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Smallest detectable difference in radiological progression.

M Lassere1, M Boers, D van der Heijde

  • 1Department of Rheumatology, St. George Hospital, Sydney, NSW, Australia. p2112049@vmsuser.acsu.unsw.edu.au

The Journal of Rheumatology
|March 25, 1999
PubMed
Summary
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Determining the smallest detectable difference (SDD) in radiological progression is crucial for developing rheumatoid arthritis (RA) response criteria. This study established SDD values using measurement error analysis for RA patients.

Area of Science:

  • Rheumatology
  • Radiology
  • Clinical Trials

Background:

  • Developing radiological response criteria for rheumatoid arthritis (RA) requires defining minimum clinically important progression.
  • Currently, a standardized definition for clinically important progression is lacking.

Purpose of the Study:

  • To establish the smallest detectable difference (SDD) in radiological progression between two radiographs in early RA patients.
  • To provide a foundational step for creating robust radiological response criteria.

Main Methods:

  • Utilized radiographs from 52 early RA patients from the COBRA study.
  • Employed the van der Heijde modified Sharp and Scott modified Larsen methods for radiological assessment.
  • Applied the Bland and Altman 95% limits of agreement to determine measurement error and SDD.

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Main Results:

  • The SDD was determined to be 11 modified Sharp score units and 8 modified Larsen score units when using the mean score of the same trained observers.
  • When using the mean score of any two trained observers, the SDD increased to 15.5 modified Sharp score units and 11 modified Larsen score units.
  • Various SDD values were calculated based on different measurement contexts.

Conclusions:

  • The smallest detectable difference (SDD) provides a valuable starting point for developing radiological response criteria in RA.
  • Further validation of these SDD findings in diverse settings is recommended.
  • This research contributes to standardizing the assessment of radiological progression in RA clinical trials.