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The Economics of Genomic Medicine

by Institute of Medicine Steve Olson Board on Health Sciences Policy Adam C. Berger Roundtable on Translating Genomic-Based Research for Health

The sequencing of the human genome and the identification of links between specific genetic variants and diseases have led to tremendous excitement over the potential of genomics to direct patient treatment toward more effective or less harmful interventions. Still, the use of whole genome sequencing challenges the traditional model of medical care where a test is ordered only when there is a clear indication for its use and a path for downstream clinical action is known. This has created a tension between experts who contend that using this information is premature and those who believe that having such information will empower health care providers and patients to make proactive decisions regarding lifestyle and treatment options. In addition, some stakeholders are concerned that genomic technologies will add costs to the health care system without providing commensurate benefits, and others think that health care costs could be reduced by identifying unnecessary or ineffective treatments. Economic models are frequently used to anticipate the costs and benefits of new health care technologies, policies, and regulations. Economic studies also have been used to examine much more specific issues, such as comparing the outcomes and cost effectiveness of two different drug treatments for the same condition. These kinds of analyses offer more than just predictions of future health care costs. They provide information that is valuable when implementing and using new technologies. Unfortunately, however, these economic assessments are often limited by a lack of data on which to base the examination. This particularly affects health economics, which includes many factors for which current methods are inadequate for assessing, such as personal utility, social utility, and patient preference. To understand better the health economic issues that may arise in the course of integrating genomic data into health care, the Roundtable on Translating Genomic-Based Research for Health hosted a workshop in Washington, DC, on July 17-18, 2012, that brought together economists, regulators, payers, biomedical researchers, patients, providers, and other stakeholders to discuss the many factors that may influence this implementation. The workshop was one of a series that the roundtable has held on this topic, but it was the first focused specifically on economic issues. The Economics of Genomic Medicine summarizes this workshop.

Educating the Student Body

by Institute of Medicine Food and Nutrition Board Heather D. Cook Committee on Physical Activity and Physical Education in the School Environment Harold W. Kohl III

Physical inactivity is a key determinant of health across the lifespan. A lack of activity increases the risk of heart disease, colon and breast cancer, diabetes mellitus, hypertension, osteoporosis, anxiety and depression and others diseases. Emerging literature has suggested that in terms of mortality, the global population health burden of physical inactivity approaches that of cigarette smoking. The prevalence and substantial disease risk associated with physical inactivity has been described as a pandemic. The prevalence, health impact, and evidence of changeability all have resulted in calls for action to increase physical activity across the lifespan. In response to the need to find ways to make physical activity a health priority for youth, the Institute of Medicine's Committee on Physical Activity and Physical Education in the School Environment was formed. Its purpose was to review the current status of physical activity and physical education in the school environment, including before, during, and after school, and examine the influences of physical activity and physical education on the short and long term physical, cognitive and brain, and psychosocial health and development of children and adolescents. Educating the Student Body makes recommendations about approaches for strengthening and improving programs and policies for physical activity and physical education in the school environment. This report lays out a set of guiding principles to guide its work on these tasks. These included: recognizing the benefits of instilling life-long physical activity habits in children; the value of using systems thinking in improving physical activity and physical education in the school environment; the recognition of current disparities in opportunities and the need to achieve equity in physical activity and physical education; the importance of considering all types of school environments; the need to take into consideration the diversity of students as recommendations are developed. This report will be of interest to local and national policymakers, school officials, teachers, and the education community, researchers, professional organizations, and parents interested in physical activity, physical education, and health for school-aged children and adolescents.

Elder Abuse and Its Prevention

by Institute of Medicine National Research Council Board on Global Health Forum on Global Violence Prevention Rachel M. Taylor

Elder Abuse and Its Prevention is the summary of a workshop convened in April 2013 by the Institute of Medicine's Forum on Global Violence Prevention. Using an ecological framework, this workshop explored the burden of elder abuse around the world, focusing on its impacts on individuals, families, communities, and societies. Additionally, the workshop addressed occurrences and co-occurrences of different types of abuse, including physical, sexual, emotional, and financial, as well as neglect. The ultimate objective was to illuminate promising global and multisectoral evidence-based approaches to the prevention of elder maltreatment. While the workshop covered scope and prevalence and unique characteristics of abuse, the intention was to move beyond what is known about elder abuse to foster discussions about how to improve prevention, intervention, and mitigation of the victims' needs, particularly through collaborative efforts. The workshop discussions included innovative intervention models and opportunities for prevention across sectors and settings. Violence and related forms of abuse against elders is a global public health and human rights problem with far-reaching consequences, resulting in increased death, disability, and exploitation with collateral effects on well-being. Data suggest that at least 10 percent of elders in the United States are victims of elder maltreatment every year. In low- and middle-income countries, where the burden of violence is the greatest, the figure is likely even higher. In addition, elders experiencing risk factors such as diminishing cognitive function, caregiver dependence, and social isolation are more vulnerable to maltreatment and underreporting. As the world population of adults aged 65 and older continues to grow, the implications of elder maltreatment for health care, social welfare, justice, and financial systems are great. However, despite the magnitude of global elder maltreatment, it has been an underappreciated public health problem. Elder Abuse and Its Prevention discusses the prevalence and characteristics of elder abuse around the world, risk factors for abuse and potential adverse health outcomes, and contextually specific factors, such as culture and the role of the community.

Emerging Infectious Diseases from the Global to the Local Perspective: A Summary of a Workshop of the Forum on Emerging Infections

by Institute of Medicine

In October 1999, the Forum on Emerging Infections of the Institute of Medicine convened a two-day workshop titled “International Aspects of Emerging Infections.” Key representatives from the international community explored the forces that drive emerging infectious diseases to prominence. Representatives from the Americas, Africa, Asia and the Pacific, and Europe made formal presentations and engaged in panel discussions. Emerging Infectious Diseases from the Global to the Local Perspective includes summaries of the formal presentations and suggests an agenda for future action. The topics addressed cover a wide range of issues, including trends in the incidence of infectious diseases around the world, descriptions of the wide variety of factors that contribute to the emergence and reemergence of these diseases, efforts to coordinate surveillance activities and responses within and across borders, and the resource, research, and international needs that remain to be addressed.

Ending Neglect: The Elimination of Tuberculosis in the United States

by Institute of Medicine

Tuberculosis emerged as an epidemic in the 1600s, began to decline as sanitation improved in the 19th century, and retreated further when effective therapy was developed in the 1950s. TB was virtually forgotten until a recent resurgence in the U.S. and around the world-ominously, in forms resistant to commonly used medicines.What must the nation do to eliminate TB? The distinguished committee from the Institute of Medicine offers recommendations in the key areas of epidemiology and prevention, diagnosis and treatment, funding and organization of public initiatives, and the U.S. role worldwide. The panel also focuses on how to mobilize policy makers and the public to effective action.The book provides important background on the pathology of tuberculosis, its history and status in the U.S., and the public and private response.The committee explains how the U.S. can act with both self-interest and humanitarianism in addressing the worldwide incidence of TB.

Engaging the Public in Critical Disaster Planning and Decision Making

by Institute of Medicine Board on Health Sciences Policy Forum on Medical and Public Health Preparedness for Catastrophic Events Theresa Wizemann Bruce Altevogt Megan Reeve

Engaging the Public in Critical Disaster Planning and Decision Making is the summary of a workshop held in March 2013 to discuss the key principles of public engagement during the development of disaster plans, the response phase, and during the dissemination phase when interested community partners and the general public are informed of the policies that have been adopted. Presenters provided specific examples of resources to assist jurisdictions in planning public engagement activities as well as challenges experienced and potential solutions. This report introduces key principles of public engagement, provides practical guidance on how to plan and implement a public engagement activity, and presents tools to facilitate planning.

Enhancing Data Systems to Improve the Quality of Cancer Care

by Institute of Medicine

One of the barriers to improving the quality of cancer care in the United States is the inadequacy of data systems. Out-of-date or incomplete information about the performance of doctors, hospitals, health plans, and public agencies makes it hard to gauge the quality of care. Augmenting today's data systems could start to fill the gap.This report examines the strengths and weaknesses of current systems and makes recommendations for enhancing data systems to improve the quality of cancer care. The board's recommendations fall into three key areas: Enhance key elements of the data system infrastructure (i.e., quality-of-care measures, cancer registries and databases, data collection technologies, and analytic capacity). Expand support for analyses of quality of cancer care using existing data systems. Monitor the effectiveness of data systems to promote quality improvement within health systems.

Enhancing Food Safety: The Role of the Food and Drug Administration

by Institute of Medicine National Research Council of the National Academies

Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.

Ensuring Quality Cancer Care

by Institute of Medicine National Research Council

We all want to believe that when people get cancer, they will receive medical care of the highest quality. Even as new scientific breakthroughs are announced, though, many cancer patients may be getting the wrong care, too little care, or too much care, in the form of unnecessary procedures.How close is American medicine to the ideal of quality cancer care for every person with cancer? Ensuring Quality Cancer Care provides a comprehensive picture of how cancer care is delivered in our nation, from early detection to end-of-life issues. The National Cancer Policy Board defines quality care and recommends how to monitor, measure, and extend quality care to all people with cancer. Approaches to accountability in health care are reviewed.What keeps people from getting care? The book explains how lack of medical coverage, social and economic status, patient beliefs, physician decision-making, and other factors can stand between the patient and the best possible care. The board explores how cancer care is shaped by the current focus on evidence-based medicine, the widespread adoption of managed care, where services are provided, and who provides care. Specific shortfalls in the care of breast and prostate cancer are identified. A status report on health services research is included.Ensuring Quality Cancer Care offers wide-ranging data and information in clear context. As the baby boomers approach the years when most cancer occurs, this timely volume will be of special interest to health policy makers, public and private healthcare purchasers, medical professionals, patient advocates, researchers, and people with cancer.

Ensuring Quality Cancer Care through the Oncology Workforce: Sustaining Care in the 21st Century

by Institute of Medicine

The American Society of Clinical Oncology (ASCO) predicts that by 2020, there will be an 81 percent increase in people living with or surviving cancer, but only a 14 percent increase in the number of practicing oncologists. As a result, there may be too few oncologists to meet the population's need for cancer care. To help address the challenges in overcoming this potential crisis of cancer care, the National Cancer Policy Forum of the Institute of Medicine (IOM) convened the workshop Ensuring Quality Cancer Care through the Oncology Workforce: Sustaining Care in the 21st Century in Washington, DC on October 20 and 21, 2008.

Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age

by Institute of Medicine

As digital technologies are expanding the power and reach of research, they are also raising complex issues. These include complications in ensuring the validity of research data; standards that do not keep pace with the high rate of innovation; restrictions on data sharing that reduce the ability of researchers to verify results and build on previous research; and huge increases in the amount of data being generated, creating severe challenges in preserving that data for long-term use. Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age examines the consequences of the changes affecting research data with respect to three issues - integrity, accessibility, and stewardship-and finds a need for a new approach to the design and the management of research projects. The report recommends that all researchers receive appropriate training in the management of research data, and calls on researchers to make all research data, methods, and other information underlying results publicly accessible in a timely manner. The book also sees the stewardship of research data as a critical long-term task for the research enterprise and its stakeholders. Individual researchers, research institutions, research sponsors, professional societies, and journals involved in scientific, engineering, and medical research will find this book an essential guide to the principles affecting research data in the digital age.

Environmental Decisions in the Face of Uncertainty

by Institute of Medicine Committee on Decision Making Under Uncertainty Board on Population Health and Public Health Practice

The U.S. Environmental Protection Agency (EPA) is one of several federal agencies responsible for protecting Americans against significant risks to human health and the environment. As part of that mission, EPA estimates the nature, magnitude, and likelihood of risks to human health and the environment; identifies the potential regulatory actions that will mitigate those risks and protect public health1 and the environment; and uses that information to decide on appropriate regulatory action. Uncertainties, both qualitative and quantitative, in the data and analyses on which these decisions are based enter into the process at each step. As a result, the informed identification and use of the uncertainties inherent in the process is an essential feature of environmental decision making. EPA requested that the Institute of Medicine (IOM) convene a committee to provide guidance to its decision makers and their partners in states and localities on approaches to managing risk in different contexts when uncertainty is present. It also sought guidance on how information on uncertainty should be presented to help risk managers make sound decisions and to increase transparency in its communications with the public about those decisions. Given that its charge is not limited to human health risk assessment and includes broad questions about managing risks and decision making, in this report the committee examines the analysis of uncertainty in those other areas in addition to human health risks. Environmental Decisions in the Face of Uncertainty explains the statement of task and summarizes the findings of the committee.

Environmental Health Sciences Decision Making: Risk Management, Evidence, and Ethics

by Institute of Medicine

Environmental health decision making can be a complex undertaking, as there is the need to navigate and find balance among three core elements: science, policy, and the needs of the American public. Policy makers often grapple with how to make appropriate decisions when the research is uncertain. The challenge for the policy maker is to make the right decision with the best available data in a transparent process. The Environmental Health Sciences Decision Making workshop, the first in a series, was convened to inform the Roundtable on Environmental Health Sciences, Research, and Medicine on emerging issues in risk management, "weight of evidence," and ethics that influence environmental health decision making. The workshop, summarized in this volume, included an overview of the principles underlying decision making, the role of evidence and challenges for vulnerable populations, and ethical issues of conflict of interest, scientific integrity, and transparency. The workshop engaged science interest groups, industry, government, and the academic sector.

Envisioning the National Health Care Quality Report

by Institute of Medicine

How good is the quality of health care in the United States? Is quality improving? Or is it suffering? While the average person on the street can follow the state of the economy with economic indicators, we do not have a tool that allows us to track trends in health care quality. Beginning in 2003, the Agency for Healthcare Research and Quality (AHRQ) will produce an annual report on the national trends in the quality of health care delivery in the United States. AHRQ commissioned the Institute of Medicine (IOM) to help develop a vision for this report that will allow national and state policy makers, providers, consumers, and the public at large to track trends in health care quality. Envisioning the National Health Care Quality Reportoffers a framework for health care quality, specific examples of the types of measures that should be included in the report, suggestions on the criteria for selecting measures, as well as advice on reaching the intended audiences. Its recommendations could help the national health care quality report to become a mainstay of our nation's effort to improve health care.

Evaluating Obesity Prevention Efforts

by Institute of Medicine Food and Nutrition Board Committee on Evaluating Progress of Obesity Prevention Effort

Obesity poses one of the greatest public health challenges of the 21st century, creating serious health, economic, and social consequences for individuals and society. Despite acceleration in efforts to characterize, comprehend, and act on this problem, including implementation of preventive interventions, further understanding is needed on the progress and effectiveness of these interventions. Evaluating Obesity Prevention Efforts develops a concise and actionable plan for measuring the nation's progress in obesity prevention efforts--specifically, the success of policy and environmental strategies recommended in the 2012 IOM report Accelerating Progress in Obesity Prevention: Solving the Weight of the Nation. This book offers a framework that will provide guidance for systematic and routine planning, implementation, and evaluation of the advancement of obesity prevention efforts. This framework is for specific use with the goals and strategies from the 2012 report and can be used to assess the progress made in every community and throughout the country, with the ultimate goal of reducing the obesity epidemic. It offers potentially valuable guidance in improving the quality and effect of the actions being implemented. The recommendations of Evaluating Obesity Prevention Efforts focus on efforts to increase the likelihood that actions taken to prevent obesity will be evaluated, that their progress in accelerating the prevention of obesity will be monitored, and that the most promising practices will be widely disseminated.

Evaluating Occupational Health and Safety Research Programs: Framework and Next Steps

by Institute of Medicine National Research Council of the National Academies

Each year, approximately 5,000 fatal work-related injuries and 4 million non-fatal injuries and illnesses occur in the United States. This number represents both unnecessary human suffering and high economic costs. In order to assist in better evaluating workplace safety and create safer work environments, the Institute of Medicine conducted a series of evaluations of the National Institute for Occupational Safety and Health (NIOSH) research programs, assessing the relevance and impact of NIOSH's work on improving worker safety and health.

Evaluating Welfare Reform in an Era of Transition

by Institute of Medicine

Reform of welfare is one of the nation's most contentious issues, with debate often driven more by politics than by facts and careful analysis. Evaluating Welfare Reform in an Era of Transition identifies the key policy questions for measuring whether our changing social welfare programs are working, reviews the available studies and research, and recommends the most effective ways to answer those questions.This book discusses the development of welfare policy, including the landmark 1996 federal law that devolved most of the responsibility for welfare policies and their implementation to the states. A thorough analysis of the available research leads to the identification of gaps in what is currently known about the effects of welfare reform.Evaluating Welfare Reform in an Era of Transition specifies what-and why-we need to know about the response of individual states to the federal overhaul of welfare and the effects of the many changes in the nation's welfare laws, policies, and practices.With a clear approach to a variety of issues, Evaluating Welfare Reform in an Era of Transition will be important to policy makers, welfare administrators, researchers, journalists, and advocates on all sides of the issue.

Evaluation of PEPFAR

by Institute of Medicine Board on Children, Youth, and Families Division of Behavioral and Social Sciences and Education Board on Global Health Committee on the Outcome and Impact Evaluation of Global HIV/AIDS Programs Implemented Under the Lantos-Hyde Act of 2008

The U.S. government supports programs to combat global HIV/AIDS through an initiative that is known as the President's Emergency Plan for AIDS Relief (PEPFAR). This initiative was originally authorized in the U.S. Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 and focused on an emergency response to the HIV/AIDS pandemic to deliver lifesaving care and treatment in low- and middle-income countries (LMICs) with the highest burdens of disease. It was subsequently reauthorized in the Tom Lantos and Henry J. Hyde U.S. Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 (the Lantos-Hyde Act). Evaluation of PEPFAR makes recommendations for improving the U.S. government's bilateral programs as part of the U.S. response to global HIV/AIDS. The overall aim of this evaluation is a forward-looking approach to track and anticipate the evolution of the U.S. response to global HIV to be positioned to inform the ability of the U.S. government to address key issues under consideration at the time of the report release.

The Evidence for Violence Prevention Across the Lifespan and Around the World

by Institute of Medicine National Research Council Board on Global Health Forum on Global Violence Prevention Rachel M. Taylor Leigh Carroll Megan M. Perez

The Evidence for Violence Prevention Across the Lifespan and Around the World is the summary of a workshop convened in January 2013 by the Institute of Medicine's Forum on Global Violence Prevention to explore value and application of the evidence for violence prevention across the lifespan and around the world. As part of the Forum's mandate is to engage in multisectoral, multidirectional dialogue that explores crosscutting approaches to violence prevention, this workshop examined how existing evidence for violence prevention can continue to be expanded, disseminated, and implemented in ways that further the ultimate aims of improved individual well-being and safer communities. This report examines violence prevention interventions that have been proven to reduce different types of violence (e.g., child and elder abuse, intimate partner and sexual violence, youth and collective violence, and self-directed violence), identifies the common approaches most lacking in evidentiary support, and discusses ways that proven effective interventions can be integrated or otherwise linked with other prevention programs.

The Experimental Program to Stimulate Competitive Research

by Institute of Medicine National Academy Of Sciences National Academy of Engineering Committee on Science, Engineering, and Public Policy Policy and Global Affairs Committee to Evaluate the Experimental Program to Stimulate Competitive Research (EPSCoR) and Similar Federal Agency Programs

The primary federal program designed to ensure that all states are capable of participating the nation's research enterprise fall under the general rubric of the Experimental Program to Stimulate Competitive Research (EPSCOR). The National Science Foundation (NSF), Department of Energy, Department of Agriculture, and National Aeronautics and Space Administration have active EPSCOR programs. Since its inaugural year in 1979, the EPSCOR program has grown from funding programs in five states to awarding funding to 31 states in 2012. The Experimental Program to Stimulate Competitive Research assesses the effectiveness of EPSCOR and similar federal agency programs in improving national research capabilities, promoting an equitable distribution of research funding, and integrating their efforts with other initiatives designed to strengthen the nation's research capacity. This report also looks at the effectiveness of EPSCOR states in using awards to develop science engineering research and education, as well a science and engineering infrastructure within their state. The Experimental Program to Stimulate Competitive Research makes recommendations for improvement for each agency to create a more focused program with greater impact.

Experiments in International Benchmarking of US Research Fields

by Institute of Medicine National Academy of Engineering National Academy of Science

Information on the Experiments in International Benchmarking of US Research Fields

Exploring the Biological Contributions to Human Health: Does Sex Matter?

by Institute of Medicine

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.

Exposure of the American People to Iodine-131 from Nevada Nuclear-bomb Tests: Review of the National Cancer Institute Report and Public Health Implications

by Institute of Medicine National Research Council

In 1997, after more than a decade of research, the National Cancer Institute (NCI) released a report which provided their assessment of radiation exposures that Americans may have received from radioactive iodine released from the atomic bomb tests conducted in Nevada during the 1950s and early 1960s. This book provides an evaluation of the soundness of the methodology used by the NCI study to estimate: Past radiation doses. Possible health consequences of exposure to iodine-131.Implications for clinical practice. Possible public health strategies--such as systematic screening for thyroid cancer--to respond to the exposures. In addition, the book provides an evaluation of the NCI estimates of the number of thyroid cancers that might result from the nuclear testing program and provides guidance on approaches the U.S. government might use to communicate with the public about Iodine-131 exposures and health risks.

Extending Medicare Coverage for Preventive and Other Services

by Institute of Medicine

The National Academies Press (NAP)--publisher for the National Academies--publishes more than 200 books a year offering the most authoritative views, definitive information, and groundbreaking recommendations on a wide range of topics in science, engineering, and health. Our books are unique in that they are authored by the nation's leading experts in every scientific field.

Extending Medicare Reimbursement in Clinical Trials

by Institute of Medicine

The National Academies Press (NAP)--publisher for the National Academies--publishes more than 200 books a year offering the most authoritative views, definitive information, and groundbreaking recommendations on a wide range of topics in science, engineering, and health. Our books are unique in that they are authored by the nation's leading experts in every scientific field.

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