[{"abstract":[{"lang":"eng","text":"Objectives: Integrating Electronic Health Record (EHR) systems into the field of clinical trials still contains several challenges and obstacles. Heterogeneous standards and specifications are used to represent healthcare and clinical trial information. Therefore, this work investigates the mapping and data interoperability between healthcare and research standards: EN13606 used for the EHRs and the Clinical Data Interchange Standards Consortium Operational Data Model (CDISC ODM) used for clinical research.\r\n\r\nMethods: Based on the specifications of CDISC ODM 1.3.2 and EN13606, a mapping between the structure and components of both standards has been performed. Archetype Definition Language (ADL) forms built with the EN13606 editor were transformed to ODM XML and reviewed. As a proof of concept, clinical sample data has been transformed into ODM and imported into an electronic data capture system. Reverse transformation from ODM to ADL has also been performed and finally reviewed concerning map-ability.\r\n\r\nResults: The mapping between EN13606 and CDISC ODM shows the similarities and differences between the components and overall record structure of the two standards. An EN13606 archetype corresponds with a group of items within CDISC ODM. Transformations of element names, descriptions, different languages, datatypes, cardinality, optionality, units, value range and terminology codes are possible from EN13606 to CDISC ODM and vice versa.\r\n\r\nConclusion: It is feasible to map data elements between EN13606 and CDISC ODM and transformation of forms between ADL and ODM XML format is possible with only minor limitations. EN13606 can accommodate clinical information in a more structured manner with more constraints, whereas CDISC ODM is more suitable and specific for clinical trials and studies. It is feasible to transform EHR data in the EN13606 form to ODM to transfer it into research database. The attempt to use EN13606 to build a study protocol (that was already built with CDISC ODM) also suggests the possibility of using EN13606 standard in place of CDISC ODM if needed to avoid transformations."}],"extern":"1","publication_identifier":{"eissn":["2055-2076"]},"date_updated":"2024-07-18T13:36:34Z","publication":"Digital health","publisher":"SAGE Publications","language":[{"iso":"eng"}],"year":"2018","publication_status":"published","keyword":["EN13606","Operational data model","clinical archetypes","electronic health records","interoperability."],"pmid":"1","volume":4,"author":[{"last_name":"Tapuria","full_name":"Tapuria, Archana","first_name":"Archana"},{"last_name":"Bruland","orcid":"0000-0001-6939-7630","id":"75847","full_name":"Bruland, Philipp","first_name":"Philipp"},{"first_name":"Brendan","full_name":"Delaney, Brendan","last_name":"Delaney"},{"full_name":"Kalra, Dipak","first_name":"Dipak","last_name":"Kalra"},{"last_name":"Curcin","first_name":"Vasa","full_name":"Curcin, Vasa"}],"date_created":"2024-07-18T13:34:20Z","article_number":"205520761877767","_id":"11746","type":"scientific_journal_article","place":"Thousand Oaks, Calif. [u.a.] ","user_id":"83781","status":"public","intvolume":"         4","department":[{"_id":"DEP5024"}],"title":"Comparison and transformation between CDISC ODM and EN13606 EHR standards in connecting EHR data with clinical trial research data","doi":"10.1177/2055207618777676","citation":{"mla":"Tapuria, Archana, et al. “Comparison and Transformation between CDISC ODM and EN13606 EHR Standards in Connecting EHR Data with Clinical Trial Research Data.” <i>Digital Health</i>, vol. 4, 205520761877767, 2018, <a href=\"https://doi.org/10.1177/2055207618777676\">https://doi.org/10.1177/2055207618777676</a>.","din1505-2-1":"<span style=\"font-variant:small-caps;\">Tapuria, Archana</span> ; <span style=\"font-variant:small-caps;\">Bruland, Philipp</span> ; <span style=\"font-variant:small-caps;\">Delaney, Brendan</span> ; <span style=\"font-variant:small-caps;\">Kalra, Dipak</span> ; <span style=\"font-variant:small-caps;\">Curcin, Vasa</span>: Comparison and transformation between CDISC ODM and EN13606 EHR standards in connecting EHR data with clinical trial research data. In: <i>Digital health</i> Bd. 4. Thousand Oaks, Calif. [u.a.] , SAGE Publications (2018)","havard":"A. Tapuria, P. Bruland, B. Delaney, D. Kalra, V. Curcin, Comparison and transformation between CDISC ODM and EN13606 EHR standards in connecting EHR data with clinical trial research data, Digital Health. 4 (2018).","van":"Tapuria A, Bruland P, Delaney B, Kalra D, Curcin V. Comparison and transformation between CDISC ODM and EN13606 EHR standards in connecting EHR data with clinical trial research data. Digital health. 2018;4.","short":"A. Tapuria, P. Bruland, B. Delaney, D. Kalra, V. Curcin, Digital Health 4 (2018).","ufg":"<b>Tapuria, Archana u. a.</b>: Comparison and transformation between CDISC ODM and EN13606 EHR standards in connecting EHR data with clinical trial research data, in: <i>Digital health</i> 4 (2018).","ama":"Tapuria A, Bruland P, Delaney B, Kalra D, Curcin V. Comparison and transformation between CDISC ODM and EN13606 EHR standards in connecting EHR data with clinical trial research data. <i>Digital health</i>. 2018;4. doi:<a href=\"https://doi.org/10.1177/2055207618777676\">10.1177/2055207618777676</a>","chicago-de":"Tapuria, Archana, Philipp Bruland, Brendan Delaney, Dipak Kalra und Vasa Curcin. 2018. Comparison and transformation between CDISC ODM and EN13606 EHR standards in connecting EHR data with clinical trial research data. <i>Digital health</i> 4. doi:<a href=\"https://doi.org/10.1177/2055207618777676\">10.1177/2055207618777676</a>, .","chicago":"Tapuria, Archana, Philipp Bruland, Brendan Delaney, Dipak Kalra, and Vasa Curcin. “Comparison and Transformation between CDISC ODM and EN13606 EHR Standards in Connecting EHR Data with Clinical Trial Research Data.” <i>Digital Health</i> 4 (2018). <a href=\"https://doi.org/10.1177/2055207618777676\">https://doi.org/10.1177/2055207618777676</a>.","ieee":"A. Tapuria, P. Bruland, B. Delaney, D. Kalra, and V. Curcin, “Comparison and transformation between CDISC ODM and EN13606 EHR standards in connecting EHR data with clinical trial research data,” <i>Digital health</i>, vol. 4, Art. no. 205520761877767, 2018, doi: <a href=\"https://doi.org/10.1177/2055207618777676\">10.1177/2055207618777676</a>.","bjps":"<b>Tapuria A <i>et al.</i></b> (2018) Comparison and Transformation between CDISC ODM and EN13606 EHR Standards in Connecting EHR Data with Clinical Trial Research Data. <i>Digital health</i> <b>4</b>.","apa":"Tapuria, A., Bruland, P., Delaney, B., Kalra, D., &#38; Curcin, V. (2018). Comparison and transformation between CDISC ODM and EN13606 EHR standards in connecting EHR data with clinical trial research data. <i>Digital Health</i>, <i>4</i>, Article 205520761877767. <a href=\"https://doi.org/10.1177/2055207618777676\">https://doi.org/10.1177/2055207618777676</a>"},"external_id":{"pmid":["29942639"]}},{"language":[{"iso":"eng"}],"year":"2016","volume":16,"keyword":["Clinical trials","Common data elements","Data quality","Electronic health records","Metadata","Secondary use"],"publication_status":"published","author":[{"last_name":"Bruland","first_name":"Philipp","full_name":"Bruland, Philipp","id":"75847","orcid":"0000-0001-6939-7630"},{"full_name":"McGilchrist, Mark","first_name":"Mark","last_name":"McGilchrist"},{"first_name":"Eric","full_name":"Zapletal, Eric","last_name":"Zapletal"},{"full_name":"Acosta, Dionisio","first_name":"Dionisio","last_name":"Acosta"},{"full_name":"Proeve, Johann","first_name":"Johann","last_name":"Proeve"},{"last_name":"Askin","first_name":"Scott","full_name":"Askin, Scott"},{"last_name":"Ganslandt","first_name":"Thomas","full_name":"Ganslandt, Thomas"},{"full_name":"Doods, Justin","first_name":"Justin","last_name":"Doods"},{"last_name":"Dugas","first_name":"Martin","full_name":"Dugas, Martin"}],"date_created":"2024-07-18T13:31:36Z","abstract":[{"lang":"eng","text":"Background: Data capture is one of the most expensive phases during the conduct of a clinical trial and the increasing use of electronic health records (EHR) offers significant savings to clinical research. To facilitate these secondary uses of routinely collected patient data, it is beneficial to know what data elements are captured in clinical trials. Therefore our aim here is to determine the most commonly used data elements in clinical trials and their availability in hospital EHR systems.\r\n\r\nMethods: Case report forms for 23 clinical trials in differing disease areas were analyzed. Through an iterative and consensus-based process of medical informatics professionals from academia and trial experts from the European pharmaceutical industry, data elements were compiled for all disease areas and with special focus on the reporting of adverse events. Afterwards, data elements were identified and statistics acquired from hospital sites providing data to the EHR4CR project.\r\n\r\nResults: The analysis identified 133 unique data elements. Fifty elements were congruent with a published data inventory for patient recruitment and 83 new elements were identified for clinical trial execution, including adverse event reporting. Demographic and laboratory elements lead the list of available elements in hospitals EHR systems. For the reporting of serious adverse events only very few elements could be identified in the patient records.\r\n\r\nConclusions: Common data elements in clinical trials have been identified and their availability in hospital systems elucidated. Several elements, often those related to reimbursement, are frequently available whereas more specialized elements are ranked at the bottom of the data inventory list. Hospitals that want to obtain the benefits of reusing data for research from their EHR are now able to prioritize their efforts based on this common data element list."}],"publication_identifier":{"issn":["1471-2288"]},"extern":"1","publication":"BMC Medical Research Methodology","date_updated":"2024-07-18T13:33:42Z","publisher":"Springer Science and Business Media LLC","place":"London","user_id":"83781","intvolume":"        16","department":[{"_id":"DEP5024"}],"status":"public","doi":"10.1186/s12874-016-0259-3","citation":{"din1505-2-1":"<span style=\"font-variant:small-caps;\"><span style=\"font-variant:small-caps;\">Bruland, Philipp</span> ; <span style=\"font-variant:small-caps;\">McGilchrist, Mark</span> ; <span style=\"font-variant:small-caps;\">Zapletal, Eric</span> ; <span style=\"font-variant:small-caps;\">Acosta, Dionisio</span> ; <span style=\"font-variant:small-caps;\">Proeve, Johann</span> ; <span style=\"font-variant:small-caps;\">Askin, Scott</span> ; <span style=\"font-variant:small-caps;\">Ganslandt, Thomas</span> ; <span style=\"font-variant:small-caps;\">Doods, Justin</span> ; u. a.</span>: Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting. In: <i>BMC Medical Research Methodology</i> Bd. 16. London, Springer Science and Business Media LLC (2016), Nr. 1","mla":"Bruland, Philipp, et al. “Common Data Elements for Secondary Use of Electronic Health Record Data for Clinical Trial Execution and Serious Adverse Event Reporting.” <i>BMC Medical Research Methodology</i>, vol. 16, no. 1, 159, 2016, <a href=\"https://doi.org/10.1186/s12874-016-0259-3\">https://doi.org/10.1186/s12874-016-0259-3</a>.","ufg":"<b>Bruland, Philipp u. a.</b>: Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting, in: <i>BMC Medical Research Methodology</i> 16 (2016), H. 1.","havard":"P. Bruland, M. McGilchrist, E. Zapletal, D. Acosta, J. Proeve, S. Askin, T. Ganslandt, J. Doods, M. Dugas, Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting, BMC Medical Research Methodology. 16 (2016).","short":"P. Bruland, M. McGilchrist, E. Zapletal, D. Acosta, J. Proeve, S. Askin, T. Ganslandt, J. Doods, M. Dugas, BMC Medical Research Methodology 16 (2016).","van":"Bruland P, McGilchrist M, Zapletal E, Acosta D, Proeve J, Askin S, et al. Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting. BMC Medical Research Methodology. 2016;16(1).","ama":"Bruland P, McGilchrist M, Zapletal E, et al. Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting. <i>BMC Medical Research Methodology</i>. 2016;16(1). doi:<a href=\"https://doi.org/10.1186/s12874-016-0259-3\">10.1186/s12874-016-0259-3</a>","chicago-de":"Bruland, Philipp, Mark McGilchrist, Eric Zapletal, Dionisio Acosta, Johann Proeve, Scott Askin, Thomas Ganslandt, Justin Doods und Martin Dugas. 2016. Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting. <i>BMC Medical Research Methodology</i> 16, Nr. 1. doi:<a href=\"https://doi.org/10.1186/s12874-016-0259-3\">10.1186/s12874-016-0259-3</a>, .","chicago":"Bruland, Philipp, Mark McGilchrist, Eric Zapletal, Dionisio Acosta, Johann Proeve, Scott Askin, Thomas Ganslandt, Justin Doods, and Martin Dugas. “Common Data Elements for Secondary Use of Electronic Health Record Data for Clinical Trial Execution and Serious Adverse Event Reporting.” <i>BMC Medical Research Methodology</i> 16, no. 1 (2016). <a href=\"https://doi.org/10.1186/s12874-016-0259-3\">https://doi.org/10.1186/s12874-016-0259-3</a>.","ieee":"P. Bruland <i>et al.</i>, “Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting,” <i>BMC Medical Research Methodology</i>, vol. 16, no. 1, Art. no. 159, 2016, doi: <a href=\"https://doi.org/10.1186/s12874-016-0259-3\">10.1186/s12874-016-0259-3</a>.","bjps":"<b>Bruland P <i>et al.</i></b> (2016) Common Data Elements for Secondary Use of Electronic Health Record Data for Clinical Trial Execution and Serious Adverse Event Reporting. <i>BMC Medical Research Methodology</i> <b>16</b>.","apa":"Bruland, P., McGilchrist, M., Zapletal, E., Acosta, D., Proeve, J., Askin, S., Ganslandt, T., Doods, J., &#38; Dugas, M. (2016). Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting. <i>BMC Medical Research Methodology</i>, <i>16</i>(1), Article 159. <a href=\"https://doi.org/10.1186/s12874-016-0259-3\">https://doi.org/10.1186/s12874-016-0259-3</a>"},"title":"Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting","issue":"1","article_number":"159","_id":"11745","type":"scientific_journal_article"}]