Paul Beatty, PhD, Office of Research and Methodology, National Center for Health Statistics, 3311 Toledo Road, Hyattsville, MD 20782, 301-458-4090, pbeatty@cdc.gov

Screening questionnaires protect the safety of the blood supply by identifying potential donors whose blood may be unsafe due to possible exposure to diseases (through travel or behaviors), use of certain medications, or other risk factors. The Food and Drug Administration (FDA) called for a revised screening questionnaire to be created as an industry standard. A Task Force of methodological and substantive experts was assembled to draft the revision based on review of FDA regulations, principles of questionnaire design, and focus groups. The objective of this study was to evaluate how well the revised questionnaire met its objectives. The primary evaluation methodology was cognitive interviewing, which is commonly used to evaluate survey questionnaires. This methodology evaluates the quality of questions and accuracy of responses through in-depth probing. Probes are used to learn about respondent interpretations, thought processes, and the circumstances reflected in responses. The methodology is particularly effective when no “gold standard” is available to assess the validity of responses. Supplemental methods used to evaluate the questionnaire included vignettes, in which respondents answered questions based on hypothetical situations, and response latency, in which time spent answering each question was measured. Results from these evaluations suggested that most revised questions were straightforward, but also yielded suggestions for reducing burden and eliminating ambiguity. The presentation will discuss the methods and demonstrate how they can be applied to other questionnaires, in addition to covering substantive findings relevant to blood donor screening.

Learning Objectives: At the conclusion of this session, participants will be able to

• List and describe three questionnaire evaluation methods
• Articulate the means for evaluating questionnaires when no "gold standard" for validation is available
• Identify some commmon indications that questions may not be meeting their measurement objectives
• Assess whether other questionnaires might benefit from application of these methods

Keywords: Methodology, Evaluation

Presenting author's disclosure statement:
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.