title: Design and multicentric implementation of a generic software architecture for patient recruitment systems re-using existing HIS tools and routine patient data.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Institute of Medical Informatics, University of Münster , Germany.
authors.forename: B
authors.initials: B
authors.lastname: Trinczek
authors.affiliation: Chair of Medical Informatics, Friedrich-Alexander-University Erlangen-Nuremberg , Germany.
authors.forename: F
authors.initials: F
authors.lastname: Köpcke
authors.affiliation: Department of Information- and Communication-Technology, Düsseldorf University Hospital , Germany.
authors.forename: T
authors.initials: T
authors.lastname: Leusch
authors.affiliation: Department of Anesthesia and Intensive Care Medicine, Justus-Liebig University Gießen , Germany.
authors.forename: R W
authors.initials: RW
authors.lastname: Majeed
authors.affiliation: Center for Information Technology and Medical Engineering, Heidelberg University Hospital , Germany.
authors.forename: B
authors.initials: B
authors.lastname: Schreiweis
authors.affiliation: Coordination Centre for Clinical Trials, Faculty of Medicine, Heinrich Heine University Düsseldorf , Germany.
authors.forename: J
authors.initials: J
authors.lastname: Wenk
authors.affiliation: Center for Information Technology and Medical Engineering, Heidelberg University Hospital , Germany.
authors.forename: B
authors.initials: B
authors.lastname: Bergh
authors.affiliation: Coordination Centre for Clinical Trials, Faculty of Medicine, Heinrich Heine University Düsseldorf , Germany.
authors.forename: C
authors.initials: C
authors.lastname: Ohmann
authors.affiliation: Department of Anesthesia and Intensive Care Medicine, Justus-Liebig University Gießen , Germany.
authors.forename: R
authors.initials: R
authors.lastname: Röhrig
authors.affiliation: Chair of Medical Informatics, Friedrich-Alexander-University Erlangen-Nuremberg , Germany.
authors.forename: H U
authors.initials: HU
authors.lastname: Prokosch
authors.affiliation: Institute of Medical Informatics, University of Münster , Germany.
authors.forename: M
authors.initials: M
authors.lastname: Dugas
mesh_terms: D019992:Databases as Topic; D005858:Germany; D006284:Health Plan Implementation; D006751:Hospital Information Systems; D006801:Humans; D018579:Patient Selection; D012984:Software
keywords: Clinical trials as topic; hospital information systems; patient identification systems; patient selection; software architecture
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