19 15 The Randomised Controlled Trial Summary 15.1 Introduction 15.2 The Protocol 15.3 Why Randomise? 15.4 Methods of Randomisation 15.5 Design Features 15.6 Design Options 15.7 Meta‐analysis 15.8 Checklists for Design, Analysis and Reporting 15.9 CONSORT 15.10 Points When Reading the Literature About a Trial 15.11 Exercises
20 16 Sample Size Issues Summary 16.1 Introduction 16.2 Study Size 16.3 Continuous Data 16.4 Binary Data 16.5 Prevalence 16.6 Subject Withdrawals 16.7 Other Aspects of Sample Size Calculations 16.8 Points When Reading the Literature 16.9 Technical Details 16.10 Exercises
21 17 Other Statistical Methods Summary 17.1 Analysing Serial or Longitudinal Data 17.2 Poisson Regression 17.3 Missing Data 17.4 Bootstrap Methods 17.5 Points When Reading the Literature 17.6 Exercises
22 18 Meta‐analysis Summary 18.1 Introduction 18.2 What is a Meta‐analysis? 18.3 Meta‐analysis Methods 18.4 Example: Mobile Phone Based Intervention for Smoking Cessation 18.5 Discussion 18.6 Technical Details 18.7 Exercises
23 19 Common Mistakes and Pitfalls Summary 19.1 Introduction 19.2 Misleading Graphs and Tables 19.3 Plotting Change Against Initial Value 19.4 Within Group Versus Between Group Analyses 19.5 Analysing Paired Data Ignoring the Matching 19.6 Unit of Analysis 19.7 Testing for Baseline Imbalances in an RCT 19.8 Repeated Measures 19.9 Clinical and Statistical Significance 19.10 Post Hoc Power Calculations 19.11 Predicting or Extrapolating Beyond the Observed Range of Data 19.12 Exploratory Data Analysis 19.13 Misuse of P‐values 19.14 Points When Reading the Literature
24 Appendix Statistical Tables
25 Solutions to Multiple‐Choice Exercises Chapter 2 Chapter 3 Chapter 4 Chapter 5