Evaluation of symptoms in respiratory syncytial virus infection in adults: psychometric evaluation of the Respiratory Infection Intensity and Impact Questionnaire™ symptom scores

Journal of Patient-Reported Outcomes

Research

Jane A. Scott¹  Eric K. H. Chan²  Benoit Callendret³  Els De Paepe³  Gabriela Ispas³  Efi Gymnopoulou³  Esther Heijnen³  Christy Comeaux³  Yannick Vandendijck³  Richard H. Osborne⁴  Nicole Williams⁵  Randall H. Bender⁵  Lauren M. Nelson⁵  Ryan Ziemiecki⁵  Lindsey Norcross⁵  Sheri Fehnel⁵ 

[1] Janssen Global Services, High Wycombe, Buckinghamshire, UK;Janssen Global Services, Raritan, NJ, USA;Janssen Infectious Diseases, Beerse, Antwerp, Belgium;Measured Solutions for Health, P.O. Box 5127, 3079, Alphington, VIC, Australia;Centre of Global Health and Equity, Swinburne University of Technology, Hawthorn, VIC, Australia;RTI Health Solutions, Research Triangle Park, NC, USA;

关键词: RiiQ™;    Respiratory syncytial virus;    Validation;    Psychometric;    Patient-reported outcome;   

DOI  :  10.1186/s41687-023-00593-9

 received in 2023-01-24, accepted in 2023-05-18,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundThe Respiratory Infection Intensity and Impact Questionnaire (RiiQ™) is a patient-reported outcome measure designed to assess symptoms and impacts of respiratory syncytial virus (RSV) infection. This study evaluated the construct validity, reliability, and responsiveness of the RiiQ™ Respiratory and Systemic Symptoms Scale scores.MethodsProspective data were analyzed from a total of 1795 participants, including from non-hospitalized patients with acute respiratory infection (ARI) and no coinfections enrolled in a Phase 2b RSV vaccine study (RSV-positive: n = 60; RSV-negative: n = 1615), and two observational studies of patients hospitalized with RSV (n = 20; n = 100). Descriptive statistics, confirmatory factor analysis (CFA), test–retest intraclass correlation coefficients (ICCs), construct validity correlations (between a clinician-assessed clinical questionnaire and the RiiQ™ symptoms scale), known-groups validity, and responsiveness (correlations of change scores) were evaluated.ResultsMean patient age ranged from 66.5 to 71.5 years and the majority of patients were female. Initial assessments in the vaccine trial (ARI Day 1) were suggestive of less severe illness than in the observational studies with hospitalized patients. CFA loadings (> 0.40) supported summary scores. ICCs exceeding the recommended threshold of 0.70 supported test–retest reliability for Respiratory and Systemic Symptoms, except in the small observational study. At the scale level, correlations were moderate to strong (|r| ≥ 0.3) and positive between the Respiratory Symptoms Scale and the related clinical questionnaire scores, reflecting measurement of similar symptoms in support of convergent validity. Correlations with change in Patient Global Impression of Severity > 0.30 supported responsiveness.ConclusionsPsychometric tests applied to the RiiQ™ Symptoms scales provide evidence of its reliability, construct validity, discriminating ability, and responsiveness for use in clinical studies to assess the onset and severity of RSV symptoms.

【 授权许可】

CC BY   
© The Author(s) 2023

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