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

INTRODUCTION

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.

AIM: 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).

METHODS

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.

RESULTS

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.

CONCLUSION

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.