Hudgens, Stacie
Phillips-Beyer, Andrea
Newton, Louise
Seboek Kinter, Dalma
Benes, Heike
Funding for this research was provided by:
Idorsia Pharmaceuticals Ltd.
Actelion Pharmaceuticals
Article History
Accepted: 13 October 2020
First Online: 1 November 2020
Declarations
:
: This work, and all studies, were funded by Idorsia Pharmaceuticals Ltd. and formerly (prior to June 2017) by Actelion Pharmaceuticals Ltd.
: Stacie Hudgens and Louise Newton are employees of Clinical Outcomes Solutions; Clinical Outcomes Solutions was funded by Actelion and Idorsia to conduct the observational study, psychometric validation, and exit interviews. Andrea Phillips-Beyer is the director of Innovus Consulting Ltd., which provided consulting services for Idorsia Pharmaceuticals Ltd. and received payment for the work outlined in the manuscript. Dalma Seboek Kinter is an employee and shareholder of Idorsia Pharmaceuticals Ltd. Heike Benes is an employee of Somni Bene Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH and University of Rostock Medical Center, Germany, which received financial support for conducting the interventional study.
: All studies including the qualitative interviews were reviewed and approved by an institutional review board/independent ethics committee and all procedures were in accordance with International Council for Harmonization Good Clinical Practice, the Declaration of Helsinki, and national laws and regulations.
: All study subjects provided written informed consent prior to enrollment.
: All authors have reviewed and approved the manuscript and consent to its publication.
: The data generated during and/or analyzed during the current study are proprietary and not publicly available but may be available from the corresponding author on reasonable request.
: Not applicable.
: SH as an independent PRO lead scientist designed, and conducted the observational study, contributed to the study design of the interventional study, performed psychometric analyses on the interventional and observational studies, interpreted data, and was lead author on the related reports. APB performed psychometric and validation analyses on the interventional and observational studies, performed analyses on qualitative study data, interpreted data, and drafted the manuscript in collaboration with the other authors. LN designed, performed, and interpreted the exit interviews. DSK provided input to the design and data interpretation for the qualitative studies, and for the interventional and observational studies. HB conducted the interventional study and interpreted data. All authors critically reviewed the manuscript and approved the final version of the manuscript for submission.