Hoffmann, Anna Teresa http://orcid.org/0000-0002-8119-6070
Mai, Anna
Baum, Klaus
Schlegtendal, Anne
Maier, Christoph
Stein, Julien
Tokic, Marianne
Dillenhöfer, Stefanie
Lücke, Thomas
Timmesfeld, Nina
Brinkmann, Folke
Funding for this research was provided by:
Katholisches Klinikum Bochum gGmbh
Article History
Received: 10 April 2024
Accepted: 6 August 2024
First Online: 15 August 2024
Declarations
:
: The study (study protocol V1.1, dated 10.11.2023) was approved without any reservation on 04.12.2023 by the ethics committee of the Ruhr University as the lead ethics committee and for the Bochum site (vote 23–7938, Supplement 2). All other centers (to be found in the flyer at ) have submitted a follow-up application to the locally responsible ethics committee. The study protocol was updated (V1.2, dated 12 June 2024) after approval of the funder. The ethics committee of Westfalen-Lippe (responsible for Bochum since 01/2024) approved all protocol amendments (vote 2024–448-f-S, Supplement 7). pwPCD who can be included in the study based on their age and genetic findings will be informed about the study and questioned about the existence of exclusion criteria. Patients who meet all inclusion criteria, do not meet any exclusion criteria, and are willing to participate provide their written informed consent followed by the screening visit (V0). The consent must be signed in the presence of the study physician. In the case of minors, separate consent from the legal guardian is also required. All participants receive a personal signed copy of the patient information and consent form (Supplement 4–6).
: No clinical details of trial participants are presented in the present article. Study results will be published, regardless of whether the results are positive or negative, according to the Consolidated Standards of Reporting Trials (CONSORT). The SAP will be published as appendix in the publication of results. Access to the participant-level dataset and statistical code will be given upon request after analyses have been finished. The study results are also presented in lay understandable language at the patient organization’s annual patient congress and are made available on their website.
: ATH, AS, CM, MT, KB: job financing or remuneration as part of the funding. FB has no competing interests for any study center or the complete study. The authors declare they have no other competing interests than shown above.