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2014 ; 27
(6
): 702-13
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Integrated image data and medical record management for rare disease registries
A general framework and its instantiation to theGerman Calciphylaxis Registry
#MMPMID24865858
Deserno TM
; Haak D
; Brandenburg V
; Deserno V
; Classen C
; Specht P
J Digit Imaging
2014[Dec]; 27
(6
): 702-13
PMID24865858
show ga
Especially for investigator-initiated research at universities and academic
institutions, Internet-based rare disease registries (RDR) are required that
integrate electronic data capture (EDC) with automatic image analysis or manual
image annotation. We propose a modular framework merging alpha-numerical and
binary data capture. In concordance with the Office of Rare Diseases Research
recommendations, a requirement analysis was performed based on several RDR
databases currently hosted at Uniklinik RWTH Aachen, Germany. With respect to the
study management tool that is already successfully operating at the Clinical
Trial Center Aachen, the Google Web Toolkit was chosen with Hibernate and Gilead
connecting a MySQL database management system. Image and signal data integration
and processing is supported by Apache Commons FileUpload-Library and ImageJ-based
Java code, respectively. As a proof of concept, the framework is instantiated to
the German Calciphylaxis Registry. The framework is composed of five mandatory
core modules: (1) Data Core, (2) EDC, (3) Access Control, (4) Audit Trail, and
(5) Terminology as well as six optional modules: (6) Binary Large Object (BLOB),
(7) BLOB Analysis, (8) Standard Operation Procedure, (9) Communication, (10)
Pseudonymization, and (11) Biorepository. Modules 1-7 are implemented in the
German Calciphylaxis Registry. The proposed RDR framework is easily instantiated
and directly integrates image management and analysis. As open source software,
it may assist improved data collection and analysis of rare diseases in near
future.
|Calciphylaxis/*diagnosis
[MESH]
|Database Management Systems/organization & administration/*statistics & numerical
data
[MESH]
|Databases, Factual/*statistics & numerical data
[MESH]
|Germany
[MESH]
|Humans
[MESH]
|Internet
[MESH]
|Medical Records Systems, Computerized/organization & administration/*statistics &
numerical data
[MESH]