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A Protocol of Manual Tests to Measure Sensation and Pain in Humans
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Testing minimal clinically important difference: consensus or conundrum?

Robert J Gatchel1, Tom G Mayer

  • 1Department of Psychology, College of Science, The University of Texas, Arlington, TX 76019, USA.

The Spine Journal : Official Journal of the North American Spine Society
|April 6, 2010
PubMed
Summary
This summary is machine-generated.

A 30% improvement in pain measures may not reflect a clinically important difference for patients with chronic disabling occupational spinal disorders when using objective outcomes. Further research is needed to validate minimal clinically important difference (MCID) using external criteria.

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Area of Science:

  • Spine Care and Rehabilitation
  • Clinical Measurement and Outcomes Research
  • Health Economics and Policy

Background:

  • Establishing a standard method for calculating the minimal clinically important difference (MCID) remains a challenge.
  • Consensus guidelines suggest a 30% improvement in self-report pain measures as a benchmark for MCID.
  • Psychometric considerations are crucial, particularly the use of independent external criteria in anchor-based MCID assessments.

Purpose of the Study:

  • To evaluate the validity of existing MCID guidelines for self-report back pain measures.
  • To compare self-report outcomes with objective socioeconomic data in patients with chronic disabling occupational spinal disorders (CDOSDs).

Main Methods:

  • Prospective study of 1,180 patients with CDOSDs undergoing interdisciplinary functional restoration.
  • Compared pre- to post-treatment changes in Oswestry Disability Index (ODI) and SF-36 (PCS and MCS) with 1-year post-treatment work status and healthcare utilization.
  • Categorized patients based on achieving ≥30% improvement versus <30% improvement in self-report measures.

Main Results:

  • Oswestry Disability Index (ODI) and SF-36 Mental Component Summary (MCS) changes were not associated with objective 1-year outcomes.
  • A weak association was observed between ≥30% improvement in SF-36 Physical Component Summary (PCS) and reduced healthcare utilization.
  • Similarly, a weak association was found between ≥30% ODI improvement and return-to-work status.

Conclusions:

  • The 30% improvement threshold for ODI and SF-36 may not represent a valid minimal clinically important difference (MCID) when assessed against objective socioeconomic outcomes in CDOSDs.
  • Findings align with previous research questioning the MCID's validity using distribution-based approaches.
  • Future research must utilize objective external criteria to establish the validity of MCID, and the operational definition of "important" requires further clarification.