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The National Clinical Trials Network (NCTN) supported by the National Cancer Institute (NCI) has played an integral role in cancer research and in establishing the standard of care for cancer patients for more than 50 years. Formerly known as the NCI Clinical Trials Cooperative Group Program, the NCTN is comprised of more than 2,100 institutions and 14,000 investigators, who enroll more than 20,000 cancer patients in clinical trials each year across the United States and internationally. Recognizing the recent transformative advances in cancer research that necessitate modernization in how cancer clinical trials are run, as well as inefficiencies and other challenges impeding the national cancer clinical trials program, the NCI asked the IOM to develop a set of recommendations to improve the federally funded cancer clinical trials system. These recommendations were published in the 2010 report, A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program. In early 2011, the NCPF and the American Society of Clinical Oncology (ASCO) held a workshop in which stakeholders discussed the changes they planned to implement in response to the IOM goals and recommendations. Two years later, on February 11-12, 2013, in Washington, DC, the NCPF and ASCO reconvened stakeholders to report on the changes they have made thus far to address the IOM recommendations. At this workshop, representatives from the NCI, the NCTN, comprehensive cancer centers, patient advocacy groups, the Food and Drug Administration (FDA), industry, and other stakeholders highlighted the progress that has been made in achieving the goals for a reinvigorated national cancer clinical trials system. Implementing a National Cancer Clinical Trials System for the 21st Century is a summary of that workshop.
As requested by Congress and the White House Office of Science and Technology Policy (OSTP), this report assists federal agencies in crafting plans and reports that are responsive to the Government Performance and Results Act (GPRA), OMB Guidance, and agency missions. Using a case study approach, the report identifies best practices used by individual agencies to evaluate the performance and results of their science and technology programs. The report takes into account individual agencies' missions and how science and technology programs and human resource needs are factored into agency GPRA plans. Specific applications of recommendations are included from COSEPUP's earlier report entitled Evaluating Federal Research Programs: Research and the Government Performance and Results Act.
Mammography is an important tool for detecting breast cancer at an early stage. When coupled with appropriate treatment, early detection can reduce breast cancer mortality. At the request of Congress, the Food and Drug Administration (FDA) commissioned a study to examine the current practice of mammography and breast cancer detection, with a focus on the FDA’s oversight via the Mammography Quality Standards Act (MQSA), to identify areas in need of improvement. Enacted in 1993, MQSA provides a general framework for ensuring national quality standards in facilities performing screening mammography, requires that each mammography facility be accredited and certified, and mandates that facilities will undergo annual inspections. This book recommends strategies for achieving continued progress in assuring mammography quality, including changes to MQSA regulation, as well as approaches that do not fall within the purview of MQSA. Specifically, this book provides recommendations aimed at improving mammography interpretation; revising MQSA regulations, inspections, and enforcement; ensuring an adequate workforce for breast cancer screening and diagnosis; and improving breast imaging quality beyond mammography.
In our society’s aggressive pursuit of cures for cancer, we have neglected symptom control and comfort care. Less than one percent of the National Cancer Institute’s budget is spent on any aspect of palliative care research or education, despite the half million people who die of cancer each year and the larger number living with cancer and its symptoms. Improving Palliative Care for Cancer examines the barriers—scientific, policy, and social—that keep those in need from getting good palliative care. It goes on to recommend public- and private-sector actions that would lead to the development of more effective palliative interventions; better information about currently used interventions; and greater knowledge about, and access to, palliative care for all those with cancer who would benefit from it.
Young adults are at a significant and pivotal time of life. They may seek higher education, launch their work lives, develop personal relationships and healthy habits, and pursue other endeavors that help set them on healthy and productive pathways. However, the transition to adulthood also can be a time of increased vulnerability and risk. Young adults may be unemployed and homeless, lack access to health care, suffer from mental health issues or other chronic health conditions, or engage in binge drinking, illicit drug use, or driving under the influence. Young adults are moving out of the services and systems that supported them as children and adolescents, but adult services and systems--for example, the adult health care system, the labor market, and the justice system--may not be well suited to supporting their needs. Improving the Health, Safety, and Well-Being of Young Adults is the summary of a workshop hosted by the Board on Children, Youth, and Families of the Institute of Medicine (IOM) and the National Research Council (NRC) in May, 2013. More than 250 researchers, practitioners, policy makers, and young adults presented and discussed research on the development, health, safety, and well-being of young adults. This report focuses on the developmental characteristics and attributes of this age group and its placement in the life course; how well young adults function across relevant sectors, including, for example, health and mental health, education, labor, justice, military, and foster care; and how the various sectors that intersect with young adults influence their health and well-being. Improving the Health, Safety, and Well-Being of Young Adults provides an overview of existing research and identifies research gaps and issues that deserve more intensive study. It also is meant to start a conversation aimed at a larger IOM/NRC effort to guide research, practices, and policies affecting young adults.
Nervous system diseases and disorders are highly prevalent and substantially contribute to the overall disease burden. Despite significant information provided by the use of animal models in the understanding of the biology of nervous system disorders and the development of therapeutics; limitations have also been identified. Treatment options that are high in efficacy and low in side effects are still lacking for many diseases and, in some cases are nonexistent. A particular problem in drug development is the high rate of attrition in Phase II and III clinical trials. Why do many therapeutics show promise in preclinical animal models but then fail to elicit predicted effects when tested in humans? On March 28 and 29, 2012, the Institute of Medicine Forum on Neuroscience and Nervous System Disorders convened the workshop "Improving Translation of Animal Models for Nervous System Disorders" to discuss potential opportunities for maximizing the translation of new therapies from animal models to clinical practice. The primary focus of the workshop was to examine mechanisms for increasing the efficiency of translational neuroscience research through discussions about how and when to use animal models most effectively and then best approaches for the interpretation of the data collected. Specifically, the workshop objectives were to: discuss key issues that contribute to poor translation of animal models in nervous system disorders, examine case studies that highlight successes and failures in the development and application of animal models, consider strategies to increase the scientific rigor of preclinical efficacy testing, explore the benefits and challenges to developing standardized animal and behavioral models. Improving the Utility and Translation of Animal Models for Nervous System Disorders: Workshop Summary also identifies methods to facilitate development of corresponding animal and clinical endpoints, indentifies methods that would maximize bidirectional translation between basic and clinical research and determines the next steps that will be critical for improvement of the development and testing of animal models of disorders of the nervous system.
This report illustrates the work of IOM committees in selected, major areas in recent years, followed by a description of IOM's convening and collaborative activities and fellowship programs. The last section provides a comprehensive bibliography of IOM reports published since 2007.
New discoveries in genomics--that is, the study of the entire human genome--are changing how we diagnose and treat diseases. As the trend shifts from genetic testing largely being undertaken for rare genetic disorders to, increasingly, individuals being screened for common diseases, general practitioners, pediatricians, obstetricians/gynecologists, and other providers need to be knowledgeable about and comfortable using genetic information to improve their patients' health. To address these changes, the Roundtable on Translating Genomic-Based Research for Health held the public workshop "Innovations in Service Delivery in the Age of Genomics" on July 27, 2008.
During the past century the major causes of morbidity and mortality in the United States have shifted from those related to communicable diseases to those due to chronic diseases. Just as the major causes of morbidity and mortality have changed, so too has the understanding of health and what makes people healthy or ill. Research has documented the importance of the social determinants of health (for example, socioeconomic status and education) that affect health directly as well as through their impact on other health determinants such as risk factors. Targeting interventions toward the conditions associated with today's challenges to living a healthy life requires an increased emphasis on the factors that affect the current cause of morbidity and mortality, factors such as the social determinants of health. Many community-based prevention interventions target such conditions. Community-based prevention interventions offer three distinct strengths. First, because the intervention is implemented population-wide it is inclusive and not dependent on access to a health care system. Second, by directing strategies at an entire population an intervention can reach individuals at all levels of risk. And finally, some lifestyle and behavioral risk factors are shaped by conditions not under an individual's control. For example, encouraging an individual to eat healthy food when none is accessible undermines the potential for successful behavioral change. Community-based prevention interventions can be designed to affect environmental and social conditions that are out of the reach of clinical services. Four foundations - the California Endowment, the de Beaumont Foundation, the W.K. Kellogg Foundation, and the Robert Wood Johnson Foundation - asked the Institute of Medicine to convene an expert committee to develop a framework for assessing the value of community-based, non-clinical prevention policies and wellness strategies, especially those targeting the prevention of long-term, chronic diseases. The charge to the committee was to define community-based, non-clinical prevention policy and wellness strategies; define the value for community-based, non-clinical prevention policies and wellness strategies; and analyze current frameworks used to assess the value of community-based, non-clinical prevention policies and wellness strategies, including the methodologies and measures used and the short- and long-term impacts of such prevention policy and wellness strategies on health care spending and public health. An Integrated Framework for Assessing the Value of Community-Based Prevention summarizes the committee's findings.
The initial sequencing of the human genome, carried out by an international group of experts, took 13 years and $2.7 billion to complete. In the decade since that achievement, sequencing technology has evolved at such a rapid pace that today a consumer can have his or her entire genome sequenced by a single company in a matter of days for less than $10,000, though the addition of interpretation may extend this timeframe. Given the rapid technological advances, the potential effect on the lives of patients, and the increasing use of genomic information in clinical care, it is important to address how genomics data can be integrated into the clinical setting. Genetic tests are already used to assess the risk of breast and ovarian cancers, to diagnose recessive diseases such as cystic fibrosis, to determine drug dosages based on individual patient metabolism, and to identify therapeutic options for treating lung and breast tumors, melanoma, and leukemia. With these issues in mind and considering the potential impact that genomics information can have on the prevention, diagnosis, and treatment of disease, the Roundtable on Translating Genomic-Based Research for Health hosted a workshop on July 19, 2011, to highlight and identify the challenges and opportunities in integrating large-scale genomic information into clinical practice. Integrating Large-Scale Genomic Information into Clinical Practice summarizes the speaker presentations and the discussions that followed them. This report focuses on several key topics, including the analysis, interpretation, and delivery of genomic information plus workforce, ethical, and legal issues.
The last century witnessed dramatic changes in the practice of health care, and coming decades promise advances that were not imaginable even in the relatively recent past. Science and technology continue to offer new insights into disease pathways and treatments, as well as mechanisms of protecting health and preventing disease. Genomics and proteomics are bringing personalized risk assessment, prevention, and treatment options within reach; health information technology is expediting the collection and analysis of large amounts of data that can lead to improved care; and many disciplines are contributing to a broadening understanding of the complex interplay among biology, environment, behavior, and socioeconomic factors that shape health and wellness. On February 25 - 27, 2009, the Institute of Medicine (IOM) convened the Summit on Integrative Medicine and the Health of the Public in Washington, DC. The summit brought together more than 600 scientists, academic leaders, policy experts, health practitioners, advocates, and other participants from many disciplines to examine the practice of integrative medicine, its scientific basis, and its potential for improving health. This publication summarizes the background, presentations, and discussions that occurred during the summit.
The past several decades have been a time of rapid globalization in the development, manufacture, marketing, and distribution of medical products and technologies. Increasingly, research on the safety and effectiveness of new drugs is being conducted in countries with little experience in regulation of medical product development. Demand has been increasing for globally harmonized, science-based standards for the development and evaluation of the safety, quality, and efficacy of medical products. Consistency of such standards could improve the efficiency and clarity of the drug development and evaluation process and, ultimately, promote and enhance product quality and the public health. To explore the need and prospects for greater international regulatory harmonization for drug development, the IOM Forum on Drug Discovery, Development, and Translation hosted a workshop on February 13-14, 2013. Discussions at the workshop helped identify principles, potential approaches, and strategies to advance the development or evolution of more harmonized regulatory standards. This document summarizes the workshop.
Every year, the Global Forum undertakes two workshops whose topics are selected by the more than 55 members of the Forum. It was decided in this first year of the Forum's existence that the workshops should lay the foundation for future work of the Forum and the topic that could best provide this base of understanding was "interprofessional education." The first workshop took place August 29-30, 2012, and the second was on November 29-30, 2012. Both workshops focused on linkages between interprofessional education (IPE) and collaborative practice. The difference between them was that Workshop 1 set the stage for defining and understanding IPE while Workshop 2 brought in speakers from around the world to provide living histories of their experience working in and between interprofessional education and interprofessional or collaborative practice. A committee of health professional education experts planned, organized, and conducted a 2-day, interactive public workshop exploring issues related to innovations in health professions education (HPE). The committee involved educators and other innovators of curriculum development and pedagogy and will be drawn from at least four health disciplines. The workshop followed a high-level framework and established an orientation for the future work of the Global Forum on Innovations in Health Professional Education. Interprofessional Education for Collaboration: Learning How to Improve Health from Interprofessional Models Across the Continuum of Education to Practice summarizes the presentations and small group discussions that focused on innovations in five areas of HPE: 1. Curricular innovations - Concentrates on what is being taught to health professions' learners to meet evolving domestic and international needs; 2. Pedagogic innovations - Looks at how the information can be better taught to students and WHERE education can takes place; 3. Cultural elements - Addresses who is being taught by whom as a means of enhancing the effectiveness of the design, development and implementation of interprofessional HPE; 4. Human resources for health - Focuses on how capacity can be innovatively expanded to better ensure an adequate supply and mix of educated health workers based on local needs; and 5. Metrics - Addresses how one measures whether learner assessment and evaluation of educational impact and care delivery systems influence individual and population health.
Even though youth crime rates have fallen since the mid-1990s, public fear and political rhetoric over the issue have heightened. The Columbine shootings and other sensational incidents add to the furor. Often overlooked are the underlying problems of child poverty, social disadvantage, and the pitfalls inherent to adolescent decisionmaking that contribute to youth crime. From a policy standpoint, adolescent offenders are caught in the crossfire between nurturance of youth and punishment of criminals, between rehabilitation and "get tough" pronouncements. In the midst of this emotional debate, the National Research Council's Panel on Juvenile Crime steps forward with an authoritative review of the best available data and analysis. Juvenile Crime, Juvenile Justice presents recommendations for addressing the many aspects of America's youth crime problem.This timely release discusses patterns and trends in crimes by children and adolescents--trends revealed by arrest data, victim reports, and other sources; youth crime within general crime; and race and sex disparities. The book explores desistance--the probability that delinquency or criminal activities decrease with age--and evaluates different approaches to predicting future crime rates.Why do young people turn to delinquency? Juvenile Crime, Juvenile Justice presents what we know and what we urgently need to find out about contributing factors, ranging from prenatal care, differences in temperament, and family influences to the role of peer relationships, the impact of the school policies toward delinquency, and the broader influences of the neighborhood and community. Equally important, this book examines a range of solutions: Prevention and intervention efforts directed to individuals, peer groups, and families, as well as day care-, school- and community-based initiatives. Intervention within the juvenile justice system. Role of the police. Processing and detention of youth offenders. Transferring youths to the adult judicial system. Residential placement of juveniles.The book includes background on the American juvenile court system, useful comparisons with the juvenile justice systems of other nations, and other important information for assessing this problem.
Randomized clinical trials (RCTs) are often referred to as the "gold standard" of clinical research. However, in its current state, the U.S. clinical trials enterprise faces substantial challenges to the efficient and effective conduct of research. Streamlined approaches to RCTs, such as large simple trials (LSTs), may provide opportunities for progress on these challenges. Clinical trials support the development of new medical products and the evaluation of existing products by generating knowledge about safety and efficacy in pre- and post-marketing settings and serve to inform medical decision making and medical product development. Although well-designed and -implemented clinical trials can provide robust evidence, a gap exists between the evidence needs of a continuously learning health system, in which all medical decisions are based on the best available evidence, and the reality, in which the generation of timely and practical evidence faces significant barriers. Large Simple Trials and Knowledge Generation in a Learning Health System is the summary of a workshop convened by the Institute of Medicine's Roundtable on Value & Science-Driven Health Care and the Forum on Drug Discovery, Development, and Translation. Experts from a wide range of disciplines--including health information technology, research funding, clinical research methods, statistics, patients, product development, medical product regulation, and clinical outcomes research--met to marshal a better understanding of the issues, options, and approaches to accelerating the use of LSTs. This publication summarizes discussions on the potential of LSTs to improve the speed and practicality of knowledge generation for medical decision making and medical product development, including efficacy and effectiveness assessments, in a continuously learning health system. Large Simple Trials and Knowledge Generation in a Learning Health System explores acceleration of the use of LSTs to improve the speed and practicality of knowledge generation for medical decision making and medical product development; considers the concepts of LST design, examples of successful LSTs, the relative advantages of LSTs, and the infrastructure needed to build LST capacity as a routine function of care; identifies structural, cultural, and regulatory barriers hindering the development of an enhanced LST capacity; discusses needs and strategies in building public demand for and participation in LSTs; and considers near-term strategies for accelerating progress in the uptake of LSTs in the United States.
This volume reports on discussions among multiple stakeholders about ways they might help transform health care in the United States. The U.S. healthcare system consists of a complex network of decentralized and loosely associated organizations
A report on Leading Health Indicators for Healthy People 2010
Women's health, as a field of study, is a developing discipline. Health theories in general have been based on studies of men. However, in recent years, more attention has shifted to women's health, realizing the disparities between men and women in relation to their health. During the last two decades, a similar shift has occurred for a group of women--lesbian women--to further identify and specify their health needs.Over the past decade, lesbians have organized to call for attention to the health issues of this community, resulting in several federally funded research initiatives. This book offers a comprehensive view of what is known about lesbian health needs and what questions need further investigation, including:How do we define who is lesbian?Are there unique health issues for lesbians?Are lesbians at higher or lower risk for such health problems as AIDS, sexually transmitted diseases, breast cancer, mental disorders, and substance abuse?How does homophobia affect lesbian health and the funding of research on lesbian health?How do lesbian health needs fit into the health care system and the larger society?What risk and protective factors shape the physical and mental health of lesbians?The book discusses how to determine which questions to ask about sexual orientation, the need to obtain information without violating privacy, the importance of considering racial and ethnic diversity in the study of lesbians, strategies for exchanging information among researchers and disseminating findings to the public, and mechanisms for supporting greater numbers of researchers.Lesbian Health takes a frank look at the political pressures, community attitudes, and professional concerns uniquely affecting the study of lesbian health issues. The book explores many other issues including the potential for transferring findings in this field to other population groups, including other rare populations and women in general.
Since 1990, when the last guidelines for weight gain during pregnancy were issued, the average body weight of women entering their childbearing years has increased considerably, with a greater percentage of these women now classified as overweight or obese. Women of childbearing age are also more likely to have chronic conditions such as high blood pressure or diabetes and to be at risk for poor maternal and child health outcomes. All of these factors increase the likelihood of poor pregnancy outcomes for women and their infants. As part of the continuing effort of The Institute of Medicine (IOM) and the National Research Council (NRC) to promote the revised pregnancy weight gain guidelines recommended in their 2009 study Weight Gain During Pregnancy: Reexamining the Guidelines, the IOM and NRC convened a workshop in March, 2013, to engage interested stakeholders, organizations, and federal agencies in a discussion of issues related to encouraging behavior change that would reflect the updated guidelines on weight gain during pregnancy. During the workshop, the IOM and NRC presented newly developed information resources to support guidance based on the recommendations of the 2009 report. Leveraging Action to Support Dissemination of the Pregnancy Weight Gain Guidelines summarizes the workshop's keynote address and the various presentations and discussions from the workshop, highlighting issues raised by presenters and attendees. Interested stakeholders, organizations, health professionals, and federal agencies met to discuss issues related to encouraging behavior change that would reflect the updated guidelines on weight gain during pregnancy. This report discusses conceptual products as well as products developed for dissemination, ways to facilitate and support behavior change to achieve healthy weight pre- and postpregnancy, and how to put the weight gain guidelines into action to implement change.
Leveraging Culture to Address Health Inequalities: Examples from Native Communities is the summary of a workshop convened in November 2012 by the Roundtable on the Promotion of Health Equity and the Elimination of Health Disparities of the Institute of Medicine. The workshop brought together more than 100 health care providers, policy makers, program administrators, researchers, and Native advocates to discuss the sizable health inequities affecting Native American, Alaska Native, First Nation, and Pacific Islander populations and the potential role of culture in helping to reduce those inequities. This report summarizes the presentations and discussion of the workshop and includes case studies that examine programs aimed at diabetes prevention and management and cancer prevention and treatment programs. In Native American tradition, the medicine wheel encompasses four different components of health: physical, emotional, mental, and spiritual. Health and well-being require balance within and among all four components. Thus, whether someone remains healthy depends as much on what happens around that person as on what happens within. Leveraging Culture to Address Health Inequalities addresses the broad role of culture in contributing to and ameliorating health inequities.
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.
Each year more than 180,000 new cases of breast cancer are diagnosed in women in the U.S. If cancer is detected when small and local, treatment options are less dangerous, intrusive, and costly-and more likely to lead to a cure.Yet those simple facts belie the complexity of developing and disseminating acceptable techniques for breast cancer diagnosis. Even the most exciting new technologies remain clouded with uncertainty. Mammography and Beyond provides a comprehensive and up-to-date perspective on the state of breast cancer screening and diagnosis and recommends steps for developing the most reliable breast cancer detection methods possible.This book reviews the dramatic expansion of breast cancer awareness and screening, examining the capabilities and limitations of current and emerging technologies for breast cancer detection and their effectiveness at actually reducing deaths. The committee discusses issues including national policy toward breast cancer detection, roles of public and private agencies, problems in determining the success of a technique, availability of detection methods to specific populations of women, women's experience during the detection process, cost-benefit analyses, and more.Examining current practices and specifying research and other needs, Mammography and Beyond will be an indispensable resource to policy makers, public health officials, medical practitioners, researchers, women's health advocates, and concerned women and their families.
Managed Care Systems and Emerging Infections: Challenges and Opportunities for Strengthening Surveillance, Research, and Prevention Workshop Summaryby Institute of Medicine
This workshop summary report from the Institute of Medicine's Forum on Emerging Infections examines how the managed care revolution has created both problems and opportunities in the fight against infectious disease. It highlights ways in which managed care systems can: -- Aid research. -- Develop clinical guidelines. -- Manage the use of antibiotics. -- Support public education efforts. -- Monitor the spread of emerging infections and microbial resistance. It will be important to anyone involved in the battle to control and eradicate infectious diseases.
The medical use of marijuana is surrounded by a cloud of social, political, and religious controversy, which obscures the facts that should be considered in the debate.This book summarizes what we know about marijuana from evidence-based medicine--the harm it may do and the relief it may bring to patients. The book helps the reader understand not only what science has to say about medical marijuana but also the logic behind the scientific conclusions.Marijuana and Medicine addresses the science base and the therapeutic effects of marijuana use for medical conditions such as glaucoma and multiple sclerosis. It covers marijuana's mechanism of action, acute and chronic effects on health and behavior, potential adverse effects, efficacy of different delivery systems, analysis of the data about marijuana as a gateway drug, and the prospects for developing cannabinoid drugs. The book evaluates how well marijuana meets accepted standards for medicine and considers the conclusions of other blue-ribbon panels.Full of useful facts, this volume will be important to anyone interested in informed debate about the medical use of marijuana: advocates and opponents as well as policymakers, regulators, and health care providers.
Health literacy--the ability for individuals to obtain, process, and understand basic health information and services to facilitate appropriate health decisions--is increasingly recognized as an important facet of health care and health outcomes. Although research on health literacy has grown tremendously in the past decade, there is no widely agreed-upon framework for health literacy as a determinant of health outcomes. Most instruments focus on assessing an individual's health literacy, yet the scope of health literacy reaches far beyond an individual's skills and abilities. Health literacy occurs in the context of the health care system, and therefore measures of health literacy must also assess the demands and complexities of the health care systems with which patients interact. For example, measures are needed to determine how well the system has been organized so that it can be navigated by individuals with different levels of health literacy and how well health organizations are doing at making health information understandable and actionable. To examine what is known about measures of health literacy, the Institute of Medicine convened a workshop. The workshop, summarized in this volume, reviews the current status of measures of health literacy, including those used in the health care setting; discusses possible surrogate measures that might be used to assess health literacy; and explores ways in which health literacy measures can be used to assess patient-centered approaches to care.
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