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

Abstract Background The 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 R...

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Main Authors: Richard H. Osborne, Lauren M. Nelson, Sheri Fehnel, Nicole Williams, Randall H. Bender, Ryan Ziemiecki, Efi Gymnopoulou, Els De Paepe, Yannick Vandendijck, Lindsey Norcross, Esther Heijnen, Gabriela Ispas, Christy Comeaux, Benoit Callendret, Eric K. H. Chan, Jane A. Scott
Format: Article
Language:English
Published: SpringerOpen 2023-06-01
Series:Journal of Patient-Reported Outcomes
Subjects:
Online Access:https://doi.org/10.1186/s41687-023-00593-9
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author Richard H. Osborne
Lauren M. Nelson
Sheri Fehnel
Nicole Williams
Randall H. Bender
Ryan Ziemiecki
Efi Gymnopoulou
Els De Paepe
Yannick Vandendijck
Lindsey Norcross
Esther Heijnen
Gabriela Ispas
Christy Comeaux
Benoit Callendret
Eric K. H. Chan
Jane A. Scott
author_facet Richard H. Osborne
Lauren M. Nelson
Sheri Fehnel
Nicole Williams
Randall H. Bender
Ryan Ziemiecki
Efi Gymnopoulou
Els De Paepe
Yannick Vandendijck
Lindsey Norcross
Esther Heijnen
Gabriela Ispas
Christy Comeaux
Benoit Callendret
Eric K. H. Chan
Jane A. Scott
author_sort Richard H. Osborne
collection DOAJ
description Abstract Background The 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. Methods Prospective 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. Results Mean 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. Conclusions Psychometric 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.
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spelling doaj.art-5b724d2c15ed41cd898aa8d9498f41372023-06-04T11:30:25ZengSpringerOpenJournal of Patient-Reported Outcomes2509-80202023-06-017111010.1186/s41687-023-00593-9Evaluation of symptoms in respiratory syncytial virus infection in adults: psychometric evaluation of the Respiratory Infection Intensity and Impact Questionnaire™ symptom scoresRichard H. Osborne0Lauren M. Nelson1Sheri Fehnel2Nicole Williams3Randall H. Bender4Ryan Ziemiecki5Efi Gymnopoulou6Els De Paepe7Yannick Vandendijck8Lindsey Norcross9Esther Heijnen10Gabriela Ispas11Christy Comeaux12Benoit Callendret13Eric K. H. Chan14Jane A. Scott15Measured Solutions for HealthRTI Health SolutionsRTI Health SolutionsRTI Health SolutionsRTI Health SolutionsRTI Health SolutionsJanssen Infectious DiseasesJanssen Infectious DiseasesJanssen Infectious DiseasesRTI Health SolutionsJanssen Infectious DiseasesJanssen Infectious DiseasesJanssen Infectious DiseasesJanssen Infectious DiseasesJanssen Global ServicesJanssen Global ServicesAbstract Background The 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. Methods Prospective 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. Results Mean 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. Conclusions Psychometric 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.https://doi.org/10.1186/s41687-023-00593-9RiiQ™Respiratory syncytial virusValidationPsychometricPatient-reported outcome
spellingShingle Richard H. Osborne
Lauren M. Nelson
Sheri Fehnel
Nicole Williams
Randall H. Bender
Ryan Ziemiecki
Efi Gymnopoulou
Els De Paepe
Yannick Vandendijck
Lindsey Norcross
Esther Heijnen
Gabriela Ispas
Christy Comeaux
Benoit Callendret
Eric K. H. Chan
Jane A. Scott
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
RiiQ™
Respiratory syncytial virus
Validation
Psychometric
Patient-reported outcome
title Evaluation of symptoms in respiratory syncytial virus infection in adults: psychometric evaluation of the Respiratory Infection Intensity and Impact Questionnaire™ symptom scores
title_full Evaluation of symptoms in respiratory syncytial virus infection in adults: psychometric evaluation of the Respiratory Infection Intensity and Impact Questionnaire™ symptom scores
title_fullStr Evaluation of symptoms in respiratory syncytial virus infection in adults: psychometric evaluation of the Respiratory Infection Intensity and Impact Questionnaire™ symptom scores
title_full_unstemmed Evaluation of symptoms in respiratory syncytial virus infection in adults: psychometric evaluation of the Respiratory Infection Intensity and Impact Questionnaire™ symptom scores
title_short Evaluation of symptoms in respiratory syncytial virus infection in adults: psychometric evaluation of the Respiratory Infection Intensity and Impact Questionnaire™ symptom scores
title_sort evaluation of symptoms in respiratory syncytial virus infection in adults psychometric evaluation of the respiratory infection intensity and impact questionnaire™ symptom scores
topic RiiQ™
Respiratory syncytial virus
Validation
Psychometric
Patient-reported outcome
url https://doi.org/10.1186/s41687-023-00593-9
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