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1 Expressing and Analyzing Variability |
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1 | (86) |
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1 | (1) |
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1.2 Variables: Types, Measurement and Role |
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2 | (1) |
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1.2.1 Variable Conversion |
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2 | (1) |
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3 | (7) |
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1.3.1 The Qualitative Variable |
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4 | (3) |
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1.3.2 The Quantitative Variable |
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7 | (1) |
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1.3.3 Measures of Central Tendency |
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7 | (1) |
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1.3.4 Measures of Dispersion |
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7 | (3) |
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1.4 The Normal Distribution |
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10 | (21) |
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1.4.1 The Standardized Normal Distribution and the Z Score |
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12 | (3) |
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1.4.2 The Confidence Interval (CI) |
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15 | (10) |
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1.4.3 Verifying Normality |
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25 | (5) |
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1.4.4 Normalization of Data |
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30 | (1) |
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31 | (1) |
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1.5.1 The Primary Risk of Error (α) |
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31 | (1) |
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1.6 The Null and Alternative Hypothesis |
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32 | (2) |
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1.6.1 Statistical Significance and the Degree of Significance |
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34 | (1) |
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34 | (5) |
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1.7.1 A Simple Parametric Test |
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34 | (1) |
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1.7.2 Unilateral Study Design |
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34 | (2) |
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1.7.3 Bilateral Study Design |
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36 | (1) |
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1.7.4 The Secondary Risk of Error |
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37 | (2) |
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1.8 Common Indices of Clinical Outcomes |
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39 | (17) |
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1.8.1 The Risk and the Odds |
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39 | (1) |
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1.8.2 The Relative Risks and the Odds Ratio |
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39 | (4) |
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43 | (6) |
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1.8.4 Relative Risk Increase (RRI) and Relative Risk Reduction (RRR) |
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49 | (1) |
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1.8.5 Absolute Risk Increase (ARI) and Reduction (ARR) |
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50 | (1) |
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1.8.6 Number Needed to Treat Benefit (NNTB) and Number Needed to Harm (NNTH) |
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50 | (1) |
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1.8.7 Calculation of the 95% Confidence Interval and Testing Statistical Significance |
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51 | (5) |
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56 | (29) |
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1.9.1 The Discriminative Measures |
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57 | (6) |
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1.9.2 The Predictive Values |
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63 | (3) |
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1.9.3 The Likelihood Ratios |
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66 | (5) |
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1.9.4 Single Indicators of Test Performance |
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71 | (11) |
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1.9.5 Choosing the Appropriate Diagnostic Test |
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82 | (1) |
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1.9.6 Comparing Two Diagnostic Tests |
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83 | (2) |
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1.9.7 The Standards for Reporting Diagnostic Accuracy (STARD) |
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85 | (1) |
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85 | (2) |
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2 Bivariate Statistical Analysis |
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87 | (160) |
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2.1 Choosing a Statistical Test |
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88 | (2) |
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2.1.1 Independence of Data: Paired Versus Unpaired Tests |
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89 | (1) |
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2.1.2 Data Distribution: Parametric Versus Distribution-Free Tests |
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89 | (1) |
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2.2 Consulting Statistical Tables |
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90 | (7) |
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2.2.1 The Test Statistics |
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90 | (1) |
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2.2.2 The Degrees of Freedom (Df) |
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91 | (2) |
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2.2.3 Consulting Individual Tables |
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93 | (4) |
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2.3 Inferences on Two Qualitative Variables |
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97 | (17) |
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97 | (12) |
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109 | (5) |
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2.4 Inferences on Means and Variances of Normal Distribution: The Parametric Tests |
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114 | (29) |
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2.4.1 The Comparison of Two Means |
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114 | (9) |
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2.4.2 The Comparison of Two Variances |
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123 | (1) |
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2.4.3 The Comparison of Multiple Means |
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124 | (19) |
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2.5 Inference on Medians and Other Distributions Than Normal: Non-parametric Tests? |
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143 | (10) |
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2.5.1 The Comparison of Two-Groups |
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143 | (7) |
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2.5.2 The Comparison of Several Groups |
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150 | (3) |
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2.6 Inference on the Relation of Two Quantitative Variables |
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153 | (21) |
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154 | (8) |
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162 | (12) |
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2.7 Inference on Survival Curves |
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174 | (17) |
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2.7.1 Introduction: Assumptions and Definitions |
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174 | (1) |
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2.7.2 Kaplan Meier Method |
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175 | (6) |
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181 | (2) |
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2.7.4 Comparison of Survival Curves |
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183 | (8) |
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2.8 Choosing the Appropriate Bivariate Statistical Test |
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191 | (4) |
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191 | (2) |
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2.8.2 The Unpaired Statistical Tests |
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193 | (1) |
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2.8.3 The Paired Statistical Tests |
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194 | (1) |
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2.8.4 The Comparison of Survival Curves |
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194 | (1) |
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2.9 Adjusting Bivariate Analysis: Prognostic Studies |
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195 | (18) |
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195 | (2) |
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2.9.2 Excluding a Qualitative (Reverse) Interaction |
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197 | (3) |
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2.9.3 Adjusting Two Proportions |
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200 | (3) |
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2.9.4 Adjusting Two Means |
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203 | (6) |
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2.9.5 Adjusting Two Quantitative Variables |
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209 | (4) |
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2.10 Measuring Agreement and Testing Reliability |
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213 | (31) |
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213 | (2) |
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2.10.2 Plan of the Analysis |
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215 | (3) |
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2.10.3 The Qualitative Outcome |
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218 | (10) |
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2.10.4 The Quantitative Outcome |
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228 | (16) |
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244 | (3) |
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247 | (92) |
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247 | (1) |
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248 | (46) |
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3.2.1 Testing the Main Effects |
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249 | (2) |
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3.2.2 Testing Interaction Effects of Qualitative Variables |
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251 | (3) |
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3.2.3 Testing Interaction Effects of Quantitative Variables: Analysis of Covariance (ANCOVA) |
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254 | (17) |
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3.2.4 Multivariate ANOVA and ANCOVA (MANOVA and MANCOVA) |
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271 | (6) |
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3.2.5 Repeated Measures ANOVA (RMANOVA) |
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277 | (17) |
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3.3 General Outlines of Multivariable Models |
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294 | (5) |
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294 | (1) |
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294 | (1) |
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3.3.3 Selection of Predictors |
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295 | (1) |
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296 | (1) |
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3.3.5 The Equations and Estimation of Regression Coefficients |
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297 | (1) |
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3.3.6 Evaluation of the Model |
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298 | (1) |
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3.4 Multiple Regression Analysis |
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299 | (16) |
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3.4.1 Introduction: Simple Versus Multiple Linear Regression |
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300 | (1) |
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3.4.2 The Basic Assumptions |
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301 | (2) |
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303 | (2) |
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3.4.4 Designing the Model |
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305 | (1) |
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3.4.5 Verification of the Assumptions |
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306 | (4) |
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310 | (4) |
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3.4.7 What Should Be Reported |
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314 | (1) |
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3.4.8 The Case of Multiple Outcome Variables |
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315 | (1) |
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3.5 Binary Logistic Regression Analysis |
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315 | (14) |
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3.5.1 Introduction: The Linear Versus the Logistic Regression |
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315 | (7) |
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3.5.2 The Basic Assumptions |
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322 | (1) |
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323 | (1) |
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3.5.4 Designing the Model |
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324 | (1) |
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3.5.5 Verification of the Assumptions |
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324 | (1) |
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325 | (3) |
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3.5.7 What Should Be Reported |
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328 | (1) |
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3.6 Cox Regression Analysis |
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329 | (8) |
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3.6.1 Introduction: Life Tables Versus Cox Regression Analysis |
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329 | (1) |
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3.6.2 The Basic Assumptions |
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330 | (2) |
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332 | (1) |
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3.6.4 Designing the Model |
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333 | (1) |
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3.6.5 Verification of the Assumptions |
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333 | (2) |
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335 | (1) |
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3.6.7 What Should Be Reported |
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336 | (1) |
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337 | (2) |
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4 Sample Size Calculation |
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339 | (82) |
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339 | (11) |
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4.1.1 Estimation of the Effect Size |
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340 | (1) |
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4.1.2 Choosing the Risks of Error |
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341 | (1) |
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4.1.3 The Direction of the Study |
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342 | (1) |
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4.1.4 Study Specific Factors |
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343 | (1) |
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4.1.5 Sample Size Calculation |
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344 | (6) |
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4.2 Comparison of Two Independent Quantitative Variables: Student and Mann & Whitney Tests |
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350 | (6) |
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350 | (2) |
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352 | (4) |
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4.3 Association of Two Independent Binary Variables: Chi-Square and Fisher's Exact Tests |
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356 | (6) |
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356 | (3) |
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359 | (3) |
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4.4 Categorical and Ordinal Variables: Chi-Square Tests of Independence and Goodness of Fit |
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362 | (4) |
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363 | (1) |
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364 | (2) |
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366 | (6) |
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4.5.1 Paired Student Test |
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366 | (2) |
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4.5.2 Paired Wilcoxon-Sign-Rank Test |
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368 | (2) |
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370 | (2) |
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4.6 Comparison of Multiple Means: One-Way ANOVA |
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372 | (5) |
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372 | (3) |
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375 | (2) |
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4.7 Simple Correlation: Pearson's Correlation Coefficient R |
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377 | (2) |
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378 | (1) |
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378 | (1) |
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4.8 Simple Linear Regression |
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379 | (2) |
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379 | (1) |
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379 | (2) |
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381 | (3) |
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381 | (1) |
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381 | (3) |
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384 | (3) |
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4.10.1 Effect Size: Log Odds Ratio |
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385 | (1) |
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385 | (2) |
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387 | (4) |
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4.11.1 Conditional Fixed Factors Model |
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387 | (2) |
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4.11.2 Unconditional Random Effect Model |
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389 | (2) |
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391 | (6) |
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4.12.1 Repeated Measures ANOVA (RMANOVA) |
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391 | (4) |
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395 | (2) |
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4.13 Non-inferiority and Equivalence Studies |
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397 | (8) |
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4.13.1 Comparison of 2 Means |
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398 | (2) |
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4.13.2 Comparison of Two Proportions |
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400 | (3) |
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4.13.3 Time to Event Analysis |
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403 | (2) |
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405 | (5) |
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4.14.1 Sensitivity and Specificity |
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405 | (3) |
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408 | (2) |
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410 | (3) |
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4.15.1 Qualitative Outcome |
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410 | (1) |
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4.15.2 Quantitative Outcome |
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411 | (2) |
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413 | (3) |
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413 | (1) |
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4.16.2 Factors Regulating Sample Size Calculation |
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413 | (1) |
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4.16.3 Sample Size Calculation |
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414 | (2) |
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416 | (5) |
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5 The Protocol of a Comparative Clinical Study: Statistical Considerations |
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421 | (20) |
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5.1 Background and Rationale |
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421 | (1) |
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421 | (1) |
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422 | (2) |
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5.3.1 The Formulation of the Study |
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422 | (1) |
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5.3.2 Number of Study Groups and Number of Effectuated Comparisons |
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422 | (1) |
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5.3.3 The Classic Parallel Groups Versus Other Designs |
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423 | (1) |
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5.3.4 Design Framework: Superiority, Non-inferiority, Equivalence or Pilot Study |
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423 | (1) |
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423 | (1) |
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424 | (4) |
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424 | (1) |
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5.4.2 Assignment of Interventions |
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424 | (4) |
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428 | (1) |
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5.5 Study Population and Samples |
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428 | (3) |
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428 | (1) |
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428 | (1) |
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429 | (1) |
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430 | (1) |
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430 | (1) |
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5.6 Treatments and Interventions |
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431 | (1) |
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5.6.1 Studied Treatments and Interventions |
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431 | (1) |
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5.6.2 Associated Treatments and Interventions |
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432 | (1) |
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432 | (1) |
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5.7.1 Data Collection and Storage |
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432 | (1) |
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5.7.2 Data Monitoring and Auditing |
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432 | (1) |
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433 | (4) |
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5.8.1 Population for the Analysis |
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433 | (1) |
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5.8.2 Statistical Hypothesis |
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433 | (1) |
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5.8.3 Statistical Analysis |
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434 | (1) |
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5.8.4 Sample Size Determination |
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435 | (2) |
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437 | (1) |
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438 | (1) |
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5.11 Data Sharing and Publication |
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438 | (1) |
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438 | (1) |
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438 | (3) |
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6 Introduction to Meta-Analysis |
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441 | (86) |
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441 | (3) |
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6.1.1 From Narrative to Systematic Review |
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441 | (1) |
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6.1.2 Why Do We Need Meta-Analysis? |
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442 | (1) |
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6.1.3 Types of Meta-Analysis |
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443 | (1) |
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6.2 Stages of Meta-Analysis |
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444 | (75) |
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6.2.1 Formulation of the Problem |
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445 | (1) |
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446 | (1) |
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6.2.3 Assessment of Risk of Bias |
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447 | (1) |
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447 | (2) |
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6.2.5 Managing the Effect Size Estimates |
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449 | (3) |
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6.2.6 Estimation of a Mean Effect Size, Se, 95% CI and P Value |
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452 | (27) |
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6.2.7 Assessment of Heterogeneity |
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479 | (7) |
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486 | (12) |
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498 | (5) |
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6.2.10 Assessment of Publication Bias and Small-Study Effects |
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503 | (8) |
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6.2.11 Sensitivity Analysis |
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511 | (2) |
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6.2.12 Reporting Meta-Analysis |
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513 | (6) |
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6.3 Psychometric Meta-Analysis (Hunter and Schmidt) |
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519 | (4) |
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519 | (1) |
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6.3.2 The Bare Bones Meta-Analysis |
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520 | (1) |
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6.3.3 Meta-Analysis Corrected for All Artifacts |
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521 | (2) |
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523 | (4) |
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7 Pitfalls and Common Errors |
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527 | (56) |
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7.1 Sample Size Calculation |
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527 | (14) |
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527 | (1) |
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7.1.2 Sculpture the Primary Outcome |
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528 | (7) |
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7.1.3 Reduce Variability by Ameliorating the Study Design |
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535 | (2) |
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7.1.4 Prepare the Study to Receive the Selected Tests |
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537 | (3) |
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7.1.5 Account for the Effect of Covariates in Multivariable Analysis |
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540 | (1) |
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7.1.6 Manage the Secondary Outcomes |
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540 | (1) |
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541 | (6) |
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7.2.1 Check on Errors and Data Consistency |
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541 | (1) |
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541 | (1) |
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7.2.3 Manage Missing Data |
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541 | (4) |
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545 | (2) |
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7.3 Tools of the Analysis |
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547 | (7) |
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7.3.1 The Statistical Software |
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547 | (4) |
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7.3.2 The Complementary Online Calculators |
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551 | (3) |
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7.4 Data Reporting in a Manuscript |
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554 | (22) |
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554 | (1) |
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7.4.2 The Material and Methods |
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555 | (5) |
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560 | (6) |
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566 | (2) |
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568 | (1) |
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7.4.6 Common Pitfalls, Misinterpretations, and Inadequate Reporting |
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569 | (7) |
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7.5 The Role of the Statistician |
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576 | (3) |
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7.5.1 Include the Statistician in the Research Team |
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576 | (1) |
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7.5.2 Begin from the Beginning |
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577 | (1) |
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7.5.3 The Protocol is not a One-Man Show |
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577 | (1) |
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578 | (1) |
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578 | (1) |
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7.5.6 Statistical Analysis |
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579 | (1) |
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579 | (1) |
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579 | (4) |
List of Equations |
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583 | (26) |
Index |
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609 | |