Medical Practice Evaluation Center, Massachusetts General Hospital, Harvard Medical School, Boston, USA.
Medical Practice Evaluation Center, Massachusetts General Hospital, Harvard Medical School, Boston, USA.
Lancet Infect Dis. 2014 Mar;14(3):239-49. doi: 10.1016/S1473-3099(13)70250-0. Epub 2013 Dec 10.
The aim of diagnostic point-of-care testing is to minimise the time to obtain a test result, thereby allowing clinicians and patients to make a quick clinical decision. Because point-of-care tests are used in resource-limited settings, the benefits need to outweigh the costs. To optimise point-of-care testing in resource-limited settings, diagnostic tests need rigorous assessments focused on relevant clinical outcomes and operational costs, which differ from assessments of conventional diagnostic tests. We reviewed published studies on point-of-care testing in resource-limited settings, and found no clearly defined metric for the clinical usefulness of point-of-care testing. Therefore, we propose a framework for the assessment of point-of-care tests, and suggest and define the term test efficacy to describe the ability of a diagnostic test to support a clinical decision within its operational context. We also propose revised criteria for an ideal diagnostic point-of-care test in resource-limited settings. Through systematic assessments, comparisons between centralised testing and novel point-of-care technologies can be more formalised, and health officials can better establish which point-of-care technologies represent valuable additions to their clinical programmes.
诊断即时检测的目的是尽量减少获得检测结果的时间，从而使临床医生和患者能够快速做出临床决策。由于即时检测是在资源有限的环境中使用的，因此其收益必须超过成本。为了在资源有限的环境中优化即时检测，诊断检测需要针对相关临床结果和运营成本进行严格评估，这与对传统诊断检测的评估不同。我们回顾了在资源有限的环境中进行即时检测的已发表研究，并未发现用于即时检测临床有用性的明确定义指标。因此，我们提出了即时检测评估框架，并建议并定义术语“检测效能”来描述诊断检测在其操作环境下支持临床决策的能力。我们还提出了资源有限环境中理想即时诊断检测的修订标准。通过系统评估，可以更正式地比较集中检测和新型即时检测技术，卫生官员可以更好地确定哪些即时检测技术是其临床项目的有价值的补充。
