Comparison of Semiautomated and Fully Automated Methods for QT Measurement During a Thorough QT/QTc Study: Variability and Sample Size Considerations
This study compares the ability of 2 semiautomated methods with a fully automated method for QT measurement to minimize the sample size required to detect a moxifloxacin effect and exclude a placebo effect in a thorough QT/QTc study. The fully automated and 1 of 2 semiautomated methods used a global...
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| Veröffentlicht in: | Journal of clinical pharmacology 2009-08, Vol.49 (8), p.905-915 |
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| container_title | Journal of clinical pharmacology |
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| creator | Tyl, Benoît Kabbaj, Meriam Fassi, Basmah De Jode, Patrick Wheeler, William |
| description | This study compares the ability of 2 semiautomated methods with a fully automated method for QT measurement to minimize the sample size required to detect a moxifloxacin effect and exclude a placebo effect in a thorough QT/QTc study. The fully automated and 1 of 2 semiautomated methods used a global QT measurement in 12 leads, whereas the other semiautomated method used a tangent method on single lead raw complexes. Mean QTcF intervals were greater when measured on a global QT electrocardiogram than on raw complexes, but the mean magnitudes of ΔQTcF were similar for all methods. The 3 methods detected a statistically significant increase in QTcF for moxifloxacin compared to placebo and were able to exclude a placebo effect on QTcF in all 62 participants. However, due to a smaller variability, the semiautomated methods allowed these detections with fewer than 20 participants, whereas the fully automated required at least 27 participants. |
| doi_str_mv | 10.1177/0091270009337944 |
| format | Article |
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However, due to a smaller variability, the semiautomated methods allowed these detections with fewer than 20 participants, whereas the fully automated required at least 27 participants.</description><subject>Adult</subject><subject>Aged</subject><subject>Aza Compounds - toxicity</subject><subject>Cross-Over Studies</subject><subject>Diagnosis, Computer-Assisted - methods</subject><subject>Double-Blind Method</subject><subject>drug safety</subject><subject>Electrocardiography, Ambulatory - methods</subject><subject>Female</subject><subject>Fluoroquinolones</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>QT interval</subject><subject>QT prolongation</subject><subject>Quinolines - toxicity</subject><subject>repolarization</subject><subject>Sample Size</subject><subject>Sensitivity and Specificity</subject><subject>thorough QT/QTc study</subject><subject>Young Adult</subject><issn>0091-2700</issn><issn>1552-4604</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkM1uEzEUhS0EoqGwZ4X8AkP9N-OYXTU0KRAKVQZYWp7YbkxnxpHtUZm-R98Xh0RFYsPq-t57vuOrA8BrjN5izPkZQgITjnKhlAvGnoAZLktSsAqxp2C2Xxf7_Ql4EeNPhHDFSvwcnGBRMkIxm4GH2vc7FVz0A_QWrk3v1Jh8r5LRUA0aLsaum-D54-yzSVuvI7Q-wOsmtyqOwfRmSPD9GNxwAxVstj748WabBWfXzQau06ind_B7_ke1rnNp-mO9Vv2uM3Dt7g2s_RCdNkEll18vwTOrumheHesp-La4aOrLYvVl-aE-XxUbRjgtLOOICLERplVUl9pWc4O4IIwTLJhu54ZbS4goCedcW2JbJWhJUIva1hLa0lOADr6b4GMMxspdcL0Kk8RI7hOW_yackTcHZDe2vdF_gWOkWcAOgjvfJRPibTfemSC3RnVpm_0QylejgmRLNM9dsR_RjFVHzHVm-u8d8mP99bKkZJ7B4gC6mMyvR1CFW1lxykv542opl81VU31arCSmvwHNiaXd</recordid><startdate>200908</startdate><enddate>200908</enddate><creator>Tyl, Benoît</creator><creator>Kabbaj, Meriam</creator><creator>Fassi, Basmah</creator><creator>De Jode, Patrick</creator><creator>Wheeler, William</creator><general>Blackwell Publishing Ltd</general><general>SAGE Publications</general><scope>BSCLL</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></search><sort><creationdate>200908</creationdate><title>Comparison of Semiautomated and Fully Automated Methods for QT Measurement During a Thorough QT/QTc Study: Variability and Sample Size Considerations</title><author>Tyl, Benoît ; Kabbaj, Meriam ; Fassi, Basmah ; De Jode, Patrick ; Wheeler, William</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4273-f470299c9eba3d5df68e0792472194db8e7ff22952777df2fba93520b0bbf23b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aza Compounds - toxicity</topic><topic>Cross-Over Studies</topic><topic>Diagnosis, Computer-Assisted - methods</topic><topic>Double-Blind Method</topic><topic>drug safety</topic><topic>Electrocardiography, Ambulatory - methods</topic><topic>Female</topic><topic>Fluoroquinolones</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>QT interval</topic><topic>QT prolongation</topic><topic>Quinolines - toxicity</topic><topic>repolarization</topic><topic>Sample Size</topic><topic>Sensitivity and Specificity</topic><topic>thorough QT/QTc study</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tyl, Benoît</creatorcontrib><creatorcontrib>Kabbaj, Meriam</creatorcontrib><creatorcontrib>Fassi, Basmah</creatorcontrib><creatorcontrib>De Jode, Patrick</creatorcontrib><creatorcontrib>Wheeler, William</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Journal of clinical pharmacology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tyl, Benoît</au><au>Kabbaj, Meriam</au><au>Fassi, Basmah</au><au>De Jode, Patrick</au><au>Wheeler, William</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comparison of Semiautomated and Fully Automated Methods for QT Measurement During a Thorough QT/QTc Study: Variability and Sample Size Considerations</atitle><jtitle>Journal of clinical pharmacology</jtitle><addtitle>J Clin Pharmacol</addtitle><date>2009-08</date><risdate>2009</risdate><volume>49</volume><issue>8</issue><spage>905</spage><epage>915</epage><pages>905-915</pages><issn>0091-2700</issn><eissn>1552-4604</eissn><abstract>This study compares the ability of 2 semiautomated methods with a fully automated method for QT measurement to minimize the sample size required to detect a moxifloxacin effect and exclude a placebo effect in a thorough QT/QTc study. 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| ispartof | Journal of clinical pharmacology, 2009-08, Vol.49 (8), p.905-915 |
| issn | 0091-2700 1552-4604 |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Adult Aged Aza Compounds - toxicity Cross-Over Studies Diagnosis, Computer-Assisted - methods Double-Blind Method drug safety Electrocardiography, Ambulatory - methods Female Fluoroquinolones Humans Male Middle Aged QT interval QT prolongation Quinolines - toxicity repolarization Sample Size Sensitivity and Specificity thorough QT/QTc study Young Adult |
| title | Comparison of Semiautomated and Fully Automated Methods for QT Measurement During a Thorough QT/QTc Study: Variability and Sample Size Considerations |
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