Bøger af Institute of Medicine

The Institute of Medicine's Roundtable on Population Health Improvement brings together individuals and organizations that represent different sectors in a dialogue about what is needed to improve population health. On September 22, 2014, the roundtable held a workshop to discuss some of the science of health communication, audiences, and messaging, and to explore what it will take to generate widespread awareness, acceptance, and action to improve health, including through the entertainment media, the news media, and social media. This report summarizes the presentations and discussion of the workshop.

"One of the challenges in treating cancer is the disease's complexity and variation among patients. Cancer manifests differently in each patient, so treatments that are effective in one patient may not be effective in another. As cancer care becomes more personalized, subpopulations of individuals will be given preventive or therapeutic interventions based on their susceptibility to a particular disease or their predicted response to a specific treatment. However, before the use of personalized cancer care can reach its full potential, the health care system must resolve a number of technological, regulatory, and reimbursement issues. To explore these policy challenges, the National Cancer Policy Forum held the workshop Policy Issues in the Development of Personalized Medicine in Oncology in June 2009. Experts provided presentations on the current state of personalized medicine technology, as well as issues in the validation of, regulation of, and reimbursement for the predictive tests that underpin personalized medicine. Participants discussed the obstacles and possible solutions to further developing and using personalized medicine technologies. This document summarizes the workshop"--

The Air Force Health Study (AFHS) is a longitudinal, prospective epidemiologic study of more than 2,700 men followed for approximately 20 years. This cohort participated in up to six intensive physical examinations with high rates of compliance. In addition to a complete record of clinical measurements and observations collected at these exams, serum and other biological samples were obtained and preserved. Extensive questionnaires addressing health, lifestyle, and socioeconomic status were administered during each exam, and other information was obtained about the participants' employment, families and offspring, and potential sources of environmental exposures. While the study was completed in 2006, the extensive health data linked to several types of longitudinally collected biologic specimens - some 91,000 serum, whole blood, urine, semen, and adipose tissue specimens - remain a resource for additional research. The AFHS assets are exceptional in the sheer multitude and range of types of information available for each participant. The longitudinal nature of the AFHS - with its extended follow-up, high rates of retention, and repeat biological samples - provides a valuable opportunity for research beyond the original aims of the study. Currently, the Institute of Medicine is the custodian of these assets. The Air Force Health Study Assets Research Program outlines the feasibility and advisability of maintaining the biospecimens based on interest generated from the general scientific community and results of pilot projects and other research projects using the AFHS assets. According to this report, sustaining access to the AFHS biospecimens and data benefits the veterans community and the public at large, who will gain from the information derived from studies of the assets. . This report discusses the scientific value of the AFHS data and biospecimens and the lessons learned in managing access to the assets.

"On September 9-11, 2014 the Global Forum on Innovation in Health Professional Education and the Forum on Public-Private Partnerships for Global Health and Safety of the Institute of Medicine convened a workshop on empowering women and strengthening health systems and services through investing in nursing and midwifery enterprise at the Rockefeller Center in Bellagio, Italy."--Page 1.

Tobacco consumption continues to be the leading cause of preventable disease and death in the United States. The Food and Drug Administration (FDA) regulates the manufacture, distribution, and marketing of tobacco products - specifically cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco - to protect public health and reduce tobacco use in the United States. Given the strong social component inherent to tobacco use onset, cessation, and relapse, and given the heterogeneity of those social interactions, agent-based models have the potential to be an essential tool in assessing the effects of policies to control tobacco.Assessing the Use of Agent-Based Models for Tobacco Regulation describes the complex tobacco environment; discusses the usefulness of agent-based models to inform tobacco policy and regulation; presents an evaluation framework for policy-relevant agent-based models; examines the role and type of data needed to develop agent-based models for tobacco regulation; provides an assessment of the agent-based model developed for FDA; and offers strategies for using agent-based models to inform decision making in the future.

In the past half century, deadly disease outbreaks caused by novel viruses of animal origin - Nipah virus in Malaysia, Hendra virus in Australia, Hantavirus in the United States, Ebola virus in Africa, along with HIV (human immunodeficiency virus), several influenza subtypes, and the SARS (sudden acute respiratory syndrome) and MERS (Middle East respiratory syndrome) coronaviruses - have underscored the urgency of understanding factors influencing viral disease emergence and spread. Emerging Viral Diseases is the summary of a public workshop hosted in March 2014 to examine factors driving the appearance, establishment, and spread of emerging, re-emerging and novel viral diseases; the global health and economic impacts of recently emerging and novel viral diseases in humans; and the scientific and policy approaches to improving domestic and international capacity to detect and respond to global outbreaks of infectious disease. This report is a record of the presentations and discussion of the event.

U.S. Marine Corps Base Camp Lejeune, located in eastern North Carolina, is a large installation that covers 156,000 acres and is home at any given time to a population of about 170,000 active-duty personnel, family members, retirees, and civilian employees living on base or in the surrounding community. Between 1957 and 1987, the ground water at Camp Lejeune was inadvertently contaminated with chemicals, primarily industrial solvents that are now known to cause cancer and other health problems. In 1980, drinking water contaminants, primarily trichloroethylene (TCE) and perchloroethylene (PCE), as well as other solvents, were first detected at Camp Lejeune in treated drinking water. The contaminated wells were closed in 1987. In 1989, the U.S. Environmental Protection Agency placed Camp Lejeune on the National Priorities List, also known as Superfund. It is estimated that between 500,000 and 1,000,000 people may have used the contaminated water and many of them continue to have concerns about the long-term effects that might result from that exposure.In 2012 Congress passed the Honoring America's Veterans and Caring for Camp Lejeune Families Act. The law provides health benefits to veterans and family members who have any of 15 health outcomes associated with exposure to TCE, PCE, or solvent mixtures. At the request of the Veteran's Administration, Review of the VA Guidance for the Health Conditions Identified by the Camp Lejeune Legislation reviews the latest scientific literature to ensure that the clinical guidance provided for the 15 covered medical conditions is scientifically sound. This report also describes the medical conditions that result from renal toxicity due to solvent exposures and characterizes neurobehavioral effects as mandated for coverage in the law.

"Workshop, August 18, 2014 ... Washington, DC"--Page 73.

"On July 9-10, 2014, the Institute of Medicine's Food Forum hosted a public workshop to explore emerging and rapidly developing research on relationships among the brain, the digestive system, and eating behavior. Drawing on expertise from the fields of nutrition and food science, animal and human physiology and behavior, and psychology and psychiatry as well as related fields, the purpose of the workshop was to (1) review current knowledge on the relationship between the brain and eating behavior, explore the interaction between the brain and the digestive system, and consider what is known about the brain's role in eating patterns and consumer choice; (2) evaluate current methods used to determine the impact of food on brain activity and eating behavior; and (3) identify gaps in knowledge and articulate a theoretical framework for future research. Relationships among the Brain, the Digestive System, and Eating Behavior summarizes the presentations and discussion of the workshop."--

"Informed consent - the process of communication between a patient or research subject and a physician or researcher that results in the explicit agreement to undergo a specific medical intervention - is an ethical concept based on the principle that all patients and research subjects should understand and agree to the potential consequences of the clinical care they receive. Regulations that govern the attainment of informed consent for treatment and research are crucial to ensuring that medical care and research are conducted in an ethical manner and with the utmost respect for individual preferences and dignity. These regulations, however, often require - or are perceived to require - that informed consent documents and related materials contain language that is beyond the comprehension level of most patients and study participants. To explore what actions can be taken to help close the gap between what is required in the informed consent process and communicating it in a health-literate and meaningful manner to individuals, the Institute of Medicine's Roundtable on Health Literacy convened a one-day public workshop featuring presentations and discussions that examine the implications of health literacy for informed consent for both research involving human subjects and treatment of patients. Topics covered in this workshop included an overview of the ethical imperative to gain informed consent from patients and research participants, a review of the current state and best practices for informed consent in research and treatment, the connection between poor informed consent processes and minority underrepresentation in research, new approaches to informed consent that reflect principles of health literacy, and the future of informed consent in the treatment and research settings. Informed Consent and Health Literacy is the summary of the presentations and discussion of the workshop."--Publisher's description.

"Review of WIC Food Packages: An Evaluation of White Potatoes in the Cash Value Voucher assesses the impact of 2009 regulation to allow the purchase of vegetables and fruits, excluding white potatoes, with a cash value voucher on food and nutrient intakes of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) population and to consider whether white potatoes should be permitted for purchase with the voucher. This report considers the effects on diet quality, the health and cultural needs of the WIC population, and allows for effective and efficient administration nationwide in a cost-effective manner. Review of WIC Food Packages: An Evaluation of White Potatoes in the Cash Value Voucher recommends that the U.S. Department of Agriculture should allow white potatoes as a WIC-eligible vegetable, in forms currently permitted for other vegetables, in the cash value voucher pending changes to starchy vegetable intake recommendations in the 2015 Dietary Guidelines for Americans."--

"Roundtable on Translating Genomic-Based Research for Health"--Cover.

The nurse workforce constitutes the largest sector of health professionals in the United States and includes individuals with varying educational backgrounds and expertise. Like other health professions, nursing includes a large number of specialties and subspecialties. Nurses may seek certification, based on various standards and criteria, from a wide range of organizations. Similarly, organizations may participate in nursing credentialing programs, which typically reflect the attainment of various nursing care standards and outcome measures. It is, however, unclear how this additional training and education affects health care quality and patient health. Future Directions of Credentialing Research in Nursing examines short- and long-term strategies to advance research on nurse certification and organizational credentialing. This report summarizes a workshop convened by the Institute of Medicine in September 2014 to examine a new framework and research priorities to guide future research on the impact of nurse credentialing and certification on outcomes for nurses, organizations, and patients. Over 100 people attended the workshop, which focused on topics such as emergent priorities for research in nursing credentialing; critical knowledge gaps and methodological limitations in the field; promising developments in research methodologies, health metrics, and data infrastructures to better evaluate the impact of nursing credentialing; and short- and long-term strategies to encourage continued activity in nursing credentialing research. Future Directions of Credentialing Research in Nursing is a record of the presentations, discussion, and break-out sessions of this event.

From 1972 to 1982, approximately 1,500-2,100 US Air Force Reserve personnel trained and worked on C-123 aircraft that had formerly been used to spray herbicides in Vietnam as part of Operation Ranch Hand. After becoming aware that some of the aircraft on which they had worked had previously served this purpose, some of these AF Reservists applied to the US Department of Veterans Affairs (VA) for compensatory coverage under the Agent Orange Act of 1991. The Act provides health care and disability coverage for health conditions that have been deemed presumptively service-related for herbicide exposure during the Vietnam War. The VA denied the applications on the basis that these veterans were ineligible because as non-Vietnam-era veterans or as Vietnam-era veterans without "e;boots on the ground"e; service in Vietnam, they were not covered. However, with the knowledge that some air and wipe samples taken between 1979 and 2009 from some of the C-123s used in Operation Ranch Hand showed the presence of agent orange residues, representatives of the C-123 Veterans Association began a concerted effort to reverse VA's position and obtain coverage.At the request of the VA, Post-Vietnam Dioxin Exposure in Agent Orange-Contaminated C-123 Aircraft evaluates whether or not service in these C-123s could have plausibly resulted in exposures detrimental to the health of these Air Force Reservists. The Institute of Medicine assembled an expert committee to address this question qualitatively, but in a scientific and evidence-based fashion. This report evaluates the reliability of the available information for establishing exposure and addresses and places in context whether any documented residues represent potentially harmful exposure by characterizing the amounts available and the degree to which absorption might be expected. Post-Vietnam Dioxin Exposure rejects the idea that the dioxin residues detected on interior surfaces of the C-123s were immobile and effectively inaccessible to the Reservists as a source of exposure. Accordingly, this report states with confidence that the Air Force Reservists were exposed when working in the Operation Ranch Hand C-123s and so experienced some increase in their risk of a variety of adverse responses.

Review of NASA's Evidence Reports on Human Health Risks 2014 Letter Report is the second in a series of five reports from the Institute of Medicine that will independently review more than 30 evidence reports that the National Aeronautics and Space Administration has compiled on human health risks for long-duration and exploration space flights. This report builds on the 2008 IOM report Review of NASA's Human Research Program Evidence Books: A Letter Report, which provided an initial and brief review of the evidence reports. This letter report reviews seven evidence reports and examines the quality of the evidence, analysis, and overall construction of each report; identifies existing gaps in report content; and provides suggestions for additional sources of expert input. The report analyzes each evidence report's overall quality, which included readability; internal consistency; the source and breadth of cited evidence; identification of existing knowledge and research gaps; authorship expertise; and, if applicable, response to recommendations from the 2008 IOM letter report.

"Protecting 18 million United States health care workers from infectious agents - known and unknown - involves a range of occupational safety and health measures that include identifying and using appropriate protective equipment. The 2009 H1N1 influenza pandemic and the 2014 Ebola virus outbreak in West Africa have called raised questions about how best to ensure appropriate and effective use of different kinds of personal protective equipment such as respirators, not only to promote occupational safety but also to reduce disease transmission. The Use and Effectiveness of Powered Air Purifying Respirators in Health Care is the summary of a workshop convened by the Institute of Medicine Standing Committee on Personal Protective Equipment for Workplace Safety and Health to explore the current state of practices and research related to powered air purifying respirator (PAPRs) and potential updates to performance requirements. Presentations and discussions highlighted current health care practices using PAPRs and outlined the research to date on the use and effectiveness of PAPRs in health care settings with a focus on the performance requirements. The Use and Effectiveness of Powered Air Purifying Respirators in Health Care focuses on efficacy, current training, maintenance, supplies, and possible enhancements and barriers to use in inpatient, clinic, nursing home, and community (home) settings. This report also explores the strengths and weaknesses of using various approaches to health care PAPR standards."--Publisher's description.

"Business Engagement in Building Healthy Communities is the summary of a workshop convened by the Institute of Medicine's Roundtable on Population Health Improvement in July 2014 to consider the role of business in improving population health beyond the usual worksite wellness and health promotion activities. The workshop followed previous roundtable discussions on the importance of applying a health lens to decision making in non-health sectors and the need for cross-sector collaborations to advance population health. Invited speakers included representatives from several businesses that have taken action to improve the health of their communities and representatives of business coalitions on health. The workshop was designed to discuss why engaging in population health improvement is good for business; explore how businesses can be effective key leaders in improving the health of communities; and discuss ways in which businesses can engage in population health improvement. This report is a record of the presentations and discussion of the event" --

The Postdoctoral Experience Revisited builds on the 2000 report Enhancing the Postdoctoral Experience for Scientists and Engineers. That ground-breaking report assessed the postdoctoral experience and provided principles, action points, and recommendations to enhance that experience. Since the publication of the 2000 report, the postdoctoral landscape has changed considerably. The percentage of PhDs who pursue postdoctoral training is growing steadily and spreading from the biomedical and physical sciences to engineering and the social sciences. The average length of time spent in postdoctoral positions seems to be increasing. The Postdoctoral Experience Revisited reexamines postdoctoral programs in the United States, focusing on how postdocs are being guided and managed, how institutional practices have changed, and what happens to postdocs after they complete their programs. This book explores important changes that have occurred in postdoctoral practices and the research ecosystem and assesses how well current practices meet the needs of these fledgling scientists and engineers and of the research enterprise. The Postdoctoral Experience Revisited takes a fresh look at current postdoctoral fellows - how many there are, where they are working, in what fields, and for how many years. This book makes recommendations to improve aspects of programs - postdoctoral period of service, title and role, career development, compensation and benefits, and mentoring. Current data on demographics, career aspirations, and career outcomes for postdocs are limited. This report makes the case for better data collection by research institution and data sharing. A larger goal of this study is not only to propose ways to make the postdoctoral system better for the postdoctoral researchers themselves but also to better understand the role that postdoctoral training plays in the research enterprise. It is also to ask whether there are alternative ways to satisfy some of the research and career development needs of postdoctoral researchers that are now being met with several years of advanced training. Postdoctoral researchers are the future of the research enterprise. The discussion and recommendations of The Postdoctoral Experience Revisited will stimulate action toward clarifying the role of postdoctoral researchers and improving their status and experience.

"The Roundtable on Health Literacy brings together leaders from academia, industry, government, foundations, and associations and representatives of patient and consumer interests who work to improve health literacy. To achieve its mission, the roundtable discusses challenges facing health literacy practice and research and identifies approaches to promote health literacy through mechanisms and partnerships in both the public and private sectors. To explore the aspects of health literacy that impact the ability of patients to understand and follow discharge instructions and to learn from examples of how discharge instructions can be written to improve patient understanding of-and hence compliance with-discharge instructions, the Roundtable on Health Literacy held a public workshop. The workshop featured presentations and discussions that examined the implications of health literacy for discharge instructions for both ambulatory and inpatient facilities. Facilitating Patient Understanding of Discharge Instructions summarizes the presentations and discussions of the workshop. This report gives an overview of the impact of discharge instructions on outcomes, and discusses the specifics of inpatient discharge summaries and outpatient after-visit summaries. The report also contains case studies illustrating different approaches to improving discharge instructions."--

"In recent years, patients' out-of-pocket costs for cancer care have been rising rapidly. These costs include health insurance deductibles, coinsurance, and copayments for covered services, as well as services that are not covered by insurance. Many cancer patients are especially vulnerable financially because their illness and/or treatment impedes their ability to work, with some patients losing employment altogether. Even with insurance, cancer patients often experience financial hardships, such as going into debt, depleting all assets to pay for cancer treatment, and personal bankruptcy. Although many elements contribute to the cost of cancer care, one important component is the cost of new cancer drugs, which has been escalating rapidly in recent years. To explore the issue of cancer drug costs and patient access to affordable, appropriate drug therapies, the Institute of Medicine's National Cancer Policy Forum convened a workshop on ensuring patient access to affordable cancer drugs in June 2014. Affordability was considered from both individual and societal perspectives. The workshop featured discussion panels as well as invited presentations from clinicians, researchers, representatives from the health insurance and pharmaceutical industries, and patient advocates. Ensuring Patient Access to Affordable Cancer Drugs summarizes the presentation and discussion of the workshop."--

Over the past decade, preparedness and response capacities of government agencies, hospitals and clinics, public health agencies, and academic researchers in the United States and abroad have been challenged by a succession of public health emergencies, ranging from radiological threats to pandemics to earthquakes. Through After Action Reports, each of these emergencies has yielded important information and lessons learned that can inform future disaster response and recovery efforts. However, important information that needs to be collected during and immediately following these emergencies is often missed because of barriers and obstacles to gathering such data, such as varying institutional review board restrictions in different states, no sustainable funding network for this type of work, uncertainty on who should be involved in research response, and a lack of knowledge around how best to integrate research into response and recovery frameworks. Taking action to enable medical and public health research during disasters was the focus of a workshop held on June 12 and 13, 2014, coordinated and supported jointly by the Institute of Medicine Forum on Medical and Public Health Preparedness for Catastrophic Events, National Institute of Environmental Health Sciences, the National Library of Medicine, the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, and the Centers for Disease Control and Prevention. Invited speakers and participants from federal, state, and local government, academia, and community and worker organizations came together to discuss how to integrate research into existing response structures; identify critical research needs and priorities; identify obstacles and barriers to research; discuss structures and strategies needed for deployment of a research study; share ideas, innovations, and technologies to support research; and explore data collection tools and data-sharing mechanisms for both rapid and longitudinal research. Enabling Rapid and Sustainable Public Health Research During Disasters summarizes the presentations and discussion of the workshop.

"The Institute of Medicine launched an innovative outreach program in 1988. Through the generosity of the Rosenthal Family Foundation (formerly the Richard and Hinda Rosenthal Foundation), a discussion series was created to bring greater attention to some of the significant health policy issues facing our nation today. Each year a major health topic is addressed through remarks and conversation between experts in the field. The IOM later publishes the proceedings from this event for the benefit of a wider audience. This volume summarizes remarks by and an engaging discussion with Dr. Rima Khabbaz, Dr. Stuart Levy, Dr. Margaret (Peg) Riley, and Dr. Brad Spellberg on "Antimicrobial Resistance: A Problem Without Borders." The Centers for Disease Control and Prevention identified antimicrobial resistance as one of five urgent health threats facing the United States this year. Antimicrobial resistance is a global health security threat that will demand collaboration from many stakeholders around the world. This report highlights the crosscutting character of antimicrobial resistance and the needs for many disciplines to be brought together to be able to deal with it more effectively."--

"There is growing evidence from developed and developing countries that community-based approaches are effective in improving the health of individuals and populations. This is especially true when the social determinants of health are considered in the design of the community-based approach. With an aging population and an emphasis on health promotion, the United States is increasingly focusing on community-based health and health care. Preventing disease and promoting health calls for a holistic approach to health interventions that rely more heavily upon interprofessional collaborations. However, the financial and structural design of health professional education remains siloed and largely focused on academic health centers for training. Despite these challenges, there are good examples of interprofessional, community-based programs and curricula for educating health professionals. In May 2014, members of the Institute of Medicine's Global Forum on Innovation in Health Professional Education came together to substantively delve into issues affecting the scale-up and spread of health professional education in communities. Participants heard a wide variety of individual accounts from innovators about work they are undertaking and opportunities for education with communities. In presenting a variety of examples that range from student community service to computer modeling, the workshop aimed to stimulate discussions about how educators might better integrate education with practice in communities. Building Health Workforce Capacity Through Community-Based Health Professional Education summarizes the presentations and discussion of this event."--

"The Role and Potential of Communuties in Population Health Improvement is the summary of a workshop held by the Institute of Medicine Roundtable on Population Health Improvement in April 2014 that featured invited speakers from community groups that have taken steps to improve the health of their communities. Speakers from communities across the United States discussed the potential roles of communities for improving population health. The workshop focused on youth organizing, community organizing or other types of community participation, and partnerships between community and institutional actors. This report explores the roles and potential of the community as leaders, partners, and facilitators in transforming the social and environmental conditions that shape health and well-being at the local level."-- Publisher's description.

"Combined with the more traditional employer occupational safety and health protection activities are newer employment-based programs to promote better health through helping workers quit smoking, lose weight, reduce stress, or exercise more regularly. In support of these efforts, some employers have made changes in their policies and facilities to support physical activity and healthier eating, and some employers connect with community resources for health education, health fairs, and other services. This diverse array of activities most typically has been planned, managed, and assessed - to the extent they exist in the workplace at all - by different, often uncoordinated departments within the business entity. Some employers have reconceptualized their safety, prevention, and promotion initiatives and attempted to bring them together into a coherent whole. The National Institute for Occupational Safety and Health (NIOSH) has supported this integration, defining Total Worker Health as "a strategy integrating occupational safety and health protection with health promotion to prevent worker injury and illness and to advance health and well-being." In May 2014, with support from NIOSH, the Institute of Medicine organized a workshop on Total Worker Health. Rather than a review of published literature, this workshop sought input from a wide variety of on-the-ground stakeholders regarding their experiences with integrating occupational safety and health protection with health promotion in the workplace. Promising and Best Practices in Total Worker Health is the summary of the discussions and presentations of the event. This report identifies prevalent and best practices in programs that integrate occupational safety and health protection with health promotion in small, medium, and large workplaces; employer and employee associations; academia; government agencies; and other stakeholder groups."--

"The United States has been a generous sponsor of global health programs for the past 25 years or more. This investment has contributed to meaningful changes, especially for women and children, who suffer the brunt of the world's disease and disability. Development experts have long debated the relative merits of vertical health programming, targeted to a specific service or patient group, and horizontal programming, supporting more comprehensive care. The U.S. government has invested heavily in vertical programs, most notably through the President's Emergency Plan for AIDS Relief (PEPFAR), its flagship initiative for HIV and AIDS. PEPFAR and programs like it have met with good success. Protecting these successes and continuing progress in the future depends on the judicious integration of vertical programs with local health systems. A strong health system is the best insurance developing countries can have against a disease burden that is shifting rapidly and in ways that history has not prepared us for. Reaching the poor with development assistance is an increasingly complicated task. The majority of the roughly 1 billion people living in dire poverty are in middle-income countries, where foreign assistance is not necessarily needed or welcome. Many of the rest live in fragile states, where political volatility and weak infrastructure make it difficult to use aid effectively. The poorest people in the world are also the sickest; they are most exposed to disease vectors and infection. Nevertheless, they are less likely to access health services. Improving their lot means removing the systemic barriers that keep the most vulnerable people from gaining such access. Investing in Global Health Systems discusses the past and future of global health. First, the report gives context by laying out broad trends in global health. Next, it discusses the timeliness of American investment in health systems abroad and explains how functional health systems support health, encourage prosperity, and advance global security. Lastly, it lays out, in broad terms, an effective donor strategy for health, suggesting directions for both the manner and substance of foreign aid given. The challenge of the future of aid programming is to sustain the successes of the past 25 years, while reducing dependence on foreign aid. Investing in Global Health Systems aims to help government decision makers assess the rapidly changing social and economic situation in developing countries and its implications for effective development assistance. This report explains how health systems improvements can lead to better health, reduce poverty, and make donor investment in health sustainable"--

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. Patient-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. In 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.

"Despite spending far more on medical care than any other nation and despite having seen a century of unparalleled improvement in population health and longevity, the United States has fallen behind many of its global counterparts and competitors in such health outcomes as overall life expectancy and rates of preventable diseases and injuries. A fundamental but often overlooked driver of the imbalance between spending and outcomes is the nation's inadequate investment in non-clinical strategies that promote health and prevent disease and injury population-wide, strategies that fall under the rubric of "population health." Given that it is unlikely that government funding for governmental public health agencies, whether at the local, state, or federal levels, will see significant and sustained increases, there is interest in finding creative sources of funding for initiatives to improve population health, both through the work of public health agencies and through the contributions of other sectors, including nonhealth entities. Financing Population Health Improvement is the summary of a workshop convened by the Institute of Medicine Roundtable on Population Health Improvement in February 2014 to explore the range of resources that might be available to provide a secure funding stream for non-clinical actions to enhance health. Presenters and participants discussed the range of potential resources (e.g., financial, human, and community) explored topics related to financial resources. This report discusses return on investment, the value of investing in population-based interventions, and possible sources of funding to improve population health"--

"Culture Matters is the summary of a workshop convened by the Government-University-Industry Research Roundtable (GUIRR) in July 2013 to address how culture and cultural perception influence and impact the process by which research agreements are made and negotiated across international boundaries. In this workshop, "Culture Matters: An Approach to International Research Agreements," representatives from around the world and from GUIRR's three constituent sectors - government, university, and industry - gathered to provide input into four specific meeting tracks or domains. The tracks focused on research and agreements affecting or involving people/human subjects; environmental and natural resources; science, engineering, and manufacturing; and agriculture and animal issues. This report examines each of these domains and the role that culture and cultural expectations may have in the forging and implementation of international research agreements."--

"Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including the underlying variability in human biology, factors associated with the chemistry of a drug, and limitations in the research and clinical trial process itself that might limit the generalizability of results. As a result, regulatory reviewers are consistently required to draw conclusions about a drug's safety and efficacy from imperfect data. Efforts are underway within the drug development community to enhance the evaluation and communication of the benefits and risks associated with pharmaceutical products, aimed at increasing the predictability, transparency, and efficiency of pharmaceutical regulatory decision making. Effectively communicating regulatory decisions necessarily includes explanation of the impact of uncertainty on decision making. On February 12 and May 12, 2014, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held public workshops to advance the development of more systematic and structured approaches to characterize and communicate the sources of uncertainty in the assessment of benefits and risks, and to consider their implications for pharmaceutical regulatory decisions. Workshop presentations and discussions on February 12 were convened to explore the science of identifying and characterizing uncertainty in scientific evidence and approaches to translate uncertainties into decisions that reflect the values of stakeholders. The May 12 workshop presentations and discussions explored tools and approaches to communicating about scientific uncertainties to a range of stakeholders in the drug development process. Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products summarizes the presentation and discussion of both events. This report explores potential analytical and communication approaches and identifies key considerations on their development, evaluation, and incorporation into pharmaceutical benefit- risk assessment throughout the entire drug development lifecycle"--