Department of Dermatology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Department of Public Health Sciences, Loyola University, Chicago, Illinois.
JAMA Dermatol. 2020 Aug 1;156(8):901-906. doi: 10.1001/jamadermatol.2020.1698.
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.
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.
These findings provide the initial validation of classification criteria for DLE for use in observational and clinical trials.
分类标准是用于为研究招募统一队列的标准化定义。它们强调高特异性，与诊断标准不同。目前，盘状红斑狼疮（DLE）尚无普遍认可的分类标准，这导致该领域的观察性和干预性临床研究存在严重的异质性。
使用 12 项先前定义的候选标准项目创建和验证 DLE 的分类标准。
设计、设置和参与者：在这项诊断研究中，候选标准项目由美国、波兰、日本和韩国的学术皮肤科诊所的皮肤科医生和皮肤科病理学家在 DLE 患者或可能与 DLE 混淆的疾病的临床就诊中前瞻性应用。数据收集于 2017 年 12 月 1 日至 2019 年 2 月 1 日，并于 2019 年 3 月 1 日至 9 月 19 日进行分析。
计算这 2 组的临床特征，并使用 χ2 或 Fisher 确切检验进行比较。使用最佳子集逻辑回归分析确定候选模型。考虑改进检验、拟合统计和区分度以选择最终模型。
9 个地点贡献了 215 名患者，其中 15 名患者的数据缺失或不完整。DLE 分类标准的最终模型仅包含临床变量：萎缩性瘢痕（3 分）、位于舟状窝（2 分）、头颈部偏好（2 分）、色素减退（1 分）、滤泡角化过度和/或栓塞（1 分）和红斑至紫蓝色（1 分），接收者操作特征曲线下面积为 0.91（95%CI，0.87-0.95）。评分至少为 5 分可在 DLE 的分类中获得 84.1%的敏感性和 75.9%的特异性，评分越高特异性越高。
这些发现为 DLE 的分类标准在观察性和临床试验中的应用提供了初步验证。
