Epidemiology and biostatistics: an introduction to clinical research
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Dordrecht [u.a.]
Springer
2009
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| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XIII, 242 S. graph. Darst. |
| ISBN: | 9780387884325 0387884327 9780387884332 |
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Datensatz im Suchindex
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|---|---|
| adam_text | Titel: Epidemiology and biostatistics
Autor: Kestenbaum, Bryan
Jahr: 2009
Contents
Epidemiology
1 Measures of Disease Frequency 3
1.1 Importance of Measures of Disease Frequency 5
1.2 Prevalence 5
1.3 Incidence 6
1.4 Relationship Between Prevalence and Incidence 9
1.5 Stratification of Disease Frequency by Person, Place,
and Time 9
1.5.1 Disease Frequency Measurements Stratified
by Characteristics of Person 10
1.5.2 Disease Frequency Measurements Stratified
by Characteristics of Place 10
1.5.3 Disease Frequency Measurements Stratified
by Characteristics of Time 11
1.5.4 Disease Frequency Measurements
To Complement Experimental Data 11
2 General Considerations in Clinical Research Design 13
2.1 Study Population 14
2.1.1 Definition of the Study Population 14
2.1.2 Choice of Study Population and Generalizability
of Study Findings 15
2.1.3 Where to Find Information About the Study
Population in a Clinical Research Article 16
2.2 Exposure and Outcome 17
2.2.1 Definition 17
2.2.2 Specifying and Measuring the Exposure and Outcome 18
2.2.3 Where to Find Exposure and Outcome
Data in a Clinical Research Article 18
2.3 Interventional Versus Observational Study Designs 19
2.4 Inferring Causation from Association Studies 21
vii
Contents
via
2.4.1 Importance of Distinguishing Causation
from Association 21
2.4.2 Factors Favoring an Inference of Causation 22
3 Case Reports and Case Series 25
4 Cross-Sectional Studies 29
5 Cohort Studies 33
5.1 Overview of Cohort Study Design 33
5.2 Ascertainment of Study Data 35
5.2.1 Validity of Measurements 35
5.2.2 Timing of Measurements 36
5.2.3 Uniform Measurements 37
5.2.4 Retrospective Versus Prospective
Data Collection 37
5.3 Advantages of Cohort Studies 38
5.3.1 Study of Multiple Outcomes 38
5.3.2 Ability to Discern Temporal Relationship
Between Exposure and Outcome 38
5.4 Disadvantages of Cohort Studies 39
5.4.1 Confounding 39
5.4.2 Inability to Examine Diseases That Are Rare
or Have a Long Latency 39
5.5 Cohort Studies for Evaluating Medication Use 40
5.6 Analysis of Data From Cohort Studies 41
5.6.1 Incidence Proportion Versus Incidence Rate 41
5.6.2 Relative Risk 42
5.6.3 Attributable Risk (also Called Risk Difference
or Excess Risk ) 44
6 Case-Control Studies 45
6.1 Case-Control Study Design 47
6.1.1 Overview 47
6.1.2 Selection of Cases 48
6.1.3 Selection of Controls 49
6.2 Advantages of Case-Control Studies 51
6.2.1 Case Control Studies Can Be Ideal for the Study
of Rare Diseases or Those with a Long Latency 51
6.2.2 Case-Control Studies Allow for the Study
of Multiple Exposures 51
6.3 Disadvantages of Case-Control Studies 52
6.3.1 Observational Study Design 52
6.3.2 Recall Bias ZZZZZZZ 52
Contents ix
6.3.3 Case Control Studies only Provide Information
Regarding the Relative Risk (Odds) of Disease 53
6.4 Analysis of Case-Control Data 53
6.4.1 Theory of the Odds Ratio 53
6.4.2 Practical Calculation of the Odds Ratio 55
6.4.3 Odds Ratios and Relative Risk 55
6.4.4 Case-Control Studies Cannot Estimate the
Actual Incidence of a Disease or Outcome 56
7 Randomized Trials 59
7.1 Rationale for Randomized Trials 59
7.1.1 Kidney Transplant and Mortality 60
7.1.2 Angioplasty versus Fibrinolysis for Patients
with Acute Myocardia] Infarction 60
7.1.3 Equipoise 61
7.2 Phases of Drug Development 61
7.2.1 Phase I Studies 62
7.2.2 Phase II Studies 62
7.2.3 Phase III/IV Studies 62
7.3 Conduct of Randomized Trials 62
7.3.1 Comparison Group 62
7.3.2 Placebo 63
7.3.3 Block Randomization 64
7.3.4 Biological Versus Clinical Endpoints 65
7.4 Limitations of Randomized Controlled Trials 65
7.4.1 Generalizability of the Study Population 65
7.4.2 Generalizability of the Study Environment 66
7.4.3 Limited Question 67
7.4.4 Limited Clinical Applicability 67
7.4.5 Randomized Design Accounts only
for Confounding 68
7.5 Analysis of Randomized Controlled Trial Data 68
7.5.1 Measures of Effect 68
7.5.2 Numbers Needed to Treat/Harm 69
7.5.3 Measures of Effect in Journal Articles 69
7.5.4 Intention-to Treat-Analysis 70
7.5.5 Subgroup Analyses 71
8 Misdassification 75
8.1 Definition of Misdassification 75
8.2 Nondifferential Misdassification 76
8.2.1 Example of Nondifferential Misdassification
of the Exposure 76
8.2.2 Definition and Impact of Nondifferential
Misdassification of the Exposure 78
Contents
8.2.3 Nondifferential Misclassification of the Outcome 81
8.2.4 Definition and Impact of Nondifferential
Misclassification of the Outcome 84
8.3 Differential Misclassification 84
8.4 Assessment of Misclassification in Clinical Research Articles 89
9 Introduction to Confounding 91
9.1 Confounding and the Interpretation of Clinical Data 91
9.2 Formal Evaluation of a Potential Confounding Factor 94
9.2.1 Evaluation of a Confounder: Association
with Exposure 95
9.2.2 Evaluation of a Confounder: Association
with Outcome 95
9.2.3 Evaluation of a Confounder: Not in the Causal
Pathway of Association 96
9.2.4 Other Examples of Factors That Reside
on the Causal Pathway of Association 98
9.3 Scientifically Meaningful Versus Statistical Associations 98
9.4 Evaluation of a Confounder in Clinical Research Articles 99
9.5 Confounding-by-Indication 100
10 Methods to Control for Confounding 101
10.1 Restriction 102
10.1.1 Method of Restriction 102
10.1.2 Pros and Cons of Restriction as a Means
to Control for Confounding 102
10.1.3 Restriction to Control for
Confounding-by-Indication 103
10.2 Stratification 103
10.2.1 Method of Stratification 103
10.2.2 Pros and Cons of Stratification as 3 Means
to Control for Confounding 105
10.2.3 Stratum-Specific Associations 105
10.3 Matching 106
10.3.1 Method of Matching 106
10.3.2 Pros and Cons of Matching as a Means
to Control Confounding 107
10.4 Regression 108
10.5 Randomization 108
10.6 Interpreting Study Results After Adjustment
for Confounding 109
10.7 Unadjusted Versus Adjusted Associations:
Confounding 109
10.8 Confounding: An Advanced Example 110
Contents xi
11 Effect Modification 113
11.1 Concept of Effect Modification 113
11.2 Synergy Between Exposure Variables 114
11.3 Effect Modification Versus Confounding 115
11.4 Evaluation of Effect Modification 116
11.4.1 Epidemiologic Evaluation of Effect Modification 116
11.4.2 Statistical Evaluation of Effect Modification 116
11.5 Effect Modification in Clinical Research Articles 117
11.6 Effect Modification on the Relative and Absolute Scales 118
12 Screening 121
12.1 General Principles of Screening 122
12.2 Qualities of Diseases Appropriate for Screening 122
12.2.1 The Disease should be Important
in the Screened Population 122
12.2.2 Early Recognition and Treatment of the Disease
Should Prevent Clinical Outcomes 123
12.2.3 The Disease Should have a Preclinical Phase 123
12.3 Qualities of Screening Tests 123
12.3.1 General Qualities 123
12.3.2 Reliability and Validity 123
12.4 Validity of Screening Tests 124
12.4.1 Sensitivity and Specificity 124
12.4.2 Positive and Negative Predictive Value 125
12.4.3 Screening Tests with Continuous Values 129
12.5 Reliability of Screening Tests 132
12.5.1 Variation in Measurement Tools and Within
an Individual 132
12.5.2 Measures of Reliability 133
12.6 Types of Bias in Screening Studies 134
12.6.1 Referral Bias 134
12.6.2 Lead Time Bias 135
12.6.3 Length Bias Sampling 136
12.6.4 Overdiagnosis Bias 137
12.7 Association versus Prediction 137
13 Diagnostic Testing 139
13.1 General Considerations in Medical Testing 139
13.2 Likelihood Ratios 143
Biostatistics
14 Summary Measures in Statistics 153
14.1 Types of Variables 153
14.2 Univariate Statistics 154
xii ContentS
14.2.1 Histograms 154
14.2.2 Measures of Location and Spread 156
14.2.3 Quantiles 158
14.2.4 Univariate Statistics for Binary Data 159
14.3 Bivariate Statistics 159
14.3.1 Tabulation Across Categories 159
14.3.2 Correlation 160
14.3.3 Quantile-Continuous Variable Plots 162
15 Introduction to Statistical Inference 163
15.1 Definition of a Population, Sample, and random Sample 163
15.2 Statistical Inference 164
15.3 Generalizability 165
15.4 Confidence Intervals 165
15.5 P-values 168
15.6 Confidence Intervals and p-values in Clinical Research 169
16 Hypothesis Testing 171
16.1 Study Hypothesis and Null Hypothesis 172
16.2 Distribution of Sampling Means 173
16.3 Properties of the Distribution of Sampling Means 174
16.3.1 Normal (Bell-Shaped) Distribution
for Reasonably Large Sample Sizes 174
16.3.2 Mean Equal to the Population Mean 175
16.3.3 Spread of the Distribution Related
to Population Variation and Sample Size 175
16.3.4 Distribution of Sampling Means: Summary 177
16.4 Conducting the Experiment 177
17 Interpreting Hypothesis Tests 181
17.1 Common Tests of Hypothesis in Clinical Research 181
17.1.1 T-Tests 181
17.1.2 Chi-Square Tests 182
17.1.3 ANOVA Tests 182
17.2 An Imperfect System 183
17.2.1 Type I Errors 183
17.2.2 Type II Errors 184
17.2.3 Power 184
18 Linear Regression )89
18.1 Describing the Association Between Two Variables 189
18.2 Univariate Linear Regression 192
18.2.1 The Linear Regression Equation 192
18.2.2 Residuals and the Sum of Squares 193
Contents xiii
18.2.3 Absolute Versus Relative Fit 194
18.3 Interpreting Results from Univariate Regression Equations 195
18.3.1 Interpreting Continuous Covariates 195
18.3.2 Interpreting Binary Covariates 195
18.4 Special Considerations 197
18.4.1 Influential Points 197
18.4.2 Nonlinear Associations 198
18.4.3 Extrapolating the Regression Equation
Beyond the Study Data 200
18.5 Multiple Linear Regression 200
18.5.1 Definition of the Multivariate Model 200
18.5.2 Interpreting Results from the Multiple
Regression Model 201
18.6 Confounding and Effect Modification in Regression Models 204
18.6.1 Confounding 204
18.6.2 Effect Modification 205
19 Non-Linear Regression 209
19.1 Regression for Ratios 209
19.2 Logistic Regression 211
19.3 Application of Logistic Regression Models 213
20 Survival Analysis 215
20.1 Limitations of Incidence Measures for Evaluating Risk 215
20.1.1 Incidence Measures: Oversimplification
of Study Results Overtime 216
20.1.2 Incidence Measures: Crude Handling
of Participant Dropout 216
20.2 Survival Data 217
20.3 Statistical Testing of Survival Data 219
20.4 Definitions of Events and Censoring 220
20.5 Kaplan-Meier Estimation 221
20.5.1 Kaplan-Meier Estimation of S(t) 221
20.5.2 Kaplan-Meier Estimation of S(t)
with Censored Data 222
20.6 Cox s Proportional Hazards Model 224
20.6.1 Description of the Proportional Hazards Model 224
20.6.2 Interpreting Survival Data and the Proportional
Hazards Model 227
20.6.3 Survival Versus Hazard Ratio Data 228
References 229
Author Index 233
Subject Index 237
|
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| spelling | Kestenbaum, Bryan Verfasser (DE-588)139439595 aut Epidemiology and biostatistics an introduction to clinical research Bryan Kestenbaum Dordrecht [u.a.] Springer 2009 XIII, 242 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Biometry Biostatistics Epidemiologic Methods Biostatistik (DE-588)4729990-3 gnd rswk-swf Epidemiologie (DE-588)4015016-1 gnd rswk-swf (DE-588)4151278-9 Einführung gnd-content Epidemiologie (DE-588)4015016-1 s Biostatistik (DE-588)4729990-3 s DE-604 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=018989346&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Kestenbaum, Bryan Epidemiology and biostatistics an introduction to clinical research Biometry Biostatistics Epidemiologic Methods Biostatistik (DE-588)4729990-3 gnd Epidemiologie (DE-588)4015016-1 gnd |
| subject_GND | (DE-588)4729990-3 (DE-588)4015016-1 (DE-588)4151278-9 |
| 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_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 | Biometry Biostatistics Epidemiologic Methods Biostatistik (DE-588)4729990-3 gnd Epidemiologie (DE-588)4015016-1 gnd |
| topic_facet | Biometry Biostatistics Epidemiologic Methods Biostatistik Epidemiologie Einführung |
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