Bradley, Helena http://orcid.org/0000-0002-7077-2183
Trennery, Claire
Jones, Amy M.
Lydon, Aoife
White, Frances
Williams-Hall, Rebecca
Arbuckle, Rob
Tomaszewski, Erin
Shih, Vivian H.
Haughney, John
Eisen, Amanda
Winders, Tonya
Coons, Stephen Joel
Eremenco, Sonya
Nelsen, Linda
Tabberer, Maggie
Mattera, Maria
Lehane, Asha
Morgan, Lucy
Krishnan, Jerry
,
Article History
Received: 3 January 2023
Accepted: 26 September 2023
First Online: 20 October 2023
Declarations
:
: Ethical approval and oversight were provided by Copernicus Group Independent Review Board (CGIRB), an independent ethical review board in the U.S. (IRB tracking number: 20200606). All caregiver participants provided informed consent and parental permission (if applicable), and all child participants provided informed assent before participating in any study activities.
: Dissemination of findings including via publication was included in the consent and parental permission forms signed by caregivers.
: Sonya Eremenco and Stephen Joel Coons are employees of Critical Path Institute, which is the copyright holder for the <i>PAD-C</i> and <i>PAD-O</i> on behalf of the PRO Consortium. Rob Arbuckle, Rebecca Williams-Hall, Helena Bradley, Amy Jones, Aoife Lydon, and Frances White are employees of Adelphi Values, a health outcomes agency commissioned to conduct research by companies in the pharmaceuticals industry. Adelphi Values received funding from Critical Path Institute to conduct the research summarized in this article. Claire Trennery was an employee of GSK when the research was completed and is now employed by Adelphi Values. Vivian H Shih was an employee of AstraZeneca when the research was conducted and is now employed by Insmed. Erin Tomaszewski is an employee of AstraZeneca. Dr. John Haughney was a consultant of Adelphi Values on behalf of Critical Path Institute as a scientific advisor and received a fee for his involvement. Amanda Eisen and Tonya Winders were consultants of Adelphi Values on behalf of Critical Path Institute as patient advocacy/caregiver representatives and received a fee for their involvement. Tonya Winders is a paid speaker and advisor to AstraZeneca, Amgen, GSK, Sanofi/Regeneron and Novartis. The authors declare that there are no other competing interests. Critical Path Institute is supported by the Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) and is 55% funded by the FDA/HHS, totaling $17,612,250, and 45% funded by non-government source(s), totaling $14,203,111. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government.