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克罗地亚外部质量评估计划中的对等组划分:同质性与样本数量之间的权衡。

Peer groups splitting in Croatian EQA scheme: a trade-off between homogeneity and sample size number.

作者信息

Vlašić Tanasković Jelena, Coucke Wim, Leniček Krleža Jasna, Vuković Rodriguez Jadranka

出版信息

Clin Chem Lab Med. 2017 Mar 1;55(4):539-545. doi: 10.1515/cclm-2016-0284.

Abstract

BACKGROUND

Laboratory evaluation through external quality assessment (EQA) schemes is often performed as 'peer group' comparison under the assumption that matrix effects influence the comparisons between results of different methods, for analytes where no commutable materials with reference value assignment are available. With EQA schemes that are not large but have many available instruments and reagent options for same analyte, homogenous peer groups must be created with adequate number of results to enable satisfactory statistical evaluation. We proposed a multivariate analysis of variance (MANOVA)-based test to evaluate heterogeneity of peer groups within the Croatian EQA biochemistry scheme and identify groups where further splitting might improve laboratory evaluation.

METHODS

EQA biochemistry results were divided according to instruments used per analyte and the MANOVA test was used to verify statistically significant differences between subgroups. The number of samples was determined by sample size calculation ensuring a power of 90% and allowing the false flagging rate to increase not more than 5%. When statistically significant differences between subgroups were found, clear improvement of laboratory evaluation was assessed before splitting groups.

RESULTS

After evaluating 29 peer groups, we found strong evidence for further splitting of six groups. Overall improvement of 6% reported results were observed, with the percentage being as high as 27.4% for one particular method.

CONCLUSIONS

Defining maximal allowable differences between subgroups based on flagging rate change, followed by sample size planning and MANOVA, identifies heterogeneous peer groups where further splitting improves laboratory evaluation and enables continuous monitoring for peer group heterogeneity within EQA schemes.

摘要

背景

对于没有可赋值参考值的可互换材料的分析物,通过外部质量评估(EQA)计划进行的实验室评估通常是在“同组”比较的情况下进行的,因为基质效应会影响不同方法结果之间的比较。对于规模不大但同一分析物有许多可用仪器和试剂选项的EQA计划,必须创建具有足够数量结果的同质同组,以便进行令人满意的统计评估。我们提出了一种基于多变量方差分析(MANOVA)的测试,以评估克罗地亚EQA生物化学计划中同组的异质性,并识别进一步细分可能改善实验室评估的组。

方法

根据每种分析物使用的仪器对EQA生物化学结果进行划分,并使用MANOVA测试来验证亚组之间的统计学显著差异。样本数量通过样本量计算确定,确保检验效能为90%,并允许误判率增加不超过5%。当发现亚组之间存在统计学显著差异时,在细分组之前评估实验室评估的明显改善。

结果

在评估了29个同组后,我们发现有充分证据表明六个组需要进一步细分。观察到报告结果总体改善了6%,其中一种特定方法的改善率高达27.4%。

结论

基于标记率变化定义亚组之间的最大允许差异,然后进行样本量规划和MANOVA,可以识别异质同组,在这些同组中进一步细分可以改善实验室评估,并能够对EQA计划中的同组异质性进行持续监测。

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