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Cover -- Title Page -- Copyright Page -- Dedication -- Table of Contents -- Foreword -- Preface -- Epidemiology Conceptualized -- Epidemiology Today -- Acknowledgments -- Author -- Section Section I : Basic research design principles and study inference -- Chapter 1: Epidemiologic research conceptualization and rationale -- 1.1 Introduction -- 1.2 Structure and function of research -- 1.3 Objective of study/research purpose -- 1.4 Research questions and study hypotheses -- 1.4.1 Research questions -- 1.4.2 Study hypothesis -- 1.5 Primary versus secondary outcomes -- 1.5.1 Scales of measurement -- 1.5.2 Clinical versus population-based research -- 1.5.3 Epidemiologic / population-based research -- 1.5.4 Research rationale -- 1.5.5 Why conduct clinical research? -- 1.6 Study subjects -- 1.6.1 Subject selection -- 1.7 Sampling -- 1.8 Generalization -- 18.1 Sample size estimation -- 1.9 Sample size and power estimations -- 1.10 Summary -- Questions for discussion -- References -- Chapter 2: Clinical research proposal development and protocol -- 2.1 Introduction -- 2.2 Study conceptualization -- 2.2.1 Study conceptualization requires variable ascertainment -- 2.2.2 Conceptualization and confounding -- 2.2.2.1 Confounding: Distortion or bias? -- 2.2.3 Validity and reliability -- 2.3 Research question -- 2.3.1 Research question in planning and conducting study -- 2.4 Study background -- 2.5 Protocol implementation -- 2.6 Data collection, management, and analysis -- 2.6.1 Data collection methods -- 2.6.1.1 Quantitative data collection -- 2.6.1.2 Qualitative data collection -- 2.6.2 Modern data collection techniques -- 2.6.3 Research data management -- 2.6.4 Data analysis -- 2.6.5 Hypothesis-specific or main analysis -- 2.7 Summary -- Questions for discussion -- References -- Chapter 3: Epidemiologic design challenges Confounding and effect measure modifier -- 3.1 Introduction -- 3.2 Confounding, covariates, and mediation -- 3.3 Assessment for confounding -- 3.4 Confounding, covariates, and mediation -- 3.5 Types of confounding -- 3.6 Confounding and biased estimate -- 3.7 Effect measure modifier -- 3.8 Interaction: Statistical versus biologic -- 3.9 Summary -- Questions for discussion -- References -- Chapter 4: Epidemiologic case ascertainment -- 4.1 Introduction -- 4.2 Screening (detection) and diagnostic (confirmation) tests -- 4.3 Disease screening: Principles, advantages, and limitations -- 4.3.1 Diagnostic or screening test accuracy/validity -- 4.3.2 Advantages and disadvantages of screening -- 4.3.3 Issues in early disease detection -- 4.3.4 Disease screening: Diagnostic tests and clinical reasoning -- 4.4 Balancing benefits and harmful effects in medicine -- 4.5 Summary -- Questions for discussion -- References -- Section Section II : Epidemiologic concepts and methods -- Chapter 5: Epidemiology, historical context, and measures of disease occurrence and association -- 5.1 Introduction -- 5.1.1 Epidemiology: Basic notion -- 5.1.2 Distribution, de.
terminants of health and health-related events, and specified population -- 5.1.2.1 Epidemiology and clinical research -- 5.1.3 Epidemiologic classification: Descriptive versus analytic -- 5.2 Epidemiology, clinical medicine, and public health research -- 5.3 The history and modern concept of epidemiology -- 5.4 Models of disease causation -- 5.5 Measures of disease frequency, occurrence, and association -- 5.5.1 Ratio -- 5.5.2 Proportion -- 5.5.3 Rate -- 5.5.4 Measures of disease occurrence -- 5.5.4.1 Formula for risk -- 5.5.4.2 Average risk or CI -- 5.5.4.3 Average risk or CI computation -- 5.5.4.4 IR or incidence density computation -- 5.5.4.5 CI estimation from ID/IR -- 5.5.5 Prevalence proportion and disease prevalence -- 5.5.5.1 Factors influencing disease prevalence -- 5.5.5.2 Formula for point prevalence and period prevalence -- 5.5.5.3 Uses of incidence and prevalence data -- 5.5.5.4 Limitations of prevalence data -- 5.5.6 Proportionate mortality and morbidity -- 5.6 Measures of disease association or effect -- 5.6.1 Types of rates (crude, specific, adjusted) -- 5.6.1.1 Crude rates -- 5.6.1.2 Specific rates -- 5.6.1.3 Adjusted rate -- 5.7 Measures of disease comparison -- 5.7.1 Survival / history / event measure -- 5.8 Sources of epidemiologic data -- 5.9 Summary -- Questions for discussion -- References -- Chapter 6: Epidemiologic study designs -- 6.1 Introduction -- 6.2 Nonexperimental versus experimental design -- 6.2.1 Disease outbreaks determinants -- 6.3 Descriptive and analytic epidemiology -- 6.4 Summary -- Questions for discussion -- References -- Chapter 7: Ecologic studies -- 7.1 Introduction -- 7.2 Ecologic studies: Description -- 7.2.1 Conducting an ecologic study -- 7.2.2 Importance of ecologic data -- 7.2.3 Examples of ecologic studies in epidemiologic evidence discovery -- 7.3 Statistical analysis in ecologic design -- 7.4 Ecologic evidence: Association or causation? -- 7.5 Limitations of ecologic study design -- 7.6 Summary -- Questions for discussion -- References -- Chapter 8: Case-control studies -- 8.1 Introduction -- 8.2 Basis of case-control design -- 8.2.1 Cases ascertained in case-control studies -- 8.2.1.1 Selection of cases -- 8.2.1.2 Selection of controls in case-control studies -- 8.2.1.3 Sources of controls -- 8.2.1.4 Ascertainment of exposure -- 8.2.1.5 Case-control analysis—measure of effect or association -- 8.3 Variance of case-control design -- 8.3.1 OR in case-control and cohort designs -- 8.3.2 Measure of disease effect or association obtained in matched case-control -- 8.3.3 Interpretation of OR in case-control study -- 8.4 Scientific reporting in case-control studies: Methods and results -- 8.5 Summary -- Questions for discussion -- References -- Chapter 9: Cross-sectional studies -- 9.1 Introduction -- 9.1.1 Basis of a cross-sectional study -- 9.1.2 Feasibility of cross-sectional design -- 9.1.3 Measure of Effect/Association -- 9.2 Summary -- Questions for discussion -- References -- Chapter 10: Co.
hort studies -- 10.1 Introduction -- 10.2 Cohort designs -- 10.2.1 Measure of disease frequency and association / effect -- 10.2.2 Prospective cohort (longitudinal/concurrent) study -- 10.2.2.1 Design -- 10.2.2.2 Prospective cohort study conduct -- 10.2.2.3 Feasibility of prospective cohort design -- 10.2.2.4 Measure of effect -- 10.2.2.5 Comparison of prospective cohort study with case-control -- 10.2.2.6 Other measures of effect in prospective cohort designs -- 10.2.3 Retrospective (historical / nonconcurrent) cohort study -- 10.2.3.1 Retrospective design -- 10.2.3.2 Retrospective study conduct -- 10.2.3.3 Feasibility of retrospective cohort study -- 10.2.3.4 The measure of effect or association in a retrospective cohort design -- 10.2.3.5 Assessment of confounding in cohort design -- 10.2.3.6 Controlling for confounding -- 10.2.3.7 Further example of cohort designs -- 10.2.4 Hybrids of cohort designs -- 10.2.4.1 Ambidirectional cohort design -- 10.3 Rate ratio estimation in cohort study -- 10.4 Summary -- Questions for discussion -- References -- Chapter 11: Clinical trials (human experimental designs) -- 11.1 Introduction -- 11.1.1 Purpose of CT -- 11.1.2 CT as experimental design -- 11.2 Phases of CTs -- 11.2.1 What are the phases of a CT? -- 11.2.2 Basic design in a CT -- 11.2.3 Feasible CT design -- 11.2.4 Blinding in CT -- 11.2.5 Elements of an RCT -- 11.3 Types of CT designs and statistical inference -- 11.3.1 Parallel design -- 11.3.2 Series design -- 11.3.3 Cross-over design -- 11.3.4 Factorial design -- 11.4 Elements of a CT -- 11.5 Conceptualization and conduct of a CT -- 11.5.1 What is the study population in CT? -- 11.5.2 Sample size for the study -- 11.6 Example of a CT -- 11.6.1 ERT and HR: Compliance Bias -- 11.6.2 Types of trial -- 11.6.3 Blinding and placebo-control designs -- 11.7 Summary -- Questions for discussion -- References -- Chapter 12: Causal inference in clinical research and quantitative evidence synthesis -- 12.1 Introduction -- 12.1.1 Causal inference -- 12.2 Critique of randomized clinical trials -- 12.2.1 Evidence description -- 12.2.2 Internal validity of RCTs -- 12.2.2.1 Internal validity -- 12.2.3 External validity—study results generalization -- 12.2.4 Results comparison with other evidence: causal relationship -- 12.3 Special consideration: Critical appraisal of public health/epidemiologic research -- 12.3.1 Scale of measurement and distribution -- 12.3.2 Role of random error -- 12.3.3 Null hypothesis and types of errors -- 12.3.4 Significance level (alpha) -- 12.3.5 Confidence interval and confidence limit -- 12.3.5.1 Application of CI in assessing evidence -- 12.3.6 Bias (systematic error) and sources of bias -- 12.3.7 Randomization and blinding (experimental and clinical trial) -- 12.3.8 Power (rejecting a false alternative hypothesis) and sample size -- 12.4 Quantitative evidence synthesis (QES) applied meta-analysis -- 12.4.1 Quantitative systematic review -- 12.4.2 Meta-analysis and pool analysis -- .