Abstract
Introduction: Hemophilia treatment includes reconstitution of lyophilized FVIII concentrates with diluent followed by intravenous injection. Several reconstitution methods are commonly employed during infusion of concentrates. The Bio-Set® (Biodome, Issoire France) is a new needleless device for reconstituting a factor VIII concentrate, Kogenate® FS (Bayer Healthcare, Elkhart IN).
Objective: To develop and evaluate a new preference questionnaire designed to capture nurse, patient, and caregiver preferences for reconstituting factor using the Bio-Set® device, the conventional method for reconstitution and the other available method, the Baxject (Baxter Healthcare, Westlake Village CA).
Methods: A 27-item preference questionnaire was developed based on a previous preference questionnaire. Four hemophilia nurses participated in content validation before pilot-testing the questionnaire. Psychometric properties were tested in a sample of 161 participants (35 hemophilia A patients who infuse themselves, 67 caregivers, 59 infusion nurses). The entire study followed an IRB approved protocol. Method names were blinded to prevent brand recognition by participants. Participants were familiarized with each method by viewing a video, watching an interviewer demonstrate each method, and practicing with each method. After performing a timed round with each method, participants completed the preference questionnaire for each method. After performing the third method, participants ranked methods on 9 attributes.
Results: Item distributions indicated acceptable response spread for most items. Following item analyses and principle components factor analysis (PCA), 2 items were eliminated. The PCA resulted in two factors, worry/safety and ease/confidence. Internal consistency reliability was good for total and subscale scores, ranging from 0.92 to 0.93. Concurrent and discriminant validity was not supported.
Conclusions: This study provides information on the psychometric properties of a new preference questionnaire that will be useful in determining inclination for and differences between patient, caregiver, and nurse preferences for reconstitution devices available for hemophilia factor concentrates.
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