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A multicenter international prospective study of the validity and reliability of a COVID-19-specific health-related quality of life questionnaire

A multicenter international prospective study of the validity and reliability of a COVID-19-specific health-related quality of life questionnaire
A multicenter international prospective study of the validity and reliability of a COVID-19-specific health-related quality of life questionnaire
Purpose: To develop and validate a health-related quality of life (HRQoL) questionnaire for patients with current or previous coronavirus disease (COVID-19) in an international setting. Methods: This multicenter international methodology study followed standardized guidelines for a four-phase questionnaire development. Here, we report on the pretesting and validation of our international questionnaire. Adults with current or previous COVID-19, in institutions or at home were eligible. In the pretesting, 54 participants completed the questionnaire followed by interviews to identify administration problems and evaluate content validity. Thereafter, 371 participants completed the revised questionnaire and a debriefing form to allow preliminary psychometric analysis. Validity and reliability were assessed (correlation-based methods, Cronbach’s α, and intra-class correlation coefficient). Results: Eleven countries within and outside Europe enrolled patients. From the pretesting, 71 of the 80 original items fulfilled the criteria for item-retention. Most participants (80%) completed the revised 71-item questionnaire within 15 min, on paper (n = 175) or digitally (n = 196). The final questionnaire included 61 items that fulfilled criteria for item retention or were important to subgroups. Item-scale correlations were > 0.7 for all but nine items. Internal consistency (range 0.68–0.92) and test–retest results (all but one scale > 0.7) were acceptable. The instrument consists of 15 multi-item scales and six single items. Conclusion: The Oslo COVID-19 QLQ-W61 is an international, stand-alone, multidimensional HRQoL questionnaire that can assess the symptoms, functioning, and overall quality of life in COVID-19 patients. It is available for use in research and clinical practice. Further psychometric validation in larger patient samples will be performed.
COVID-19, HRQoL, PROM, Patient-reported outcome measure, Quality of life, Questionnaire
0962-9343
Amdal, Cecilie Delphin
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Falk, Ragnhild Sørum
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Singer, Susanne
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Pe, Madeline
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Piccinin, Claire
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Bottomley, Andrew
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Appiah, Lambert Tetteh
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Arraras, Juan Ignacio
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Bayer, Oliver
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Buanes, Eirik Alnes
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Darlington, Anne Sophie
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Arbanas, Gracia Dekanic
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Hofsø, Kristin
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Holzner, Bernard
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Sahlstrand-johnson, Pernilla
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Kuliś, Dagmara
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Parmar, Ghansyam
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Rmeileh, Niveen M. E. Abu
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Schranz, Melanie
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Sodergren, Samantha
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Bjordal, Kristin
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Amdal, Cecilie Delphin
48300972-b106-4471-8450-5fe4250a9376
Falk, Ragnhild Sørum
7f1c0388-2020-4afd-8111-833858ef6c48
Singer, Susanne
7fa65198-a58a-476f-acd6-1bf67d3e9f76
Pe, Madeline
f8974edd-ce99-4dd1-aef2-917866cba650
Piccinin, Claire
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Bottomley, Andrew
aa0c035f-f787-4557-8b12-9e757c413cd0
Appiah, Lambert Tetteh
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Arraras, Juan Ignacio
cfd50eba-4987-4fda-9069-36dccffa87d2
Bayer, Oliver
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Buanes, Eirik Alnes
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Darlington, Anne Sophie
472fcfc9-160b-4344-8113-8dd8760ff962
Arbanas, Gracia Dekanic
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Hofsø, Kristin
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Holzner, Bernard
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Sahlstrand-johnson, Pernilla
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Kuliś, Dagmara
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Parmar, Ghansyam
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Rmeileh, Niveen M. E. Abu
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Schranz, Melanie
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Sodergren, Samantha
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Bjordal, Kristin
9b0f6119-b522-41d9-9424-b20acdee391c

Amdal, Cecilie Delphin, Falk, Ragnhild Sørum, Singer, Susanne, Pe, Madeline, Piccinin, Claire, Bottomley, Andrew, Appiah, Lambert Tetteh, Arraras, Juan Ignacio, Bayer, Oliver, Buanes, Eirik Alnes, Darlington, Anne Sophie, Arbanas, Gracia Dekanic, Hofsø, Kristin, Holzner, Bernard, Sahlstrand-johnson, Pernilla, Kuliś, Dagmara, Parmar, Ghansyam, Rmeileh, Niveen M. E. Abu, Schranz, Melanie, Sodergren, Samantha and Bjordal, Kristin (2022) A multicenter international prospective study of the validity and reliability of a COVID-19-specific health-related quality of life questionnaire. Quality of Life Research. (doi:10.1007/s11136-022-03272-2).

Record type: Article

Abstract

Purpose: To develop and validate a health-related quality of life (HRQoL) questionnaire for patients with current or previous coronavirus disease (COVID-19) in an international setting. Methods: This multicenter international methodology study followed standardized guidelines for a four-phase questionnaire development. Here, we report on the pretesting and validation of our international questionnaire. Adults with current or previous COVID-19, in institutions or at home were eligible. In the pretesting, 54 participants completed the questionnaire followed by interviews to identify administration problems and evaluate content validity. Thereafter, 371 participants completed the revised questionnaire and a debriefing form to allow preliminary psychometric analysis. Validity and reliability were assessed (correlation-based methods, Cronbach’s α, and intra-class correlation coefficient). Results: Eleven countries within and outside Europe enrolled patients. From the pretesting, 71 of the 80 original items fulfilled the criteria for item-retention. Most participants (80%) completed the revised 71-item questionnaire within 15 min, on paper (n = 175) or digitally (n = 196). The final questionnaire included 61 items that fulfilled criteria for item retention or were important to subgroups. Item-scale correlations were > 0.7 for all but nine items. Internal consistency (range 0.68–0.92) and test–retest results (all but one scale > 0.7) were acceptable. The instrument consists of 15 multi-item scales and six single items. Conclusion: The Oslo COVID-19 QLQ-W61 is an international, stand-alone, multidimensional HRQoL questionnaire that can assess the symptoms, functioning, and overall quality of life in COVID-19 patients. It is available for use in research and clinical practice. Further psychometric validation in larger patient samples will be performed.

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Accepted/In Press date: 5 October 2022
e-pub ahead of print date: 23 October 2022
Additional Information: Funding Information: Open access funding provided by University of Oslo (incl Oslo University Hospital). Internal research funds from Oslo University Hospital HF (project nr 41595 and 35444) and research funds from University of Oslo (project nr 102372066). Grant from the Health Department—Government of Navarra (0011-3638-2020-000012) (JI Arraras). Funding Information: The current study is a multicenter international methodology study for a questionnaire development. Guidelines from the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group (QLG) were followed []. The four-phase procedure covers general principles for questionnaire development and is supported by the Food and Drug Administration []. The first two phases (gathering relevant issues through literature review, interviews with health-care workers and patients in seven countries, and operationalization from issues to items) were performed from April to October 2020 and have been published [, ]. Publisher Copyright: © 2022, The Author(s).
Keywords: COVID-19, HRQoL, PROM, Patient-reported outcome measure, Quality of life, Questionnaire

Identifiers

Local EPrints ID: 471937
URI: http://eprints.soton.ac.uk/id/eprint/471937
ISSN: 0962-9343
PURE UUID: 6b11e614-79c6-4cff-9b48-d72273e9e95e
ORCID for Samantha Sodergren: ORCID iD orcid.org/0000-0001-8755-146X

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Date deposited: 22 Nov 2022 17:58
Last modified: 17 Mar 2024 07:34

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Contributors

Author: Cecilie Delphin Amdal
Author: Ragnhild Sørum Falk
Author: Susanne Singer
Author: Madeline Pe
Author: Claire Piccinin
Author: Andrew Bottomley
Author: Lambert Tetteh Appiah
Author: Juan Ignacio Arraras
Author: Oliver Bayer
Author: Eirik Alnes Buanes
Author: Gracia Dekanic Arbanas
Author: Kristin Hofsø
Author: Bernard Holzner
Author: Pernilla Sahlstrand-johnson
Author: Dagmara Kuliś
Author: Ghansyam Parmar
Author: Niveen M. E. Abu Rmeileh
Author: Melanie Schranz
Author: Kristin Bjordal

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