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.

"The combination of scientific and institutional integrity represented by this book is unusual. It should be a model for future endeavors to help quantify environmental risk as a basis for good decisionmaking." â€"William D. Ruckelshaus, from the foreword. This volume, prepared under the auspices of the Health Effects Institute, an independent research organization created and funded jointly by the Environmental Protection Agency and the automobile industry, brings together experts on atmospheric exposure and on the biological effects of toxic substances to examine what is knownâ€"and not knownâ€"about the human health risks of automotive emissions.

Discusses mathematical exposure models which may assist industrial hygienists in determining acceptable exposure limits in the workplace.

This book presents revised guideline values for the four most common air pollutants - particulate matter, ozone, nitrogen dioxide and sulfur dioxide - based on a recent review of the accumulated scientific evidence. The rationale for selection of each guideline value is supported by a synthesis of information emerging from research on the health effects of each pollutant. As a result, these guidelines now also apply globally. They can be read in conjunction with Air quality guidelines for Europe, 2nd edition, which is still the authority on guideline values for all other air pollutants. As well as revised guideline values, this book makes a brief yet comprehensive review of the issues affecting the application of the guidelines in risk assessment and policy development. Further, it summarizes information on: . pollution sources and levels in various parts of the world, . population exposure and characteristics affecting sensitivity to pollution, . methods for quantifying the health burden of air pollution, and . the use of guidelines in developing air quality standards and other policy tools. Finally, the special case of indoor air pollution is explored. Prepared by a large team of renowned international experts who considered conditions in various parts of the globe, these guidelines are applicable throughout the world. They provide reliable guidance for policy-makers everywhere when considering the various options for air quality management.

The U.S. Environmental Protection Agency (EPA) has a mission and regulatory responsibility to protect human health and the environment. EPA's pursuit of that goal includes a variety of research activities involving human subjects, such as epidemiologic studies and surveys. Those research activities also involve studies of individuals who volunteer to be exposed to air pollutants intentionally in controlled laboratory settings so that measurements can be made of transient and reversible biomarker or physiologic responses to those exposures that can indicate pathways of toxicity and mechanisms of air-pollution responses. The results of those controlled human inhalation exposure (CHIE) studies, also referred to as human clinical studies or human challenge studies, are used to inform policy decisions and help establish or revise standards to protect public health and improve air quality. Controlled Human Inhalation-Exposure Studies at EPA addresses scientific issues and provides guidance on the conduct of CHIE studies. This report assesses the utility of CHIE studies to inform and reduce uncertainties in setting air-pollution standards to protect public health and assess whether continuation of such studies is warranted. It also evaluates the potential health risks to test subjects who participated in recent studies of air pollutants at EPA's clinical research facility.

Military operations produce a great deal of trash in an environment where standard waste management practices may be subordinated to more pressing concerns. As a result, ground forces have long relied on incineration in open-air pits as a means of getting rid of refuse. Concerns over possible adverse effects of exposure to smoke from trash burning in the theater were first expressed in the wake of the 1990â€"1991 Gulf War and stimulated a series of studies that indicated that exposures to smoke from oil-well fires and from other combustion sources, including waste burning, were stressors for troops. In January 2013, Congress directed the Department of Veterans Affairs (VA) to establish and maintain a registry for service members who may have been exposed to toxic airborne chemicals and fumes generated by open burn pits. Assessment of the Department of Veterans Affairs Airborne Hazards and Open Burn Pit Registry analyzes the initial months of data collected by the registry and offers recommendations on ways to improve the instrument and best use the information it collects. This report assesses the effectiveness of the VA's information gathering efforts and provides recommendations for addressing the future medical needs of the affected groups, and provides recommendations on collecting, maintaining, and monitoring information collected by the VA's Airborne Hazards and Open Burn Pit Registry.

This book closes a current gap by providing the scientific basis for consumer exposure assessment in the context of regulatory risk assessment. Risk is defined as the likelihood of an event occurring and the severity of its effects. The margin between the dose that leads to toxic effects and the actual dose of a chemical is identified by estimating population exposure. The objective of this book is to provide an introduction into the scientific principles of consumer exposure assessment, and to describe the methods used to estimate doses of chemicals, the statistics applied and computer tools needed. This is presented through the backgrounds of the special fields in exposure analysis, such as exposure via food and by the use of consumer products, toys, clothing and other items. As a general concept, human exposure is also understood to include exposure via the environment and from the work setting. In this context, the specific features of consumer exposure are pointed out and put into the context of regulation, in particular food safety, chemicals safety (REACh) and consumer product safety. The book is structured into three parts: The first part deals with the general concepts of consumer exposure as part of the overall risk analysis framework of risk characterization, risk assessment and risk communication. It describes the three basic features of exposure assessment (i) the exposure scenario (ii) the exposure model and (iii) the exposure parameters, addressing external and internal exposure. Also, the statistical presentation of data to characterize populations, in connection with variability, uncertainty and quality of information and the presentation of exposure evaluation results is described. The second part deals with the specific issues of exposure assessment, exposure via food consumption, exposure from use of consumer products, household products, toys, cosmetic products, textiles, pesticides and others. This part also covers methods for acquisition of data for exposure estimations, including the relevant information from regulations needed to perform an accurate exposure assessment. The third part portrays a prospect for further needs in the development and improvement of consumer exposure assessment, as well as international activities and descriptions of the work of institutions that are involved in exposure assessment on the regulatory and scientific level. And conversely, it creates the rationale for the exposure assessment details necessary to satisfy regulatory needs such as derivation of upper limits and risk management issues.

In fact, with the control and containment of most infectious conditions and diseases of the past millennium having been achieved in most developed countries, and with the resultant increase in life expectancies, much more attention seems to have shifted to degenerative health problems. Many of the degenerative health conditions have been linked to thousands of chemicals regularly encountered in human living and occupational/work environments. It is important, therefore, that human health risk assessments are undertaken on a consistent basis - in order to determine the potential impacts of the target chemicals on public health.