VARIABILITY OF SKIN SCORES AND CLINICAL MEASUREMENTS IN SCLERODERMA

Objective. To determine the variability of several clinical outcome me asurements commonly used in scleroderma clinical trials. Methods. Ten researchers, members of a multicenter placebo controlled trial of meth otrexate in early diffuse scleroderma, studied the intraobserver and i nterobserver variability of variables used to assess efficacy in scler oderma trials. Results. For most measures, the variability within an o bserver was less than that found between observers, and therefore the intraobserver reliability was better than the interobserver reliabilit y. The reliability of the modified Rodnan skin score exceeded the Rodn an skin score. Measures with inherent interpretation such as global as sessments and skin scores had more variability than easily performed m easurements such as grip strength and oral opening. Conclusion. Some o f our variability was higher than variability previously reported; thi s could be due to the large number of examiners and patients in our st udy.