Chapter Contents Subgroup Analyses 216 What Readers Should Look for With Subgroup Analyses 218 Interim Analyses 219 Early Termination and Biased Estimates of Treatment Effects 221 Stopping for Harm or…
Chapter Contents Introduction 228 Multicentre Randomised Controlled Trial 228 Prospective Meta-Analysis 228 Some Disadvantages of Multicentre Randomised Trials 229 Some Potential Disadvantages of PMAs 231 Basic Steps in a PMA…
Chapter Contents What Is a Surrogate Endpoint? 193 Advantages of Surrogate Endpoints 194 Disadavantages of Surrogate Endpoints 194 Validation of Surrogate Endpoints 196 Terminological Tangles 196 Levels of Evidence 198…
Chapter Contents Introduction 184 Single Blinding: Participants, Investigators, or Assessors 184 Participants 185 Investigators 185 Assessors 185 Implementation Issues: Participants 185 Sham Procedures 186 Implementation Issues: Assessors 187 Double Blinding:…
Chapter Contents Potential Effects of Blinding 174 Lexicon of Blinding 175 Masking or Blinding? 176 Placebos and Blinding 177 Does Blinding Prevent Bias? 178 What to Look for in Descriptions…
Chapter Contents Exclusions Before Randomisation 164 What to Look for in Exclusions Before Randomisation 164 Exclusions After Randomisation 164 What to Look for in Exclusions After Randomisation 166 Discovery of…
Chapter Contents Allocation Concealment 154 Importance of Allocation Concealment 154 Personal Accounts of Deciphering 155 What to Look for With Allocation Concealment 156 Baseline Comparisons 159 What to Look for…
Chapter Contents What to Look for With Sequence Generation 133 Nonrandom Methods Masquerading as Random 133 Method of Generation of an Allocation Sequence 133 Simple (Unrestricted) Randomisation 134 Restricted Randomisation…
Chapter Contents Forcing Cosmetic Credibility 142 Unequal Group Sizes in Restricted Trials 143 Alternatives in Non–Double-Blinded Trials 144 Mixed Randomisation 145 Full Disclosure in the Protocol? 149 Conclusion 149 We…
Chapter Contents Components of Sample Size Calculations 122 Effect of Selecting α Error and Power 123 Estimation of Population Parameters 125 Low Power With Limited Available Participants 126 Sample Size…
