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Minimal clinically important difference. Low back pain: outcome measures.

C Bombardier1, J Hayden, D E Beaton

  • 1Institute for Work and Health, Department of Medicine, University of Toronto, Ontario, Canada. claire.bombardier@utoronto.ca

The Journal of Rheumatology
|March 15, 2001
PubMed
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This study evaluates the Roland-Morris Disability Questionnaire (RDQ) and Oswestry Disability Index (ODI) for measuring low back pain changes. It provides guidance for using these tools in clinical trials to ensure accurate sample size calculations.

Area of Science:

  • Rehabilitation Medicine
  • Clinical Epidemiology
  • Health Outcomes Research

Background:

  • A standard core set of outcome measures for low back pain is proposed, encompassing back-specific function, generic health status, pain, work disability, and patient satisfaction.
  • This review focuses on two key back-specific functional measures: the Roland-Morris Disability Questionnaire (RDQ) and the Oswestry Disability Index (ODI).

Framework:

  • Systematic literature review of 78 articles for RDQ and 71 for ODI to assess their responsiveness in measuring change.
  • Analysis includes study population, type of change measured, effect size, and time interval for change assessment.
  • Tables are provided for reference in sample size calculations for clinical trials.

Implementation:

  • Literature review identified 78 (RDQ) and 71 (ODI) relevant articles.

Related Experiment Videos

  • Responsiveness of RDQ ranges from 2 to 8 points on a 0-24 scale, varying by measured change.
  • Roland recommends a 2-3 point change on the RDQ as the minimum clinically important difference.

    • Implications:

    • Findings guide the selection of appropriate outcome measures for low back pain research.
    • Understanding measure responsiveness is crucial for accurate sample size calculation, preventing underpowered trials.
    • This work supports evidence-based clinical trial design for low back pain interventions.