Introduction:A portable multi-parameter blood coagulation analysis device (EnzySystem) is being developed to improve the diagnosis and management of patients with haemophilia A (PwHA).It simultaneously measures factor VIII activity and thrombin generation in 100 μL of capillary whole blood within 1 h.This study surveys use case scenarios for the EnzySystem in Europe.Methods: Use-case analysis was performed with healthcare professionals (HCPs) and patients to determine their preferences regarding the use of the EnzySystem.Data was acquired using questionnaires and (online) interviews.Results: Most respondents (61%) were excited about the portable testing device.Both near-patient use (37%) and home-use (48%) were identified as attractive applications of such a device.The interest in (clinical) laboratory use (15%) was limited.In Western and Northern Europe, diagnosis and clinical laboratory testing are considered in place.Haemophilia treatment centres are accessible to all patients despite the great distances in some Northern European countries.PwHA would use the home-testing device to guide haemophilia A management in a (severe) bleeding situation and in unstable conditions.HCPs would prefer to gain experience with testing in a near-patient setting before advising patients to use the device at home.HCPs see added value of a near-patient device for use in remote areas as well as in emergency situations when laboratory testing is unavailable.80% of the HCPs would consider the portable testing device for their daily routine.In some Eastern European countries, the use of the device for diagnosis of haemophilia A is mentioned as not all PwHA have been diagnosed and haemophilia treatment centres are not accessible to all patients.Discussion/Conclusion: From the interim data analysis it can be concluded that the recommended use case scenario for Western and Northern European countries is the management of haemophilia A with a home-use device.Additionally, it was suggested to first raise awareness using the near-patient device.For some Eastern European countries, the near-patient device for diagnosis is put forward.
Chidinma Onweni, Saima Rashid, Rachna Goswami, Jennifer Treece, Lindsey C. Shipley, Randal De Souza, Luke O'neill, Tander Simberloff, Steven J. Baumrucker
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