Scoring of radiographic progression in randomised clinical trials in ankylosing spondylitis: a preference for paired reading order. Issue 12 (5th August 2004)

• Record Type: Journal Article
• Authors: Wanders, A; Landewé, R; Spoorenberg, A; de Vlam, K; Mielants, H; Dougados, M; van der Linden, S; van der Heijde, D
• Is Part Of: Annals of the rheumatic diseases. Volume 63:Issue 12(2004)
• Page Start: 1601
• Page End: 1604
• Publication Date: 2004-08-05
• Subjects: AS, ankylosing spondylitis -- D-CART, disease controlling antirheumatic treatment -- RA, rheumatoid arthritis -- RCT, randomised controlled trial -- SASSS, Stoke Ankylosing Spondylitis Spinal Score; radiographs -- radiographic progression -- reading order -- ankylosing spondylitis -- randomised controlled trials; Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/ard.2004.022038
• Languages: English
• ISSNs: 0003-4967

Abstract

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.