Mohammed Amel Beshir, Mohammed Fewzia Shikur, Zewdu Feleke Tilahun, Nigusse Shimelis Doni, Lambert Saba, Marks Michael, Walker Stephen L, Gadisa Endalamaw
ALERT Hospital, Addis Ababa, Ethiopia.
Department of Dermatovenereology, College of Health Sciences, Addis Ababa University, Addis Ababa, Addis Ababa, Ethiopia.
NIHR Open Res. 2025 May 14;5:12. doi: 10.3310/nihropenres.13869.2. eCollection 2025.
Cutaneous leishmaniasis (CL) remains a major public health challenge, especially in endemic regions like Ethiopia, where an estimated 40,000 new cases occur annually. Effective treatment evaluation for CL relies on consistent clinical assessments, yet variability in lesion descriptions can complicate reliable outcome measures.
We conducted an inter-reliability study of clinicians' evaluations of CL lesion morphology and size at ALERT Hospital, Addis Ababa. Twelve clinicians independently examined 12 patients with parasitologically confirmed CL, each clinician assessing lesion morphology, size, and severity.
We found high consistency in reporting major morphological categories (e.g., plaques) but significant variability in secondary features like dyspigmentation and scale, as well as mucosal involvement. Lesion size measurements showed limited variability, suggesting its reliability as a potential measure for future clinical trials. Disparities in severity assessments highlight the need for a standardized scoring system in CL.
Our findings underscore the importance of training for consistent, high-quality clinical evaluations of CL and suggests that lesion size could be a reproducible outcome measure in treatment efficacy trials.
皮肤利什曼病(CL)仍然是一项重大的公共卫生挑战,尤其是在埃塞俄比亚等流行地区,据估计每年有40000例新发病例。对CL进行有效的治疗评估依赖于一致的临床评估,但病变描述的变异性会使可靠的疗效衡量指标变得复杂。
我们在亚的斯亚贝巴的ALERT医院对临床医生对CL病变形态和大小的评估进行了一致性研究。12名临床医生独立检查了12例经寄生虫学确诊为CL的患者,每位临床医生评估病变的形态、大小和严重程度。
我们发现,在报告主要形态类别(如斑块)方面具有高度一致性,但在色素沉着异常、鳞屑等次要特征以及黏膜受累情况方面存在显著变异性。病变大小测量显示变异性有限,表明其作为未来临床试验潜在衡量指标的可靠性。严重程度评估的差异凸显了CL标准化评分系统的必要性。
我们的研究结果强调了进行CL一致、高质量临床评估培训的重要性,并表明病变大小可能是治疗疗效试验中可重复的疗效衡量指标。