Assessing the patient experience of respiratory syncytial virus infection: development of a patient-reported outcome measure

Carla DeMuro Romano; Lyn Finelli; Sandy Lewis; Valerie Williams; Emily Martin; Matthew Phillips; Todd L Saretsky; Josephine Norquist

doi:10.1186/s12955-022-02066-x

Assessing the patient experience of respiratory syncytial virus infection: development of a patient-reported outcome measure

Health Qual Life Outcomes. 2023 Feb 28;21(1):20. doi: 10.1186/s12955-022-02066-x.

Authors

Carla DeMuro Romano¹, Lyn Finelli², Sandy Lewis³, Valerie Williams³, Emily Martin⁴, Matthew Phillips², Todd L Saretsky⁵, Josephine Norquist⁵

Affiliations

¹ RTI Health Solutions, 3040 East Cornwallis Road, Post Office Box 12194 Research Triangle Park, Durham, NC, 27709-2194, USA. demuromercon@rti.org.
² Center for Observational and Real-World Evidence, Merck and Co., Inc, Rahway, NJ, USA.
³ RTI Health Solutions, 3040 East Cornwallis Road, Post Office Box 12194 Research Triangle Park, Durham, NC, 27709-2194, USA.
⁴ School of Public Health, University of Michigan, Ann Arbor, MI, USA.
⁵ Biostatistics and Research Data Sciences, Patient-Centered Endpoints and Strategy Group, Merck and Co., Inc, Rahway, NJ, USA.

Abstract

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 symptoms and severity of RSV infection from the perspective of adult patients with acute RSV. The objective of this study was to describe the initial conceptualization and development of the RSV Infection, Intensity and Impact Questionnaire (RSV-iiiQ), a new patient-reported outcome measure.

Methods: A targeted review of the literature identified relevant existing measures, symptoms, and impacts of RSV. A draft version of the RSV-iiiQ was developed based on the Influenza Intensity and Impact Questionnaire (Flu-iiQ) with expert input. Qualitative interviews (N = 20) were conducted with participants to optimize the RSV-iiiQ conceptual model and confirm the content validity of the RSV-iiiQ. Interviews included concept elicitation and a cognitive debriefing assessment. A draft conceptual framework was developed, and the electronic clinical outcome assessment was piloted. All steps of instrument development followed Food and Drug Administration guidance for patient-reported outcomes.

Results: In-depth concept elicitation interviews followed by cognitive debriefings demonstrated that the content of the items was comprehensive, covered the breadth of RSV symptoms and impacts, and was relevant to the experiences of individuals with RSV. Both the paper and electronic versions of the RSV-iiiQ were easily completed. Minor refinements were made to some items based on participant feedback, and the draft conceptual framework was refined.

Conclusions: The RSV-iiiQ was developed for use in clinical trials to measure the symptom intensity and impact of acute RSV infection from the perspective of adult patients. The tool was developed in accordance with current regulatory guidance and is useful to support patient-focused drug development.

Keywords: Disease burden; Impact; RSV Infection, Intensity and Impact Questionnaire (RSV-iiiQ); Respiratory syncytial virus (RSV); Symptoms.

Publication types

Review

MeSH terms

Aged
Humans
Influenza Vaccines*
Influenza, Human*
Patient Reported Outcome Measures
Quality of Life
Respiratory Syncytial Virus Infections*
United States

Substances

Influenza Vaccines