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Quantitative Performance of E-Scribe Warehouse in Detecting Quality Issues With Digital Annotated ECG Data From Healthy Subjects

From Daiichi Sankyo Pharma Development, Edison, New Jersey (Dr Sarapa); Mortara Instrument, Milwaukee, Wisconsin (Dr Mortara, Mr Brown); and AMPS-LLC, New York City, New York (Mr Isola, Dr Badilini).

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.

Key Words: FDA • QTc • warehouse • digital annotated ECG • quality

Address for correspondence: Nenad Sarapa, MD, Johnson & Johnson PRD, Welsh and McKean Roads, Spring House, PA 19477; e-mail: nsarapa{at}prdus.jnj.com.

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