Measuring FVIII Activity and Thrombin Generation Simultaneously With a Novel Point of Care Platform (EnzySystem HemA): Qualitative Usability Evaluation
Notice bibliographique
Résumé
Background: 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 (FVIII) activity and thrombin generation within 1 hour of 100 µL of whole blood. Objective: This study assessed the usability of the EnzySystem HemA by health care professionals without prior training and gathered information on its perceived usability, effectiveness, usefulness, and acceptability. Methods: A qualitative, single-center formative usability assessment was performed. Participants performed an 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. Results: A total of 7 health care providers participated, all unaffiliated with the EnzySystem's developer. Participants included 1 (14%) pediatric hematologist, 3 (43%; pediatric) nurses, and 3 (43%; pediatric) nurse practitioners. Two (29%) of the participants also held management positions. Five (71%) participants successfully performed the FVIII activity assay as intended. Of the remaining 2 participants, one applied insufficient force when inserting the blood tube, whereas the other was unable to transfer the blood into the EnzySystem. This latter step caused difficulties in 3 (60%) other participants; however, they completed it correctly. Five (71%) participants did not dispose of the EnzySystem components as intended, primarily due to compatibility issues of the disposable parts with the inlet of the 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. Conclusions: 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.
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Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,044 | 0,042 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,002 | 0,001 |
| Études des sciences et des technologies | 0,003 | 0,005 |
| Communication savante | 0,002 | 0,002 |
| Science ouverte | 0,001 | 0,004 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,002 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».