**Abbreviated Donor History Questionnaire Study, 2005**

# **AABB**

**Donor History Task Force**

**Study Manual**

**[Introduction]{.underline}**

In 2000, AABB commissioned the Donor History Task Force to develop a
donor history questionnaire (DHQ) that would standardize screening of
potential blood donors. The length, complexity and content of existing
questionnaires was markedly different across blood collecting facilities
making the donor screening process more elaborate and more confusing for
donors than was necessary. The Task Force has attempted to enhance donor
comprehension by developing a questionnaire that asks each point of
information separately, rather than in multiple, complex questions, and
has organized questions into a logical format based on the time frame to
which the questions refer. This questionnaire has been designed to be
fully self-administered. In 2004, FDA issued a draft "Guidance for
Industry: Acceptable Full-Length Donor History Questionnaire and
Accompanying Materials for Use in Screening Human Donors of Blood and
Blood Components" document indicating their acceptance of the new
uniform Donor History Questionnaire (DHQ) for donor screening. Blood
collecting facilities commenced implementation of the new questionnaire
in 2004.

The Task Force has also developed an abbreviated DHQ (aDHQ) for frequent
donors. The aDHQ has introduced two medical capture questions to replace
many of the questions regarding donor medical problems and treatment.
The aDHQ has not been accepted by FDA for use in donor screening. The
goal of this study is to test how well these two medical capture
questions identify relevant donor eligibility information when compared
to questions on the new full-length DHQ that they are designed to
replace. The results of the study will be submitted to FDA.

**[Specific Objectives:]{.underline}**

-   To determine whether or not the two medical capture questions
    identify deferrable risks as well as the full-length questionnaire.

-   To compare responses to the two medical capture questions with
    responses to the relevant questions on the full-length
    questionnaire.

-   To identify reasons for discrepancies between answers provided to
    the two medical capture questions and relevant questions on the
    full-length questionnaire, using cognitive interviews.

These objectives will be met by studying donors who are eligible to use
the aDHQ and have a discordant result between the two capture questions
on the aDHQ, and the questions on the DHQ that they are intended to
replace (see definition of discordant result below). For donors with
discordant results, follow-up cognitive interviews will be conducted
using trained interviewers. Additional information will be collected to
ensure that the donors in the study are representative of donors who
would be using the aDHQ.

**[Study Sites]{.underline}**

The study will be conducted in five blood centers: New York Blood
Center, Hoxworth Blood Center, Gulf Coast Regional Blood Center,
Mississippi Valley Regional Blood Center and ARC, Lewis & Clark Region.
.

**[Study Administration]{.underline}**

The study will be administered through AABB in close communication with
Center Coordinators at all participating blood centers.

**[Study Term]{.underline}**

The study will begin in the summer of 2005.

**[Role of the Center Coordinator]{.underline}**

The Center Coordinator will be responsible for implementation of this
protocol at their Center. The steps in implementation will be carried
out as described below, although minor details of the implementation
will be tailored to the collection site structure of each Blood Center.
The Study Administrator will assist in selection of appropriate
collection sites at the various Centers. The Center Coordinator will
oversee data collection in the collection sites, ensure that the
protocol is implemented correctly and that all forms described in this
manual are complete and correct, and are forwarded to the Study
Administrator as described.

**[Sample Size]{.underline}**

Each blood center will enroll 250 donors who meet the selection criteria
outlined below. As there will be five blood centers participating in the
study, the final sample size for this study will be 1,250 donors.

**[Definition of a Discordant Result]{.underline}**

A discordant result has occurred when a donor's answer to the medical
capture questions on the aDHQ is not congruent with answers to questions
on the full-length questionnaire that the aDHQ questions should capture.

Medical capture questions on the aDHQ :

[Since your last donation, have you]{.underline}

Had any new medical problems or diagnoses?

Had any new medical treatments?

**should be compared** with the following questions on the DHQ:

[Are you]{.underline}

#### Currently taking an antibiotic?

#### Currently taking any other medication for an infection?

[In the past 12 months have you]{.underline}

#### 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?

[Have you EVER]{.underline}

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?

If the donor answered yes to any of these questions on the aDHQ or the
DHQ, the donor should be assessed as usual to determine whether or not
the response indicates a reason for deferral.

**It is a discordant result :**

If the donor answers No to the medical capture questions on the aDHQ,
but answered Yes to any of the DHQ questions referred to above,
regardless of whether the response constitutes a reason for deferral.

**OR**

If the donor answers Yes to either medical capture question on the aDHQ,
but answered No to all of the DHQ questions referred to above regardless
of whether the response constitutes a reason for deferral.

> **Also discordant**

It is possible that the donor answers No to the medical capture
questions and reports on the DHQ, by answering Yes to one of the
questions listed above, a deferrable risk that should have been reported
on their last donation. This is a discordant result.

**It is not a discordant result:**

If the donor answers No to the two medical capture questions on the aDHQ
and answers No to all of the questions on the DHQ listed above and
during your assessment the donor volunteers no information to the
contrary.

**OR**

If the donor answers Yes to either medical capture question on the aDHQ
and answers Yes to the corresponding DHQ question(s) indicating the same
information on both questionnaires.

**[Donor Selection]{.underline}**

In order to participate in the study, donors must have completed donor
screening twice using the new full-length DHQ, with at least the second
use having occurred within the last six months. Both whole blood and
apheresis donors may participate in the study. Donors who meet the
criteria will be offered enrollment, from selected collection sites, on
a consecutive basis in order to minimize selection bias. The proportion
of donors with each donation type will be agreed upon between the Center
Coordinator and the Study Administrator, but at least 30 % should be
whole blood donors. This is because it is very important that the final
sample includes donors from the full range of the six-month interval
since their last donation. An effort will be made to include donors with
the longest possible interval since the last donation. It is expected
that some mobile sites will be involved as well as fixed sites, although
frequent donors are more likely to come to a fixed site than a mobile
site.

**[Informed Consent]{.underline}**

Prior to participating in the study, the study will be explained and
donors will be asked to sign a consent form. Donors who do not wish to
participate will not be pressured to agree to participate, and donors
will be permitted to stop at any time and to refuse to answer any
questions that are not part of the routine assessment for donor
eligibility.

**[Follow-up Cognitive Interviews]{.underline}**

Donors that are identified as having discordant results will be invited
to participate in a follow-up interview to determine why the donor
answered the two questionnaires differently. An interviewer who has
completed training in cognitive interview techniques will carry out a
semi-scripted interview specifically designed for this study. The
interview should not take more than five to ten minutes. The interviewer
will make an audio recording of the interview with the donor, which will
later be transcribed.

If an interviewer is available at the collection site, the interview
will be carried out in a private room with minimal noise in order to
ensure a good quality recording of the interview, and in order to ensure
that the donor's responses are confidential.

It is anticipated that most interviews will be conducted, via telephone,
within three days of the questionnaires being answered. As the donor's
ability to remember how they were thinking at the time of donation may
be less over time, every effort will be made to ensure that the
interviews are carried out as soon as possible within the three day
interval.

**[Implementation Steps]{.underline}**

The following are the steps that will be carried out in this order at
each blood center. Each Center Coordinator will input details in a
separate document entitled "Collection Site Instructions" so that
instructions for the staff are specific to that center.

1.  Assess the donor's eligibility to participate.

2.  Explain the study to the donor and obtain informed consent to
    participate.

3.  Assign a Study ID Number to all eligible donors. Track the number of
    donors who are elibigle to participate and the number who have
    refused. Record the Study ID Number on the Donor Registration Sheet
    along with the last two donation dates.

4.  The donor completes the aDHQ (identified by Study ID Number).

5.  The donor returns the aDHQ to the staff.

6.  Give the donor the DHQ and the Demographic Questionnaire and and ask
    the donor to complete them. (Identify Demographic Questionnaire by
    Study ID Number).

7.  During the health assessment Blood Center staff will determine
    eligibility to donate. Determine whether the donor's responses to
    the questionnaires are discordant or not discordant (with the reason
    for discordance). Document this information on the DHQ/aDHQ
    Assessment Sheet.

8.  When donors with discordant responses are identified arrangements
    must be made for a cognitive interview. If a trained interviewer is
    available at the collection site the interview will take place
    following the donation process. When a trained interviewer is not
    available at the collection site ask the donor to provide a contact
    telephone number for the cognitive interview.

9.  Forward a copy of the aDHQ and DHQ to the interviewer if a cognitive
    interview is required.

10. Collect and paper clip together all forms (aDHQ, Demographic
    Questionnaire, and Consent Form) for each donor.

11. Complete the Collection Site Summary Sheet at the end of the day.

12. Collect the Collection Site Summary Sheet, the DHQ/aDHQ Assessment
    Sheet and the Donor Registration Sheet at the end of the day.

**[Confidentiality]{.underline}**

All information provided by the donor is confidential, and will not be
traceable to the donor record unless information is identified that
would affect the donor's eligibility to donate. The donor will be
identified on all study materials by a Study ID Number for which a
separate list is maintained to identify the donor. This list will be
stored separate from the other study materials. All study materials will
be maintained in a locked environment, and once data is recorded in an
electronic format, it will be stored in a secure, password protected
server. All data will be reported in aggregate form and details of Blood
Centers' operations will not be reported.

**[Risks and Benefits]{.underline}**

There are no known physical or emotional risks associated with this
study beyond what would normally be encountered in donating blood. The
potential benefit of participation is that the data collected in this
study will help to assess the abbreviated donor health questionnaire. As
frequent donors, the participants in the study may be contributing to
the implementation of a shorter, more concise questionnaire for all
frequent donors.

**[Data Management and Evaluation]{.underline}**

The completed data forms will be forwarded to the Study Administrator.
Data will be coded and recorded electronically. The cognitive interviews
will be transcribed and the transcription will be forwarded to the
National Center for Health Statistics, Centers for Disease Control and
Prevention where the transcriptions will be analyzed and a report will
be written.

**[Final Comments]{.underline}**

If a donor has a question or concern for which staff do not have the
answer, or the donor feels the answer is not adequate, the donor should
be encouraged to call 1-XXX-XXX-XXXX

**Appendix:**

**Donor Registration Sheet**

**DHQ/aDHQ Assessment Sheet**

**Collection Site Summary Sheet**

**Consent Form**

**Demographic Questionnaire**

**Donor History Questionnaire (DHQ)**

**Abbreviated Donor History Questionnaire (aDHQ)**