There are many connections between human communities and their surrounding environments that influence community resilience and health in the Gulf of Mexico. The impacts of the Deepwater Horizon oil spill on Gulf communities and ecosystems - coupled with the region's preexisting health challenges and environmental stressors - illustrate the need to better understand these connections. In the future, natural and man-made disasters, climate change impacts, and other environmental stressors will present complex challenges to the physical, mental, and social well-being of communities in the Gulf. Understanding the interrelationships among health, ecological, and economic impacts of disasters and other environmental stressors will be crucial to addressing these challenges. Opportunities for the Gulf Research Program: Community Resilience and Health summarizes a Gulf Research Program workshop held on September 22-23, 2014, in New Orleans, Louisiana. The workshop examined opportunities to improve the health, well-being, and resilience of communities in the Gulf region through discussions with about 50 participants with diverse expertise and experience. These discussions identified perceived needs, challenges, and opportunities that align with the Gulf Research Program's mission and goals - particularly its goal to improve understanding of the connections between human health and the environment to support the development of health and resilient Gulf communities. This workshop is expected to lead to the development of additional Program activities and opportunities for the research community. Table of Contents Front Matter 1 Introduction 2 Human Health, Public Health Practice, and Community Resilience 3 Perspectives on Resilient Communities 4 Reducing Risk and Improving Disaster Recovery 5 Building Resilience in the Gulf Region 6 Capacity to Address Environmental Health Risks 7 Long-term Opportunities 8 Lasting Benefit References A--Workshop Agenda B--Statement of Task C--Speaker Biographies D--Workshop Attendees E--Related Funding Programs

Recent scientific and technological advances have accelerated our understanding of the causes of disease development and progression, and resulted in innovative treatments and therapies. Ongoing work to elucidate the effects of individual genetic variation on patient outcomes suggests the rapid pace of discovery in the biomedical sciences will only accelerate. However, these advances belie an important and increasing shortfall between the expansion in therapy and treatment options and knowledge about how these interventions might be applied appropriately to individual patients. The impressive gains made in Americans' health over the past decades provide only a preview of what might be possible when data on treatment effects and patient outcomes are systematically captured and used to evaluate their effectiveness. Needed for progress are advances as dramatic as those experienced in biomedicine in our approach to assessing clinical effectiveness. In the emerging era of tailored treatments and rapidly evolving practice, ensuring the translation of scientific discovery into improved health outcomes requires a new approach to clinical evaluation. A paradigm that supports a continual learning process about what works best for individual patients will not only take advantage of the rigor of trials, but also incorporate other methods that might bring insights relevant to clinical care and endeavor to match the right method to the question at hand. The Institute of Medicine Roundtable on Value & Science-Driven Health Care's vision for a learning healthcare system, in which evidence is applied and generated as a natural course of care, is premised on the development of a research capacity that is structured to provide timely and accurate evidence relevant to the clinical decisions faced by patients and providers. As part of the Roundtable's Learning Healthcare System series of workshops, clinical researchers, academics, and policy makers gathered for the workshop "Redesigning the Clinical Effectiveness Research Paradigm: Innovation and Practice-Based Approaches." Participants explored cutting-edge research designs and methods and discussed strategies for development of a research paradigm to better accommodate the diverse array of emerging data resources, study designs, tools, and techniques. Presentations and discussions are summarized in this volume.

Fungal diseases have contributed to death and disability in humans, triggered global wildlife extinctions and population declines, devastated agricultural crops, and altered forest ecosystem dynamics. Despite the extensive influence of fungi on health and economic well-being, the threats posed by emerging fungal pathogens to life on Earth are often underappreciated and poorly understood. On December 14 and 15, 2010, the IOM's Forum on Microbial Threats hosted a public workshop to explore the scientific and policy dimensions associated with the causes and consequences of emerging fungal diseases. Table of Contents Front Matter Workshop Overview Appendix A: Contributed Manuscripts Appendix B: Agenda Appendix C: Acronyms Appendix D: Glossary Appendix E: Forum Member Biographies Appendix FSpeaker Biographies

It is essential for patients and clinicians to have the resources needed to make informed, collaborative care decisions. Despite this need, only a small fraction of health-related expenditures in the United States have been devoted to comparative effectiveness research (CER). To improve the effectiveness and value of the care delivered, the nation needs to build its capacity for ongoing study and monitoring of the relative effectiveness of clinical interventions and care processes through expanded trials and studies, systematic reviews, innovative research strategies, and clinical registries, as well as improving its ability to apply what is learned from such study through the translation and provision of information and decision support. As part of its Learning Health System series of workshops, the Institute of Medicine's (IOM's) Roundtable on Value & Science-Driven Health Care hosted a workshop to discuss capacity priorities to build the evidence base necessary for care that is more effective and delivers higher value for patients. Learning What Works summarizes the proceedings of the seventh workshop in the Learning Health System series. This workshop focused on the infrastructure needs-including methods, coordination capacities, data resources and linkages, and workforce-for developing an expanded and efficient national capacity for CER. Learning What Works also assesses the current and needed capacity to expand and improve this work, and identifies priority next steps. Learning What Works is a valuable resource for health care professionals, as well as health care policy makers. Table of Contents Front Matter Summary 1 The Need and Potential Returns for Comparative Effectiveness Research 2 The Work Required 3 The Information Networks Required 4 The Talent Required 5 Implementation Priorities 6 Moving Forward Appendix A: Learning What Works Best: The Nation's Need for Evidence on Comparative Effectiveness in Health Care Appendix B: Comparative Effectiveness Studies Inventory Project Appendix C: Comparative Effectiveness Research Priorities: IOM Recommendations (2009) Appendix D: Comparative Effectiveness Research Priorities: FCCCER Recommendations (2009) Appendix E: Affordable Care Act (ACA) (2010) Provisions for the Patient-Centered Outcomes Research Institute (PCORI) Appendix F: Workshop Agenda Appendix G: Biographical Sketches of Workshop Participants Appendix H: Workshop Attendee List Other Publications in The Learning Health System Series

Over the past several decades, new scientific tools and approaches for detecting microbial species have dramatically enhanced our appreciation of the diversity and abundance of the microbiota and its dynamic interactions with the environments within which these microorganisms reside. The first bacterial genome was sequenced in 1995 and took more than 13 months of work to complete. Today, a microorganism's entire genome can be sequenced in a few days. Much as our view of the cosmos was forever altered in the 17th century with the invention of the telescope, these genomic technologies, and the observations derived from them, have fundamentally transformed our appreciation of the microbial world around us. On June 12 and 13, 2012, the Institute of Medicine's (IOM's) Forum on Microbial Threats convened a public workshop in Washington, DC, to discuss the scientific tools and approaches being used for detecting and characterizing microbial species, and the roles of microbial genomics and metagenomics to better understand the culturable and unculturable microbial world around us. Through invited presentations and discussions, participants examined the use of microbial genomics to explore the diversity, evolution, and adaptation of microorganisms in a wide variety of environments; the molecular mechanisms of disease emergence and epidemiology; and the ways that genomic technologies are being applied to disease outbreak trace back and microbial surveillance. Points that were emphasized by many participants included the need to develop robust standardized sampling protocols, the importance of having the appropriate metadata, data analysis and data management challenges, and information sharing in real time. The Science and Applications of Microbial Genomics summarizes this workshop. Table of Contents Front Matter Workshop Overview Appendix A Appendix B--Agenda Appendix C--Acronyms Appendix D--Glossary Appendix E--Speaker Biographies

Beginning with the germ theory of disease in the 19th century and extending through most of the 20th century, microbes were believed to live their lives as solitary, unicellular, disease-causing organisms . This perception stemmed from the focus of most investigators on organisms that could be grown in the laboratory as cellular monocultures, often dispersed in liquid, and under ambient conditions of temperature, lighting, and humidity. Most such inquiries were designed to identify microbial pathogens by satisfying Koch's postulates.3 This pathogen-centric approach to the study of microorganisms produced a metaphorical "war" against these microbial invaders waged with antibiotic therapies, while simultaneously obscuring the dynamic relationships that exist among and between host organisms and their associated microorganisms-only a tiny fraction of which act as pathogens. Despite their obvious importance, very little is actually known about the processes and factors that influence the assembly, function, and stability of microbial communities. Gaining this knowledge will require a seismic shift away from the study of individual microbes in isolation to inquiries into the nature of diverse and often complex microbial communities, the forces that shape them, and their relationships with other communities and organisms, including their multicellular hosts. On March 6 and 7, 2012, the Institute of Medicine's (IOM's) Forum on Microbial Threats hosted a public workshop to explore the emerging science of the "social biology" of microbial communities. Workshop presentations and discussions embraced a wide spectrum of topics, experimental systems, and theoretical perspectives representative of the current, multifaceted exploration of the microbial frontier. Participants discussed ecological, evolutionary, and genetic factors contributing to the assembly, function, and stability of microbial communities; how microbial communities adapt and respond to environmental stimuli; theoretical and experimental approaches to advance this nascent field; and potential applications of knowledge gained from the study of microbial communities for the improvement of human, animal, plant, and ecosystem health and toward a deeper understanding of microbial diversity and evolution. The Social Biology of Microbial Communities: Workshop Summary further explains the happenings of the workshop. Table of Contents Front Matter Workshop Overview Appendix A: Contributed Manuscripts Appendix B: Agenda Appendix C: Acronyms Appendix D: Glossary Appendix E: Speaker Biographies

As past, current, or future patients, the public should be the health care system's unwavering focus and serve as change agents in its care. Taking this into account, the quality of health care should be judged not only by whether clinical decisions are informed by the best available scientific evidence, but also by whether care is tailored to a patient's individual needs and perspectives. However, too often it is provider preference and convenience, rather than those of the patient, that drive what care is delivered. As part of its Learning Health System series of workshops, the Roundtable on Value & Science-Driven Health Care hosted a workshop to assess the prospects for improving health and lowering costs by advancing patient involvement in the elements of a learning health system. Table of Contents Front Matter Synopsis and Overview 1 The Learning Health System 2 Clinical Research, Patient Care, and Learning That Is Real-Time and Continuous 3 Clinical Data as a Public Good for Discovery 4 Engaging Patients to Improve Science and Value in a Learning Health System 5 Health Information Technology as the Engine for Learning 6 Patients, Clinical Decisions, and Health Information Management in the Information Age 7 Applying Evidence for Patient-Centered Care: Standards and Expectations 8 Team-Based Care and the Learning Culture 9 Incentives Aligned with Value and Learning 10 Common Themes and Opportunities for Action Appendixes Appendix A: Workshop Agenda Appendix B: Biographical Sketches of Workshop Participants Appendix C: Workshop Attendee List Appendix D: The Learning Health System Series: Workshop Common Themes OTHER PUBLICATIONS IN THE LEARNING HEALTH SYSTEM SERIES

Improving our nation's healthcare system is a challenge which, because of its scale and complexity, requires a creative approach and input from many different fields of expertise. Lessons from engineering have the potential to improve both the efficiency and quality of healthcare delivery. The fundamental notion of a high-performing healthcare system-one that increasingly is more effective, more efficient, safer, and higher quality-is rooted in continuous improvement principles that medicine shares with engineering. As part of its Learning Health System series of workshops, the Institute of Medicine's Roundtable on Value and Science-Driven Health Care and the National Academy of Engineering, hosted a workshop on lessons from systems and operations engineering that could be applied to health care. Building on previous work done in this area the workshop convened leading engineering practitioners, health professionals, and scholars to explore how the field might learn from and apply systems engineering principles in the design of a learning healthcare system. Engineering a Learning Healthcare System: A Look at the Future: Workshop Summary focuses on current major healthcare system challenges and what the field of engineering has to offer in the redesign of the system toward a learning healthcare system. Table of Contents Front Matter Summary 1 Engineering a Learning Healthcare System 2 Engaging Complex Systems Through Engineering Concepts 3 Healthcare System Complexities, Impediments, and Failures 4 Case Studies in Transformation Through Systems Engineering 5 Fostering Systems Change to Drive Continuous Learning in Health Care 6 Next Steps: Aligning Policies with Leadership Opportunities Appendixes Appendix A: Workshop Agenda Appendix B: Biographical Sketches of Workshop Participants Appendix C: Workshop Attendee List Other Publications in The Learning Health System Series

Successful development of clinical data as an engine for knowledge generation has the potential to transform health and health care in America. As part of its Learning Health System Series, the Roundtable on Value & Science-Driven Health Care hosted a workshop to discuss expanding the access to and use of clinical data as a foundation for care improvement. Table of Contents Front Matter Summary 1 Clinical Data as the Basic Staple of the Learning Health System 2 U.S. Healthcare Data Today: Current State of Play 3 Changing the Terms: Data System Transformation in Progress 4 Healthcare Data: Public Good or Private Property? 5 Healthcare Data as a Public Good: Privacy and Security 6 Creating a Next-Generation Data Utility: Building Blocks and the Action Agenda 7 Engaging the Public 8 Clinical Data as the Basic Staple of Health Learning: Ideas for Action Appendixes Appendix A: Workshop Agenda Appendix B: Biographical Sketches of Workshop Participants Appendix C: Workshop Attendee List Appendix D: The IOM Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule Other Publications in the Learning Healthcare System Series

The United States has the highest per capita spending on health care of any industrialized nation. Yet despite the unprecedented levels of spending, harmful medical errors abound, uncoordinated care continues to frustrate patients and providers, and U.S. healthcare costs continue to increase. The growing ranks of the uninsured, an aging population with a higher prevalence of chronic diseases, and many patients with multiple conditions together constitute more complicating factors in the trend to higher costs of care. A variety of strategies are beginning to be employed throughout the health system to address the central issue of value, with the goal of improving the net ratio of benefits obtained per dollar spent on health care. However, despite the obvious need, no single agreed-upon measure of value or comprehensive, coordinated systemwide approach to assess and improve the value of health care exists. Without this definition and approach, the path to achieving greater value will be characterized by encumbrance rather than progress. To address the issues central to defining, measuring, and improving value in health care, the Institute of Medicine convened a workshop to assemble prominent authorities on healthcare value and leaders of the patient, payer, provider, employer, manufacturer, government, health policy, economics, technology assessment, informatics, health services research, and health professions communities. The workshop, summarized in this volume, facilitated a discussion of stakeholder perspectives on measuring and improving value in health care, identifying the key barriers and outlining the opportunities for next steps.

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, services, relationships, and participants. Each of the healthcare system's component sectors--patients, healthcare professionals, healthcare delivery organizations, healthcare product developers, clinical investigators and evaluators, regulators, insurers, employers and employees, and individuals involved in information technology--conducts activities that support a common goal: to improve patient health and wellbeing. Implicit in this goal is the commitment of each stakeholder group to contribute to the evidence base for health care, that is, to assist with the development and application of information about the efficacy, safety, effectiveness, value, and appropriateness of the health care delivered.

Individually and collectively, resident microbes play important roles in host health and survival. Shaping and shaped by their host environments, these microorganisms form intricate communities that are in a state of dynamic equilibrium. This ecologic and dynamic view of host-microbe interactions is rapidly redefining our view of health and disease. It is now accepted that the vast majority of microbes are, for the most part, not intrinsically harmful, but rather become established as persistent, co-adapted colonists in equilibrium with their environment, providing useful goods and services to their hosts while deriving benefits from these host associations. Disruption of such alliances may have consequences for host health, and investigations in a wide variety of organisms have begun to illuminate the complex and dynamic network of interaction - across the spectrum of hosts, microbes, and environmental niches - that influence the formation, function, and stability of host-associated microbial communities. Microbial Ecology in States of Health and Disease is the summary of a workshop convened by the Institute of Medicine's Forum on Microbial Threats in March 2013 to explore the scientific and therapeutic implications of microbial ecology in states of health and disease. Participants explored host-microbe interactions in humans, animals, and plants; emerging insights into how microbes may influence the development and maintenance of states of health and disease; the effects of environmental change(s) on the formation, function, and stability of microbial communities; and research challenges and opportunities for this emerging field of inquiry. Table of Contents Front Matter Workshop Overview A1 Effector and memory T cell responses to commensal bacteria--Yasmine Belkaid, Nicolas Bouladoux, and Timothy W. Hand A2 What are the consequences of the disappearing human microbiota?--Martin J. Blaser and Stanley Falkow A3 Pathways in microbe-induced obesity--Laura M. Cox and Martin J. Blaser A4 Microbial exposure during early life has persistent effects on natural killer T Cell function--Torsten Olszak, Dingding An, Sebastian Zeissig, Miguel Penilla Vera, Julia Richter, Andre Franke, Jonathan N. Glickman, Reiner Siebert, Rebecca M. Barron, Dennis L. Kasper, and Richard S. Blumberg A5 The application of ecological theory toward an understanding of the human microbiome--Elizabeth K. Costello, Keaton Stagaman, Les Dethlefsen, Brendan J. M. Bohannan, and David A. Relman A6 Seasonal restructuring of the ground squirrel gutmicrobiota over the annual hibernation cycle--Hannah V. Carey, William A. Walters, and Rob Knight A7 Lessons from studying insect symbioses--Angela E. Douglas A8 A new vision of immunity: homeostasis of the superorganism--Grard Eberl A9 Host defense and immunomodulation of mucosal candidiasis--Paul L. Fidel, Jr., and Mairi C. Noverr A10 Microbiota-targeted therapies: An ecological perspective--Katherine P. Lemon, Gary C. Armitage, David A. Relman, and Michael Fischbach A11 Community ecology and the vaginal microbiome--Larry J. Forney and Jacques Ravel A12 Investigating bacterial-animal symbioses with light sheet microscopy--Michael J. Taormina, Matthew Jemielita, W. Zac Stephens, Adam R. Burns, Joshua V. Troll, Raghuveer Parthasarathy, and Karen Guillemin A13 Clinical application of fecal microbiota transplantation in Clostridium difficile infection and beyond--Josbert J. Keller and Els van Nood A14 Consumption of human milk glycoconjugates by infant-associated bifidobacteria: Mechanisms and implications--Daniel Garrido, David C. Dallas, and David A. Mills A15 Bacteriophage adhering to mucus providea nonhost-derived immunity--Jeremy J. Barr, Rita Auro, Mike Furlan, Katrine L. Whiteson, Marcella L. Erb, Joe Pogliano, Aleksandr Stotland, Roland Wolkowicz, Andrew S. Cutting, Kelly S. Doran, Peter Salamon, Merry Youle, and Forest Rohwer A16 Topographic diversity of fungal and bacterial communities in human skin--Keisha Findley, Julia Oh, Joy Yang, Sean Conlan, Clayton Deming, Jennifer A. Meyer, Deborah Schoenfeld, Effie Nomicos, Morgan Park, NIH Intramural Sequencing Center Comparative Sequencing Program, Heidi H. Kong, and Julia A. Segre A17 Distinct microbial communities within the endosphere and rhizosphere of Populus deltoides roots across contrasting soil types--Neil R. Gottel, Hector F. Castro, Marilyn Kerley, Zamin Yang, Dale A. Pelletier, Mircea Podar, Tatiana Karpinets, Ed Uberbacher, Gerald A. Tuskan, Rytas Vilgalys, Mitchel J. Doktycz, and Christopher W. Schadt A18 Interactions between commensal fungi and the C-type lectin receptor Dectin-1 influence colitis--Iliyan D. Iliev, Vincent A. Funari, Kent D. Taylor, Quoclinh Nguyen, Christopher N. Reyes, Samuel P. Strom, Jordan Brown, Courtney A. Becker, Phillip R. Fleshner, Marla Dubinsky, Jerome I. Rotter, Hanlin L. Wang, Dermot P. B. McGovern, Gordon D. Brown, and David M. Underhill A19 Metagenomics and personalized medicine--Herbert W. Virgin and John A. Todd A20 From genetics of inflammatory bowel disease towards mechanistic insights--Daniel B. Graham and Ramnik J. Xavier A21 Antimicrobial peptides and the microbiome--Michael Zasloff Appendix B: Agenda Appendix C: Acronyms Appendix D: Glossary Appendix E: Speaker Biographies

Globalization of the food supply has created conditions favorable for the emergence, reemergence, and spread of food-borne pathogens-compounding the challenge of anticipating, detecting, and effectively responding to food-borne threats to health. In the United States, food-borne agents affect 1 out of 6 individuals and cause approximately 48 million illnesses, 128,000 hospitalizations, and 3,000 deaths each year. This figure likely represents just the tip of the iceberg, because it fails to account for the broad array of food-borne illnesses or for their wide-ranging repercussions for consumers, government, and the food industry-both domestically and internationally. A One Health approach to food safety may hold the promise of harnessing and integrating the expertise and resources from across the spectrum of multiple health domains including the human and veterinary medical and plant pathology communities with those of the wildlife and aquatic health and ecology communities. The IOM's Forum on Microbial Threats hosted a public workshop on December 13 and 14, 2011 that examined issues critical to the protection of the nation's food supply. The workshop explored existing knowledge and unanswered questions on the nature and extent of food-borne threats to health. Participants discussed the globalization of the U.S. food supply and the burden of illness associated with foodborne threats to health; considered the spectrum of food-borne threats as well as illustrative case studies; reviewed existing research, policies, and practices to prevent and mitigate foodborne threats; and, identified opportunities to reduce future threats to the nation's food supply through the use of a "One Health" approach to food safety. Improving Food Safety Through a One Health Approach: Workshop Summary covers the events of the workshop and explains the recommendations for future related workshops. Table of Contents Front Matter Workshop Overview Appendix A: Contributed Manuscripts Appendix B: Agenda Appendix C: Acronyms Appendix D: Glossary Appendix E: Speaker Biographies

The United States has the highest per capita spending on health care of any industrialized nation but continually lags behind other nations in health care outcomes including life expectancy and infant mortality. National health expenditures are projected to exceed $2.5 trillion in 2009. Given healthcare's direct impact on the economy, there is a critical need to control health care spending. According to The Health Imperative: Lowering Costs and Improving Outcomes, the costs of health care have strained the federal budget, and negatively affected state governments, the private sector and individuals. Healthcare expenditures have restricted the ability of state and local governments to fund other priorities and have contributed to slowing growth in wages and jobs in the private sector. Moreover, the number of uninsured has risen from 45.7 million in 2007 to 46.3 million in 2008. The Health Imperative: Lowering Costs and Improving Outcomes identifies a number of factors driving expenditure growth including scientific uncertainty, perverse economic and practice incentives, system fragmentation, lack of patient involvement, and under-investment in population health. Experts discussed key levers for catalyzing transformation of the delivery system. A few included streamlined health insurance regulation, administrative simplification and clarification and quality and consistency in treatment. The book is an excellent guide for policymakers at all levels of government, as well as private sector healthcare workers.

As our nation enters a new era of medical science that offers the real prospect of personalized health care, we will be confronted by an increasingly complex array of health care options and decisions. The Learning Healthcare System considers how health care is structured to develop and to apply evidence-from health profession training and infrastructure development to advances in research methodology, patient engagement, payment schemes, and measurement-and highlights opportunities for the creation of a sustainable learning health care system that gets the right care to people when they need it and then captures the results for improvement. This book will be of primary interest to hospital and insurance industry administrators, health care providers, those who train and educate health workers, researchers, and policymakers. The Learning Healthcare System is the first in a series that will focus on issues important to improving the development and application of evidence in health care decision making. The Roundtable on Evidence-Based Medicine serves as a neutral venue for cooperative work among key stakeholders on several dimensions: to help transform the availability and use of the best evidence for the collaborative health care choices of each patient and provider; to drive the process of discovery as a natural outgrowth of patient care; and, ultimately, to ensure innovation, quality, safety, and value in health care. Table of Contents Front Matter Summary 1 Hints of a Different Way-Case Studies in Practice-Based Evidence 2 The Evolving Evidence Base-Methodologic and Policy Challenges 3 Narrowing the Research-Practice Divide-Systems Considerations 4 New Approaches-Learning Systems in Progress 5 Developing the Test Bed: Linking Integrated Service Delivery Systems 6 The Patient as a Catalyst for Change 7 Training the Learning Health Professional 8 Structuring the Incentives for Change Appendix A Workshop Agenda Appendix B Biographical Sketches of Participants Appendix C Workshop Attendee List Appendix D IOM Roundtable on Evidence-Based Medicine