Premium
Quantitative Performance of E‐Scribe Warehouse in Detecting Quality Issues With Digital Annotated ECG Data From Healthy Subjects
Author(s) -
Sarapa Nenad,
Mortara Justin L.,
Brown Barry D.,
Isola Lamberto,
Badilini Fabio
Publication year - 2008
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/0091270008316326
Subject(s) - food and drug administration , quality (philosophy) , computer science , protocol (science) , medicine , qt interval , database , reliability (semiconductor) , data mining , medical emergency , power (physics) , physics , quantum mechanics , philosophy , alternative medicine , epistemology , pathology
The US Food and Drug Administration recommends submission of digital electrocardiograms in the standard HL7 XML format into the electrocardiogram warehouse to support preapproval review of new drug applications. The Food and Drug Administration scrutinizes electrocardiogram quality by viewing the annotated waveforms and scoring electrocardiogram quality by the warehouse algorithms. Part of the Food and Drug Administration warehouse is commercially available to sponsors as the E‐Scribe Warehouse. The authors tested the performance of E‐Scribe Warehouse algorithms by quantifying electrocardiogram acquisition quality, adherence to QT annotation protocol, and T‐wave signal strength in 2 data sets: “reference” (104 digital electrocardiograms from a phase I study with sotalol in 26 healthy subjects with QT annotations by computer‐assisted manual adjustment) and “test” (the same electrocardiograms with an intentionally introduced predefined number of quality issues). The E‐Scribe Warehouse correctly detected differences between the 2 sets expected from the number and pattern of errors in the “test” set (except for 1 subject with QT misannotated in different leads of serial electrocardiograms) and confirmed the absence of differences where none was expected. E‐Scribe Warehouse scores below the threshold value identified individual electrocardiograms with questionable T‐wave signal strength. The E‐Scribe Warehouse showed satisfactory performance in detecting electrocardiogram quality issues that may impair reliability of QTc assessment in clinical trials in healthy subjects.