Supporting material

ATTACHMENT 6

ATTACHMENT 6.1

COMMITTEE MEMBERS

Steering Committee Members:
Cable, Ritchard, MD
Principal Investigator
New England Region, American Red Cross Blood Services (NEARC)
American Red Cross Blood Services, 209 Farmington Avenue, Farmington, CT 06032,
Email: [email protected]
Phone: 860.678.2860
Fax: 860.676.8093
Dodd, Roger Y., PhD
Principal Investigator
Jerome H. Holland Laboratory
Executive Director
15601 Crabbs Branch Way, Rockville, MD 20855-2743
Email: [email protected]
Phone: 301.738.0641
Fax: 301.738.0495
Gottschall, Jerome, MD
Principal Investigator
Blood Center of Wisconsin (BCW)
The Blood Center of Wisconsin, P.O. Box 2178, Milwaukee, WI 53201-2178
Email: [email protected]
Phone: 414.937.6231
Fax: 414.933.6803
Kakaiya, Ram, MD
Principal Investigator
Institute for Transfusion Medicine/LifeSource Blood Services (ITxM)
Medical Director
LifeSource Blood Services, 1205 N. Milwaukee Avenue, Glenview, IL 60025
Email: [email protected]
Phone: 847.803.7825
Fax: 847.803.7685
Christopher Hillyer, MD
Principal Investigator
Emory University/Southern Region, American Red Cross Blood Services (SARC)
Professor
Emory University, D-655, Emory University Hospital, 1364 Clifton Road, NE, Atlanta,
GA 30322,
Email: [email protected]

Phone: 404.712.5870
Fax: 404.712.0893
Murphy, Edward L., MD, MPH
Principal Investigator
Blood Systems Research Institute (BSRI)
Professor
University of California, San Francisco, and Blood Systems Research Institute, 270
Masonic Avenue, San Francisco, CA 94118, USA
Email: [email protected]
Phone: 415.749.6668
Fax: 415.901.0733
Sacher, Ronald, MD
Principal Investigator
Hoxworth Blood Center/University of Cincinnati Medical Center
Director, Professor and Interim Dean, University of Cincinnati Medical Center
University of Cincinnati Medical Center, 3130 Highland Avenue, Cincinnati, OH 452670055, USA
Email: [email protected]
Phone: 513.558.1201
Fax: 513.558.1300
Schreiber, George B., ScD
Principal Investigator
Westat, Health Studies
Vice President & Associate Director
1650 Research Blvd., TB186, Rockville, MD 20850-3195 , USA
Email: [email protected]
Phone: 301.251.8203
Fax: 301.517.4079
Michael P. Busch, M.D., Ph.D.
REDS-II Central Laboratory
Blood Centers of the Pacific/BSRI
Blood Systems Research Institute
270 Masonic Avenue
San Francisco, CA 94118 USA
Email: [email protected]
Phone: 415.749.6615
Fax: 415.775.3859

Iron Working Group
Cable, Ritchard, MD
Principal Investigator
New England Region, American Red Cross Blood Services (NEARC)
American Red Cross Blood Services, 209 Farmington Avenue, Farmington, CT 06032,
Email: [email protected]
Phone: 860.678.2860
Fax: 860.676.8093
Gottschall, Jerome, MD
Principal Investigator
Blood Center of Wisconsin (BCW)
The Blood Center of Wisconsin, P.O. Box 2178, Milwaukee, WI 53201-2178
Email: [email protected]
Phone: 414.937.6231
Fax: 414.933.6803
Mast Alan E., M.D., Ph.D.
Co-Principal Investigator
Blood Research Institute
P.O. Box 2178, Milwaukee, WI 53201-2178
Email: [email protected]
Phone: 414.937.6310
Fax: 414.933.6284
Michael P. Busch, M.D., Ph.D.
REDS-II Central Laboratory
Blood Centers of the Pacific/BSRI
Blood Systems Research Institute
270 Masonic Avenue
San Francisco, CA 94118 USA
Email: [email protected]
Phone: 415.749.6615
Fax: 415.775.3859
Murphy, Edward L., MD, MPH
Principal Investigator
Blood Systems Research Institute (BSRI)
Professor
University of California, San Francisco, and Blood Systems Research Institute, 270
Masonic Avenue, San Francisco, CA 94118, USA
Email: [email protected]
Phone: 415.749.6668
Fax: 415.901.0733

Schreiber, George B., ScD
Principal Investigator
Westat, Health Studies
Vice President & Associate Director
1650 Research Blvd., TB186, Rockville, MD 20850-3195 , USA
Email: [email protected]
Phone: 301.251.8203
Fax: 301.517.4079
Wright, David J., Ph.D.
Statistician
Westat
4357 Wavetree Street
San Luis Obispo, CA 93401
Email: [email protected]
Phone: 805.542.9953
Fax: 805.542.9953
Observational Study Monitoring Board (OSMB) members:
Stephen J. Wagner, Ph.D.
Director, Pathogen Management and Blood Product Improvement
Blood Components Dept., Holland Laboratory
American Red Cross
15601 Crabbs Branch Way
Rockville, MD 20855
Phone: (301) 738-0701
Fax: (301) 738-0704
Neil Blumberg MD
Professor of Pathology & Laboratory Medicine
Director, Clinical Laboratories, Strong Memorial Hospital
Director, Transfusion Medicine/Blood Bank
University of Rochester Medical Center
Box 608
601 Elmwood Avenue
Rochester, NY 14642 (USA)
Phone: 585/275-9656
Fax: 585/273-3002
Harold Kaplan, MD
Columbia Presbyterian Campus
622 W 168th St
New York, NY 10032
Phone: 212-305-2677
Email: [email protected]

Marion Danis, MD
Clinicla Bioethics Department
Clinical Center, Bldg 10
Room 1C128, MSC 1156
Bethesda, MD 20897
Phone: 301-435-8727
Email: [email protected]
Stephen Feinberg, PhD
Statistics and Survey Research
Carnegie Mellon University
Baler Hall
5000 Forbes Ave
Pittsburgh, PA 15213
Phone: 412-268-2723
Email: [email protected]
Henry Chang, MD
Division of Blood Diseases and Resources
Rockledge II, Room 10170 MSC 7950
Bethesda, MD 20892-7950
Phone: 301-435-0067
Fax: 301-480-1060
Email: [email protected]

ATTACHMENT 6.2

Contents and Executive Summary

NATIONAL HEART, LUNG, AND BLOOD
INSITUTE

Introduction
Development & Progression of Disease
Diagnosis of Disease
Treatment of Disease
Maintenance of Health / Prevention of

STRATEGIC PLAN
FY 2002-2006

Disease
Translation of Research Results Into Practice
Reduction of Health Disparities
Research Workforce and Research Resources
Appendix

Maintenance of Health/Prevention of Disease
Goal 1: Increase understanding of how individual and organizational behavior affects the
development and progression of risk factors for cardiovascular, lung, blood, and sleep disorders.
Morbidity and mortality from cardiovascular, lung, blood, and sleep disorders would decrease
significantly if known risk factors could be controlled or prevented. A better understanding of how some
lifestyles contribute to risk factor development would allow more effective interventions to be designed.
The effects of years of poor diet, physical inactivity, or smoking are obvious. But other questions remain
unanswered, such as what causes blood pressure and weight to increase with age; how genes,
environment, and behavior interact to affect development of risk factors; and how diet, weight, sleep, and
stress early in life affect risk development later on. Much is known about behaviors that are healthful and
those that are not, but more effective methods are needed to help people replace unhealthful behaviors
with healthful ones in the long-term.
Action:
Potential FY 2002 initiative:
• Develop and test worksite and community-based interventions to promote weight loss and
maintenance of weight loss. Since about half the adult population in the U.S. is overweight,
interventions are needed that will reach large numbers of individuals. Interventions at worksites
and interventions involving community organizations, local governments, and the business
community are able to reach a wide population. Innovative approaches are needed to promote
population-wide improvement in long-term weight loss and increased physical activity.
Interventions designed for minority individuals and low socioeconomic status (SES) populations
are especially needed.
Additional action:
• Form a working group to evaluate research in organizational and workplace systems that could be
applied to reduce behavioral risk factors, such as occupational stress and other health habits that
contribute to heart, lung, and blood diseases.
• Hold a workshop to identify potential uses for improved environmental and behavioral measures
in population-based epidemiologic studies.
• Analyze the relationship between behavioral and environmental factors early in life and
cardiovascular disease risk factors later in life.
• Test interventions for maintaining long-term healthful behaviors.

123

ATTACHMENT 6.3

IRON QUESTIONNAIRE: DESCRIPTION OF EACH QUESTION OTEM,
SOURCE AND GOAL

1. First time ever donated blood? Number of donations ever? Source: REDS Survey.
This data is important to confirm the donor status: first time, reactivated or repeat.
2. Date of last donation? Source: REDS Survey. This data is collected to evaluate the
association of the time between last donation and the current donor iron status.
3. Number of donations in the last 2 years? Source: REDS Survey. This data will
help confirm the donor status and also relate the frequency of donation to the
donor iron depletion.
4. Any apheresis donations? Source: REDS Survey. This data is useful to assess the
red blood cell volume based on the type of donation: platelets, plasma, red cells,
or a combination of these
5. Smoked at least 100 cigarettes in entire life? Any cigarettes smoked in the last 90
days? Number of days smoked in the last 30 days? How many cigarettes smoked
per day? Source: California Smoking Survey. This data will provide basis for
relationship between smoking behavior and donor iron status.
6. Food frequency questions, Any vitamins, supplements and aspirin taken in last 12
months and the frequency of intake? Source: NIH Diet History Questionnaire.
This is a very important information to determine the iron status of the donor
based on his dietary iron intake and also if the donor routinely consumes any
vitamin supplements.
7. Menstrual history questions: Source: NHANES, Menstrual flow question:
Mansfield-Voda-Jorgensen Menstrual Bleeding Scale.
8. Ever been pregnant? Source: NHANES. This question is designed to identify
female donors who have ever been pregnant. This is important as pregnancy is
related to the iron status and results in an iron loss of 700-1000 mg, equivalent to
the donation of 3-4 units of blood.
9. Number of pregnancies? Source: NHANES. Female donors are asked the number
of times they have been pregnant to assess the iron loss related to number of
pregnancy.
10. Number of pregnancies resulting in live birth? Source: NHANES. Female donors
are asked to give the number of pregnancies ending in live births. This data is
important to differentiate these women with the ones who had miscarriages or
abortions. This data is crucial as the iron loss varies for pregnancy resulting in

live birth to those resulting in miscarriages. Miscarriage or other earlier termination
of pregnancy will have a lesser, but meaningful impact on body iron stores.
11. Date of birth of last baby born? Source: NHANES. Female donors are asked this
question to relate their iron status to the time period between current donation and
last pregnancy resulting in live birth.

ATTACHMENT 6.4

Public Health Service
National Institutes of Health
National Heart, Lung, and
Blood Institute
Bethesda, Maryland 20892

August 29, 2006
MEMORANDUM
TO:

George Schreiber, Sc.D.
REDS-II DCC Principal Investigator

FROM:

Traci Heath Mondoro, Ph.D.
REDS-II OSMB Executive Secretary

SUBJECT:

SUMMARY OF PROTOCOL REVIEW

The Observational Study Monitoring Board (OSMB) for the Retrovirus Epidemiology Donor
Study II (REDS II) met by conference call August 24, 2006 to review the REDS II protocol titled
“Predicting Hemoglobin Deferral and Development of Iron Depletion in Blood Donors”.
The REDS-II OSMB recommended that the study proceed and made the following
recommendations.
• Consider adding text to Section E. 3 "Final Study Size" to acknowledge that
measurement errors and the multiplicity of hypotheses to be examined decrease the
power of the study relative to the values stated in the protocol, although not necessarily
providing details about the extent of the degradation since this is an exploratory study.
• If there are substantial margins built into the sample size calculations then consider
adding text to indicate why these concerns are unlikely to seriously compromise the
most important features of the study.
• To increase the comfort level of the donors, add language to the informed consent
document stating that no additional genetic testing will be performed on the sample.
• Consider eliminating the concept of using financial compensation to motivate donors
who do not come in for the last follow-up visit. This gives the appearance of treating
subjects within the same cohort differently.

The Institute accepted the OSMB recommendations.
If you have any questions regarding this approval, please contact the Project Officer, George J.
Nemo, Ph.D. at [email protected] or 301-435-0065.