Aligning diagnostics to the point-of-care: lessons for innovators, evaluators and decision-makers from tuberculosis and HIV.
Aligning diagnostics to the point-of-care: lessons for innovators, evaluators and decision-makers from tuberculosis and HIV.
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DOI：
10.1136/bmjgh-2020-003457
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发表时间：
2020-11
影响因子：
8.1
通讯作者：
Wolffs PFG
中科院分区：
文献类型：
--
作者：
Engel N;Wolffs PFG
诊断，包括那些在护理地点工作的诊断，是成功应对传染病和大流行的公共卫生对策的重要组成部分。然而，它们并不总是被使用或适合预期的使用设置。本文报告了一项关于参与开发和实施新的结核病(TB)和艾滋病毒(HIV)护理点(POC)诊断的人员如何确保这些技术在POC工作的定性研究的关键见解。2015至2017年间的人种学田野工作包括对全球利益攸关方的53次半结构化访谈和对研讨会、公司和会议的访问，以及对印度利益攸关方的15次半结构化访谈，其中包括提供者、决策者、科学家和开发人员以及对公司、诊所和实验室的访问。我们的结果表明，HIV和TB POC诊断的开发人员和实施者的目标是了解并使他们的诊断与更多环境中的元素保持一致，而不仅仅是预期用途，还包括开发人员、全球中介机构、错误/疾病和竞争对手的设置。这五个环境中的参与者和元素定义了什么是好的诊断，但他们的需求可能会发生冲突或变化，而且他们很难访问。要使诊断与概念验证保持一致，需要在整个开发和实施阶段进行持续的需求评估，并在与用户的关系上进行持续的大量投资。这种持续调整和迭代所需的灵活性与全球卫生领域既定的评估程序和商业模式相冲突，并存在偏袒某些产品的风险。文章最后提出了加强这一对接工作的建议，并将该框架应用于新冠肺炎之后的研究需求。
Diagnostics, including those that work at point-of-care, are an essential part of successful public health responses to infectious diseases and pandemics. Yet, they are not always used or fit intended use settings. This paper reports on key insights from a qualitative study on how those engaged with developing and implementing new point-of-care (POC) diagnostics for tuberculosis (TB) and HIV ensure these technologies work at POC. Ethnographic fieldwork between 2015 and 2017 consisting of 53 semistructured interviews with global stakeholders and visits to workshops, companies, and conferences was combined with 15 semistructured interviews with stakeholders in India including providers, decision-makers, scientists and developers and visits to companies, clinics and laboratories. Our results show how developers and implementer of HIV and TB POC diagnostics aim to know and align their diagnostics to elements in more settings than just intended use, but also the setting of the developer, the global intermediaries, the bug/disease and the competitor. Actors and elements across these five settings define what a good diagnostic is, yet their needs might conflict or change and they are difficult to access. Aligning diagnostics to the POC requires continuous needs assessment throughout development and implementation phases as well as substantive, ongoing investment in relationships with users. The flexibility required for such continuous realigning and iteration clashes with established evaluation procedures and business models in global health and risks favouring certain products over others. The paper concludes with suggestions to strengthen this alignment work and applies this framework to research needs in the wake of COVID-19.
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影响因子：
8.1
作者：
Engel N;Wachter K;Pai M;Gallarda J;Boehme C;Celentano I;Weintraub R
通讯作者：
Weintraub R
影响因子：
2.5
作者：
Engel N;Krumeich A
通讯作者：
Krumeich A
影响因子：
3.7
作者：
Engel, Nora;Ganesh, Gayatri;Pai, Madhukar
通讯作者：
Pai, Madhukar
影响因子：
3
作者：
Beisel U;Umlauf R;Hutchinson E;Chandler CI
通讯作者：
Chandler CI
影响因子：
6.4
作者：
Cobelens, Frank;van den Hof, Susan;Kimerling, Michael E.
通讯作者：
Kimerling, Michael E.