OBJECTIVES : PRESORS was developed using best practice methods to monitor the clinical course of pediatric RSV disease based on clinicians’ (ClinRO) and parents’/caregivers’ (ObsRO) ratings of the severity of RSV signs they observed. This study sought to evaluate the content validity and feasibility of completing the PRESORS to assess RSV severity in pediatric patients during hospitalization and post discharge at home.

METHODS : Clinicians and parents/caregivers of pediatric patients (≤24 months) with lab-confirmed RSV infection completed PRESORSv6 electronically (eCOA) twice daily while the child was hospitalized and post discharge for 7 days in a global observational study. Concept elicitation and topline cognitive debriefing telephone exit interviews were conducted with caregivers and investigators. Interviews were audio-recorded, transcribed verbatim and anonymized. Transcripts were subject to thematic analysis using AtlasTi.

RESULTS : Interviews with 102 caregivers and 7 investigators were conducted across 16 sites in the US, Argentina and Chile. Parents/caregivers and clinicians confirmed PRESORSv6 item wording was well-understood. PRESORS ObsRO included 20 of 24 RSV signs spontaneously described by caregivers including difficulty breathing (n=81/102; 79%), change in behavior (n=72/102; 71%) and coughing (n=59/102, 58%). Most caregivers reported that no important concepts were missing (78.4%) and that they observed all signs assessed in PRESORS (76.4%). Investigators confirmed that PRESORS assesses important signs of RSV for pediatric patients, with the most important of these being difficulty breathing [71%] and difficulty eating/drinking [57%]). Most caregivers and investigators reported the PRESORS questions and response options are clear and appropriate. Caregivers and clinicians confirmed that the eCOA device was easy to use and completion rates were high (92% to 100% of scheduled ObsRO and ClinRO PRESORS).

CONCLUSIONS : Reports from caregiver and clinician interviews from a multinational study of pediatric patients treated for RSV disease in hospitals confirm the PRESORSv6 is well-understood, conceptually comprehensive and easy to complete electronically.