Funding for this research was provided by:
National Heart, Lung, and Blood Institute (U01HL159880)
Received: 26 July 2022
Accepted: 10 October 2022
First Online: 21 October 2022
: This study was approved by the Institutional Review Board (IRB) at Children’s Hospital of Philadelphia (FWA00000459) on July 23, 2021. Prior to study commencement at each participating site, each US site established an IRB reliance agreement with Children’s Hospital of Philadelphia’s IRB using an electronic reliance platform. The Canadian site obtained local Research Ethics Board (REB) approval independently. Due to a number of challenges posed by the pandemic, including but not limited to staffing challenges and low bronchiolitis patient volumes, we amended the protocol to improve the feasibility for participating sites. In order to provide the most up-to-date protocol for publication, this manuscript represents the fourth scientific amendment, including recommendations from our Data and Safety Monitoring Board, protocol version date May 20, 2022, approved by the IRB on June 20, 2022. All amendment letters describing each change are automatically forwarded to relying sites via the electronic IRB system. For patients who are the subjects of data collection, the IRB granted a waiver of consent/parental permission per 45 CFR 46.116(f)(3), a waiver of assent per 45 CFR 46.408(a), and a waiver of HIPAA authorization per 45 CFR 164.512(i)(2)(ii). For staff who are the subjects of questionnaires and qualitative interviews, the IRB granted a waiver of documentation of consent under 45 CFR 46.117(c)(1)(ii). For parents/guardians who are the subjects of qualitative interviews, the IRB granted a waiver of documentation of consent under 45 CFR 46.117(c)(1)(ii) and an alteration of HIPAA authorization (to obtain verbal authorization) under 45 CFR 164.512(i)(2)(ii).
: Not applicable.
: RSB is an Associate Editor of <i>Implementation Science</i>; all decisions on this paper were made by other editors. RSB is the principal at Implementation Science & Practice, LLC. She receives royalties from Oxford University Press, consulting fees from United Behavioral Health and OptumLabs, and serves on the advisory boards for Optum Behavioral Health, AIM Youth Mental Health Foundation, and the Klingenstein Third Generation Foundation, outside of the submitted work. The other authors declare that they have no competing interests.