Lee Nathaniel, Smith Chris, Bailey Robin, Ariyoshi Koya, Smith Sarah, Black Nick, Edwards Tansy
Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK.
School of Tropical Medicine and Global Health, Nagasaki University, Nagasaki, Japan.
Trials. 2025 Jan 6;26(1):6. doi: 10.1186/s13063-024-08713-6.
Leptospirosis is a zoonotic bacterial infection occurring worldwide. It is of particular public health concern due to its global distribution, epidemic potential and high mortality without appropriate treatment. The method for the management of leptospirosis, particularly in severe disease, is clouded by methodological inconsistency and a lack of standardized outcome measures. The study this protocol details aims to develop a core outcome set (COS) for leptospirosis research. A COS is a set of outcomes with international consensus as a minimum for reporting in future studies focusing on leptospirosis. Establishing a COS will contribute to harmonizing Leptospirosis treatment research and will be instrumental in constructing a high-quality evidence base to feed into a planned future rigorous international clinical trial on leptospirosis.
The COS-LEP study will employ a COS development methodology standardized by the COMET initiative framework. This includes (1) a systematic review of available quantitative and qualitative literature reporting therapeutic response and safety outcomes and measures; (2) focused interviews with healthcare professional and people treated for leptospirosis exploring outcomes of interests using qualitative methodology; (3) narrowing the choice of outcomes by international consensus using a Delphi survey process; and (4) undertaking a hybrid consensus meeting with key stakeholders to build the final COS.
This protocol describes the method to develop the first core outcome set for use in human leptospirosis studies. This will not only be a key feature in the design of a future definitive randomized controlled trial, but also provide a structure for clinicians and researchers collecting treatment cohort data in the various settings where leptospirosis is a public health issue.
钩端螺旋体病是一种在全球范围内发生的人畜共患细菌感染。由于其全球分布、流行潜力以及在未进行适当治疗时的高死亡率，它尤其引起了公共卫生方面的关注。钩端螺旋体病的管理方法，特别是在重症疾病中的管理方法，因方法上的不一致和缺乏标准化的结局指标而模糊不清。本方案详细描述的研究旨在为钩端螺旋体病研究制定一个核心结局集（COS）。核心结局集是一组具有国际共识的结局，是未来聚焦钩端螺旋体病研究报告中至少应包含的内容。建立核心结局集将有助于使钩端螺旋体病治疗研究趋于一致，并有助于构建高质量的证据基础，为未来计划开展的关于钩端螺旋体病的严格国际临床试验提供依据。
COS-LEP研究将采用由COMET倡议框架标准化的核心结局集开发方法。这包括：（1）对报告治疗反应和安全性结局及指标的现有定量和定性文献进行系统综述；（2）使用定性方法对医疗保健专业人员和接受过钩端螺旋体病治疗的人员进行聚焦访谈，探讨感兴趣的结局；（3）通过德尔菲调查过程，经国际共识缩小结局选择范围；（4）与关键利益相关者举行混合共识会议，以构建最终的核心结局集。
本方案描述了开发首个用于人类钩端螺旋体病研究的核心结局集的方法。这不仅将成为未来确定性随机对照试验设计的关键特征，还将为在钩端螺旋体病成为公共卫生问题的各种环境中收集治疗队列数据的临床医生和研究人员提供一个框架。
