title: Five-year experience with setup and implementation of an integrated database system for clinical documentation and research.
abstract: In radiation oncology, where treatment concepts are elaborated in interdisciplinary collaborations, handling distributed, large heterogeneous amounts of data efficiently is very important, yet challenging, for an optimal treatment of the patient as well as for research itself. This becomes a strong focus, as we step into the era of modern personalized medicine, relying on various quantitative data information, thus involving the active contribution of multiple medical specialties. Hence, combining patient data from all involved information systems is inevitable for analyses. Therefore, we introduced a documentation and data management system integrated in the clinical environment for electronic data capture. We discuss our concept and five-year experience of a precise electronic documentation system, with special focus on the challenges we encountered. We specify how such a system can be designed and implemented to plan, tailor and conduct (multicenter) clinical trials, ultimately reaching the best clinical performance, and enhancing interdisciplinary and clinical research.
authors.affiliation: Heidelberg University Hospital, Department of Radiation Oncology, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany. Electronic address: Kerstin.Kessel@med.uni-heidelberg.de.
authors.forename: Kerstin A
authors.initials: KA
authors.lastname: Kessel
authors.affiliation: CHILI GmbH, Friedrich-Ebert-Str. 2, 69221 Dossenheim, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Bohn
authors.affiliation: CHILI GmbH, Friedrich-Ebert-Str. 2, 69221 Dossenheim, Germany.
authors.forename: Uwe
authors.initials: U
authors.lastname: Engelmann
authors.affiliation: Heidelberg University Hospital, Department of Radiation Oncology, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany.
authors.forename: Dieter
authors.initials: D
authors.lastname: Oetzel
authors.affiliation: Heidelberg University Hospital, Department of Radiation Oncology, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany.
authors.forename: Nina
authors.initials: N
authors.lastname: Bougatf
authors.affiliation: Heilbronn University, Department of Medical Informatics, Max-Planck-Str. 39, 74081 Heilbronn, Germany.
authors.forename: Rolf
authors.initials: R
authors.lastname: Bendl
authors.affiliation: Heidelberg University Hospital, Department of Radiation Oncology, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Debus
authors.affiliation: Heidelberg University Hospital, Department of Radiation Oncology, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany; Technical University of Munich (TUM), Department of Radiation Oncology, Ismaninger Straße 122, Munich, Germany.
authors.forename: Stephanie E
authors.initials: SE
authors.lastname: Combs
mesh_terms: D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D016494:Computer Security; D003628:Database Management Systems; D016208:Databases, Factual; D057286:Electronic Health Records; D006801:Humans; D020407:Internet; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data; D011446:Prospective Studies; D011880:Radiotherapy Planning, Computer-Assisted / Q000706:statistics & numerical data; D012189:Retrospective Studies; D012984:Software
keywords: Clinical trials; Data capture; Data management; Documentation system; Electronic analysis; Information systems