Funding for this research was provided by:
Deutsche Forschungsgemeinschaft (GZ: EB 525/2-1)
Text and Data Mining valid from 2019-06-03
Received: 24 January 2019
Accepted: 14 April 2019
First Online: 3 June 2019
Ethics approval and consent to participate
: The ethical review committee of the Charité – University Medicine Berlin (EA4/109/15) has given ethics approval on September 2, 2015. B_PROUD is embedded in the ‘Berlin - specific acute therapy in ischemic or hemorrhagic stroke with long-term follow-up’ (B-SPATIAL) registry that has been established to assess process and outcome quality of hyperacute stroke care in Berlin. Since B-SPATIAL constitutes a quality registry, all patients are automatically included if they fulfill the inclusion criteria of the registry that also covers all inclusion criteria of the B_PROUD trial. With regard to the follow-up assessment process, an opt-out clause ensures the patient’s right to retract participation at any time before contact, during follow-up or even afterwards. Patients are informed with an information leaflet at discharge and again approximately 4 weeks before telephone follow-up.
: As described above and due to quality assurance issues, no written agreement from the patient is needed beforehand. However, patients are contacted at discharge or postally, and informed about the use of their anonymized data in scientific publications. Again, it is the patients’ right to opt-out at any time before contact, during follow-up or even afterwards.
: The authors declare that they have no competing interests.
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