@BOOK{NAP author = "Institute of Medicine", editor = "Claudia Grossmann and Joe Alper", title = "Observational Studies in a Learning Health System: Workshop Summary", isbn = "978-0-309-29081-4", abstract = "Clinical research strains to keep up with the rapid and iterative evolution of medical interventions, clinical practice innovation, and the increasing demand for information on the clinical effectiveness of these advancements. In response to the growing availability of archived and real-time digital health data and the opportunities this data provides for research, as well as the increasing number of studies using prospectively collected clinical data, the Institute of Medicine's Roundtable on Value & Science-Driven Health Care convened a workshop on Observational Studies in a Learning Health System. Participants, including experts from a wide range of disciplines - clinical researchers, statisticians, biostatisticians, epidemiologists, health care informaticians, health care analytics, research funders, health products industry, clinicians, payers, and regulators - explored leading edge approaches to observational studies, charted a course for the use of the growing health data utility, and identified opportunities to advance progress. Workshop speakers and individual participants strove to identify stakeholder needs and barriers to the broader application of observational studies.\nObservational Studies in a Learning Health Systemis the summary of the workshop. This report explores the role of observational studies in the generation of evidence to guide clinical and health policy decisions. The report discusses concepts of rigorous observational study design and analysis, emerging statistical methods, and opportunities and challenges of observational studies to complement evidence from experimental methods, treatment heterogeneity, and effectiveness estimates tailored toward individual patients.", url = "https://nap.nationalacademies.org/catalog/18438/observational-studies-in-a-learning-health-system-workshop-summary", year = 2013, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", title = "Advancing the Framework for Assessing Causality of Health and Welfare Effects to Inform National Ambient Air Quality Standard Reviews", isbn = "978-0-309-69011-9", abstract = "As part of its responsibilities under the Clean Air Act, the U.S. Environmental Protection Agency sets National Ambient Air Quality Standards (NAAQS) for the air pollutants carbon monoxide, lead, oxides of nitrogen, particulate matter, ozone, and sulfur dioxide. EPA uses a \"weight of evidence approach\" to evaluate evidence from scientific studies and describe the causal relationships between these \"criteria pollutants\" and any adverse impacts on human health and on public welfare - including impacts on wildlife, water, forests, agriculture, and climate. The evaluation, called an Integrated Science Assessment, is used to inform standards setting associated with the criteria pollutants.\nThis report, produced at the request of EPA, describes EPAs and several other frameworks for inferring causality of health or welfare effects and the characteristics of evidence useful for forming a causal determination. The report concludes that EPAs causal framework is effective, reliable, and scientifically defensible, provided that key scientific questions are identified and a range of necessary expertise is engaged. More transparency in how EPA integrates evidence could improve confidence in their determinations, and more guidance is needed in the framework on how evidence should be examined for vulnerable groups (e.g., human sub-populations) and sensitive ecosystems or species.", url = "https://nap.nationalacademies.org/catalog/26612/advancing-the-framework-for-assessing-causality-of-health-and-welfare-effects-to-inform-national-ambient-air-quality-standard-reviews", year = 2022, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", title = "Potential Hydrodynamic Impacts of Offshore Wind Energy on Nantucket Shoals Regional Ecology: An Evaluation from Wind to Whales", isbn = "978-0-309-70668-1", abstract = "The transition to renewable energy has spurred many efforts to scale up the U.S. portfolio of efficient clean energy resources, including the development of offshore wind farms. The Nantucket Shoals region off the coast of Massachusetts is the first large scale wind farm installation under development in U.S. waters. To ensure Nantucket Shoals region offshore wind energy installations are being planned, constructed, and developed in an environmentally responsible way, the Bureau of Ocean Energy Management (BOEM) asked the National Academies to evaluate the potential for offshore wind farms in the Nantucket Shoals region to affect oceanic physical processes, and, in turn, how those hydrodynamic alterations might affect local to regional ecosystems. Of particular interest to BOEM are the potential effects of hydrodynamic changes on zooplankton productivity and aggregations, which may affect foraging for the critically endangered North Atlantic right whale.\nThis report found the impacts of offshore wind projects on the North Atlantic right whale and the availability of their prey in the Nantucket Shoals region will likely be difficult to distinguish from the significant impacts of climate change and other influences on the ecosystem. Further study and monitoring of the oceanography and ecology of the Nantucket Shoals region is needed to fully understand the impact of future wind farms. This report recommends the Bureau of Ocean Energy Management, the National Oceanic and Atmospheric Administration, and others should promote observational studies and modeling that will advance understanding of potential hydrodynamic effects and their consequent impacts on ecology in the Nantucket Shoals region during all phases of wind energy development.", url = "https://nap.nationalacademies.org/catalog/27154/potential-hydrodynamic-impacts-of-offshore-wind-energy-on-nantucket-shoals-regional-ecology", year = 2024, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Transportation Research Board and National Academies of Sciences, Engineering, and Medicine", editor = "Darren J. Torbic and Karin M. Bauer and Chris A. Fees and Douglas W. Harwood and Ron Van Houten and John LaPlante and Nathan Roseberry", title = "Recommended Bicycle Lane Widths for Various Roadway Characteristics", abstract = "TRB\u2019s National Cooperative Highway Research Program (NCHRP) Report 766: Recommended Bicycle Lane Widths for Various Roadway Characteristics presents an analysis of the research and design guidance for bicycle lane widths on existing travel lane widths and parking lane widths. The conclusions are most applicable to urban and suburban roadways with level grade and a posted speed limit of 30 mph and should be used cautiously for the design of roadways with motor vehicle speeds outside of the range of 25 to 35 mph, and in particular for higher-speed roadways.", url = "https://nap.nationalacademies.org/catalog/22350/recommended-bicycle-lane-widths-for-various-roadway-characteristics", year = 2014, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Research Council", editor = "Eileen M. Crimmins and Samuel H. Preston and Barney Cohen", title = "Explaining Divergent Levels of Longevity in High-Income Countries", isbn = "978-0-309-18640-7", abstract = "During the last 25 years, life expectancy at age 50 in the United States has been rising, but at a slower pace than in many other high-income countries, such as Japan and Australia. This difference is particularly notable given that the United States spends more on health care than any other nation. Concerned about this divergence, the National Institute on Aging asked the National Research Council to examine evidence on its possible causes. \n\nAccording to Explaining Divergent Levels of Longevity in High-Income Countries, the nation's history of heavy smoking is a major reason why lifespans in the United States fall short of those in many other high-income nations. Evidence suggests that current obesity levels play a substantial part as well. The book reports that lack of universal access to health care in the U.S. also has increased mortality and reduced life expectancy, though this is a less significant factor for those over age 65 because of Medicare access. For the main causes of death at older ages -- cancer and cardiovascular disease -- available indicators do not suggest that the U.S. health care system is failing to prevent deaths that would be averted elsewhere. In fact, cancer detection and survival appear to be better in the U.S. than in most other high-income nations, and survival rates following a heart attack also are favorable.\n\nExplaining Divergent Levels of Longevity in High-Income Countries identifies many gaps in research. For instance, while lung cancer deaths are a reliable marker of the damage from smoking, no clear-cut marker exists for obesity, physical inactivity, social integration, or other risks considered in this book. Moreover, evaluation of these risk factors is based on observational studies, which -- unlike randomized controlled trials -- are subject to many biases.", url = "https://nap.nationalacademies.org/catalog/13089/explaining-divergent-levels-of-longevity-in-high-income-countries", year = 2011, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Research Council", editor = "Robert Pool", title = "Proposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary", isbn = "978-0-309-28823-1", abstract = "On July 26, 2011, the U.S. Department of Health and Human Services issued an advance notice of proposed rulemaking (ANPRM) with the purpose of soliciting comments on how current regulations for protecting research participants could be modernized and revised. The rationale for revising the regulations was as follows: this ANPRM seeks comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The current regulations governing human subjects research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Although the regulations have been amended over the years, they have not kept pace with the evolving human research enterprise, the proliferation of multisite clinical trials and observational studies, the expansion of health services research, research in the social and behavioral sciences, and research involving databases, the Internet, and biological specimen repositories, and the use of advanced technologies, such as genomics.\nProposed Revisions to the Common Rule: Perspectives of Social and Behavioral Scientists: Workshop Summary focuses on six broad topic areas:\n1. Evidence on the functioning of the Common Rule and of institutional review boards (IRBs), to provide context for the proposed revisions.\n2. The types and levels of risks and harms encountered in social and behavioral sciences, and issues related to the severity and probability of harm, because the ANPRM asks for input on calibration of levels of review to levels of risk.\n3. The consent process and special populations, because new rules have been proposed to improve informed consent (e.g., standard consent form, consent for future uses of biospecimens, and re-consenting for further use of existing research data).\n4. Issues related to the protection of research participants in studies that involve use of existing data and data sharing, because the ANPRM proposed applying standards for protecting the privacy of healthcare data to research data.\n5. Multidisciplinary and multisite studies, because the ANPRM proposed a revision to the regulations that would allow multisite studies to be covered by a single IRB.\n6. The purview and roles of IRBs, because the ANPRM included possible revisions to categories of research that could entail changes in IRB oversight.", url = "https://nap.nationalacademies.org/catalog/18383/proposed-revisions-to-the-common-rule-perspectives-of-social-and", year = 2013, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Transportation Research Board and National Academies of Sciences, Engineering, and Medicine", editor = "Darren J. Torbic and Lindsay M. Lucas and Douglas W. Harwood and Marcus A. Brewer and Eun Sug Park and Raul Avelar and Michael P. Pratt and Akram Abu-Odeh and Elizabeth Depwe and Kimberly Rau", title = "Design of Interchange Loop Ramps and Pavement/Shoulder Cross-Slope Breaks", abstract = "TRB's National Cooperative Highway Research Program (NCHRP) Web-Only Document 227: Design of Interchange Loop Ramps and Pavement\/Shoulder Cross-Slope Breaks is presented in two parts. Part 1 presents design guidance for interchange loop ramps based on observational field studies and safety analyses and includes suggestions for the next edition of A Policy on Geometric Design of Highways and Streets published by the American Association of State Highway and Transportation Officials (AASHTO). Part 2 assesses AASHTO\u2019s current design policy for pavement\/shoulder cross-slope breaks on superelevated horizontal curves.", url = "https://nap.nationalacademies.org/catalog/24683/design-of-interchange-loop-ramps-and-pavementshoulder-cross-slope-breaks", year = 2017, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Jill Eden and Ben Wheatley and Barbara McNeil and Harold Sox", title = "Knowing What Works in Health Care: A Roadmap for the Nation", isbn = "978-0-309-11356-4", abstract = "There is currently heightened interest in optimizing health care through the generation of new knowledge on the effectiveness of health care services. The United States must substantially strengthen its capacity for assessing evidence on what is known and not known about \"what works\" in health care. Even the most sophisticated clinicians and consumers struggle to learn which care is appropriate and under what circumstances. Knowing What Works in Health Care looks at the three fundamental health care issues in the United States\u2014setting priorities for evidence assessment, assessing evidence (systematic review), and developing evidence-based clinical practice guidelines\u2014and how each of these contributes to the end goal of effective, practical health care systems. This book provides an overall vision and roadmap for improving how the nation uses scientific evidence to identify the most effective clinical services. Knowing What Works in Health Care gives private and public sector firms, consumers, health care professionals, benefit administrators, and others the authoritative, independent information required for making essential informed health care decisions.", url = "https://nap.nationalacademies.org/catalog/12038/knowing-what-works-in-health-care-a-roadmap-for-the", year = 2008, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Research Council", editor = "Maxine Weinstein and James W. Vaupel and Kenneth W. Wachter", title = "Biosocial Surveys", isbn = "978-0-309-10867-6", abstract = "Biosocial Surveys analyzes the latest research on the increasing number of multipurpose household surveys that collect biological data along with the more familiar interviewer\u2013respondent information. This book serves as a follow-up to the 2003 volume, Cells and Surveys: Should Biological Measures Be Included in Social Science Research? and asks these questions: What have the social sciences, especially demography, learned from those efforts and the greater interdisciplinary communication that has resulted from them? Which biological or genetic information has proven most useful to researchers? How can better models be developed to help integrate biological and social science information in ways that can broaden scientific understanding? This volume contains a collection of 17 papers by distinguished experts in demography, biology, economics, epidemiology, and survey methodology. It is an invaluable sourcebook for social and behavioral science researchers who are working with biosocial data.", url = "https://nap.nationalacademies.org/catalog/11939/biosocial-surveys", year = 2008, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP title = "", url = "", year = , publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Jonathan M. Samet and Catherine C. Bodurow", title = "Improving the Presumptive Disability Decision-Making Process for Veterans", isbn = "978-0-309-10730-3", abstract = "The United States has long recognized and honored the service and sacrifices of its military and veterans. Veterans who have been injured by their service (whether their injury appears during service or afterwards) are owed appropriate health care and disability compensation. For some medical conditions that develop after military service, the scientific information needed to connect the health conditions to the circumstances of service may be incomplete. When information is incomplete, Congress or the Department of Veterans Affairs (VA) may need to make a \"presumption\" of service connection so that a group of veterans can be appropriately compensated.\n \nThe missing information may be about the specific exposures of the veterans, or there may be incomplete scientific evidence as to whether an exposure during service causes the health condition of concern. For example, when the exposures of military personnel in Vietnam to Agent Orange could not be clearly documented, a presumption was established that all those who set foot on Vietnam soil were exposed to Agent Orange. The Institute of Medicine (IOM) Committee was charged with reviewing and describing how presumptions have been made in the past and, if needed, to make recommendations for an improved scientific framework that could be used in the future for determining if a presumption should be made. The Committee was asked to consider and describe the processes of all participants in the current presumptive disability decision-making process for veterans. The Committee was not asked to offer an opinion about past presumptive decisions or to suggest specific future presumptions.\n\nThe Committee heard from a range of groups that figure into this decision-making process, including past and present staffers from Congress, the VA, the IOM, veterans service organizations, and individual veterans. The Department of Defense (DoD) briefed the Committee about its current activities and plans to better track the exposures and health conditions of military personnel. The Committee further documented the current process by developing case studies around exposures and health conditions for which presumptions had been made. Improving the Presumptive Disability Decision-Making Process for Veterans explains recommendations made by the committee general methods by which scientists, as well as government and other organizations, evaluate scientific evidence in order to determine if a specific exposure causes a health condition.", url = "https://nap.nationalacademies.org/catalog/11908/improving-the-presumptive-disability-decision-making-process-for-veterans", year = 2008, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Joe Alper and Claudia Grossmann", title = "Integrating Research and Practice: Health System Leaders Working Toward High-Value Care: Workshop Summary", isbn = "978-0-309-31201-1", abstract = "Health care has been called one of the most complex sectors of the U.S. economy. Driven largely by robust innovation in treatments and interventions, this complexity has created an increased need for evidence about what works best for whom in order to inform decisions that lead to safe, efficient, effective, and affordable care. As health care becomes more digital, clinical datasets are becoming larger and more numerous. By realizing the potential of knowledge generation that is more closely integrated with the practice of care, it should be possible not only to produce more usable evidence to inform decisions, but also to increase the efficiency and decrease the costs of doing clinical research.\nPatient-Centered Clinical Research Network, or PCORnet, is a nation-wide patient-centered clinical research network intended to form a resource of clinical, administrative, and patient data that can be used to carry out observational and interventional research studies and enhance the use of clinical data to advance the learning health care system. The primary goal of the first phase of PCORnet will be to establish the data infrastructure necessary to do such research.\nIn April and June 2014 the Institute of Medicine's Roundtable on Value and Science-Driven Health Care convened two workshops aimed at accelerating progress toward real-time knowledge generation through the seamless integration of clinical practice and research, one of the fundamental concepts of a continuously learning health system, centered on the development of the PCORnet. The first workshop brought together health care system leaders, both administrative and clinical, and researchers to consider issues and strategic priorities for building a successful and durable clinical research network and facilitate progress toward a continuously learning health care system more broadly, including issues related to science, technology, ethics, business, regulatory oversight, sustainability, and governance. The second workshop focused on implementation approaches. Health system CEOs convened to consider strategic priorities and explore approaches to implementation. These workshops will inform the decisions of field leaders moving forward, including PCORI, the PCORnet steering committee, and PCORnet grantees. Integrating Research and Practice is the summary of the presentations and discussions of the workshops. ", url = "https://nap.nationalacademies.org/catalog/18945/integrating-research-and-practice-health-system-leaders-working-toward-high", year = 2015, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Research Council", title = "Under the Weather: Climate, Ecosystems, and Infectious Disease", isbn = "978-0-309-07278-6", abstract = "Since the dawn of medical science, people have recognized connections between a change in the weather and the appearance of epidemic disease. With today's technology, some hope that it will be possible to build models for predicting the \nemergence and spread of many infectious diseases based on climate and weather forecasts. However, separating the effects of climate from other effects presents a tremendous scientific challenge. \n\nCan we use climate and weather forecasts to predict infectious disease outbreaks? Can the field of public health advance from \"surveillance and response\" to \"prediction and prevention?\" And perhaps the most important question of all: Can we predict how global warming will affect the emergence and transmission of infectious disease agents around the world? \n\nUnder the Weather evaluates our current understanding of the linkages among climate, ecosystems, and infectious disease; it then goes a step further and outlines the research needed to improve our understanding of these linkages. The book also examines the potential for using climate forecasts and ecological observations to help predict infectious disease outbreaks, identifies the necessary components for an epidemic early warning system, and reviews lessons learned from the use of climate forecasts in other realms of human activity.\n", url = "https://nap.nationalacademies.org/catalog/10025/under-the-weather-climate-ecosystems-and-infectious-disease", year = 2001, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP title = "Clinical Trials and Statistics: Proceedings of a Symposium", url = "https://nap.nationalacademies.org/catalog/21086/clinical-trials-and-statistics-proceedings-of-a-symposium", year = 1993, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", title = "Ethical and Scientific Issues in Studying the Safety of Approved Drugs", isbn = "978-0-309-21813-9", abstract = "An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period.\nWritten in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions.\nEthical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.", url = "https://nap.nationalacademies.org/catalog/13219/ethical-and-scientific-issues-in-studying-the-safety-of-approved-drugs", year = 2012, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", title = "Ethical Issues in Studying the Safety of Approved Drugs: A Letter Report", abstract = "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.", url = "https://nap.nationalacademies.org/catalog/12948/ethical-issues-in-studying-the-safety-of-approved-drugs-a", year = 2010, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", title = "Evolution of Evidence for Selected Nutrient and Disease Relationships", isbn = "978-0-309-08308-9", abstract = "The Committee on Examination of the Evolving Science for Dietary Supplements of the Institute of Medicine's Food and Nutrition Board was directed to review, retrospectively, selected case studies of diet and health relationships that were relevant to dietary supplements and identified as important in the National Research Council report, Diet and Health: Implications for Chronic Disease Risk (D&H) (NRC, 1989). It was then to determine the extent to which subsequent scientific evidence from the peerreviewed literature used in published reports from the Dietary Reference Intakes (DRI) series (IOM, 1997, 1998, 2000a, 2001) either agreed with the preliminary evidence used to support the relationship identified originally in the 1989 review or significantly modified the original hypotheses and preliminary conclusions. The committee's analysis was to include characteristics of research with apparent high probability of predicting future confirmation by new science in support of a diet and health relationship. It also was to consider characteristics of information useful to consumers that would allow them to make scientifically informed judgments about the role that a specific food component or nutrient plays in health.", url = "https://nap.nationalacademies.org/catalog/10379/evolution-of-evidence-for-selected-nutrient-and-disease-relationships", year = 2002, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Melissa Maitin-Shepard and Marian Flaxman", title = "Use of Meta-Analyses in Nutrition Research and Policy: Interpretation and Application of Meta-Analysis to Evaluate the Totality of Evidence: Proceedings of a Workshop–in Brief", abstract = "The third workshop in the series on the use of meta-analysis in nutrition research and policy, held on October 3, 2023, focused on the process for evaluating the strength of the totality of evidence for diet and health relationships, with consideration of the type of study designs (observational and interventions) and risk of bias. The workshop series concluded with a discussion of the different applications of meta-analysis to inform policy and guidance.", url = "https://nap.nationalacademies.org/catalog/27468/use-of-meta-analyses-in-nutrition-research-and-policy-interpretation", year = 2024, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Ben Kahn and Amanda Wagner Gee and Carolyn Shore", title = "Examining the Impact of Real-World Evidence on Medical Product Development: II. Practical Approaches: Proceedings of a Workshop—in Brief", abstract = "On March 6\u20137, 2018, the National Academies of Sciences, Engineering, and Medicine held the second workshop of a three-part series titled Examining the Impact of Real-World Evidence on Medical Product Development. The workshops are intended to advance discussions and common knowledge among key stakeholders about complex issues relating to the generation and use of real-world evidence (RWE). The second workshop focused on practical approaches for the collection of real-world data (RWD)\u2014data generated outside of the traditional clinical trial setting\u2014and the use of RWE. This publication summarizes the presentations and discussions from this second workshop.", url = "https://nap.nationalacademies.org/catalog/25176/examining-the-impact-of-real-world-evidence-on-medical-product-development", year = 2018, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Research Council", title = "Current Mesoscale Meteorological Research in the United States", url = "https://nap.nationalacademies.org/catalog/18492/current-mesoscale-meteorological-research-in-the-united-states", year = 1981, publisher = "The National Academies Press", address = "Washington, DC" }