Evaluating Evidence of Mechanisms in Medicine

by Veli-Pekka Parkkinen
Evaluating Evidence of Mechanisms in Medicine
Author: Veli-Pekka Parkkinen
Publisher: Springer
Total Pages: 131
Release: 2018-07-13
Genre: Medical
ISBN: 3319946102
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This book is open access under a CC BY license. This book is the first to develop explicit methods for evaluating evidence of mechanisms in the field of medicine. It explains why it can be important to make this evidence explicit, and describes how to take such evidence into account in the evidence appraisal process. In addition, it develops procedures for seeking evidence of mechanisms, for evaluating evidence of mechanisms, and for combining this evaluation with evidence of association in order to yield an overall assessment of effectiveness. Evidence-based medicine seeks to achieve improved health outcomes by making evidence explicit and by developing explicit methods for evaluating it. To date, evidence-based medicine has largely focused on evidence of association produced by clinical studies. As such, it has tended to overlook evidence of pathophysiological mechanisms and evidence of the mechanisms of action of interventions. The book offers a useful guide for all those whose work involves evaluating evidence in the health sciences, including those who need to determine the effectiveness of health interventions and those who need to ascertain the effects of environmental exposures.

Evidence-Based Medicine and the Changing Nature of Health Care

by Institute of Medicine
Evidence-Based Medicine and the Changing Nature of Health Care
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 202
Release: 2008-09-06
Genre: Medical
ISBN: 0309113695
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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.

Adverse Effects of Vaccines

by Institute of Medicine
Adverse Effects of Vaccines
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 894
Release: 2012-04-26
Genre: Medical
ISBN: 0309214351
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In 1900, for every 1,000 babies born in the United States, 100 would die before their first birthday, often due to infectious diseases. Today, vaccines exist for many viral and bacterial diseases. The National Childhood Vaccine Injury Act, passed in 1986, was intended to bolster vaccine research and development through the federal coordination of vaccine initiatives and to provide relief to vaccine manufacturers facing financial burdens. The legislation also intended to address concerns about the safety of vaccines by instituting a compensation program, setting up a passive surveillance system for vaccine adverse events, and by providing information to consumers. A key component of the legislation required the U.S. Department of Health and Human Services to collaborate with the Institute of Medicine to assess concerns about the safety of vaccines and potential adverse events, especially in children. Adverse Effects of Vaccines reviews the epidemiological, clinical, and biological evidence regarding adverse health events associated with specific vaccines covered by the National Vaccine Injury Compensation Program (VICP), including the varicella zoster vaccine, influenza vaccines, the hepatitis B vaccine, and the human papillomavirus vaccine, among others. For each possible adverse event, the report reviews peer-reviewed primary studies, summarizes their findings, and evaluates the epidemiological, clinical, and biological evidence. It finds that while no vaccine is 100 percent safe, very few adverse events are shown to be caused by vaccines. In addition, the evidence shows that vaccines do not cause several conditions. For example, the MMR vaccine is not associated with autism or childhood diabetes. Also, the DTaP vaccine is not associated with diabetes and the influenza vaccine given as a shot does not exacerbate asthma. Adverse Effects of Vaccines will be of special interest to the National Vaccine Program Office, the VICP, the Centers for Disease Control and Prevention, vaccine safety researchers and manufacturers, parents, caregivers, and health professionals in the private and public sectors.

Evidence-Based Practice for Public Health Emergency Preparedness and Response

by National Academies of Sciences, Engineering, and Medicine
Evidence-Based Practice for Public Health Emergency Preparedness and Response
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 501
Release: 2020-11-28
Genre: Medical
ISBN: 0309670381
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When communities face complex public health emergencies, state local, tribal, and territorial public health agencies must make difficult decisions regarding how to effectively respond. The public health emergency preparedness and response (PHEPR) system, with its multifaceted mission to prevent, protect against, quickly respond to, and recover from public health emergencies, is inherently complex and encompasses policies, organizations, and programs. Since the events of September 11, 2001, the United States has invested billions of dollars and immeasurable amounts of human capital to develop and enhance public health emergency preparedness and infrastructure to respond to a wide range of public health threats, including infectious diseases, natural disasters, and chemical, biological, radiological, and nuclear events. Despite the investments in research and the growing body of empirical literature on a range of preparedness and response capabilities and functions, there has been no national-level, comprehensive review and grading of evidence for public health emergency preparedness and response practices comparable to those utilized in medicine and other public health fields. Evidence-Based Practice for Public Health Emergency Preparedness and Response reviews the state of the evidence on PHEPR practices and the improvements necessary to move the field forward and to strengthen the PHEPR system. This publication evaluates PHEPR evidence to understand the balance of benefits and harms of PHEPR practices, with a focus on four main areas of PHEPR: engagement with and training of community-based partners to improve the outcomes of at-risk populations after public health emergencies; activation of a public health emergency operations center; communication of public health alerts and guidance to technical audiences during a public health emergency; and implementation of quarantine to reduce the spread of contagious illness.

Finding What Works in Health Care

by Institute of Medicine
Finding What Works in Health Care
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 267
Release: 2011-07-20
Genre: Medical
ISBN: 0309164257
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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.

Registries for Evaluating Patient Outcomes

by Agency for Healthcare Research and Quality/AHRQ
Registries for Evaluating Patient Outcomes
Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
Total Pages: 385
Release: 2014-04-01
Genre: Medical
ISBN: 1587634333
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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.

Bridging the Evidence Gap in Obesity Prevention

by Institute of Medicine
Bridging the Evidence Gap in Obesity Prevention
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 336
Release: 2010-12-24
Genre: Medical
ISBN: 0309149894
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To battle the obesity epidemic in America, health care professionals and policymakers need relevant, useful data on the effectiveness of obesity prevention policies and programs. Bridging the Evidence Gap in Obesity Prevention identifies a new approach to decision making and research on obesity prevention to use a systems perspective to gain a broader understanding of the context of obesity and the many factors that influence it.

Modern Methods of Clinical Investigation

by Institute of Medicine
Modern Methods of Clinical Investigation
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 241
Release: 1990-02-01
Genre: Medical
ISBN: 0309042860
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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.