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Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
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OCR for page 105
An Assessment of the NIH Women's Health Initiative
D
Documents Received by the Institute of Medicine from the National Institutes of Health
Received: March 1993
Solicitation (RFP) NIH-WH-92-13
Clinical Coordinating Center for the Clinical Trials and Observational
Dated: 3/1/72
Amendments to Solicitation NIH-WH-92-13
Clinical Coordinating Center for the Clinical Trials and Observational Study of the Women's Health Initiative
Dated: 4/22/92
Solicitation (RFP) NIH-WH-92-19-E
Vanguard Clinical Centers for Clinical Trials and Observational Study of the Women's Health Initiative
Dated 4/29/92
Amendments to Solicitation NIH-WH-92-19-E
Vanguard Clinical Centers for Clinical Trials and Observational Study of the Women's Health Initiative
Dated 4/29/92
Information to Offerors
Subheadings
Scientific Information
Objectives
Inclusion Criteria for Clinical Trial
Exclusion Criteria for Clinical Trial
Enrollment
Key Baseline and Follow-Up Variables
Clinical Outcomes of Interest
Partial Factorial Design
Testimony from NIH Women's Health Initiative Public Hearing, October 28-29, 1991.
Received: May 25, 1993
May 13, 1993 Protocol (was not yet approved)
OCR for page 106
An Assessment of the NIH Women's Health Initiative
Received: May 31, 1993
March 8, 1993 Protocol (approved)
Received: July 7, 1993
Response to June 29, 1993 Dr. Thaul letter
RFP: NIH-WH-93-30
Business Proposals from the Vanguard Centers, with all cost information deleted
June 28, 1993 Protocol (approved by the Data Safety and Monitoring Board, June 16, 1993) red-lined
Received: July 9, 1993
Behavioral constructs
Description and cost information of NIH-sponsored women's health studies
Received: July 12, 1993
Additional response to June 29, 1993 Dr. Thaul letter
RFP: July 7, 1993
Power calculations and sample size information from Laurence Freedman
Additional quality of life construct information from Robert Kaplan
Journal articles on clinical trials
Incidence tables on colorectal cancer, hip fractures, and other fractures
Received: July 26, 1993
Additional response to June 29, 1993 Dr. Thaul letter
VCC levels of effort and budget information (does not include salaries)
Description and cost information of NHLBI-sponsored women's health studies
Information and costs re Women's Health Studies in NIH institutes
Proceedings from the October 28, 1991 Public Hearing
Letter from Reubin Andres on the Baltimore Longitudinal Study
Report on Progress: Study Design and Time Line. Memo, October 17, 1991.
Received: August 3, 1993
Information on the Women's Health Trial Feasibility Study in Minority Populations
May 13, 1991 Technical and Scientific Working Group, including:
Draft Proposal from NHLBI; Osteoporosis Component;
Draft Proposal from NCI and NHLBI;
Recommendations for Design of Trials;
NCI Biometry Branch; Recommendations for Cancer
Biomarker and Prevention Studies, NCI; and
OCR for page 107
An Assessment of the NIH Women's Health Initiative
NCI Biometry Branch; Recommendations for Cancer
Biomarker and Prevention Studies, NCI; and
Repository Feasibility Information, NCI
NIDDK Proposal for Obesity Component (May 13, 1991)
Proposal by Scientific and Technical Working Group on WHI (June 4, 1991)
Consultant Recommendations on Endometrial Biopsies (June 27, 1991)
Reviews by Susan R. Johnson (On behalf of group of PEPI gynecology consultants) (July 23, 1991 and August 5, 1991)
Minutes of Advisory Meeting on Calcium/Vitamin D Intervention (August 15, 1991)
Minutes of Meeting with Expert Consultants in Epidemiology (September 13, 1991)
Review by ICD Directors October 17, 1991
Protocol Comments from Jeffrey A. Perlman, Chief, Contraceptive and Reproductive Evaluation Branch (October 22, 1991)
Comments on WHI Prospectus by Linda J. Golden, FDA, Center for Drug Evaluation and Research (November 20, 1991)
Minutes of Concept Review for Clinical Trial and Observational Study of the WHI (January 15, 1992)
Minutes of Hormone Replacement Working Group Meeting (January 21, 1993)
Minutes of Advisory Meeting for Dietary Intervention (May 10, 1993)
Received: August 4, 1993
Response to July 27, 1993 Dr. Thaul letter
Memo from Jacques Rossouw, with attachments:
age distribution;
rate calculations;
power calculations;
discussion of dietary modification and breast cancer hypothesis;
Hollinghead scale;
adjustments to minority group rate;
budgets for additional 6,000 WHI CT participants;
subcommittee membership rosters;
Data Safety and Monitoring Board documents;
memo from Mark Kestin on plasma triglycerides and a low fat diet;
information on why calcium and vitamin D are combined in the Clinical Trial;
minutes from the Concept Review meeting for the Clinical Trial and Observational Study; and
the scripts for the VCC videotapes.
Additional response to June 29, 1993 Dr. Thaul letter
Description and cost information of NIH-sponsored women's health studies, including:
NHLBI; NIDDK; NCI; NINDS; NCI; NIAMS; NIDR; NIAAA; NIA; and
other multi-ICD-sponsored studies
OCR for page 108
An Assessment of the NIH Women's Health Initiative
Received: August 11, 1993
Information on conceivable changes in scope of work
Information on WHI contract dates
Additional description and cost information of NIH-sponsored women 's health studies
Representative terms from entire chapter:
health studies
