https://sudepwiki.pathology.jhmi.edu/index.php?title=Errors_and_misconceptions_in_ECG_measurement_used_for_the_detection_of_drug_induced_QT_interval_prolongation&feed=atom&action=history
Errors and misconceptions in ECG measurement used for the detection of drug induced QT interval prolongation - Revision history
2024-03-29T14:13:49Z
Revision history for this page on the wiki
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https://sudepwiki.pathology.jhmi.edu/index.php?title=Errors_and_misconceptions_in_ECG_measurement_used_for_the_detection_of_drug_induced_QT_interval_prolongation&diff=1448&oldid=prev
Alano at 17:30, 17 June 2019
2019-06-17T17:30:14Z
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<td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">← Older revision</td>
<td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">Revision as of 17:30, 17 June 2019</td>
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<tr><td class='diff-marker'>−</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div><del class="diffchange diffchange-inline">''Malik M(2004) Errors and misconceptions in ecg measurement used for the detection of drug induced QT interval prolongation. J Electrocardiol 37 Suppl: 25–33.''</del></div></td><td class='diff-marker'>+</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div><ins class="diffchange diffchange-inline">{{Reference</ins></div></td></tr>
<tr><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td></tr>
<tr><td class='diff-marker'>−</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div><del class="diffchange diffchange-inline">'''[https://ac.els-cdn.com/S0022073604000743/1-s2.0-S0022073604000743-main.pdf?_tid</del>=<del class="diffchange diffchange-inline">6184e018-a448-11e7-9091-00000aab0f6b&acdnat=1506601824_c8320327e8ac478b268609e40c1fdb86 Link to Article]'''</del></div></td><td class='diff-marker'>+</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div><ins class="diffchange diffchange-inline">|reference</ins>=</div></td></tr>
<tr><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td></tr>
<tr><td class='diff-marker'>−</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div><del class="diffchange diffchange-inline">'''Abstract:''' Drug-induced changes in cardiac repolarisation receive substantial attention by regulatory agencies. Since there are presently no established accurate possibilities of testing the propensity to torsade induction during clinical drug development, the regulators require drug-related QT interval changes to be thoroughly investigated with almost all new pharmacological agents. Small QT interval changes are easy to miss </del>and <del class="diffchange diffchange-inline">the regulators therefore expect the relevant studies to be very precise. Such a precision is not easy to achieve and different strategies have been proposed. The purpose of this article is to review the most frequent </del>misconceptions <del class="diffchange diffchange-inline">and errors </del>in <del class="diffchange diffchange-inline">the electrocardiogram handling and measurements related to </del>the detection <del class="diffchange diffchange-inline">to </del>drug<del class="diffchange diffchange-inline">-</del>induced QT interval <del class="diffchange diffchange-inline">changes</del>. <del class="diffchange diffchange-inline">Specifically, the article discusses (a) the possibilities of automatic measurement by standard electrocardiographic equipment, (b) the danger of casual measurement by central laboratories handling the electrocardiograms, (c) the selection of recording leads for QT interval measurement, and (d) the problem of the so-called heart rate hysteresis of the QT interval adaptation. Suggestions are made for drug developers of what study design and quality control aspects are needed to avoid the most frequent imprecisions</del>.</div></td><td class='diff-marker'>+</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div><ins class="diffchange diffchange-inline">Malik M(2004) Errors </ins>and misconceptions in <ins class="diffchange diffchange-inline">ecg measurement used for </ins>the detection <ins class="diffchange diffchange-inline">of </ins>drug induced QT interval <ins class="diffchange diffchange-inline">prolongation</ins>. <ins class="diffchange diffchange-inline">J Electrocardiol 37 Suppl: 25–33</ins>.</div></td></tr>
<tr><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td></tr>
<tr><td class='diff-marker'>−</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div><del class="diffchange diffchange-inline">'''Keywords:''' Thorough QT/QTc studies, proarrhythmia, drug approval</del></div></td><td class='diff-marker'>+</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div><ins class="diffchange diffchange-inline">|url=</ins></div></td></tr>
<tr><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td></tr>
<tr><td class='diff-marker'>−</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>=<del class="diffchange diffchange-inline">Context</del>=</div></td><td class='diff-marker'>+</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div><ins class="diffchange diffchange-inline">https://ac.els-cdn.com/S0022073604000743/1-s2.0-S0022073604000743-main.pdf?_tid</ins>=<ins class="diffchange diffchange-inline">6184e018-a448-11e7-9091-00000aab0f6b&acdnat=1506601824_c8320327e8ac478b268609e40c1fdb86</ins></div></td></tr>
<tr><td colspan="2"> </td><td class='diff-marker'>+</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div> </div></td></tr>
<tr><td colspan="2"> </td><td class='diff-marker'>+</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div><ins class="diffchange diffchange-inline">|abstract=</ins></div></td></tr>
<tr><td colspan="2"> </td><td class='diff-marker'>+</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div> </div></td></tr>
<tr><td colspan="2"> </td><td class='diff-marker'>+</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div><ins class="diffchange diffchange-inline">Drug-induced changes in cardiac repolarisation receive substantial attention by regulatory agencies. Since there are presently no established accurate possibilities of testing the propensity to torsade induction during clinical drug development, the regulators require drug-related QT interval changes to be thoroughly investigated with almost all new pharmacological agents. Small QT interval changes are easy to miss and the regulators therefore expect the relevant studies to be very precise. Such a precision is not easy to achieve and different strategies have been proposed. The purpose of this article is to review the most frequent misconceptions and errors in the electrocardiogram handling and measurements related to the detection to drug-induced QT interval changes. Specifically, the article discusses (a) the possibilities of automatic measurement by standard electrocardiographic equipment, (b) the danger of casual measurement by central laboratories handling the electrocardiograms, (c) the selection of recording leads for QT interval measurement, and (d) the problem of the so-called heart rate hysteresis of the QT interval adaptation. Suggestions are made for drug developers of what study design and quality control aspects are needed to avoid the most frequent imprecisions.</ins></div></td></tr>
<tr><td colspan="2"> </td><td class='diff-marker'>+</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div> </div></td></tr>
<tr><td colspan="2"> </td><td class='diff-marker'>+</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div><ins class="diffchange diffchange-inline">|keywords=</ins></div></td></tr>
<tr><td colspan="2"> </td><td class='diff-marker'>+</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div> </div></td></tr>
<tr><td colspan="2"> </td><td class='diff-marker'>+</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div><ins class="diffchange diffchange-inline">Thorough QT/QTc studies, proarrhythmia, drug approval</ins></div></td></tr>
<tr><td colspan="2"> </td><td class='diff-marker'>+</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div> </div></td></tr>
<tr><td colspan="2"> </td><td class='diff-marker'>+</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div><ins class="diffchange diffchange-inline">|context</ins>=</div></td></tr>
<tr><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td></tr>
<tr><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>*Review of QT measurement providing data on differences between manual and automated values, demonstration of errors made by automated detection methods, and comparison of QT across leads. Lag time of change in QT following change in heart rate (‘QT hysteresis’) is also discussed.</div></td><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>*Review of QT measurement providing data on differences between manual and automated values, demonstration of errors made by automated detection methods, and comparison of QT across leads. Lag time of change in QT following change in heart rate (‘QT hysteresis’) is also discussed.</div></td></tr>
<tr><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td></tr>
<tr><td class='diff-marker'>−</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>=<del class="diffchange diffchange-inline">Comments=</del></div></td><td class='diff-marker'>+</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div><ins class="diffchange diffchange-inline">|comments</ins>=</div></td></tr>
<tr><td colspan="2"> </td><td class='diff-marker'>+</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div> </div></td></tr>
<tr><td colspan="2"> </td><td class='diff-marker'>+</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div> </div></td></tr>
<tr><td colspan="2"> </td><td class='diff-marker'>+</td><td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div><ins class="diffchange diffchange-inline">}}</ins></div></td></tr>
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Alano
https://sudepwiki.pathology.jhmi.edu/index.php?title=Errors_and_misconceptions_in_ECG_measurement_used_for_the_detection_of_drug_induced_QT_interval_prolongation&diff=542&oldid=prev
Ycarmen1: Created page with "''Malik M(2004) Errors and misconceptions in ecg measurement used for the detection of drug induced QT interval prolongation. J Electrocardiol 37 Suppl: 25–33.'' '''[https:..."
2017-09-28T12:28:10Z
<p>Created page with "''Malik M(2004) Errors and misconceptions in ecg measurement used for the detection of drug induced QT interval prolongation. J Electrocardiol 37 Suppl: 25–33.'' '''[https:..."</p>
<p><b>New page</b></p><div>''Malik M(2004) Errors and misconceptions in ecg measurement used for the detection of drug induced QT interval prolongation. J Electrocardiol 37 Suppl: 25–33.''<br />
<br />
'''[https://ac.els-cdn.com/S0022073604000743/1-s2.0-S0022073604000743-main.pdf?_tid=6184e018-a448-11e7-9091-00000aab0f6b&acdnat=1506601824_c8320327e8ac478b268609e40c1fdb86 Link to Article]'''<br />
<br />
'''Abstract:''' Drug-induced changes in cardiac repolarisation receive substantial attention by regulatory agencies. Since there are presently no established accurate possibilities of testing the propensity to torsade induction during clinical drug development, the regulators require drug-related QT interval changes to be thoroughly investigated with almost all new pharmacological agents. Small QT interval changes are easy to miss and the regulators therefore expect the relevant studies to be very precise. Such a precision is not easy to achieve and different strategies have been proposed. The purpose of this article is to review the most frequent misconceptions and errors in the electrocardiogram handling and measurements related to the detection to drug-induced QT interval changes. Specifically, the article discusses (a) the possibilities of automatic measurement by standard electrocardiographic equipment, (b) the danger of casual measurement by central laboratories handling the electrocardiograms, (c) the selection of recording leads for QT interval measurement, and (d) the problem of the so-called heart rate hysteresis of the QT interval adaptation. Suggestions are made for drug developers of what study design and quality control aspects are needed to avoid the most frequent imprecisions.<br />
<br />
'''Keywords:''' Thorough QT/QTc studies, proarrhythmia, drug approval<br />
<br />
=Context=<br />
<br />
*Review of QT measurement providing data on differences between manual and automated values, demonstration of errors made by automated detection methods, and comparison of QT across leads. Lag time of change in QT following change in heart rate (‘QT hysteresis’) is also discussed.<br />
<br />
=Comments=</div>
Ycarmen1