Alternative methods for analysis of radiographic damage in a randomized, double blind, parallel group clinical trial comparing hydroxychloroquine and sulfasalazine.
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.
van der Heijde
D M
DM
Department of Internal Medicine, University Hospital Maastricht, The Netherlands. dhe@sint.azm.nl
van Riel
P L
PL
Nuver-Zwart
I H
IH
van de Putte
L B
LB
D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000000981:diagnostic imaging* / Q000188:drug therapy; D004311:Double-Blind Method; D006801:Humans; D006886:Hydroxychloroquine / Q000627:therapeutic use*; D011859:Radiography / Q000379:methods*; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012460:Sulfasalazine / Q000627:therapeutic use*
D018501:Antirheumatic Agents; D012460:Sulfasalazine; D006886:Hydroxychloroquine