Protocol for a prospective observational cohort study of cutaneous leishmaniasis in Ethiopia

Amel Beshir Mohammed, Fewzia Dhikur Mohammed, Feleke Tilahun Zewdu, Shimelis Doni Nigusse, Yohannes Hailemichael, Teklu Cherkose, Abebaw Yeshambel Alemu, Eshetu Molla, Kidist Bobosha, Vanessa Yardley, Iris Mosweu, Mirgissa Kaba, Catherine Pitt, Elizabeth Allen, Saba Maria Lambert, Michael Marks, Stephen L. Walker, Endalamaw Gadisa
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Abstract

Background: Cutaneous leishmaniasis (CL) is a skin neglected tropical disease, with an estimated 40,000 new cases each year in Ethiopia. CL causes ulcers, nodules, and plaques on the skin, and in some instances the destruction of the nasopharyngeal mucosa and cartilage. Some CL lesions may heal spontaneously, whilst other lesions may require therapies which are associated with discomfort, adverse effects, prolonged treatment, and a frequent lack of a complete response. Scarring, a sequela of CL, causes permanent disfigurement and is associated with stigma linked with a reduction in health-related quality of life. The choice of treatment for CL is based upon factors including the causative species; the number, extent, size, and location of lesions; and the availability of treatments. The development of robust evidence for CL treatment is hindered by a lack of validated and appropriate outcome measures and few data to support hypothesis-generation and trial design. There is a paucity of prospective data with well-defined treatment outcomes for CL caused by L. aethiopica. Aim: The overall aim of this study is to improve the understanding of the health and economic burden of CL. Methods: We have designed an observational, multi-centre cohort study to examine treatment outcomes for CL in Ethiopia which includes clinical outcomes, laboratory outcomes, patient reported outcome measures, scar assessments and cost effectiveness. We aim to recruit up to 750 participants across two hospital sites. We present here the protocol for this cohort study with a 12-month follow up period for each participant. Conclusions: These data will inform the design of randomized controlled trials to evaluate new treatment strategies, with appropriate economic evaluations. This will help improve evidence-based guidelines and support evidence-led policy decisions, not only in Ethiopia but also globally.
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埃塞俄比亚皮肤利什曼病的前瞻性观察队列研究方案
背景:皮肤利什曼病(CL)是一种被忽视的皮肤热带病,埃塞俄比亚每年估计有4万例新病例。CL引起皮肤溃疡、结节和斑块,在某些情况下还会破坏鼻咽黏膜和软骨。一些CL病变可以自发愈合,而其他病变可能需要治疗,这与不适、不良反应、长期治疗和经常缺乏完全反应有关。结疤是恶性淋巴瘤的后遗症,可导致永久性毁容,并与与健康相关的生活质量下降相关的耻辱感有关。CL的治疗选择是基于各种因素,包括致病物种;病变的数量、范围、大小和位置;以及治疗的可用性。缺乏经过验证和适当的结果测量,以及支持假设生成和试验设计的数据很少,阻碍了CL治疗的有力证据的发展。埃塞俄比亚乳杆菌引起的CL缺乏明确的治疗结果的前瞻性数据。目的:本研究的总体目的是提高对慢性阻塞性肺病的健康和经济负担的认识。方法:我们设计了一项观察性、多中心队列研究,以检查埃塞俄比亚CL的治疗结果,包括临床结果、实验室结果、患者报告的结果测量、疤痕评估和成本效益。我们的目标是在两家医院招募750名参与者。我们在此提出了这项队列研究的方案,并对每位参与者进行了12个月的随访。结论:这些数据将为随机对照试验的设计提供信息,以评估新的治疗策略,并进行适当的经济评估。这将有助于改进以证据为基础的指导方针,支持以证据为主导的决策,不仅在埃塞俄比亚,而且在全球。
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