Attachment3 -Qx Source Goals

ATTACHMENT 3

IRON QUESTIONNAIRE

DESCRIPTION OF EACH QUESTION ITEM, 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.

12. Sleeping questions, when you try to relax in the evening or sleep at night, how often do you have unpleasant, restless feelings in your legs that can be relieved by walking or movement? How often do you experience a strong urge to move your legs usually accompanied or caused by unpleasant sensations in your legs - for example, restlessness, creepy-crawly, or tingly feelings? Source: Dr. David Rye, Emory Hospital. These questions are asked to all donors to establish whether or not the donor is having sensations of restlessness in their legs.

13. Sleeping questions, Is the urge to move your legs or are the unpleasant sensations partially or totally relieved by movement, such as walking or stretching? Does the urge to move your legs begin, or do the unpleasant sensations begin or worsen, during periods of rest or inactivity such as when sitting or lying down? At what times is the urge to move your legs or the unpleasant sensations most bothersome? Source: Dr. David Rye, Emory Hospital. These questions are used to concentrate on one of the diagnostic criteria used clinically to establish whether the donor has RLS.

14. 14-19 Eating Symptoms questions. Source: An extensive literature review was performed to obtain questions previously used to research and diagnose pica. These questions were adapted from the following sources. (e.g. Dr. Susan leitman and :Dr. Adrien Kettaneh).

15. Do you ever crave and regularly eat or chew non-nutritional substances, such as ice, clay, dirt, starch, raw pastas, chalk or coal? This question asks if the subject craves and regularly eats non-nutritional food substances. A yes or no answer to this question will determine if the subject experiences pica. If the subject answers “no” to this question they will skip the next five questions. If they answer “yes” they will proceed to the next five questions designed to assess the type of pica, the severity of pica and the relation of pica to blood donation.

16. Which non-nutritional substances do you consume (check all applicable)? This question will determine the type of pica by determining the substances most commonly craved. Knowledge of the substances most commonly craved by blood donors will assist blood centers seeking to identify donors with pica symptoms.

17. How often do you consume one or more of the above substance(s)? This question will determine the severity of the pica by determining how often the craving occurs. It is important to know how often blood donors with pica experience cravings to understand the impact of blood donation on donor health.

18. How does blood donation impact these cravings? This question will determine if the cravings are impacted in a positive or negative way by blood donation. An assessment of whether or not donors have correlated their craving with blood donation will be important for institution of new educational programs in blood centers about pica.

19. How long do your cravings last? This question will determine the severity of the pica by determining how long the cravings persist. It is important to know how long blood donors with pica experience cravings to understand the impact of blood donation on donor health.

20. Are you currently experiencing this type of craving? This question will determine if the subject is experiencing the cravings at the time of the survey. Since the laboratory iron studies will be repeated at the same time as the survey is conducted this question will allow direct comparison between symptoms and iron status.