Scoring of radiographic progression in randomised clinical trials in ankylosing spondylitis: a preference for paired reading order
2004 (English)In: Ann Rheum Dis, Vol. 63, no 12, 1601-4 p.Article in journal (Refereed) Published
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.
Place, publisher, year, edition, pages
2004. Vol. 63, no 12, 1601-4 p.
Adult, Chronology as Topic, Disease Progression, Epidemiologic Methods, Female, Humans, Male, Middle Aged, Randomized Controlled Trials as Topic/*methods, Reproducibility of Results, Research Design, Sensitivity and Specificity, Severity of Illness Index, Spondylitis, Ankylosing/drug therapy/*radiography, Time Factors, Treatment Outcome
IdentifiersURN: urn:nbn:se:umu:diva-110945ISBN: 0003-4967 (Print) 0003-4967 (Linking)OAI: oai:DiVA.org:umu-110945DiVA: diva2:865831
Wanders, A Landewe, R Spoorenberg, A de Vlam, K Mielants, H Dougados, M van der Linden, S van der Heijde, D eng Multicenter Study England 2004/08/07 05:00 Ann Rheum Dis. 2004 Dec;63(12):1601-4. Epub 2004 Aug 5.2015-10-292015-10-292015-10-29