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Alternative methods for analysis of radiographic damage in a randomized, double blind, parallel group clinical trial
D M van der Heijde1, P L van Riel, I H Nuver-Zwart
1Department of Internal Medicine, University Hospital Maastricht, The Netherlands. dhe@sint.azm.nl
Abstract:
Radiographic data of a 48-week double-blind, randomized, parallel trial comparing hydroxychloroquine (HCQ) and sulfasalazine (SASP) and its open label extension to 3 years of follow-up are analyzed in various ways. The focus of the paper is the methodological issues involved in analyses of radiographic data in a trial. Both the traditional method of increase in erosions and total score calculated on a group level, as well as individual progression on a patient level are presented. Regardless of which method is used, there is a statistically significant reduction in radiographic progression in the SASP group compared to the HCQ group.