Redesigning The Clinical Effectiveness Research Paradigm

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Redesigning the Clinical Effectiveness Research Paradigm

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 030911988X
Total Pages : 442 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Redesigning the Clinical Effectiveness Research Paradigm by : Institute of Medicine

Download or read book Redesigning the Clinical Effectiveness Research Paradigm written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-20 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Redesigning the Clinical Effectiveness Research Paradigm

Author : Roundtable on Value and Science-Driven Health Care
Publisher :
ISBN 13 : 9780309385930
Total Pages : 442 pages
Book Rating : 4.3/5 (859 download)

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Book Synopsis Redesigning the Clinical Effectiveness Research Paradigm by : Roundtable on Value and Science-Driven Health Care

Download or read book Redesigning the Clinical Effectiveness Research Paradigm written by Roundtable on Value and Science-Driven Health Care and published by . This book was released on 2010-09-20 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Redesigning the Clinical Effectiveness Research Paradigm

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309162327
Total Pages : 442 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Redesigning the Clinical Effectiveness Research Paradigm by : Institute of Medicine

Download or read book Redesigning the Clinical Effectiveness Research Paradigm written by Institute of Medicine and published by National Academies Press. This book was released on 2010-09-20 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Patients Charting the Course

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309149932
Total Pages : 338 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Patients Charting the Course by : Institute of Medicine

Download or read book Patients Charting the Course written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-21 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Inquiry and Leadership: A Resource for the DNP Project

Author : Kathy Reavy
Publisher : F.A. Davis
ISBN 13 : 0803657846
Total Pages : 336 pages
Book Rating : 4.8/5 (36 download)

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Book Synopsis Inquiry and Leadership: A Resource for the DNP Project by : Kathy Reavy

Download or read book Inquiry and Leadership: A Resource for the DNP Project written by Kathy Reavy and published by F.A. Davis. This book was released on 2016-07-13 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: Here’s your guide to understanding, applying, and coordinating the process of evidence-based practice for your DNP scholarly or capstone project. Step-by-step, you’ll learn everything you need to know to successfully complete your project and develop the leadership skills that enhance the DNP’s role in practice.

Best Care at Lower Cost

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309282810
Total Pages : 437 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Best Care at Lower Cost by : Institute of Medicine

Download or read book Best Care at Lower Cost written by Institute of Medicine and published by National Academies Press. This book was released on 2013-05-10 with total page 437 pages. Available in PDF, EPUB and Kindle. Book excerpt: America's health care system has become too complex and costly to continue business as usual. Best Care at Lower Cost explains that inefficiencies, an overwhelming amount of data, and other economic and quality barriers hinder progress in improving health and threaten the nation's economic stability and global competitiveness. According to this report, the knowledge and tools exist to put the health system on the right course to achieve continuous improvement and better quality care at a lower cost. The costs of the system's current inefficiency underscore the urgent need for a systemwide transformation. About 30 percent of health spending in 2009-roughly $750 billion-was wasted on unnecessary services, excessive administrative costs, fraud, and other problems. Moreover, inefficiencies cause needless suffering. By one estimate, roughly 75,000 deaths might have been averted in 2005 if every state had delivered care at the quality level of the best performing state. This report states that the way health care providers currently train, practice, and learn new information cannot keep pace with the flood of research discoveries and technological advances. About 75 million Americans have more than one chronic condition, requiring coordination among multiple specialists and therapies, which can increase the potential for miscommunication, misdiagnosis, potentially conflicting interventions, and dangerous drug interactions. Best Care at Lower Cost emphasizes that a better use of data is a critical element of a continuously improving health system, such as mobile technologies and electronic health records that offer significant potential to capture and share health data better. In order for this to occur, the National Coordinator for Health Information Technology, IT developers, and standard-setting organizations should ensure that these systems are robust and interoperable. Clinicians and care organizations should fully adopt these technologies, and patients should be encouraged to use tools, such as personal health information portals, to actively engage in their care. This book is a call to action that will guide health care providers; administrators; caregivers; policy makers; health professionals; federal, state, and local government agencies; private and public health organizations; and educational institutions.

Envisioning a Transformed Clinical Trials Enterprise in the United States

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309253187
Total Pages : 248 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Envisioning a Transformed Clinical Trials Enterprise in the United States by : Institute of Medicine

Download or read book Envisioning a Transformed Clinical Trials Enterprise in the United States written by Institute of Medicine and published by National Academies Press. This book was released on 2012-09-13 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop.

Introduction to Quality and Safety Education for Nurses

Author : Carolyn Christie-McAuliffe, PhD, FNP
Publisher : Springer Publishing Company
ISBN 13 : 0826121837
Total Pages : 497 pages
Book Rating : 4.8/5 (261 download)

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Book Synopsis Introduction to Quality and Safety Education for Nurses by : Carolyn Christie-McAuliffe, PhD, FNP

Download or read book Introduction to Quality and Safety Education for Nurses written by Carolyn Christie-McAuliffe, PhD, FNP and published by Springer Publishing Company. This book was released on 2014-03-14 with total page 497 pages. Available in PDF, EPUB and Kindle. Book excerpt: Print+CourseSmart

Introduction to Quality and Safety Education for Nurses

Author : Diann Cameron Kelly, PhD, LMSW
Publisher : Springer Publishing Company
ISBN 13 : 0826121845
Total Pages : 496 pages
Book Rating : 4.8/5 (261 download)

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Book Synopsis Introduction to Quality and Safety Education for Nurses by : Diann Cameron Kelly, PhD, LMSW

Download or read book Introduction to Quality and Safety Education for Nurses written by Diann Cameron Kelly, PhD, LMSW and published by Springer Publishing Company. This book was released on 2014-03-14 with total page 496 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the first undergraduate textbook to provide a comprehensive overview of essential knowledge, skill, and attitudes about safety in nursing practice. It reflects the six areas of nursing competencies as developed by the Quality and Safety Education Program for Nurses (QSEN) initiative, which are currently required content in undergraduate nursing programs. Using an inter-professional focus, the book addresses the fundamental knowledge required of entry-level nurses in each of the six QSEN areas: quality improvement, patient safety, teamwork and collaboration, evidence-based practice, informatics, and patient-centered care. The book includes all of the content required for nursing programs to be accredited by AACN or NLN. Contributors include nurse educators, faculty, researchers, administrators, case managers, quality improvement practitioners, and entrepreneurs of nursing as well as physicians and librarians from throughout the U.S. Readers will be privy to the unique perspectives of different health care partners who provide real life examples from an inter-professional team perspective. These include pharmacists, lawyers, physicians, librarians, quality improvement nurses, radiology technologists, nurse practitioners, hospital board members, patients, and others. Each chapter includes objectives, opening scenarios, case studies, critical thinking exercises, key terms, NCLEX-style questions, photos, tables, figures, web resources, recommendations for additional reading, and PowerPoint slides. An important feature of the book is the listing of QSEN competencies and the associated knowledge, skills, and attitudes (KSA) in the Appendix. Key Features: Comprises the only undergraduate text to address the six areas of requisite nursing competencies as developed by the QSEN initiative Provides a strong foundation for safe, evidence-based care Presents an inter-professional approach that reflects health care today Supports teaching with PowerPoint slides, critical thinking exercises, case studies, and rationales for review questions Includes objectives, critical thinking exercises, case studies, real world interviews, tables, figures, visuals, and suggested readings in each chapter

Engineering a Learning Healthcare System

Author : National Academy of Engineering
Publisher : National Academies Press
ISBN 13 : 0309224772
Total Pages : 340 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Engineering a Learning Healthcare System by : National Academy of Engineering

Download or read book Engineering a Learning Healthcare System written by National Academy of Engineering and published by National Academies Press. This book was released on 2011-06-14 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Informing the Future

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309215366
Total Pages : 203 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Informing the Future by : Institute of Medicine

Download or read book Informing the Future written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-12 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report illustrates the work of IOM committees in selected, major areas in recent years, followed by a description of IOM's convening and collaborative activities and fellowship programs. The last section provides a comprehensive bibliography of IOM reports published since 2007.

Evidence-Based Medicine and the Changing Nature of Health Care

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309185866
Total Pages : 202 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Evidence-Based Medicine and the Changing Nature of Health Care by : Institute of Medicine

Download or read book Evidence-Based Medicine and the Changing Nature of Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 2008-08-06 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drawing on the work of the Roundtable on Evidence-Based Medicine, the 2007 IOM Annual Meeting assessed some of the rapidly occurring changes in health care related to new diagnostic and treatment tools, emerging genetic insights, the developments in information technology, and healthcare costs, and discussed the need for a stronger focus on evidence to ensure that the promise of scientific discovery and technological innovation is efficiently captured to provide the right care for the right patient at the right time. As new discoveries continue to expand the universe of medical interventions, treatments, and methods of care, the need for a more systematic approach to evidence development and application becomes increasingly critical. Without better information about the effectiveness of different treatment options, the resulting uncertainty can lead to the delivery of services that may be unnecessary, unproven, or even harmful. Improving the evidence-base for medicine holds great potential to increase the quality and efficiency of medical care. The Annual Meeting, held on October 8, 2007, brought together many of the nation's leading authorities on various aspects of the issues - both challenges and opportunities - to present their perspectives and engage in discussion with the IOM membership.

MEDINFO 2015: EHealth-enabled Health

Author : I.N. Sarkar
Publisher : IOS Press
ISBN 13 : 1614995648
Total Pages : 1180 pages
Book Rating : 4.6/5 (149 download)

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Book Synopsis MEDINFO 2015: EHealth-enabled Health by : I.N. Sarkar

Download or read book MEDINFO 2015: EHealth-enabled Health written by I.N. Sarkar and published by IOS Press. This book was released on 2015-08-12 with total page 1180 pages. Available in PDF, EPUB and Kindle. Book excerpt: Health and Biomedical Informatics is a rapidly evolving multidisciplinary field; one in which new developments may prove crucial in meeting the challenge of providing cost-effective, patient-centered healthcare worldwide. This book presents the proceedings of MEDINFO 2015, held in São Paulo, Brazil, in August 2015. The theme of this conference is ‘eHealth-enabled Health’, and the broad spectrum of topics covered ranges from emerging methodologies to successful implementations of innovative applications, integration and evaluation of eHealth systems and solutions. Included here are 178 full papers and 248 poster abstracts, selected after a rigorous review process from nearly 800 submissions by 2,500 authors from 59 countries. The conference brings together researchers, clinicians, technologists and managers from all over the world to share their experiences on the use of information methods, systems and technologies to promote patient-centered care, improving patient safety, enhancing care outcomes, facilitating translational research and enabling precision medicine, as well as advancing education and skills in Health and Biomedical Informatics. This comprehensive overview of Health and Biomedical Informatics will be of interest to all those involved in designing, commissioning and providing healthcare, wherever they may be.

Learning What Works

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309120683
Total Pages : 610 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Learning What Works by : Institute of Medicine

Download or read book Learning What Works written by Institute of Medicine and published by National Academies Press. This book was released on 2011-07-09 with total page 610 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Small Clinical Trials

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 9780309171144
Total Pages : 222 pages
Book Rating : 4.1/5 (711 download)

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Book Synopsis Small Clinical Trials by : Institute of Medicine

Download or read book Small Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2001-01-01 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.

The Healthcare Imperative

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309144337
Total Pages : 852 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Healthcare Imperative by : Institute of Medicine

Download or read book The Healthcare Imperative written by Institute of Medicine and published by National Academies Press. This book was released on 2011-01-17 with total page 852 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Returning Individual Research Results to Participants

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309475171
Total Pages : 399 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Returning Individual Research Results to Participants by : National Academies of Sciences, Engineering, and Medicine

Download or read book Returning Individual Research Results to Participants written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-09-23 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.