The relationship between disease activity and expert physician's decision to start major treatment in active systemic lupus erythematosus: a decision aid for development of entry criteria for clinical trials.

Objective: To explore the relationship between patients' systemic lupus erythematosus (SLE) activity and physicians' decision to treat with steroids or alternative medication.
Methods: Baseline information and clinical status was extracted from case histories of 30 patients with lupus and represented in clinical vignettes. These vignettes were then mailed to 60 physicians (rheumatologists and immunologists with experience in the treatment of lupus), asking them in each case whether they would initiate treatment or not. The relationship between the 38 complete responses and the SLE Activity Measure (SLAM-R) and SLE Disease Activity Index (SLEDAI) lupus activity scores was analyzed using a general additive model.
Results: SLE disease activity measured by SLAM-R or SLEDAI is a significant predictor (p < 0.0001) of physicians' decision to initiate treatment for patients with lupus. Variation between physicians was observed but was mostly due to a few outliers. Some other variations remained unexplained by patients' SLE disease activity, damage, or by specific organ involvement.
Conclusion: We present reference tables and curves for research that may be used as a basis to derive standardized quantitative criteria for entry in clinical trials. More research is needed on how these tools can be used by clinicians to guide them in their decision to treat or not.