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. 2025 Jan 30;7(1):5.
doi: 10.1186/s42466-024-00362-z.

Development and application of a clinical core data set for deep brain stimulation in Parkinson's disease, dystonia or tremor: from data collection to data exchange and data sharing

Anna-Lena Hofmann  1   2 , Jonas Widmann  3 , Lilly Brandstetter  3 , Udo Selig  3 , Fabian Haug  4 , Julian Haug  4 , Rüdiger Pryss  3   4 , Jasper Mecklenburg  5 , Andrea Kreichgauer  5 , Philipp Capetian  6 , Christian J Hartmann  7 , Christian Niklas  8 , Petra Ritter  9   10   11   12 , Patricia Krause  5 , Alfons Schnitzler  7 , Jens Volkmann  6 , Andrea A Kühn  5 , Peter Heuschmann  3   4   13 , Kirsten Haas  3
Affiliations

Development and application of a clinical core data set for deep brain stimulation in Parkinson's disease, dystonia or tremor: from data collection to data exchange and data sharing

Anna-Lena Hofmann et al. Neurol Res Pract. .

Abstract

Background: Comprehensive clinical data regarding factors influencing the individual disease course of patients with movement disorders treated with deep brain stimulation might help to better understand disease progression and to develop individualized treatment approaches.

Methods: The clinical core data set was developed by a multidisciplinary working group within the German transregional collaborative research network ReTune. The development followed standardized methodology comprising review of available evidence, a consensus process and performance of the first phase of the study. To ensure high data quality, measures for standardized training, monitoring as well as plausibility and data quality tests were implemented.

Results: The clinical core data set comprises information about medical history, clinical symptoms, information about deep brain stimulation surgery, complications and outcome for the main neurological movement disorders Parkinson's disease, tremor, and dystonia. Its applicability as well as data exchange and quality control was tested within the first phase of the study in 51 patients from Würzburg.

Conclusions: Within the ReTune project, a standardised clinical core data set for Parkinson's disease, dystonia and tremor was developed. The collection as well as concepts for the implementation of monitoring and data exchange were elaborated and successfully tested. Trial registration number ClinicalTrials.gov (DRKS-ID: DRKS00031878).

Keywords: Clinical core data set; Data exchange; Dystonia; Parkinson’s disease; Tremor.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The study was approved by the ethics committee of the Medical Faculty of the University of Würzburg (EC Würzburg 29/20-me) as well as by the ethics committee in Düsseldorf (Study No.2022–2098) and the Charité-Universitätsmedizin Berlin (CTO 23–0983). A written declaration of consent is obtained from all patients (Broad Consent V1.6.f of the Medical Informatics Initiative). We confirm that we have read the Journal’s position on issues involved in ethical publication and affirm that this work is consistent with those guidelines. Consent for publication: Not applicable. Competing interests: PUH reports grants from the German Research Foundation during the work, research grants from the German Ministry of Education and Research, German Research Foundation, European Union, German Parkinson Society, University Hospital Würzburg, Robert Koch Institute, German Heart Foundation, Federal Joint Committee (G-BA) within the Innovationfond, Bavarian State, German Cancer Aid, University Hospital Heidelberg (within RASUNOA-prime; supported by an unrestricted research grant to the University Hospital Heidelberg from Bayer, BMS, Boehringer Ingelheim, and Daiichi Sankyo), Charité–Universitätsmedizin Berlin (within Mondafis; supported by an unrestricted research grant to the Charité from Bayer), and University Göttingen (within FIND-AF randomized; supported by an unrestricted research grant to the University Göttingen from Boehringer Ingelheim) outside the submitted work. AAK has received research grants from Deutsche Forschungsgemeinschaft, German Federal Ministry of Education and Research, and Lundbeck Foundation. She has served on advisory boards for Medtronic and Boston Scientific; and has received honoraria for talks sponsored by Medtronic, Boston Scientific, Ipsen, and Teva. She is supported by the Deutsche Forschungsgemeinschaft (project ID 424778381–TRR 295). JV has received research grants from Deutsche Forschungsgemeinschaft, German Federal Ministry of Education and Research, and ERANET-Neuron. He has served on advisory boards for Medtronic, Boston Scientific, Ceregate, Bayer and Newronika; and has received honoraria for talks sponsored by Medtronic, Boston Scientific, Abbott, AbbVie, Stadapharm. He is supported by the Deutsche Forschungsgemeinschaft (project ID 424778381–TRR 295). PR acknowledges support by the Virtual Research Environment at the Charité Berlin – a node of EBRAINS Health Data Cloud; Digital Europe TEF-Health 101100700, EU H2020 Virtual Brain Cloud 826421, Human Brain Project SGA2 785907; Human Brain Project SGA3 945539, ERC Consolidator 683049; German Research Foundation SFB 1436 (project ID 425899996); SFB 1315 (project ID 327654276); SFB 936 (project ID 178316478; SFB-TRR 295 (project ID 424778381); SPP Computational Connectomics RI 2073/6–1, RI 2073/10–2, RI 2073/9–1; PHRASE Horizon EIC grant 101058240; Berlin Institute of Health & Foundation Charité, Johanna Quandt Excellence Initiative; ERAPerMed Pattern. PK Received speaker´s honoraria from Medtronic, AbbVie and Stadapharm and is in the Advisory Board of Abbot, MedTronic and Stadapharm, outside the submitted work. AS was supported by the Brunhilde Moll Foundation unrelated to this research. He received, unrelated to this research, consulting fees and/or speaker honoraria from Abbott, Abbvie, Alexion, bsh medical communication, GE Healtcare, Kyowa Kirin, Novartis, Zambon, and an editor's fee from Georg Thieme Verlag. CJH received honoraria from Abbott.

Figures

Fig. 1
Fig. 1
Data flow clinical core data set ReTune
See this image and copyright information in PMC

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