Construct validity and responsiveness of ASAS Health Index assessed in two longitudinal studies of tumour necrosis factor alpha inhibitor initiation and dose reduction in patients with axial spondyloarthritis

Background The Assessment of SpondyloArthritis international Society Health Index (ASAS HI) is a novel questionnaire of global functioning for patients with axial spondyloarthritis (SpA).Objective The objective was to assess the construct validity, discriminatory ability and responsiveness of ASAS H...

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Main Authors: Merete Lund Hetland, Inge Juul Sørensen, Mikkel Østergaard, Mikael Boesen, Susanne Juhl Pedersen, Sara Nysom Christiansen, Ole Rintek Madsen, Mette Klarlund, Marie Wetterslev, Mate Lorincz, Mads Bakkegaard, Anne Duer, Kasper Kjærulf Gosvig
Format: Article
Language:English
Published: BMJ Publishing Group 2024-12-01
Series:RMD Open
Online Access:https://rmdopen.bmj.com/content/10/4/e004948.full
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author Merete Lund Hetland
Inge Juul Sørensen
Mikkel Østergaard
Mikael Boesen
Susanne Juhl Pedersen
Sara Nysom Christiansen
Ole Rintek Madsen
Mette Klarlund
Marie Wetterslev
Mate Lorincz
Mads Bakkegaard
Anne Duer
Kasper Kjærulf Gosvig
author_facet Merete Lund Hetland
Inge Juul Sørensen
Mikkel Østergaard
Mikael Boesen
Susanne Juhl Pedersen
Sara Nysom Christiansen
Ole Rintek Madsen
Mette Klarlund
Marie Wetterslev
Mate Lorincz
Mads Bakkegaard
Anne Duer
Kasper Kjærulf Gosvig
author_sort Merete Lund Hetland
collection DOAJ
description Background The Assessment of SpondyloArthritis international Society Health Index (ASAS HI) is a novel questionnaire of global functioning for patients with axial spondyloarthritis (SpA).Objective The objective was to assess the construct validity, discriminatory ability and responsiveness of ASAS HI in relation to patient-reported outcome measures (PROMs), MRI and radiography.Methods Data from two longitudinal studies with tumour necrosis factor inhibitor (TNFi) initiation (novel MRI And biomarkers in Golimumab-treated patients with axial spondyloarthritis (MANGO): n=45) respectively tapering (Dose adjustment of Biological treatment in patients with SpA (DOBIS): n=106) were used. Analyses included a wide panel of PROMs, MRI and radiography scores of the spine and sacroiliac joints (SIJs).Results In the MANGO study, 30 (68%) patients were clinical responders at week 16. In the DOBIS study, 105 (99%) patients flared after mean (SD; min–max) 31 (17; 2.7–81) weeks. After initiation of TNF inhibitor in MANGO, ASAS HI significantly decreased from baseline to week 4, 16 and 52. In DOBIS, ASAS significantly increased from baseline to the flare visit and significantly decreased from the flare visit to week 96. In multivariate regression models, ASAS HI was independently associated with Spondyloarthritis Research Consortium of Canada MRI SIJ Inflammation score, Canada-Denmark MRI Spine Inflammation score, EuroQol, Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Disease Activity Index and Patient Global. Patients stratified according to ASAS HI health status groups (good, moderate, poor) at baseline and change categories (absolute and percentage change) from baseline to week 16/flare showed good discriminatory ability for almost all outcome variables (p≤0.001). ASAS HI had a large responsiveness in MANGO (standardised response mean (SRM)=−1.3, effect size (ES)=−1.7) and moderate responsiveness in DOBIS (SRM=0.7, ES=0.6).Conclusion ASAS HI showed good construct validity, discriminatory ability and responsiveness.Trial registration number ClinicalTrials.gov: NCT02011386.
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spelling doaj-art-aeb67ebed1514c1fb261f6b6804fd49d2025-01-14T20:25:08ZengBMJ Publishing GroupRMD Open2056-59332024-12-0110410.1136/rmdopen-2024-004948Construct validity and responsiveness of ASAS Health Index assessed in two longitudinal studies of tumour necrosis factor alpha inhibitor initiation and dose reduction in patients with axial spondyloarthritisMerete Lund Hetland0Inge Juul Sørensen1Mikkel Østergaard2Mikael Boesen3Susanne Juhl Pedersen4Sara Nysom Christiansen5Ole Rintek Madsen6Mette Klarlund7Marie Wetterslev8Mate Lorincz9Mads Bakkegaard10Anne Duer11Kasper Kjærulf Gosvig12Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet Glostrup, Glostrup, Denmark3 Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Copenhagen, Denmark2 Department of Clinical Medicine, Faculty of Health and Medical Science, University of Copenhagen, Copenhagen, Denmark6 Department of Radiology, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark1 Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Copenhagen, Denmark3 Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Copenhagen, Denmark3 Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Copenhagen, Denmark3 Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Copenhagen, Denmark1 Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Copenhagen, Denmark1 Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Copenhagen, Denmark3 Center for Rheumatology and Spine Diseases, Centre for Head and Orthopaedics, Rigshospitalet, Copenhagen, Denmark5 Department of Radiology, Rigshospitalet Glostrup, Copenhagen, Denmark7 Department of Radiology, Herlev and Gentofte Hospital, Copenhagen, DenmarkBackground The Assessment of SpondyloArthritis international Society Health Index (ASAS HI) is a novel questionnaire of global functioning for patients with axial spondyloarthritis (SpA).Objective The objective was to assess the construct validity, discriminatory ability and responsiveness of ASAS HI in relation to patient-reported outcome measures (PROMs), MRI and radiography.Methods Data from two longitudinal studies with tumour necrosis factor inhibitor (TNFi) initiation (novel MRI And biomarkers in Golimumab-treated patients with axial spondyloarthritis (MANGO): n=45) respectively tapering (Dose adjustment of Biological treatment in patients with SpA (DOBIS): n=106) were used. Analyses included a wide panel of PROMs, MRI and radiography scores of the spine and sacroiliac joints (SIJs).Results In the MANGO study, 30 (68%) patients were clinical responders at week 16. In the DOBIS study, 105 (99%) patients flared after mean (SD; min–max) 31 (17; 2.7–81) weeks. After initiation of TNF inhibitor in MANGO, ASAS HI significantly decreased from baseline to week 4, 16 and 52. In DOBIS, ASAS significantly increased from baseline to the flare visit and significantly decreased from the flare visit to week 96. In multivariate regression models, ASAS HI was independently associated with Spondyloarthritis Research Consortium of Canada MRI SIJ Inflammation score, Canada-Denmark MRI Spine Inflammation score, EuroQol, Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Disease Activity Index and Patient Global. Patients stratified according to ASAS HI health status groups (good, moderate, poor) at baseline and change categories (absolute and percentage change) from baseline to week 16/flare showed good discriminatory ability for almost all outcome variables (p≤0.001). ASAS HI had a large responsiveness in MANGO (standardised response mean (SRM)=−1.3, effect size (ES)=−1.7) and moderate responsiveness in DOBIS (SRM=0.7, ES=0.6).Conclusion ASAS HI showed good construct validity, discriminatory ability and responsiveness.Trial registration number ClinicalTrials.gov: NCT02011386.https://rmdopen.bmj.com/content/10/4/e004948.full
spellingShingle Merete Lund Hetland
Inge Juul Sørensen
Mikkel Østergaard
Mikael Boesen
Susanne Juhl Pedersen
Sara Nysom Christiansen
Ole Rintek Madsen
Mette Klarlund
Marie Wetterslev
Mate Lorincz
Mads Bakkegaard
Anne Duer
Kasper Kjærulf Gosvig
Construct validity and responsiveness of ASAS Health Index assessed in two longitudinal studies of tumour necrosis factor alpha inhibitor initiation and dose reduction in patients with axial spondyloarthritis
RMD Open
title Construct validity and responsiveness of ASAS Health Index assessed in two longitudinal studies of tumour necrosis factor alpha inhibitor initiation and dose reduction in patients with axial spondyloarthritis
title_full Construct validity and responsiveness of ASAS Health Index assessed in two longitudinal studies of tumour necrosis factor alpha inhibitor initiation and dose reduction in patients with axial spondyloarthritis
title_fullStr Construct validity and responsiveness of ASAS Health Index assessed in two longitudinal studies of tumour necrosis factor alpha inhibitor initiation and dose reduction in patients with axial spondyloarthritis
title_full_unstemmed Construct validity and responsiveness of ASAS Health Index assessed in two longitudinal studies of tumour necrosis factor alpha inhibitor initiation and dose reduction in patients with axial spondyloarthritis
title_short Construct validity and responsiveness of ASAS Health Index assessed in two longitudinal studies of tumour necrosis factor alpha inhibitor initiation and dose reduction in patients with axial spondyloarthritis
title_sort construct validity and responsiveness of asas health index assessed in two longitudinal studies of tumour necrosis factor alpha inhibitor initiation and dose reduction in patients with axial spondyloarthritis
url https://rmdopen.bmj.com/content/10/4/e004948.full
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