The Abbreviated Donor Questionnaire Update from AABB Donor History Task Force to BPAC

1. The Abbreviated Donor QuestionnaireUpdate from AABB Donor History Task Force to BPAC March 2005 Debra Kessler RN, MS Task Force Chair

2. Donor History Questionnaire • In 2000 the process to redesign the blood donor screening questionnaire began • Initiated by FDA • Extensive collaborative effort by numerous stakeholders • Groundbreaking approach to design • First time a blood screening document has been systematically evaluated

3. DHQ Overview • The old Uniform Donor History Questionnaire (UDHQ) was a very different document from the current DHQ. Questions were complex, included compound elements and did not follow any identifiable order of time frames.

4. DHQ Overview, con’t The Task Force made many changes in creating the new DHQ: • eliminated a number of questions that were not required by FDA or AABB • broke up compound questions • simplified language • restructured the format into time periods that begin at the present and go backwards in time.

5. DHQ Overview, con’t • Changes were made with input of experts in the field of questionnaire development and reading comprehension. • Focus groups were used to review the new questions • Individual cognitive interviews by NCHS were performed to validate that the questions elicited the information intended.

6. Donor History Questionnaire: Recent History June 2002 - Blood Products Advisory Committee Unanimously endorsed the full length Donor History Questionnaire. April 2004 - FDA Draft Guidance for Industry: Acceptable Full- Length Donor History Questionnaire and Accompanying Materials for Use In Screening Human Donors of Blood and Blood Components.

7. Donor History Questionnaire: Recent History • December 2004 - DHTF • Submitted responses to comments to the docket • with related revisions to the DHQ (v.1.1) and associated materials • Currently • The DHQ is in use in many collection sites • Next steps - • AABB receive any FDA feedback on revisions • AABB to issue revised materials as version 1.1 • FDA to issue final guidance on full length DHQ

8. Abbreviated Donor History Questionnaire (aDHQ)

9. Abbreviated Questionnaire for Frequent Donors Currently, all donors answer all questions at every donation, including non-repeatable events What Abbreviated Questionnaire Does: • Eliminates non-repeatable event questions • Identifies recent changes in health, travel, behavior • Retains questions about risk-associated activities that might have changed since last donation

10. aDHQ • Precedent • Abbreviated screening document approved for Blood Center of Iowa in 1999 • Abbreviated screening document approved for Blood Systems in 2002

11. aDHQ-What do we hope to accomplish? • Safety Safety and efficacy equivalent to DHQ • Satisfaction Increase donor satisfaction • Availability Possibly increase availability of blood

12. Equivalent safety to DHQ • The aDHQ is based on the full length DHQ which is a validated document • Testing of aDHQ capture approach for recent changes in health status was performed on 4 subjects by one-on-one cognitive interview when the initial DHQ evaluation was conducted “Since your last donation have you had any new medical problems, diagnoses or treatments including vaccinations?”

13. Equivalent safety to DHQ, cont. • Capture question one-on-one cognitive interviews: • Performed on only 4 persons due to lack of resources. • While this was not a full large-scale test, preliminary findings generated optimism that the approach is worth pursuing further. • The event not reported was a miscarriage • Pregnancy in past 6 weeks is not rolled into the medical capture questions. It continues to be asked specifically on the aDHQ.

14. Equivalent safety to DHQ • Increased donor focus on recent risk behaviors and activities “behavioral risk screening needs to be optimized to query donors about factors that best predict recent infection.” from Blood Safety in the New Millennium, 2001 Alan Williams, PhD and Sharyn Orton, MSPH, PhD

15. Equivalent safety to DHQ • Increased donor attention by reducing time required to complete screening

16. Increased availability of blood? • Increased donor satisfaction • Decrease phenomenon of “lapsed donors” • Increased frequency of donation

17. Which donors will use the aDHQ • Definition of Frequent Donor • Successfully complete full-length DHQ (DHQ) at least twice • At least one donation within previous 6 month period Rationale: The donor will answer all of the newvalidated screening questions at least twice. Anecdotal evidence indicates that donors may remember information at the second donation that they did not remember at the first donation. However, this is less likely to occur after a second experience with the questions.

18. Development of aDHQ • Validated DHQ basis for aDHQ • Question-by-question consideration • Delete questions for single risk in past “From 1980 through 1996, were you a member of the U.S. military, a civilian military employee, or a dependent of a member of the U.S. military?” • Consolidate travel into a single capture question about recent travel • Consolidate medical questions by use of 2 capture questions • HIV and Hepatitis risk questions remain intact

19. BPAC discussion re: aDHQDec 11, 2003 • Question - “Does current knowledge support the use of the AABB DHQ abbreviated questionnaire as an alternative to the current screening process for appropriately selected donors?” • Yes 10 • No 2 • Abstain 1

20. Nevertheless • FDA requested that the Task Force develop some kind of pre-implementation study to compare the full length and abbreviated donor forms as related to medical capture questions.

21. aDHQ Study

22. aDHQ Study Development Team • Subgroup of AABB DHTF • Representatives from: • AABB • FDA • NCHS • Blood Centers

23. aDHQ Study Objectives • Determine whether two medical capture questions identify deferrable risks as well as the full-length questionnaire. • Compare responses to the two medical capture questions with responses to the questions they cover in the full-length questionnaire. • Identify reasons for discrepancies between answers provided to the capture questions and the full-length questionnaire using cognitive interviews

24. aDHQ Medical Capture Questions • Since your last donation have you • Had any new medical problems or diagnoses? • Had any new medical treatments?

25. DHQ Questions rolled into capture questions • Are you • Currently taking an antibiotic? • Currently taking any other medication for an infection? • In the past 12 months have you • Had a blood transfusion? • Had a transplant such as organ, tissue, or bone marrow? • Had a graft such as bone or skin? • Had or been treated for syphilis or gonorrhea?

26. DHQ Questions rolled into capture questions • Have you EVER • Had a positive test for the HIV/AIDS virus? • Used clotting factor concentrates? • Had hepatitis? • Had malaria? • Had Chagas’ disease? • Had babesiosis? • Received a dura mater (or brain covering) graft? • Had any type of cancer, including leukemia? • Had any problems with your heart or lungs? • Had a bleeding condition or a blood disease?

27. Study Sites • New York Blood Center • Hoxworth Blood Center • Gulf Coast Regional Blood Center • Mississippi Valley Regional Blood Center • ARC, Lewis & Clark Region • Centers selected to represent mixed U.S. geographic areas

28. Study Size • 250 donors from each of the Blood Centers who meet the definition of frequent donor. Total sample =1250 • the final sample will include donors from the full range of the 6 month interval since their last donation.

29. Study Process • Donor will be enrolled by designated staff and give consent • Donor will fill out aDHQ first and return it to study personnel. • Donor will then fill out standard full length DHQ. • Study personnel will evaluate for discordant responses.

30. Study Process, con’t • During study the donor’s eligibility to donate will be based on BOTH questionnaires • If discordant responses are found, donor will undergo cognitive interview on site or as soon as possible via phone. Interviews will be audio-taped.

31. Cognitive Interviews • Each center will provide 2 staff members for cognitive interview training by NCHS staff. Blood center staff selected will be those with skills that lend themselves to cognitive interviewing (eg. donor counselors)

32. Data Evaluation • Audio tapes will be transcribed • The transcription and, if needed, audio tape will be evaluated by NCHS • Demographic information and discordant responses will be entered into a database for evaluation.

33. Study Timeline • May 3, 2005 - NCHS to train blood center staff in cognitive interviewing • June-Dec, 2005 - execute protocol • Jan 2006 - transcription of cognitive interviews • Feb-Mar, 2006 - NCHS analysis of cognitive interviews • May 2006 - Submission of results to FDA

34. Cost Burden • Cost to AABB • Interviewer travel for training by NCHS • Interviewer training and analysis of cognitive interviews by NCHS • Study Administrator • Data Entry • Blood Center • Study personnel time • Materials

35. Conclusions: • aDHQ developed at the request of FDA • Received BPAC endorsement in 2003 • At the request of FDA, the Task Force has developed a study for aDHQ • This is NOT intended to be a epidemiologic study • The emphasis for evaluation is on the cognitive interviews • Post implementation evaluation will add additional data