Clinical composite measures of disease activity and damage used to evaluate patients with systemic lupus erythematosus: A systematic literature review.

OBJECTIVES To determine the most appropriate indices to evaluate the disease activity and damage in patients with sytemic lupus erythematosus (SLE). METHODS A systematic literature search was performed to identify validation studies of indices used to evaluate disease activity and damage. We collected information for each instrument on every aspect of validation including feasibility, reliability, validity and sensitivity to change using ad hoc forms. RESULTS A total of 38 articles were included addressing the validation of 6 composite indices to evaluate disease activity (BILAG, ECLAM, SLAM, SLEDAI, LAI and SLAQ); and 3 indices to evaluate damage (SLICC/ACE-DI, LDIQ and BILD). Only the SLAQ, LIDIQ and the BILD were self-administered. Feasibility and internal consistency was only studied in 3 indices (BILAG, SLAQ and SDI) with a Cronbach's α ranging from 0.35 to 0.87. The intra-observer reliability was examined by the intraclass correlation coefficient for BILAG with a result of 0.48 (95%CI: 0,23-0,81) and using analysis of variance for SLAM-R (0,78), SLEDAI (0,33) and the LAI (0,81). The inter-observer feasibility was evaluated using the correlation coefficient for ECLAM (0,90-0,93), the SLAM (0,86) and MEX-SLEDAI (0,97-0,89). The construct validity was examined by means of convergence with other instruments, specifically with global assessment by the physician, with similar results between indices (0,48-0,75). Lastly, responsiveness was tested in all indices except LAI, SDI and LDIQ, with a standardized response mean ranging from 0.12 to 0.75. CONCLUSIONS Although multiple instruments have been validated for use in SLE it was not possible to find direct evidence of which is the most appropriate. BILAG and SLEDAI, with moderate feasibility and low responsiveness, are the 2 indices with a most complete validation and more extensively used.