Development of a novel observer-reported outcome measure for the assessment of Respiratory Syncytial Virus (RSV) infection symptoms in pediatric clinical trials.

ABSTRACT:

Background

Respiratory syncytial virus (RSV) is a seasonal infection affecting most children by 2 years of age and the leading cause of lower respiratory tract infection requiring hospitalization in infants. Novel antiviral medications are in development to improve the clinical outcomes of RSV; however, no clinical outcome assessments (COAs) for RSV have been developed in alignment with the United States Food and Drug Administration patient-reported outcome guidance to assist in the evaluation of new therapies. To address this need, an observer-reported outcome (ObsRO) measure designed to assess observable RSV symptoms was created.

Methods

The literature was reviewed to evaluate existing COAs and identify constructs of interest. Individual caregiver interviews elicited conce

SUBMITTER: Lewis S 

PROVIDER: S-EPMC5935018 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature