An assessment of the NIH Women's Health Initiative / Committee to Review the NIH Women's Health Initiative, Food and Nutrition Board, and Board on Health Sciences Policy, Institute of Medicine ; Susan Thaul and Dana Hotra, editors.

Format:

Book

Author/Creator:

Institute of Medicine (U.S.). Committee to Review the NIH Women's Health Initiative.

Contributor:

Thaul, Susan.

Hotra, Dana.

Language:

English

Subjects (All):

National Institutes of Health (U.S.).

Women--Health and hygiene--United States.

Women.

Physical Description:

xv, 142 p.

Edition:

1st ed.

Place of Publication:

Washington, D.C. : National Academy Press, 1993.

Language Note:

English

Summary:

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.

Contents:

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

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

DESIGN AND METHODS

COST

4 Community Prevention Study

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.

Notes:

Bibliographic Level Mode of Issuance: Monograph

Includes bibliographical references (p. 91-93).

ISBN:

9786610195701

9781280195709

1280195703

9780309573146

0309573149

9780585155289

0585155283

OCLC:

923264831