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Article History

Received: 3 May 2022

Accepted: 1 June 2022

First Online: 17 June 2022

Declarations

:

: The study was approved by the review board of the ethics committee of the Technical University of Munich. This scientific study is aiming to examine whether better information for patients has positive effects on patient-relevant outcomes. The evidence-based information will be presented in a computer-based format. However, the SDM-assistant should only enhance the process of shared-decision making and is not intended to be developed as a medical product or to pursue a commercial interest.Patients meeting inclusion criteria will be asked to provide informed consent (template of the informed consent form available upon request) for study participation, and their capability to provide informed consent will be ensured by trained study staff. Furthermore, we will pay special attention to how many patients decline to participate in the study and ask about the underlying reasons. Participation in the study is voluntary. Consent can be withdrawn at any time, without giving reasons and without disadvantages for further medical care. Should the study be terminated by the physician or patient, the data stored up to this point will continue to be used unless the patient or caregiver explicitly withdraws the release of their patient data. This procedure is pointed out verbally and in the consent form and, in the event of a cancellation, this is recorded accordingly in writing.Data will be saved and exchanged exclusively in pseudonymised forms. Neither the initials nor the date of birth will therefore appear in the encryption code. A study file will be kept for each patient-physician dyad (Case Report Form, CRF), which will be transferred to an electronic study file (eCRF) at the end of the study. After the finalisation of data collection (close out visit) of each patient, copies of both study files, CRF and eCRF, are sent to the managing study centre (AG Patient Orientation and Health Services Research, RDI). The names of the patients and all other confidential information are subject to medical confidentiality and the provisions of the Federal Data Protection Act, i.e., the consent form and personal data remain in the recruiting centre.The transfer of the pseudonymised data to the study management, as well as information on data protection are included in the consent form. In the event of withdrawal of consent, the stored data will be destroyed at the patient’s request.

: Not applicable.

: In the past 3 years Stefan Leucht has received honoraria as a consultant and/or advisor and/or for lectures from Alkermes, Angelini, Eisai, Gedeon Richter, Janssen, Lundbeck, Lundbeck Institute, Merck Sharpp and Dome, Otsuka, Recordati, Rovi, Sanofi Aventis, TEVA, Medichem, Mitshubishi. The other authors have nothing to disclose.