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Related Experiment Videos

Minimally important difference in diffuse systemic sclerosis: results from the D-penicillamine study.

D Khanna1, D E Furst, R D Hays

  • 1Division of Immunology, Department of Medicine, University of Cincinnati, ML 0563, Cincinnati, OH 45267-0563, USA. dinesh.khanna@uc.edu

Annals of the Rheumatic Diseases
|March 17, 2006
PubMed
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This summary is machine-generated.

This study determined minimally important differences (MIDs) for the modified Rodnan Skin Score (mRSS) and Health Assessment Questionnaire-Disability Index (HAQ-DI) in diffuse systemic sclerosis (SSc) clinical trials. These MIDs aid in interpreting trial results and planning future studies.

Area of Science:

  • Rheumatology
  • Clinical Trials
  • Scleroderma Research

Background:

  • Diffuse systemic sclerosis (SSc) is a serious autoimmune disease.
  • Interpreting clinical trial outcomes in SSc requires defined minimally important differences (MIDs).
  • Previous MIDs for key outcome measures in SSc were not well-established.

Purpose of the Study:

  • To estimate MIDs for the modified Rodnan Skin Score (mRSS) and Health Assessment Questionnaire-Disability Index (HAQ-DI).
  • To provide benchmarks for assessing treatment efficacy in diffuse SSc clinical trials.

Main Methods:

  • A 2-year, double-blind, randomized clinical trial involving 134 participants with diffuse SSc.
  • Investigator global assessment of patient health change at multiple time points.

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  • Comparison of patients with 'slight improvement' to those with 'moderate or marked improvement' to define MIDs.

    • Main Results:

    • Estimated MIDs for mRSS improvement ranged from 3.2 to 5.3 (effect size 0.40–0.66).
    • Estimated MIDs for HAQ-DI improvement ranged from 0.10 to 0.14 (effect size 0.15–0.21).
    • Greater improvements (more than slight) showed larger effect sizes on both mRSS and HAQ-DI.

    Conclusions:

    • Established MIDs for mRSS and HAQ-DI in diffuse SSc.
    • These MIDs are valuable for interpreting clinical trial results.
    • The findings can inform sample size calculations for future SSc clinical trials.