User Preference for 3 Hemophilia Factor Reconstitution Methods.

Introduction: Treatment of hemophilia includes the reconstitution of lyophilized FVIII concentrates with diluent followed by intravenous injection. Several reconstitution devices exist for 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: Comparison of preferences for reconstitution methods by hemophilia patients, caregivers to hemophilia patients, and care providers.

Methods: A total of 35 hemophilia A patients who infuse themselves, 67 caregivers, and 59 infusion nurses were recruited following an IRB-approved protocol. Infusion method names were blinded to participants to prevent brand recognition. Reconstitution methods used in this study were Bio-Set®, a conventional 2 vial, transfer needle reconstitution method, and Baxject (Baxter Healthcare, Westlake Village CA). Participants viewed a video demonstrating the three methods, watched the interviewer demonstrate each method, and then practiced each method once. Each participant performed 1 timed round with each method and completed preference questionnaires about each method. The preference questionnaire was scored into domains for safety/worry and ease/confidence, in addition to a total preference score. Participants’ comments about the reconstitution methods were also recorded.

Results: Participants preferred the Bio-Set® in terms of worry/safety, ease/confidence, and overall preference. These results were consistent across participant group. Participants agreed on their preferences for the Bio-Set® in terms of safety from needlesticks, amount of waste produced, and convenience for traveling (all p<0.0001). Analysis of the qualitative data indicated that exposure to needles and product contamination were issues commonly noted. Safety and complexity of instructions were also common issues for participants.

Conclusions: Results of this study show that patients, caregivers, and nurse providers prefer the Bio-Set® reconstitution device over other methods for preparing factor concentrates for infusion.