Introduction This document is about how to extract real-time ECG data as stated in new ECG specification (see Annex for more details). The current version of Onyx is only configured to perform and collect data related to resting ECG measurement. These data are extracted from a XML file and saved in Onyx database, along with this file and a resting-ECG PDF report. According to the new specification document, information about real-time ECG measurement is enclosed in <FullDisclosure> node in the same XML file. 1. <FullDisclosure> node description: Figure 1. ECG resulting XML file screenshot The following table describes in detail each node in <FullDisclosure> section. In description column, section refers to a node that may contain either child nodes or fields and field means a leaf node. 1 Tag Description Attributes Range Required Instance FullDisclosure This section contains the full disclosure data This fields contains the number of acquired leads This field contains the number of samples per second One sample increment meets to this number of microvolts This field contains all leads separated by comma All full-disclosure samples are separated by comma in the following order: Sample-1 Lead-1, Sample-1 Lead-2… Sample1 Lead NumberOfChannels, Sample-2 Lead-1. Sample-2 Lead-2…Sample2 Lead NumberOfChannels None --- No Single None --- Yes Single Units= [Hz] Units= [uVperLsb] None [100,200,500] Yes Single [5.0] Yes Single --- Yes Single None --- Yes Single Yes Single Yes Single No Multiple No Multiple Yes Single Yes Single NumberOfChannels SampleRate Resolution LeadOrder FullDisclosureData SampleCount EventList Event Time Minute Second This field contains the number None --of samples that the tag FullDisclosureData contains This section contains the None --events, detected while full disclosure was active This field contains the event None --name This section contains the time None --of the event This field contains the minute None --when the event occurred This field contains the second None --when the event occurred Table 1. XML Data Export: Real-time ECG XML tags1 For CARTaGENE study, only real-time ECG graph and interpretation are relevant, so other data enclosed in <FullDisclosure> won’t be parsed. Fortunately, ECG software includes a functionality that does exactly what we need. By adding specific configuration codes (code for real-time ECG memorization (EGMO) and code for stress test (ERG2)), real-time ECG graph will be generated as a PDF document and real-time interpretation will be printed in resting ECG PDF report. 1 CASE, CardioSoft V6 XML Export Reference Manual 2025486-001 2 Steps to generate real-time ECG graph from the software: 1. Click on “start real-time ECG button”: 2. After two minutes, click on “Stop real-time ECG/post-test review”: 3 3. Go to “real-time ECG tab” and click on “Print” icon: 4. Choose which derivation to include in the PDF and then click on “Print”: It is possible to save selected option for next sessions by clicking on “Save” button. 4 The resulting real-time ECG PDF looks like: And the interpretation is included in resting ECG PDF report: 5 For the moment, it’s the easiest and the less expensive solution that we found to implement the new specification. However, it will be more interesting if we can automate the PDF generation, without requiring manual clicks from the nurses (only two clicks). 2. Implementation: To implement this, Onyx would be modified in order to: Add a new output for ECG measurement and modify initialization files; Add validation to see whether the real-time ECG measurement was taken and PDF document generated or not, and save the PDF to Onyx database; Define a new export destination (more details about export destinations will follow), which will contain real-time ECG graph and resting ECG report, that are generated directly from ECG software, as a node in an XML file; When exporting data from Onyx, put PDF documents in the according export destination. Once at CARTaGENE, use available tools (free converters or home-developed ones, Opal, etc.) to regenerate the real-time ECG PDF and resting ECG PDF, and make them available for specialists. Onyx features includes defining several export destinations via a configuration file named “WEB-INF/config/export-destinations.xml”: 6 Figure 2. export-destinations.xml file screenshot For instance, in the case of CARTaGENE, PDF consent forms of completed and closed interviews are exported to a folder with the same name. Besides cancelled interviews related information, are exported to appointment-unit folder. It is then possible to add a new export destination called for example: “CARTaGENE cardiologist” or “ECG specialist” where to put the generated PDF files, converted to XML nodes. Does modifying Onyx classes to collect real-time ECG measurement has further implications? (for old interviews for example) 7 Annex: Nouvelles spécifications de la mesure de la bande de rythme cardiaque Input : Idem de ce qui est déjà configuré dans la version actuelle d’onyx Output : Tous les paramètres du module ECG actuel mais en plus des données d’interprétation d’ECG temps réel (ECG temps réel permet d’avoir le rythme cardiaque de plusieurs minutes au lieu de 10 secondes) et les tracés des bandes de rythme. Ces données devraient être sauvegardées dans un fichier PDF et XML. Il est possible d’avoir un échantillon d’ECG de 10 secondes d’où les mesures du rythme cardiaque sont calculées et les tracés sont sauvegardés. En ce qui concerne les données de l’option ECG temps réel, CardioSoft ne permet pas d’avoir les tracés dans un fichier PDF, mais il les sauvegardes dans le fichier XML. Procédure : La fonction ECG temps réel nécessite des codes spécifiques pour chaque ECG Étape d’enregistrement des données : 1. Acquisition de l’ECG (étape pour l’acquisition des données de 10 secondes) 2. Démarrage temps réel (étape pour l’acquisition des données de 1-2 minutes) 3. Revue post-épreuve (étape pour sauvegarder les données de 10 secondes en PDF et l’ECG temps réel dans un fichier XML). Le fichier XML contient également les données d’ECG de 10 secondes. Note : Les tracés d’ECG de temps réel sont codés dans un nœud appelé « FullDisclosure » dans le fichier XML; malheureusement, la compagnie ne fournie pas d’application pour régénérer ces tracés. Une fois que les fichiers PDF et XML sont rendus dans les serveurs de CaG (à partir des tous les serveurs des différents sites, un fichier PDF contenant les données du rythme cardiaque (résumé des tracés de 10 secondes, l’analyse d’ECG temps réel et son tracé de 1 à 3 minutes) de chaque participant doit être reproduit dans un fichier PDF pour le mettre à la disposition d’un spécialiste pour qu’il puisse le consulter. La stratégie pour mettre les fichiers PDF des participants à la disposition du spécialiste est à la discrétion de Serge. 8
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