Evidence map›Paper›PMID 41403342›Full record

ArticleHaemophilia : the official journal of the World Federation of Hemophilia

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

Aernoud P Bavinck, Kyle Davis, Lisa van Engelshoven, Monique G van Lier, Tanja Hamacher, Nicole M A Blijlevens, Amy Shapiro, Saskia E M Schols, Waander L van Heerde

Abstract read
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Article in Haemophilia : the official journal of the World Federation of Hemophilia. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

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4 · The record

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5 · Who and what money

Authors and funding

9 authors.

Aernoud P BavinckDepartment of Hematology, Radboud University Medical Centre, Nijmegen, the Netherlands.ORCID https://orcid.org/0000-0002-8448-9151
Kyle DavisDepartment of Pediatric Hematology, Innovative Hematology, Indiana Hemophilia and Thrombosis Center, Indianapolis, Indiana, USA.ORCID https://orcid.org/0009-0003-1272-1307
Lisa van EngelshovenEnzyre, Nijmegen, the Netherlands.
Monique G van LierTeledyne Healthcare, Eindhoven, the Netherlands.ORCID https://orcid.org/0000-0002-1166-6639
Tanja HamacherHolland Innovative, Eindhoven, the Netherlands.ORCID https://orcid.org/0000-0001-9760-9143
Nicole M A BlijlevensDepartment of Hematology, Radboud University Medical Centre, Nijmegen, the Netherlands.ORCID https://orcid.org/0000-0002-1801-2072
Amy ShapiroDepartment of Pediatric Hematology, Innovative Hematology, Indiana Hemophilia and Thrombosis Center, Indianapolis, Indiana, USA.ORCID https://orcid.org/0000-0003-2821-7159
Saskia E M ScholsDepartment of Hematology, Radboud University Medical Centre, Nijmegen, the Netherlands.ORCID https://orcid.org/0000-0003-2423-2829
Waander L van HeerdeEnzyre, Nijmegen, the Netherlands.ORCID https://orcid.org/0000-0001-7101-8775

Funding

Enzyre BV
6 · The paper itself

Abstract

introductionCoagulation 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.

aimTo 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).

methodsA 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.

resultsAcceptability 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.

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

Indexed as

Hemophilia AAdultBlood Coagulation TestsCross-Sectional StudiesFactor VIIIFemaleHumansMaleMiddle AgedSurveys and QuestionnairesFactor VIIIblood coagulation testshaemophilia Apatient preferencepoint‐of‐care testingthrombin generation assayuser‐centred design

Identifiers

PMID41403342
PMCPMC12984464

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LicenceCC BY-NC
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.