Epidemiology and biostatistics: an introduction to clinical research
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| Format: | Book |
| Language: | English |
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[2019]
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| Edition: | Second edition |
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| Online Access: | Inhaltsverzeichnis Klappentext |
| Physical Description: | XIV, 277 Seiten Illustrationen |
| ISBN: | 9783319966427 |
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| adam_text | Contents Part I Epidemiology 1 Causal Relationships in Health and Disease.......................................... 1.1 Inferring Causation from EpidemiologicStudies.............................. 1.2 Factors Favoring an Inference of Causation.................................... 1.2.1 EvidenceArising from Randomized Studies......................... 1.2.2 Strength of Association......................................................... 1.2.3 Temporal Relationship........................................................... 1.2.4 Exposure-Varying Association............................................... 1.2.5 Biological Plausibility........................................................... References................................................................................................... 3 6 7 7 8 8 9 9 10 2 Basic Measures of Disease Frequency..................................................... 2.1 Prevalence......................................................................................... 2.1.1 Definition of Prevalence......................................................... 2.1.2 Applications of Prevalence Data........................................... 2.1.3 Limitation of Prevalence Measures...................................... 2.2 Incidence........................................................................................... 2.2.1 Definitions of Incidence......................................................... 2.2.2 Applications of Incidence Data............................................ 2.3 Relationship Between Prevalence and
Incidence.............................. 2.4 Stratification of Disease Frequencies by Person, Place, and Time........................................................................................... 2.4.1 Measures of Disease Frequency Stratified by Characteristics of Person................................................... 2.4.2 Measures of Disease Frequency Stratified by Characteristics of Place..................................................... 2.4.3 Measures of Disease Frequency Stratified by Characteristics of Time..................................................... References................................................................................................... 11 12 12 12 13 13 13 16 17 18 18 19 19 19 vii
viii 3 Contents General Considerations in Epidemiologic Research............................ 3.1 Interventional Versus Observational Study Designs........................ 3.1.1 Interventional Studies Can Isolate the Causal Impact of Specific Treatments.............................................. 3.1.2 Interventional Studies Are Limited to Evaluation of Specific Treatments and Diseases.................................... 3.1.3 The Results of Interventional Studies May Have Limited Applicability.................................................. 3.2 Study Population............................................................................... 3.2.1 Source Population................................................................ 3.2.2 Exclusion Criteria................................................................. 3.2.3 Where to Find Information About the Study Population in a Research Article............................................................ 3.3 Exposure and Outcome..................................................................... 3.3.1 Definition............................................................................... 3.3.2 Measuring the Study Data.................................................... 3.3.3 Where to Find Information About the Exposure and Outcome in a Research Article...................................... 3.4 Internal and External Validity.......................................................... 3.5 Summary of Common Research Study Designs..............................
Reference.................................................................................................. 21 22 4 Case Reports and Case Series................................................................. References.................................................................................................. 35 38 5 Cross-Sectional Studies............................................................................. 39 Reference.................................................................................................. 43 6 Cohort Studies........................................................................................... 6.1 Cohort Study Design........................................................................ 6.1.1 Exclusion for Prevalent Disease.......................................... 6.1.2 Creation of the Cohorts........................................................ 6.1.3 Determination of the Outcome.............................................. 6.2 Quality of the Exposure Measurements............................................ 6.2.1 Are the Measurements Accurate?........................................ 6.2.2 Are the Measurements Precise?............................................ 6.2.3 Are the Measurements Applied Impartially to the Study Population?...................................................... 6.2.4 Are the Measurements Performed at the Right Time?.......... 6.2.5 Retrospective Versus Prospective Data Collection.............. 6.3 Pharmacoepidemiology Studies........................................................ 6.4 Analysis of
Cohort Study Data........................................................ 6.4.1 Calculation of Disease Incidences Among theCohorts......... 6.4.2 Comparison of Disease Incidences Among the Cohorts .... 6.5 Advantages of Cohort Studies........................................................... 22 24 25 25 26 27 29 29 29 31 32 32 33 34 45 46 46 47 48 49 49 50 50 50 51 51 53 53 54 59
Contents x 6.5.1 Ability to Discern Temporal Relationships Between Exposure and Disease........................................................... 6.5.2 Ability to Study Multiple Outcomes.................................... 6.6 Limitations of Cohort Studies........................................................... 6.6.1 Confounding......................................................................... 6.6.2 Inefficient Design for Rare Diseases and Those with a Long Latency Period................................................... References................................................................................................... 7 8 Case-Control Studies............................................................................... 7.1 Case-Control Study Design............................................................... 7.2 Selection of Cases and Controls....................................................... 7.2.1 Select Case Individuals Using a Specific Definition of the Disease......................................................................... 7.2.2 Select Case Individuals Close to the Time of Initial Disease Development............................................................. 7.2.3 Select Control Individuals from the Same Underlying Population as the Cases......................................................... 7.2.4 Select Control Individuals Who Have the Same Opportunity to Be Counted as a Case.................................. 7.2.5 Nested Case-Control Studies................................................. 7.2.6
Matching............................................................................... 7.2.7 Number of Controls............................................................... 7.3 Analysis of Case Control Study Data............................................... 7.3.1 Concept of the Odds Ratio..................................................... 7.3.2 Practical Calculation of the Odds Ratio................................ 7.3.3 Odds Ratios and Relative Risk............................................... 7.4 Advantages of Case Control Studies................................................. 7.4.1 Ideal for Studying Rare Diseases and Those with a Long Latency Period................................................... 7.4.2 Efficiency............................................................................... 7.4.3 Evaluation of Multiple Exposures......................................... 7.5 Limitations of Case Control Studies................................................. 7.5.1 Confounding......................................................................... 7.5.2 Requires Ascertainment of Previous Exposures in Retrospect......................................................................... 7.5.3 Inability to Directly Determine the Incidence of Disease............................................................................... References................................................................................................... 59 59 60 60 60 61 63 64 65 65 66 66 67 67 68 69 69 69 72 72 74 74 75 76 76 76 76 78 78 Randomized
Trials................................................................................... 79 8.1 Rationale for Randomized Trials....................................................... 80 8.2 General Design of Randomized Trials............................................... 82 8.3 Trial Populations............................................................................... 82 8.3.1 Definition of the Target Condition......................................... 83
x Contents 8.3.2 Exclusion of People Suspected to Have Difficulty Adhering to the Study Treatments........................................ 83 8.3.3 Exclusion of People Who Have Comorbid Conditions............................................................ 84 8.3.4 Exclusion of People Who Are Already Receiving the Study Treatment.............................................................. 84 8.3.5 Exclusion for Safety.............................................................. 85 8.3.6 Broadly Inclusive Healthcare Settings Promote Applicability of Trial Results................................................ 86 8.4 Interventions and Control Procedures.............................................. 86 8.4.1 Intervention.......................................................................... 86 8.4.2 Control Procedures................................................................ 86 8.5 Outcomes of Trials............................................................................ 88 8.5.1 Capture Important Benefits and Harms of the Intervention................................................................ 88 8.5.2 Types of Outcomes.............................................................. 89 8.5.3 Mortality Outcomes.............................................................. 89 8.5.4 Surrogate Outcomes.............................................................. 90 8.5.5 Premature Termination of Trials.......................................... 90 8.6 Procedures to Promote Internal Validityof Trials............................. 91 8.6.1
Randomization...................................................................... 91 8.6.2 Blinding................................................................................ 92 8.6.3 Concealment of Treatment Allocation.................................. 93 8.6.4 Efficacy and Effectiveness.................................................... 93 8.6.5 Trial Reporting....................................................................... 94 8.7 Specific Trial Designs....................................................................... 94 8.7.1 Factorial Trials...................................................................... 94 8.7.2 Crossover Trials.................................................................... 95 8.7.3 Phases of Drug Development................................................ 98 8.8 Analysis of Clinical Trial Data...........................................................100 8.8.1 Measures of Effect...................................................................100 8.8.2 Intention-To-Treat Analysis.....................................................103 8.8.3 Subgroup Analyses...................................................................105 8.9 Limitations of Randomized Trials.......................................................108 8.9.1 Limited External Validity (Applicability) of the Trial Population.............................................................108 8.9.2 Limited External Validity (Applicability) of the Trial Environment.........................................................108 8.9.3 Narrow Study
Question...........................................................109 8.9.4 Randomized Design Accounts Only for Confounding.......................................................................109 8.9.5 Negative Trials.........................................................................110 References.................................................................................................. 110
Contents xi 9 Misclassifïcation....................................................................................... 113 9.1 Definition of Miscalculation............................................................... 114 9.2 Non-differential Miscalculation........................................................... 115 9.2.1 Non-differential Misclassification of the Exposure.............. 115 9.2.2 Non-differential Misclassification of the Outcome.................118 9.2.3 Summary of Non-differential Misclassification.......................120 9.3 Differential Misclassification............................................................... 120 9.3.1 Differential Misclassification of the Exposure...................... 120 9.3.2 Differential Misclassification of the Outcome.........................122 9.3.3 Summary of Differential Misclassification.............................122 9.4 Assessment of Misclassification in Research Articles.........................123 Reference......................................................................................................124 10 Confounding................................................................................................125 10.1 Confounding Obscure Understanding of Causal Relationships. ... 125 10.2 Evaluation of a Potential Confounding Characteristic.......................127 10.2.1 Confounding Characteristic Associated with the Exposure 127 10.2.2 Confounding Characteristic Associated with the Outcome 129 10.2.3 Confounding Characteristic Not on the Causal Pathway of Association 129 10.2.4 Evaluation of
Confounding Characteristics in Research Articles 131 10.3 Residual Confounding........................................................................133 10.4 Confounding by Indication............................................................... 133 10.5 Methods to Control for Confounding............................................... 134 10.5.1 Method of Restriction 135 10.5.2 Method of Stratification plus Adjustment 136 10.5.3 Method of Matching 139 10.5.4 Method of Regression 141 10.6 Interpreting Results After Adjustment for Confounding................ 141 Reference......................................................................................................142 11 Effect Modification......................................................................................143 11.1 Concept of Effect Modification......................................................... 144 11.2 Evaluation of Effect Modification..................................................... 146 11.2.1 Criteria for Assessing the Presence of Effect Modification 147 11.2.2 Statistical Considerations for Evaluating Effect Modification 148 11.3 Effect Modification and Confounding Are Distinct Concepts..............................................................................................152 11.4 Effect Modification on the Relative and Absolute Scales.............. 154 References......................................................................................................155
xjį Contents 12 Screening and Diagnosis.................................................................................. 157 12.1 General Principles of Screening and Diagnosis...................................158 12.2 Utility of Testing.................................................................................... 159 12.3 Qualities of Diseases Appropriatefor Screening..................................160 12.3.1 Early Recognition of the Disease Should Provide Meaningful Benefit 160 12.3.2 Screening Tests Should Target Diseases that Have Potentially Serious Consequences 161 12.3.3 Diseases Targeted by Screening Require a Preclinical Phase 161 12.4 Qualities of Tests Appropriate for Screening or Diagnosis..........................................................................................161 12.4.1 Validity 162 12.4.2 Reliability 170 12.5 Defining Cut Points for Continuous Tests........................................... 174 12.6 Types of Biases in Screening Studies............................................... 177 12.6.1 Confounding (Referral Bias) 177 12.6.2 Lead Time Bias 177 12.6.3 Length Bias Sampling 179 12.7 Levels of Prevention................................................................................179 12.7.1 Primary Prevention 179 12.7.2 Secondary Prevention 180 12.7.3 Tertiary Prevention 180 12.8 Association Is Not Sufficient for Prediction....................................... 181 References......................................................................................................... 183 Part II Biostatistics 13 Summary Measures in
Statistics...................................................................187 13.1 Types of Variables..................................................................................187 13.2 Univariate Statistics............................................................................... 188 13.2.1 Histograms 188 13.2.2 Measures of Location and Spread 190 13.2.3 Quantiles 192 13.2.4 Univariate Statistics for Binary Data 193 13.3 Bivariate Statistics..................................................................................194 13.3.1 Tabulation Across Categories 194 13.3.2 Correlation 194 13.3.3 Quantile-Continuous Variable Plots 195 14 Introduction to Statistical Inference............................................................ 197 14.1 Definition of a Population and a Sample............................................. 197 14.2 External Validity...................................................................................... 198 14.3 Statistical Inference................................................................................199 14.4 Confidence Intervals............................................................................. 199
Contents xiii 14.5 Hypothesis Testing..............................................................................203 14.5.1 Construction of StatisticalHypotheses 203 14.5.2 P-Values 204 Reference..................................................................................................... 206 15 Hypothesis Tests in Practice.......................................................................207 15.1 Two-Sample Hypothesis Tests...........................................................207 15.1.1 T- Test 208 15.1.2 Chi-Square Test 209 15.1.3 Hypothesis Tests for Other Types of Study Data 210 15.1.4 Multiple Sample Hypothesis Tests 210 15.2 An Imperfect System......................................................................... 211 15.2.1 Type I Error 211 15.2.2 Type II Error 212 15.3 Power................................................................................................. 212 15.3.1 Sample Size (TV) 213 15.3.2 Effect Size (m) 214 15.3.3 Variability (σ) 215 15.3.4 Significance Level (a) 216 16 Linear Regression................................................................................... 217 16.1 Describing the Association Between Two Variables........................ 218 16.2 Univariate Linear Regression.............................................................219 16.2.1 The Linear Regression Equation 219 16.2.2 Residuals and the Sum of Squares 220 16.2.3 Interpreting Continuous Covariates from a Linear Regression Model 221 16.2.4 Interpreting Binary Covariates from Linear Regression Equations 223 16.3
Diagnostics......................................................................................... 224 16.3.1 Absolute Versus Relative Fit 224 16.3.2 Nonlinear Associations 225 16.3.3 Influential Points 228 16.3.4 Extrapolating the Regression Equation Beyond the Observed Data 229 16.4 Multiple Linear Regression...............................................................230 16.4.1 Definition of the Multiple Regression Model 230 16.4.2 Interpreting Results from the Multiple Regression Model 231 16.5 Confounding and Effect Modificationin Multiple Regression Models............................................................................. 234 16.5.1 Confounding 234 16.5.2 Effect Modification 236
xiv Contents 17 Log-Link and Logistic Regression.............................................................239 17.1 Regression for Ratios.........................................................................239 17.1.1 Log-Link Regression 239 17.1.2 Interpretation of Log-Link Regression Models 240 17.1.3 Hypothesis Testing for Log-Link Regression Results 243 17.2 Logistic Regression.......................................................................... 243 17.2.1 Definition and Interpretation of the Logistic Regression Model 243 17.2.2 Interpreting Logistic Regression Results from Research Articles 245 18 Survival Analysis.........................................................................................247 18.1 Motivation for Survival Data............................................................ 248 18.2 Interpretation of Survival Data.......................................................... 249 18.2.1 Description of the Survivor Function 249 18.2.2 Estimating Time-Specific and Median Survival from S(t) 250 18.2.3 Statistical Testing of Survival Data 251 18.3 Estimation of the Survivor Function................................................ 252 18.3.1 Definitions of Outcomes and Censoring 252 18.3.2 Kaplan-Meier Estimation of the Survivor Function for Uncensored Data 253 18.3.3 Kaplan-Meier Estimation of the Survivor Function for Censored Data 255 18.4 Cox’s Proportional Hazards Model................................................... 257 18.5 Interpreting Survival Data................................................................. 259 18.5.1
Interpreting Hazard Ratios 259 18.5.2 Interpreting Survival Versus Hazard Ratio Data 261 Reference.................................................................................................... 262 Glossary of Terms.............................................................................................. 263 Index.................................................................................................................... 273
Bryan Kestenbaum Epidemiology and Biostatistics An Introduction to Clinical Research Second Edition This is a concise introduction to epidemiology and biostatistics writ ten specifically for medical students and first-time learners of clinical research methods. It presents the core concepts of epidemiology and of biostatistics and illustrates them with extensive examples from the clinical literature. It is the only book on the market written to speak directi}· to medical students and first-time biomedical researchers by using language and examples that are easy to understand. This newly updated second edition is extensively rewritten to provide the clearest explanations and examples. There is also a sister-text, a 150-problem workbook of practice problems that can be purchased alongside this textbook. The author continues to provide a text that is attractively fast-paced and concise for use in condensed courses, such as those taught in medical school. The book is an excellent review for the epidemiology section of the United States Medical Licensing Examination Part I which all medical students must take at the end of the second year.
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Contents Part I Epidemiology 1 Causal Relationships in Health and Disease. 1.1 Inferring Causation from EpidemiologicStudies. 1.2 Factors Favoring an Inference of Causation. 1.2.1 EvidenceArising from Randomized Studies. 1.2.2 Strength of Association. 1.2.3 Temporal Relationship. 1.2.4 Exposure-Varying Association. 1.2.5 Biological Plausibility. References. 3 6 7 7 8 8 9 9 10 2 Basic Measures of Disease Frequency. 2.1 Prevalence. 2.1.1 Definition of Prevalence. 2.1.2 Applications of Prevalence Data. 2.1.3 Limitation of Prevalence Measures. 2.2 Incidence. 2.2.1 Definitions of Incidence. 2.2.2 Applications of Incidence Data. 2.3 Relationship Between Prevalence and
Incidence. 2.4 Stratification of Disease Frequencies by Person, Place, and Time. 2.4.1 Measures of Disease Frequency Stratified by Characteristics of Person. 2.4.2 Measures of Disease Frequency Stratified by Characteristics of Place. 2.4.3 Measures of Disease Frequency Stratified by Characteristics of Time. References. 11 12 12 12 13 13 13 16 17 18 18 19 19 19 vii
viii 3 Contents General Considerations in Epidemiologic Research. 3.1 Interventional Versus Observational Study Designs. 3.1.1 Interventional Studies Can Isolate the Causal Impact of Specific Treatments. 3.1.2 Interventional Studies Are Limited to Evaluation of Specific Treatments and Diseases. 3.1.3 The Results of Interventional Studies May Have Limited Applicability. 3.2 Study Population. 3.2.1 Source Population. 3.2.2 Exclusion Criteria. 3.2.3 Where to Find Information About the Study Population in a Research Article. 3.3 Exposure and Outcome. 3.3.1 Definition. 3.3.2 Measuring the Study Data. 3.3.3 Where to Find Information About the Exposure and Outcome in a Research Article. 3.4 Internal and External Validity. 3.5 Summary of Common Research Study Designs.
Reference. 21 22 4 Case Reports and Case Series. References. 35 38 5 Cross-Sectional Studies. 39 Reference. 43 6 Cohort Studies. 6.1 Cohort Study Design. 6.1.1 Exclusion for Prevalent Disease. 6.1.2 Creation of the Cohorts. 6.1.3 Determination of the Outcome. 6.2 Quality of the Exposure Measurements. 6.2.1 Are the Measurements Accurate?. 6.2.2 Are the Measurements Precise?. 6.2.3 Are the Measurements Applied Impartially to the Study Population?. 6.2.4 Are the Measurements Performed at the Right Time?. 6.2.5 Retrospective Versus Prospective Data Collection. 6.3 Pharmacoepidemiology Studies. 6.4 Analysis of
Cohort Study Data. 6.4.1 Calculation of Disease Incidences Among theCohorts. 6.4.2 Comparison of Disease Incidences Among the Cohorts . 6.5 Advantages of Cohort Studies. 22 24 25 25 26 27 29 29 29 31 32 32 33 34 45 46 46 47 48 49 49 50 50 50 51 51 53 53 54 59
Contents x 6.5.1 Ability to Discern Temporal Relationships Between Exposure and Disease. 6.5.2 Ability to Study Multiple Outcomes. 6.6 Limitations of Cohort Studies. 6.6.1 Confounding. 6.6.2 Inefficient Design for Rare Diseases and Those with a Long Latency Period. References. 7 8 Case-Control Studies. 7.1 Case-Control Study Design. 7.2 Selection of Cases and Controls. 7.2.1 Select Case Individuals Using a Specific Definition of the Disease. 7.2.2 Select Case Individuals Close to the Time of Initial Disease Development. 7.2.3 Select Control Individuals from the Same Underlying Population as the Cases. 7.2.4 Select Control Individuals Who Have the Same Opportunity to Be Counted as a Case. 7.2.5 Nested Case-Control Studies. 7.2.6
Matching. 7.2.7 Number of Controls. 7.3 Analysis of Case Control Study Data. 7.3.1 Concept of the Odds Ratio. 7.3.2 Practical Calculation of the Odds Ratio. 7.3.3 Odds Ratios and Relative Risk. 7.4 Advantages of Case Control Studies. 7.4.1 Ideal for Studying Rare Diseases and Those with a Long Latency Period. 7.4.2 Efficiency. 7.4.3 Evaluation of Multiple Exposures. 7.5 Limitations of Case Control Studies. 7.5.1 Confounding. 7.5.2 Requires Ascertainment of Previous Exposures in Retrospect. 7.5.3 Inability to Directly Determine the Incidence of Disease. References. 59 59 60 60 60 61 63 64 65 65 66 66 67 67 68 69 69 69 72 72 74 74 75 76 76 76 76 78 78 Randomized
Trials. 79 8.1 Rationale for Randomized Trials. 80 8.2 General Design of Randomized Trials. 82 8.3 Trial Populations. 82 8.3.1 Definition of the Target Condition. 83
x Contents 8.3.2 Exclusion of People Suspected to Have Difficulty Adhering to the Study Treatments. 83 8.3.3 Exclusion of People Who Have Comorbid Conditions. 84 8.3.4 Exclusion of People Who Are Already Receiving the Study Treatment. 84 8.3.5 Exclusion for Safety. 85 8.3.6 Broadly Inclusive Healthcare Settings Promote Applicability of Trial Results. 86 8.4 Interventions and Control Procedures. 86 8.4.1 Intervention. 86 8.4.2 Control Procedures. 86 8.5 Outcomes of Trials. 88 8.5.1 Capture Important Benefits and Harms of the Intervention. 88 8.5.2 Types of Outcomes. 89 8.5.3 Mortality Outcomes. 89 8.5.4 Surrogate Outcomes. 90 8.5.5 Premature Termination of Trials. 90 8.6 Procedures to Promote Internal Validityof Trials. 91 8.6.1
Randomization. 91 8.6.2 Blinding. 92 8.6.3 Concealment of Treatment Allocation. 93 8.6.4 Efficacy and Effectiveness. 93 8.6.5 Trial Reporting. 94 8.7 Specific Trial Designs. 94 8.7.1 Factorial Trials. 94 8.7.2 Crossover Trials. 95 8.7.3 Phases of Drug Development. 98 8.8 Analysis of Clinical Trial Data.100 8.8.1 Measures of Effect.100 8.8.2 Intention-To-Treat Analysis.103 8.8.3 Subgroup Analyses.105 8.9 Limitations of Randomized Trials.108 8.9.1 Limited External Validity (Applicability) of the Trial Population.108 8.9.2 Limited External Validity (Applicability) of the Trial Environment.108 8.9.3 Narrow Study
Question.109 8.9.4 Randomized Design Accounts Only for Confounding.109 8.9.5 Negative Trials.110 References. 110
Contents xi 9 Misclassifïcation. 113 9.1 Definition of Miscalculation. 114 9.2 Non-differential Miscalculation. 115 9.2.1 Non-differential Misclassification of the Exposure. 115 9.2.2 Non-differential Misclassification of the Outcome.118 9.2.3 Summary of Non-differential Misclassification.120 9.3 Differential Misclassification. 120 9.3.1 Differential Misclassification of the Exposure. 120 9.3.2 Differential Misclassification of the Outcome.122 9.3.3 Summary of Differential Misclassification.122 9.4 Assessment of Misclassification in Research Articles.123 Reference.124 10 Confounding.125 10.1 Confounding Obscure Understanding of Causal Relationships. . 125 10.2 Evaluation of a Potential Confounding Characteristic.127 10.2.1 Confounding Characteristic Associated with the Exposure 127 10.2.2 Confounding Characteristic Associated with the Outcome 129 10.2.3 Confounding Characteristic Not on the Causal Pathway of Association 129 10.2.4 Evaluation of
Confounding Characteristics in Research Articles 131 10.3 Residual Confounding.133 10.4 Confounding by Indication. 133 10.5 Methods to Control for Confounding. 134 10.5.1 Method of Restriction 135 10.5.2 Method of Stratification plus Adjustment 136 10.5.3 Method of Matching 139 10.5.4 Method of Regression 141 10.6 Interpreting Results After Adjustment for Confounding. 141 Reference.142 11 Effect Modification.143 11.1 Concept of Effect Modification. 144 11.2 Evaluation of Effect Modification. 146 11.2.1 Criteria for Assessing the Presence of Effect Modification 147 11.2.2 Statistical Considerations for Evaluating Effect Modification 148 11.3 Effect Modification and Confounding Are Distinct Concepts.152 11.4 Effect Modification on the Relative and Absolute Scales. 154 References.155
xjį Contents 12 Screening and Diagnosis. 157 12.1 General Principles of Screening and Diagnosis.158 12.2 Utility of Testing. 159 12.3 Qualities of Diseases Appropriatefor Screening.160 12.3.1 Early Recognition of the Disease Should Provide Meaningful Benefit 160 12.3.2 Screening Tests Should Target Diseases that Have Potentially Serious Consequences 161 12.3.3 Diseases Targeted by Screening Require a Preclinical Phase 161 12.4 Qualities of Tests Appropriate for Screening or Diagnosis.161 12.4.1 Validity 162 12.4.2 Reliability 170 12.5 Defining Cut Points for Continuous Tests. 174 12.6 Types of Biases in Screening Studies. 177 12.6.1 Confounding (Referral Bias) 177 12.6.2 Lead Time Bias 177 12.6.3 Length Bias Sampling 179 12.7 Levels of Prevention.179 12.7.1 Primary Prevention 179 12.7.2 Secondary Prevention 180 12.7.3 Tertiary Prevention 180 12.8 Association Is Not Sufficient for Prediction. 181 References. 183 Part II Biostatistics 13 Summary Measures in
Statistics.187 13.1 Types of Variables.187 13.2 Univariate Statistics. 188 13.2.1 Histograms 188 13.2.2 Measures of Location and Spread 190 13.2.3 Quantiles 192 13.2.4 Univariate Statistics for Binary Data 193 13.3 Bivariate Statistics.194 13.3.1 Tabulation Across Categories 194 13.3.2 Correlation 194 13.3.3 Quantile-Continuous Variable Plots 195 14 Introduction to Statistical Inference. 197 14.1 Definition of a Population and a Sample. 197 14.2 External Validity. 198 14.3 Statistical Inference.199 14.4 Confidence Intervals. 199
Contents xiii 14.5 Hypothesis Testing.203 14.5.1 Construction of StatisticalHypotheses 203 14.5.2 P-Values 204 Reference. 206 15 Hypothesis Tests in Practice.207 15.1 Two-Sample Hypothesis Tests.207 15.1.1 T- Test 208 15.1.2 Chi-Square Test 209 15.1.3 Hypothesis Tests for Other Types of Study Data 210 15.1.4 Multiple Sample Hypothesis Tests 210 15.2 An Imperfect System. 211 15.2.1 Type I Error 211 15.2.2 Type II Error 212 15.3 Power. 212 15.3.1 Sample Size (TV) 213 15.3.2 Effect Size (m) 214 15.3.3 Variability (σ) 215 15.3.4 Significance Level (a) 216 16 Linear Regression. 217 16.1 Describing the Association Between Two Variables. 218 16.2 Univariate Linear Regression.219 16.2.1 The Linear Regression Equation 219 16.2.2 Residuals and the Sum of Squares 220 16.2.3 Interpreting Continuous Covariates from a Linear Regression Model 221 16.2.4 Interpreting Binary Covariates from Linear Regression Equations 223 16.3
Diagnostics. 224 16.3.1 Absolute Versus Relative Fit 224 16.3.2 Nonlinear Associations 225 16.3.3 Influential Points 228 16.3.4 Extrapolating the Regression Equation Beyond the Observed Data 229 16.4 Multiple Linear Regression.230 16.4.1 Definition of the Multiple Regression Model 230 16.4.2 Interpreting Results from the Multiple Regression Model 231 16.5 Confounding and Effect Modificationin Multiple Regression Models. 234 16.5.1 Confounding 234 16.5.2 Effect Modification 236
xiv Contents 17 Log-Link and Logistic Regression.239 17.1 Regression for Ratios.239 17.1.1 Log-Link Regression 239 17.1.2 Interpretation of Log-Link Regression Models 240 17.1.3 Hypothesis Testing for Log-Link Regression Results 243 17.2 Logistic Regression. 243 17.2.1 Definition and Interpretation of the Logistic Regression Model 243 17.2.2 Interpreting Logistic Regression Results from Research Articles 245 18 Survival Analysis.247 18.1 Motivation for Survival Data. 248 18.2 Interpretation of Survival Data. 249 18.2.1 Description of the Survivor Function 249 18.2.2 Estimating Time-Specific and Median Survival from S(t) 250 18.2.3 Statistical Testing of Survival Data 251 18.3 Estimation of the Survivor Function. 252 18.3.1 Definitions of Outcomes and Censoring 252 18.3.2 Kaplan-Meier Estimation of the Survivor Function for Uncensored Data 253 18.3.3 Kaplan-Meier Estimation of the Survivor Function for Censored Data 255 18.4 Cox’s Proportional Hazards Model. 257 18.5 Interpreting Survival Data. 259 18.5.1
Interpreting Hazard Ratios 259 18.5.2 Interpreting Survival Versus Hazard Ratio Data 261 Reference. 262 Glossary of Terms. 263 Index. 273
Bryan Kestenbaum Epidemiology and Biostatistics An Introduction to Clinical Research Second Edition This is a concise introduction to epidemiology and biostatistics writ ten specifically for medical students and first-time learners of clinical research methods. It presents the core concepts of epidemiology and of biostatistics and illustrates them with extensive examples from the clinical literature. It is the only book on the market written to speak directi}· to medical students and first-time biomedical researchers by using language and examples that are easy to understand. This newly updated second edition is extensively rewritten to provide the clearest explanations and examples. There is also a sister-text, a 150-problem workbook of practice problems that can be purchased alongside this textbook. The author continues to provide a text that is attractively fast-paced and concise for use in condensed courses, such as those taught in medical school. The book is an excellent review for the epidemiology section of the United States Medical Licensing Examination Part I which all medical students must take at the end of the second year. |
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| dewey-full | 614.4 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 614 - Forensic medicine; incidence of disease |
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| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| discipline_str_mv | Medizin |
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| spelling | Kestenbaum, Bryan Verfasser (DE-588)139439595 aut Epidemiology and biostatistics an introduction to clinical research Bryan Kestenbaum Second edition Cham Springer [2019] XIV, 277 Seiten Illustrationen txt rdacontent n rdamedia nc rdacarrier Epidemiology Biostatistics Statistical methods Biostatistik (DE-588)4729990-3 gnd rswk-swf Epidemiologie (DE-588)4015016-1 gnd rswk-swf 1\p (DE-588)4151278-9 Einführung gnd-content Epidemiologie (DE-588)4015016-1 s Biostatistik (DE-588)4729990-3 s DE-604 Erscheint auch als Online-Ausgabe 978-3-319-96644-1 Digitalisierung UB Augsburg - ADAM Catalogue Enrichment application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=032613777&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis Digitalisierung UB Augsburg - ADAM Catalogue Enrichment application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=032613777&sequence=000003&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA Klappentext 1\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk |
| spellingShingle | Kestenbaum, Bryan Epidemiology and biostatistics an introduction to clinical research Epidemiology Biostatistics Statistical methods Biostatistik (DE-588)4729990-3 gnd Epidemiologie (DE-588)4015016-1 gnd |
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| title | Epidemiology and biostatistics an introduction to clinical research |
| title_auth | Epidemiology and biostatistics an introduction to clinical research |
| title_exact_search | Epidemiology and biostatistics an introduction to clinical research |
| title_exact_search_txtP | Epidemiology and biostatistics an introduction to clinical research |
| title_full | Epidemiology and biostatistics an introduction to clinical research Bryan Kestenbaum |
| title_fullStr | Epidemiology and biostatistics an introduction to clinical research Bryan Kestenbaum |
| title_full_unstemmed | Epidemiology and biostatistics an introduction to clinical research Bryan Kestenbaum |
| title_short | Epidemiology and biostatistics |
| title_sort | epidemiology and biostatistics an introduction to clinical research |
| title_sub | an introduction to clinical research |
| topic | Epidemiology Biostatistics Statistical methods Biostatistik (DE-588)4729990-3 gnd Epidemiologie (DE-588)4015016-1 gnd |
| topic_facet | Epidemiology Biostatistics Statistical methods Biostatistik Epidemiologie Einführung |
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