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Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385
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Book Description
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385
Get Book Here
Book Description
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309212421
Category : Medical
Languages : en
Pages : 318
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Book Description
Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442
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Book Description
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309162904
Category : Medical
Languages : en
Pages : 141
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Book Description
The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.
Author: United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources and Intergovernmental Relations
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 218
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Book Description
Author: Peter C. Neligan
Publisher: Elsevier Health Sciences
ISBN: 0323243991
Category : Medical
Languages : en
Pages : 451
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Book Description
Core Procedures in Plastic Surgery, edited by Drs. Peter C. Neligan and Donald W. Buck, II, is a one-of-a-kind medical reference book designed to help you master the 20 most in-demand operative techniques from Plastic Surgery, 3rd Edition - the definitive 6-volume masterwork in plastic and reconstructive surgery. Quick-access bulleted procedures, photos, and online videos provide the high-yield, highly visual guidance you need to perform these procedures confidently and achieve optimal outcomes. The result is a must-have for every plastic surgeon's library! Master 20 essential plastic surgery procedures including open and closed rhinoplasty, abdominal wall reconstruction, expander/implant reconstruction of the breast (including latissimus dorsi technique), local flaps for facial coverage (including cheek and lip reconstruction), cleft lip and cleft palate repair, flexor tendon reconstructions, and more. Depend on the preeminent authority that has made Dr. Neligan's Plastic Surgery, 3rd Edition the most trusted reference in plastic surgery. Review techniques quickly and easily thanks to a highly templated, bulleted format. See what to look for and how to proceed by viewing full-color photos throughout. Access the complete content and procedural videos online at Expert Consult.
Author: Marcia Angell
Publisher: W. W. Norton & Company
ISBN: 9780393316728
Category : Business & Economics
Languages : en
Pages : 276
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Book Description
In the early 1990s, sympathetic juries awarded huge damages to women claiming injury from silicone breast implants, leading to a $4.25 billion class-action settlement that still wasn't large enough to cover all the claims. Shockingly, rigorous scientific studies of breast implants have now shown that there is no significant link between breast implants and disease. Why were the courts and the public so certain that breast implants were dangerous when medical researchers were not? The answer to this question reveals important differences in the way science, the law, and the public regard evidence--and not just in the breast implant controversy.
Author:
Publisher:
ISBN:
Category : Medical
Languages : en
Pages : 64
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Author:
Publisher:
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Category : Cancer
Languages : en
Pages : 980
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Author: United States. Congress. House. Committee on Government Reform and Oversight
Publisher:
ISBN:
Category :
Languages : en
Pages :
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