Assessment of the NIH Women's Health Initiative

The National Institutes of Health Women's Health Initiative (WHI) is the largest research study ever funded by NIH ($625 million over 14 years) and is designed to test strategies to prevent cardiovascular disease, breast cancer, and osteoporotic fractures—leading causes of death, disability, and decreased quality of life for older women. Although the WHI has already begun, serious questions remain about its design, cost, and the likelihood that it can answer the questions it asks. This book evaluates whether the effort can be justified scientifically.Table of ContentsFront MatterExecutive SummaryIntroductionClinical TrialObservational StudyCommunity Prevention StudyConcluding RemarksReferencesAppendix A: Clinical Trial Exclusion CriteriaAppendix B: U.S. House of Representatives Appropriations COmmitteeAppendix C: Statement of TaskAppendix D: Documents Received by the Institute of Medicine from the National Institutes of HealthAppendix E: Meeting Participants June, July, and August 1993Appendix F: Primary and Subsidiary Hypotheses of the Women's Health Initiative Clinical TrialAppendix G: Women's Health Initiative CommitteesAppendix H: NIH-Sponsored Women's Health StudiesAppendix I: NIH Cost and FTE Summary for Vanguard Clinical CentersAppendix J: NIH Power CalculationsAppendix K: Women's Health Initiative Clinical Coordinating Center and Vanguard Clinical Centers Principal InvestigatorsAppendix L: Abbreviations and AcronymsAppendix M: Committee and Staff Biographies