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 -- IOM STAFF.