Boye, Kristina S. https://orcid.org/0000-0002-5953-5929
Clark, Amy
Kanu, Chisom https://orcid.org/0000-0002-2621-8652
Neff, Lisa M.
Skalicky, Anne M.
Article History
Received: 14 March 2025
Accepted: 4 June 2025
First Online: 11 July 2025
Declarations
:
: Anne M. Skalicky and Amy Clark are employees of Evidera, which received funding from Eli Lilly to conduct the study. Kristina Secnik Boye, Chisom Kanu, and Lisa M. Neff are employees and shareholders of Eli Lilly and Company.
: The CE interview protocol was approved by a US ethical central institutional review board (IRB), in accordance with local law (IRB study number WCG IRB# 20225362), and the methodology was developed in line with the FDA and the ISPOR guidance on best practice for eliciting concepts for a new PRO instrument [, ]. This study was also performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with good clinical practice and applicable regulatory requirements. Written informed consent was obtained from all participants to publish data and verbatim responses. Consent was obtained from parents and assent obtained from child and adolescent participants to publish verbatim responses.