scope:

General

The availability of annotated arrhythmia and ST databases has permitted different automated arrhythmia detection algorithms to be tested on the same data. This recommended practice provides a protocol for a reproducible test with realistic clinical requirements, and emphasizes record-by-record presentation of results that reflect an algorithm's ability to detect events of clinical significance. Beat-by-beat comparisons are used to measure performance in QRS (see 2.7), ventricular ectopic beat (VEB), and supraventricular ectopic beat (SVEB) detection. Run-by-run comparisons are used to measure an algorithm's ability to detect consecutive VEBs and SVEBs. Detection of ventricular flutter, atrial flutter, ventricular fibrillation, and atrial fibrillation are addressed. The evaluation of heart-rate variability measurement algorithms and ST segment measurement algorithms are also examined.

Although this document seeks to establish clinically relevant measures of performance for the comparison of algorithms, it must be recognized that certain clinical concerns cannot be addressed within the context of this recommended practice. Available databases do not yet contain a representative sample of nonventricular arrhythmias, paced patients or artifacts typical of a very significant portion of ECG signals originating in the clinical setting. In addition, these databases have a limited bandwidth and should be used with caution when testing algorithms designed for full ECG diagnostic bandwidth devices. Therefore, the clinical implications of a test are necessarily limited by the size, scope, and characteristics of the databases used for testing. Performance measures derived from such testing should be regarded as uncertain indicators of performance in clinical settings.

This recommended practice has been developed for testing algorithms, not entire systems. It is not a performance standard, but rather a set of recommendations for testing cardiac rhythm and ST measurement and reporting the results of those tests. The intent of this recommended practice is that automated testing methods be reproducible.

Inclusions

This recommended practice applies to algorithms implemented in devices or systems that use automated methods to analyze the ECG.

This document applies both to human-operated, stand-alone devices that use automated methods to analyze the recorded ECG, and to so-called real-time event recorders that use automated methods to select abnormal events for recording.

Exclusions

Testing methodologies other than beat-by beat techniques, specified rhythm analysis, and ST segment analysis are outside the scope of this document. The evaluation of systems that rely on intensive interaction by a skilled user is also outside the scope of this document. However, if beat-by-beat evaluations are performed, the results of such testing should conform to this recommended practice.