Differences in Warfarin Dosing Decisions Based on International Normalized Ratio Measurements with Two Point-of-Care Testing Devices and a Reference Laboratory Measurement

Study Objectives. To assess the accuracy of warfarin dosing decisions and the degree of numeric bias between two point‐of‐care devices using a local reference laboratory's international normalized ratio (INR) as the standard measure, and to determine the relationship between dosing decisions an...

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Veröffentlicht in:Pharmacotherapy 2002-11, Vol.22 (11), p.1397-1404
Hauptverfasser: Shermock, Kenneth M., Bragg, Lee, Connor, Jason T., Fink, Jodie, Mazzoli, Georgann, Kottke-Marchant, Kandice
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container_end_page 1404
container_issue 11
container_start_page 1397
container_title Pharmacotherapy
container_volume 22
creator Shermock, Kenneth M.
Bragg, Lee
Connor, Jason T.
Fink, Jodie
Mazzoli, Georgann
Kottke-Marchant, Kandice
description Study Objectives. To assess the accuracy of warfarin dosing decisions and the degree of numeric bias between two point‐of‐care devices using a local reference laboratory's international normalized ratio (INR) as the standard measure, and to determine the relationship between dosing decisions and INR values obtained with the pointof‐care devices. Design. Prospective study. Setting. Outpatient anticoagulation clinic. Subjects. Two hundred two patients taking oral warfarin and 10 control subjects. Interventions. For the two point‐of‐care devices, AvoSure and ProTime, the finger‐stick method was used to collect capillary blood samples in each subject. At the same visit, one venous blood sample was collected from each subject for the laboratory analysis. Measurements and Main Results. Dosing agreement was assessed as the proportion of agreement between each device and the laboratory in terms of maintenance dosage adjustments (increase, decrease, or no change). The level of agreement between each device and the laboratory was evaluated by dosing agreement analysis, bias analysis, and concordance coefficient analysis. In the dosing agreement analysis, 78% of INR values from the AvoSure device would have resulted in the same dosing decision as that with the laboratory INR values compared with 66% from the ProTime device (p
doi_str_mv 10.1592/phco.22.16.1397.33699
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To assess the accuracy of warfarin dosing decisions and the degree of numeric bias between two point‐of‐care devices using a local reference laboratory's international normalized ratio (INR) as the standard measure, and to determine the relationship between dosing decisions and INR values obtained with the pointof‐care devices. Design. Prospective study. Setting. Outpatient anticoagulation clinic. Subjects. Two hundred two patients taking oral warfarin and 10 control subjects. Interventions. For the two point‐of‐care devices, AvoSure and ProTime, the finger‐stick method was used to collect capillary blood samples in each subject. At the same visit, one venous blood sample was collected from each subject for the laboratory analysis. Measurements and Main Results. Dosing agreement was assessed as the proportion of agreement between each device and the laboratory in terms of maintenance dosage adjustments (increase, decrease, or no change). The level of agreement between each device and the laboratory was evaluated by dosing agreement analysis, bias analysis, and concordance coefficient analysis. In the dosing agreement analysis, 78% of INR values from the AvoSure device would have resulted in the same dosing decision as that with the laboratory INR values compared with 66% from the ProTime device (p&lt;0.001). The mean bias for the ProTime device (0.5 ± 0.4 INR units) was significantly higher (p=0.005) than that for the AvoSure device (0.4 ± 0.5 INR units). The ProTime device overestimated low INR values to a greater extent than did the AvoSure device. Concordance between the laboratory measurement and each device was similar (pc = 0.82 for ProTime, pc = 0.76 for AvoSure). Conclusions. Assessing dosing decisions yielded distinct, useful clinical information. The AvoSure device is associated with less systematic bias and a higher degree of clinical agreement with our reference laboratory measurement than those of the ProTime device.</description><identifier>ISSN: 0277-0008</identifier><identifier>EISSN: 1875-9114</identifier><identifier>DOI: 10.1592/phco.22.16.1397.33699</identifier><identifier>PMID: 12432965</identifier><identifier>CODEN: PHPYDQ</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Biological and medical sciences ; Blood. Blood coagulation. Reticuloendothelial system ; Confidence Intervals ; Female ; Humans ; International Normalized Ratio - methods ; International Normalized Ratio - standards ; International Normalized Ratio - statistics &amp; numerical data ; Male ; Medical sciences ; Middle Aged ; Pharmacology. Drug treatments ; Point-of-Care Systems - standards ; Point-of-Care Systems - statistics &amp; numerical data ; Prospective Studies ; Reference Standards ; Warfarin - administration &amp; dosage</subject><ispartof>Pharmacotherapy, 2002-11, Vol.22 (11), p.1397-1404</ispartof><rights>2002 Pharmacotherapy Publications Inc.</rights><rights>2003 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4254-ab84d2c04a76e71d489a5bc3a105aaabbd5a571f424748ab8a3e17e758200ed03</citedby><cites>FETCH-LOGICAL-c4254-ab84d2c04a76e71d489a5bc3a105aaabbd5a571f424748ab8a3e17e758200ed03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1592%2Fphco.22.16.1397.33699$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1592%2Fphco.22.16.1397.33699$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=14001882$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/12432965$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Shermock, Kenneth M.</creatorcontrib><creatorcontrib>Bragg, Lee</creatorcontrib><creatorcontrib>Connor, Jason T.</creatorcontrib><creatorcontrib>Fink, Jodie</creatorcontrib><creatorcontrib>Mazzoli, Georgann</creatorcontrib><creatorcontrib>Kottke-Marchant, Kandice</creatorcontrib><title>Differences in Warfarin Dosing Decisions Based on International Normalized Ratio Measurements with Two Point-of-Care Testing Devices and a Reference Laboratory Measurement</title><title>Pharmacotherapy</title><addtitle>Pharmacotherapy</addtitle><description>Study Objectives. To assess the accuracy of warfarin dosing decisions and the degree of numeric bias between two point‐of‐care devices using a local reference laboratory's international normalized ratio (INR) as the standard measure, and to determine the relationship between dosing decisions and INR values obtained with the pointof‐care devices. Design. Prospective study. Setting. Outpatient anticoagulation clinic. Subjects. Two hundred two patients taking oral warfarin and 10 control subjects. Interventions. For the two point‐of‐care devices, AvoSure and ProTime, the finger‐stick method was used to collect capillary blood samples in each subject. At the same visit, one venous blood sample was collected from each subject for the laboratory analysis. Measurements and Main Results. Dosing agreement was assessed as the proportion of agreement between each device and the laboratory in terms of maintenance dosage adjustments (increase, decrease, or no change). The level of agreement between each device and the laboratory was evaluated by dosing agreement analysis, bias analysis, and concordance coefficient analysis. In the dosing agreement analysis, 78% of INR values from the AvoSure device would have resulted in the same dosing decision as that with the laboratory INR values compared with 66% from the ProTime device (p&lt;0.001). The mean bias for the ProTime device (0.5 ± 0.4 INR units) was significantly higher (p=0.005) than that for the AvoSure device (0.4 ± 0.5 INR units). The ProTime device overestimated low INR values to a greater extent than did the AvoSure device. Concordance between the laboratory measurement and each device was similar (pc = 0.82 for ProTime, pc = 0.76 for AvoSure). Conclusions. Assessing dosing decisions yielded distinct, useful clinical information. The AvoSure device is associated with less systematic bias and a higher degree of clinical agreement with our reference laboratory measurement than those of the ProTime device.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Biological and medical sciences</subject><subject>Blood. Blood coagulation. Reticuloendothelial system</subject><subject>Confidence Intervals</subject><subject>Female</subject><subject>Humans</subject><subject>International Normalized Ratio - methods</subject><subject>International Normalized Ratio - standards</subject><subject>International Normalized Ratio - statistics &amp; numerical data</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pharmacology. Drug treatments</subject><subject>Point-of-Care Systems - standards</subject><subject>Point-of-Care Systems - statistics &amp; numerical data</subject><subject>Prospective Studies</subject><subject>Reference Standards</subject><subject>Warfarin - administration &amp; dosage</subject><issn>0277-0008</issn><issn>1875-9114</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2002</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkUGP0zAQhSMEYrsLPwHkC9xSbMeOE3FaWtguKmVVFVXiYk2SCWtI7WKnW8pf4k-SkIjlyMnWzPfmPelF0TNGp0zm_NX-tnRTzqcsnbIkV9MkSfP8QTRhmZJxzph4GE0oVyqmlGZn0XkIXynlLBX8cXTGuEh4nspJ9Gtu6ho92hIDMZZswdfgu8_cBWO_kDmWJhhnA3kDASviLLm2LXoLbTeFhqyc30Fjfna7dT8jHxDCweMObRvI0bS3ZHN05MYZ28aujmfgkWwwtMP1O9Mbg60IkDWOScgSCuehdf7077kn0aMamoBPx_ci-vTu7Wa2iJcfr65nl8u4FFyKGIpMVLykAlSKilUiy0EWZQKMSgAoikqCVKwWXCiRdTQkyBQqmXFKsaLJRfRyuLv37vuhi6p3JpTYNGDRHYJWPM1kLkUHygEsvQvBY6333uzAnzSjum9J9y1pzjVLdd-S_tNSp3s-GhyKHVb3qrGWDngxAhBKaGoPtqvhnhOUsizjHfd64I6mwdP_ueubxeWaJ6KPHw9qE1r88VcN_ptOVaKk3q6u9Prz-3y1mG21SH4Dyh_Ahg</recordid><startdate>200211</startdate><enddate>200211</enddate><creator>Shermock, Kenneth M.</creator><creator>Bragg, Lee</creator><creator>Connor, Jason T.</creator><creator>Fink, Jodie</creator><creator>Mazzoli, Georgann</creator><creator>Kottke-Marchant, Kandice</creator><general>Blackwell Publishing Ltd</general><general>Pharmacotherapy</general><scope>BSCLL</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>200211</creationdate><title>Differences in Warfarin Dosing Decisions Based on International Normalized Ratio Measurements with Two Point-of-Care Testing Devices and a Reference Laboratory Measurement</title><author>Shermock, Kenneth M. ; Bragg, Lee ; Connor, Jason T. ; Fink, Jodie ; Mazzoli, Georgann ; Kottke-Marchant, Kandice</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4254-ab84d2c04a76e71d489a5bc3a105aaabbd5a571f424748ab8a3e17e758200ed03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2002</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Biological and medical sciences</topic><topic>Blood. Blood coagulation. Reticuloendothelial system</topic><topic>Confidence Intervals</topic><topic>Female</topic><topic>Humans</topic><topic>International Normalized Ratio - methods</topic><topic>International Normalized Ratio - standards</topic><topic>International Normalized Ratio - statistics &amp; numerical data</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pharmacology. Drug treatments</topic><topic>Point-of-Care Systems - standards</topic><topic>Point-of-Care Systems - statistics &amp; numerical data</topic><topic>Prospective Studies</topic><topic>Reference Standards</topic><topic>Warfarin - administration &amp; dosage</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Shermock, Kenneth M.</creatorcontrib><creatorcontrib>Bragg, Lee</creatorcontrib><creatorcontrib>Connor, Jason T.</creatorcontrib><creatorcontrib>Fink, Jodie</creatorcontrib><creatorcontrib>Mazzoli, Georgann</creatorcontrib><creatorcontrib>Kottke-Marchant, Kandice</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Pharmacotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Shermock, Kenneth M.</au><au>Bragg, Lee</au><au>Connor, Jason T.</au><au>Fink, Jodie</au><au>Mazzoli, Georgann</au><au>Kottke-Marchant, Kandice</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Differences in Warfarin Dosing Decisions Based on International Normalized Ratio Measurements with Two Point-of-Care Testing Devices and a Reference Laboratory Measurement</atitle><jtitle>Pharmacotherapy</jtitle><addtitle>Pharmacotherapy</addtitle><date>2002-11</date><risdate>2002</risdate><volume>22</volume><issue>11</issue><spage>1397</spage><epage>1404</epage><pages>1397-1404</pages><issn>0277-0008</issn><eissn>1875-9114</eissn><coden>PHPYDQ</coden><abstract>Study Objectives. To assess the accuracy of warfarin dosing decisions and the degree of numeric bias between two point‐of‐care devices using a local reference laboratory's international normalized ratio (INR) as the standard measure, and to determine the relationship between dosing decisions and INR values obtained with the pointof‐care devices. Design. Prospective study. Setting. Outpatient anticoagulation clinic. Subjects. Two hundred two patients taking oral warfarin and 10 control subjects. Interventions. For the two point‐of‐care devices, AvoSure and ProTime, the finger‐stick method was used to collect capillary blood samples in each subject. At the same visit, one venous blood sample was collected from each subject for the laboratory analysis. Measurements and Main Results. Dosing agreement was assessed as the proportion of agreement between each device and the laboratory in terms of maintenance dosage adjustments (increase, decrease, or no change). The level of agreement between each device and the laboratory was evaluated by dosing agreement analysis, bias analysis, and concordance coefficient analysis. In the dosing agreement analysis, 78% of INR values from the AvoSure device would have resulted in the same dosing decision as that with the laboratory INR values compared with 66% from the ProTime device (p&lt;0.001). The mean bias for the ProTime device (0.5 ± 0.4 INR units) was significantly higher (p=0.005) than that for the AvoSure device (0.4 ± 0.5 INR units). The ProTime device overestimated low INR values to a greater extent than did the AvoSure device. Concordance between the laboratory measurement and each device was similar (pc = 0.82 for ProTime, pc = 0.76 for AvoSure). Conclusions. Assessing dosing decisions yielded distinct, useful clinical information. The AvoSure device is associated with less systematic bias and a higher degree of clinical agreement with our reference laboratory measurement than those of the ProTime device.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>12432965</pmid><doi>10.1592/phco.22.16.1397.33699</doi><tpages>8</tpages></addata></record>
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subjects Adult
Aged
Aged, 80 and over
Biological and medical sciences
Blood. Blood coagulation. Reticuloendothelial system
Confidence Intervals
Female
Humans
International Normalized Ratio - methods
International Normalized Ratio - standards
International Normalized Ratio - statistics & numerical data
Male
Medical sciences
Middle Aged
Pharmacology. Drug treatments
Point-of-Care Systems - standards
Point-of-Care Systems - statistics & numerical data
Prospective Studies
Reference Standards
Warfarin - administration & dosage
title Differences in Warfarin Dosing Decisions Based on International Normalized Ratio Measurements with Two Point-of-Care Testing Devices and a Reference Laboratory Measurement
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