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. 2004 Aug 5;63(12):1601–1604. doi: 10.1136/ard.2004.022038

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

A Wanders 1, R Landewe 1, A Spoorenberg 1, K de Vlam 1, H Mielants 1, M Dougados 1, S van der Linden 1, D van der Heijde 1
PMCID: PMC1754835  PMID: 15297280

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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Figure 1.

Figure 1

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 Probability plot of 1 year progression in modified SASSS scores for paired and chronological reading order.

Figure 2.

Figure 2

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 Probability plot of 2 year progression in modified SASSS scores for paired and chronological reading order.

Selected References

These references are in PubMed. This may not be the complete list of references from this article.

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