An Assessment of the NIH Women's Health Initiative

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National Academies Press, Jan 15, 1993 - Medical - 125 pages
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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.
 

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Contents

Executive Summary
1
1 Introduction
19
2 Clinical Trial
25
3 Observational Study
77
4 Community Prevention Study
81
5 Concluding Remarks
85
References
91
Appendixes
95
D Documents Received by the Institute of Medicine from the National Institutes of Health
105
E Meeting Participants June July and August 1993
109
F Primary and Subsidiary Hypotheses of the Womens Health Initiative Clinical Trial
113
G Womens Health Initiative Committees
115
H NIHSponsored Womens Health Studies
117
I NIH Cost and FTE Summary for Vanguard Clinical Centers
123
J NIH Power Calculations
127
K Womens Health Initiative Clinical Coordinating Center and Vanguard Clinical Centers Principal Investigators
133

A Clinical Trial Exclusion Criteria June 28 1993 WHI Protocol
97
B US House of Representatives Appropriations Committee
101
C Statement of Task
103
M Committee and Staff Biographies
137
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