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Article History

Received: 16 October 2018

Accepted: 12 March 2019

First Online: 8 April 2019

Ethics approval and consent to participate

: MenDis-CHD was approved by the Ethics Commission of Cologne University’s Faculty of Medicine (committee’s reference number: 17–220) on September 26th, 2017. The ethics approval for MenDis-CHD is valid for all of the seven recruitment facilities (please refer to ‘procedures’ for further information). The German Medical Association approved that if the researchers from MenDis-CHD-team recruit the patients in the listed facilities exclusively and the physicians of these facilities do not recruit patients, there is no need for an additional ethics approval. The decision of the ethics committee of the University Hospital of Cologne is therefore sufficient for all recruitment facilities.The procedure for obtaining informed consent from the participants is as follows: when recruiting patients in cardiology departments, cardiologic rehabilitation clinics, and cardiologic practices, the first step is that the physician in charge screens his patient list for diagnoses that match our inclusion criteria. Afterward, these patients are notified to our research team. The next step is that a member of the research team introduces him/herself to the patient and provides information about MenDis-CHD. Apart from the verbal information, every patient is handed out an information sheet, which contains details about content, procedure, and purpose of the study, contact details of the researchers, if further questions arise, commuting accident insurance, and declaration of data privacy. After the patient has read the information, the researchers detail the informed consent point-by-point. If the patient agrees to participate in the study, he/she signs the informed consent with his/her name and home address. In the informed consent, the patient is also asked, if he/she allows the research team to hand out a questionnaire-package for their relatives. If the informed consent is given, the patient and/or the relative version of the questionnaire are handed out. The questionnaire-packages contain the information letter, the copy of the informed consent, the questionnaire, as well as contact details of the research team, to address further questions. In case that the addressed relatives agree to participate in the study, the relative questionnaire-packages contain a self-addressed envelope. The described procedure for the physicians is the same as for the patients except that the physicians are identified on the basis of the participating institutions and by the information provided by the patients.

: Not applicable.

: The authors declare that they have no competing interests.

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