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Educational needs of hematologists and laboratory professionals regarding factor activity assays

Authors Adcock DM, Rasulnia M, Holot N, Cooper DL

Received 18 November 2017

Accepted for publication 13 February 2018

Published 13 April 2018 Volume 2018:9 Pages 51—59


Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Ms Justinn Cochran

Peer reviewer comments 2

Editor who approved publication: Dr Martin Bluth

Dorothy M Adcock,1 Mazi Rasulnia,2 Natalia Holot,3 David L Cooper3

1Laboratory Corporation of America Holdings, Burlington, NC, 2M Consulting LLC, Birmingham, AL, 3Clinical, Medical, and Regulatory Affairs,Novo Nordisk Inc., Plainsboro, NJ, USA

Introduction: Diagnosis and management of hemophilia require accurate and precise measurements of factor activity levels. Activity is traditionally measured via one-stage (OS) clot-based assay; however, chromogenic substrate (CS) assays may be needed for certain cases. A survey was performed to understand assay-related knowledge gaps among hematologists and laboratory professionals.
Methods: Separate web-based surveys were administered to hematologists who manage hemophilia and to laboratory professionals and queried practice patterns, knowledge of/attitudes toward CS assays, and interest in continuing education.
Results: A total of 51 hematologists participated in this study; 67% managed hemophilia patients for ≥10 years and 24% were affiliated with a hemophilia treatment center (HTC). Most (80%) stated familiarity with general assay interpretation. Majorities of non-HTC and HTC respondents agreed that CS assays are more accurate than OS assays (62%/67%), although non-HTC hematologists indicated less understanding of when to order a CS assay (49%/67%). Fewer non-HTC respondents expressed concerns regarding the reliability of OS assays for diagnosis (38%/67%) and monitoring (38%/75%). Most (80%) expressed an interest in factor assay education, especially on available assays, efficacy, and best practices (39%). A total of 57 laboratory professionals participated, averaging 10 years in their current position; most (88%) were hospital based. More performed OS (72%) than CS (10%) or both (17%) assays; only 11% reported confidence with the interpretation of CS results. Few expressed concerns regarding the reliability of OS for diagnosis (9%) or monitoring (12%). Reported barriers to CS use included infrequent need (68%), lack of US Food and Drug Administration (FDA) approval (61%), and need for validation work (56%). Most (70%) were interested in CS assay education; top interests included advantages over traditional assays, general information on CS assays, and indications for testing (each 18%).
Conclusion: Future educational efforts may focus on limitations of OS assays, indications for CS assay diagnosis/monitoring, and support for clinic-laboratory dialog.

hemophilia, factor activity assay, chromogenic substrate assay, coagulation factor VIII, coagulation factor IX, monitoring

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