Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide

Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide PDF Author: Agency for Health Care Research and Quality (U.S.)
Publisher: Government Printing Office
ISBN: 1587634236
Category : Medical
Languages : en
Pages : 236

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Book Description
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)

Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide

Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide PDF Author: Agency for Health Care Research and Quality (U.S.)
Publisher: Government Printing Office
ISBN: 1587634236
Category : Medical
Languages : en
Pages : 236

Get Book Here

Book Description
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)

Sustaining Global Surveillance and Response to Emerging Zoonotic Diseases

Sustaining Global Surveillance and Response to Emerging Zoonotic Diseases PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309137349
Category : Medical
Languages : en
Pages : 339

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Book Description
H1N1 ("swine flu"), SARS, mad cow disease, and HIV/AIDS are a few examples of zoonotic diseases-diseases transmitted between humans and animals. Zoonotic diseases are a growing concern given multiple factors: their often novel and unpredictable nature, their ability to emerge anywhere and spread rapidly around the globe, and their major economic toll on several disparate industries. Infectious disease surveillance systems are used to detect this threat to human and animal health. By systematically collecting data on the occurrence of infectious diseases in humans and animals, investigators can track the spread of disease and provide an early warning to human and animal health officials, nationally and internationally, for follow-up and response. Unfortunately, and for many reasons, current disease surveillance has been ineffective or untimely in alerting officials to emerging zoonotic diseases. Sustaining Global Surveillance and Response to Emerging Zoonotic Diseases assesses some of the disease surveillance systems around the world, and recommends ways to improve early detection and response. The book presents solutions for improved coordination between human and animal health sectors, and among governments and international organizations. Parties seeking to improve the detection and response to zoonotic diseases-including U.S. government and international health policy makers, researchers, epidemiologists, human health clinicians, and veterinarians-can use this book to help curtail the threat zoonotic diseases pose to economies, societies, and health.

Exposure Assessment in Environmental Epidemiology

Exposure Assessment in Environmental Epidemiology PDF Author: Mark J. Nieuwenhuijsen
Publisher: Oxford University Press, USA
ISBN: 0199378789
Category : Medical
Languages : en
Pages : 417

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Book Description
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.

IPCS Risk Assessment Terminology

IPCS Risk Assessment Terminology PDF Author: International Program on Chemical Safety
Publisher: World Health Organization
ISBN: 9241562676
Category : Medical
Languages : en
Pages : 126

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Book Description
A joint project of IPCS/OECD. In two parts: Part 1: IPCS/OECD Key Generic Terms used in Chemical Hazard/Risk Assessment. Part 2: IPCS Glossary of Key Exposure Assessment Terminology. IPCS project on the Harmonization of Approaches to the Assessment of Risk from Exposure to Chemicals

Risk Assessment in the Federal Government

Risk Assessment in the Federal Government PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309033497
Category : Medical
Languages : en
Pages : 206

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Book Description
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.

EPA National Publications Catalog

EPA National Publications Catalog PDF Author: United States. Environmental Protection Agency
Publisher:
ISBN:
Category : Environmental protection
Languages : en
Pages : 848

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Book Description


Science and Decisions

Science and Decisions PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 0309120462
Category : Political Science
Languages : en
Pages : 422

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Book Description
Risk assessment has become a dominant public policy tool for making choices, based on limited resources, to protect public health and the environment. It has been instrumental to the mission of the U.S. Environmental Protection Agency (EPA) as well as other federal agencies in evaluating public health concerns, informing regulatory and technological decisions, prioritizing research needs and funding, and in developing approaches for cost-benefit analysis. However, risk assessment is at a crossroads. Despite advances in the field, risk assessment faces a number of significant challenges including lengthy delays in making complex decisions; lack of data leading to significant uncertainty in risk assessments; and many chemicals in the marketplace that have not been evaluated and emerging agents requiring assessment. Science and Decisions makes practical scientific and technical recommendations to address these challenges. This book is a complement to the widely used 1983 National Academies book, Risk Assessment in the Federal Government (also known as the Red Book). The earlier book established a framework for the concepts and conduct of risk assessment that has been adopted by numerous expert committees, regulatory agencies, and public health institutions. The new book embeds these concepts within a broader framework for risk-based decision-making. Together, these are essential references for those working in the regulatory and public health fields.

Small Clinical Trials

Small Clinical Trials PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309171148
Category : Medical
Languages : en
Pages : 221

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Book Description
Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.

Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals

Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 030907553X
Category : Political Science
Languages : en
Pages : 225

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Book Description
Standing Operating Procedures for Developing Acute Exposure Guideline Levels for Hazardous Chemicals contains a detailed and comprehensive methodology for developing acute exposure guideline levels (AEGLs) for toxic substances from inhalation exposures. The book provides guidance on what documents and databases to use, toxicity endpoints that need to be evaluated, dosimetry corrections from animal to human exposures, selection of appropriate uncertainty factors to address the variability between animals and humans and within the human population, selection of modifying factors to address data deficiencies, time scaling, and quantitative cancer risk assessment. It also contains an example of a summary of a technical support document and an example of AEGL derivation. This book will be useful to persons in the derivation of levels from other exposure routesâ€"both oral and dermalâ€"as well as risk assessors in the government, academe, and private industry.

Risk Assessment and Management

Risk Assessment and Management PDF Author:
Publisher:
ISBN:
Category : Environmental policy
Languages : en
Pages : 44

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Book Description