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This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. 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. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)
This completely updated edition of Exposure Assessment in Environmental Epidemiology offers a practical introduction to exposure assessment methodologies in environmental epidemiologic studies. In addition to methods for traditional methods -- questionnaires, biomonitoring -- this new edition is expanded to include geographic information systems, modeling, personal sensoring, remote sensing, and OMICs technologies. In addition, each of these methods is contextualized within a recent epidemiology study, maximizing illustration for students and those new to these to these techniques. With clear writing and extensive illustration, this book will be useful to anyone interested in exposure assessment, regardless of background.
From the use of personal products to our consumption of food, water, and air, people are exposed to a wide array of agents each day-many with the potential to affect health. Exposure Science in the 21st Century: A Vision and A Strategy investigates the contact of humans or other organisms with those agents (that is, chemical, physical, and biologic stressors) and their fate in living systems. The concept of exposure science has been instrumental in helping us understand how stressors affect human and ecosystem health, and in efforts to prevent or reduce contact with harmful stressors. In this way exposure science has played an integral role in many areas of environmental health, and can help meet growing needs in environmental regulation, urban and ecosystem planning, and disaster management. Exposure Science in the 21st Century: A Vision and A Strategy explains that there are increasing demands for exposure science information, for example to meet needs for data on the thousands of chemicals introduced into the market each year, and to better understand the health effects of prolonged low-level exposure to stressors. Recent advances in tools and technologies-including sensor systems, analytic methods, molecular technologies, computational tools, and bioinformatics-have provided the potential for more accurate and comprehensive exposure science data than ever before. This report also provides a roadmap to take advantage of the technologic innovations and strategic collaborations to move exposure science into the future.
The public depends on competent risk assessment from the federal government and the scientific community to grapple with the threat of pollution. When risk reports turn out to be overblownâ€"or when risks are overlookedâ€"public skepticism abounds. This comprehensive and readable book explores how the U.S. Environmental Protection Agency (EPA) can improve its risk assessment practices, with a focus on implementation of the 1990 Clean Air Act Amendments. With a wealth of detailed information, pertinent examples, and revealing analysis, the volume explores the "default option" and other basic concepts. It offers two views of EPA operations: The first examines how EPA currently assesses exposure to hazardous air pollutants, evaluates the toxicity of a substance, and characterizes the risk to the public. The second, more holistic, view explores how EPA can improve in several critical areas of risk assessment by focusing on cross-cutting themes and incorporating more scientific judgment. This comprehensive volume will be important to the EPA and other agencies, risk managers, environmental advocates, scientists, faculty, students, and concerned individuals.
The field of occupational health and safety constantly changes, especially as it pertains to biomedical research. New infectious hazards are of particular importance at nonhuman-primate facilities. For example, the discovery that B virus can be transmitted via a splash on a mucous membrane raises new concerns that must be addressed, as does the discovery of the Reston strain of Ebola virus in import quarantine facilities in the U.S. The risk of such infectious hazards is best managed through a flexible and comprehensive Occupational Health and Safety Program (OHSP) that can identify and mitigate potential hazards. Occupational Health and Safety in the Care and Use of Nonhuman Primates is intended as a reference for vivarium managers, veterinarians, researchers, safety professionals, and others who are involved in developing or implementing an OHSP that deals with nonhuman primates. The book lists the important features of an OHSP and provides the tools necessary for informed decision-making in developing an optimal program that meets all particular institutional needs.
Can the electric and magnetic fields (EMF) to which people are routinely exposed cause health effects? This volume assesses the data and draws conclusions about the consequences of human exposure to EMF. The committee examines what is known about three kinds of health effects associated with EMF: cancer, primarily childhood leukemia; reproduction and development; and neurobiological effects. This book provides a detailed discussion of hazard identification, dose-response assessment, exposure assessment, and risk characterization for each. Possible Health Effects of Exposure to Residential Electric and Magnetic Fields also discusses the tools available to measure exposure, common types of exposures, and what is known about the effects of exposure. The committee looks at correlations between EMF exposure and carcinogenesis, mutagenesis, neurobehavioral effects, reproductive and developmental effects, effects on melatonin and other neurochemicals, and effects on bone healing and stimulated cell growth.
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.
Determining the health risks to humans of exposure to toxic substances in the environment is made difficult by problems such as measuring the degree to which people have been exposed and determining causationâ€"whether observed health effects are due to exposure to a suspected toxicant. Building on the well-received first volume, Environmental Epidemiology: Hazardous Wastes and Public Health, this second volume continues the examination of ways to address these difficulties. It describes effective epidemiological methods for analyzing data and focuses on errors that may occur in the course of analyses. The book also investigates the utility of the gray literature in helping to identify the often elusive causative agent behind reported health effects. Although gray literature studies are often based on a study group that is quite small, use inadequate measures of exposure, and are not published, many of the reports from about 20 states that were examined by the committee were judged to be publishable with some additional work. The committee makes recommendations to improve the utility of the gray literature by enhancing quality and availability.
In the late 1980s, the National Cancer Institute initiated an investigation of cancer risks in populations near 52 commercial nuclear power plants and 10 Department of Energy nuclear facilities (including research and nuclear weapons production facilities and one reprocessing plant) in the United States. The results of the NCI investigation were used a primary resource for communicating with the public about the cancer risks near the nuclear facilities. However, this study is now over 20 years old. The U.S. Nuclear Regulatory Commission requested that the National Academy of Sciences provide an updated assessment of cancer risks in populations near USNRC-licensed nuclear facilities that utilize or process uranium for the production of electricity. Analysis of Cancer Risks in Populations near Nuclear Facilities: Phase 1 focuses on identifying scientifically sound approaches for carrying out an assessment of cancer risks associated with living near a nuclear facility, judgments about the strengths and weaknesses of various statistical power, ability to assess potential confounding factors, possible biases, and required effort. The results from this Phase 1 study will be used to inform the design of cancer risk assessment, which will be carried out in Phase 2. This report is beneficial for the general public, communities near nuclear facilities, stakeholders, healthcare providers, policy makers, state and local officials, community leaders, and the media.
The regulation of potentially hazardous substances has become a controversial issue. This volume evaluates past efforts to develop and use risk assessment guidelines, reviews the experience of regulatory agencies with different administrative arrangements for risk assessment, and evaluates various proposals to modify procedures. The book's conclusions and recommendations can be applied across the entire field of environmental health.