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Scoring of radiogra...
Scoring of radiographic progression in randomised clinical trials in ankylosing spondylitis : a preference for paired reading order
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Wanders, A. (författare)
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Landewe, R. (författare)
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Spoorenberg, A. (författare)
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visa fler...
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de Vlam, K. (författare)
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Mielants, H. (författare)
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Dougados, M. (författare)
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van der Linden, S. (författare)
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van der Heijde, D. (författare)
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- 2004
- 2004
- Engelska.
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Ingår i: Ann Rheum Dis. ; 63:12, s. 1601-4
- Relaterad länk:
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http://www.ncbi.nlm....
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visa fler...
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https://urn.kb.se/re...
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Abstract
Ämnesord
Stäng
- 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine (hsv//eng)
Nyckelord
- 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
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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