Clinical Epidemiology

Focusing on improving the diagnosis, prognosis, and management of human disease, this book takes on the issues of research design, measurement, and evaluation which are critical to clinical epidemiology. This second edition of Clinical Epidemiology: Practice and Methods opens with how best to frame a clinical research question, the ethics associated with doing a research project in humans, and the definition of various biases that occur in clinical research. From there, it continues by examining issues of design, measurement, and analysis associated with various research designs, including determination of risk in longitudinal studies, assessment of therapy in randomized controlled clinical trials, and evaluation of diagnostic tests, and then delves into the more specialized area of clinical genetic research, before concluding with basic methods used in evidence-based decision making including critical appraisal, aggregation of multiple studies using meta-analysis, health technology assessment, clinical practice guidelines, development of health policy, translational research, how to utilize administrative databases, and knowledge translation. Written for the highly successful Methods in Molecular Biology series, chapters include the kind of detail and practical advice to ensure real world success.

On Framing the Research Question and Choosing the Appropriate Research Design.- Research Ethics for Clinical Researchers.- Definitions of Bias in Clinical Research.- Longitudinal Studies 1: Determination of Risk.- Longitudinal Studies 2: Modeling Data Using Multivariate Analysis.- Longitudinal Studies 3: Data Modeling Using Standard Regression Models and Extensions.- Longitudinal Studies 4: Matching Strategies to Evaluate Risk.- Longitudinal Studies 5: Development of Risk Prediction Models for Patients with Chronic Disease.- Randomized Controlled Trials 1: Design.- Randomized Controlled Trials 2: Analysis.- Randomized Controlled Trials 3: Measurement and Analysis of Patient-Reported Outcomes.- Randomized Controlled Trials 4: Biomarkers and Surrogate Outcomes.- Randomized Controlled Trials 5: Determining the Sample Size and Power for Clinical Trials and Cohort Studies.- Randomized Controlled Trials 6: On Contamination and Estimating the Actual Treatment Effect.- Randomized Controlled Trials 7: Analysis and Interpretation of Quality of Life Scores.- Randomized Controlled Trials 8: Planning, Monitoring, and Execution.- Evaluation of Diagnostic Tests.- Qualitative Research in Clinical Epidemiology.- Health Economics in Clinical Research.- Clinical Genetic Research 1: Bias.- Clinical Genetic Research 2:  Genetic Epidemiology of Complex Phenotypes.- Clinical Genetic Research 3: Genetics ELSI (Ethical, Legal and Social Issues) Research.- Evidence-Based Decision Making 1: Critical Appraisal.- Evidence-Based Decision Making 2: Systematic Reviews and Meta-Analysis.- Evidence-Based Decision Making 3: Health Technology Assessment.- Evidence-Based Decision Making 4: Development and Limitations of Clinical Practice Guidelines.- Evidence-Based Decision-Making 5: Translational Research.- Evidence-Based Decision Making 6: Utilization ofAdministrative Databases for Health Services Research.- Evidence-Based Decision Making 7: Knowledge Translation.- Evidence-Based Decision Making 8: Health Policy, A Primer for Researchers.