Background and aims To evaluate the construct validity of the Lupus Low Disease Activity State (LLDAS), a treatment target in systemic lupus erythematosus (SLE).
Methods Fifty SLE case summaries based on real patients were prepared and assessed independently for meeting the operational definition of LLDAS. Fifty international rheumatologists with expertise in SLE, but with no prior involvement in the LLDAS project, responded to a survey in which they were asked to categorise the disease activity state of each case as remission, low, moderate or high. Agreement between expert opinion and LLDAS was assessed using Cohen’s Kappa.
Results Overall agreement between expert opinion and the operational definition of LLDAS was 77.96% (95% CI 76.34%–79.58%), with a Cohen’s Kappa of 0.57 (95% CI 0.55–0.61). Of the cases (22 of 50) that fulfilled the operational definition of LLDAS, only 5.34% (59 of 22 × 50) of responses classified the cases as moderate/high activity. Of the cases that did not fulfil the operational definition of LLDAS (28 of 50), 35.14% (492 of 28 × 50) of responses classified the cases as remission/low activity. Common reasons for discordance were assignment to remission/low activity of cases with higher corticosteroid doses than defined in LLDAS (prednisolone ≤7.5 mg) or with SLEDAI-2K>4 due to serological activity (high anti-dsDNA antibody and/or low complement).
Conclusions LLDAS has good construct validity with high overall agreement between the operational definition of LLDAS and expert opinion. Discordance of results suggests that the operational definition of LLDAS is more stringent than expert opinion at defining a low disease activity state.
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