Accepted for/Published in: JMIR Medical Informatics
Date Submitted: Jan 30, 2019
Open Peer Review Period: Feb 4, 2019 - Mar 23, 2019
Date Accepted: May 31, 2019
(closed for review but you can still tweet)
Core Data Elements in Acute Myeloid Leukemia
ABSTRACT
Background:
For cancer domains as Acute Myeloid Leukemia (AML), a large set of data elements is obtained from different institutions with heterogeneous data definitions within one patient course. The lack of clinical data harmonization impedes cross-institutional electronic data exchange and future meta-analyses.
Objective:
To identify and harmonize a semantic core of common data elements (CDEs) in clinical routine and research documentation based on a systematic metadata analysis of existing documentation models.
Methods:
Lists of relevant data items were collected and reviewed by hematologists from two university hospitals regarding routine documentation and several case report forms of clinical trials for AML. In addition, existing registries and international recommendations were included. Data items were coded to medical concepts via the Unified Medical Language System and then systematically analyzed for concept overlaps and identification of most frequent concepts. The most frequent concepts were then implemented as data elements in the standardized format Operational Data Model by the Clinical Data Interchange Standards Consortium.
Results:
3265 medical concepts were identified of which 1414 were unique. Among 1414 unique medical concepts, the 50 most frequent cover 27.0% percent of all concept occurrences within the collected AML documentation. The top 100 concepts represent 39.5% of all concepts occurrences. Implementation of common data elements is available on a European research infrastructure and can be downloaded in different formats for reuse in different electronic data capture systems.
Conclusions:
Information management is a complex process for research-intense disease entities as AML that is associated with a large set of lab-based diagnostics and different treatment options. Our systematic UMLS-based analysis revealed the existence of a core data set and an exemplary reusable implementation for harmonized data capture is available on an established metadata repository.
Citation
Per the author's request the PDF is not available.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.