The EnzySystem HemA, a novel point-of-care platform to measure FVIII activity and Thrombin Generation simultaneously: Qualitative usability evaluation (Preprint)

<sec> <title>BACKGROUND</title> Hemophilia A is an inherited bleeding disorder with an increased risk of excessive bleeding. People affected by hemophilia A with a severe bleeding phenotype are treated prophylactically with hemostatic agents. Monitoring treatment and adjusting it to the individual patient’s needs is complicated by the scarcity of laboratories equipped to perform relevant coagulation assays and the absence of point-of-care testing platforms. A novel near-patient testing platform called the EnzySystem HemA aims to address this issue by measuring Factor VIII activity and Thrombin Generation within one hour out of 100 µL of whole blood. </sec> <sec> <title>OBJECTIVE</title> This study assessed the usability of the EnzySystem HemA by healthcare professionals without prior training and gathered information on its perceived usability, effectiveness, usefulness, and acceptability. </sec> <sec> <title>METHODS</title> A qualitative, single-center formative usability assessment was performed. Seven healthcare providers participated, all unaffiliated with the EnzySystem’s developer (Enzyre). Participants included one pediatric hematologist, three (pediatric) nurses, and three (pediatric) nurse practitioners. Two of the participants also held management positions. Participants performed a FVIII activity assay with a mockup of the EnzySystem HemA and were interviewed about its acceptability, usability, effectiveness, and usefulness. Video recordings of the sessions were obtained with permission and subsequently reviewed to assess usability; thematic analysis was performed on the interview transcripts. </sec> <sec> <title>RESULTS</title> Five participants (71%, 5/7) successfully performed the FVIII activity assay as intended. Of the remaining two participants, one applied insufficient force when inserting the blood tube, while the other was unable to transfer the blood into the EnzySystem. This latter step caused difficulties in three other participants, however they completed it correctly. Five participants (71%, 5/7) did not dispose of the EnzySystem components as intended, primarily due to compatibility issues of the disposable parts with the inlet of US standard medical waste containers. Five themes were generated from the interviews: “Functional the way it is” focuses on the acceptance of the prototype despite suggestions for various improvements; “Utility through faster results and increased access” and “Potential for patient engagement” relate to the envisioned benefits of the platform; and “Financial investment and return” and “Ensuring accuracy” reflect on potential barriers for implementation. </sec> <sec> <title>CONCLUSIONS</title> Despite significant usability issues, the need for faster and more accessible testing led participants to conclude that the current platform was acceptable for use, provided that proof of assay accuracy was demonstrated. The results of this study will form the basis for further development of the EnzySystem HemA. The effectiveness of any updates will be evaluated in future usability studies, which will also include people with hemophilia A as participants. </sec> <sec> <title>CLINICALTRIAL</title> <p/> </sec>