Content validity and psychometric properties of the inFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus^©) instrument in patients with COVID-19.

"Declarations Conflict of interestTJHK, PG, HJB, and AL are employees of, and hold stocks/shares in, GSK. CR and SS are employees of, and hold stocks/shares in, Vir Biotechnology. KR, MK, CDS, and AMF are employees of QualityMetric Incorporated; QualityMetric Incorporated received funding from GSK to conduct part of this research and did not receive funding for manuscript development. HLG is an employee of Evidera; Evidera received funding from GSK to conduct part of this research and did not receive funding for manuscript development. JHP has served as a consultant for Arrevus, Eicos, Eli Lilly, Evofem, Eyecheck, Gilead, GlaxoSmithKline, Johnson & Johnson, Microbion, OPKO, Otsuka, Resolve, Romark, Shinogi, SpineBioPharma, UTIlity, and Vir. Ethical approvalEthics approval for the qualitative study was granted by the New England Independent Review Board (NEIRB). NEIRB reviewed and approved all qualitative study materials prior to the start of recruitment. Ethics approval for the psychometric evaluation was covered by the COMET-ICE trial (NCT04545060) IRB. Consent to participateAll subjects who participated in the qualitative interviews were required to sign an informed consent form prior to interview. Use of patient data in the psychometric evaluation was covered under the COMET-ICE trial's ethical approval (NCT04545060). Consent to publishConsent to publish was included in the informed consent form subjects were required to sign before participating in the qualitative interviews. Publishing of patient data analyzed in the psychometric evaluation was covered under the COMET-ICE trial's ethical approval (NCT04545060). Conflict of interest TJHK, PG, HJB, and AL are employees of, and hold stocks/shares in, GSK. CR and SS are employees of, and hold stocks/shares in, Vir Biotechnology. KR, MK, CDS, and AMF are employees of QualityMetric Incorporated; QualityMetric Incorporated received funding from GSK to conduct part of this research and did not receive funding for manuscript development. HLG is an employee of Evidera; Evidera received funding from GSK to conduct part of this research and did not receive funding for manuscript development. JHP has served as a consultant for Arrevus, Eicos, Eli Lilly, Evofem, Eyecheck, Gilead, GlaxoSmithKline, Johnson & Johnson, Microbion, OPKO, Otsuka, Resolve, Romark, Shinogi, SpineBioPharma, UTIlity, and Vir."

"Funding This study was funded by GlaxoSmithKline in collaboration with Vir (GSK study 215031 and GSK study 215032, Vir-7831-5001, ClinicalTrials.gov ID: NCT04545060)."

"Trial Registration: ClinicalTrials.Gov: NCT04545060, September 10, 2020; retrospectively registered."