{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T20:34:36Z","timestamp":1740170076666,"version":"3.37.3"},"reference-count":25,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2022,4,26]],"date-time":"2022-04-26T00:00:00Z","timestamp":1650931200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,4,26]],"date-time":"2022-04-26T00:00:00Z","timestamp":1650931200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ther Innov Regul Sci"],"published-print":{"date-parts":[[2022,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Sites participating in clinical trials may not have the expertise and infrastructure to accurately measure cardiac intervals on 12-lead ECGs and rely heavily on the automated ECG device generated results for clinical decision-making.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Using a dataset of over 260,000 ECGs collected in clinical oncology studies, we investigated the mean difference and the rate of false negative results between the digital ECG machine QTc and QRS measurements compared to those obtained by a centralized ECG core lab.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>The mean differences between the core lab and the automated algorithm QTcF and QRS measurements were\u2009+\u20091.8\u2009\u00b1\u200916.0\u00a0ms and\u2009\u2212\u20091.0\u2009\u00b1\u20098.8\u00a0ms, respectively. Among the ECGs with a centralized QTcF value\u2009&gt;\u2009450 or\u2009&gt;\u2009470\u00a0ms, 39.5% and 47.8% respectively had a device reported QTcF value\u2009\u2264\u2009450\u00a0ms or\u2009\u2264\u2009470\u00a0ms. Among the ECGs with a centrally measured QTcF\u2009&gt;\u2009500\u00a0ms, 55.8% had a device reported value\u2009\u2264\u2009500\u00a0ms. Automated QTcF measurements failed to detect a QTcF increase\u2009&gt;\u200960\u00a0ms for 53.9% of the ECGs identified by the core lab. Automated measurements also failed to detect QRS prolongation, though to a lesser extent than failures to detect QTc prolongation. Among the ECGs with a centrally measured QRS\u2009&gt;\u2009110 or 120\u00a0ms, 7.9% and 7.3% respectively had a device reported QRS value\u2009\u2264\u2009110\u00a0ms or\u2009\u2264\u2009120\u00a0ms.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Relying on automated measurements from ECG devices for patient inclusion and treatment (dis)continuation decisions poses a potential risk to patients participating in oncology studies.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s43441-022-00405-0","type":"journal-article","created":{"date-parts":[[2022,4,26]],"date-time":"2022-04-26T15:03:06Z","timestamp":1650985386000},"page":"667-676","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["False\u00a0Negative ECG Device Results May Increase the\u00a0Risk of Adverse Events in Clinical Oncology Trials"],"prefix":"10.1007","volume":"56","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5706-8813","authenticated-orcid":false,"given":"Luc","family":"Dekie","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert B.","family":"Kleiman","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2022,4,26]]},"reference":[{"issue":"5 Suppl 1","key":"405_CR1","first-page":"1","volume":"43","author":"MM Bednar","year":"2001","unstructured":"Bednar MM, Harrigan EP, Anziano RJ, et al. 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