The Women's Health Initiative as a platform for methodologic development

Oregon Convention Center 

The Women's Health Initiative (WHI), a large, population-based study sponsored by the National Heart Lung and Blood Institute, has stimulated a plethora of statistical innovations over the past 3 decades. The initial design included a partial factorial randomized trial testing three chronic disease prevention hypotheses in 68,132 postmenopausal women and a parallel observational study of over 93,000 similar women. To support its broad scientific mandate and diverse investigator interests, the WHI has collect multiple types of data, ranging from biomarkers and genomics, behavioral and livestyle factors, to time-to event and longitudinal outcomes using diverse sources (self-report, medical records, data linkages, laboratory and clinical assessments). Analyses of these data are often made "interesting" by design factors (e.g., data collection limited to subsamples), inherent biases (e.g., self-reports of behavior or informative missingness), or by the challenges of multiplicity. These data analytic challenges have spawned a range of innovative methodologic responses, some of which will be discussed in this session.