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The validity, responsiveness, and score interpretation of the PROMISnq Physical Function – Multiple Sclerosis 15a short form in multiple sclerosis

Paul Kamudoni, Dagmar Amtmann, Jeffrey Johns, Karon F. Cook, Rana Salem, Sam Salek, Jana Raab, Rod Middleton Orcid Logo, Pavle Repovic, Kevin N. Alschuler, Gloria von Geldern, Annette Wundes, Amy Barrett, Oyebimpe Olayinka-Amao, Christian Henke

Multiple Sclerosis and Related Disorders, Volume: 62, Start page: 103753

Swansea University Author: Rod Middleton Orcid Logo

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DOI (Published version): 10.1016/j.msard.2022.103753

Abstract

BackgroundA valid, sensitive patient-reported outcome (PRO) measure of physical function (PF) for people with multiple sclerosis (MS) would have substantial value in routine care and clinical research. We now describe development of the PROMISnq Short Form v2.0 PF – Multiple Sclerosis 15a [PROMISnq...

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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/cronfa61485
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fullrecord <?xml version="1.0"?><rfc1807><datestamp>2022-10-20T14:53:37.8435450</datestamp><bib-version>v2</bib-version><id>61485</id><entry>2022-10-07</entry><title>The validity, responsiveness, and score interpretation of the PROMISnq Physical Function &#x2013; Multiple Sclerosis 15a short form in multiple sclerosis</title><swanseaauthors><author><sid>005518f819ef1a2a13fdf438529bdfcd</sid><ORCID>0000-0002-2130-4420</ORCID><firstname>Rod</firstname><surname>Middleton</surname><name>Rod Middleton</name><active>true</active><ethesisStudent>false</ethesisStudent></author></swanseaauthors><date>2022-10-07</date><deptcode>HDAT</deptcode><abstract>BackgroundA valid, sensitive patient-reported outcome (PRO) measure of physical function (PF) for people with multiple sclerosis (MS) would have substantial value in routine care and clinical research. We now describe development of the PROMISnq Short Form v2.0 PF &#x2013; Multiple Sclerosis 15a [PROMISnq PF(MS)15a] for assessing PF in relapsing and progressive MS. Also, the validity, reliability, and responsiveness of the PROMISnq PF(MS)15a is evaluated, minimal important difference (MID) thresholds for score change estimated and a score interpretation guide developed.MethodsA mixed-methods sequential design was employed. Relevant PF concepts were elicited through semi-structured interviews with people with relapsing MS, and then mapped to the PROMIS PF item bank. Measurement experts integrated results from interviews with people with MS and input from a panel of neurologists to generate a draft short form. Relevance and comprehensiveness of the draft short form were assessed in cognitive debriefing interviews with people with relapsing or progressive MS. Subsequently, item reduction and evaluation of psychometric properties were performed in two observational studies: a cross-sectional study in the US (n = 296), and a 96-week longitudinal study in the UK MS Register cohort (n = 558). The main outcomes and measures are estimates of: known-groups validity, convergent validity, reliability, responsiveness; MID for worsening.ResultsFactor analyses supported the unidimensionality of the newly derived 15-item short form. Cronbach's alpha (&#x2265; 0.97) and intraclass correlation coefficient (&#x2265; 0.97) of test-retest scores (5&#x2013;27 days) indicated strong reliability. Convergent validity was demonstrated by moderate-to-strong correlations with scores on related PRO measures. Scores discriminated among patient groups classified by levels of physical health and other criteria. Score changes of 2.3&#x2013;2.7 points are proposed as MID criteria for minimal worsening in PF.ConclusionPROMISnq PF(MS)15a demonstrated reliability, validity and sensitivity to change. 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spelling 2022-10-20T14:53:37.8435450 v2 61485 2022-10-07 The validity, responsiveness, and score interpretation of the PROMISnq Physical Function – Multiple Sclerosis 15a short form in multiple sclerosis 005518f819ef1a2a13fdf438529bdfcd 0000-0002-2130-4420 Rod Middleton Rod Middleton true false 2022-10-07 HDAT BackgroundA valid, sensitive patient-reported outcome (PRO) measure of physical function (PF) for people with multiple sclerosis (MS) would have substantial value in routine care and clinical research. We now describe development of the PROMISnq Short Form v2.0 PF – Multiple Sclerosis 15a [PROMISnq PF(MS)15a] for assessing PF in relapsing and progressive MS. Also, the validity, reliability, and responsiveness of the PROMISnq PF(MS)15a is evaluated, minimal important difference (MID) thresholds for score change estimated and a score interpretation guide developed.MethodsA mixed-methods sequential design was employed. Relevant PF concepts were elicited through semi-structured interviews with people with relapsing MS, and then mapped to the PROMIS PF item bank. Measurement experts integrated results from interviews with people with MS and input from a panel of neurologists to generate a draft short form. Relevance and comprehensiveness of the draft short form were assessed in cognitive debriefing interviews with people with relapsing or progressive MS. Subsequently, item reduction and evaluation of psychometric properties were performed in two observational studies: a cross-sectional study in the US (n = 296), and a 96-week longitudinal study in the UK MS Register cohort (n = 558). The main outcomes and measures are estimates of: known-groups validity, convergent validity, reliability, responsiveness; MID for worsening.ResultsFactor analyses supported the unidimensionality of the newly derived 15-item short form. Cronbach's alpha (≥ 0.97) and intraclass correlation coefficient (≥ 0.97) of test-retest scores (5–27 days) indicated strong reliability. Convergent validity was demonstrated by moderate-to-strong correlations with scores on related PRO measures. Scores discriminated among patient groups classified by levels of physical health and other criteria. Score changes of 2.3–2.7 points are proposed as MID criteria for minimal worsening in PF.ConclusionPROMISnq PF(MS)15a demonstrated reliability, validity and sensitivity to change. Input from patients and clinicians ensured the content is comprehensive and relevant for people with MS. Journal Article Multiple Sclerosis and Related Disorders 62 103753 Elsevier BV 2211-0348 Multiple sclerosis disability; Physical function; PROMIS 1 6 2022 2022-06-01 10.1016/j.msard.2022.103753 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). 2022-10-20T14:53:37.8435450 2022-10-07T12:10:58.2263212 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Paul Kamudoni 1 Dagmar Amtmann 2 Jeffrey Johns 3 Karon F. Cook 4 Rana Salem 5 Sam Salek 6 Jana Raab 7 Rod Middleton 0000-0002-2130-4420 8 Pavle Repovic 9 Kevin N. Alschuler 10 Gloria von Geldern 11 Annette Wundes 12 Amy Barrett 13 Oyebimpe Olayinka-Amao 14 Christian Henke 15 61485__25534__bcc55f6fae9144638366ab7826c49df0.pdf 61485_VoR.pdf 2022-10-20T14:51:45.9006266 Output 1907932 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 The validity, responsiveness, and score interpretation of the PROMISnq Physical Function – Multiple Sclerosis 15a short form in multiple sclerosis
spellingShingle The validity, responsiveness, and score interpretation of the PROMISnq Physical Function – Multiple Sclerosis 15a short form in multiple sclerosis
Rod Middleton
title_short The validity, responsiveness, and score interpretation of the PROMISnq Physical Function – Multiple Sclerosis 15a short form in multiple sclerosis
title_full The validity, responsiveness, and score interpretation of the PROMISnq Physical Function – Multiple Sclerosis 15a short form in multiple sclerosis
title_fullStr The validity, responsiveness, and score interpretation of the PROMISnq Physical Function – Multiple Sclerosis 15a short form in multiple sclerosis
title_full_unstemmed The validity, responsiveness, and score interpretation of the PROMISnq Physical Function – Multiple Sclerosis 15a short form in multiple sclerosis
title_sort The validity, responsiveness, and score interpretation of the PROMISnq Physical Function – Multiple Sclerosis 15a short form in multiple sclerosis
author_id_str_mv 005518f819ef1a2a13fdf438529bdfcd
author_id_fullname_str_mv 005518f819ef1a2a13fdf438529bdfcd_***_Rod Middleton
author Rod Middleton
author2 Paul Kamudoni
Dagmar Amtmann
Jeffrey Johns
Karon F. Cook
Rana Salem
Sam Salek
Jana Raab
Rod Middleton
Pavle Repovic
Kevin N. Alschuler
Gloria von Geldern
Annette Wundes
Amy Barrett
Oyebimpe Olayinka-Amao
Christian Henke
format Journal article
container_title Multiple Sclerosis and Related Disorders
container_volume 62
container_start_page 103753
publishDate 2022
institution Swansea University
issn 2211-0348
doi_str_mv 10.1016/j.msard.2022.103753
publisher Elsevier BV
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
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
document_store_str 1
active_str 0
description BackgroundA valid, sensitive patient-reported outcome (PRO) measure of physical function (PF) for people with multiple sclerosis (MS) would have substantial value in routine care and clinical research. We now describe development of the PROMISnq Short Form v2.0 PF – Multiple Sclerosis 15a [PROMISnq PF(MS)15a] for assessing PF in relapsing and progressive MS. Also, the validity, reliability, and responsiveness of the PROMISnq PF(MS)15a is evaluated, minimal important difference (MID) thresholds for score change estimated and a score interpretation guide developed.MethodsA mixed-methods sequential design was employed. Relevant PF concepts were elicited through semi-structured interviews with people with relapsing MS, and then mapped to the PROMIS PF item bank. Measurement experts integrated results from interviews with people with MS and input from a panel of neurologists to generate a draft short form. Relevance and comprehensiveness of the draft short form were assessed in cognitive debriefing interviews with people with relapsing or progressive MS. Subsequently, item reduction and evaluation of psychometric properties were performed in two observational studies: a cross-sectional study in the US (n = 296), and a 96-week longitudinal study in the UK MS Register cohort (n = 558). The main outcomes and measures are estimates of: known-groups validity, convergent validity, reliability, responsiveness; MID for worsening.ResultsFactor analyses supported the unidimensionality of the newly derived 15-item short form. Cronbach's alpha (≥ 0.97) and intraclass correlation coefficient (≥ 0.97) of test-retest scores (5–27 days) indicated strong reliability. Convergent validity was demonstrated by moderate-to-strong correlations with scores on related PRO measures. Scores discriminated among patient groups classified by levels of physical health and other criteria. Score changes of 2.3–2.7 points are proposed as MID criteria for minimal worsening in PF.ConclusionPROMISnq PF(MS)15a demonstrated reliability, validity and sensitivity to change. Input from patients and clinicians ensured the content is comprehensive and relevant for people with MS.
published_date 2022-06-01T04:20:20Z
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score 11.012678

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