Abbreviated Donor History Questionnaire: Background and Introduction

1. Abbreviated Donor History Questionnaire: Background and Introduction Sharyn Orton, Ph.D. OBRR/CBER/FDA Blood Products Advisory Committee March 2005

2. Background AABB Donor History Questionnaire Task Force • 2001: TF submitted to FDA a proposal to revise the full length questionnaire • Used focus groups and one-on-one cognitive interviews to assess donor comprehension of questions • 2002: TF submitted final materials to FDA, including the full length questionnaire, medication deferral list, educational materials and an aDHQ

3. continued • In 2003 FDA completed review and proposed to accept the full length questionnaire, medication deferral list, educational materials, but not the aDHQ • “Draft Guidance for Industry: Acceptable Full-Length Donor History Questionnaire and Accompanying Materials for Use in Screening Human Donors of Blood and Blood Components” - 4/23/2004 • Comments have been reviewed by FDA, shared with the TF, and revisions submitted

4. Abbreviated Donor History Questionnaires Concept has always been endorsed by FDA: • 1993/1994: AIR Report • 1997: Blood Action Plan • 1998: first aDHQ approved by FDA • 1999: FDA approached industry to develop a Task Force • To include evaluation of an aDHQ

5. continued • 2000: AABB/FDA workshop • 2001 BPAC discussion • 2003: second aDHQ approved by FDA • 2003 BPAC discussion

6. December 2003 BPAC Discussion: aDHQ • Discussion covered: • Abbreviated surveys in general • Survey concepts and design • Survey participant behaviors • Donor motivation (or lack thereof) when answering questions • Donor satisfaction and retention • Impact on blood safety • Focusing donor attention to recent events

7. continued • Use of capture questions vs specific questions** • Methods of aDHQ assessment including comparison to rates for deferrals, infectious disease markers, post-donation information reporting; biological product deviation reporting; post-transfusion disease • Historical and/or prospectively • Data collection, analysis and interpretation • Potential study designs • Opinions by the major blood organizations

8. continued • Question to BPAC (in 2003): • “Does current knowledge support the use of the AABB UDHQ abbreviated donor questionnaire as an alternative to the current donor screening process for appropriately selected donors?” • Outcome: • BPAC members vote was one abstention, two no, ten yes, and the non-voting member and industry representative voted yes

9. Why Not Accept the TF aDHQ? • Use of a capture question for new medical events • “Since your last donation, have you had any new medical problems, diagnosis, or treatments, including vaccinations?” • Administered to 4 subjects during one-on-one cognitive interviews • One subject did not provide information on a significant medical event (25%); this was the only subject that had a significant medical event

10. continued • Albeit in a small sample size, FDA was concerned about this result • Determined that some sort of assessment of the aDHQ compared to the accepted AABB TF full length DHQ should be performed • Supports measures to improve the predictive value of the donor screening process, including use of an AHDQ • AABB TF will propose a study design today for assessment of 2 medical capture questions in the aDHQ

11. Questions to BPAC 1. Does the committee agree that the proposed study design (exclusive of sample size) is adequate to reasonably demonstrate equivalence (or lack of equivalence) between the two capture questions on the abbreviated questionnaire, and the 17 specific questions on the full-length questionnaire?

12. continued 2. If yes, does the committee agree that the proposed sample size is adequate? 3. If no, what alternative study design and/or sample size does the committee propose would be adequate?