Funding for this research was provided by:
Medizinische Hochschule Hannover (MHH)
Article History
Received: 5 January 2022
Accepted: 2 September 2022
First Online: 15 September 2022
Declarations
:
: This was an observational, cross-sectional study carried out using routinely collected data from an intervention, which was previously evaluated and retrospectively registered in the German Registry of Clinical Trials on 04/09/2018 (study no. DRKS00015463). The independent research ethics committee of the University of Lübeck approved the original study (Re.-No.14 –249, dated 20/11/2014).All participants consented in writing to the usage of their health questionnaires and health records for research purposes. As the informed consent, the self-reported questionnaire and purpose of participant selection, the customer invitation process, enrolment process and data linkage process have remained unchanged since the last ethical vote, they are still valid in accordance with the ethics proposal. Therefore, no new ethics decision was necessary for the present study. This was in accordance with national legislation (e.g., SGB V, paragraph 303e). All procedures performed in the present study were in accordance with the 1964 Helsinki declaration and its later amendments.Written informed consent was obtained from all study participants.A written agreement to use and process the raw data was concluded with Generali Health Solutions (GHS) and Generali Deutschland Krankenversicherung AG (hereinafter referred to as “Generali Deutschland”). This also explicitly includes the right to use the data for research purposes. As employees of GHS, MH, PR and MW therefore have access to the raw data and are allowed to use it for research purposes.
: Not applicable, No individual data.
: Martin Hochheim (MH) works part-time for Generali Health Solutions GmbH (GHS), a company affiliated with Generali Deutschland. Max Wunderlich (MW) is Managing Director of GHS, and Philipp Ramm (PR) is currently responsible for the investigated back pain intervention. All three declare that this research was conducted in the absence of any commercial or financial relationship that could be construed as a potential conflict of interest. Volker Amelung (VA) declares that he has no conflicts of interest.