%0 Book %A Institute of Medicine %T Resources for Clinical Investigation: Report of a Study %D 1988 %U https://nap.nationalacademies.org/catalog/9931/resources-for-clinical-investigation-report-of-a-study %> https://nap.nationalacademies.org/catalog/9931/resources-for-clinical-investigation-report-of-a-study %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 93 %0 Book %A Institute of Medicine %E Townsend, Jessica %T Strengthening Research in Academic OB/GYN Departments %@ 978-0-309-04697-8 %D 1992 %U https://nap.nationalacademies.org/catalog/1970/strengthening-research-in-academic-obgyn-departments %> https://nap.nationalacademies.org/catalog/1970/strengthening-research-in-academic-obgyn-departments %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 320 %X Research conducted in academic departments of obstetrics and gynecology could result in substantial improvements in the health of women and the outcomes of pregnancy. Strengthening Research in Academic OB/GYN Departments determines whether such departments are capable of fulfilling this promise. The committee finds that these departments have a poor track record in their ability to compete for research funds and in the extent to which their faculty contribute to research. Adding to the problem are factors that deter OB/GYNs from a research career and a dearth of dynamic research leaders in the profession. The volume explores reasons for this situation and makes recommendations to counteract them. Also included is an agenda of needed research. %0 Book %A National Academies of Sciences, Engineering, and Medicine %T Rapid Expert Consultation on Understanding Causes of Health Care Worker Deaths Due to the COVID-19 Pandemic (December 10, 2020) %D 2020 %U https://nap.nationalacademies.org/catalog/26018/rapid-expert-consultation-on-understanding-causes-of-health-care-worker-deaths-due-to-the-covid-19-pandemic-december-10-2020 %> https://nap.nationalacademies.org/catalog/26018/rapid-expert-consultation-on-understanding-causes-of-health-care-worker-deaths-due-to-the-covid-19-pandemic-december-10-2020 %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 10 %X The COVID-19 pandemic has created both acute and chronic stresses on the health care system and on health care personnel nationwide. At present, the nation lacks a uniform system to collect, collate, and report illnesses and deaths among health care workers due to COVID-19, and only a few studies report on efforts to improve the health and well-being of health care workers. At the request of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, this rapid expert consultation reviews current resources and methods for tracking and evaluating health care worker deaths related to COVID-19 in the health care setting. This rapid expert consultation also examines some ways to support health care worker well-being and safety during the pandemic. %0 Book %A Institute of Medicine %A National Research Council %T BioWatch and Public Health Surveillance: Evaluating Systems for the Early Detection of Biological Threats: Abbreviated Version %@ 978-0-309-13971-7 %D 2011 %U https://nap.nationalacademies.org/catalog/12688/biowatch-and-public-health-surveillance-evaluating-systems-for-the-early %> https://nap.nationalacademies.org/catalog/12688/biowatch-and-public-health-surveillance-evaluating-systems-for-the-early %I The National Academies Press %C Washington, DC %G English %K Conflict and Security Issues %P 252 %X Following the attacks of September 11, 2001 and the anthrax letters, the ability to detect biological threats as quickly as possible became a top priority. In 2003 the Department of Homeland Security (DHS) introduced the BioWatch program—a federal monitoring system intended to speed detection of specific biological agents that could be released in aerosolized form during a biological attack. The present volume evaluates the costs and merits of both the current BioWatch program and the plans for a new generation of BioWatch devices. BioWatch and Public Health Surveillance also examines infectious disease surveillance through hospitals and public health agencies in the United States, and considers whether BioWatch and traditional infectious disease surveillance are redundant or complementary. %0 Book %A National Academy of Sciences %A National Research Council %T Accidental Death and Disability: The Neglected Disease of Modern Society %@ 978-0-309-07532-9 %D 1966 %U https://nap.nationalacademies.org/catalog/9978/accidental-death-and-disability-the-neglected-disease-of-modern-society %> https://nap.nationalacademies.org/catalog/9978/accidental-death-and-disability-the-neglected-disease-of-modern-society %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 39 %0 Book %A Institute of Medicine %T Extending Life, Enhancing Life: A National Research Agenda on Aging %@ 978-0-309-04399-1 %D 1991 %U https://nap.nationalacademies.org/catalog/1632/extending-life-enhancing-life-a-national-research-agenda-on-aging %> https://nap.nationalacademies.org/catalog/1632/extending-life-enhancing-life-a-national-research-agenda-on-aging %I The National Academies Press %C Washington, DC %G English %K Behavioral and Social Sciences %K Health and Medicine %P 164 %X Americans are living longer than ever before. For many, though, these extra years have become a bitter gift, marred by dementia, disability, and loss of independence. Extending Life, Enhancing Life sets the course toward practical solutions to these problems by specifying 15 research priorities in five key areas of investigation: Basic biomedicine—To understand the fundamental processes of aging. Clinical—To intervene against common disabilities and maladies of older persons. Behavioral and social—To build on past successes with behavioral and social interventions. Health services delivery—To seek answers to the troubling issues of insufficient delivery of health care in the face of increasing health care costs. Biomedical ethics—To clarify underlying ethical guidelines about life and death decisions. Most important, the volume firmly establishes the connection between research and its beneficial results for the quality of life for older persons. %0 Book %A Institute of Medicine %T Posttraumatic Stress Disorder: Diagnosis and Assessment %@ 978-0-309-10207-0 %D 2006 %U https://nap.nationalacademies.org/catalog/11674/posttraumatic-stress-disorder-diagnosis-and-assessment %> https://nap.nationalacademies.org/catalog/11674/posttraumatic-stress-disorder-diagnosis-and-assessment %I The National Academies Press %C Washington, DC %G English %K Conflict and Security Issues %K Health and Medicine %P 86 %X In response to growing national concern about the number of veterans who might be at risk for posttraumatic stress disorder (PTSD) as a result of their military service, the Department of Veterans Affairs (VA) asked the Institute of Medicine (IOM) to conduct a study on the diagnosis and assessment of, and treatment and compensation for PTSD. An existing IOM committee, the Committee on Gulf War and Health: Physiologic, Psychologic and Psychosocial Effects of Deployment-Related Stress, was asked to conduct the diagnosis, assessment, and treatment aspects of the study because its expertise was well-suited to the task. The committee was specifically tasked to review the scientific and medical literature related to the diagnosis and assessment of PTSD, and to review PTSD treatments (including psychotherapy and pharmacotherapy) and their efficacy. In addition, the committee was given a series of specific questions from VA regarding diagnosis, assessment, treatment, and compensation. Posttraumatic Stress Disorder is a brief elaboration of the committee's responses to VA's questions, not a detailed discussion of the procedures and tools that might be used in the diagnosis and assessment of PTSD. The committee decided to approach its task by separating diagnosis and assessment from treatment and preparing two reports. This first report focuses on diagnosis and assessment of PTSD. Given VA's request for the report to be completed within 6 months, the committee elected to rely primarily on reviews and other well-documented sources. A second report of this committee will focus on treatment for PTSD; it will be issued in December 2006. A separate committee, the Committee on Veterans' Compensation for Post Traumatic Stress Disorder, has been established to conduct the compensation study; its report is expected to be issued in December 2006. %0 Book %A Institute of Medicine %T Personnel Needs and Training for Biomedical and Behavioral Reserach: 1976 Report %D 1976 %U https://nap.nationalacademies.org/catalog/9910/personnel-needs-and-training-for-biomedical-and-behavioral-reserach-1976 %> https://nap.nationalacademies.org/catalog/9910/personnel-needs-and-training-for-biomedical-and-behavioral-reserach-1976 %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 243 %0 Book %A Institute of Medicine %T Expanding Access to Investigational Therapies for HIV Infection and AIDS %@ 978-0-309-04490-5 %D 1991 %U https://nap.nationalacademies.org/catalog/1778/expanding-access-to-investigational-therapies-for-hiv-infection-and-aids %> https://nap.nationalacademies.org/catalog/1778/expanding-access-to-investigational-therapies-for-hiv-infection-and-aids %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 84 %X The call for a "parallel track" for AIDS drug development—a proposal that would allow the early distribution of AIDS drugs to large numbers of patients in parallel with the conventional clinical trials that assess the drugs' safety and efficacy—has sparked controversy within the scientific community. Questions have arisen about the risks to patients of such a plan, about its potential effect on the successful completion of standard controlled trials, and about whether the parallel track will generate useful data. Larger questions have also been raised about whether the parallel track heralds fundamental changes in the philosophy underlying drug regulation in the United States, about the costs and financing of investigational therapies and associated medical costs, and about the role of expanded access mechanisms for drugs in reaching those whose health care is generally inadequate. This volume summarizes a conference hosted by the Institute of Medicine that illuminated these issues. %0 Book %A Institute of Medicine %T Personnel Needs and Training for Biomedical and Behavioral Research: Volume 1 %D 1977 %U https://nap.nationalacademies.org/catalog/9908/personnel-needs-and-training-for-biomedical-and-behavioral-research-volume %> https://nap.nationalacademies.org/catalog/9908/personnel-needs-and-training-for-biomedical-and-behavioral-research-volume %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 276 %0 Book %A National Academies of Sciences, Engineering, and Medicine %T Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise %@ 978-0-309-27148-6 %D 2021 %U https://nap.nationalacademies.org/catalog/26373/ensuring-an-effective-public-health-emergency-medical-countermeasures-enterprise %> https://nap.nationalacademies.org/catalog/26373/ensuring-an-effective-public-health-emergency-medical-countermeasures-enterprise %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 138 %X The U.S. medical countermeasures (MCMs) enterprise is interconnected, complex, and dynamic. It includes public and private entities that develop and manufacture new and existing MCMs, ensure procurement, storage, and distribution of MCMs, and administer, monitor, and evaluate MCMs. The interagency group known as the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) is the nation's sole coordinating body, responsible for ensuring end-to-end MCM preparedness and response. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise provides recommendations from an expert committee for a re-envisioned PHEMCE. Four priority areas of improvement emerged from committee deliberations: (1) articulating PHEMCE's mission and role and explicating the principles guiding PHEMCE's operating principles and processes, (2) revising PHEMCE operations and processes, (3) collaborating more effectively with external public and private partners, and (4) navigating legal and policy issues. %0 Book %A National Academies of Sciences, Engineering, and Medicine %E Liverman, Catharyn T. %E Alper, Joe %T Integration of FDA and NIOSH Processes Used to Evaluate Respiratory Protective Devices for Health Care Workers: Proceedings of a Workshop %@ 978-0-309-45127-7 %D 2017 %U https://nap.nationalacademies.org/catalog/23679/integration-of-fda-and-niosh-processes-used-to-evaluate-respiratory-protective-devices-for-health-care-workers %> https://nap.nationalacademies.org/catalog/23679/integration-of-fda-and-niosh-processes-used-to-evaluate-respiratory-protective-devices-for-health-care-workers %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 76 %X Both the Food and Drug Administration (FDA) and the National Institute for Occupational Safety and Health (NIOSH) have responsibilities for evaluating and regulating respiratory protective devices (“respirators”) for health care workers. Respirators protect the user from respiratory hazards by either removing contaminants from the air (air-purifying respirators) or by supplying clean air from another source (air-supplying respirators). Respirators that are used in workplaces in the United States must be approved by NIOSH and meet standards and test results specified by regulation. Respirators used by health care workers are air-purifying respirators that generally fall into three types: (1) disposable particulate filtering facepiece respirators (also termed N95s); (2) elastomeric respirators, also known as reusable respirators because they use a replaceable filter; or (3) powered air-purifying air respirators. To provide input to NIOSH and FDA and to discuss potential next steps to integrate the two agencies’ processes to certify and approve N95 respirators for use in health care settings, a workshop was held by the National Academies of Sciences, Engineering, and Medicine in August 2016. The workshop was focused on exploring the strengths and limitations of several current test methods for N95 respirators as well as identifying ongoing research and research needs. This publication summarizes the presentations and discussions from the workshop. %0 Book %A Institute of Medicine %A National Research Council %E Patel, Deepali M. %E Simon, Melissa A. %E Taylor, Rachel M. %T Contagion of Violence: Workshop Summary %@ 978-0-309-26364-1 %D 2013 %U https://nap.nationalacademies.org/catalog/13489/contagion-of-violence-workshop-summary %> https://nap.nationalacademies.org/catalog/13489/contagion-of-violence-workshop-summary %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 186 %X The past 25 years have seen a major paradigm shift in the field of violence prevention, from the assumption that violence is inevitable to the recognition that violence is preventable. Part of this shift has occurred in thinking about why violence occurs, and where intervention points might lie. In exploring the occurrence of violence, researchers have recognized the tendency for violent acts to cluster, to spread from place to place, and to mutate from one type to another. Furthermore, violent acts are often preceded or followed by other violent acts. In the field of public health, such a process has also been seen in the infectious disease model, in which an agent or vector initiates a specific biological pathway leading to symptoms of disease and infectivity. The agent transmits from individual to individual, and levels of the disease in the population above the baseline constitute an epidemic. Although violence does not have a readily observable biological agent as an initiator, it can follow similar epidemiological pathways. On April 30-May 1, 2012, the Institute of Medicine (IOM) Forum on Global Violence Prevention convened a workshop to explore the contagious nature of violence. Part of the Forum's mandate is to engage in multisectoral, multidirectional dialogue that explores crosscutting, evidence-based approaches to violence prevention, and the Forum has convened four workshops to this point exploring various elements of violence prevention. The workshops are designed to examine such approaches from multiple perspectives and at multiple levels of society. In particular, the workshop on the contagion of violence focused on exploring the epidemiology of the contagion, describing possible processes and mechanisms by which violence is transmitted, examining how contextual factors mitigate or exacerbate the issue. Contagion of Violence: Workshop Summary covers the major topics that arose during the 2-day workshop. It is organized by important elements of the infectious disease model so as to present the contagion of violence in a larger context and in a more compelling and comprehensive way. %0 Book %A Institute of Medicine %E Donaldson, Molla S. %E Capron, Alexander M. %T Patient Outcomes Research Teams (PORTS): Managing Conflict of Interest %@ 978-0-309-04482-0 %D 1991 %U https://nap.nationalacademies.org/catalog/1821/patient-outcomes-research-teams-ports-managing-conflict-of-interest %> https://nap.nationalacademies.org/catalog/1821/patient-outcomes-research-teams-ports-managing-conflict-of-interest %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 184 %X The new Agency for Health Care Policy and Research in the U.S. Public Health Service is funding a set of multidisciplinary groups called Patient Outcomes Research Teams (PORTs). Their purpose is to assess alternative treatments for medical conditions using a variety of outcome measures. In guiding insurance coverage, these PORTs are expected to wield considerable influence on medical practice and health policy. This book addresses possible threats to their credibility that might be based on real or apparent conflicts of interest, including both financial and other conflicts. It raises points to consider for the new agency, for PORTs and their institutions, for industry, for the health services research community, and for the U.S. Congress in avoiding and managing conflicts of interest. %0 Book %A Institute of Medicine %A National Research Council %T Research on Health Effects of Low-Level Ionizing Radiation Exposure: Opportunities for the Armed Forces Radiobiology Research Institute %@ 978-0-309-30209-8 %D 2014 %U https://nap.nationalacademies.org/catalog/18732/research-on-health-effects-of-low-level-ionizing-radiation-exposure %> https://nap.nationalacademies.org/catalog/18732/research-on-health-effects-of-low-level-ionizing-radiation-exposure %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 178 %X It is probably only a matter of time before we witness the next event in which large numbers of people are exposed to ionizing radiation. In the past, planning a response to such an occurrence would have likely focused on the management of casualties from high-dose exposure. However, more recently, a different threat has come to the fore: accidental (through a containment breach in a nuclear power plant, for example) or intentional (via a "dirty bomb") releases of radioactivity resulting in low-dose exposure to a population. The magnitude of the health risks arising from low-dose radiation exposure is uncertain, and this uncertainty has significant economic implications for public health decision making. Research on Health Effects of Low-Level Ionizing Radiation Exposure examines recent scientific knowledge about the human effects of exposure to low-dose radiation from medical, occupational, and environmental ionizing-radiation sources. This report is intended to provide advice to the Armed Forces Radiobiology Research Institute (AFRRI) about its role in low-dose radiation health effects research. The report identifies current research directions in radiobiological science and assesses how AFRRI programs are advancing research along these directions. The recommendations of Research on Health Effects of Low-Level Ionizing Radiation Exposure will provide guidance for AFRRI to build on its strengths and advance its mission while contributing to the body of scientific knowledge on the health effects of exposure to low-dose ionizing radiation. %0 Book %A Institute of Medicine %A National Academies of Sciences, Engineering, and Medicine %E Graig, Laurene A. %E Phillips, Jonathan K. %E Moses, Harold L. %T Biomarker Tests for Molecularly Targeted Therapies: Key to Unlocking Precision Medicine %@ 978-0-309-38134-5 %D 2016 %U https://nap.nationalacademies.org/catalog/21860/biomarker-tests-for-molecularly-targeted-therapies-key-to-unlocking-precision %> https://nap.nationalacademies.org/catalog/21860/biomarker-tests-for-molecularly-targeted-therapies-key-to-unlocking-precision %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 292 %X Every patient is unique, and the evolving field of precision medicine aims to ensure the delivery of the right treatment to the right patient at the right time. In an era of rapid advances in biomedicine and enhanced understanding of the genetic basis of disease, health care providers increasingly have access to advanced technologies that may identify molecular variations specific to an individual patient, which subsequently can be targeted for treatment. Known as biomarker tests for molecularly targeted therapies, these complex tests have the potential to enable the selection of the most beneficial treatment (and also to identify treatments that may be harmful or ineffective) for the molecular underpinnings of an individual patient's disease. Such tests are key to unlocking the promise of precision medicine. Biomarker tests for molecularly targeted therapies represent a crucial area of focus for developing methods that could later be applicable to other areas of precision medicine. The appropriate regulatory oversight of these tests is required to ensure that they are accurate, reliable, properly validated, and appropriately implemented in clinical practice. Moreover, common evidentiary standards for assessing the beneficial impact of biomarker-guided therapy selection on patient outcomes, as well as the effective collection and sharing of information related to those outcomes, are urgently needed to better inform clinical decision making. Biomarker Tests of Molecularly Targeted Therapies examines opportunities for and challenges to the use of biomarker tests to select optimal therapy and offers recommendations to accelerate progress in this field. This report explores regulatory issues, reimbursement issues, and clinical practice issues related to the clinical development and use of biomarker tests for targeting therapies to patients. Properly validated, appropriately implemented biomarker tests hold the potential to enhance patient care and improve outcomes, and therefore addressing the challenges facing such tests is critical. %0 Book %A Institute of Medicine %E Field, Marilyn J. %E Boat, Thomas F. %T Rare Diseases and Orphan Products: Accelerating Research and Development %@ 978-0-309-15806-0 %D 2010 %U https://nap.nationalacademies.org/catalog/12953/rare-diseases-and-orphan-products-accelerating-research-and-development %> https://nap.nationalacademies.org/catalog/12953/rare-diseases-and-orphan-products-accelerating-research-and-development %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 442 %X Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development. %0 Book %A National Academies of Sciences, Engineering, and Medicine %E Olson, Steve %T Implications of the California Wildfires for Health, Communities, and Preparedness: Proceedings of a Workshop %@ 978-0-309-49987-3 %D 2020 %U https://nap.nationalacademies.org/catalog/25622/implications-of-the-california-wildfires-for-health-communities-and-preparedness %> https://nap.nationalacademies.org/catalog/25622/implications-of-the-california-wildfires-for-health-communities-and-preparedness %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 160 %X California and other wildfire-prone western states have experienced a substantial increase in the number and intensity of wildfires in recent years. Wildlands and climate experts expect these trends to continue and quite likely to worsen in coming years. Wildfires and other disasters can be particularly devastating for vulnerable communities. Members of these communities tend to experience worse health outcomes from disasters, have fewer resources for responding and rebuilding, and receive less assistance from state, local, and federal agencies. Because burning wood releases particulate matter and other toxicants, the health effects of wildfires extend well beyond burns. In addition, deposition of toxicants in soil and water can result in chronic as well as acute exposures. On June 4-5, 2019, four different entities within the National Academies of Sciences, Engineering, and Medicine held a workshop titled Implications of the California Wildfires for Health, Communities, and Preparedness at the Betty Irene Moore School of Nursing at the University of California, Davis. The workshop explored the population health, environmental health, emergency preparedness, and health equity consequences of increasingly strong and numerous wildfires, particularly in California. This publication is a summary of the presentations and discussion of the workshop. %0 Book %A Institute of Medicine %E Brachman, Philip S. %E O'Maonaigh, Heather C. %E Miller, Richard N. %T Perspectives on the Department of Defense Global Emerging Infections Surveillance and Response System: A Program Review %@ 978-0-309-07635-7 %D 2001 %U https://nap.nationalacademies.org/catalog/10203/perspectives-on-the-department-of-defense-global-emerging-infections-surveillance-and-response-system %> https://nap.nationalacademies.org/catalog/10203/perspectives-on-the-department-of-defense-global-emerging-infections-surveillance-and-response-system %I The National Academies Press %C Washington, DC %G English %K Health and Medicine %P 214 %X Perspectives on the Department of Defense Global Emerging Infections Surveillance and Response System: A Program Review describes the capacity, quality, and effectiveness of the international and domestic facilities and programs that are a part of a DoD system to monitor and address emerging infectious diseases globally. The committee concludes that the goals of the system are in U.S. military, U.S. civilian, and global public health interests and that substantial progress has been made toward achieving system goals. %0 Book %A Institute of Medicine %E Kelley, William N. %E Randolph, Mark A. %T Careers in Clinical Research: Obstacles and Opportunities %@ 978-0-309-04890-3 %D 1994 %U https://nap.nationalacademies.org/catalog/2142/careers-in-clinical-research-obstacles-and-opportunities %> https://nap.nationalacademies.org/catalog/2142/careers-in-clinical-research-obstacles-and-opportunities %I The National Academies Press %C Washington, DC %G English %K Education %K Health and Medicine %P 344 %X Transforming biological discoveries into medical treatment calls for a cadre of health professionals skilled in patient-oriented research. Yet many factors discourage talented persons from choosing clinical research as a profession. This new volume lays out the problem in detail, with specific recommendations to the federal government, the biotechnology and pharmaceutical industries, professional organizations, the health care industry, organized medicine, and the nation's universities and academic health centers. The volume explores How clinical research is conducted, what human resources are available, and what research opportunities lie ahead. Why health professionals become discouraged about clinical research. How the educational system has failed in this area and what programs stand out as models. How funding affects the supply of researchers. This practical book will be of immediate interest to public and private agencies funding research, research administrators, medical educators, health professionals, and those pursuing a career in clinical investigation.