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

Journal of Patient-reported Outcomes
Sandy LewisValerie Williams

Abstract

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. The literature was reviewed to evaluate existing COAs and identify constructs of interest. Individual caregiver interviews elicited concepts that informed item development, and candidate items were subsequently evaluated in two rounds of cognitive testing. Separate cohorts of caregivers of RSV-infected nonhospitalized and hospitalized infants participated. Therapeutic-area experts provided input throughout the instrument development process. Caregivers of 39 children < 24 months old with RSV (31 nonhospitalized, 8 hospitalized) participated in in-depth, individual interviews during concept elicitation and cogni...Continue Reading

References

Dec 1, 1993·Archives of Disease in Childhood·S KristjánssonK H Carlsen
Dec 18, 2002·Pediatric Allergy and Immunology : Official Publication of the European Society of Pediatric Allergy and Immunology·James E GernRobert F Lemanske
Aug 14, 2009·Health and Quality of Life Outcomes·Bruce BarrettMozhdeh Bahrainian
Oct 22, 2013·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Chidi N ObasiBruce P Barrett
Jan 1, 2017·Journal of Patient-reported Outcomes·Valerie WilliamsJason W Chien

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Citations

Sep 14, 2021·The Cleft Palate-craniofacial Journal : Official Publication of the American Cleft Palate-Craniofacial Association·Todd C EdwardsDonald L Patrick

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Software Mentioned

ClinRO
ObsRO

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