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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">A markup language for electrocardiogram data acquisition and analysis (ecgML)</title><author><name sortKey="Wang, Haiying" sort="Wang, Haiying" uniqKey="Wang H" first="Haiying" last="Wang">Haiying Wang</name><affiliation><nlm:aff id="I1">School of Computing and Mathematics, University of Ulster, Newtownabbey, BT37 0QB, Co. Antrim, Northern Ireland, U.K</nlm:aff></affiliation></author><author><name sortKey="Azuaje, Francisco" sort="Azuaje, Francisco" uniqKey="Azuaje F" first="Francisco" last="Azuaje">Francisco Azuaje</name><affiliation><nlm:aff id="I1">School of Computing and Mathematics, University of Ulster, Newtownabbey, BT37 0QB, Co. Antrim, Northern Ireland, U.K</nlm:aff></affiliation></author><author><name sortKey="Jung, Benjamin" sort="Jung, Benjamin" uniqKey="Jung B" first="Benjamin" last="Jung">Benjamin Jung</name><affiliation><nlm:aff id="I2">Centre for Health Informatics, Trinity College Dublin, Dublin 2, Ireland</nlm:aff></affiliation></author><author><name sortKey="Black, Norman" sort="Black, Norman" uniqKey="Black N" first="Norman" last="Black">Norman Black</name><affiliation><nlm:aff id="I3">Faculty of Informatics, University of Ulster, Newtownabbey, BT37 0QB, Co. Antrim, Northern Ireland, U.K</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">12735790</idno><idno type="pmc">161810</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC161810</idno><idno type="RBID">PMC:161810</idno><idno type="doi">10.1186/1472-6947-3-4</idno><date when="2003">2003</date><idno type="wicri:Area/Pmc/Corpus">000132</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000132</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">A markup language for electrocardiogram data acquisition and analysis (ecgML)</title><author><name sortKey="Wang, Haiying" sort="Wang, Haiying" uniqKey="Wang H" first="Haiying" last="Wang">Haiying Wang</name><affiliation><nlm:aff id="I1">School of Computing and Mathematics, University of Ulster, Newtownabbey, BT37 0QB, Co. Antrim, Northern Ireland, U.K</nlm:aff></affiliation></author><author><name sortKey="Azuaje, Francisco" sort="Azuaje, Francisco" uniqKey="Azuaje F" first="Francisco" last="Azuaje">Francisco Azuaje</name><affiliation><nlm:aff id="I1">School of Computing and Mathematics, University of Ulster, Newtownabbey, BT37 0QB, Co. Antrim, Northern Ireland, U.K</nlm:aff></affiliation></author><author><name sortKey="Jung, Benjamin" sort="Jung, Benjamin" uniqKey="Jung B" first="Benjamin" last="Jung">Benjamin Jung</name><affiliation><nlm:aff id="I2">Centre for Health Informatics, Trinity College Dublin, Dublin 2, Ireland</nlm:aff></affiliation></author><author><name sortKey="Black, Norman" sort="Black, Norman" uniqKey="Black N" first="Norman" last="Black">Norman Black</name><affiliation><nlm:aff id="I3">Faculty of Informatics, University of Ulster, Newtownabbey, BT37 0QB, Co. Antrim, Northern Ireland, U.K</nlm:aff></affiliation></author></analytic><series><title level="j">BMC Medical Informatics and Decision Making</title><idno type="eISSN">1472-6947</idno><imprint><date when="2003">2003</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>The storage and distribution of electrocardiogram data is based on different formats. There is a need to promote the development of standards for their exchange and analysis. Such models should be platform-/ system- and application-independent, flexible and open to every member of the scientific community.</p></sec><sec sec-type="methods"><title>Methods</title><p>A minimum set of information for the representation and storage of electrocardiogram signals has been synthesised from existing recommendations. This specification is encoded into an XML-vocabulary. The model may aid in a flexible exchange and analysis of electrocardiogram information.</p></sec><sec><title>Results</title><p>Based on advantages of XML technologies, ecgML has the ability to present a system-, application- and format-independent solution for representation and exchange of electrocardiogram data. The distinction between the proposal developed by the <italic>U.S Food and Drug Administration </italic>and ecgML model is given. A series of tools, which aim to facilitate ecgML-based applications, are presented.</p></sec><sec><title>Conclusions</title><p>The models proposed here can facilitate the generation of a data format, which opens ways for better and clearer interpretation by both humans and machines. Its structured and transparent organisation will allow researchers to expand and test its capabilities in different application domains. The specification and programs for this protocol are publicly available.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct></listBibl></div1></back></TEI><pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">BMC Med Inform Decis Mak</journal-id><journal-title>BMC Medical Informatics and Decision Making</journal-title><issn pub-type="epub">1472-6947</issn><publisher><publisher-name>BioMed Central</publisher-name><publisher-loc>London</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">12735790</article-id><article-id pub-id-type="pmc">161810</article-id><article-id pub-id-type="publisher-id">1472-6947-3-4</article-id><article-id pub-id-type="doi">10.1186/1472-6947-3-4</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group></article-categories><title-group><article-title>A markup language for electrocardiogram data acquisition and analysis (ecgML)</article-title></title-group><contrib-group><contrib id="A1" contrib-type="author"><name><surname>Wang</surname><given-names>Haiying</given-names></name><xref ref-type="aff" rid="I1">1</xref><email>hy.wang@ulster.ac.uk</email></contrib><contrib id="A2" corresp="yes" contrib-type="author"><name><surname>Azuaje</surname><given-names>Francisco</given-names></name><xref ref-type="aff" rid="I1">1</xref><email>fj.azuaje@ulster.ac.uk</email></contrib><contrib id="A3" contrib-type="author"><name><surname>Jung</surname><given-names>Benjamin</given-names></name><xref ref-type="aff" rid="I2">2</xref><email>benjamin.jung@cs.tcd.ie</email></contrib><contrib id="A4" contrib-type="author"><name><surname>Black</surname><given-names>Norman</given-names></name><xref ref-type="aff" rid="I3">3</xref><email>nd.black@ulst.ac.uk</email></contrib></contrib-group><aff id="I1"><label>1</label>School of Computing and Mathematics, University of Ulster, Newtownabbey, BT37 0QB, Co. Antrim, Northern Ireland, U.K</aff><aff id="I2"><label>2</label>Centre for Health Informatics, Trinity College Dublin, Dublin 2, Ireland</aff><aff id="I3"><label>3</label>Faculty of Informatics, University of Ulster, Newtownabbey, BT37 0QB, Co. Antrim, Northern Ireland, U.K</aff><pub-date pub-type="collection"><year>2003</year></pub-date><pub-date pub-type="epub"><day>7</day><month>5</month><year>2003</year></pub-date><volume>3</volume><fpage>4</fpage><lpage>4</lpage><ext-link ext-link-type="uri" xlink:href="http://www.biomedcentral.com/1472-6947/3/4"></ext-link><history><date date-type="received"><day>19</day><month>3</month><year>2003</year></date><date date-type="accepted"><day>7</day><month>5</month><year>2003</year></date></history><permissions><copyright-statement>Copyright © 2003 Wang et al; licensee BioMed Central Ltd. This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along with the article's original URL.</copyright-statement><copyright-year>2003</copyright-year><copyright-holder>Wang et al; licensee BioMed Central Ltd. This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along with the article's original URL.</copyright-holder></permissions><abstract><sec><title>Background</title><p>The storage and distribution of electrocardiogram data is based on different formats. There is a need to promote the development of standards for their exchange and analysis. Such models should be platform-/ system- and application-independent, flexible and open to every member of the scientific community.</p></sec><sec sec-type="methods"><title>Methods</title><p>A minimum set of information for the representation and storage of electrocardiogram signals has been synthesised from existing recommendations. This specification is encoded into an XML-vocabulary. The model may aid in a flexible exchange and analysis of electrocardiogram information.</p></sec><sec><title>Results</title><p>Based on advantages of XML technologies, ecgML has the ability to present a system-, application- and format-independent solution for representation and exchange of electrocardiogram data. The distinction between the proposal developed by the <italic>U.S Food and Drug Administration </italic>and ecgML model is given. A series of tools, which aim to facilitate ecgML-based applications, are presented.</p></sec><sec><title>Conclusions</title><p>The models proposed here can facilitate the generation of a data format, which opens ways for better and clearer interpretation by both humans and machines. Its structured and transparent organisation will allow researchers to expand and test its capabilities in different application domains. The specification and programs for this protocol are publicly available.</p></sec></abstract></article-meta></front><body><sec><title>Background</title><p>Electrocardiogram (ECG) data are acquired, stored and analysed using different formats and software platforms. Medical informatics will fully exploit the benefits from its research only when data can be openly shared and interpreted. Therefore, there is a need to develop cross-platform solutions to support biomedical training, decision-making and telemedicine applications [<xref ref-type="bibr" rid="B1">1</xref>].</p><p>An important goal is to describe these data independently on the number of channels, instrumentation platform or type of experiments. Moreover, an ECG record should also include annotations relating to the acquisition protocols, patient information and analysis results. These data modelling tasks should consist of flexible and inexpensive tools to enhance pattern recognition capabilities.</p><p>The development of these systems will depend on the existence of information that clearly specifies domain terminologies, functional hierarchies and decision rules. The availability of such ontological representations [<xref ref-type="bibr" rid="B2">2</xref>] will allow the emergence of standards, which will facilitate the integration of information on a global communication infrastructure.</p><p>ECG data have been traditionally recorded using flat file formats, such as the <italic>MIT-BIH </italic>file library [<xref ref-type="bibr" rid="B3">3</xref>]. This type of data format lacks the information necessary to support a meaningful analysis, interoperability and integration of multiple resources. Different governmental, academic and private organisations have proposed minimum requirements for the representation and storage of biomedical information, including signals and images [<xref ref-type="bibr" rid="B4">4</xref>]. These efforts aimed to promote the application of standards for message exchange and data integration. In 1993, for example, the CEN/TC251 WG3 (Comité Européen de Normalisation European, Committee for Standardisation, Technical Committee 251) reviewed several data exchange formats for healthcare applications. It includes <italic>Abstract Syntax Notation </italic>(ASN.1) and <italic>Health Level Seven </italic>(HL7) [<xref ref-type="bibr" rid="B5">5</xref>]. The former defines norms to describe an electronic message based on different data types. One of the disadvantages of ASN.1 is that it does not fully support scalable solutions and query processing. HL7 has been a Standards Development Organisation affiliated to the ANSI (American National Standards Organisation) since 1997 and has become the standard for electronic exchange of historical and administrative data in health services worldwide. The next generation of the messaging standard (V3) has been under development since.</p><p>CORBAmed, the <italic>Healthcare Domain Task Force of the Object Management Group </italic>(OMG) [<xref ref-type="bibr" rid="B6">6</xref>], deals with interoperability problems between heterogeneous information systems. To facilitate the seamless and automated data exchange between numerous applications, a common interface architecture was developed that serves in a number of today's information systems. Liaisons have been established with other organisations such as HL7.</p><p>The <italic>Digital Imaging and Communications in Medicine </italic>(DICOM) standards committee supports the achievement of data compatibility between imaging systems and other healthcare information at different levels. This standard has been applied by many private organisations, which need to incorporate diverse bio-signals associated to medical imaging. The DICOM standard is a useful resource that also provides guidelines on how to represent ECG features [<xref ref-type="bibr" rid="B4">4</xref>].</p><p>More recently, the <italic>eXtensible Markup Language </italic>(XML) [<xref ref-type="bibr" rid="B7">7</xref>] has been suggested as a promising approach to representing biomedical data. Developed as a subset of SGML in 1996 to "be straightforwardly usable over the Internet" and published as a first recommendation by the W3C (World Wide Web Consortium) in 1998, XML soon became a ubiquitous syntax for data and data-exchange over the Internet. Since then, XML-based Markup Languages, specified as e.g. Document Type Definitions (DTD) or XML Schemas (XSD) have been emerging in unlimited numbers and in nearly every imaginable domain [<xref ref-type="bibr" rid="B8">8</xref>]. Advantages of XML syntax include platform-, vendor- and application independence as well as an easy-to-follow hierarchical data structure and wide support. "XML's greatest advantage is that it is a user-driven, open standard for exchanging data both over corporate networks and between different enterprises, notably over the Internet. XML's biggest potential lies undoubtedly in its ability to mark up mission-critical document elements self-descriptively" [<xref ref-type="bibr" rid="B9">9</xref>]. By following a strict separation of content and presentation information, XML technologies increase the re-usability of information in its purest way as access to the original (raw) data is always given. The use of XML syntax for the exchange of electronic patient records was shown in all aspects in Synapses [<xref ref-type="bibr" rid="B10">10</xref>] and SynEx [<xref ref-type="bibr" rid="B11">11</xref>] project implementations [<xref ref-type="bibr" rid="B12">12</xref>-<xref ref-type="bibr" rid="B14">14</xref>].</p><p>The <italic>U.S Food and Drug Administration </italic>(FDA) Centre for Drug Evaluation and Research has proposed recommendations for the exchange of time-series data. It includes a hierarchical structure for the representation of signals, including ECG data, which may be encoded as an XML file. This protocol focuses on the acquisition of multiple records from different subjects within a single file [<xref ref-type="bibr" rid="B15">15</xref>,<xref ref-type="bibr" rid="B16">16</xref>]. The HL7 committee has been actively cooperating with the <italic>World Wide Web Consortium </italic>(W3C) to define XML guidelines to represent medical information [<xref ref-type="bibr" rid="B17">17</xref>]. HL7 has endorsed the <italic>Clinical Document Architecture </italic>(CDA), which supports the generation and exchange of clinical messages [<xref ref-type="bibr" rid="B18">18</xref>]. Other XML-based initiatives for the representation and distribution of biomedical information are: The <italic>ASTM E31.25 </italic>subcommittee [<xref ref-type="bibr" rid="B19">19</xref>], the <italic>CEN/TC251 Task Force on XML Applications in Healthcare </italic>[<xref ref-type="bibr" rid="B20">20</xref>] and the <italic>Clinical Data Interchange Standards Consortium </italic>(CDISC) [<xref ref-type="bibr" rid="B21">21</xref>]. However, these efforts have not focused on ECG data. Some of them place a greater emphasis on the administrative and financial transactions associated with a clinical environment.</p><p>Recent advances include <italic>I-Med</italic>, which is an XML-based format for clinical data [<xref ref-type="bibr" rid="B22">22</xref>]. This project consists of a domain-independent interface for exchanging several types of medical information. Its major goal is to provide a unique platform for clinical transactions. These messages can include ECG records, which may be described by basic features, such as QRS duration and text-based interpretations. One major limitation of this solution is that it partially addresses important ECG data content-definitions.</p><p>This article introduces a markup language for supporting ECG data exchange and analysis (ecgML). It synthesises key recommendations specified by the initiatives presented above.</p></sec><sec sec-type="methods"><title>Methods</title><p>There is a need to harmonise the representation of digital ECG data originating from the full spectrum of devices along with annotations for events, and to include necessary associated information, such as patient identification, interpretation and other clinical data. The hierarchical data tree structures depicted in Figures <xref ref-type="fig" rid="F1">1</xref> to <xref ref-type="fig" rid="F6">6</xref> are proposed to address such concerns. Tables <xref ref-type="table" rid="T1">1</xref> to <xref ref-type="table" rid="T8">8</xref> describe the elements and attributes defined in this model. In this paper terms written in <bold>bold </bold>and <italic>italic </italic>prints represent either XML <italic>element </italic>or <italic>attribute </italic>names. Element names should be words concatenated with the first letter of each word capitalised (UpperCamelCase, <ext-link ext-link-type="uri" xlink:href="http://searchwebservices.techtarget.com/sDefinition/0,290660, sid26_gci824363,00.html"></ext-link>). Attribute names satisfy the same rule except for the first word (lowerCamelCase, <ext-link ext-link-type="uri" xlink:href="http://searchwebservices.techtarget.com/sDefinition/0,,sid26_gci824366,00.html"></ext-link>).</p><fig position="float" id="F1"><label>Figure 1</label><caption><p>The tree diagram of ecgML: ECGRecord element</p></caption><graphic xlink:href="1472-6947-3-4-1"></graphic></fig><fig position="float" id="F2"><label>Figure 2</label><caption><p>The tree diagram of ecgML: Record element</p></caption><graphic xlink:href="1472-6947-3-4-2"></graphic></fig><fig position="float" id="F3"><label>Figure 3</label><caption><p>The tree diagram of ecgML: ClinicalProtocol element</p></caption><graphic xlink:href="1472-6947-3-4-3"></graphic></fig><fig position="float" id="F4"><label>Figure 4</label><caption><p>The tree diagram of ecgML: <italic>RecordData </italic>element</p></caption><graphic xlink:href="1472-6947-3-4-4"></graphic></fig><fig position="float" id="F5"><label>Figure 5</label><caption><p>The tree diagram of ecgML: <italic>Waveforms </italic>element</p></caption><graphic xlink:href="1472-6947-3-4-5"></graphic></fig><fig position="float" id="F6"><label>Figure 6</label><caption><p>The tree diagram of ecgML: Annotations element</p></caption><graphic xlink:href="1472-6947-3-4-6"></graphic></fig><table-wrap position="float" id="T1"><label>Table 1</label><caption><p>The description of ecgML: <italic>ECGRecord </italic>element</p></caption><table frame="hsides" rules="groups"><thead><tr><td align="left"><bold><italic>ECGRecord</italic></bold></td><td align="left" colspan="4">The root element for XML-based ECG record</td></tr></thead><tbody><tr><td align="left"><bold>Element/attribute</bold></td><td align="left"><bold>Description/Origin</bold></td><td align="left"><bold>Required </bold></td><td align="left"><bold>Values/Data Type</bold></td><td align="left"><bold>Example</bold></td></tr><tr><td colspan="5"><hr></hr></td></tr><tr><td align="left"><bold><italic>studyID</italic></bold></td><td align="left">Unique ID for an ECG record.</td><td align="left">Required</td><td align="left">string</td><td align="left">ECG000001</td></tr><tr><td align="left"><bold><italic>StudyDate</italic></bold></td><td align="left">Study date. To be expressed as YYYY-MM-DD.</td><td align="left">Required</td><td align="left">date</td><td align="left">2002-10-22</td></tr><tr><td align="left"><bold><italic>StudyTime</italic></bold></td><td align="left">Study time. To be expressed as HH:MM:SS.SSS</td><td align="left">Required</td><td align="left">time</td><td align="left">12:01:00</td></tr><tr><td align="left"><bold><italic>Comment</italic></bold></td><td align="left">Comments about the ECG Record</td><td align="left">Optional</td><td align="left">string</td><td align="left">Subject under stress 1 hour after dose.</td></tr><tr><td align="left"><bold><italic>PatientDemographics</italic></bold></td><td align="left">Describes patient demographics</td><td align="left">Required</td><td align="left">See Table <xref ref-type="table" rid="T2">2</xref></td><td></td></tr><tr><td align="left"><bold><italic>Record</italic></bold></td><td align="left">The details for ECG data.</td><td align="left">Required</td><td align="left">See Table <xref ref-type="table" rid="T3">3</xref></td><td></td></tr><tr><td align="left"><bold><italic>MedicalHistory</italic></bold></td><td align="left">Description of the patient's clinical problems and diagnoses.</td><td align="left">Optional</td><td align="left">string</td><td align="left">Ventricular ectopy</td></tr><tr><td align="left"><bold><italic>Diagnosis</italic></bold></td><td align="left">For the latest diagnostic interpretation of the ECG.</td><td align="left">Optional</td><td align="left">string</td><td align="left">Myocardial infarction</td></tr></tbody></table></table-wrap><table-wrap position="float" id="T2"><label>Table 2</label><caption><p>The description of ecgML: <italic>PatientDemorgraphics </italic>element</p></caption><table frame="hsides" rules="groups"><thead><tr><td align="left"><bold><italic>PatientDemographics</italic></bold></td><td align="left" colspan="4">Describes patient demographics</td></tr></thead><tbody><tr><td align="left"><bold>Element/attribute</bold></td><td align="left"><bold>Description/Origin</bold></td><td align="left"><bold>Required</bold></td><td align="left"><bold>Values/Data Type</bold></td><td align="left"><bold>Example</bold></td></tr><tr><td colspan="5"><hr></hr></td></tr><tr><td align="left"><bold><italic>patientID</italic></bold></td><td align="left">Patient Data (Based on SCP-ECG).</td><td align="left">Optional</td><td align="left">string</td><td align="left">1532948</td></tr><tr><td align="left"><bold><italic>DOB</italic></bold></td><td></td><td align="left">Optional</td><td align="left">Date</td><td align="left">1965-04-05</td></tr><tr><td align="left"><bold><italic>Sex</italic></bold></td><td></td><td align="left">Optional</td><td align="left">-Male -Female -Unknown -Unspecified</td><td align="left">Male</td></tr><tr><td align="left"><bold><italic>Race</italic></bold></td><td></td><td align="left">Optional</td><td align="left">string</td><td align="left">African</td></tr><tr><td align="left"><bold><italic>Phone</italic></bold></td><td align="left">Phone number</td><td align="left">Optional</td><td align="left">string</td><td align="left">00442890368197</td></tr><tr><td align="left"><bold><italic>Fax</italic></bold></td><td align="left">Fax number</td><td align="left">Optional</td><td align="left">string</td><td align="left">00440289036</td></tr><tr><td align="left"><bold><italic>Email</italic></bold></td><td align="left">Email address</td><td align="left">Optional</td><td align="left">string</td><td align="left">hy.wang@ulst.ac.uk
</td></tr><tr><td align="left"><bold><italic>Address</italic></bold></td><td align="left" colspan="4">Patient address. Based on HL7's PRA and I-Med recommendation</td></tr><tr><td align="left"><bold><italic>StreetAddress</italic></bold></td><td align="left">Street address</td><td align="left">Optional</td><td align="left">string</td><td align="left">24 Shore Road</td></tr><tr><td align="left"><bold><italic>State</italic></bold></td><td align="left">State or province</td><td align="left">Optional</td><td align="left">string</td><td align="left">N. Ireland</td></tr><tr><td align="left"><bold><italic>PostalCode</italic></bold></td><td align="left">Zip or postal code</td><td align="left">Optional</td><td align="left">string</td><td align="left">BT37 0QB</td></tr><tr><td align="left"><bold><italic>City</italic></bold></td><td align="left">City name</td><td align="left">Optional</td><td align="left">string</td><td align="left">Belfast</td></tr><tr><td align="left"><bold><italic>Country</italic></bold></td><td align="left">Country name</td><td align="left">Optional</td><td align="left">string</td><td align="left">UK</td></tr><tr><td align="left"><bold><italic>Name</italic></bold></td><td align="left" colspan="4">Patient name. Based on IMed DTD</td></tr><tr><td align="left"><bold><italic>FirstName</italic></bold></td><td align="left">Patient firstname</td><td align="left">Optional</td><td align="left">string</td><td align="left">Frank</td></tr><tr><td align="left"><bold><italic>MiddleName</italic></bold></td><td align="left">Patient middle name</td><td align="left">Optional</td><td align="left">string</td><td align="left">J</td></tr><tr><td align="left"><bold><italic>LastName</italic></bold></td><td align="left">Patient lastname</td><td align="left">Optional</td><td align="left">string</td><td align="left">Smith</td></tr></tbody></table></table-wrap><table-wrap position="float" id="T3"><label>Table 3</label><caption><p>The description of ecgML: <italic>Record </italic>element</p></caption><table frame="hsides" rules="groups"><thead><tr><td align="left"><bold><italic>Record</italic></bold></td><td align="left" colspan="4">The element for the details of ECG data</td></tr></thead><tbody><tr><td align="left"><bold>Element/attribute</bold></td><td align="left"><bold>Description/Origin</bold></td><td align="left"><bold>Required</bold></td><td align="left"><bold>Values/Data Type</bold></td><td align="left"><bold>Example</bold></td></tr><tr><td colspan="5"><hr></hr></td></tr><tr><td align="left"><bold><italic>investigatorID</italic></bold></td><td align="left">A text description of the referring physician</td><td align="left">Optional</td><td align="left">string</td><td align="left">Dr. John</td></tr><tr><td align="left"><bold><italic>siteID</italic></bold></td><td align="left">A text description of the place where the ECG data was acquired.</td><td align="left">Optional</td><td align="left">string</td><td align="left">Loyal Hosptial</td></tr><tr><td align="left"><bold><italic>AcquisitionDate</italic></bold></td><td align="left">Acquisition date of the recording. To be expressed as YYYY-MM-DD</td><td align="left">Optional</td><td align="left">date</td><td align="left">2002-10-20</td></tr><tr><td align="left"><bold><italic>AcquisitionTime</italic></bold></td><td align="left">Acquisition time of the recording. To be expressed as HH:MM:SS.SSS</td><td align="left">Optional</td><td align="left">time</td><td align="left">11:05:32.00</td></tr><tr><td align="left"><bold><italic>RecordingDevice</italic></bold></td><td align="left">Description of the device that made the recording</td><td align="left">Optional</td><td align="left">See Table <xref ref-type="table" rid="T4">4</xref></td><td></td></tr><tr><td align="left"><bold><italic>ClinicalProtocol</italic></bold></td><td align="left">Additional patient clinical information</td><td align="left">Optional</td><td align="left">See Table <xref ref-type="table" rid="T5">5</xref></td><td></td></tr><tr><td align="left"><bold><italic>RecordData</italic></bold></td><td align="left">Ecg data for each channel.</td><td align="left">Required</td><td align="left">See Table <xref ref-type="table" rid="T6">6</xref></td><td></td></tr></tbody></table></table-wrap><table-wrap position="float" id="T4"><label>Table 4</label><caption><p>The description of ecgML: <italic>RecordingDevice </italic>element</p></caption><table frame="hsides" rules="groups"><thead><tr><td align="left"><bold><italic>RecordingDevice</italic></bold></td><td align="left" colspan="4">Description of the device that made the recording. Based on FDA XML Data Format Specification (revision C) and SCP-ECG.</td></tr></thead><tbody><tr><td align="left"><bold>Element/attribute</bold></td><td align="left"><bold>Description/Origin</bold></td><td align="left"><bold>Required </bold></td><td align="left"><bold>Values/Data Type</bold></td><td align="left"><bold>Example</bold></td></tr><tr><td colspan="5"><hr></hr></td></tr><tr><td align="left"><bold><italic>deviceID</italic></bold></td><td align="left">ID number of recording device.</td><td align="left">Optional</td><td align="left">string</td><td align="left">35</td></tr><tr><td align="left"><bold><italic>Type</italic></bold></td><td align="left">Type of recording device.</td><td align="left">Optional</td><td align="left">string</td><td align="left">12-lead ECG</td></tr><tr><td align="left"><bold><italic>Manufacturer</italic></bold></td><td align="left">Manufacture of recording device.</td><td align="left">Optional</td><td align="left">string</td><td align="left">GE Medical Systems</td></tr><tr><td align="left"><bold><italic>Model</italic></bold></td><td align="left">Model of recording device.</td><td align="left">Optional</td><td align="left">string</td><td align="left">MAC 500</td></tr><tr><td align="left"><bold><italic>SerialNumber</italic></bold></td><td align="left">Serial number of recording device</td><td align="left">Optional</td><td align="left">string</td><td align="left">023001236</td></tr><tr><td align="left"><bold><italic>BaselineFilter</italic></bold></td><td align="left">High cut off in Hz. Based on SCP-ECG acquisition data.</td><td align="left">Optional</td><td align="left">float</td><td align="left">0.5</td></tr><tr><td align="left"><bold><italic>LowpassFilter</italic></bold></td><td align="left">Low cut off in Hz. Based on SCP-ECG acquisition data.</td><td align="left">Optional</td><td align="left">float</td><td align="left">120</td></tr><tr><td align="left"><bold><italic>FilterBitMap</italic></bold></td><td align="left">Other filters. Based on SCP-ECG acquisition data.</td><td align="left">Optional</td><td align="left">-60 Hz notch filter -50 Hz notch filter -Artifact filter -Baseline filter -Undefined</td><td align="left">60 Hz notch filter</td></tr></tbody></table></table-wrap><table-wrap position="float" id="T5"><label>Table 5</label><caption><p>The description of ecgML: <italic>ClinicalProtocol </italic>element</p></caption><table frame="hsides" rules="groups"><thead><tr><td align="left"><bold><italic>ClinicalProtocol</italic></bold></td><td align="left" colspan="4">Additional patient clinical information</td></tr></thead><tbody><tr><td align="left"><bold>Element/attribute</bold></td><td align="left"><bold>Description/Origin</bold></td><td align="left"><bold>Required</bold></td><td align="left"><bold>Values/Data Type</bold></td><td align="left"><bold>Example</bold></td></tr><tr><td colspan="5"><hr></hr></td></tr><tr><td align="left"><bold><italic>DiastolicBP</italic></bold></td><td align="left">Diastolic blood pressure in mmHg. Based on SCP-ECG patient data.</td><td align="left">Optional</td><td align="left">unsignedInt</td><td align="left">72</td></tr><tr><td align="left"><bold><italic>SystolicBP</italic></bold></td><td align="left">Systolic blood pressure in mmHg. Based on SCP-ECG patient data.</td><td align="left">Optional</td><td align="left">unsignedInt</td><td align="left">120</td></tr><tr><td align="left"><bold><italic>HeartRate</italic></bold></td><td align="left">Heart rate in BPM.</td><td align="left">Optional</td><td align="left">unsignedInt</td><td align="left">75</td></tr><tr><td align="left"><bold><italic>Height</italic></bold></td><td align="left">Height in cm. Based on SCP-ECG patient data.</td><td align="left">Optional</td><td align="left">float</td><td align="left">172</td></tr><tr><td align="left"><bold><italic>Weight</italic></bold></td><td align="left">Weight in Kg. Based on SCP-ECG patient data.</td><td align="left">Optional</td><td align="left">float</td><td align="left">120</td></tr><tr><td align="left"><bold><italic>Pale</italic></bold></td><td align="left">Abnormal-looking skin on the face, or tongue</td><td align="left">Optional</td><td align="left">Yes/No</td><td align="left">Yes</td></tr><tr><td align="left"><bold><italic>Sweaty</italic></bold></td><td align="left">Abnormal reaction to heat</td><td align="left">Optional</td><td align="left">Yes/No</td><td align="left">No</td></tr><tr><td align="left"><bold><italic>Smoker</italic></bold></td><td align="left">Smoking?</td><td align="left">Optional</td><td align="left">string</td><td align="left">A pack</td></tr><tr><td align="left"><bold><italic>Alcohol</italic></bold></td><td align="left">Drinking alcohol</td><td align="left">Optional</td><td align="left">string</td><td align="left">seldom</td></tr><tr><td align="left"><bold><italic>Hypertension</italic></bold></td><td align="left">A disorder characterised by high blood pressure</td><td align="left">Optional</td><td align="left">Unknown/Yes/No</td><td align="left">Yes</td></tr><tr><td align="left"><bold><italic>Diabetes</italic></bold></td><td align="left">A disease marked by elevated levels of sugar in the blood.</td><td align="left">Optional</td><td align="left">Yes/No</td><td align="left">No</td></tr><tr><td align="left"><bold><italic>OtherProtocol</italic></bold></td><td align="left">Other clinical symptom</td><td align="left">Optional</td><td align="left">string</td><td align="left">SOB(short of breath)</td></tr><tr><td align="left"><bold><italic>Medication</italic></bold></td><td align="left">Drugs. Based on SCP-ECG drug information.</td><td align="left">Optional</td><td align="left">string</td><td align="left">Digoxin</td></tr></tbody></table></table-wrap><table-wrap position="float" id="T6"><label>Table 6</label><caption><p>The description of ecgML: <italic>RecordData </italic>element</p></caption><table frame="hsides" rules="groups"><thead><tr><td align="left"><bold><italic>RecordData</italic></bold></td><td align="left" colspan="4">Ecg data for each channel</td></tr></thead><tbody><tr><td align="left"><bold>Element/attribute</bold></td><td align="left"><bold>Description/Origin</bold></td><td align="left"><bold>Required</bold></td><td align="left"><bold>Values/Data Type</bold></td><td align="left"><bold>Example</bold></td></tr><tr><td colspan="5"><hr></hr></td></tr><tr><td align="left"><bold><italic>Channel</italic></bold></td><td align="left">Lead identifier</td><td align="left">Required</td><td align="left">Base on DICOM lead labelling scheme</td><td align="left">Lead I</td></tr><tr><td align="left"><bold><italic>Waveforms</italic></bold></td><td align="left">A description of ECG waveform</td><td align="left">Optional</td><td align="left">See Table <xref ref-type="table" rid="T6">6</xref></td><td></td></tr><tr><td align="left"><bold><italic>Annotations</italic></bold></td><td align="left">A collection of annotations</td><td align="left">Optional</td><td align="left">See Table <xref ref-type="table" rid="T7">7</xref></td><td></td></tr><tr><td align="left"><bold><italic>Measurements</italic></bold></td><td align="left">A collection of each channel measurements</td><td align="left">Optional</td><td align="left">See Table <xref ref-type="table" rid="T8">8</xref></td><td></td></tr></tbody></table></table-wrap><table-wrap position="float" id="T7"><label>Table 7</label><caption><p>The description of ecgML: <italic>Waveforms </italic>element</p></caption><table frame="hsides" rules="groups"><thead><tr><td align="left"><bold><italic>Waveforms</italic></bold></td><td align="left" colspan="4">A 2-D plot with an X and Y axis is used to display the ECG waveform data. Refer to FDA XML Data Format Design Specification (revision C).</td></tr></thead><tbody><tr><td align="left"><bold>Element/attribute</bold></td><td align="left"><bold>Description/Origin</bold></td><td align="left"><bold>Required</bold></td><td align="left"><bold>Values/Data Type</bold></td><td align="left"><bold>Example</bold></td></tr><tr><td colspan="5"><hr></hr></td></tr><tr><td align="left"><bold><italic>XValues</italic></bold></td><td align="left" colspan="4">Describe the X-axis domain</td></tr><tr><td align="left"><bold><italic>XOffset</italic></bold></td><td align="left">Offset from the StartTime.</td><td align="left">Required</td><td align="left">time</td><td align="left">00:23:10</td></tr><tr><td align="left"><bold><italic>Duration</italic></bold></td><td align="left">Duration of the each record.</td><td align="left">Required</td><td align="left">time</td><td align="left">00:00:10</td></tr><tr><td align="left"><bold><italic>SampleRate</italic></bold></td><td align="left">Sample rate in Hz for ECG records.</td><td align="left">Required</td><td align="left">unsignedInt</td><td align="left">500</td></tr><tr><td align="left"><bold><italic>YValues</italic></bold></td><td align="left" colspan="4">Describe the Y-axis domain.</td></tr><tr><td align="left"><bold><italic>unit</italic></bold></td><td align="left">Name of base unit for Y-axis.</td><td align="left">Required</td><td align="left">Use UCUM when appropriate.</td><td align="left">mV</td></tr><tr><td align="left"><bold><italic>FileLink</italic></bold></td><td align="left">A reference to an external file storing ECG data.</td><td align="left">Optional</td><td align="left">string</td><td></td></tr><tr><td align="left"><bold><italic>RealValue</italic></bold></td><td align="left" colspan="4">A list of actual value of ECG data</td></tr><tr><td align="left"><bold><italic>From</italic></bold></td><td align="left">Offset from the origin of the x axis to the beginning of waveform</td><td align="left">Required</td><td align="left">time or samples</td><td align="left">20:00:00</td></tr><tr><td align="left"><bold><italic>To</italic></bold></td><td align="left">Offset from the origin of the x axis to the ending of waveform</td><td align="left">Required</td><td align="left">time or samples</td><td align="left">21:00:04</td></tr><tr><td align="left"><bold><italic>Data</italic></bold></td><td align="left">The list of Y values separated by white space</td><td align="left">Required</td><td align="left">A list of float values</td><td align="left">1.25 2.23 3.2</td></tr><tr><td align="left"><bold><italic>Comment</italic></bold></td><td align="left">Comments on the format, e.g. separated by a specific delimiter</td><td align="left">Optional</td><td align="left">string</td><td align="left">separated by white spaces</td></tr><tr><td align="left"><bold><italic>Binary Data</italic></bold></td><td align="left" colspan="4">Binary representation of ECG data</td></tr><tr><td align="left"><bold><italic>encoding</italic></bold></td><td align="left">Encoding scheme for embedding the binary data within XML document</td><td align="left">Required</td><td align="left">Base64/Hexidecimal</td><td align="left">Base64</td></tr><tr><td align="left"><bold><italic>From</italic></bold></td><td align="left">Offset from the origin of the x axis to the beginning of waveform</td><td align="left">Required</td><td align="left">time or samples</td><td align="left">00:00:00</td></tr><tr><td align="left"><bold><italic>To</italic></bold></td><td align="left">Offset from the origin of the x axis to the ending of waveform</td><td align="left">Required</td><td align="left">time or samples</td><td align="left">12:00:04</td></tr><tr><td align="left"><bold><italic>Scale</italic></bold></td><td align="left">Scale factor to use to convert a binary data into a real value</td><td align="left">Required</td><td align="left">float</td><td align="left">1.0</td></tr><tr><td align="left"><bold><italic>Data</italic></bold></td><td align="left">Encoded binary ECG data</td><td align="left">Required</td><td align="left">string</td><td align="left">A923B420</td></tr></tbody></table></table-wrap><table-wrap position="float" id="T8"><label>Table 8</label><caption><p>The description of ecgML: Annotations element</p></caption><table frame="hsides" rules="groups"><thead><tr><td align="left"><bold><italic>Annotations</italic></bold></td><td align="left" colspan="4">Annotations for each ECG record. Based on FDA XML Data Format Specification (revision C).</td></tr></thead><tbody><tr><td align="left"><bold>Element/attribute</bold></td><td align="left"><bold>Description/Origin</bold></td><td align="left"><bold>Required</bold></td><td align="left"><bold>Values/Data Type</bold></td><td align="left"><bold>Example</bold></td></tr><tr><td colspan="5"><hr></hr></td></tr><tr><td align="left"><bold><italic>PointNotation</italic></bold></td><td align="left" colspan="4">A set of fiducial points with an X and Y position.</td></tr><tr><td align="left"><bold><italic>PointLabel</italic></bold></td><td align="left">Name of the fiducial points.</td><td align="left">Required</td><td align="left">Based on DICOM waveform list</td><td align="left">R peak</td></tr><tr><td align="left"><bold><italic>XValue</italic></bold></td><td align="left">X position of notation. To be expressed as HH:MM:SS.SSS</td><td align="left">Required</td><td align="left">time or samples</td><td align="left">00:27:01</td></tr><tr><td align="left"><bold><italic>YValue</italic></bold></td><td align="left">Y position in mV of notation</td><td align="left">Optional</td><td align="left">float</td><td align="left">0.3</td></tr><tr><td align="left"><bold><italic>Comment</italic></bold></td><td align="left">Comment about the point notation</td><td align="left">Optional</td><td align="left">string</td><td align="left">Paced beat</td></tr><tr><td align="left"><bold><italic>WaveNotation</italic></bold></td><td align="left" colspan="4">Annotations for interval measurements.</td></tr><tr><td align="left"><bold><italic>Pwave</italic></bold></td><td align="left">The annotations of P wave (onset, offset, peak, annotation, comment)</td><td align="left">Optional</td><td align="left">See Table <xref ref-type="table" rid="T9">9</xref></td><td align="left">Normal</td></tr><tr><td align="left"><bold><italic>QRSwave</italic></bold></td><td align="left">The annotations of QRS wave (onset, offset, peak, annotation, comment)</td><td align="left">Required</td><td align="left">See Table <xref ref-type="table" rid="T9">9</xref></td><td align="left">PVC</td></tr><tr><td align="left"><bold><italic>Twave</italic></bold></td><td align="left">The features of T wave (onset, offset, peak, annotation, comment)</td><td align="left">Optional</td><td align="left">See Table <xref ref-type="table" rid="T9">9</xref></td><td align="left">inverted</td></tr><tr><td align="left"><bold><italic>Uwave</italic></bold></td><td align="left">The annotations of U wave (onset, offset, peak, annotation, comment)</td><td align="left">Optional</td><td align="left">See Table <xref ref-type="table" rid="T9">9</xref></td><td align="left">Normal</td></tr><tr><td align="left"><bold><italic>OtherWave</italic></bold></td><td align="left">The annotations for other duration (onset, offset, peak, annotation, comment).</td><td align="left">Optional</td><td align="left">See Table <xref ref-type="table" rid="T9">9</xref></td><td></td></tr></tbody></table></table-wrap><table-wrap position="float" id="T9"><label>Table 9</label><caption><p>The description of ecgML: <italic>Measurements </italic>element</p></caption><table frame="hsides" rules="groups"><thead><tr><td align="left"><bold><italic>Measurements</italic></bold></td><td align="left" colspan="4">Measurements of each recorded lead</td></tr></thead><tbody><tr><td align="left"><bold>Element/attribute</bold></td><td align="left"><bold>Description/Origin</bold></td><td align="left"><bold>Required</bold></td><td align="left"><bold>Values/Data Type</bold></td><td align="left"><bold>Example</bold></td></tr><tr><td colspan="5"><hr></hr></td></tr><tr><td align="left"><bold><italic>Values</italic></bold></td><td align="left">The each measurement.</td><td align="left">Required</td><td align="left">float</td><td align="left">20</td></tr><tr><td align="left"><bold><italic>label</italic></bold></td><td align="left">Based on SCP-ECG the lead measurements.</td><td align="left">Required</td><td align="left">string</td><td align="left">P-duration</td></tr><tr><td align="left"><bold><italic>unit</italic></bold></td><td align="left">Name of base unit for the each measurement.</td><td align="left">Required</td><td align="left">Use UCUM when appropriate.</td><td align="left">ms</td></tr><tr><td align="left"><bold><italic>Comment</italic></bold></td><td align="left">Comments on a measurement.</td><td align="left">Optional</td><td align="left">string</td><td align="left">normal</td></tr></tbody></table></table-wrap><table-wrap position="float" id="T10"><label>Table 10</label><caption><p>The description of ecgML: subelements for elements <italic>Pwave</italic>, <italic>QRSwave</italic>, <italic>Twave</italic>, <italic>Uwave </italic>and <italic>OtherWave</italic></p></caption><table frame="hsides" rules="groups"><thead><tr><td align="left"><bold>Element/attribute</bold></td><td align="left"><bold>Description/Origin</bold></td><td align="left"><bold>Required</bold></td><td align="left"><bold>Values/Data Type</bold></td><td align="left"><bold>Example</bold></td></tr></thead><tbody><tr><td align="left"><bold><italic>Onset</italic></bold></td><td align="left">Beginning value of the wave in time or samples</td><td align="left">Required</td><td align="left">Time/samples</td><td align="left">00:00:12.000</td></tr><tr><td align="left"><bold><italic>Peak</italic></bold></td><td align="left">Peak value of the wave in time or samples</td><td align="left">Required</td><td align="left">Time/samples</td><td align="left">00:00:12.600</td></tr><tr><td align="left"><bold><italic>Offset</italic></bold></td><td align="left">Ending value of the wave in time or samples</td><td align="left">Required</td><td align="left">Time/samples</td><td align="left">00:00:13.002</td></tr><tr><td align="left"><bold><italic>Annotation</italic></bold></td><td align="left">Annotation of the wave</td><td align="left">Optional</td><td align="left">string</td><td align="left">Normal</td></tr><tr><td align="left"><bold><italic>Comment</italic></bold></td><td align="left">Any comments on the annotation</td><td align="left">Optional</td><td align="left">string</td><td></td></tr></tbody></table></table-wrap><p>Each patient record starts with a root element <bold><italic>ECGRecord</italic></bold>, which is uniquely identified by its attribute <bold><italic>studyID</italic></bold>. The <bold><italic>StudyDate </italic></bold>and <bold><italic>StudyTime </italic></bold>elements represent the latest time record of the study of the ECG recording. <bold><italic>Diagnosis </italic></bold>contains a text version of the latest diagnostic interpretation of the ECG, while <bold><italic>MedicalHistory </italic></bold>is a description of medical history of patient's clinical problems and disgnoses. There are two main components for each record: one <bold><italic>PatientDemographic </italic></bold>and one or more <bold><italic>Record </italic></bold>components. It is worth noting that each record can have only one <bold><italic>PatientDemographic </italic></bold>element, which would be kept updated all the time; while multiple <bold><italic>Record </italic></bold>elements are allowed to be held in one patient record. This opens up every opportunity to keep track of the history of the patient's diagnoses.</p><p><bold><italic>PatientDemographic </italic></bold>contains information of general interest concerning the person from whom the recording is obtained, such as demographic data (e.g. <bold><italic>patientID</italic></bold>, <bold><italic>Name</italic></bold>, etc.) and contact information (e.g. <bold><italic>Address</italic></bold>, etc.). This component is required in each record.</p><p><bold><italic>Record </italic></bold>represents the physical storage for the basic content of an ECG recording. The <bold><italic>AcquisitionDate </italic></bold>and <bold><italic>AcquisitionTime </italic></bold>attributes specify the acquisition date and time for each record, which makes it possible to include multiple time-related ECG recordings within a file. <bold><italic>investigatorID </italic></bold>and <bold><italic>siteID </italic></bold>are used to identify who is responsible for the recording and where it is acquired. There are three main components: zero-or-one <bold><italic>RecordingDevice</italic></bold>, zero-or-one <bold><italic>ClinicalProtocol</italic></bold>, and one-or-more <bold><italic>RecordDate</italic></bold>. Such flexible structure allows each recording to have its own characteristics.</p><p><bold><italic>RecordingDevice </italic></bold>is an optional element, which describes the device that generated the data. It should support the full spectrum of ECG devices, including standard 12-lead ECGs, Holter monitors, transtelephonic monitors and implanted devices. The main components in this section include <bold><italic>deviceID</italic></bold>, <bold><italic>Type</italic></bold>, <bold><italic>Manufacturer</italic></bold>, <bold><italic>Model </italic></bold>and a description of filtering technique used during the ECG acquisition (e.g. <bold><italic>BaselineFilter </italic></bold>and <bold><italic>LowpassFilter</italic></bold>).</p><p><bold><italic>ClinicalProtocol </italic></bold>is an optional element, which may include information relating to a patient's clinical report. The <bold><italic>unit </italic></bold>attribute of each element is used to describe the measurement unit of each observation. Currently, this section only includes basic clinical dimensions, such as <bold><italic>DiastolicBP </italic></bold>and <bold><italic>HeartRate</italic></bold>. However, other variables can be easily added.</p><p><bold><italic>RecordData </italic></bold>is a key ecgML element. There can be multiple <bold><italic>RecordData </italic></bold>elements within a file, which are identified by their <bold><italic>Channel </italic></bold>element names. The DICOM lead labelling format is recommended for this purpose. <bold><italic>RecordData </italic></bold>includes three main sub-components: <bold><italic>Waveforms</italic></bold>, <bold><italic>Annotations </italic></bold>and <bold><italic>Measurements</italic></bold>.</p><p>Based on the FDA-recommended <italic>PlotGroup </italic>format [<xref ref-type="bibr" rid="B16">16</xref>], <bold><italic>Waveforms </italic></bold>are represented by a series of values along two dimensions <italic>X</italic>, <italic>Y </italic>(<bold><italic>XValues </italic></bold>and <bold><italic>YValues</italic></bold>). Based on these values, a plot of voltage <italic>vs. </italic>time may be generated with a viewer program. The <bold><italic>XValues </italic></bold>(time) are evenly spaced. <bold><italic>Xoffset </italic></bold>represents the initial value. <bold><italic>SampleRate </italic></bold>represents the sampling frequency measured in Hz. The duration of a channel signal is represented by the element <bold><italic>Duration</italic></bold>. ecgML supports three formats to represent <bold><italic>YValues</italic></bold>: a <bold><italic>RealValue </italic></bold>element, a <bold><italic>BinaryData </italic></bold>element (associated with a specified <bold><italic>encoding </italic></bold>scheme, which may be <italic>base64 </italic>or hexadecimal), and a <bold><italic>FileLink </italic></bold>to refer to an external file.</p><p>The elements <bold><italic>From </italic></bold>and <bold><italic>To</italic></bold>, which are encoded into the elements <bold><italic>BinaryData </italic></bold>and <bold><italic>RealValue</italic></bold>, illustrate the beginning and ending values of the corresponding waveform. The <bold><italic>Scale </italic></bold>associated with <bold><italic>BinaryData </italic></bold>indicates how to convert the binary <bold><italic>YValues </italic></bold>into real values. The element <bold><italic>Data </italic></bold>in <bold><italic>RealValue </italic></bold>contains a list of float data separated by delimiters, representing the real value of each sample ECG data.</p><p><bold><italic>Annotations </italic></bold>would typically be used to describe events specific to the corresponding channel. It defines a time point or interval, which can be used for performing the measurements. This consists of a collection of <bold><italic>PointNotation </italic></bold>and <bold><italic>WaveNotation </italic></bold>elements. Each <bold><italic>PointNotation </italic></bold>can be specified with a <bold><italic>PointLabel </italic></bold>(the name of the specific point, e.g. P wave onset), a <bold><italic>XValue </italic></bold>(time, expressed as HH:MM:SS.SSS format), <bold><italic>YValue </italic></bold>(amplitude in mV) and any relevant comment. <bold><italic>WaveNotation </italic></bold>includes descriptions for basic ECG waves, such as <bold><italic>Pwave</italic></bold>, <bold><italic>QRSwave</italic></bold>, <bold><italic>Twave</italic></bold>, <bold><italic>Uwave</italic></bold>, and other events that can be defined by the user (<bold><italic>OtherWave</italic></bold>). Wave descriptions are based on the following five elements: <bold><italic>Onset </italic></bold>(the beginning value), <bold><italic>Peak </italic></bold>(the peak value, for a T wave, it is possible to have two <bold><italic>Peak </italic></bold>values), <bold><italic>Offset </italic></bold>(the ending value), <bold><italic>Annotation </italic></bold>(annotation for the specified wave, such as "normal" or "abnormal"), and any comments on the annotation are given using the <bold><italic>Comment </italic></bold>element. The value of <bold><italic>Onset</italic></bold>, <bold><italic>Peak</italic></bold>, and <bold><italic>Offset </italic></bold>can be expressed as either time or sample values.</p><p>The <bold><italic>Measurements </italic></bold>element contains a list of <bold><italic>Values </italic></bold>(the measurements of each recorded channel). Each <bold><italic>Values </italic></bold>element may be associated with a <bold><italic>label </italic></bold>and a measurement <bold><italic>unit</italic></bold>.</p><p>There are different levels at which a record can define supplementary information. A <bold><italic>Comment </italic></bold>at the <bold><italic>ECGRecord </italic></bold>level can be used to indicate additional acquisition information, for example, place and technical conditions of the acquisition process. A <bold><italic>Comment </italic></bold>at the <bold><italic>YValues </italic></bold>level may typically be used to define the format of the representation of the <bold><italic>YValues</italic></bold>, e.g. which delimiter is used. A <bold><italic>Comment </italic></bold>at the <bold><italic>Measurement </italic></bold>level may be used to describe, for example, whether a measurement is a global average or an instantaneous value.</p><p>This research applies the DICOM recommendation for defining ECG channel names, fiducial point markers and waveform encoding details. Moreover, it applies the Unified Code for Units of Measure (UCUM) scheme for defining measurement units, such as cm for <bold><italic>Height </italic></bold>and mV for <bold><italic>YValues </italic></bold>[24] when appropriate.</p><p>This specification has been encoded into an XML-based data protocol. <xref ref-type="supplementary-material" rid="S1">Additional files 1</xref> and <xref ref-type="supplementary-material" rid="S2">2</xref> are the DTD and XSD files for ecgML respectively. <xref ref-type="supplementary-material" rid="S3">Additional file 3</xref> is an ECG record, which has been generated using ecgML.</p></sec><sec><title>Results</title><sec><title>Evaluation of the model</title><p>It is fundamental to demonstrate the system-, application- and format-independence of ECG data when using ecgML. Special importance should be given to illustrate the autonomy of content from its presentational scheme, e.g. printed graphs, tabular data to be imported into data mining systems for further analysis or audio files. Figure <xref ref-type="fig" rid="F7">7</xref> illustrates the distinction separation of the five important components in XML publishing. Based on advantages of XML technologies, ecgML exhibits a remarkable advantage over existing systems where every information system has its own internal information-model and information is merged and intertwined with its representation format. Figure <xref ref-type="fig" rid="F8">8</xref> exemplifies a scenario where the raw ECG data is kept in an ecgML data file and therefore independently from possible presentation information. Various XSLT transformations (stored as XSL files and applied on the fly, transparent to the user) convert the ecgML source into user- and/or application-specific data formats, such as MPEG (audio), MatLab (text) and SVG/PNG (graphics). The centralised storage of the ECG record and dynamic creation of data representations avoids redundancy.</p><fig position="float" id="F7"><label>Figure 7</label><caption><p>Publication Model</p></caption><graphic xlink:href="1472-6947-3-4-7"></graphic></fig><fig position="float" id="F8"><label>Figure 8</label><caption><p>Dynamic transformation of ecgML data</p></caption><graphic xlink:href="1472-6947-3-4-8"></graphic></fig><p>The FDA, together with a number of other institutions, has developed and published an XML vocabulary [<xref ref-type="bibr" rid="B16">16</xref>] to represent collected time-series data. However, there are some significant differences between the FDA proposal and ecgML. The FDA proposal is intended to represent collected biological data, including ECG, electroencephalogram (EEG), or other time series data such as temperature, pressure and oxygen saturation. The main goal is to facilitate the submission of the biological data and to make sure that accuracy and consistency of the measurements made from the collected biological data is achieved. It is important for the FDA to view the biological data in an appropriate way. Thus, the data model (specified in a DTD) includes some presentation information, such as elements <italic>MinorTickInterval</italic>, <italic>MajorTickInterval </italic>and <italic>LogScale. </italic>On the other hand, the purpose of ecgMLis to develop anopen and transparent way of representing, exchanging and mining ECG data. Therefore, ecgML not only consists of basic components, which may be used to perform knowledge discovery in ECG data (e.g. <bold><italic>ClinicalProtocol</italic></bold>, <bold><italic>Diagnosis </italic></bold>and <bold><italic>Measurements</italic></bold>) but also follows the principle of separating content and presentation information, which will exhibit great advantages when using ecgML in combination with inter-media transformation.</p></sec><sec><title>Accompanying tools</title><p>A series of tools are being developed to assist users in exploiting ecgML-based applications. These include an XML-based ECG record generator, ECG parser and ECG viewer. The generator will automatically produce XML-based ECG records from existing ECG databases, e.g. the MIT-BIH database [<xref ref-type="bibr" rid="B3">3</xref>]. The ECG parser allows the user reading the ECG records and access their contents and structure, whereas the ECG viewer provides onscreen display of the required waveform data (Figure <xref ref-type="fig" rid="F9">9</xref>). It shows all annotation information of the individual waveform. The hierarchical structure of the XML-based ECG record is displayed. It can be expanded and shrunk at any level. This interface can also show individual episodes of the ECG waveform chosen from the ecgML structure. The viewer tool graphically locates boundaries (i.e. beginning, peak, and end) of the P, QRS and T waveforms for each selected QRS complex.</p><fig position="float" id="F9"><label>Figure 9</label><caption><p>Screenshot of ECG viewer</p></caption><graphic xlink:href="1472-6947-3-4-9"></graphic></fig></sec></sec><sec><title>Conclusions</title><p>ecgML will enable the seamless integration of ECG data into electronic patient records (EPRs) and medical guidelines. This protocol can support data exchange between different ECG acquisition and visualisation devices. Similarly, it may enable data mining using heterogeneous software platforms and applications. The data and metadata contained in an ecgML record may be useful to improve pattern recognition in ECG applications. It would also aid the implementation of automated decision support models such as case-based reasoning. Figure <xref ref-type="fig" rid="F10">10</xref> illustrates the utilisation of map files to convert "raw" ecgML files into customised output formats, which will be imported into data mining systems for further analysis. ecgML may also be significant for problems such as future proof storage, context-sensitive (textual) search of patterns in ECG data, and its native inclusion into medical guidelines. Further research will address the following issues.</p><fig position="float" id="F10"><label>Figure 10</label><caption><p>Converting XML-based ECG record into tabular data using map files. Notations for all tree diagrams are illustrated as follows. Lines of descriptive text outside an element box indicate attributes that the element should have. Default value is shown underlined.</p></caption><graphic xlink:href="1472-6947-3-4-10"></graphic></fig><p>• How does ecgML affect storage capacity?</p><p>• Does on-the-fly compression (as used by HTTP 1.1) make a difference in terms of transmission speed?</p><p>• Is it feasible to use ecgML in applications such as 24 hour monitoring?</p><p>• Does ecgML data contain all the significant information required for ECG analysis?</p></sec><sec><title>Competing interests</title><p>None declared.</p></sec><sec><title>Authors' contributions</title><p>HW co-designed and implemented ecgML (DTD and XSD files), developed support tools and drafted the manuscript. FA conceived the study, participated in the design of the model and drafted the manuscript. BJ helped to refine ecgML, brought expertise in XML and EPRs, and help to draft the paper. NB participated in the coordination of this study and contributed to the preparation of this manuscript. All authors read and approved the final manuscript.</p></sec><sec><title>Pre-publication history</title><p>The pre-publication history for this paper can be accessed here:</p><p><ext-link ext-link-type="uri" xlink:href="http://www.biomedcentral.com/1472-6947/3/4/prepub"></ext-link></p></sec><sec sec-type="supplementary-material"><title>Supplementary Material</title><supplementary-material content-type="local-data" id="S1"><caption><title>Additional File 1</title><p>A DTD file for ecgML</p></caption><media xlink:href="1472-6947-3-4-S1.dtd" mimetype="text" mime-subtype="plain"><caption><p>Click here for file</p></caption></media></supplementary-material><supplementary-material content-type="local-data" id="S2"><caption><title>Additional File 2</title><p>An XML schema for ecgML</p></caption><media xlink:href="1472-6947-3-4-S2.xsd" mimetype="text" mime-subtype="plain"><caption><p>Click here for file</p></caption></media></supplementary-material><supplementary-material content-type="local-data" id="S3"><caption><title>Additional File 3</title><p>A sample file using ecgML</p></caption><media xlink:href="1472-6947-3-4-S3.xml" mimetype="text" mime-subtype="xml"><caption><p>Click here for file</p></caption></media></supplementary-material></sec></body><back><ref-list><ref id="B1"><citation citation-type="journal"><person-group person-group-type="author"><name><surname>Värni</surname><given-names>A</given-names></name><name><surname>Kemp</surname><given-names>B</given-names></name><name><surname>Penzel</surname><given-names>T</given-names></name><name><surname>Schlögl</surname><given-names>A</given-names></name></person-group><article-title>Standards for biomedical signal databases</article-title><source>IEEE Engineering in Medicine and Biology</source><year>2001</year><volume>20</volume><fpage>33</fpage><lpage>37</lpage><pub-id pub-id-type="doi">10.1109/51.932722</pub-id></citation></ref><ref id="B2"><citation citation-type="other"><article-title>Ontology Homepage</article-title><ext-link ext-link-type="uri" xlink:href="http://www.ontology.org/index.html"></ext-link></citation></ref><ref id="B3"><citation citation-type="other"><article-title>Physionet Homepage</article-title><ext-link ext-link-type="uri" xlink:href="http://www.physionet.org/"></ext-link></citation></ref><ref id="B4"><citation citation-type="other"><article-title>NEMA's OFFICIAL DICOM WEB Page</article-title><ext-link ext-link-type="uri" xlink:href="http://medical.nema.org/dicom.html"></ext-link></citation></ref><ref id="B5"><citation citation-type="other"><article-title>Health Level Seven Homepage</article-title><ext-link ext-link-type="uri" xlink:href="http://www.hl7.org"></ext-link></citation></ref><ref id="B6"><citation citation-type="other"><article-title>CORBAmed Homepage</article-title><ext-link ext-link-type="uri" xlink:href="http://www.acl.lanl.gov/OMG/"></ext-link></citation></ref><ref id="B7"><citation citation-type="other"><article-title>Extensible Markup language (XML)</article-title><ext-link ext-link-type="uri" xlink:href="http://www.w3.org/xml/"></ext-link></citation></ref><ref id="B8"><citation citation-type="other"><article-title>XML Core Standards</article-title><ext-link ext-link-type="uri" xlink:href="http://xml.coverpages.org/coreStandards.html"></ext-link></citation></ref><ref id="B9"><citation citation-type="other"><person-group person-group-type="author"><name><surname>Schroeter</surname><given-names>G</given-names></name></person-group><article-title>How XML is improving data exchange in healthcare</article-title><ext-link ext-link-type="uri" xlink:href="http://www.softwareag.com/xml/library/schroeter_healthcare.htm"></ext-link></citation></ref><ref id="B10"><citation citation-type="other"><article-title>Synapses Homepage</article-title><ext-link ext-link-type="uri" xlink:href="http://www.cs.tcd.ie/synapses/public/"></ext-link></citation></ref><ref id="B11"><citation citation-type="other"><article-title>SynEx Homepage</article-title><ext-link ext-link-type="uri" xlink:href="http://www.gesi.it/synex/"></ext-link></citation></ref><ref id="B12"><citation citation-type="book"><person-group person-group-type="author"><name><surname>Jung</surname><given-names>B</given-names></name><name><surname>Grimson</surname><given-names>J</given-names></name></person-group><person-group person-group-type="editor"><name><surname>Peter K, Blaz Z, Janez S, Marjan P, Rolf E</surname></name></person-group><article-title>Synapses/SynEx goes XML</article-title><source>In Proceedings of the Medical Informatics Europe '99 Conference (MIE99): August, 1999; 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