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Multicenter Study
. 2004 Dec;63(12):1601-4.
doi: 10.1136/ard.2004.022038. Epub 2004 Aug 5.

Scoring of radiographic progression in randomised clinical trials in ankylosing spondylitis: a preference for paired reading order

A Wanders  1 , R Landewé, A Spoorenberg, K de Vlam, H Mielants, M Dougados, S van der Linden, D van der Heijde
Affiliations
Multicenter Study

Scoring of radiographic progression in randomised clinical trials in ankylosing spondylitis: a preference for paired reading order

A Wanders et al. Ann Rheum Dis. 2004 Dec.

Abstract

Objectives: To describe the influence of the reading order (chronological v paired) on radiographic scoring results in ankylosing spondylitis. To investigate whether this method is sufficiently sensitive to change because paired reading is requested for establishing drug efficacy in clinical trials.

Methods: Films obtained from 166 patients (at baseline, 1 year, and 2 years) were scored by one observer, using the modified Stoke Ankylosing Spondylitis Spinal Score. Films were first scored chronologically, and were scored paired 6 months later.

Results: Chronological reading showed significantly more progression than paired reading both at 1 year (mean (SD) progression 1.3 (2.6) v 0.5 (2.4) units) and at 2 years (2.1 (3.9) v 1.0 (2.9) units); between-method difference: p<0.001 at 1 year, and p<0.001 at 2 years. After 1 year, progression (>0 units) was found in 35/166 (21%) patients after paired reading and in 55/166 (33%) after chronological reading. After 2 years, these figures were 50/166 (30%) and 68/166 (41%), respectively. Sample size calculations showed that 94 patients in each treatment arm are required in a randomised clinical trial (RCT) to provide sufficient statistical power to detect a difference in 2 year progression if films are scored paired.

Conclusion: Reading with chronological time order is more sensitive to change than reading with paired time order, but paired reading is sufficiently sensitive to pick up change with a follow up of 2 years, resulting in an acceptable sample size for RCTs.

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Figures

Figure 1
Figure 1
Probability plot of 1 year progression in modified SASSS scores for paired and chronological reading order.
Figure 2
Figure 2
Probability plot of 2 year progression in modified SASSS scores for paired and chronological reading order.
See this image and copyright information in PMC

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