Rutsch, Mercedes
Frommhold, Jördis
Buhr-Schinner, Heike
Djeiranachvili, Levan
Gross, Thomas
Schüller, Per Otto
Katalinic, Alexander
Deck, Ruth
Funding for this research was provided by:
Deutsche Rentenversicherung Bund (0421/40-64-50-74)
Universität zu Lübeck
Article History
Received: 27 March 2021
Accepted: 12 April 2021
First Online: 22 April 2021
Declarations
:
: This study will be performed in accordance with the Declaration of Helsinki. The ethical committee of the University of Lübeck approved the study for all cooperating rehabilitation-clinics (register number: 20–391) on 5 November 2020. The participants sign a consent form. The data protection concept is implemented according to the current guidelines of the German Pension Insurance (“Deutsche Rentenversicherung Bund”, DRV Bund).Before the study begins, all potential participants are informed in writing about the study and asked for their signed consent. Therefore, the documents (patient information sheet, declaration of consent) were prepared in accordance with the guidelines of the DRV Bund data protection officer [,]. Based on the General Data Protection Regulation (European Union), the participants may contact the competent authority for data protection and the contact person of the respective supervisory authority. With regard to data protection, we refer the study participants to the DRV Bund, which is in charge of this aspect of the study.All personal data are pseudonymised in the rehabilitation clinics and stay password-protected in each clinic. Participants who meet the inclusion criteria and provide consent are included in the study. All personal data (questionnaire data) are pseudonymised by the clinic (using ID numbers). The assignment list (ID number and address) is kept and stored strictly separate from the questionnaire file. Immediately after completion of the twelve-month follow-up and data control, this key file will be deleted, and the data are anonymised. The original documents will be kept in accordance with the Guidelines and Recommendations for Securing Good Epidemiological Practice (GEP) [] for up to ten years after the end of the study.
: Not applicable because the manuscript does not contain any personal data.
: The authors declare that they have no competing interests.