@BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Ruby Takanishi and Suzanne Le Menestrel", title = "Promoting the Educational Success of Children and Youth Learning English: Promising Futures", isbn = "978-0-309-45537-4", abstract = "Educating dual language learners (DLLs) and English learners (ELs) effectively is a national challenge with consequences both for individuals and for American society. Despite their linguistic, cognitive, and social potential, many ELs\u2014who account for more than 9 percent of enrollment in grades K-12 in U.S. schools\u2014are struggling to meet the requirements for academic success, and their prospects for success in postsecondary education and in the workforce are jeopardized as a result.\nPromoting the Educational Success of Children and Youth Learning English: Promising Futures examines how evidence based on research relevant to the development of DLLs\/ELs from birth to age 21 can inform education and health policies and related practices that can result in better educational outcomes. This report makes recommendations for policy, practice, and research and data collection focused on addressing the challenges in caring for and educating DLLs\/ELs from birth to grade 12.", url = "https://nap.nationalacademies.org/catalog/24677/promoting-the-educational-success-of-children-and-youth-learning-english", year = 2017, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", title = "Taking Care of Kids: English Version", isbn = "978-0-309-30373-6", abstract = "Communities across the United States face the threat of emergencies and disasters nearly every day. Although children represent about 25 percent of the U.S. population, current state and local disaster preparedness plans often do not include specific considerations for children and families. The preparedness and resilience of communities in areas related to children requires a systems framework that incorporates traditional and non-traditional medical and public health stakeholders - including community organizations, schools, and other partners in municipal planning. The Institute of Medicine's poster, Taking Care of Kids, provides resources to assist parents, child care providers, schools, and pediatricians in preparing for, responding to, and recovering from disasters. Based on the recent report Preparedness, Response, and Recovery Considerations for Children and Families: Workshop Summary, this poster (11 x 36 inches) is a useful resource and reminder of the special needs of children in crisis situations.", url = "https://nap.nationalacademies.org/catalog/18757/taking-care-of-kids-english-version", year = 2014, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Joe Alper", title = "Integrating Health Literacy, Cultural Competence, and Language Access Services: Workshop Summary", isbn = "978-0-309-44237-4", abstract = "The aging and evolving racial and ethnic composition of the U.S. population has the United States in the midst of a profound demographic shift and health care organizations face many issues as they move to address and adapt to this change. In their drive to adequately serve increasingly diverse communities, health care organizations are searching for approaches that will enable them to provide information and service to all persons, regardless of age, race, cultural background, or language skills, in a manner that facilitates understanding and use of that information to make appropriate health decisions. \n\nTo better understand how the dynamic forces operating in health care today impact the delivery of services in a way that is health literate, culturally competent, and in an appropriate language for patients and their families, the National Academies of Sciences, Engineering, and Medicine conducted a public workshop on the integration of health literacy, cultural competency, and language access services. Participants discussed skills and competencies needed for effective health communication, including health literacy, cultural competency, and language access services; interventions and strategies for integration; and differing perspectives such as providers and systems, patients and families, communities, and payers. This report summarizes the presentations and discussions from the workshop.", url = "https://nap.nationalacademies.org/catalog/23498/integrating-health-literacy-cultural-competence-and-language-access-services-workshop", year = 2016, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", title = "Infographic Poster for Accelerating Progress in Obesity Prevention: English version", isbn = "978-0-309-26155-5", url = "https://nap.nationalacademies.org/catalog/13458/infographic-poster-for-accelerating-progress-in-obesity-prevention-english-version", year = 2012, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", title = "Breast Cancer and the Environment: Questions and Answers: English Version", isbn = "978-0-309-31164-9", abstract = "Throughout their lives, women have experiences and make decisions that can influence their chances of getting breast cancer. While we have little control over some of these risk factors, we can sometimes make choices - good or bad - that affect our risk of getting breast cancer. In a 2011 Institute of Medicine (IOM) report, obesity, alcohol consumptions, and some medical treatments were found to raise these risks at least a little. For other factors, the evidence wasn't as clear. Look through this question and answer booklet to learn more.", url = "https://nap.nationalacademies.org/catalog/18937/breast-cancer-and-the-environment-questions-and-answers-english-version", year = 2014, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Joe Alper", title = "A Proposed Framework for Integration of Quality Performance Measures for Health Literacy, Cultural Competence, and Language Access Services: Proceedings of a Workshop", isbn = "978-0-309-46672-1", abstract = "Health literacy, cultural competence, and language access services are distinct but inextricably linked concepts for delivering equitable care to all members of the increasingly diverse population of the United States. These concepts are linked, but they developed via different paths, and each has its own unique focus with regard to enabling every individual to obtain the ability to process and understand basic health information and services needed to make appropriate health care decisions. Fragmentation of these disciplines has impeded implementation of relevant measures for quality improvement and accountability. \n\nTo foster an integrated approach to health literacy, cultural competency, and language access services, the Roundtable on Health Literacy initiated a project with three components: a commissioned paper to propose a framework for integrating measurements of health literacy, cultural competency, and language access; a workshop to review and discuss the framework; and a second commissioned paper that will provide a roadmap for integrating health literacy, cultural competency, and language access services as well as a revised measurement framework. Held on May 4, 2017, the workshop explored the quality performance measures for integration of health literacy, cultural competence, and language access services. This publication summarizes the presentations and discussions from the workshop.", url = "https://nap.nationalacademies.org/catalog/24918/a-proposed-framework-for-integration-of-quality-performance-measures-for-health-literacy-cultural-competence-and-language-access-services", year = 2018, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine and National Academies of Sciences, Engineering, and Medicine", editor = "Sara Rosenbaum and Patti Simon", title = "Speech and Language Disorders in Children: Implications for the Social Security Administration's Supplemental Security Income Program", isbn = "978-0-309-38875-7", abstract = "Speech and language are central to the human experience; they are the vital means by which people convey and receive knowledge, thoughts, feelings, and other internal experiences. Acquisition of communication skills begins early in childhood and is foundational to the ability to gain access to culturally transmitted knowledge, organize and share thoughts and feelings, and participate in social interactions and relationships. Thus, speech disorders and language disorders\u2014disruptions in communication development\u2014can have wide-ranging and adverse impacts on the ability to communicate and also to acquire new knowledge and fully participate in society. Severe disruptions in speech or language acquisition have both direct and indirect consequences for child and adolescent development, not only in communication, but also in associated abilities such as reading and academic achievement that depend on speech and language skills.\nThe Supplemental Security Income (SSI) program for children provides financial assistance to children from low-income, resource-limited families who are determined to have conditions that meet the disability standard required under law. Between 2000 and 2010, there was an unprecedented rise in the number of applications and the number of children found to meet the disability criteria. The factors that contribute to these changes are a primary focus of this report.\nSpeech and Language Disorders in Children provides an overview of the current status of the diagnosis and treatment of speech and language disorders and levels of impairment in the U.S. population under age 18. This study identifies past and current trends in the prevalence and persistence of speech disorders and language disorders for the general U.S. population under age 18 and compares those trends to trends in the SSI childhood disability population.", url = "https://nap.nationalacademies.org/catalog/21872/speech-and-language-disorders-in-children-implications-for-the-social", year = 2016, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Cheryl Ulmer and Bernadette McFadden and David R. Nerenz", title = "Race, Ethnicity, and Language Data: Standardization for Health Care Quality Improvement", isbn = "978-0-309-14012-6", abstract = "The goal of eliminating disparities in health care in the United States remains elusive. Even as quality improves on specific measures, disparities often persist. Addressing these disparities must begin with the fundamental step of bringing the nature of the disparities and the groups at risk for those disparities to light by collecting health care quality information stratified by race, ethnicity and language data. Then attention can be focused on where interventions might be best applied, and on planning and evaluating those efforts to inform the development of policy and the application of resources. A lack of standardization of categories for race, ethnicity, and language data has been suggested as one obstacle to achieving more widespread collection and utilization of these data. \nRace, Ethnicity, and Language Data identifies current models for collecting and coding race, ethnicity, and language data; reviews challenges involved in obtaining these data, and makes recommendations for a nationally standardized approach for use in health care quality improvement. \n ", url = "https://nap.nationalacademies.org/catalog/12696/race-ethnicity-and-language-data-standardization-for-health-care-quality", year = 2009, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Maria Hewitt", title = "Facilitating State Health Exchange Communication Through the Use of Health Literate Practices: Workshop Summary", isbn = "978-0-309-22029-3", abstract = "Implementation of the Affordable Care Act (ACA) of 2010 will result in significant changes to the U.S. health care system. Among its many provisions, the ACA will extend access to health care coverage to millions of Americans who have been previously uninsured. Many of the newly eligible health insurance consumers will be individuals of low health literacy, some speakers of English and others more comfortable using languages other than English. Health insurance terms such as \"deductible,\" \"co-insurance,\" and \"out-of-pocket limit\" are difficult to communicate even to those with moderate-to-high levels of health literacy and so health exchanges will face challenges as they attempt to communicate to the broader community. In addition to having to convey some of these basic, and yet complex, principles of insurance, state exchanges will be attempting to adapt to the many changes to enrollment and eligibility brought about by ACA.\n\nThe Institute of Medicine (IOM) convened the Roundtable on Health Literacy that brings together leaders from the federal government, foundations, health plans, associations, and private companies to discuss challenges facing health literacy practice and research and to identify approaches to promote health literacy in both the public and private sectors. The roundtable sponsored a workshop in Washington, DC, on July 19, 2011, that focused on ways in which health literacy can facilitate state health insurance exchange communication with potential enrollees. The roundtable's workshop focused on four topics: (1) lessons learned from existing state insurance exchanges; (2) the impact of state insurance exchanges on consumers; (3) the relevance of health literacy to health insurance exchanges; and (4) current best practices in developing materials and communicating with consumers.\n\nFacilitating State Health Exchange Communication Through the Use of Health Literate Practices summarizes the presentations and discussion that occurred during the workshop. The report provides an overview of health insurance exchanges, presents evidence on the extent to which consumers understand underlying health insurance concepts, and describes the relevancy of health literacy to health insurance reform and how health literacy interventions can facilitate the implementation of health insurance reforms. The report also provides a review of best practices in developing materials and communicating with consumers, and concludes with reflections on the workshop presentations and discussions by members of the roundtable and its chair. Further information is provided in the appendixes, the workshop agenda (Appendix A), workshop speaker biosketches (Appendix B), and testimony provided by the organization America's Health Insurance Plans (AHIP) (Appendix C).", url = "https://nap.nationalacademies.org/catalog/13255/facilitating-state-health-exchange-communication-through-the-use-of-health-literate-practices", year = 2012, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP editor = "Kenneth W. Kizer and Rebecca A. English and Meredith Hackmann", title = "Realizing the Promise of Equity in the Organ Transplantation System", isbn = "978-0-309-27072-4", abstract = "Each year, the individuals and organizations in the U.S. organ donation, procurement, allocation, and distribution system work together to provide transplants to many thousands of people, but thousands more die before getting a transplant due to the ongoing shortage of deceased donor organs and inequitable access to transplant waiting lists.\nRealizing the Promise of Equity in the Organ Transplantation System, a new consensus study report from the National Academies of Sciences, Engineering, and Medicine\u2019s Committee on A Fairer and More Equitable, Cost-Effective, and Transparent System of Donor Organ Procurement, Allocation, and Distribution, provides expert recommendations to improve fairness, equity, transparency, and cost-effectiveness in the donor organ system.", url = "https://nap.nationalacademies.org/catalog/26364/realizing-the-promise-of-equity-in-the-organ-transplantation-system", year = 2022, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Kelly McHugh and Rose Marie Martinez and Joe Alper", title = "Adoption of Health Literacy Best Practices to Enhance Clinical Research and Community Participation: Proceedings of a Workshop—in Brief", abstract = "Clinical research is critical to developing new treatments and therapies for patients. To maximize societal benefit and health equity, it is important that clinical research information be accessible and inclusive, and participants should be representative of the patient population. To explore the role that patient comprehension of clinical research can have in delivering high-quality clinical care and in increasing the diversity of the populations enrolled in clinical research, the National Academies of Sciences, Engineering, and Medicine's Roundtable on Health Literacy held a virtual public workshop on October 28, 2021.\nWorkshop attendees discussed current and promising resources and approaches for ensuring that the public receives clinical research information in accessible language that promotes health literacy. They also discussed strategies for integrating clinical research information into various care and community settings to improve research awareness and engagement. This Proceedings of a Workshop-in Brief highlights the presentations and discussions of the workshop.", url = "https://nap.nationalacademies.org/catalog/26506/adoption-of-health-literacy-best-practices-to-enhance-clinical-research-and-community-participation", year = 2022, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Rebecca English and Lyle Carrera and Ashley Bologna and Joe Alper", title = "Amyotrophic Lateral Sclerosis: Accelerating Treatments and Improving Quality of Life: Proceedings of a Workshop–in Brief", abstract = "Amyotrophic lateral sclerosis (ALS) is a rapidly progressive, invariably fatal neurological disease. No present treatments can stop or reverse the disease, although Food and Drug Administration (FDA)-approved formulations may extend life by several months. As part of the information-gathering phase of a study on ALS, the National Academies Board on Health Care Services and Board on Health Sciences Policy cohosted a virtual public workshop series in August and September 2023 to identify key actions for the public, private, and nonprofit sectors to undertake to make ALS a livable disease within a decade. Speakers explored topics including access to high-quality, evidence-based ALS care, the lived experience of ALS, and ALS research and therapeutic development. This publication summarizes the presentations and discussion of the workshop.", url = "https://nap.nationalacademies.org/catalog/27395/amyotrophic-lateral-sclerosis-accelerating-treatments-and-improving-quality-of-life", year = 2023, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Joe Alper and Rose Marie Martinez and Kelly McHugh", title = "Optimizing Care Systems for People with Intellectual and Developmental Disabilities: Proceedings of a Workshop", isbn = "978-0-309-69060-7", abstract = "Approximately 7.4 million people in the United States live with an intellectual or developmental disability (IDD), defined by the Centers for Disease Control and Prevention as \"a group of conditions due to an impairment in physical, learning, language, or behavior areas. These conditions begin during the developmental period, may impact day-to-day functioning, and usually last throughout a person\u2019s lifetime.\" Individuals with IDD and their caretakers face exceptional barriers to staying healthy and accessing appropriate health services. Among these barriers are difficulty finding care providers that are adequately trained in meeting their specialized needs, unwieldy payment structures, and a lack of coordination between the various systems of care with which patients with IDD may interact (e.g., education, social work, various segments of the health care system).\nThe National Academies of Sciences, Engineering, and Medicine hosted a workshop to discuss promising innovations in (1) workforce development, (2) financing and payment, and (3) care coordination; and to share visions for improved systems of care. Participants noted that while many existing approaches could serve as models for improving care, large changes will need to be made in these 3 facets of the care system in order to make them accessible to all IDD patients. This publication summarizes the presentations and discussions of the workshop.", url = "https://nap.nationalacademies.org/catalog/26624/optimizing-care-systems-for-people-with-intellectual-and-developmental-disabilities", year = 2022, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Kat M. Anderson", title = "Contact Tracing and the Challenges of Health Equity in Vulnerable Latino and Native American Communities: Proceedings of a Workshop—in Brief", abstract = "Communities of color are experiencing significantly higher rates of COVID-19 infection and significantly higher mortality rates when compared to white Americans. It is critical that contact tracing efforts are executed in ways that are appropriate to those communities experiencing a greater burden of COVID-19. In some cases these efforts should take into account the distrust some communities have in health care systems and providers. Other issues relevant to contact tracing include language, cultural competency, health literacy, stigma, and privacy concerns, particularly in multigenerational households. Furthermore, contact tracers may identify individuals who lack access to care and\/or health insurance, or the supportive services needed to isolate if they test positive, and some individuals will be residents without documentation. Recruiting and building a new cadre of contact tracers should meet the immediate goal of addressing the pandemic, but attention could also be paid to building a public health infrastructure in communities that supports health equity.\nThe National Academies of Sciences, Engineering, and Medicine's Roundtable on the Promotion of Health Equity hosted a public webinar titled, Doing It Right: Contact Tracing and Health Equity, on July 30, 2020, which focused on the role of contact tracing for vulnerable groups, in this case, Native Americans and Latino communities, during the COVID-19 pandemic. This publication provides a summary of the discussions from the workshop.", url = "https://nap.nationalacademies.org/catalog/26174/contact-tracing-and-the-challenges-of-health-equity-in-vulnerable-latino-and-native-american-communities", year = 2021, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "National Academies of Sciences, Engineering, and Medicine", editor = "Enriqueta C. Bond and Sean Mackey and Rebecca English and Cathy T. Liverman and Olivia Yost", title = "Temporomandibular Disorders: Priorities for Research and Care", isbn = "978-0-309-67048-7", abstract = "Temporomandibular disorders (TMDs), are a set of more than 30 health disorders associated with both the temporomandibular joints and the muscles and tissues of the jaw. TMDs have a range of causes and often co-occur with a number of overlapping medical conditions, including headaches, fibromyalgia, back pain and irritable bowel syndrome. TMDs can be transient or long-lasting and may be associated with problems that range from an occasional click of the jaw to severe chronic pain involving the entire orofacial region. Everyday activities, including eating and talking, are often difficult for people with TMDs, and many of them suffer with severe chronic pain due to this condition. Common social activities that most people take for granted, such as smiling, laughing, and kissing, can become unbearable. This dysfunction and pain, and its associated suffering, take a terrible toll on affected individuals, their families, and their friends. Individuals with TMDs often feel stigmatized and invalidated in their experiences by their family, friends, and, often, the health care community. Misjudgments and a failure to understand the nature and depths of TMDs can have severe consequences - more pain and more suffering - for individuals, their families and our society.\nTemporomandibular Disorders: Priorities for Research and Care calls on a number of stakeholders - across medicine, dentistry, and other fields - to improve the health and well-being of individuals with a TMD. This report addresses the current state of knowledge regarding TMD research, education and training, safety and efficacy of clinical treatments of TMDs, and burden and costs associated with TMDs. The recommendations of Temporomandibular Disorders focus on the actions that many organizations and agencies should take to improve TMD research and care and improve the overall health and well-being of individuals with a TMD.", url = "https://nap.nationalacademies.org/catalog/25652/temporomandibular-disorders-priorities-for-research-and-care", year = 2020, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", title = "Taking Care of Kids: Spanish Version", isbn = "978-0-309-30374-3", abstract = "Communities across the United States face the threat of emergencies and disasters nearly every day. Although children represent about 25 percent of the U.S. population, current state and local disaster preparedness plans often do not include specific considerations for children and families. The preparedness and resilience of communities in areas related to children requires a systems framework that incorporates traditional and non-traditional medical and public health stakeholders - including community organizations, schools, and other partners in municipal planning. The Institute of Medicine's poster, Taking Care of Kids, provides resources to assist parents, child care providers, schools, and pediatricians in preparing for, responding to, and recovering from disasters. Based on the recent report Preparedness, Response, and Recovery Considerations for Children and Families: Workshop Summary, this poster (11 x 36 inches) is a useful resource and reminder of the special needs of children in crisis situations.\n \nThe poster is also available in English. Click here to purchase the English version.", url = "https://nap.nationalacademies.org/catalog/18758/taking-care-of-kids-spanish-version", year = 2014, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Leslie Pray and Laura Pillsbury", title = "Leveraging Food Technology for Obesity Prevention and Reduction Efforts: Workshop Summary", isbn = "978-0-309-21261-8", abstract = "Obesity is a major public health challenge. More than one-third of the U.S. adult population is considered obese, a figure that has more than doubled since the mid-1970s. Among children, obesity rates have more than tripled over the same period. Not only is obesity associated with numerous medical complications, but it incurs significant economic cost. At its simplest, obesity is a result of an energy imbalance, with obese (and overweight) people consuming more energy (calories) than they are expending.\n\nDuring the last 10-20 years, behavioral scientists have made significant progress toward building an evidence base for understanding what drives energy imbalance in overweight and obese individuals. Meanwhile, food scientists have been tapping into this growing evidence base to improve existing technologies and create new technologies that can be applied to alter the food supply in ways that reduce the obesity burden on the American population. Leveraging Food Technology for Obesity Prevention and Reduction Effort examines the complexity of human eating behavior and explores ways in which the food industry can continue to leverage modern food processing technologies to influence energy intake. The report also examines the opportunities and challenges of altering the food supply--both at home and outside the home--and outlines lessons learned, best practices, and next steps.", url = "https://nap.nationalacademies.org/catalog/13153/leveraging-food-technology-for-obesity-prevention-and-reduction-efforts-workshop", year = 2011, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine and National Academies of Sciences, Engineering, and Medicine", editor = "Anne Claiborne and Rebecca English and Jeffrey Kahn", title = "Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations", isbn = "978-0-309-38870-2", abstract = "Mitochondrial replacement techniques (MRTs) are designed to prevent the transmission of mitochondrial DNA (mtDNA) diseases from mother to child. While MRTs, if effective, could satisfy a desire of women seeking to have a genetically related child without the risk of passing on mtDNA disease, the technique raises significant ethical and social issues. It would create offspring who have genetic material from two women, something never sanctioned in humans, and would create mitochondrial changes that could be heritable (in female offspring), and therefore passed on in perpetuity. The manipulation would be performed on eggs or embryos, would affect every cell of the resulting individual, and once carried out this genetic manipulation is not reversible.\n\nMitochondrial Replacement Techniques considers the implications of manipulating mitochondrial content both in children born to women as a result of participating in these studies and in descendants of any female offspring. This study examines the ethical and social issues related to MRTs, outlines principles that would provide a framework and foundation for oversight of MRTs, and develops recommendations to inform the Food and Drug Administration's consideration of investigational new drug applications.\n", url = "https://nap.nationalacademies.org/catalog/21871/mitochondrial-replacement-techniques-ethical-social-and-policy-considerations", year = 2016, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Victoria Weisfeld and Rebecca A. English and Anne B. Claiborne", title = "Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary", isbn = "978-0-309-21929-7", abstract = "Clinical trials provide essential information needed to turn basic medical research findings into patient treatments. New treatments must be studied in large numbers of humans to find out whether they are effective and to assess any harm that may arise from treatment. There is growing recognition among many stakeholders that the U.S. clinical trials enterprise is unable to keep pace with the national demand for research results. The IOM, along with the Mount Sinai School of Medicine, held a workshop June 27-28, 2011, to engage stakeholders and experts in a discussion about possible solutions to improve public engagement in clinical trials.", url = "https://nap.nationalacademies.org/catalog/13237/public-engagement-and-clinical-trials-new-models-and-disruptive-technologies", year = 2012, publisher = "The National Academies Press", address = "Washington, DC" } @BOOK{NAP author = "Institute of Medicine", editor = "Denise Caruso and Rebecca A. English and Anne B. Claiborne", title = "Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products: Workshop Summary", isbn = "978-0-309-31000-0", abstract = "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. \nOn 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\nconsiderations on their development, evaluation, and incorporation into pharmaceutical benefit-\nrisk assessment throughout the entire drug development lifecycle. \n", url = "https://nap.nationalacademies.org/catalog/18870/characterizing-and-communicating-uncertainty-in-the-assessment-of-benefits-and-risks-of-pharmaceutical-products", year = 2014, publisher = "The National Academies Press", address = "Washington, DC" }