BACKGROUND: Respiratory syncytial virus (RSV) causes significant morbidity and mortality in older adults. Despite a number of RSV vaccine candidates in clinical trials, there are no existing disease-specific, self-reported measures that assess the signs, symptoms, and severity of RSV infection from the perspective of adult patients with acute RSV. The objective of this study is to describe the development of the RSV Infection Intensity and Impact Questionnaire (RSV-iiiQ), a new patient-reported outcomes measure.
METHODS: A targeted review of the literature identified relevant existing measures, signs, symptoms, and impacts of RSV. A draft version of the RSV-iiiQ was developed based on the Influenza Intensity and Impact Questionnaire (Flu-iiO) with expert input. Qualitative interviews (N = 20) were conducted with participants to confirm content validity and to optimize instrument structure. Interviews included concept elicitation and a cognitive debriefing assessment. A draft conceptual framework was developed and eCOA piloted. All steps of instrument development followed FDA patient-reported outcome guidance.
RESULTS: In-depth interviews confirmed the comprehensive nature of the tool, relevancy to the experience of RSV infection and the ease of completion (paper and electronic versions) of the measure. Minor refinements were made based on participant feedback. The draft conceptual framework was refined using participant input.
CONCLUSIONS: The RSV-iiiQ was developed for use in clinical trials to measure symptom intensity and impact of acute infection from the perspective of adult patients. The tool was developed in accordance to current regulatory guidance and is useful to support patient-focused drug development. Psychometric evaluation is currently underway.
