| Autor: |
Sandy Lewis, Carla DeMuro, Stan L. Block, Shelly Senders, Paul Wisman, Seth Toback, Jason W. Chien, Valerie Williams |
| Jazyk: |
angličtina |
| Rok vydání: |
2018 |
| Předmět: |
|
| Zdroj: |
Journal of Patient-Reported Outcomes, Vol 2, Iss 1, Pp 1-9 (2018) |
| Druh dokumentu: |
article |
| ISSN: |
2509-8020 |
| DOI: |
10.1186/s41687-018-0034-9 |
| Popis: |
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 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. Results Caregivers of 39 children |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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Full text from SpringerLink