A comparison of the measurement properties of the PROMIS Fatigue (MS) 8a against legacy fatigue questionnaires

Kamudoni, Paul; Johns, Jeffrey; Cook, Karon F.; Salem, Rana; Salek, Sam; Raab, Jana; Middleton, Rod; Henke, Christian; Amtmann, Dagmar

doi:10.1016/j.msard.2022.104048

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A comparison of the measurement properties of the PROMIS Fatigue (MS) 8a against legacy fatigue questionnaires

Paul Kamudoni, Jeffrey Johns, Karon F. Cook, Rana Salem, Sam Salek, Jana Raab, Rod Middleton

, Christian Henke, Dagmar Amtmann

Multiple Sclerosis and Related Disorders, Volume: 66, Start page: 104048

Swansea University Author: Rod Middleton

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DOI (Published version): 10.1016/j.msard.2022.104048

Abstract

BackgroundAmidst the growing number of patient-reported outcome (PRO) measures of fatigue being used in multiple sclerosis (MS) clinical trials and clinics, evidence-based consensus on the most appropriate and generalizable measures across different settings would be beneficial for clinical research...

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Published in:	Multiple Sclerosis and Related Disorders
ISSN:	2211-0348
Published:	Elsevier BV 2022
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URI:	https://cronfa.swan.ac.uk/Record/cronfa61483
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The objective of this research was to compare the validity and responsiveness of scores from the PROMIS Fatigue (MS) 8a with those of the Fatigue Severity Scale (FSS) and the Modified Fatigue Impact Scale (MFIS), across US and UK MS populations.MethodsTwo observational studies were performed in MS populations as part of a PRO measure development project, including a cross-sectional study in two tertiary US MS centers (n = 340) and a 96-week longitudinal study in the UK MS Register cohort (n = 352). In post-hoc analyses, we examined relative validity, based on ability to discriminate across patient groups with different fatigue levels or functional status at baseline (i.e., ANOVA-F PROX ÷ ANOVA-F PROMIS (MS) 8a), and relative responsiveness, based on baseline-to-Week-52 score change (effect sizes) across fatigue or functional status response groups .ResultsMean ± standard deviation (SD) age was 44.6 ± 11.3/50.0 ± 9.7; and 72.9%/77.3% were female (US/UK samples). The mean PROMIS Fatigue (MS) 8a T-score ± SD at baseline was 57.7 ± 10.5/58.9 ± 9.3 (US/UK samples). Compared with the PROMIS Fatigue (MS) 8a, relative validity (anchor: Global Health Score [GHS] fatigue global question) was 85% for MFIS symptom score, 48% for MFIS total score, and 44% for the FSS. Relative to the FSS, PROMIS Fatigue (MS) 8a scores were more sensitive to worsening (effect size = -0.43 versus -0.18) as well as improvement (effect size = 0.5 versus 0.2) in fatigue (≥1-point increase/decrease in GHS fatigue global question) over 52 weeks of follow-up. A similar pattern of score changes was observed based on a second anchor.ConclusionThe PROMIS Fatigue (MS) 8a scores showed higher responsiveness to fatigue changes than those of the FSS. The PROMIS measure also had higher precision in differentiating levels of fatigue compared to the FSS, the MFIS physical, and MFIS total scores. These differences have practical implications for the application of these questionnaires in both clinical practice and research settings (e.g., sample size estimation in clinical trials).</abstract><type>Journal Article</type><journal>Multiple Sclerosis and Related Disorders</journal><volume>66</volume><journalNumber/><paginationStart>104048</paginationStart><paginationEnd/><publisher>Elsevier BV</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint>2211-0348</issnPrint><issnElectronic/><keywords>Fatigue; Multiple sclerosis; Outcome measurement; Quality of life; PROMIS</keywords><publishedDay>1</publishedDay><publishedMonth>10</publishedMonth><publishedYear>2022</publishedYear><publishedDate>2022-10-01</publishedDate><doi>10.1016/j.msard.2022.104048</doi><url/><notes/><college>COLLEGE NANME</college><department>Health Data Science</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>HDAT</DepartmentCode><institution>Swansea University</institution><apcterm/><funders>This study was sponsored by Merck Healthcare KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945).</funders><projectreference/><lastEdited>2022-10-20T15:06:51.0262537</lastEdited><Created>2022-10-07T12:09:35.4207577</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Medicine</level></path><authors><author><firstname>Paul</firstname><surname>Kamudoni</surname><order>1</order></author><author><firstname>Jeffrey</firstname><surname>Johns</surname><order>2</order></author><author><firstname>Karon F.</firstname><surname>Cook</surname><order>3</order></author><author><firstname>Rana</firstname><surname>Salem</surname><order>4</order></author><author><firstname>Sam</firstname><surname>Salek</surname><order>5</order></author><author><firstname>Jana</firstname><surname>Raab</surname><order>6</order></author><author><firstname>Rod</firstname><surname>Middleton</surname><orcid>0000-0002-2130-4420</orcid><order>7</order></author><author><firstname>Christian</firstname><surname>Henke</surname><order>8</order></author><author><firstname>Dagmar</firstname><surname>Amtmann</surname><order>9</order></author></authors><documents><document><filename>61483__25536__4c7c630be7c644bcb6b9e72c3515597b.pdf</filename><originalFilename>61483_VoR.pdf</originalFilename><uploaded>2022-10-20T15:06:02.2007870</uploaded><type>Output</type><contentLength>1560506</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><documentNotes>© 2022 The Authors. 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spelling	2022-10-20T15:06:51.0262537 v2 61483 2022-10-07 A comparison of the measurement properties of the PROMIS Fatigue (MS) 8a against legacy fatigue questionnaires 005518f819ef1a2a13fdf438529bdfcd 0000-0002-2130-4420 Rod Middleton Rod Middleton true false 2022-10-07 HDAT BackgroundAmidst the growing number of patient-reported outcome (PRO) measures of fatigue being used in multiple sclerosis (MS) clinical trials and clinics, evidence-based consensus on the most appropriate and generalizable measures across different settings would be beneficial for clinical research and patient care. The objective of this research was to compare the validity and responsiveness of scores from the PROMIS Fatigue (MS) 8a with those of the Fatigue Severity Scale (FSS) and the Modified Fatigue Impact Scale (MFIS), across US and UK MS populations.MethodsTwo observational studies were performed in MS populations as part of a PRO measure development project, including a cross-sectional study in two tertiary US MS centers (n = 340) and a 96-week longitudinal study in the UK MS Register cohort (n = 352). In post-hoc analyses, we examined relative validity, based on ability to discriminate across patient groups with different fatigue levels or functional status at baseline (i.e., ANOVA-F PROX ÷ ANOVA-F PROMIS (MS) 8a), and relative responsiveness, based on baseline-to-Week-52 score change (effect sizes) across fatigue or functional status response groups .ResultsMean ± standard deviation (SD) age was 44.6 ± 11.3/50.0 ± 9.7; and 72.9%/77.3% were female (US/UK samples). The mean PROMIS Fatigue (MS) 8a T-score ± SD at baseline was 57.7 ± 10.5/58.9 ± 9.3 (US/UK samples). Compared with the PROMIS Fatigue (MS) 8a, relative validity (anchor: Global Health Score [GHS] fatigue global question) was 85% for MFIS symptom score, 48% for MFIS total score, and 44% for the FSS. Relative to the FSS, PROMIS Fatigue (MS) 8a scores were more sensitive to worsening (effect size = -0.43 versus -0.18) as well as improvement (effect size = 0.5 versus 0.2) in fatigue (≥1-point increase/decrease in GHS fatigue global question) over 52 weeks of follow-up. A similar pattern of score changes was observed based on a second anchor.ConclusionThe PROMIS Fatigue (MS) 8a scores showed higher responsiveness to fatigue changes than those of the FSS. The PROMIS measure also had higher precision in differentiating levels of fatigue compared to the FSS, the MFIS physical, and MFIS total scores. These differences have practical implications for the application of these questionnaires in both clinical practice and research settings (e.g., sample size estimation in clinical trials). Journal Article Multiple Sclerosis and Related Disorders 66 104048 Elsevier BV 2211-0348 Fatigue; Multiple sclerosis; Outcome measurement; Quality of life; PROMIS 1 10 2022 2022-10-01 10.1016/j.msard.2022.104048 COLLEGE NANME Health Data Science COLLEGE CODE HDAT Swansea University This study was sponsored by Merck Healthcare KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945). 2022-10-20T15:06:51.0262537 2022-10-07T12:09:35.4207577 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Paul Kamudoni 1 Jeffrey Johns 2 Karon F. Cook 3 Rana Salem 4 Sam Salek 5 Jana Raab 6 Rod Middleton 0000-0002-2130-4420 7 Christian Henke 8 Dagmar Amtmann 9 61483__25536__4c7c630be7c644bcb6b9e72c3515597b.pdf 61483_VoR.pdf 2022-10-20T15:06:02.2007870 Output 1560506 application/pdf Version of Record true © 2022 The Authors. This is an open access article under the CC BY-NC-ND license true eng http://creativecommons.org/licenses/by-nc-nd/4.0/
title	A comparison of the measurement properties of the PROMIS Fatigue (MS) 8a against legacy fatigue questionnaires
spellingShingle	A comparison of the measurement properties of the PROMIS Fatigue (MS) 8a against legacy fatigue questionnaires Rod Middleton
title_short	A comparison of the measurement properties of the PROMIS Fatigue (MS) 8a against legacy fatigue questionnaires
title_full	A comparison of the measurement properties of the PROMIS Fatigue (MS) 8a against legacy fatigue questionnaires
title_fullStr	A comparison of the measurement properties of the PROMIS Fatigue (MS) 8a against legacy fatigue questionnaires
title_full_unstemmed	A comparison of the measurement properties of the PROMIS Fatigue (MS) 8a against legacy fatigue questionnaires
title_sort	A comparison of the measurement properties of the PROMIS Fatigue (MS) 8a against legacy fatigue questionnaires
author_id_str_mv	005518f819ef1a2a13fdf438529bdfcd
author_id_fullname_str_mv	005518f819ef1a2a13fdf438529bdfcd_***_Rod Middleton
author	Rod Middleton
author2	Paul Kamudoni Jeffrey Johns Karon F. Cook Rana Salem Sam Salek Jana Raab Rod Middleton Christian Henke Dagmar Amtmann
format	Journal article
container_title	Multiple Sclerosis and Related Disorders
container_volume	66
container_start_page	104048
publishDate	2022
institution	Swansea University
issn	2211-0348
doi_str_mv	10.1016/j.msard.2022.104048
publisher	Elsevier BV
college_str	Faculty of Medicine, Health and Life Sciences
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hierarchy_top_title	Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id	facultyofmedicinehealthandlifesciences
hierarchy_parent_title	Faculty of Medicine, Health and Life Sciences
department_str	Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
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description	BackgroundAmidst the growing number of patient-reported outcome (PRO) measures of fatigue being used in multiple sclerosis (MS) clinical trials and clinics, evidence-based consensus on the most appropriate and generalizable measures across different settings would be beneficial for clinical research and patient care. The objective of this research was to compare the validity and responsiveness of scores from the PROMIS Fatigue (MS) 8a with those of the Fatigue Severity Scale (FSS) and the Modified Fatigue Impact Scale (MFIS), across US and UK MS populations.MethodsTwo observational studies were performed in MS populations as part of a PRO measure development project, including a cross-sectional study in two tertiary US MS centers (n = 340) and a 96-week longitudinal study in the UK MS Register cohort (n = 352). In post-hoc analyses, we examined relative validity, based on ability to discriminate across patient groups with different fatigue levels or functional status at baseline (i.e., ANOVA-F PROX ÷ ANOVA-F PROMIS (MS) 8a), and relative responsiveness, based on baseline-to-Week-52 score change (effect sizes) across fatigue or functional status response groups .ResultsMean ± standard deviation (SD) age was 44.6 ± 11.3/50.0 ± 9.7; and 72.9%/77.3% were female (US/UK samples). The mean PROMIS Fatigue (MS) 8a T-score ± SD at baseline was 57.7 ± 10.5/58.9 ± 9.3 (US/UK samples). Compared with the PROMIS Fatigue (MS) 8a, relative validity (anchor: Global Health Score [GHS] fatigue global question) was 85% for MFIS symptom score, 48% for MFIS total score, and 44% for the FSS. Relative to the FSS, PROMIS Fatigue (MS) 8a scores were more sensitive to worsening (effect size = -0.43 versus -0.18) as well as improvement (effect size = 0.5 versus 0.2) in fatigue (≥1-point increase/decrease in GHS fatigue global question) over 52 weeks of follow-up. A similar pattern of score changes was observed based on a second anchor.ConclusionThe PROMIS Fatigue (MS) 8a scores showed higher responsiveness to fatigue changes than those of the FSS. The PROMIS measure also had higher precision in differentiating levels of fatigue compared to the FSS, the MFIS physical, and MFIS total scores. These differences have practical implications for the application of these questionnaires in both clinical practice and research settings (e.g., sample size estimation in clinical trials).
published_date	2022-10-01T04:20:19Z
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A comparison of the measurement properties of the PROMIS Fatigue (MS) 8a against legacy fatigue questionnaires

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