Bias analysis quantifies the influence of systematic error on an epidemiology study’s estimate of association. The fundamental methods of bias analysis in epi- miology have been well described for decades, yet are seldom applied in published presentations of epidemiologic research. More recent advances in bias analysis, such as probabilistic bias analysis, appear even more rarely. We suspect that there are both supply-side and demand-side explanations for the scarcity of bias analysis. On the demand side, journal reviewers and editors seldom request that authors address systematic error aside from listing them as limitations of their particular study. This listing is often accompanied by explanations for why the limitations should not pose much concern. On the supply side, methods for bias analysis receive little attention in most epidemiology curriculums, are often scattered throughout textbooks or absent from them altogether, and cannot be implemented easily using standard statistical computing software. Our objective in this text is to reduce these supply-side barriers, with the hope that demand for quantitative bias analysis will follow.

Bias analysis quantifies the influence of systematic error on an epidemiology study’s estimate of association. The fundamental methods of bias analysis in epi- miology have been well described for decades, yet are seldom applied in published presentations of epidemiologic research. More recent advances in bias analysis, such as probabilistic bias analysis, appear even more rarely. We suspect that there are both supply-side and demand-side explanations for the scarcity of bias analysis. On the demand side, journal reviewers and editors seldom request that authors address systematic error aside from listing them as limitations of their particular study. This listing is often accompanied by explanations for why the limitations should not pose much concern. On the supply side, methods for bias analysis receive little attention in most epidemiology curriculums, are often scattered throughout textbooks or absent from them altogether, and cannot be implemented easily using standard statistical computing software. Our objective in this text is to reduce these supply-side barriers, with the hope that demand for quantitative bias analysis will follow.

This textbook and guide focuses on methodologies for bias analysis in epidemiology and public health, not only providing updates to the first edition but also further developing methods and adding new advanced methods. As computational power available to analysts has improved and epidemiologic problems have become more advanced, missing data, Bayes, and empirical methods have become more commonly used. This new edition features updated examples throughout and adds coverage addressing: Measurement error pertaining to continuous and polytomous variables Methods surrounding person-time (rate) data Bias analysis using missing data, empirical (likelihood), and Bayes methods A unique feature of this revision is its section on best practices for implementing, presenting, and interpreting bias analyses. Pedagogically, the text guides students and professionals through the planning stages of bias analysis, including the design of validation studies and the collection of validity data from other sources. Three chapters present methods for corrections to address selection bias, uncontrolled confounding, and measurement errors, and subsequent sections extend these methods to probabilistic bias analysis, missing data methods, likelihood-based approaches, Bayesian methods, and best practices.

First edition published in 2002. Second edition published in 2008.

The thoroughly revised and updated Third Edition of the acclaimed Modern Epidemiology reflects both the conceptual development of this evolving science and the increasingly focal role that epidemiology plays in dealing with public health and medical problems. Coauthored by three leading epidemiologists, with sixteen additional contributors, this Third Edition is the most comprehensive and cohesive text on the principles and methods of epidemiologic research. The book covers a broad range of concepts and methods, such as basic measures of disease frequency and associations, study design, field methods, threats to validity, and assessing precision. It also covers advanced topics in data analysis such as Bayesian analysis, bias analysis, and hierarchical regression. Chapters examine specific areas of research such as disease surveillance, ecologic studies, social epidemiology, infectious disease epidemiology, genetic and molecular epidemiology, nutritional epidemiology, environmental epidemiology, reproductive epidemiology, and clinical epidemiology.

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.

Epidemiologic Research Principles and Quantitative Methods DavidG. Kleinbaum, Ph.D. Lawrence L. Kupper. Ph.D. Hal Morgenstern,Ph.D. Epidemiologic Research covers the principles and methodsof planning, analysis and interpretation of epidemiologic researchstudies. It supplies the applied researcher with the mostup-to-date methodological thought and practice. Specifically, thebook focuses on quantitative (including statistical) issues arisingfrom epidemiologic investigations, as well as on the questions ofstudy design, measurement and validity. EpidemiologicResearch emphasizes practical techniques, procedures andstrategies. It presents them through a unified approach whichfollows the chronology of issues that arise during theinvestigation of an epidemic. The book's viewpoint ismultidisciplinary and equally useful to the epidemiologicresearcher and to the biostatistician. Theory is supplemented bynumerous examples, exercises and applications. Full solutions aregiven to all exercises in a separate solutions manual. Importantfeatures * Thorough discussion of the methodology of epidemiologicresearch * Stress on validity and hence on reliability * Balanced approach, presenting the most important prevailingviewpoints * Three chapters with applications of mathematical modeling