Minimal important change was on the lower spectrum of previous estimates and responsiveness was sufficient for core outcomes in chronic low back pain.

Humans Disability Evaluation Low Back Pain / drug therapy Patient Reported Outcome Measures Quality of Life Surveys and Questionnaires
EuroQol's health related quality of life Low back pain Minimal important change Oswestry disability index Pain intensity numerical rating scale Patient reported outcome measure Predictive modeling Responsiveness Roland-Morris disability questannaire

Journal

Journal of clinical epidemiology
ISSN: 1878-5921
Titre abrégé: J Clin Epidemiol
Pays: United States
ID NLM: 8801383

Informations de publication

Date de publication:
11 2022
Historique:
received: 10 04 2022
revised: 13 07 2022
accepted: 21 07 2022
pubmed: 5 8 2022
medline: 21 12 2022
entrez: 4 8 2022
Statut: ppublish

Résumé

The objective of this study was to estimate the minimal important change (MIC) and responsiveness of core patient reported outcome measures for chronic low back pain (LBP) and Modic changes. In the Antibiotics in Modic changes (AIM) trial we measured disability (RMDQ, ODI), LBP intensity (NRS) and health-related quality of life (EQ5D) electronically at baseline, three- and 12-month follow-up. MICs were estimated using Receiver Operating Curve (ROC) curve and Predictive modeling analyses against the global perceived effect. Credibility of the estimates was assessed by a standardized set of criteria. Responsiveness was assessed by a construct and criterion approach according to COSMIN guidelines. The MIC estimates of RMDQ, ODI and NRS scores varied between a 15-40% reduction, depending on including "slightly improved" in the definition of MIC or not. The MIC estimates for EQ5D were lower. The credibility of the estimates was moderate. For responsiveness, five out of six hypotheses were confirmed and AUC was >0.7 for all PROMs. When evaluated in a clinical trial of patients with chronic LBP and Modic changes, MIC thresholds for all PROMs were on the lower spectrum of previous estimates, varying depending on the definition of MIC. Responsiveness was sufficient.

Identifiants

DOI: 10.1016/j.jclinepi.2022.07.012 PMID: 35926821
pubmed: 35926821
pii: S0895-4356(22)00185-8
doi: 10.1016/j.jclinepi.2022.07.012
pii:
doi:

Types de publication

Clinical Trial Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

75-87

Informations de copyright

Copyright © 2022 The Author(s). Published by Elsevier Inc. All rights reserved.

Auteurs

Lars Christian Haugli Bråten (LCH)

Department of Research and Innovation, Division of Clinical Neuroscience, Oslo University Hospital HF, Ulleval, Bygg 37b, Postbox 4956, Nydalen, 0424, Oslo, Norway. Electronic address: l.c.h.braten@studmed.uio.no.

Lars Grøvle (L)

Department of Rheumatology, Østfold Hospital Trust, PB 300, 1714, Grålum, Norway.

Monica Wigemyr (M)

Department of Research and Innovation, Division of Clinical Neuroscience, Oslo University Hospital HF, Ulleval, Bygg 37b, Postbox 4956, Nydalen, 0424, Oslo, Norway.

Maja Wilhelmsen (M)

Department of Rehabilitation, University Hospital of North Norway, P.O. Box 100, 9038 Tromsø, Norway; Faculty of Health Sciences, Department of Clinical Medicine, UiT The Arctic University of Norway, Tromsø, Norway.

Elisabeth Gjefsen (E)

Department of Research and Innovation, Division of Clinical Neuroscience, Oslo University Hospital HF, Ulleval, Bygg 37b, Postbox 4956, Nydalen, 0424, Oslo, Norway; Faculty of Medicine, University of Oslo, P.O. Box 1072 Blindern, 0316, Oslo, Norway.

Ansgar Espeland (A)

Department of Radiology, Haukeland University Hospital, Jonas Liesvei 65, 5021 Bergen, Norway; Department of Clinical Medicine, University of Bergen, P.O. Box 7804, 5020, Bergen, Norway.

Anne Julsrud Haugen (AJ)

Department of Rheumatology, Østfold Hospital Trust, PB 300, 1714, Grålum, Norway.

Jan Sture Skouen (JS)

Department of Physical Medicine and Rehabilitation, Haukeland University Hospital, Helse Bergen HF, Box 1, 5021 Bergen, Norway.

Jens Ivar Brox (JI)

Department of Physical Medicine and Rehabilitation, Oslo University Hospital HF, Ulleval, Postbox 4956, Nydalen, 0424, Oslo, Norway.

John-Anker Zwart (JA)

Department of Research and Innovation, Division of Clinical Neuroscience, Oslo University Hospital HF, Ulleval, Bygg 37b, Postbox 4956, Nydalen, 0424, Oslo, Norway; Faculty of Medicine, University of Oslo, P.O. Box 1072 Blindern, 0316, Oslo, Norway.

Kjersti Storheim (K)

Department of Research and Innovation, Division of Clinical Neuroscience, Oslo University Hospital HF, Ulleval, Bygg 37b, Postbox 4956, Nydalen, 0424, Oslo, Norway; Oslo Metropolitan University, Department of Physiotherapy, PO box 4 St. Olavs plass, NO-0130 Oslo, Norway.

Raymond Wjg Ostelo (RW)

Department of Health Sciences, Faculty of Science, VU University Amsterdam, Amsterdam Movement Sciences Research Institute Amsterdam, Amsterdam, Netherlands; Department of Epidemiology and Data Science, Amsterdam University Medical Centre, Location VUmc, Amsterdam, Netherlands; Oslo Metropolitan University, Department of Physiotherapy, PO box 4 St. Olavs plass, NO-0130 Oslo, Norway.

Margreth Grotle (M)

Department of Research and Innovation, Division of Clinical Neuroscience, Oslo University Hospital HF, Ulleval, Bygg 37b, Postbox 4956, Nydalen, 0424, Oslo, Norway; Oslo Metropolitan University, Department of Physiotherapy, PO box 4 St. Olavs plass, NO-0130 Oslo, Norway.

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Minimal important change was on the lower...
questionsmedicales.fr › Diagnostic › Techniques et procédures diagnostiques › Évaluation de l'invalidité › Minimal important change was on the lower...
questionsmedicales.fr › États, signes et symptômes pathologiques › Signes et symptômes › Manifestations neurologiques › Dorsalgie › Lombalgie › Minimal important change was on the lower...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Collecte de données › Enquêtes et questionnaires › Enquêtes sur les soins de santé › Mesures des résultats rapportés par les patients › Minimal important change was on the lower...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Mesures épidémiologiques › Démographie › État de santé › Qualité de vie › Minimal important change was on the lower...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Collecte de données › Enquêtes et questionnaires › Minimal important change was on the lower...