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欧洲艰难梭菌诊断不足:艰难梭菌感染的欧洲、多中心、前瞻性、半年期、现患率研究,研究对象为住院腹泻患者(EUCLID)。

Underdiagnosis of Clostridium difficile across Europe: the European, multicentre, prospective, biannual, point-prevalence study of Clostridium difficile infection in hospitalised patients with diarrhoea (EUCLID).

机构信息

EUCLID European Coordinators, University of Leeds, Leeds, UK.

Astellas Pharma Europe, Chertsey, UK.

出版信息

Lancet Infect Dis. 2014 Dec;14(12):1208-19. doi: 10.1016/S1473-3099(14)70991-0. Epub 2014 Nov 7.

Abstract

BACKGROUND

Variations in testing for Clostridium difficile infection can hinder patients' care, increase the risk of transmission, and skew epidemiological data. We aimed to measure the underdiagnosis of C difficile infection across Europe.

METHODS

We did a questionnaire-based study at 482 participating hospitals across 20 European countries. Hospitals were questioned about their methods and testing policy for C difficile infection during the periods September, 2011, to August, 2012, and September, 2012, to August, 2013. On one day in winter, 2012-13 (December, 2012, or January, 2013), and summer, 2013 (July or August), every hospital sent all diarrhoeal samples submitted to their microbiology laboratory to a national coordinating laboratory for standardised testing of C difficile infection. Our primary outcome measures were the rates of testing for and cases of C difficile infection per 10 000 patient bed-days. Results of local and national C difficile infection testing were compared with each other. If the result was positive at the national laboratory but negative at the local hospital, the result was classified as undiagnosed C difficile infection. We compared differences in proportions with the Mann-Whitney test, or McNemar's test if data were matched.

FINDINGS

During the study period, participating hospitals reported a mean of 65·8 tests (country range 4·6-223·3) for C difficile infection per 10 000 patient-bed days and a mean of 7·0 cases (country range 0·7-28·7) of C difficile infection per 10 000 patient-bed days. Only two-fifths of hospitals reported using optimum methods for testing of C difficile infection (defined by European guidelines), although the number of participating hospitals using optimum methods increased during the study period, from 152 (32%) of 468 in 2011-12 to 205 (48%) of 428 in 2012-13. Across all 482 European hospitals on the two sampling days, 148 (23%) of 641 samples positive for C difficile infection (as determined by the national laboratory) were not diagnosed by participating hospitals because of an absence of clinical suspicion, equating to about 74 missed diagnoses per day.

INTERPRETATION

A wide variety of testing strategies for C difficile infection are used across Europe. Absence of clinical suspicion and suboptimum laboratory diagnostic methods mean that an estimated 40 000 inpatients with C difficile infection are potentially undiagnosed every year in 482 European hospitals.

FUNDING

Astellas Pharmaceuticals Europe.

摘要

背景

艰难梭菌感染检测方法的差异可能会妨碍患者的治疗,增加传播风险,并导致流行病学数据出现偏差。我们旨在衡量整个欧洲艰难梭菌感染的漏诊情况。

方法

我们在 20 个欧洲国家的 482 家参与医院进行了一项基于问卷调查的研究。医院被问及在 2011 年 9 月至 2012 年 8 月和 2012 年 9 月至 2013 年 8 月期间进行艰难梭菌感染检测的方法和检测政策。在 2012-13 年冬季(2012 年 12 月或 2013 年 1 月)和 2013 年夏季(7 月或 8 月)的某一天,每家医院都将送往微生物实验室的所有腹泻样本送到国家协调实验室进行标准化艰难梭菌感染检测。我们的主要结局指标是每 10000 张病床接受检测的艰难梭菌感染检测率和每 10000 张病床的艰难梭菌感染病例数。当地和国家艰难梭菌感染检测结果进行了相互比较。如果国家实验室的结果为阳性而当地医院的结果为阴性,则将结果归类为未确诊的艰难梭菌感染。我们使用曼-惠特尼检验比较比例差异,或者如果数据匹配,则使用麦克内尔检验。

结果

在研究期间,参与医院报告的每 10000 张病床接受艰难梭菌感染检测的平均次数为 65.8 次(国家范围为 4.6-223.3),每 10000 张病床的艰难梭菌感染病例数平均为 7.0 例(国家范围为 0.7-28.7)。尽管参与医院使用最佳艰难梭菌感染检测方法的数量在研究期间有所增加(从 2011-12 年的 468 家医院中的 152 家增加到 2012-13 年的 428 家中的 205 家),但只有五分之二的医院报告使用了欧洲指南定义的最佳检测方法。在两次抽样日的所有 482 家欧洲医院中,有 148 份(国家实验室确定的)艰难梭菌感染阳性样本(641 份)未被参与医院诊断,因为缺乏临床怀疑,相当于每天约有 74 例漏诊。

解释

欧洲各地使用了多种艰难梭菌感染检测策略。由于缺乏临床怀疑和次优的实验室诊断方法,估计每年有 40000 名在欧洲 482 家医院住院的艰难梭菌感染患者可能未被诊断。

结论

欧洲各地使用了多种艰难梭菌感染检测策略。由于缺乏临床怀疑和次优的实验室诊断方法,估计每年有 40000 名在欧洲 482 家医院住院的艰难梭菌感染患者可能未被诊断。

资金

安斯泰来制药欧洲公司。

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