaders have seen a need for improved management of global public health emergencies. The effects of the Ebola epidemic go well beyond the three hardest-hit countries and beyond the health sector. Education, child protection, commerce, transportation, and human rights have all suffered. The consequences and lethality of Ebola have increased interest in coordinated global response to infectious threats, many of which could disrupt global health and commerce far more than the recent outbreak. In order to explore the potential for improving international management and response to outbreaks the National Academy of Medicine agreed to manage an international, independent, evidence-based, authoritative, multistakeholder expert commission. As part of this effort, the Institute of Medicine convened four workshops in summer of 2015 to inform the commission report. The presentations and discussions from the Workshop on Research and Development of Medical Products are summarized in this report.
When a nation or region prepares for public health emergencies such as a pandemic influenza, a large-scale earthquake, or any major disaster scenario in which the health system may be destroyed or stressed to its limits, it is important to describe how standards of care would change due to shortages of critical resources. At the 17th World Congress on Disaster and Emergency Medicine, the IOM Forum on Medical and Public Health Preparedness sponsored a session that focused on the promise of and challenges to integrating crisis standards of care principles into international disaster response plans.
The number of women participating in clinical trials has increased during the last two decades, but women are still underrepresented in clinical trials in general. Some of the overall increase can be attributed to the greater number of women-only trials (of therapies for diseases that affect only women). Even when women are included in clinical trials, the results are often not analyzed separately by sex. On August 30, 2011, the Institute of Medicine (IOM) Board on Population Health and Public Health Practice hosted the workshop Sex-Specific Reporting of Scientific Research. The workshop explored the need for sex-specific reporting of scientific results; potential barriers and unintended consequences of sex-specific reporting of scientific results; experiences of journals that have implemented sex-specific requirements, including the challenges and benefits of such editorial policies; and steps to facilitate the reporting of sex-specific results. Presenters and participants included current and former editors of scientific journals, researchers, and scientists and policymakers from government, industry, and nonprofit organizations. Presentations and discussions highlighted the importance to both women and men of having sex-specific data, the problems with sample size and financial constraints for conducting the research, the appropriateness of sex-specific analyses, and the limitations of journal policies to change experimental designs. Sex-Specific Reporting of Scientific Research summarizes the presentations and discussions by the expert panelists during the IOM workshop. The workshop's first session focused on why sex-specific reporting is important. Panelists highlighted historical and current events that have hindered or helped to advance the study of women. In the next session, panelists in academe discussed the challenges of collecting, analyzing, and reporting sex-specific data from the researcher's perspective. That was followed by two panels of leading journal editors who shared their experiences in developing and implementing editorial policies and the implications of sex-specific reporting policies for journals.
Nervous system diseases and disorders are highly prevalent and substantially contribute to the overall disease burden. Despite significant information provided by the use of animal models in the understanding of the biology of nervous system disorders and the development of therapeutics; limitations have also been identified. Treatment options that are high in efficacy and low in side effects are still lacking for many diseases and, in some cases are nonexistent. A particular problem in drug development is the high rate of attrition in Phase II and III clinical trials. Why do many therapeutics show promise in preclinical animal models but then fail to elicit predicted effects when tested in humans? On March 28 and 29, 2012, the Institute of Medicine Forum on Neuroscience and Nervous System Disorders convened the workshop "Improving Translation of Animal Models for Nervous System Disorders" to discuss potential opportunities for maximizing the translation of new therapies from animal models to clinical practice. The primary focus of the workshop was to examine mechanisms for increasing the efficiency of translational neuroscience research through discussions about how and when to use animal models most effectively and then best approaches for the interpretation of the data collected. Specifically, the workshop objectives were to: discuss key issues that contribute to poor translation of animal models in nervous system disorders, examine case studies that highlight successes and failures in the development and application of animal models, consider strategies to increase the scientific rigor of preclinical efficacy testing, explore the benefits and challenges to developing standardized animal and behavioral models. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary also identifies methods to facilitate development of corresponding animal and clinical endpoints, indentifies methods that would maximize bidirectional translation between basic and clinical research and determines the next steps that will be critical for improvement of the development and testing of animal models of disorders of the nervous system.
The Role and Potential of Communuties in Population Health Improvement is the summary of a workshop held by the Institute of Medicine Roundtable on Population Health Improvement in April 2014 that featured invited speakers from community groups that have taken steps to improve the health of their communities. Speakers from communities across the United States discussed the potential roles of communities for improving population health. The workshop focused on youth organizing, community organizing or other types of community participation, and partnerships between community and institutional actors. This report explores the roles and potential of the community as leaders, partners, and facilitators in transforming the social and environmental conditions that shape health and well-being at the local level."-- Publisher's description.
It's obvious why only men develop prostate cancer and why only women get ovarian cancer. But it is not obvious why women are more likely to recover language ability after a stroke than men or why women are more apt to develop autoimmune diseases such as lupus. Sex differences in health throughout the lifespan have been documented. Exploring the Biological Contributions to Human Health begins to snap the pieces of the puzzle into place so that this knowledge can be used to improve health for both sexes. From behavior and cognition to metabolism and response to chemicals and infectious organisms, this book explores the health impact of sex (being male or female, according to reproductive organs and chromosomes) and gender (one's sense of self as male or female in society). Exploring the Biological Contributions to Human Health discusses basic biochemical differences in the cells of males and females and health variability between the sexes from conception throughout life. The book identifies key research needs and opportunities and addresses barriers to research. Exploring the Biological Contributions to Human Health will be important to health policy makers, basic, applied, and clinical researchers, educators, providers, and journalists-while being very accessible to interested lay readers.
One of the largest treatment gaps for mental, neurological, and substance use (MNS) disorders in the world can be seen in Sub-Saharan Africa (SSA). According to the World Health Organization (WHO), about 80% of people with serious MNS disorders living in low- and middle-income countries do not receive needed health services. A critical barrier to bridge this treatment gap is the ability to provide adequate human resources for the delivery of essential interventions for MNS disorders. An international workshop was convened in 2009, by the .S. Institute of Medicine (IOM) Forum on Neuroscience and Nervous Systems Disorders and the Uganda National Academy of Sciences (UNAS) Forum on Health and Nutrition, to bring together stakeholders from across SSA and to foster discussions about improving care for people suffering from MNS disorders and what steps, with potential for the greatest impact, might be considered to bridge the treatment gap. Due to the broad interest to further examine the treatment gap, the IOM forum organized a second workshop in Kampala, Uganda on September 4 and 5, 2012. The workshop\'s purpose was to discuss candidate core competencies that providers might need to help ensure the effective delivery of services for MNS disorders. The workshop focused specifically on depression, psychosis, epilepsy, and alcohol use disorders. Strengthening Human Resources Through Development of Candidate Core Competencies for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa: Workshop Summary outlines the presentations and discussions by expert panelists and participants of the plenary sessions of the workshop. This summary includes an overview of challenges faced by MNS providers in the SSA, perspectives on the next steps, the 2009 workshop, and more.
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