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.
- An Assessment of the NIH Women's Health Initiative
- Copyright
- Preface
- Contents
- List of Figures
- Executive Summary
- THE WOMEN'S HEALTH INITIATIVE
- THE IOM STUDY
- FINDINGS AND SUGGESTIONS
- Clinical Trial
- Factorial Design
- Sample Characteristics
- Proposed Analytic Techniques
- Ethics
- Minority Analysis Plan
- Specificity of Intervention and Effect
- Outcome Definition and Measurement
- Recruitment, Retention, and Adherence
- Secular Trends
- Provision of Health Care Services to Participants
- Cost
- Observational Study
- Community Prevention Study
- RECOMMENDATIONS
- Clinical Trial
- Observational Study
- Community Prevention Study
- RESPONSES TO THE STATEMENT OF TASK
- 1 Introduction
- DESCRIPTION OF THE NIH WOMEN'S HEALTH INITIATIVE
- HISTORY OF INSTITUTE OF MEDICINE INVOLVEMENT
- COMMITTEE SELECTION AND PARTICIPATION
- STATEMENT OF TASK
- COMMITTEE ACTIVITIES
- 2 Clinical Trial
- INTRODUCTION
- RATIONALE
- General Issues
- Integration of the CT with Other Components of the WHI
- 3 Observational Study
- RATIONALE
- DESIGN AND METHODS
- COST
- RECOMMENDATIONS
- 4 Community Prevention Study
- INTRODUCTION
- RATIONALE
- DESIGN AND METHODS
- COST
- RECOMMENDATIONS
- 5 Concluding Remarks
- RESPONSE TO THE STATEMENT OF TASK
- SOCIETAL CONTEXT
- Efficacy and Effectiveness
- Public Health Choice versus Individual Choice
- Considerations beyond Science
- References
- Appendixes
- A Clinical Trial Exclusion Criteria (June 28, 1993, WHI Protocol)
- A. EXCLUSION CRITERIA FOR ALL COMPONENTS
- B. ADDITIONAL EXCLUSION CRITERIA FOR ALL CLINICAL TRIAL COMPONENTS
- C. ADDITIONAL EXCLUSION CRITERIA FOR HORMONE REPLACEMENT COMPONENT
- D. ADDITIONAL EXCLUSION CRITERIA FOR DIETARY MODIFICATION COMPONENT
- E. ADDITIONAL EXCLUSION CRITERIA FOR CALCIUM/VITAMIN D COMPONENT
- B U.S. House of Representatives Appropriations Committee
- C Statement of Task
- D Documents Received by the Institute of Medicine from the National Institutes of Health
- E Meeting Participants June, July, and August 1993
- F Primary and Subsidiary Hypotheses of the Women's Health Initiative Clinical Trial
- G Women's Health Initiative Committees
- H NIH-Sponsored Women's Health Studies
- I NIH Cost and FTE Summary for Vanguard Clinical Centers
- J NIH Power Calculations
- K Women's Health Initiative Clinical Coordinating Center and Vanguard Clinical Centers Principal Investigators
- M Committee and Staff Biographies
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