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Julian Varghese, Christian Holz, Phillip Neuhaus, Massimo Bernardi, Alexandra Boehm, Arnold Ganser, Steven Gore, Mark Heaney, Andreas Hochhaus, Wolf-Karsten Hofmann, Utz Krug, Carsten Müller-Tidow, Alexandra Smith, Ansgar Weltermann, Theo de Witte, Rüdiger Hehlmann, Martin Dugas
Data standards consisting of key data elements for clinical routine and trial documentation harmonize documentation within and across different health care institutions making documentation more efficient and improving scientific data analysis. This work focusses on the field of myeloid leukemia (ML), where a semantic core of common data elements (CDEs) in routine and trial documentation is established by automatic UMLS-based form analysis of existing documentation models. These CDEs (n = 227) were initially reviewed and commented by leukemia experts before they were systematically surveyed by an international voting process through seven hematologists of four countries. The total agreement score was 86%. 116 elements (51%) of these share an agreement score of 100%. This work generated CDEs with language-independent semantic codes and international clinical expert review to build a first approach towards an international data standard for ML. A first version of the CDE list is implemented in the data standard Operational Data Model and additional other data formats for reuse in different medical information systems.
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