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International Normalised Ratio Monitoring in Children: Comparing the accuracy of portable point-of-care monitors to standard of care laboratory monitoring at Red Cross War Memorial Children's Hospital

Background. There is an increasing trend in the use of long-term oral anticoagulation therapy in children. Monitoring the international normalised ratio (INR) is an integral part in management of these patients, but standard laboratory testing of the INR presents challenges in this age group. Point-...

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Main Author: Moore, Ryan
Other Authors: Zühlke, Lisel Joanna
Format: Thesis
Language:English
Published: Department of Paediatrics and Child Health 2021
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access_status_str Open Access
author Moore, Ryan
author2 Zühlke, Lisel Joanna
author_browse Moore, Ryan
Zühlke, Lisel Joanna
author_facet Zühlke, Lisel Joanna
Moore, Ryan
author_sort Moore, Ryan
collection Thesis
description Background. There is an increasing trend in the use of long-term oral anticoagulation therapy in children. Monitoring the international normalised ratio (INR) is an integral part in management of these patients, but standard laboratory testing of the INR presents challenges in this age group. Point-of-care INR monitors such as the Mission® PT/INR monitor provide advantages in efficiency and accessibility but have not been evaluated for accuracy in the South African paediatric setting. Objectives. This is a feasibility study with the aim to evaluate the accuracy of the Mission® PT/INR Monitor in comparison to standard laboratory INR measurement, in children presenting for INR testing. Methods. We compared the accuracy of the Mission® PT/INR monitor to the Sysmex Cs2100i laboratory analyser in 37 children aged between 1 year and 17 years, who presented for INR testing. The sample size was limited due to time constraints. 40 paired POC INR and laboratory INR values were obtained. Results. The majority of participants in the study were outpatients (62%) and required INR testing as part of screening in non-cardiac disease (81%) - the majority had chronic liver disease, and a minority were on warfarin therapy (13.5%). The mean INR value on the Mission® PT/INR was 1.49 (standard deviation (SD) 0.73) and was comparable to the Sysmex Cs-2100i (mean INR value 1.39 with SD 0.69). The Bland-Altman difference plot revealed good agreement. Bias between the two methods was 0.13 (SD 0.23). In total, 92.5% of POC INR values were within 0.5 units of laboratory INR value. Conclusion. The Mission® PT/INR point-of-care monitor has a clinically acceptable level of accuracy in children when compared with laboratory INR measurement, but larger studies are needed in the paediatric setting to evaluate patient safety and clinical outcomes. There is a need for implementing POC INR monitoring in outpatient settings but this practice will require robust assessment of infrastructure and quality control before application.
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institution University of Cape Town (South Africa)
language eng
last_indexed 2026-06-10T12:32:50.328Z
license_str Not specified — see source repository
provenance_str_mv Harvested via OAI-PMH from UCTD — University of Cape Town Open Access Repository
publishDate 2021
publishDateRange 2021
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publisher Department of Paediatrics and Child Health
publisherStr Department of Paediatrics and Child Health
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source_str UCTD — University of Cape Town Open Access Repository
spelling oai:open.uct.ac.za:11427/32880 International Normalised Ratio Monitoring in Children: Comparing the accuracy of portable point-of-care monitors to standard of care laboratory monitoring at Red Cross War Memorial Children's Hospital Moore, Ryan Zühlke, Lisel Joanna de Decker, Rik Paediatrics Background. There is an increasing trend in the use of long-term oral anticoagulation therapy in children. Monitoring the international normalised ratio (INR) is an integral part in management of these patients, but standard laboratory testing of the INR presents challenges in this age group. Point-of-care INR monitors such as the Mission® PT/INR monitor provide advantages in efficiency and accessibility but have not been evaluated for accuracy in the South African paediatric setting. Objectives. This is a feasibility study with the aim to evaluate the accuracy of the Mission® PT/INR Monitor in comparison to standard laboratory INR measurement, in children presenting for INR testing. Methods. We compared the accuracy of the Mission® PT/INR monitor to the Sysmex Cs2100i laboratory analyser in 37 children aged between 1 year and 17 years, who presented for INR testing. The sample size was limited due to time constraints. 40 paired POC INR and laboratory INR values were obtained. Results. The majority of participants in the study were outpatients (62%) and required INR testing as part of screening in non-cardiac disease (81%) - the majority had chronic liver disease, and a minority were on warfarin therapy (13.5%). The mean INR value on the Mission® PT/INR was 1.49 (standard deviation (SD) 0.73) and was comparable to the Sysmex Cs-2100i (mean INR value 1.39 with SD 0.69). The Bland-Altman difference plot revealed good agreement. Bias between the two methods was 0.13 (SD 0.23). In total, 92.5% of POC INR values were within 0.5 units of laboratory INR value. Conclusion. The Mission® PT/INR point-of-care monitor has a clinically acceptable level of accuracy in children when compared with laboratory INR measurement, but larger studies are needed in the paediatric setting to evaluate patient safety and clinical outcomes. There is a need for implementing POC INR monitoring in outpatient settings but this practice will require robust assessment of infrastructure and quality control before application. 2021-02-17T13:00:45Z 2021-02-17T13:00:45Z 2020 2021-02-16T12:42:53Z Master Thesis Masters MMed http://hdl.handle.net/11427/32880 eng application/pdf Department of Paediatrics and Child Health Faculty of Health Sciences
spellingShingle Paediatrics
Moore, Ryan
International Normalised Ratio Monitoring in Children: Comparing the accuracy of portable point-of-care monitors to standard of care laboratory monitoring at Red Cross War Memorial Children's Hospital
thesis_degree_str Master's
title International Normalised Ratio Monitoring in Children: Comparing the accuracy of portable point-of-care monitors to standard of care laboratory monitoring at Red Cross War Memorial Children's Hospital
title_full International Normalised Ratio Monitoring in Children: Comparing the accuracy of portable point-of-care monitors to standard of care laboratory monitoring at Red Cross War Memorial Children's Hospital
title_fullStr International Normalised Ratio Monitoring in Children: Comparing the accuracy of portable point-of-care monitors to standard of care laboratory monitoring at Red Cross War Memorial Children's Hospital
title_full_unstemmed International Normalised Ratio Monitoring in Children: Comparing the accuracy of portable point-of-care monitors to standard of care laboratory monitoring at Red Cross War Memorial Children's Hospital
title_short International Normalised Ratio Monitoring in Children: Comparing the accuracy of portable point-of-care monitors to standard of care laboratory monitoring at Red Cross War Memorial Children's Hospital
title_sort international normalised ratio monitoring in children comparing the accuracy of portable point of care monitors to standard of care laboratory monitoring at red cross war memorial children s hospital
topic Paediatrics
url http://hdl.handle.net/11427/32880
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