Clinical Practice Guidelines We Can Trust

Clinical Practice Guidelines We Can Trust

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2011-06-16

Total Pages: 217

ISBN-13: 030921646X

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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.


Current Catalog

Current Catalog

Author: National Library of Medicine (U.S.)

Publisher:

Published: 1993

Total Pages: 1628

ISBN-13:

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First multi-year cumulation covers six years: 1965-70.


Beyond Regulations

Beyond Regulations

Author: Nancy M. P. King

Publisher: UNC Press Books

Published: 2005-10-12

Total Pages: 294

ISBN-13: 0807876062

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Across a broad range of disciplines--in medicine, social science, and the humanities--researchers, scholars, teachers, and administrators increasingly are looking for new ways to approach ethical issues in research with human subjects. Questions about how relationships between funders and researchers should affect research design, for example, or whether the potential benefits of research can outweigh the importance of its subjects' interests are inadequately addressed by the prevailing, regulation-based research ethics paradigm. This book constitutes a reexamination of research ethics. It combines case studies and commentaries by a multidisciplinary group of scholars and researchers to explore such topics as informed consent, conflict of interest, confidentiality, and research on illegal behavior. All human subjects research takes place within complex social, cultural, and political contexts, the contributors argue. Increased consideration of the relationships between researchers and their subjects, funders, and institutions within these contexts will facilitate research that is sensitive and responsible as well as scientifically fruitful. Beyond Regulations features a keynote essay by Ruth Macklin. Other contributors are Marcela Aracena Alvarez, Jorge Balan, B. Susan Bauer, Alan F. Benjamin, Lynn Blanchard, Allan M. Brandt, J. Pat Browder, Barbara Entwisle, Sue E. Estroff, Renee C. Fox, Lara Freidenfelds, Gail E. Henderson, Nancy M. P. King, Loretta M. Kopelman, Ernest N. Kraybill, Barry M. Popkin, Silvina Ramos, Desmond K. Runyan, Jane Stein, Ronald P. Strauss, Keith A. Wailoo, and Cynthia Waszak. Across a broad range of disciplines--in biomedicine, the social sciences, and the humanities--researchers, scholars, administrators, and teachers increasingly struggle with questions of ethics in research with human subjects. All research takes place in complex social, cultural, political, and economic contexts; yet the prevailing principle-based research ethics paradigm does not adequately account for them. This book reexamines research ethics using a new relationships paradigm. Through in-depth cases, commentaries, and essays, a multidisciplinary group of scholars and researchers addresses informed consent, conflict of interest, confidentiality, and other issues, considering questions like: What relationships should researchers have with their subjects' communities? When researchers and subjects have different views about research, who should have control? How should relationships between funders and researchers affect research design? Can research be so potentially beneficial that its importance outweighs the interests of subjects? Examining the relationships between researchers and subjects, communities, funders, and institutions--including considerations of authority and voice--can facilitate human subjects research that is morally sensitive and responsible as well as scientifically fruitful.


Validation Compliance Annual

Validation Compliance Annual

Author: International Validation Forum

Publisher: CRC Press

Published: 2024-11-15

Total Pages: 1114

ISBN-13: 1040280684

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"Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."


The Belmont Report

The Belmont Report

Author: United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Publisher:

Published: 1978

Total Pages: 614

ISBN-13:

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An Introduction to Biomaterials, Second Edition

An Introduction to Biomaterials, Second Edition

Author: Jeffrey O. Hollinger

Publisher: CRC Press

Published: 2011-11-28

Total Pages: 646

ISBN-13: 143981256X

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A practical road map to the key families of biomaterials and their potential applications in clinical therapeutics, Introduction to Biomaterials, Second Edition follows the entire path of development from theory to lab to practical application. It highlights new biocompatibility issues, metrics, and statistics as well as new legislation for intellectual property. Divided into four sections (Biology, Biomechanics, Biomaterials Interactions; Biomaterials Testing, Statistics, Regulatory Considerations, Intellectual Property; Biomaterials Compositions; and Biomaterials Applications), this dramatically revised edition includes both new and revised chapters on cells, tissues, and signaling molecules in wound healing cascades, as well as two revised chapters on standardized materials testing with in vitro and in vivo paradigms consistent with regulatory guidelines. Emphasizing biocompatibility at the biomaterial-host interface, it investigates cell-cell interactions, cell-signaling and the inflammatory and complement cascades, specific interactions of protein-adsorbed materials, and other inherent biological constraints including solid-liquid interfaces, diffusion, and protein types. Unique in its inclusion of the practicalities of biomaterials as an industry, the book also covers the basic principles of statistics, new U.S. FDA information on the biomaterials-biology issues relevant to patent applications, and considerations of intellectual property and patent disclosure. With nine completely new chapters and 24 chapters extensively updated and revised with new accomplishments and contemporary data, this comprehensive introduction discusses 13 important classes of biomaterials, their fundamental and applied research, practical applications, performance properties, synthesis and testing, potential future applications, and commonly matched clinical applications. The authors include extensive references, to create a comprehensive, yet manageable didactic work that is an invaluable desk references and instructional text for undergraduates and working professionals alike.


Guide for the Care and Use of Laboratory Animals -- Japanese Edition

Guide for the Care and Use of Laboratory Animals -- Japanese Edition

Author: National Research Council

Publisher: National Academies Press

Published: 1997-01-31

Total Pages: 142

ISBN-13: 0309100186

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A respected resource for decades, the Guide for the Care and Use of Laboratory Animals has been updated by a committee of experts, taking into consideration input from the scientific and laboratory animal communities and the public at large. The Guide incorporates new scientific information on common laboratory animals, including aquatic species, and includes extensive references. It is organized around major components of animal use: Key concepts of animal care and use. The Guide sets the framework for the humane care and use of laboratory animals. Animal care and use program. The Guide discusses the concept of a broad Program of Animal Care and Use, including roles and responsibilities of the Institutional Official, Attending Veterinarian and the Institutional Animal Care and Use Committee. Animal environment, husbandry, and management. A chapter on this topic is now divided into sections on terrestrial and aquatic animals and provides recommendations for housing and environment, husbandry, behavioral and population management, and more. Veterinary care. The Guide discusses veterinary care and the responsibilities of the Attending Veterinarian. It includes recommendations on animal procurement and transportation, preventive medicine (including animal biosecurity), and clinical care and management. The Guide addresses distress and pain recognition and relief, and issues surrounding euthanasia. Physical plant. The Guide identifies design issues, providing construction guidelines for functional areas; considerations such as drainage, vibration and noise control, and environmental monitoring; and specialized facilities for animal housing and research needs. The Guide for the Care and Use of Laboratory Animals provides a framework for the judgments required in the management of animal facilities. This updated and expanded resource of proven value will be important to scientists and researchers, veterinarians, animal care personnel, facilities managers, institutional administrators, policy makers involved in research issues, and animal welfare advocates.