gms | German Medical Science

Treatment of chronic wounds is still a topic with a high research potential, yet data for observational studies are difficult to access and hardly available. At the Department of Dermatology at University Hospital Erlangen, data evaluation for clinical research predominantly relies on free text data and manual chart reviews. The process involves manually searching patient records, transcribing necessary information, and sorting it for analysis. The introduction of Data Integration Centers (DICs) within the Medical Informatics Initiative in Germany aims at making routine care data available for research [1]. The goal of this study is to describe the initial experiences with the process of accessing wound care-related DIC data from a physician’s perspective. At the University Hospital Erlangen, the local DIC and data warehouse integrate data from nearly all digital systems and patient records from routine clinical processes. For local evaluations (e.g. controlling, local research), the extraction of a data set can be requested via the DIC following a regulated access process. Researchers submit a detailed study plan, including scientific questions and an ethics vote. Consent from the heads of the involved clinical departments is required. In the next step the DIC calculates the costs associated with data extraction and provides a cost estimate before processing the request. Then the “Use and Access Committee” (UAC) [2], [3], comprising interdisciplinary members, assesses the application. If approved, the request is forwarded to the DIC for data extraction. The DIC extracts and provides the requested data in a format suitable for statistical analysis and further research. If data sharing with external partners is needed, the DIC anonymizes the data to comply with legal requirements. We requested data for patients with chronic wounds (ICD 10 GM-Codes L97, I83.0, I83.2, I87.01, I87.21, I70.24, L88, E10.75) treated from January 1, 2021, to November 2, 2023 to answer research questions about the characteristics of the population of wound patients in Erlangen. The first application for data extraction was in May 2022. The initial data export occurred in March, 2023. The delay was due to individual factors such as high workload on the one hand and on the other hand to a lack of clarity as to where which information is stored and who was the right contact person for which question. In conclusion, the process to obtain data was understandable, but time consuming. The earlier the applicants know which data they want and where exactly it is documented, the faster they can obtain the necessary consent and the faster they can receive the data. A checklist with all necessary steps, data available, and the contact person for access approval could help clinicians to shorten the process.

The authors declare that they have no competing interests.

The authors declare that a positive ethics committee vote has been obtained.