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Annotated ECG

Annotated ECG. Status Report to RCRIM 1/20/2014 Given by: Barry Brown. Continuous ECGs for FDA. FDA wants to receive annotated ECG waveforms from continuous ECG recordings collected in clinical trials

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Annotated ECG

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  1. Annotated ECG Status Report to RCRIM 1/20/2014 Given by: Barry Brown

  2. Continuous ECGs for FDA • FDA wants to receive annotated ECG waveforms from continuous ECG recordings collected in clinical trials • FDA commissioned Mortara to augment the ECG Warehouse to support receipt, analysis, and display of continuous ECGs

  3. Too Much Data for XML • Continuous ECGs contain too much data for XML • Worst case for FDA requirements would require a 9 GB aECG XML file • Everyone agrees that the waveform data must be left in binary files • Mortara added minimal (but proprietary) changes to HL7 aECG to support use of external files for ECG Warehouse project

  4. Dec. 2013 Workshop in D.C. • Mortara, AMPS, and FDA hosted a workshop for pharmaceutical industry about submitting continuous data to ECG Warehouse • The proprietary aECG changes were discussed so industry could start submitting data to ECG Warehouse while HL7 works through the standardization process

  5. How to Standardize in HL7? • Barry Brown worked with Gunther Schadow and Mead Walker to propose minimal changes to HL7 while meeting the needs of FDA • Most changes can be handled in a supplemental Implementation Guide for aECG • However, we also need to make a small change to the SLIST data type

  6. SLIST • SLIST is for “sampled” lists, like ECG waveforms • Today, the“digits” of SLIST are listed directly in the aECG XML

  7. SLIST.digits >> ED • We just need to allow for encapsulation of the SLIST digits • Let’s use ED-like attributes to describe the location of digits in an external binary file

  8. XML for ED <!-- type ED --> <x nullFlavor = ( NI | INV | OTH | NINF | PINF | UNC | DER | UNK | ASKU | NAV | QS | NASK | TRC | MSK | NA ) flavorId = ST* updateMode = (A | D | R | AR | N | U | K) representation = (B64 | TXT) : TXT language = CS mediaType = CS compression = CS integrityCheck = BIN description = ST integrityCheckAlgorithm = (SHA-1 | SHA-256) : SHA-1 > Content: ( reference, thumbnail, translation*, (#PCDATA | any) ) </x>

  9. Need More Attributes • ECG waveform leads are normally interleaved (or multiplexed) in a binary file. • Need to describe location of each lead separately.

  10. SLIST.digits Attributes * Not from ED

  11. SLIST.digits in Binary File

  12. Beat-by-Beat Annotations • Continuous ECGs are often analyzed with signal processing algorithms • Sponsors and labs may want to submit beat-by-beat annotations with the continuous waveforms • The beat-by-beat annotations should also be encoded in external binary files

  13. Beat-by-Beat Annotations

  14. MDC Beat Types

  15. Beat Types in Binary File

  16. QRST Onset in Binary File

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