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Dengue illness index—A tool to characterize the subjective dengue illness experience

机译:登革热疾病指数-表征主观登革热经验的工具

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摘要

Dengue virus infections are a major cause of febrile illness that significantly affects individual and societal productivity and drives up health care costs principally in the developing world. Two dengue vaccine candidates are in advanced clinical efficacy trials in Latin America and Asia, and another has been licensed in more than fifteen countries but its uptake has been limited. Despite these advances, standardized metrics for comparability of protective efficacy between dengue vaccines remain poorly defined. The Dengue Illness Index (DII) is a tool that we developed thru refinement of previous similar iterations in an attempt to improve and standardize the measurement of vaccine and drug efficacy in reducing moderate dengue illness. The tool is designed to capture an individual’s overall disease experience based on how the totality of their symptoms impacts their general wellness and daily functionality. We applied the DII to a diary card, the Dengue Illness Card (DIC), which was examined and further developed by a working group. The card was then refined with feedback garnered from a Delphi methodology-based query that addressed the adequacy and applicability of the tool in clinical dengue research. There was overall agreement that the tool would generate useful data and provide an alternative perspective to the assessment of drug or vaccine candidates, which in the case of vaccines, are assessed by their reduction in any virologically confirmed dengue of any severity with a focus on the more severe. The DIC needs to be evaluated in the field in the context of vaccine or drug trials, prospective cohort studies, or during experimental human infection studies. Here, we present the final DIC resulting from the Delphi process and offer its further development or use to the dengue research community.
机译:登革热病毒感染是高热病的主要原因,这主要影响着发展中国家的个人和社会生产力,并增加了医疗费用。两名登革热疫苗候选药物正在拉丁美洲和亚洲进行先进的临床功效试验,另一种已在15个以上的国家/地区获得许可,但其使用受到限制。尽管取得了这些进步,但登革热疫苗之间保护功效可比性的标准化指标仍然定义不清。登革热疾病指数(DII)是我们通过对先前类似迭代的改进而开发的一种工具,旨在改善和标准化降低中度登革热疾病的疫苗和药物功效的测量方法。该工具旨在根据症状的整体如何影响其总体健康和日常功能来捕获个人的总体疾病经历。我们将DII应用于日记卡,即登革热疾病卡(DIC),该文档已由工作组进行了检查和进一步开发。然后,根据基于Delphi方法论的查询所获得的反馈来完善该卡,该查询解决了该工具在临床登革热研究中的充分性和适用性。总体上认为,该工具将产生有用的数据,并为评估候选药物或疫苗提供替代视角,对于疫苗或候选疫苗,应通过其在病毒学上确认的任何严重程度的登革热减少量进行评估,重点是更严重。需要在疫苗或药物试验,前瞻性队列研究或实验性人类感染研究期间对DIC进行现场评估。在这里,我们介绍由Delphi流程产生的最终DIC,并向登革热研究界提供其进一步的开发或使用。

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