カテゴリー: CDISCラボ

A small consideration about terminology for EGTESTCD.


In CDISC terminology, there are several terms that represent ECG related measurements. For example, PRMAX, PRMEAN, PRMED, PRMIN, PRAG and PRSB are decleard for PR. One question about these terminologies is "What are differences among PRMAEN, PRAG and PRSB?". We'd like to discuss this.

Several methods exits for ECG measurements. For example, 24-hour measurement. Other example is 10-seconds measurements. In all measurements, mulitple complex (complex of waves) are obtained.

PRSB is used for PR time based on paticular complex. In other words, it's PR interval of single beat. Any beats can be selected for measurements of PR duration. However, clean (without noise) wave is chosen. When you use this terminology, EGBEATNO variable is also used to specify the complex.

PR time based on single beat may be unstable. To obtain more stable and reliable PR duration, aggregated PR interval is calculated based on several complexs. If you have many complexs, you can extract 10-second data. The source of data is a single ECG measurement, but a part of data is referred for aggregation. For example, 24-hour ECG data is obtained. Sponsor extracts 10-second ECG data at the protocol specified time point. PR duration (average, median) is measured and calculated based on that selection.

In general, ECG is taken for safty purpose. In this case, 10-second measurement is performed and summary data is reported by the device. This value is also based on several complexs, but any complex data is extracted.

This is our internal interpreation of CDISC terminology. Please be informed that this is not guaranteed. We welcome any comments/suggestions to this entry.
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URL | [ 編集 ] 2015/04/21(火) 00:48:59

Thank you for giving me a information.
I understand that difference between PRAG and PRMEAN is "continuous value" or not.