识别诊断试验准确性系统综述的方法学异质性

李志霞; 杨智荣; 项骁; 高培; 舒正; 黄元升; 曹宇; 孙凤; 詹思延

Abstract

李志霞,杨智荣,项骁,高培,舒正,黄元升,曹宇,孙凤,詹思延.识别诊断试验准确性系统综述的方法学异质性[J].Chinese journal of Epidemiology,2016,37(2):286-290

识别诊断试验准确性系统综述的方法学异质性

Methodological bias and variation of systematic reviews on diagnostic test accuracy

Received:July 09, 2015

DOI：10.3760/cma.j.issn.0254-6450.2016.02.027

KeyWord: 诊断试验准确性系统综述异质性

English Key Word: Diagnostic test accuracy Systematic reviews Bias and variation

FundProject:高等学校博士学科点专项科研基金(20120001110015)

Author Name	Affiliation	E-mail
Li Zhixia	Department of Epidemiology and Bio-statistics, Peking University Health Science Center, Beijing 100191, China
Yang Zhirong	Department of Epidemiology and Bio-statistics, Peking University Health Science Center, Beijing 100191, China
Xiang Xiao	Department of Epidemiology and Bio-statistics, Peking University Health Science Center, Beijing 100191, China
Gao Pei	Department of Epidemiology and Bio-statistics, Peking University Health Science Center, Beijing 100191, China
Shu Zheng	Department of Epidemiology and Bio-statistics, Peking University Health Science Center, Beijing 100191, China
Huang Yuansheng	Department of Epidemiology and Bio-statistics, Peking University Health Science Center, Beijing 100191, China
Cao Yu	Department of Epidemiology and Bio-statistics, Peking University Health Science Center, Beijing 100191, China
Sun Feng	Department of Epidemiology and Bio-statistics, Peking University Health Science Center, Beijing 100191, China
Zhan Siya	Department of Epidemiology and Bio-statistics, Peking University Health Science Center, Beijing 100191, China	siyan-zhan@bjmu.edu.c

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Abstract:

目的分析诊断试验系统综述的方法学异质性来源。方法通过检索2008年1月1日至2012年12月31日发表在Medline、Embase、Cochrane(CDSR和DARE)数据库中关于诊断试验准确性(DTA)的Meta分析文献,纳入了至少包含10篇原始研究的Meta分析。两名人员独立地对研究特点以及原始研究的数据进行提取,使用混合线性模型对14种潜在的方法学异质性因素来源进行探讨,进而计算出14种异质性因素的诊断比值比(DOR)之比(RDOR)值及其95% CI,从而判断其异质性大小和方向。结果最终纳入了23篇DTA的系统综述,涵盖550篇原始研究。纳入的550篇原始研究的质量良好。单因素混合线性模型分析显示,"金标准是否足够准确"和"金标准与待检试验是否相互独立"是DTA系统综述的异质性来源。多因素混合线性模型分析显示,金标准不准确的诊断试验,其DOR合并值低于金标准足够准确的诊断试验,RDOR=0.018 6(95% CI:0.001 0~0.358 5);金标准与待检试验不独立的诊断试验,其DOR合并值高于金标准与待检试验相互独立的诊断试验,RDOR=2.396 6(95% CI:1.242 8~4.622 7)。结论对于诊断试验系统综述,原始研究的金标准是否足够准确、金标准与待检试验是否相互独立为其方法学异质性的来源。

English Abstract:

Objective To analyze methodological bias and variation of systematic reviews on diagnostic test accuracy(DTA).Methods Meta-analyses on DTA were identified through an electronic search through databases as Medline, Embase and Cochrane between 1 January 2008 and 31 December 2012.Results from Meta-analyses on 10 primary studies were included.Pairs of reviewers worked independently to extract the related data of interest, together with those original data of the primary studies.Mixed linear model was used to investigate the direction and strength of the association among the 14 studies, featuring on estimates of the diagnostic accuracy.Results A total of 23 papers on Meta-analyses with 550 primary studies were included.Results from mixed linear model showed that significant low estimates of diagnostic accuracy in studies unsatisfying "the reference standard would likely to correctly classify the target condition" [relative diagnostic odds ration(RDOR)=0.018 6, 95% CI:0.001 0-0.358 5].Studies whose reference standard were not independent of the index test produced significantly higher estimates of diagnostic accuracy(RDOR=2.396 6, 95% CI:1.242 8-4.622 7).Conclusion Messages as "Is the reference standard likely to correctly classify the target condition?" and "Was the reference standard independent of the index test", were the origin of the methodological bias and variation of systematic reviews on diagnostic test accuracy.

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