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Institute of Medicine,Board on Health Sciences Policy,Clinical Research Roundtable
Author : Institute of Medicine,Board on Health Sciences Policy,Clinical Research Roundtable Publisher : National Academies Press Page : 120 pages File Size : 45,8 Mb Release : 2002-06-14 Category : Medical ISBN : 9780309182904
The Role of Purchasers and Payers in the Clinical Research Enterprise by Institute of Medicine,Board on Health Sciences Policy,Clinical Research Roundtable Pdf
In a workshop organized by the Clinical Research roundtable, representatives from purchaser organizations (employers), payer organizations (health plans and insurance companies), and other stakeholder organizations (voluntary health associations, clinical researchers, research organizations, and the technology community) came together to explore: What do purchasers and payers need from the Clinical Research Enterprise? How have current efforts in clinical research met their needs? What are purchasers, payers, and other stakeholders willing to contribute to the enterprise? This book documents these discussions and summarizes what employers and insurers need from and are willing to contribute to clinical research from both a business and a national health care perspective.
Institute of Medicine,Board on Health Care Services,Board on Health Sciences Policy,Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule
Author : Institute of Medicine,Board on Health Care Services,Board on Health Sciences Policy,Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule Publisher : National Academies Press Page : 334 pages File Size : 49,7 Mb Release : 2009-03-24 Category : Computers ISBN : 9780309124997
Beyond the HIPAA Privacy Rule by Institute of Medicine,Board on Health Care Services,Board on Health Sciences Policy,Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule Pdf
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.
Institute of Medicine,Board on Health Care Services,Committee on Standards for Developing Trustworthy Clinical Practice Guidelines
Author : Institute of Medicine,Board on Health Care Services,Committee on Standards for Developing Trustworthy Clinical Practice Guidelines Publisher : National Academies Press Page : 217 pages File Size : 42,6 Mb Release : 2011-06-16 Category : Medical ISBN : 9780309216463
Clinical Practice Guidelines We Can Trust by Institute of Medicine,Board on Health Care Services,Committee on Standards for Developing Trustworthy Clinical Practice Guidelines Pdf
Advances in medical, biomedical and health services research have reduced the level of uncertainty in clinical practice. Clinical practice guidelines (CPGs) complement this progress by establishing standards of care backed by strong scientific evidence. CPGs are statements that include recommendations intended to optimize patient care. These statements are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options. Clinical Practice Guidelines We Can Trust examines the current state of clinical practice guidelines and how they can be improved to enhance healthcare quality and patient outcomes. Clinical practice guidelines now are ubiquitous in our healthcare system. The Guidelines International Network (GIN) database currently lists more than 3,700 guidelines from 39 countries. Developing guidelines presents a number of challenges including lack of transparent methodological practices, difficulty reconciling conflicting guidelines, and conflicts of interest. Clinical Practice Guidelines We Can Trust explores questions surrounding the quality of CPG development processes and the establishment of standards. It proposes eight standards for developing trustworthy clinical practice guidelines emphasizing transparency; management of conflict of interest ; systematic review-guideline development intersection; establishing evidence foundations for and rating strength of guideline recommendations; articulation of recommendations; external review; and updating. Clinical Practice Guidelines We Can Trust shows how clinical practice guidelines can enhance clinician and patient decision-making by translating complex scientific research findings into recommendations for clinical practice that are relevant to the individual patient encounter, instead of implementing a one size fits all approach to patient care. This book contains information directly related to the work of the Agency for Healthcare Research and Quality (AHRQ), as well as various Congressional staff and policymakers. It is a vital resource for medical specialty societies, disease advocacy groups, health professionals, private and international organizations that develop or use clinical practice guidelines, consumers, clinicians, and payers.
Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Publisher : National Academies Press Page : 151 pages File Size : 53,9 Mb Release : 2010-10-22 Category : Medical ISBN : 9780309163354
Transforming Clinical Research in the United States by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation Pdf
An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.
Institute of Medicine,Board on Health Care Services,Committee on Standards for Systematic Reviews of Comparative Effectiveness Research
Author : Institute of Medicine,Board on Health Care Services,Committee on Standards for Systematic Reviews of Comparative Effectiveness Research Publisher : National Academies Press Page : 267 pages File Size : 47,6 Mb Release : 2011-07-20 Category : Medical ISBN : 9780309164252
Finding What Works in Health Care by Institute of Medicine,Board on Health Care Services,Committee on Standards for Systematic Reviews of Comparative Effectiveness Research Pdf
Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.
Doing Clinical Healthcare Research by Sarah Winch,Amanda Henderson,Linda Shields Pdf
Doing Clinical Healthcare Research: A Survival Guide will help students, academics and healthcare staff identify and overcome organisational barriers to conducting research in busy clinical environments and show how research should be project managed in order to guarantee successful outcomes for all involved.
Oxford Handbook of Clinical and Healthcare Research by Sumantra Ray,Sue Fitzpatrick,Rajna Golubic,Susan Fisher Pdf
This handbook is a definitive, up-to-date, and succinct text covering the legislative requirements, scientific foundations, and clinical good practice necessary for clinical, academic, and healthcare research.
Institute of Medicine,Committee on Quality of Health Care in America
Author : Institute of Medicine,Committee on Quality of Health Care in America Publisher : National Academies Press Page : 312 pages File Size : 53,8 Mb Release : 2000-03-01 Category : Medical ISBN : 9780309068376
To Err Is Human by Institute of Medicine,Committee on Quality of Health Care in America Pdf
Experts estimate that as many as 98,000 people die in any given year from medical errors that occur in hospitals. That's more than die from motor vehicle accidents, breast cancer, or AIDSâ€"three causes that receive far more public attention. Indeed, more people die annually from medication errors than from workplace injuries. Add the financial cost to the human tragedy, and medical error easily rises to the top ranks of urgent, widespread public problems. To Err Is Human breaks the silence that has surrounded medical errors and their consequenceâ€"but not by pointing fingers at caring health care professionals who make honest mistakes. After all, to err is human. Instead, this book sets forth a national agendaâ€"with state and local implicationsâ€"for reducing medical errors and improving patient safety through the design of a safer health system. This volume reveals the often startling statistics of medical error and the disparity between the incidence of error and public perception of it, given many patients' expectations that the medical profession always performs perfectly. A careful examination is made of how the surrounding forces of legislation, regulation, and market activity influence the quality of care provided by health care organizations and then looks at their handling of medical mistakes. Using a detailed case study, the book reviews the current understanding of why these mistakes happen. A key theme is that legitimate liability concerns discourage reporting of errorsâ€"which begs the question, "How can we learn from our mistakes?" Balancing regulatory versus market-based initiatives and public versus private efforts, the Institute of Medicine presents wide-ranging recommendations for improving patient safety, in the areas of leadership, improved data collection and analysis, and development of effective systems at the level of direct patient care. To Err Is Human asserts that the problem is not bad people in health careâ€"it is that good people are working in bad systems that need to be made safer. Comprehensive and straightforward, this book offers a clear prescription for raising the level of patient safety in American health care. It also explains how patients themselves can influence the quality of care that they receive once they check into the hospital. This book will be vitally important to federal, state, and local health policy makers and regulators, health professional licensing officials, hospital administrators, medical educators and students, health caregivers, health journalists, patient advocatesâ€"as well as patients themselves. First in a series of publications from the Quality of Health Care in America, a project initiated by the Institute of Medicine
Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data Publisher : National Academies Press Page : 304 pages File Size : 48,9 Mb Release : 2015-04-20 Category : Medical ISBN : 9780309316323
Sharing Clinical Trial Data by Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data Pdf
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Institute of Medicine,Committee on Quality of Health Care in America
Author : Institute of Medicine,Committee on Quality of Health Care in America Publisher : National Academies Press Page : 360 pages File Size : 52,8 Mb Release : 2001-08-19 Category : Medical ISBN : 9780309072809
Crossing the Quality Chasm by Institute of Medicine,Committee on Quality of Health Care in America Pdf
Second in a series of publications from the Institute of Medicine's Quality of Health Care in America project Today's health care providers have more research findings and more technology available to them than ever before. Yet recent reports have raised serious doubts about the quality of health care in America. Crossing the Quality Chasm makes an urgent call for fundamental change to close the quality gap. This book recommends a sweeping redesign of the American health care system and provides overarching principles for specific direction for policymakers, health care leaders, clinicians, regulators, purchasers, and others. In this comprehensive volume the committee offers: A set of performance expectations for the 21st century health care system. A set of 10 new rules to guide patient-clinician relationships. A suggested organizing framework to better align the incentives inherent in payment and accountability with improvements in quality. Key steps to promote evidence-based practice and strengthen clinical information systems. Analyzing health care organizations as complex systems, Crossing the Quality Chasm also documents the causes of the quality gap, identifies current practices that impede quality care, and explores how systems approaches can be used to implement change.
Principles and Practice of Clinical Research by John I. Gallin,Frederick P Ognibene Pdf
The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers. *Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research *Delves into data management and addresses how to collect data and use it for discovery *Contains valuable, up-to-date information on how to obtain funding from the federal government
Institute of Medicine,Board on Health Sciences Policy,Committee on Conflict of Interest in Medical Research, Education, and Practice
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Conflict of Interest in Medical Research, Education, and Practice Publisher : National Academies Press Page : 436 pages File Size : 50,7 Mb Release : 2009-09-16 Category : Medical ISBN : 9780309145442
Conflict of Interest in Medical Research, Education, and Practice by Institute of Medicine,Board on Health Sciences Policy,Committee on Conflict of Interest in Medical Research, Education, and Practice Pdf
Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.
Doing Clinical Healthcare Research by Sarah Winch,Amanda Henderson,Linda Shields Pdf
Doing Clinical Healthcare Research: A Survival Guide will help students, academics and healthcare staff identify and overcome organisational barriers to conducting research in busy clinical environments and show how research should be project managed in order to guarantee successful outcomes for all involved.
Institute of Medicine,LeighAnne M. Olsen,Elizabeth G. Nabel,J. Michael McGinnis,Mark B. McClellan
Author : Institute of Medicine,LeighAnne M. Olsen,Elizabeth G. Nabel,J. Michael McGinnis,Mark B. McClellan Publisher : National Academies Press Page : 202 pages File Size : 43,6 Mb Release : 2008-09-06 Category : Medical ISBN : 9780309113694
Evidence-Based Medicine and the Changing Nature of Health Care by Institute of Medicine,LeighAnne M. Olsen,Elizabeth G. Nabel,J. Michael McGinnis,Mark B. McClellan Pdf
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.
Instruments for Clinical Health-care Research by Marilyn Frank-Stromborg,Sharon J. Olsen Pdf
Instruments for Clinical Health-Care Research, Third Edition will facilitate researching clinical concepts and variables of interest, and will enhance the focus on linking clinical variable assessment with routine measurement of everyday clinical interventions.