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

Lars Christian Haugli Bråten; Lars Grøvle; Monica Wigemyr; Maja Wilhelmsen; Elisabeth Gjefsen; Ansgar Espeland; Anne Julsrud Haugen; Jan Sture Skouen; Jens Ivar Brox; John-Anker Zwart; Kjersti Storheim; Raymond Wjg Ostelo; Margreth Grotle

doi:10.1016/j.jclinepi.2022.07.012

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

J Clin Epidemiol. 2022 Nov:151:75-87. doi: 10.1016/j.jclinepi.2022.07.012. Epub 2022 Aug 1.

Affiliations

¹ 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.
² Department of Rheumatology, Østfold Hospital Trust, PB 300, 1714, Grålum, Norway.
³ Department of Research and Innovation, Division of Clinical Neuroscience, Oslo University Hospital HF, Ulleval, Bygg 37b, Postbox 4956, Nydalen, 0424, Oslo, Norway.
⁴ 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.
⁵ 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.
⁶ 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.
⁷ Department of Physical Medicine and Rehabilitation, Haukeland University Hospital, Helse Bergen HF, Box 1, 5021 Bergen, Norway.
⁸ Department of Physical Medicine and Rehabilitation, Oslo University Hospital HF, Ulleval, Postbox 4956, Nydalen, 0424, Oslo, Norway.
⁹ 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.
¹⁰ 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.

PMID: 35926821
DOI: 10.1016/j.jclinepi.2022.07.012

Abstract

Objectives: 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.

Study design and setting: 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.

Results: 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.

Conclusion: 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.

Keywords: 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.

Publication types

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

MeSH terms

Disability Evaluation
Humans
Low Back Pain* / drug therapy
Patient Reported Outcome Measures
Quality of Life
Surveys and Questionnaires