Kendrew, Rachael https://orcid.org/0009-0007-6737-0945
Ajraoui, Salma https://orcid.org/0009-0003-4003-8804
Beaudet, Amélie https://orcid.org/0000-0003-0535-672X
Kelly, Kimberly https://orcid.org/0009-0009-3254-3193
Kiely, David G https://orcid.org/0000-0003-0184-6502
Rothman, Alexander https://orcid.org/0000-0002-7847-4500
Varian, Frances https://orcid.org/0000-0002-4644-8391
Davis, Stacy https://orcid.org/0000-0003-4201-0891
Pillai, Nadia https://orcid.org/0000-0003-2076-9100
Article History
Received: 10 July 2024
Accepted: 8 December 2024
First Online: 18 December 2024
Declarations
:
: This study was performed in accordance with the provisions of the Declaration of Helsinki, International Conference on Harmonization Guideline for Good Clinical Practice, Good Pharmacoepidemiology Practice, and the applicable legislation on Non-Interventional Studies and/or Observational Studies. The participating study staff at Sheffield teaching hospital in the UK and physicians in the USA performed their duties in accordance with the regulations and guidelines governing medical practice and ethics in their country, and in accordance with currently acceptable techniques and know-how. The research protocol, discussion guide, and all patient communication templates were reviewed and approved by the WIRB-Copernicus Group Institutional Review Board prior to the study commencing (Confirmation ID 45282790). Ethical approval was also granted in the UK by the Yorkshire & The Humber – Leeds West Research Ethics Committee (Reference: 2/YH/0166). Participant interviews were conducted in line with the recommended guidelines provided by the International Society for Pharmacoeconomics and Outcome Research Good Research Practices Task Force [, ]. All patients were given the chance to ask questions throughout the study and had the right to withdraw at any point. Patient confidentiality and anonymity was ensured through the assignment of patient identification numbers and all transcripts were deidentified (i.e., any information that could possibly identify a patient was removed) prior to analysis. All participants provided written informed consent prior to the interview. Clinical trial number not applicable.
: Not applicable.
: AB and NP are employees of Actelion Pharmaceuticals Ltd, a Johnson & Johnson company. AB and NP own stock in Johnson & Johnson. SD is an employee of Janssen Global Services, LLC, a Johnson & Johnson company. DGK has received grants from Janssen Pharmaceuticals and Ferrer; consulting fees from Janssen Pharmaceuticals, MSD, Ferrer, Altavant and United Therapeutics; honoraria from Janssen Pharmaceuticals, MSD, Ferrer and United Therapeutics; funding from Janssen Pharmaceuticals, MSD and Ferrer to attend scientific meetings; has participated in a data safety monitoring board or Advisory Board for Janssen Pharmaceuticals and MSD; serves on the Specialist Respiratory Clinical Reference Group (unpaid) and as the UK National Audit Chair. RK, SA, and KK are employees of IQVIA Patient Centered Solutions, which received funding from Actelion Pharmaceuticals Ltd. for conducting this research. AR and FV declare no competing interests.