Can a broadly applicable set of classification criteria be developed to classify a lesion or a rash as discoid lupus erythematosus for research purposes?
In this diagnostic study, previously defined candidate criteria items were applied prospectively to 215 patients at international academic dermatology centers who were identified as having discoid lupus erythematosus or a disease mimicker. Features were compared between groups, and candidate models were identified using best subsets logistic regression analysis to select 1 final model yielding a points-based system for discoid lupus erythematosus classification.
This diagnostic study presents the initial validation of classification criteria for discoid lupus erythematosus for use in clinical research.
Classification criteria are the standardized definitions that are used to enroll uniform cohorts for research studies. They emphasize high specificity and are distinct from diagnostic criteria. No universally recognized classification criteria currently exist for discoid lupus erythematosus (DLE), which has led to problematic heterogeneity in observational and interventional clinical studies across the field.
To create and validate classification criteria for DLE using 12 previously defined candidate criteria items.
Design, Setting, and Participants
For this diagnostic study, candidate criteria items were prospectively applied by dermatologists and dermatopathologists at clinical visits of patients with DLE or a condition that could be confused for DLE, termed a DLE mimicker, at academic dermatology practices across the United States, Poland, Japan, and South Korea. Data were collected from December 1, 2017, to February 1, 2019, and analyzed from March 1 to September 19, 2019.
Main Outcomes and Measures
Clinical features among these 2 groups were calculated and compared with χ2 or Fisher exact tests. Candidate models were identified using best subsets logistic regression analysis. Improvement tests, fit statistics, and discrimination were considered to choose a final model.
Nine sites contributed 215 patients, 15 of whom had missing or incomplete data. The final model for DLE classification criteria includes only clinical variables: atrophic scarring (3 points), location in the conchal bowl (2 points), preference for the head and neck (2 points), dyspigmentation (1 point), follicular hyperkeratosis and/or plugging (1 point), and erythematous to violaceous in color (1 point), with an area under the receiving operating characteristic curve of 0.91 (95% CI, 0.87-0.95). A score of at least 5 points yields a sensitivity of 84.1% and a specificity of 75.9% in the classification of DLE, with increasing scores yielding higher specificity.
Conclusions and Relevance
These findings provide the initial validation of classification criteria for DLE for use in observational and clinical trials.
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Elman SA, Joyce C, Braudis K, et al. Creation and Validation of Classification Criteria for Discoid Lupus Erythematosus. JAMA Dermatol. Published online June 17, 2020. doi:10.1001/jamadermatol.2020.1698
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