The 1999 Stockholm Consensus Conference on quality specifications in laboratory medicine
The 1999 Stockholm Consensus Conference on quality specifications in laboratory medicine
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DOI：
10.1515/cclm-2014-0914
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发表时间：
2015-05-01
影响因子：
6.8
通讯作者：
Fraser, Callum G.
中科院分区：
文献类型：
--
作者：
Fraser, Callum G.
50多年来，检验医学分析质量规范的制定一直是一个讨论和辩论的话题：15年前，随着该主题的成熟和大量建议的出现，其中许多建议来自专家小组，许多领先的专业人员意识到，有必要就此类规范的制定达成全球共识。1999年举行的斯德哥尔摩会议“制定实验室医学全球分析质量规格的战略”实现了这一目标，并倡导普遍采用层级结构的方法。该层次有五个级别，即：1)在特定临床环境中对分析性能对临床结果的影响的评估；2)使用a)基于生物变异成分的数据，或b)临床医生意见的分析；3)发布来自a)国家和国际专家机构的专业建议，或b)专家本地团体或个人；4)由监管机构设定的性能目标，或b)外部质量评估(EQA)计划的组织者，来评估分析性能对临床决策的影响；以及5)基于当前技术状态的目标，如a)由来自EQA或能力测试方案的数据所展示的，或b)在当前关于方法学的出版物中找到的。这一方法自广泛颁布以来已被广泛使用，但也有不断的批评和新的发展。现在似乎是对所建议的战略进行客观重新评估以设定分析性业绩目标的时候了。
The setting of analytical quality specifications in laboratory medicine has been a topic of discussion and debate for over 50 years: 15 years ago, as the subject matured and a profusion of recommendations appeared, many of them from expert groups, it was realised by a number of leading professionals that there was a need for a global consensus on the setting of such specifications. The Stockholm Conference held in 1999 on "Strategies to set global analytical quality specifications in laboratory medicine" achieved this and advocated the ubiquitous application of a hierarchical structure of approaches. The hierarchy has five levels, namely: 1) evaluation of the effect of analytical performance on clinical outcomes in specific clinical settings; 2) evaluation of the effect of analytical performance on clinical decisions in general using a) data based on components of biological variation, or b) analysis of clinicians' opinions; 3) published professional recommendations from a) national and international expert bodies, or b) expert local groups or individuals; 4) performance goals set by a) regulatory bodies, or b) organisers of external quality assessment (EQA) schemes; and 5) goals based on the current state of the art as a) demonstrated by data from EQA or proficiency testing scheme, or b) found in current publications on methodology. This approach has been much used since its wide promulgation, but there have been ongoing criticisms and new developments. The time seems right for an objective reappraisal of recommended strategies to set analytical performance goals.