Sundmacher, Leonie
Flemming, Ronja
Leve, Verena
Geiger, Isabel
Franke, Sebastian
Czihal, Thomas
Krause, Clemens
Wiese, Birgitt
Meyer, Frank
Brittner, Matthias
Pollmanns, Johannes
Martin, Johannes
Brandenburg, Paul
Schultz, Annemarie
Brua, Emmanuelle
Schneider, Udo
Dortmann, Olga
Rupprecht, Christoph
Wilm, Stefan
Schüttig, Wiebke http://orcid.org/0000-0003-2669-2933
Funding for this research was provided by:
German Federal Joint Committee - GBA (01VSF16046 (ACD))
Technische Universität München
Article History
Received: 27 November 2020
Accepted: 31 August 2021
First Online: 15 September 2021
Declarations
:
: This protocol was reviewed and approved by the ethics committee of Düsseldorf Medical School (granted 2017/09/22), the State Ministry of Employment, Health and Social Affairs in North Rhine Westphalia, the State Ministry of Social Affairs, Health, Youth, Families and Seniors in Schleswig Holstein, the Senate for Health and Consumer Protection in Hamburg and the Federal Office for Social Security in their role as supervisory authorities of the Regional Associations of SHI Physicians and statutory health insurers. All changes in the protocol throughout the trial must be approved by the ethics committee and the responsible supervisory authorities.In accordance with Section 75 and Section 67b of Book X of the German Code of Social Law (§67b and §75 SGB X) the regulatory authorities confirmed that patients and office-based physicians do not need to be asked for written, informed consent in order for administrative data to be used to identify the informal networks of office-based physicians. This is because the data were two-way pseudonymised (please see section on data management).The regional authorities also confirmed that, according to Section 75 of Book X of the German Code of Social Law, Section 80 of Book X of the German Code of Social Law and Section 287 of Book X of the German Code of Social Law (§75, §80 and §287 SGB X), the Regional Associations of SHI Physicians are allowed to contact and send feedback sheets containing information on (quality) indicators at the level of patients, physicians and networks without the need to obtain prior written, informed consent from the office-based SHI physicians in the identified informal networks.
: Not applicable
: The authors declare that they do not have competing interests.