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An Assessment of the NIH Women's Health Initiative (1993)

Chapter: Appendix C: Statement of Task

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Suggested Citation:"Appendix C: Statement of Task." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
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C

Statement of Task

The committee will review the design, organization, and operation plans of the Women's Health Initiative (WHI) to answer, at the end of a six-month period, the following questions:

  1. What was the rationale behind the choice of these particular studies? Are appropriate topics considered? Should other topics be included?

  2. Are the methodologies and the study designs appropriate to address the stated research objectives? Is the size of the study population appropriate?

  3. Are the costs accurately estimated and sufficient to reach the desired objectives?

  4. Will the study produce sufficiently reliable results to justify the costs?

To support the review and recommendation deliberations, the committee will:

  1. Review documents provided by the National Institutes of Health (NIH), including the Requests for Proposals (RFPs), responses to the RFPs by the entities awarded contracts as the Clinical Coordinating Center and the fifteen Vanguard Clinical Centers, and public testimony concerning the NIH plan;

  2. Conduct critical review of published literature appropriate for the fields of study; and

  3. Seek the counsel of recognized experts in the intervention and outcome fields of study, as well as experts in the estimation and management of cost, by way of workshops conducted concurrently with the committee meetings.

The Committee will meet three times over the six-month study period. The Committee will invite NIH scientists involved in the WHI design and investigators from the funded Coordinating Center and the Vanguard Centers to participate in workshops coincident with the first two meetings.

A final report will be delivered to the sponsor at the end of the study, with an interim copy of the final report to be delivered 14 days before public release of the report.

Suggested Citation:"Appendix C: Statement of Task." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
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Suggested Citation:"Appendix C: Statement of Task." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
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Page 103
Suggested Citation:"Appendix C: Statement of Task." Institute of Medicine. 1993. An Assessment of the NIH Women's Health Initiative. Washington, DC: The National Academies Press. doi: 10.17226/2271.
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Page 104
Next: Appendix D: Documents Received by the Institute of Medicine from the National Institutes of Health »
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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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