开发一个核心成果测量工具; "LeishCOM_LCL",用于局部皮肤莱什曼病
Shalindra Ranasinghe1, Sujai Senarathne1, Vijani Somaratne2
1Department of Parasitology, University of Sri Jayewardenepura, Gangodawila, Nugegoda, Sri Lanka.
PLoS neglected tropical diseases
|August 29, 2024
概括
为局部皮肤莱什曼病 (LCL) 开发了一种新的核心结果集 (COS). 这种标准化工具确保了对LCL临床试验和患者结果的一致评估.
科学领域:
- 皮肤病学 皮肤病学
- 寄生虫学的寄生虫学
- 临床试验方法论 临床试验方法论
背景情况:
- 局部皮肤雷什曼病 (LCL) 是一种慢性,性皮肤疾病.
- 现有的LCL临床试验缺乏标准化的结果指标,导致结果不一致.
- 对于LCL评估,需要一个以共识为导向的核心成果集 (COS).
研究的目的:
- 建立对评估LCL的关键领域的共识.
- 定义用于测量这些领域的特定参数.
- 开发一个全面的工具,一个COS,用于标准化临床评估LCL.
主要方法:
- 进行了文献审查,以确定LCL的现有COS和结果措施.
- 来自特有地区的专家利益相关者 (n=20) 参与的国际合作方法被用来确定潜在的结果领域.
- 面对面的多学科会议利用名义小组技术进行判断验证和共识建设.
主要成果:
- 没有确定LCL之前的COS.
- 商定了五个核心结果领域:标志 (损伤形态,直径,硬化),治疗有效性 (损伤大小变化,重新表皮化),治疗影响 (研究者和患者视觉模拟得分) 和临床后续 (痕).
- "临床治疗"被定义为主要的一般概念,并包含了两个开放式问题,以捕捉与健康有关的生活质量.
结论:
- 莱什COM_LCL工具是作为局部皮肤莱什曼病的COS开发的.
- 该COS包括人口统计细节,商定的结果领域以及LCL评估的具体措施.
- 未来的工作将包括验证LeishCOM_LCL和考虑患者报告结果措施.
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