Acceptability and Determinants for Implementation of the EnzySystem, a Novel Near-Patient Testing Platform for...

Coagulation testing in haemophilia A is limited by the scarcity of testing facilities capable of performing relevant assays. This issue incentivized the development of the EnzySystem for haemophilia A, a near-patient testing platform aimed to measure Factor VIII activity and thrombin generation simultaneously within 1 h from 100 µL of whole blood. Involving end-users throughout the development ensures innovations are well-suited to meet real-world clinical needs.

To determine EnzySystem's acceptance, envisioned use scenarios and determinants for implementation according to healthcare providers (HCPs) and persons with haemophilia A and caregivers (PwHA/C).

A single-centre, cross-sectional mixed methods study was performed involving two participant groups. The first involved 36 PwHA/C. The second group comprised five advanced practice providers, eight nurses, four pharmacists and five haematologists, all involved in haemophilia A care. The participants' attitudes and preferences toward the EnzySystem for haemophilia A were assessed through questionnaires and focus groups.

Acceptability was high for both groups. The platform was considered suitable for use in various scenarios, but self-testing at home was prioritized by PwHA/C. HCPs placed equal emphasis on near-patient testing in clinic to address issues with current test accessibility and turnaround time. For all potential use scenarios, demonstrating assay accuracy was a non-negotiable prerequisite. The turnaround time and accessibility were identified as other key attributes by both groups.

The results of this study support the further development of the EnzySystem for haemophilia A and highlight barriers that should be addressed to facilitate implementation.