A Framework for the Development and Interpretation of Different Sepsis Definitions and Clinical Criteria.

A Framework for the Development and Interpretation of Different Sepsis Definitions and Clinical Criteria.
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DOI:
10.1097/ccm.0000000000001730
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发表时间:
2016-03
影响因子:
8.8
通讯作者:
Watson RS
Watson RS
中科院分区:
医学1区
文献类型:
--
作者:
Angus DC;Seymour CW;Coopersmith CM;Deutschman CS;Klompas M;Levy MM;Martin GS;Osborn TM;Rhee C;Watson RS

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尽管败血症在2,000多年前就被描述过,临床医生仍然很难定义它,但没有“黄金标准”,并且存在多种相互竞争的方法和术语。挑战包括不断变化的知识基础,告知我们对脓毒症的理解,任何潜在定义的哪些方面是最重要的竞争观点,以及大多数潜在标准在高危人群中分布的趋势,以这种方式阻碍分离成离散的患者组。我们建议,任何定义或诊断标准的制定和评估应遵循四个步骤:1)定义认识论基础,2)同意用于框架练习的所有相关术语,3)说明任何拟议标准的预期目的,以及4)采用科学方法来告知其在预期目的方面的有用性。可通过六个领域来衡量幸福感:1)可靠性(重测期间、评分者之间、随时间推移和跨设置的标准稳定性),2)内容效度(类似于表面效度),3)结构效度(标准是否测量它们意图测量的东西),4)标准有效性(新标准与标准相比如何),5)测量负担(成本、安全性和复杂性),和6)及时性(标准是否与护理决策同时可用)。这些有用领域的相对重要性取决于预期目的,其中有四大类:1)临床护理,2)研究,3)监督,以及4)质量改进和审计。这一拟议的方法框架旨在帮助理解不同方法的优势和劣势,提供一种解释不同方法产生的流行病学估计差异的机制,并指导未来定义和诊断标准的制定。
Although sepsis was described more than 2,000 years ago, and clinicians still struggle to define it, there is no “gold standard,” and multiple competing approaches and terms exist. Challenges include the ever-changing knowledge base that informs our understanding of sepsis, competing views on which aspects of any potential definition are most important, and the tendency of most potential criteria to be distributed in at-risk populations in such a way as to hinder separation into discrete sets of patients. We propose that the development and evaluation of any definition or diagnostic criteria should follow four steps: 1) define the epistemologic underpinning, 2) agree on all relevant terms used to frame the exercise, 3) state the intended purpose for any proposed set of criteria, and 4) adopt a scientific approach to inform on their usefulness with regard to the intended purpose. Usefulness can be measured across six domains: 1) reliability (stability of criteria during retesting, between raters, over time, and across settings), 2) content validity (similar to face validity), 3) construct validity (whether criteria measure what they purport to measure), 4) criterion validity (how new criteria fare compared to standards), 5) measurement burden (cost, safety, and complexity), and 6) timeliness (whether criteria are available concurrent with care decisions). The relative importance of these domains of usefulness depends on the intended purpose, of which there are four broad categories: 1) clinical care, 2) research, 3) surveillance, and 4) quality improvement and audit. This proposed methodologic framework is intended to aid understanding of the strengths and weaknesses of different approaches, provide a mechanism for explaining differences in epidemiologic estimates generated by different approaches, and guide the development of future definitions and diagnostic criteria.