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Appl Clin Inform 2014; 05(01): 264-283
DOI: 10.4338/ACI-2013-07-RA-0047
Research Article
Schattauer GmbH

Design and multicentric Implementation of a generic Software Architecture for Patient Recruitment Systems re-using existing HIS tools and Routine Patient Data

B. Trinczek
1   Institute of Medical Informatics, University of Münster, Germany
,
F. Köpcke
2   Chair of Medical Informatics, Friedrich-Alexander-University Erlangen-Nuremberg, Germany
,
T. Leusch
3   Department of Information- and Communication-Technology, Düsseldorf University Hospital, Germany
,
R.W. Majeed
4   Department of Anesthesia and Intensive Care Medicine, Justus-Liebig University Gießen, Germany
,
B. Schreiweis
5   Center for Information Technology and Medical Engineering, Heidelberg University Hospital, Germany
,
J. Wenk
6   Coordination Centre for Clinical Trials, Faculty of Medicine, Heinrich Heine University Düsseldorf, Germany
,
B. Bergh
6   Coordination Centre for Clinical Trials, Faculty of Medicine, Heinrich Heine University Düsseldorf, Germany
,
C. Ohmann
6   Coordination Centre for Clinical Trials, Faculty of Medicine, Heinrich Heine University Düsseldorf, Germany
,
R. Röhrig
4   Department of Anesthesia and Intensive Care Medicine, Justus-Liebig University Gießen, Germany
,
H.U. Prokosch
2   Chair of Medical Informatics, Friedrich-Alexander-University Erlangen-Nuremberg, Germany
,
M. Dugas
1   Institute of Medical Informatics, University of Münster, Germany
› Author Affiliations
Further Information

Publication History

received: 08 July 2013

accepted: 26 January 2014

Publication Date:
20 December 2017 (online)

Also available at
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Summary

Objective: (1) To define features and data items of a Patient Recruitment System (PRS); (2) to design a generic software architecture of such a system covering the requirements; (3) to identify implementation options available within different Hospital Information System (HIS) environments; (4) to implement five PRS following the architecture and utilizing the implementation options as proof of concept.

Methods: Existing PRS were reviewed and interviews with users and developers conducted. All reported PRS features were collected and prioritized according to their published success and user’s request. Common feature sets were combined into software modules of a generic software architecture. Data items to process and transfer were identified for each of the modules. Each site collected implementation options available within their respective HIS environment for each module, provided a prototypical implementation based on available implementation possibilities and supported the patient recruitment of a clinical trial as a proof of concept.

Results: 24 commonly reported and requested features of a PRS were identified, 13 of them prioritized as being mandatory. A UML version 2 based software architecture containing 5 software modules covering these features was developed. 13 data item groups processed by the modules, thus required to be available electronically, have been identified. Several implementation options could be identified for each module, most of them being available at multiple sites. Utilizing available tools, a PRS could be implemented in each of the five participating German university hospitals.

Conclusion: A set of required features and data items of a PRS has been described for the first time. The software architecture covers all features in a clear, well-defined way. The variety of implementation options and the prototypes show that it is possible to implement the given architecture in different HIS environments, thus enabling more sites to successfully support patient recruitment in clinical trials.

Citation: Trinczek B, Köpcke F, Leusch T, Majeed RW, Schreiweis B, Wenk J, Bergh B, Ohmann C, Röhrig R, Prokosch HU, Dugas M. Design and multicentric implementation of a generic software architecture for patient recruitment systems re-using existing HIS tools and routine patient data. Appl Clin Inf 2014; 5: 264–283 http://dx.doi.org/10.4338/ACI-2013-07-RA-0047

Keywords

Clinical trials as topic - patient selection - software architecture - patient identification systems - hospital information systems
 

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