Patient-Reported Questionnaire Could Aid the Evaluation of Respiratory Syncytial Virus Symptoms

Findings of a new study create a patient-reported outcome measure, called The Respiratory Infection Intensity and Impact Questionnaire (RiiQ) to access and evaluate symptoms of respiratory syncytial virus (RSV), according to the Journal of Patient-Reported Outcomes. The RiiQ is intended to evaluate the reliability and responsive of the RSV Symptoms Scale scores.

Peter Hansen - stock.adobe.com

RSV is a common illness that can create serious health concerns for young children, adults who are 60 years and older, individuals that are immunocompromised, and those with high-risk health conditions. RSV is often undiagnosed in older adults, increasing the mortality risk for those infected. According to the study, 11,000 individuals who are 65 years and older die annually from the virus in the United States.

In the study, the authors explain that the virus attacks individuals differently and can present numerous symptoms that may go unnoticed. In order to effectively detect the symptoms and sensitive changes of RSV, a patient-reported outcome (PRO) is used.

“The RiiQ, a PRO measure of symptom severity and impacts of RSV infection, was developed for use in clinical trials to evaluate the efficacy of new RSV vaccines and treatments. Consistent with Food and Drug Administration guidance, the RiiQ was adapted from a well-developed PRO, the Influenza Intensity and Impact Questionnaire, a measure widely used to detect and monitor symptoms of influenza and acute respiratory infection (ARI),” said the authors of the study.

According to the study, data was collected and organized from 1795 individuals who participated in the research. The participants were selected from patients who were not hospitalized with an ARI and were enrolled in a Phase 2b of the RSV vaccine trial. The additional participants were in 2 observational studies of patients who were infected with RSV. Between the 3 different studies, the psychometric properties of the RiiQ were evaluated.

“An ARI episode commenced when a participant reported experiencing at least 1 respiratory symptom that was new or worse than usually experienced at baseline. Resolution of an ARI episode was defined as 2 consecutive days with no symptoms listed on the RiiQ Symptoms Scale, or for participants who had symptoms on the RiiQ Symptoms Scale present at baseline, as 2 consecutive days on which all symptoms on the RiiQ Symptoms Scale returned to the severity reported at baseline. Participants who experienced symptoms suggesting an ARI episode were tested for RSV via an RT-PCR assay. Data from the primary analysis (ie, through the end of the first RSV season) were used in this evaluation,” said the authors of the study.

The results from the vaccine trial determined a less severe illness than the hospital patients that were observed.

“At the scale level, correlations were moderate to strong and positive between the Respiratory Symptoms Scale and the related clinical questionnaire scores, reflecting measurement of similar symptoms in support of convergent validity,” said the authors of the study.

The findings suggest that the psychometric tests used for the RiiQ Symptoms scale provides reliable, construct validity, and responsive evidence to use in clinical trials in order to detect onset symptoms of RSV.

Reference

Evaluation of Symptoms in Respiratory Syncytial Virus Infection in Adults: Psychometric Evaluation of the Respiratory Infection Intensity and Impact Questionnaire™ Symptom Scores. News release. Springer Open. June 1, 2023. Accessed June 23, 2023. doi:https://doi.org/10.1186/s41687-023-00593-9