van der Heijde D, Boers M, Lassere M
Department of Internal Medicine, University Hospital Maastricht, The Netherlands.
J Rheumatol. 1999 Mar;26(3):726-30.
Radiographs are important endpoints in clinical trials in rheumatoid arthritis (RA). Several scoring methods exist. However, many methodological issues are unsolved and require more attention. The following issues will be addressed: the abnormalities that should be scored; joints that should be included in a scoring method; whether both right and left hands and feet should be scored; views that should be used; the order in which radiographs should be scored; how data should be evaluated; how intra/interobserver variation and sensitivity to change should be assessed; the optimum number of readers to assess radiographs; the score to be used if there are multiple readers; quality assurance, international training, a validation set of radiographs, and automated scoring of radiographs.
X线片是类风湿关节炎(RA)临床试验中的重要终点指标。现有多种评分方法。然而,许多方法学问题尚未解决,需要更多关注。以下问题将得到探讨:应评分的异常情况;评分方法中应纳入的关节;是否应对双手和双脚的左右两侧均进行评分;应使用的视图;X线片的评分顺序;数据应如何评估;应如何评估观察者内/间差异以及对变化的敏感性;评估X线片的最佳读者数量;如有多名读者应使用的评分;质量保证、国际培训、X线片验证集以及X线片的自动评分。