Cluster Randomization Trials: Statistical Design and Analysis

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Half Title
Series Information
Title Page
Copyright Page
Table of Contents
Preface
1 Introduction
	References
2 One-Sample Binary Data
	Estimation of Binomial Proportions
	Modified McNemar\'s Test for Clustered Paired Binary Data
		Clustered McNemar’s Test
		Real Data Example
	Sample Size Calculations for Clustered Binary Data
		Example
		NumericalStudies
	References
3 Chi-Square Test for Two-Sample Clustered Binary Data (I): Donner\'s Adjustment
	Donner\'s Test Statistic
	Validation of Donner\'s Test
		Distribution of Donner’s Test Statistic
	Numerical Studies
	Example
	References
4 Chi-Square Test for Two-Sample Clustered Binary Data (II): GEE Adjustment
	Modified Chi-Square Test with GEE-Type Adjustment
		Test Statistic based on Optimal Estimators
		Efficiency of Weighted Estimators
	Sample Size Calculation
	Numerical Studies
		Example
		Simulations
	References
5 Subunit Randomization Trials: GEE-Type Test for Two-Sample Clustered Binary Data
	Modified Chi-Square Test with GEE-Type Adjustment
	Sample size Calculation
	Numerical Studies
		Simulations
		Real Data Example
	References
6 Random Number Generation of Clustered Binary Data
	Lunn-Davies Method
	Kang-Jung Method
	Basic Algorithm
	Beta-Binomial Distribution
	Method based on Multivariate Normal Random Variables
		Under Cluster Randomization
		Under Subunit Randomization
	References
7 Tests for RC Contingency Tables with Clustered Categorical Data
	Tests for 2K Contingency Tables with Clustered Ordered Categorical Data
	Score Tests for Independent Data
		Score Tests for Clustered Data
		Simulation Studies
		Real Data Examples
	Chi-Square Test for RC Contingency Tables with Clustered Categorical Data
		Simulation Studies
		Real Data Analysis
	References
8 Clustered Continuous Data
	Cluster Randomization Trials
		Modified t-Test for CRTs
		Sample Size Calculation for CRTs
	Subunit Randomization Trials
		Modified t-Test for SRTs
		Sample Size Calculation for SRTs
	An Equivalence Test for Clustered Pair Data
		Equivalence Test
		Example
9 Inference of Medians for Paired Survival Data
	Statistical Testing on Paired Median Survival Times
	Sample Size for Testing on Paired Median Survival Times
	Confidence Interval of Ratio or Difference of Median Survival Times
	Real Data Examples
	Simulation Studies
	References
10 Rank Tests for Matched Survival Data and Sample Size Calculation
	Weighted Rank Tests for Matched Survival Data
		Paired Two-Sample Data Case
		Matched K-Sample Data Case
		Real Data Examples
		Simulation Studies
	Sample Size Calculation for the Weighted Rank Tests with Paired Survival Data
		Sample Size under Some Practical Settings
		When Accrual Rate Is Given Instead of Accrual Period
		When Historical Data Are Available with Both of the Paired Subjects Treated by the Same Treatment
		Simulation Studies
		Examples
	Discussion
	References
11 Rank Tests for Clustered Survival Data and Sample Size Calculation under Cluster Randomization
	Weighted Rank Tests for Clustered Survival Data
		Extension To K Sample Cases
		Simulation Studies
		Real Example
	Sample Size Calculation of the Log-Rank Test for Two-Arm CRTs
		Specification of Survival Distribution
		Specification of Censoring Distribution
		Sample Size Calculation under Practical Design Settings
		Sample Size Calculation for given Accrual Rate instead of Accrual Period
		Simulation Studies
		Examples
	References
12 Rank Tests for Clustered Survival Data and Sample Size Calculation under Subunit Randomization
	Two-Sample Weighted Rank Tests for Subunit Randomization Trials
		Shared Gamma Frailty Model
		Simulation Studies
		Examples
	Sample Size Calculation of the Log-Rank Test for SRTs
		Specification of Survival Distribution
		Specification of Censoring Distribution
		When Accrual Rate Is Specified Instead of Accrual Period
		Subunit Randomization versus Cluster Randomization
		Numerical Studies
	References
13 Group Sequential Testing for Cluster Randomized Trials with Time-to-Event Endpoint
	Single-Stage Clustered Log-Rank Tests
	Group Sequential Testing for the Clustered Log-Rank Statistic
	Estimation of Covariance Matrix and Information Times
	Maximal Sample Size
	Numerical Studies
		Comparison of Stopping Boundaries
		Simulations
		Examples
	Discussion
	References
14 Random Number Generation of Clustered Survival Data
	Moran\'s Method
		Under Cluster Randomization
	Sequential Random Number Generation using Conditional Survival Functions
		Under Cluster Randomization
		Under Subunit Randomization
	Gamma-Exponential Frailty Model
		Under Cluster Randomization
		Under Subunit Randomization
	References
15 Cox\'s Regression for Clustered Survival Data
	Cox\'s PHM for Clustered Survival Data
	Example
	References
16 Design and Analysis of Individually Randomized Group-Treatment Trials
	IRGT Trials with Binary Data
		Modified Chi-Squared Test
		Sample Size Calculation for the Modified Chi-Squared Test
	IRGT Trials with Continuous Data
		Modified t-Test
		Sample Size Calculation for the Modified t-Test
	IRGT Trials with Survival Data
		Rank Test for IRGT
		Sample Size Calculation for the Log-Rank Test
		Distributional Assumptions for Sample Size Calculation
		When Number of Clustersis Given
		Optimal Designs
		Numerical Studies
		Discussion
	References
17 Analysis of Medical Tests I: Comparison of Concordance Rates with Clustered Data
	Concordance Rates of Clustered Binary Data
		Statistical Testing to Compare Concordance Rates
		Powerand Sample Size Calculation
		Simulation Studies
		Example
		Concordance Rates of Clustered Categorical Data
		Numerical Studies and Results
	References
18 Comparison of Binary Medical Tests and ROC Curves with Clustered Data
	Comparison of Binary Tests with Clustered Data
		Statistical Testing Methods
		Simulations
		Example
	Comparison of Paired ROC Curves
		A Statistical Test for Comparing Two Paired ROC Curves
		Sample Size Calculation
		Normally Distributed Biomarkers
		Numerical Studies
	Comparison of Two ROC Curves with Clustered Pair Data
	References
Index