ABSTRACT

Interpretation Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 257 8.8 HTE Assessment in Practice: The Diabetes Prevention Program . . . 258 8.9 HTE in Meta-Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 260 8.10 HTE and Clinical Decision Making . . . . . . . . . . . . . . . . . . . . . . . . 261 8.11 Concluding Remarks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 262

Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 263 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 263

ABSTRACT We survey concepts of heterogeneity of treatment effects (HTE) in the context of comparative effectiveness research and address variability of individual causal effects (person-level HTE) and variability of conditional average causal effects (group-level HTE or effect measure modification). We provide an overview of statistical methods for quantifying and testing HTE in randomized trials and observational studies and address the reporting and interpretation of such analyses in the biomedical literature. Using data from a clinical trial of diabetes prevention, we illustrate the concepts and methods discussed in the chapter. Finally, we touch upon the role of HTE assessment in meta-analyses and decision analyses.