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Author : Joe Selby
Publisher :
ISBN 13 : 9781947103047
Total Pages : 100 pages
Book Rating : 4.1/5 (3 download)
Download or read book Accelerating Medical Evidence Generation and Use written by Joe Selby and published by . This book was released on 2017 with total page 100 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : National Academy of Medicine
Publisher :
ISBN 13 : 9780309705622
Total Pages : 0 pages
Book Rating : 4.7/5 (56 download)
Download or read book Accelerating Medical Evidence Generation and Use written by National Academy of Medicine and published by . This book was released on 2023-09-09 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 2016, the National Academy of Medicine (NAM) hosted a series of meetings, which was sponsored by the Patient-Centered Outcomes Research Institute, with support from NAM's Executive Leadership Network. The series underscored the importance of partnerships between researchers and health system leadership and considered opportunities to build institutional capacity, cross-institutional synergy, and system-wide learning. During these meetings, health system executives, researchers, and others discussed building infrastructure that simultaneously facilitates care delivery, care improvement and evidence development. The vision is a digital system-wide progress toward continuous and seamless learning and improvement throughout health and health care. This publication aims to answer the following questions: How can evidence development be accelerated, given current knowledge and resources? What might that mean for better outcomes for patients and greater efficiency in health care? What system and culture changes are required to generate evidence from the care experience? How much progress has been made in preparing the field for the paradigm shift? What are the hallmarks of successful partnerships among care executives and research leaders? What are the priorities in advancing executive leadership to the next level for continuously learning health and health care?
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309289149
Total Pages : 114 pages
Book Rating : 4.3/5 (92 download)
Download or read book Large Simple Trials and Knowledge Generation in a Learning Health System written by Institute of Medicine and published by National Academies Press. This book was released on 2013-12-05 with total page 114 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized clinical trials (RCTs) are often referred to as the "gold standard" of clinical research. However, in its current state, the U.S. clinical trials enterprise faces substantial challenges to the efficient and effective conduct of research. Streamlined approaches to RCTs, such as large simple trials (LSTs), may provide opportunities for progress on these challenges. Clinical trials support the development of new medical products and the evaluation of existing products by generating knowledge about safety and efficacy in pre- and post-marketing settings and serve to inform medical decision making and medical product development. Although well-designed and -implemented clinical trials can provide robust evidence, a gap exists between the evidence needs of a continuously learning health system, in which all medical decisions are based on the best available evidence, and the reality, in which the generation of timely and practical evidence faces significant barriers. Large Simple Trials and Knowledge Generation in a Learning Health System is the summary of a workshop convened by the Institute of Medicine's Roundtable on Value & Science-Driven Health Care and the Forum on Drug Discovery, Development, and Translation. Experts from a wide range of disciplines-including health information technology, research funding, clinical research methods, statistics, patients, product development, medical product regulation, and clinical outcomes research-met to marshal a better understanding of the issues, options, and approaches to accelerating the use of LSTs. This publication summarizes discussions on the potential of LSTs to improve the speed and practicality of knowledge generation for medical decision making and medical product development, including efficacy and effectiveness assessments, in a continuously learning health system. Large Simple Trials and Knowledge Generation in a Learning Health System explores acceleration of the use of LSTs to improve the speed and practicality of knowledge generation for medical decision making and medical product development; considers the concepts of LST design, examples of successful LSTs, the relative advantages of LSTs, and the infrastructure needed to build LST capacity as a routine function of care; identifies structural, cultural, and regulatory barriers hindering the development of an enhanced LST capacity; discusses needs and strategies in building public demand for and participation in LSTs; and considers near-term strategies for accelerating progress in the uptake of LSTs in the United States.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309455626
Total Pages : 103 pages
Book Rating : 4.3/5 (94 download)
Download or read book Real-World Evidence Generation and Evaluation of Therapeutics written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-08-05 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects on medical product development in the context of this wealth of real-world data could be numerous and varied, ranging from the ability to determine both large-scale and patient-specific effects of treatments to the ability to assess how therapeutics affect patients' lives through measurement of lifestyle changes. In October 2016, the National Academies of Sciences, Engineering, and Medicine held a workshop to facilitate dialogue among stakeholders about the opportunities and challenges for incorporating real-world evidence into all stages in the process for the generation and evaluation of therapeutics. Participants explored unmet stakeholder needs and opportunities to generate new kinds of evidence that meet those needs. This publication summarizes the presentations and discussions from the workshop.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 030948832X
Total Pages : 231 pages
Book Rating : 4.3/5 (94 download)
Download or read book Examining the Impact of Real-World Evidence on Medical Product Development written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-04-05 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inherent limitations and may not reflect the use of medical products in the real world. Additionally, RCTs are expensive, time consuming, and cannot answer all questions about a product or intervention. Evidence generated from real-world use, such as real-world evidence (RWE) may provide valuable information, alongside RCTs, to inform medical product decision making. To explore the potential for using RWE in medical product decision making, the National Academies of Sciences, Engineering, and Medicine planned a three-part workshop series. The series was designed to examine the current system of evidence generation and its limitations, to identify when and why RWE may be an appropriate type of evidence on which to base decisions, to learn from successful initiatives that have incorporated RWE, and to describe barriers that prevent RWE from being used to its full potential. This publication summarizes the discussions from the entire workshop series.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309113695
Total Pages : 202 pages
Book Rating : 4.3/5 (91 download)
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 2008-09-06 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.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 030948829X
Total Pages : 231 pages
Book Rating : 4.3/5 (94 download)
Download or read book Examining the Impact of Real-World Evidence on Medical Product Development written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-05-05 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inherent limitations and may not reflect the use of medical products in the real world. Additionally, RCTs are expensive, time consuming, and cannot answer all questions about a product or intervention. Evidence generated from real-world use, such as real-world evidence (RWE) may provide valuable information, alongside RCTs, to inform medical product decision making. To explore the potential for using RWE in medical product decision making, the National Academies of Sciences, Engineering, and Medicine planned a three-part workshop series. The series was designed to examine the current system of evidence generation and its limitations, to identify when and why RWE may be an appropriate type of evidence on which to base decisions, to learn from successful initiatives that have incorporated RWE, and to describe barriers that prevent RWE from being used to its full potential. This publication summarizes the discussions from the entire workshop series.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309133939
Total Pages : 374 pages
Book Rating : 4.3/5 (91 download)
Download or read book The Learning Healthcare System written by Institute of Medicine and published by National Academies Press. This book was released on 2007-06-01 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309133947
Total Pages : 346 pages
Book Rating : 4.3/5 (91 download)
Download or read book The Future of Drug Safety written by Institute of Medicine and published by National Academies Press. This book was released on 2007-02-27 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309292492
Total Pages : 107 pages
Book Rating : 4.3/5 (92 download)
Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.
Author : Rachel Richesson
Publisher : Springer Science & Business Media
ISBN 13 : 1848824483
Total Pages : 415 pages
Book Rating : 4.8/5 (488 download)
Download or read book Clinical Research Informatics written by Rachel Richesson and published by Springer Science & Business Media. This book was released on 2012-02-10 with total page 415 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of the book is to provide an overview of clinical research (types), activities, and areas where informatics and IT could fit into various activities and business practices. This book will introduce and apply informatics concepts only as they have particular relevance to clinical research settings.
Author : Janet Marchibroda
Publisher :
ISBN 13 :
Total Pages : 29 pages
Book Rating : 4.:/5 (958 download)
Download or read book Using Real-world Evidence to Accelerate Safe and Effective Cures written by Janet Marchibroda and published by . This book was released on 2016 with total page 29 pages. Available in PDF, EPUB and Kindle. Book excerpt: Modernizing the drug discovery, development, and approval of new cures and treatments plays a critical role in addressing this issue and should be a key priority for the United States. It takes too long and costs too much to bring treatments and cures to patients in need. The digitization of biology and the vast increase in the amount of electronic data captured during routine care, or by patients themselves, creates an unprecedented opportunity to modernize and augment clinical trials and improve the post-market monitoring process. The need to advance the generation and use of real-world evidence was one of the key recommendations of BPC’s July 2015 report. This report highlights opportunities to modernize and improve the current drug development process through the use of real-world evidence, as well as the policy actions needed to realize those opportunities. The findings and recommendations in this report were developed by BPC based on a review of the literature and interviews and roundtable discussions with 30 experts and practitioners.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309124999
Total Pages : 334 pages
Book Rating : 4.3/5 (91 download)
Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309042860
Total Pages : 241 pages
Book Rating : 4.3/5 (9 download)
Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
Author : Paul E. Plsek
Publisher : CRC Press
ISBN 13 : 1040082262
Total Pages : 218 pages
Book Rating : 4.0/5 (4 download)
Download or read book Accelerating Health Care Transformation with Lean and Innovation written by Paul E. Plsek and published by CRC Press. This book was released on 2013-10-07 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accelerating Health Care Transformation with Lean and Innovation: The Virginia Mason Experience describes how Virginia Mason Medical Center (VMMC) has systematically integrated innovative structures, methods, and cultural practices into its implementation of Lean. Describing how an organization can create a strategy and build a culture of innovation and learning, it supplies concrete examples that show how Lean and innovation can work hand-in-hand to improve and transform value streams. It also explains how to use the voices of patients and their families to drive improvement and innovation.
Author : Ronda Hughes
Publisher : Department of Health and Human Services
ISBN 13 :
Total Pages : 592 pages
Book Rating : 4.:/5 (318 download)
Download or read book Patient Safety and Quality written by Ronda Hughes and published by Department of Health and Human Services. This book was released on 2008 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Nurses play a vital role in improving the safety and quality of patient car -- not only in the hospital or ambulatory treatment facility, but also of community-based care and the care performed by family members. Nurses need know what proven techniques and interventions they can use to enhance patient outcomes. To address this need, the Agency for Healthcare Research and Quality (AHRQ), with additional funding from the Robert Wood Johnson Foundation, has prepared this comprehensive, 1,400-page, handbook for nurses on patient safety and quality -- Patient Safety and Quality: An Evidence-Based Handbook for Nurses. (AHRQ Publication No. 08-0043)." - online AHRQ blurb, http://www.ahrq.gov/qual/nurseshdbk/
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 030909643X
Total Pages : 277 pages
Book Rating : 4.3/5 (9 download)
Download or read book Building a Better Delivery System written by Institute of Medicine and published by National Academies Press. This book was released on 2005-10-20 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: In a joint effort between the National Academy of Engineering and the Institute of Medicine, this books attempts to bridge the knowledge/awareness divide separating health care professionals from their potential partners in systems engineering and related disciplines. The goal of this partnership is to transform the U.S. health care sector from an underperforming conglomerate of independent entities (individual practitioners, small group practices, clinics, hospitals, pharmacies, community health centers et. al.) into a high performance "system" in which every participating unit recognizes its dependence and influence on every other unit. By providing both a framework and action plan for a systems approach to health care delivery based on a partnership between engineers and health care professionals, Building a Better Delivery System describes opportunities and challenges to harness the power of systems-engineering tools, information technologies and complementary knowledge in social sciences, cognitive sciences and business/management to advance the U.S. health care system.
