van Henten Saskia, Diro Ermias, Tesfaye Annisa Befekadu, Tilahun Zewdu Feleke, van Griensven Johan, Enbiale Wendemagegn
Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
Department of General Internal Medicine, University of Washington, Seattle, Washington, United States of America.
PLoS Negl Trop Dis. 2025 Aug 22;19(8):e0013458. doi: 10.1371/journal.pntd.0013458. eCollection 2025 Aug.
Cutaneous leishmaniasis (CL) is clinically classified into localized (LCL), mucocutaneous (MCL) and diffuse (DCL) types. While conducting a treatment study on CL at two sites in Ethiopia (Boru Meda and Gondar), differences in opinion in the classification of CL became apparent. The lack of uniformly understandable classifications has made comparison and generalizability of research findings challenging. We wanted to investigate the extent of agreement in CL classification between CL experts and describe on which points there was disagreement.
METHODOLOGY/PRINCIPAL FINDINGS: Thirteen CL experts in Ethiopia were provided with 26 high-quality photographs of CL lesions from patients enrolled in a clinical study on miltefosine treatment. Patients were selected for this sub study due to potential classification difficulties. The most common (majority vote) classification category was noted, and the proportion of experts which choose this (% agreement). Majority vote classification was used to reclassify patients compared to the original study classification. Among included patients, sixteen were originally classified as DCL, eight as MCL, one as LCL, and one as Leishmania recidivans. There was no unanimous consensus for any of the selected cases. The maximum agreement was 80%, which was seen for 38% (10/26) cases. Disagreements existed on whether patients had mucosal involvement, how to classify patients with singular large diffusely swollen lesions and when to classify patients with multiple lesions as DCL. According to the majority vote, 62% of selected patients would be reclassified to a different CL classification compared to the original study from which photographs were selected.
CONCLUSIONS/SIGNIFICANCE: There is no clear understanding and harmony in the classification of CL. Reproducible classification guidelines and training of healthcare providers on CL are needed to ensure consistency in further classification to allow generalizability and comparison of clinical trial findings. Simpler classifications with direct links to treatment decision-making would be valuable.
皮肤利什曼病（CL）在临床上分为局限性（LCL）、黏膜皮肤型（MCL）和弥漫性（DCL）。在埃塞俄比亚的两个地点（博鲁梅达和贡德尔）开展CL治疗研究时，CL分类的意见分歧变得明显。缺乏统一易懂的分类使得研究结果的比较和推广具有挑战性。我们想调查CL专家之间CL分类的一致程度，并描述存在分歧的点。
方法/主要发现：向埃塞俄比亚的13名CL专家提供了26张来自参与米替福新治疗临床研究患者的CL病变高质量照片。由于潜在的分类困难，这些患者被选入该子研究。记录最常见的（多数投票）分类类别以及选择该类别的专家比例（一致率）。与原始研究分类相比，使用多数投票分类对患者进行重新分类。纳入的患者中，16例最初被分类为DCL，8例为MCL，1例为LCL，1例为复发性利什曼病。对于任何选定的病例都没有达成一致共识。最大一致率为80%，见于38%（10/26）的病例。在患者是否有黏膜受累、如何对单个大的弥漫性肿胀病变患者进行分类以及何时将多个病变患者分类为DCL方面存在分歧。根据多数投票，与选择照片的原始研究相比，62%的选定患者将被重新分类为不同的CL分类。
结论/意义：CL分类没有清晰的认识和统一标准。需要可重复的分类指南以及对医疗保健提供者进行CL培训，以确保进一步分类的一致性，从而使临床试验结果具有可推广性和可比性。与治疗决策直接相关的更简单分类将很有价值。
