An 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 fracturesleading 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 Contents Front Matter Executive Summary Introduction Clinical Trial Observational Study Community Prevention Study Concluding Remarks References Appendix A: Clinical Trial Exclusion Criteria Appendix B: U.S. House of Representatives Appropriations COmmittee Appendix C: Statement of Task Appendix D: Documents Received by the Institute of Medicine from the National Institutes of Health Appendix E: Meeting Participants June, July, and August 1993 Appendix F: Primary and Subsidiary Hypotheses of the Women's Health Initiative Clinical Trial Appendix G: Women's Health Initiative Committees Appendix H: NIH-Sponsored Women's Health Studies Appendix I: NIH Cost and FTE Summary for Vanguard Clinical Centers Appendix J: NIH Power Calculations Appendix K: Women's Health Initiative Clinical Coordinating Center and Vanguard Clinical Centers Principal Investigators Appendix L: Abbreviations and Acronyms Appendix M: Committee and Staff Biographies