---
_id: '11746'
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."
article_number: '205520761877767'
author:
- first_name: Archana
full_name: Tapuria, Archana
last_name: Tapuria
- first_name: Philipp
full_name: Bruland, Philipp
id: '75847'
last_name: Bruland
orcid: 0000-0001-6939-7630
- first_name: Brendan
full_name: Delaney, Brendan
last_name: Delaney
- first_name: Dipak
full_name: Kalra, Dipak
last_name: Kalra
- first_name: Vasa
full_name: Curcin, Vasa
last_name: Curcin
citation:
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. Digital health. 2018;4. doi:10.1177/2055207618777676
apa: Tapuria, A., Bruland, P., Delaney, B., Kalra, D., & Curcin, V. (2018).
Comparison and transformation between CDISC ODM and EN13606 EHR standards in connecting
EHR data with clinical trial research data. Digital Health, 4, Article
205520761877767. https://doi.org/10.1177/2055207618777676
bjps: Tapuria A et al. (2018) Comparison and Transformation between
CDISC ODM and EN13606 EHR Standards in Connecting EHR Data with Clinical Trial
Research Data. Digital health 4.
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.” Digital Health
4 (2018). https://doi.org/10.1177/2055207618777676.
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. Digital
health 4. doi:10.1177/2055207618777676,
.
din1505-2-1: 'Tapuria, Archana ; Bruland, Philipp ; Delaney,
Brendan ; Kalra, Dipak ;
Curcin, Vasa: Comparison and transformation
between CDISC ODM and EN13606 EHR standards in connecting EHR data with clinical
trial research data. In: Digital health 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).
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,” Digital health, vol. 4, Art. no.
205520761877767, 2018, doi: 10.1177/2055207618777676.'
mla: Tapuria, Archana, et al. “Comparison and Transformation between CDISC ODM and
EN13606 EHR Standards in Connecting EHR Data with Clinical Trial Research Data.”
Digital Health, vol. 4, 205520761877767, 2018, https://doi.org/10.1177/2055207618777676.
short: A. Tapuria, P. Bruland, B. Delaney, D. Kalra, V. Curcin, Digital Health 4
(2018).
ufg: 'Tapuria, Archana u. a.: Comparison and transformation between CDISC
ODM and EN13606 EHR standards in connecting EHR data with clinical trial research
data, in: 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.
date_created: 2024-07-18T13:34:20Z
date_updated: 2024-07-18T13:36:34Z
department:
- _id: DEP5024
doi: 10.1177/2055207618777676
extern: '1'
external_id:
pmid:
- '29942639'
intvolume: ' 4'
keyword:
- EN13606
- Operational data model
- clinical archetypes
- electronic health records
- interoperability.
language:
- iso: eng
place: 'Thousand Oaks, Calif. [u.a.] '
pmid: '1'
publication: Digital health
publication_identifier:
eissn:
- 2055-2076
publication_status: published
publisher: SAGE Publications
status: public
title: Comparison and transformation between CDISC ODM and EN13606 EHR standards in
connecting EHR data with clinical trial research data
type: scientific_journal_article
user_id: '83781'
volume: 4
year: '2018'
...
---
_id: '11745'
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."
article_number: '159'
author:
- first_name: Philipp
full_name: Bruland, Philipp
id: '75847'
last_name: Bruland
orcid: 0000-0001-6939-7630
- first_name: Mark
full_name: McGilchrist, Mark
last_name: McGilchrist
- first_name: Eric
full_name: Zapletal, Eric
last_name: Zapletal
- first_name: Dionisio
full_name: Acosta, Dionisio
last_name: Acosta
- first_name: Johann
full_name: Proeve, Johann
last_name: Proeve
- first_name: Scott
full_name: Askin, Scott
last_name: Askin
- first_name: Thomas
full_name: Ganslandt, Thomas
last_name: Ganslandt
- first_name: Justin
full_name: Doods, Justin
last_name: Doods
- first_name: Martin
full_name: Dugas, Martin
last_name: Dugas
citation:
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. BMC Medical Research Methodology. 2016;16(1).
doi:10.1186/s12874-016-0259-3
apa: Bruland, P., McGilchrist, M., Zapletal, E., Acosta, D., Proeve, J., Askin,
S., Ganslandt, T., Doods, J., & Dugas, M. (2016). 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(1),
Article 159. https://doi.org/10.1186/s12874-016-0259-3
bjps: Bruland P et al. (2016) 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.
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.” BMC Medical Research
Methodology 16, no. 1 (2016). https://doi.org/10.1186/s12874-016-0259-3.
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. BMC Medical Research Methodology
16, Nr. 1. doi:10.1186/s12874-016-0259-3,
.
din1505-2-1: 'Bruland,
Philipp ; McGilchrist, Mark
; Zapletal, Eric ; Acosta,
Dionisio ; Proeve, Johann
; Askin, Scott ; Ganslandt,
Thomas ; Doods, Justin ;
u. a.: Common data elements for secondary use of electronic health record
data for clinical trial execution and serious adverse event reporting. In: BMC
Medical Research Methodology Bd. 16. London, Springer Science and Business
Media LLC (2016), Nr. 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).
ieee: 'P. Bruland 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, vol. 16, no. 1, Art. no. 159, 2016, doi:
10.1186/s12874-016-0259-3.'
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.”
BMC Medical Research Methodology, vol. 16, no. 1, 159, 2016, https://doi.org/10.1186/s12874-016-0259-3.
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).
ufg: 'Bruland, Philipp u. a.: Common data elements for secondary use of electronic
health record data for clinical trial execution and serious adverse event reporting,
in: BMC Medical Research Methodology 16 (2016), H. 1.'
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).
date_created: 2024-07-18T13:31:36Z
date_updated: 2024-07-18T13:33:42Z
department:
- _id: DEP5024
doi: 10.1186/s12874-016-0259-3
extern: '1'
intvolume: ' 16'
issue: '1'
keyword:
- Clinical trials
- Common data elements
- Data quality
- Electronic health records
- Metadata
- Secondary use
language:
- iso: eng
place: London
publication: BMC Medical Research Methodology
publication_identifier:
issn:
- 1471-2288
publication_status: published
publisher: Springer Science and Business Media LLC
status: public
title: Common data elements for secondary use of electronic health record data for
clinical trial execution and serious adverse event reporting
type: scientific_journal_article
user_id: '83781'
volume: 16
year: '2016'
...