Müller, Karolina http://orcid.org/0000-0001-5241-2945
Kuipers, Jens G.
Weis, Joachim
Fischer, Irene
Pukrop, Tobias
Rüffer, Jens U.
Koller, Michael http://orcid.org/0000-0001-5252-6010
Funding for this research was provided by:
Chugai Pharma Germany GmbH (ID 16 Klinik Publikationsvertrag Version 4.0)
Universität Regensburg
Article History
Received: 25 May 2021
Accepted: 10 July 2021
First Online: 16 July 2021
Declarations
:
: JGK reports grants and personal fees from Chugai during the conduct of the study. JGK reports outside the submitted work grants, personal fees and non-financial support from Abbvie, Actelion, Boehringer-Ingelheim, Biogen, Gilead, GSK, Janssen-Cilag, Lilly, MSD, Novartis, Pfizer, Roche, Takeda, UCB. JW received a grant from EORTC Quality of Life Department and from DFaG for the development of EORTC FA12. MK received a grant from DFaG for the conduct of the TRACE study. All other authors have declared no conflicts of interest in the context of this research.
: Study 1, TRACE (Therapie bei Rheumatoider Arthritis Correlate und Einfluss) on adherence with therapy and quality of life of patients with rheumatoid arthritis, was approved by the Ethical Committee of the University of Regensburg (number 13-160-0275). The trial was registered with study database of the German Network of Health Services (VfD_TRACE_14_003438). Study 2, psychometric validation study of the EORTC QLQ-FA12 measuring fatigue in patients with cancer, obtained national and local ethics approvals (reference number of leading Ethics Committee of the University of Freiburg 165/11). The study was registered with the German Clinical Trial Studies Registry (DRKS00003091). Both studies were conducted in compliance with the Declaration of Helsinki and patients gave their written informed consent.