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Objective  To determine the level of agreement of disease flare severity (distinguishing severe, moderate, and mild flare and persistent disease activity) in a large paper‐patient exercise involving 988 individual cases of systemic lupus erythematosus.    Methods  A total of 988 individual lupus case histories were assessed by 3 individual physicians. Complete agreement about the degree of flare (or persistent disease activity) was obtained in 451 cases (46%), and these provided the reference standard for the second part of the study. This component used 3 flare activity instruments (the British Isles Lupus Assessment Group [ BILAG ] 2004, Safety of Estrogens in Lupus Erythematosus National Assessment [ SELENA ] flare index [ SFI ] and the revised  SELENA  flare index [ rSFI ]). The 451 patient case histories were distributed to 18 pairs of physicians, carefully randomized in a manner designed to ensure a fair case mix and equal distribution of flare according to severity.    Results  The 3‐physician assessment of flare matched the level of flare using the 3 indices, with 67% for  BILAG  2004, 72% for  SFI , and 70% for  rSFI . The corresponding weighted kappa coefficients for each instrument were 0.82, 0.59, and 0.74, respectively. We undertook a detailed analysis of the discrepant cases and several factors emerged, including a tendency to score moderate flares as severe and persistent activity as flare, especially when the  SFI  and  rSFI  instruments were used. Overscoring was also driven by scoring treatment change as flare, even if there were no new or worsening clinical features.    Conclusion  Given the complexity of assessing lupus flare, we were encouraged by the overall results reported. However, the problem of capturing lupus flare accurately is not completely solved.

Study of Flare Assessment in Systemic Lupus Erythematosus Based on Paper Patients