Urwyler, Pascal
Boesing, Maria http://orcid.org/0000-0001-8605-1893
Abig, Kristin
Cattaneo, Marco
Dieterle, Thomas
Zeller, Andreas
Bachler, Herbert
Markun, Stefan
Senn, Oliver
Merlo, Christoph
Essig, Stefan
Ullmer, Elke
Rutishauser, Jonas
Schuurmans, Macé M
Leuppi, Joerg Daniel
Funding for this research was provided by:
Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung (32003B_160072)
Lungenliga Schweiz (2015-08)
Article History
Received: 13 August 2019
Accepted: 25 October 2019
First Online: 16 December 2019
Ethics approval and consent to participate
: Ethics approval to conduct this trial at the coordinating study center in Liestal was first granted by the local ethics committee for the Region of Northwestern and Central Switzerland (EKNZ, project ID 2015–017) on 31 January 2015. Four amendments regarding financial compensation for recruiting GPs, structural changes of the CRFs, and the archiving of study documents were approved by the EKNZ between April 2015 and January 2017. The study was first extended from the greater Basel area to the cantons of Luzern, Aargau, Solothurn, and later to the canton of Zurich, with the approval of the cantonal ethics committee in Zurich in May 2017. Approval for an extension to the greater Innsbruck area from the ethics committee of the University of Innsbruck was given in September 2018. Furthermore, we are currently awaiting ethics approval for another extension to the canton of Bern.The trial meets the criteria and principles of the Declaration of Helsinki and is registered in the Clinicaltrials.gov database (trial registration number NCT02386735). It was registered on 12 March 2015.Informed consent to participate in the trial is obtained by the recruiting GPs from all patients prior to study entry. Each patient is informed that participation in the study is voluntary, that they may withdraw from the study at any time without giving a reason, and that withdrawal of consent will not affect their subsequent medical assistance or treatment. On the consent form, participants are asked to allow their data to be used if they choose to withdraw from the trial. Participants are also asked to allow the research team to share their personal data with regulatory authorities, when relevant. Furthermore, patients are informed on an obligatory basis that their medical records may be examined by authorized individuals other than their treating physician. All patients are covered by liability insurance for the total duration of the study.
: We aim to publish the results of this study in a peer-reviewed journal and do not intend to use professional writers. Since no personal data will be published, consent for publication has not been obtained.
: The authors declare that they have no competing interests.