Validation of a diagnosis-agnostic symptom questionnaire for asthma and/or COPD

Background The Respiratory Symptoms Questionnaire (RSQ) is a novel, four-item patient-reported diagnosis-agnostic tool designed to assess the frequency of respiratory symptoms and their impact on activity, without specifying a particular diagnosis. Our objective was to examine its validity in patien...

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Main Authors: Niklas Karlsson, Mark J. Atkinson, Hana Müllerová, Marianna Alacqua, Christina Keen, Rod Hughes, Christer Janson, Barry Make, David Price, Helen K. Reddel
Format: Article
Language:English
Published: European Respiratory Society 2021-02-01
Series:ERJ Open Research
Online Access:http://openres.ersjournals.com/content/7/1/00828-2020.full
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author Niklas Karlsson
Mark J. Atkinson
Hana Müllerová
Marianna Alacqua
Christina Keen
Rod Hughes
Christer Janson
Barry Make
David Price
Helen K. Reddel
author_facet Niklas Karlsson
Mark J. Atkinson
Hana Müllerová
Marianna Alacqua
Christina Keen
Rod Hughes
Christer Janson
Barry Make
David Price
Helen K. Reddel
author_sort Niklas Karlsson
collection DOAJ
description Background The Respiratory Symptoms Questionnaire (RSQ) is a novel, four-item patient-reported diagnosis-agnostic tool designed to assess the frequency of respiratory symptoms and their impact on activity, without specifying a particular diagnosis. Our objective was to examine its validity in patients with asthma and/or chronic obstructive pulmonary disease (COPD). Methods Baseline data were randomly sampled from patients who completed the RSQ in the NOVELTY study (ClinicalTrials.gov: NCT02760329). The total sample (n=1530) comprised three randomly selected samples (n=510 each) from each physician-assigned diagnostic group (asthma, asthma+COPD and COPD). The internal consistency and structural validity of the RSQ were evaluated using exploratory and confirmatory factor analyses; psychometric performance was observed using Classical Test Theory and Item Response Theory analyses. Results For the total sample, the mean±sd RSQ score was 5.6±4.3 (range 0–16). Irrespective of diagnosis, the internal consistency of items was uniformly adequate (Cronbach's α=0.76–0.80). All items had high factor loadings and structural characteristics of the measure were invariant across groups. Using the total sample, RSQ items informatively covered the θ score range of –2.0 to 2.8, with discrimination coefficients for individual items being high to very high (1.7–2.6). Strong convergent correlations were observed between the RSQ and the St George's Respiratory Questionnaire (0.77, p<0.001). Conclusions The RSQ is a valid, brief, patient-reported tool for assessing respiratory symptoms in patients across the whole spectrum of asthma and/or COPD, rather than using different questionnaires for each diagnosis. It can be used for monitoring respiratory symptoms in clinical practice, clinical trials and real-world studies.
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spelling doaj.art-a0950d25b9e348dcb8b6b8fea6579c242022-12-21T21:30:28ZengEuropean Respiratory SocietyERJ Open Research2312-05412021-02-017110.1183/23120541.00828-202000828-2020Validation of a diagnosis-agnostic symptom questionnaire for asthma and/or COPDNiklas Karlsson0Mark J. Atkinson1Hana Müllerová2Marianna Alacqua3Christina Keen4Rod Hughes5Christer Janson6Barry Make7David Price8Helen K. Reddel9 BioPharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden Evidera, Bethesda, MD, USA BioPharmaceuticals Medical, AstraZeneca, Cambridge, UK BioPharmaceuticals Medical, AstraZeneca, Cambridge, UK BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden BioPharmaceuticals Medical, AstraZeneca, Cambridge, UK Dept of Medical Sciences: Respiratory, Allergy and Sleep Research, Uppsala University, Uppsala, Sweden National Jewish Health and University of Colorado Denver, Denver, CO, USA Observational and Pragmatic Research Institute, Singapore, Singapore Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia Background The Respiratory Symptoms Questionnaire (RSQ) is a novel, four-item patient-reported diagnosis-agnostic tool designed to assess the frequency of respiratory symptoms and their impact on activity, without specifying a particular diagnosis. Our objective was to examine its validity in patients with asthma and/or chronic obstructive pulmonary disease (COPD). Methods Baseline data were randomly sampled from patients who completed the RSQ in the NOVELTY study (ClinicalTrials.gov: NCT02760329). The total sample (n=1530) comprised three randomly selected samples (n=510 each) from each physician-assigned diagnostic group (asthma, asthma+COPD and COPD). The internal consistency and structural validity of the RSQ were evaluated using exploratory and confirmatory factor analyses; psychometric performance was observed using Classical Test Theory and Item Response Theory analyses. Results For the total sample, the mean±sd RSQ score was 5.6±4.3 (range 0–16). Irrespective of diagnosis, the internal consistency of items was uniformly adequate (Cronbach's α=0.76–0.80). All items had high factor loadings and structural characteristics of the measure were invariant across groups. Using the total sample, RSQ items informatively covered the θ score range of –2.0 to 2.8, with discrimination coefficients for individual items being high to very high (1.7–2.6). Strong convergent correlations were observed between the RSQ and the St George's Respiratory Questionnaire (0.77, p<0.001). Conclusions The RSQ is a valid, brief, patient-reported tool for assessing respiratory symptoms in patients across the whole spectrum of asthma and/or COPD, rather than using different questionnaires for each diagnosis. It can be used for monitoring respiratory symptoms in clinical practice, clinical trials and real-world studies.http://openres.ersjournals.com/content/7/1/00828-2020.full
spellingShingle Niklas Karlsson
Mark J. Atkinson
Hana Müllerová
Marianna Alacqua
Christina Keen
Rod Hughes
Christer Janson
Barry Make
David Price
Helen K. Reddel
Validation of a diagnosis-agnostic symptom questionnaire for asthma and/or COPD
ERJ Open Research
title Validation of a diagnosis-agnostic symptom questionnaire for asthma and/or COPD
title_full Validation of a diagnosis-agnostic symptom questionnaire for asthma and/or COPD
title_fullStr Validation of a diagnosis-agnostic symptom questionnaire for asthma and/or COPD
title_full_unstemmed Validation of a diagnosis-agnostic symptom questionnaire for asthma and/or COPD
title_short Validation of a diagnosis-agnostic symptom questionnaire for asthma and/or COPD
title_sort validation of a diagnosis agnostic symptom questionnaire for asthma and or copd
url http://openres.ersjournals.com/content/7/1/00828-2020.full
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