Clinical Epidemiology: Principles, Methods, and Applications for Clinical Research

487 Pages·2014·5.8 MB·English

by  Diederick E. Grobbee

DEDICATION
To Sjoukje and Carin
CONTENTS
Preface
Foreword
The Julius Center
About the Authors
Contributors
Acknowledgments
Quick Start
PART 1 OVERVIEW
Chapter 1: Introduction to Clinical Epidemiology
Introduction
Clinical Epidemiology
Research Relevant to Patient Care
Epidemiologic Study Design
Design of Data Collection
Design of Data Analysis
Diagnostic, Etiologic, Prognostic, and Intervention Research
Moving from Research to Practice: Validity, Relevance, and Generalizability
PART 2 PRINCIPLES OF CLINICAL RESEARCH
Chapter 2: Diagnostic Research
Introduction
Diagnosis in Clinical Practice
From Diagnosis in Clinical Practice to Diagnostic Research
Diagnostic Research versus Test Research
Diagnostic Research
Application of Study Results in Practice
Worked-Out Example
Chapter 3: Etiologic Research
Introduction
Etiologic Research in Epidemiology
Theoretical Design
Confounding
Causality
Modification and Interaction
Modifiers and Confounders
Design of Data Collection
Common Etiologic Questions in Clinical Epidemiology
Worked-Out Example
Chapter 4: Prognostic Research
Introduction
Prognosis in Clinical Practice
Approaches to Prognostication
Prognostication Is a Multivariable Process
Added Prognostic Value
From Prognosis in Clinical Practice to Prognostic Research
The Predictive Nature of Prognostic Research
Appraisal of Prevailing Prognostic Research
Prognostic Research
Bias in Prognostic Research
Design of Data Analysis
Worked-Out Example
Conclusion
Chapter 5: Intervention Research: Intended Effects
Introduction
Intervention Effects
Treatment Effect
Comparability of Natural History
Randomization
Comparability of Extraneous Effects
Comparability of Observations
Trial Limitations
The Randomized Trial as a Paradigm for Etiologic Research
Chapter 6: Intervention Research: Unintended Effects
Introduction
Research on Unintended Effects of Interventions
Studies on Unintended Effects of Interventions: Causal Research
Type A and Type B Unintended Effects
Other Unintended Effects
Theoretical Design
Design of Data Collection
Comparability in Observational Research on Unintended Effects
Methods Used to Limit Confounding
Healthcare Databases as a Framework for Research on Unintended Effects of
Interventions
PART 3 TOOLS FOR CLINICAL RESEARCH
Chapter 7: Design of Data Collection
Introduction
Time
Census or Sampling
Experimental or Observational Studies
Taxonomy of Epidemiological Data Collection
Chapter 8: Cohort and Cross-Sectional Studies
Introduction
Timing of the Association Relative to the Timing of Data Collection
Causal and Descriptive Cohort Studies
Experimental Cohort Studies
Cross-Sectional Studies
Ecologic Studies
Cohort Studies Using Routine Care Data
Limitations of Cohort Studies
Worked-Out Example: The SMART Study
Chapter 9: Case-Control Studies
Introduction
The Rationale for Case-Control Studies
The Essence of Case-Control Studies
A Brief History of Case-Control Studies in Clinical Research
Theoretical Design
Design of Data Collection
Design of Data Analysis
Case-Cohort Studies
Case-Crossover Studies
Case-Control Studies Without Controls
Advantages and Limitations of Case-Control Studies
Worked-Out Example
Chapter 10: Randomized Trials
Introduction
“Regular” Parallel, Factorial, Crossover, Non-Inferiority, and Cluster Trials
Participants
Treatment Allocation and Randomization
Informed Consent
Blinding
Adherence to Allocated Treatment
Outcome
Design of Data Analysis (Including Sample Size Calculation)
Chapter 11: Meta-Analyses
Introduction
Rationale
Principles
Theoretical Design
Design of Data Collection
Critical Appraisal
Design of Data Analysis
Reporting Results from a Meta-Analysis
Data Analysis Software
Inference from Meta-Analysis
Chapter 12: Clinical Epidemiologic Data Analysis
Introduction
Measures of Disease Frequency: Incidence and Prevalence
Data Analysis Strategies in Clinical Epidemiologic Research
The Relationship Between Determinant and Outcome
Probability Values or 95% Confidence Intervals
Adjustment for Confounding
Frequentists and Bayesians

References
Index