TY - BOOK AU - Institute of Medicine TI - Ethical Issues in Studying the Safety of Approved Drugs: A Letter Report DO - 10.17226/12948 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12948/ethical-issues-in-studying-the-safety-of-approved-drugs-a PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - The FDA requested that the IOM examine the ethical and informed consent issues that should be considered when conducting clinical trials to evaluate drug safety. This report outlines when and how the FDA should conduct clinical trials to protect the public's health and the health of trial participants. ER - TY - BOOK AU - Institute of Medicine TI - Research Priorities for Assessing Health Effects from the Gulf of Mexico Oil Spill: A Letter Report SN - DO - 10.17226/13036 PY - 2010 UR - https://nap.nationalacademies.org/catalog/13036/research-priorities-for-assessing-health-effects-from-the-gulf-of-mexico-oil-spill PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - It is as yet uncertain how the Gulf of Mexico oil spill will affect the health of clean-up workers and volunteers, residents, and visitors in the Gulf. The IOM recommends that the U.S. Department of Health and Human Services focus on researching psychological and behavioral health, exposure information to oil and dispersants, seafood safety, communication methods for health studies, and methods for conducting research in order to better understand and mitigate the effects on human health for this oil spill and for future disasters. ER - TY - BOOK AU - Institute of Medicine A2 - Lynn Goldman A2 - Abigail Mitchell A2 - Margie Patlak TI - Review of the Proposal for the Gulf Long-Term Follow-Up Study: Highlights from the September 2010 Workshop: Workshop Report SN - DO - 10.17226/13025 PY - 2010 UR - https://nap.nationalacademies.org/catalog/13025/review-of-the-proposal-for-the-gulf-long-term-follow-up-study PB - The National Academies Press CY - Washington, DC LA - English KW - Environment and Environmental Studies AB - The Gulf of Mexico oil spill is unprecedented not only in its size but also in the use of chemical dispersants and controlled burns to remove the oil. The National Institute of Environmental Health Sciences (NIEHS) is designing a study to investigate the health effects on clean-up workers. The IOM held a workshop to review and comment on NIEHS'o;s study protocol. ER - TY - BOOK AU - Institute of Medicine A2 - Karen M. Anderson TI - Demographic Changes, a View from California: Implications for Framing Health Disparities: Workshop Summary SN - DO - 10.17226/12830 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12830/demographic-changes-a-view-from-california-implications-for-framing-health PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - The IOM held a workshop on July 28, 2008, to examine strategies for discussing health disparities in ways that engage the public and motivate change. Speakers focused on health disparities in California, which continues to see dramatic demographic shifts. ER - TY - BOOK AU - Institute of Medicine A2 - Cori Vancheri TI - The Safe Use Initiative and Health Literacy: Workshop Summary SN - DO - 10.17226/12975 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12975/the-safe-use-initiative-and-health-literacy-workshop-summary PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Every year at least 1.5 million people suffer adverse effects from medication. These problems occur because people misunderstand labels, are unaware of drug interactions, or otherwise use medication improperly. The Food and Drug Administration's Safe Use Initiative seeks to identify preventable medication risks and develop solutions to them. The IOM held a workshop to discuss the FDA's Safe Use Initiative and other efforts to improve drug labeling and safety. ER - TY - BOOK AU - Institute of Medicine A2 - Theresa Wizemann TI - Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report SN - DO - 10.17226/12960 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12960/public-health-effectiveness-of-the-fda-510k-clearance-process-balancing PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop. ER - TY - BOOK AU - Institute of Medicine TI - Women's Health Research: Progress, Pitfalls, and Promise SN - DO - 10.17226/12908 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12908/womens-health-research-progress-pitfalls-and-promise PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Even though slightly over half of the U.S. population is female, medical research historically has neglected the health needs of women. However, over the past two decades, there have been major changes in government support of women's health research—in policies, regulations, and the organization of research efforts. To assess the impact of these changes, Congress directed the Department of Health and Human Services (HHS) to ask the IOM to examine what has been learned from that research and how well it has been put into practice as well as communicated to both providers and women. Women's Health Research finds that women's health research has contributed to significant progress over the past 20 years in lessening the burden of disease and reducing deaths from some conditions, while other conditions have seen only moderate change or even little or no change. Gaps remain, both in research areas and in the application of results to benefit women in general and across multiple population groups. Given the many and significant roles women play in our society, maintaining support for women's health research and enhancing its impact are not only in the interest of women, they are in the interest of us all. ER - TY - BOOK AU - Institute of Medicine TI - HIV Screening and Access to Care: Exploring Barriers and Facilitators to Expanded HIV Testing SN - DO - 10.17226/12932 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12932/hiv-screening-and-access-to-care-exploring-barriers-and-facilitators PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - More than 200,000 people in the United States living with HIV/AIDS do not know they are infected. The Institute of Medicine's Committee on HIV Screening and Access to Care held a workshop and reviewed literature to explore barriers and facilitators to more widespread HIV testing. This book contains the committee's conclusions. ER - TY - BOOK AU - Institute of Medicine TI - A Population-Based Policy and Systems Change Approach to Prevent and Control Hypertension SN - DO - 10.17226/12819 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12819/a-population-based-policy-and-systems-change-approach-to-prevent-and-control-hypertension PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Hypertension is one of the leading causes of death in the United States, affecting nearly one in three Americans. It is prevalent in adults and endemic in the older adult population. Hypertension is a major contributor to cardiovascular morbidity and disability. Although there is a simple test to diagnose hypertension and relatively inexpensive drugs to treat it, the disease is often undiagnosed and uncontrolled. A Population-Based Policy and Systems Change Approach to the Prevention and Control Hypertension identifies a small set of high-priority areas in which public health officials can focus their efforts to accelerate progress in hypertension reduction and control. It offers several recommendations that embody a population-based approach grounded in the principles of measurement, system change, and accountability. The recommendations are designed to shift current hypertension reduction strategies from an individual-based approach to a population-based approach. They are also designed to improve the quality of care provided to individuals with hypertension and to strengthen the Center for Disease Control and Prevention's leadership in seeking a reduction in the sodium intake in the American diet to meet dietary guidelines. The book is an important resource for federal public health officials and organizations, especially the Center for Disease Control and Prevention, as well as medical professionals and community health workers. ER - TY - BOOK AU - Institute of Medicine A2 - Heather M. Colvin A2 - Abigail E. Mitchell TI - Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C SN - DO - 10.17226/12793 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12793/hepatitis-and-liver-cancer-a-national-strategy-for-prevention-and PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - The global epidemic of hepatitis B and C is a serious public health problem. Hepatitis B and C are the major causes of chronic liver disease and liver cancer in the world. In the next 10 years, 150,000 people in the United States will die from liver disease or liver cancer associated with chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infections. Today, between 800,000 and 1.4 million people in the United States have chronic hepatitis B and between 2.7 and 3.9 million have chronic hepatitis C. People most at risk for hepatitis B and C often are the least likely to have access to medical services. Reducing the rates of illness and death associated with these diseases will require greater awareness and knowledge among health care workers, improved identification of at-risk people, and improved access to medical care. Hepatitis B is a vaccine-preventable disease. Although federal public health officials recommend that all newborns, children, and at-risk adults receive the vaccine, about 46,000 new acute cases of the HBV infection emerge each year, including 1,000 in infants who acquire the infection during birth from their HBV-positive mothers. Unfortunately, there is no vaccine for hepatitis C, which is transmitted by direct exposure to infectious blood. Hepatitis and Liver Cancer identifies missed opportunities related to the prevention and control of HBV and HCV infections. The book presents ways to reduce the numbers of new HBV and HCV infections and the morbidity and mortality related to chronic viral hepatitis. It identifies priorities for research, policy, and action geared toward federal, state, and local public health officials, stakeholder, and advocacy groups and professional organizations. ER - TY - BOOK AU - Institute of Medicine TI - Priorities for the National Vaccine Plan SN - DO - 10.17226/12796 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12796/priorities-for-the-national-vaccine-plan PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Vaccination is a fundamental component of preventive medicine and public health. The use of vaccines to prevent infectious diseases has resulted in dramatic decreases in disease, disability, and death in the United States and around the world. The current political, economic, and social environment presents both opportunities for and challenges to strengthening the U.S. system for developing, manufacturing, regulating, distributing, funding, and administering safe and effective vaccines for all people. Priorities for the National Vaccine Plan examines the extraordinarily complex vaccine enterprise, from research and development of new vaccines to financing and reimbursement of immunization services. Priorities for the National Vaccine Plan examines the extraordinarily complex vaccine enterprise, from research and development of new vaccines to financing and reimbursement of immunization services. The book makes recommendations about priority actions in the update to the National Vaccine Plan that are intended to achieve the objectives of disease prevention and enhancement of vaccine safety. It is centered on the plan's five goals in the areas of vaccine development, safety, communication, supply and use, and global health. ER - TY - BOOK AU - Institute of Medicine TI - Secondhand Smoke Exposure and Cardiovascular Effects: Making Sense of the Evidence SN - DO - 10.17226/12649 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12649/secondhand-smoke-exposure-and-cardiovascular-effects-making-sense-of-the PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Data suggest that exposure to secondhand smoke can result in heart disease in nonsmoking adults. Recently, progress has been made in reducing involuntary exposure to secondhand smoke through legislation banning smoking in workplaces, restaurants, and other public places. The effect of legislation to ban smoking and its effects on the cardiovascular health of nonsmoking adults, however, remains a question. Secondhand Smoke Exposure and Cardiovascular Effects reviews available scientific literature to assess the relationship between secondhand smoke exposure and acute coronary events. The authors, experts in secondhand smoke exposure and toxicology, clinical cardiology, epidemiology, and statistics, find that there is about a 25 to 30 percent increase in the risk of coronary heart disease from exposure to secondhand smoke. Their findings agree with the 2006 Surgeon General's Report conclusion that there are increased risks of coronary heart disease morbidity and mortality among men and women exposed to secondhand smoke. However, the authors note that the evidence for determining the magnitude of the relationship between chronic secondhand smoke exposure and coronary heart disease is not very strong. Public health professionals will rely upon Secondhand Smoke Exposure and Cardiovascular Effects for its survey of critical epidemiological studies on the effects of smoking bans and evidence of links between secondhand smoke exposure and cardiovascular events, as well as its findings and recommendations. ER - TY - BOOK AU - National Research Council TI - Accounting for Health and Health Care: Approaches to Measuring the Sources and Costs of Their Improvement SN - DO - 10.17226/12938 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12938/accounting-for-health-and-health-care-approaches-to-measuring-the PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine KW - Behavioral and Social Sciences KW - Surveys and Statistics AB - It has become trite to observe that increases in health care costs have become unsustainable. How best for policy to address these increases, however, depends in part on the degree to which they represent increases in the real quantity of medical services as opposed to increased unit prices of existing services. And an even more fundamental question is the degree to which the increased spending actually has purchased improved health. Accounting for Health and Health Care addresses both these issues. The government agencies responsible for measuring unit prices for medical services have taken steps in recent years that have greatly improved the accuracy of those measures. Nonetheless, this book has several recommendations aimed at further improving the price indices. ER - TY - BOOK AU - Institute of Medicine A2 - Pierre L. Yong A2 - Robert S. Saunders A2 - LeighAnne Olsen TI - The Healthcare Imperative: Lowering Costs and Improving Outcomes: Workshop Series Summary SN - DO - 10.17226/12750 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12750/the-healthcare-imperative-lowering-costs-and-improving-outcomes-workshop-series PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - The United States has the highest per capita spending on health care of any industrialized nation but continually lags behind other nations in health care outcomes including life expectancy and infant mortality. National health expenditures are projected to exceed $2.5 trillion in 2009. Given healthcare's direct impact on the economy, there is a critical need to control health care spending. According to The Health Imperative: Lowering Costs and Improving Outcomes, the costs of health care have strained the federal budget, and negatively affected state governments, the private sector and individuals. Healthcare expenditures have restricted the ability of state and local governments to fund other priorities and have contributed to slowing growth in wages and jobs in the private sector. Moreover, the number of uninsured has risen from 45.7 million in 2007 to 46.3 million in 2008. The Health Imperative: Lowering Costs and Improving Outcomes identifies a number of factors driving expenditure growth including scientific uncertainty, perverse economic and practice incentives, system fragmentation, lack of patient involvement, and under-investment in population health. Experts discussed key levers for catalyzing transformation of the delivery system. A few included streamlined health insurance regulation, administrative simplification and clarification and quality and consistency in treatment. The book is an excellent guide for policymakers at all levels of government, as well as private sector healthcare workers. ER - TY - BOOK AU - National Research Council A2 - Gooloo S. Wunderlich TI - Improving Health Care Cost Projections for the Medicare Population: Summary of a Workshop SN - DO - 10.17226/12985 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12985/improving-health-care-cost-projections-for-the-medicare-population-summary PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine KW - Behavioral and Social Sciences KW - Surveys and Statistics AB - Developing credible short-term and long-term projections of Medicare health care costs is critical for public- and private-sector policy planning, but faces challenges and uncertainties. There is uncertainty not only in the underlying economic and demographic assumptions used in projection models, but also in what a policy modeler assumes about future changes in the health status of the population and the factors affecting health status , the extent and pace of scientific and technological breakthroughs in medical care, the preferences of the population for particular kinds of care, the likelihood that policy makers will alter current law and regulations, and how each of these factors relates to health care costs for the elderly population. Given the substantial growth in the Medicare population and the continued increases in Medicare, Medicaid, and private health insurance spending, the availability of well-specified models and analyses that can provide useful information on the likely cost implications of health care policy alternatives is essential. It is therefore timely to review the capabilities and limitations of extant health care cost models and to identify areas for research that offer the most promise to improve modeling, not only of current U.S. health care programs, but also of policy alternatives that may be considered in the coming years. The National Research Council conducted a public workshop focusing on areas of research needed to improve health care cost projections for the Medicare population, and on the strengths and weaknesses of competing frameworks for projecting health care expenditures for the elderly. The workshop considered major classes of projection and simulation models that are currently used and the underlying data sources and research inputs for these models. It also explored areas in which additional research and data are needed to inform model development and health care policy analysis more broadly. The workshop, summarized in this volume, drew people from a wide variety of disciplines and perspectives, including federal agencies, academia, and nongovernmental organizations. ER - TY - BOOK AU - Institute of Medicine A2 - Pierre L. Yong A2 - LeighAnne Olsen A2 - J. Michael McGinnis TI - Value in Health Care: Accounting for Cost, Quality, Safety, Outcomes, and Innovation: Workshop Summary SN - DO - 10.17226/12566 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12566/value-in-health-care-accounting-for-cost-quality-safety-outcomes PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - The United States has the highest per capita spending on health care of any industrialized nation. Yet despite the unprecedented levels of spending, harmful medical errors abound, uncoordinated care continues to frustrate patients and providers, and U.S. healthcare costs continue to increase. The growing ranks of the uninsured, an aging population with a higher prevalence of chronic diseases, and many patients with multiple conditions together constitute more complicating factors in the trend to higher costs of care. A variety of strategies are beginning to be employed throughout the health system to address the central issue of value, with the goal of improving the net ratio of benefits obtained per dollar spent on health care. However, despite the obvious need, no single agreed-upon measure of value or comprehensive, coordinated systemwide approach to assess and improve the value of health care exists. Without this definition and approach, the path to achieving greater value will be characterized by encumbrance rather than progress. To address the issues central to defining, measuring, and improving value in health care, the Institute of Medicine convened a workshop to assemble prominent authorities on healthcare value and leaders of the patient, payer, provider, employer, manufacturer, government, health policy, economics, technology assessment, informatics, health services research, and health professions communities. The workshop, summarized in this volume, facilitated a discussion of stakeholder perspectives on measuring and improving value in health care, identifying the key barriers and outlining the opportunities for next steps. ER - TY - BOOK AU - National Research Council A2 - Eileen M. Crimmins A2 - Samuel H. Preston A2 - Barney Cohen TI - International Differences in Mortality at Older Ages: Dimensions and Sources SN - DO - 10.17226/12945 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12945/international-differences-in-mortality-at-older-ages-dimensions-and-sources PB - The National Academies Press CY - Washington, DC LA - English KW - Behavioral and Social Sciences AB - In 1950 men and women in the United States had a combined life expectancy of 68.9 years, the 12th highest life expectancy at birth in the world. Today, life expectancy is up to 79.2 years, yet the country is now 28th on the list, behind the United Kingdom, Korea, Canada, and France, among others. The United States does have higher rates of infant mortality and violent deaths than in other developed countries, but these factors do not fully account for the country's relatively poor ranking in life expectancy. International Differences in Mortality at Older Ages: Dimensions and Sources examines patterns in international differences in life expectancy above age 50 and assesses the evidence and arguments that have been advanced to explain the poor position of the United States relative to other countries. The papers in this deeply researched volume identify gaps in measurement, data, theory, and research design and pinpoint areas for future high-priority research in this area. In addition to examining the differences in mortality around the world, the papers in International Differences in Mortality at Older Ages look at health factors and life-style choices commonly believed to contribute to the observed international differences in life expectancy. They also identify strategic opportunities for health-related interventions. This book offers a wide variety of disciplinary and scholarly perspectives to the study of mortality, and it offers in-depth analyses that can serve health professionals, policy makers, statisticians, and researchers. ER - TY - BOOK AU - Institute of Medicine A2 - Claudia Grossmann A2 - W. Alexander Goolsby A2 - LeighAnne Olsen A2 - J. Michael McGinnis TI - Clinical Data as the Basic Staple of Health Learning: Creating and Protecting a Public Good: Workshop Summary SN - DO - 10.17226/12212 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12212/clinical-data-as-the-basic-staple-of-health-learning-creating PB - The National Academies Press CY - Washington, DC LA - English KW - Health and Medicine AB - Successful development of clinical data as an engine for knowledge generation has the potential to transform health and health care in America. As part of its Learning Health System Series, the Roundtable on Value & Science-Driven Health Care hosted a workshop to discuss expanding the access to and use of clinical data as a foundation for care improvement. ER - TY - BOOK AU - National Research Council A2 - Amy Smith TI - Grand Challenges of Our Aging Society: Workshop Summary SN - DO - 10.17226/12852 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12852/grand-challenges-of-our-aging-society-workshop-summary PB - The National Academies Press CY - Washington, DC LA - English KW - Behavioral and Social Sciences AB - Aging populations are generating both challenges and opportunities for societies around the globe. Increases in longevity and improvements in health raise many questions. What steps can be taken to optimize physical and cognitive health and productivity across the life span? How will older people finance their retirement and health care? What will be the macroeconomic implications of an aging population? How will communities be shaped by the shift in age structure? What global interconnections will affect how each society handles the aging of its population? To address these questions, the National Academies organized a symposium, summarized in the present volume, to determine how best to contribute to an evidence-based dialogue on population aging that will shape policies and programs. Presentations in the fields of biology, public health, medicine, informatics, macroeconomics, finance, urban planning, and engineering approached the challenges of aging from many different angles. The presenters reviewed the current state of knowledge in their respective fields, identifying areas of consensus and controversy and delineating the priority questions for further research and policy development. ER - TY - BOOK AU - Institute of Medicine A2 - Shiriki K. Kumanyika A2 - Lynn Parker A2 - Leslie J. Sim TI - Bridging the Evidence Gap in Obesity Prevention: A Framework to Inform Decision Making SN - DO - 10.17226/12847 PY - 2010 UR - https://nap.nationalacademies.org/catalog/12847/bridging-the-evidence-gap-in-obesity-prevention-a-framework-to PB - The National Academies Press CY - Washington, DC LA - English KW - Food and Nutrition KW - Health and Medicine AB - To battle the obesity epidemic in America, health care professionals and policymakers need relevant, useful data on the effectiveness of obesity prevention policies and programs. Bridging the Evidence Gap in Obesity Prevention identifies a new approach to decision making and research on obesity prevention to use a systems perspective to gain a broader understanding of the context of obesity and the many factors that influence it. ER -