Development of a clinical chart to compute different disease activity indices for systemic lupus erythematosus.
Between 1990 and 1995 a European Consensus Group carried out a multicenter study to reach agreement of the definition of disease activity in systemic lupus erythematosus (SLE). A new index, the European Consensus Lupus Activity Measurement (ECLAM) index, was developed. In a second phase of the study, a prospective survey aimed at validating ECLAM and 4 other scales as steady-state and transition indices for disease activity in SLE was completed. We present the results of this survey. A standardized clinical chart was developed, together with a computer program that could automatically calculate the ECLAM score, as well as the scores for some of the disease activity scales most widely used at present, i.e., the British Isles Lupus Assessment Group, Systemic Lupus Activity Measure, SLE Disease Activity Index, and the SLE Index Score (SIS). With the participation of 28 centers in 15 different European countries, data from 121 prospectively selected new lupus patients were collected. The validity of the 5 activity scales was assessed by comparing the computed scores for each patient to a gold standard, i.e., the physician's subjective judgment on disease activity measured using a semiquantitative scale. All the indices were found to be valid instruments for measuring disease activity in SLE in both the steady-state and transition phases. The results for the various indices closely correlated with one another. Thus, the computerized chart developed by the European Consensus Group offers a simple and reliable instrument to assess disease activity and could be used to monitor lupus patients both in clinical practice and in clinical trials.
Vitali
C
C
Department of Internal Medicine, University of Pisa, Italy.
Bencivelli
W
W
Mosca
M
M
Carrai
P
P
Sereni
M
M
Bombardieri
S
S
D003198:Computer Simulation; D018450:Disease Progression; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000175:diagnosis*; D010338:Pathology, Clinical / Q000592:standards*; D012720:Severity of Illness Index; D012986:Software Validation