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实验室在遵循心肌梗死管理推荐临床指南方面的情况如何:欧洲心脏标志物指南应用研究(CARMAGUE)

How Well Do Laboratories Adhere to Recommended Clinical Guidelines for the Management of Myocardial Infarction: The CARdiac MArker Guidelines Uptake in Europe Study (CARMAGUE).

作者信息

Collinson Paul, Hammerer-Lercher Angelika, Suvisaari Janne, Apple Fred S, Christenson Rob H, Pulkki Kari, van Dieijen-Visser Marja P, Duff Christopher J, Baum Hannsjörg, Stavljenic-Rukavina Ana, Aakre Kristin M, Langlois Michel R, Stankovic Sanja, Laitinen Paivi

机构信息

Departments of Chemical Pathology and Cardiology, St George's Hospital, London, UK;

Kantonspital Aarau AG, Aarau, Switzerland;

出版信息

Clin Chem. 2016 Sep;62(9):1264-71. doi: 10.1373/clinchem.2016.259515. Epub 2016 Jul 26.

Abstract

BACKGROUND

We undertook an assessment of current use of evidence-based guidelines for the use of cardiac biomarkers in Europe (EU) and North America (NA).

METHODS

In 2013-2014 a web-based questionnaire was distributed via NA and EU biochemical societies. Questions covered cardiac biomarkers measured, analytical methods used, decision thresholds, and use of decision-making protocols. Results were collated using a central database and analyzed using comparative and descriptive nonparametric statistics.

RESULTS

In EU, returns were obtained from 442 hospitals, 50% central or university hospitals, and 39% from local hospitals from 35 countries with 395/442 (89%) provided an acute service. In NA there were 91 responses (63.7% central or university hospitals, 19.8% community hospitals) with 76/91 (83.5%) providing an acute service. Cardiac troponin was the preferred cardiac biomarker in 99.5% (EU) and 98.7% (NA), and the first line marker in 97.7% (EU) and 97.4% (NA). There were important differences in the choice of decision limits and their derivations. The origin of the information was also significantly different, with EU vs NA as follows: package insert, 61.9% vs 40%; publications, 17.1% vs 15.0%; local clinical or analytical validation choice, 21.0% vs 45.0%; P = 0.0003.

CONCLUSIONS

There are significant differences between EU and NA use of cardiac biomarkers. This probably relates to different availability of assays between EU and NA (such as high-sensitivity troponin assays) and different laboratory practices on assay introduction (greater local evaluation of assay performance occurred in NA).

摘要

背景

我们对欧洲(EU)和北美(NA)当前使用基于证据的心脏生物标志物指南的情况进行了评估。

方法

2013 - 2014年,通过北美和欧洲的生化协会分发了一份基于网络的调查问卷。问题涵盖所测量的心脏生物标志物、使用的分析方法、决策阈值以及决策协议的使用情况。使用中央数据库整理结果,并采用比较性和描述性非参数统计方法进行分析。

结果

在欧洲,从35个国家的442家医院收到了回复,其中50%为中心医院或大学医院,39%为当地医院,395/442(89%)提供急性服务。在北美,有91份回复(63.7%为中心医院或大学医院,19.8%为社区医院),76/91(83.5%)提供急性服务。心肌肌钙蛋白是99.5%(欧洲)和98.7%(北美)首选的心脏生物标志物,也是97.7%(欧洲)和97.4%(北美)的一线标志物。在决策限值的选择及其推导方面存在重要差异。信息来源也有显著不同,欧洲与北美情况如下:药品说明书,61.9%对40%;出版物,17.1%对15.0%;当地临床或分析验证选择,21.0%对45.0%;P = 0.0003。

结论

欧洲和北美在心脏生物标志物的使用方面存在显著差异。这可能与欧洲和北美检测方法的不同可用性(如高敏肌钙蛋白检测方法)以及检测方法引入时不同的实验室操作有关(北美对检测性能进行了更多的本地评估)。

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