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诊断试验准确性比较研究重要性的实证证据。

Empirical evidence of the importance of comparative studies of diagnostic test accuracy.

机构信息

Public Health, Epidemiology and Biostatistics, University of Birmingham, Birmingham, United Kingdom.

出版信息

Ann Intern Med. 2013 Apr 2;158(7):544-54. doi: 10.7326/0003-4819-158-7-201304020-00006.

Abstract

BACKGROUND

Systematic reviews that "compare" the accuracy of 2 or more tests often include different sets of studies for each test.

PURPOSE

To investigate the availability of direct comparative studies of test accuracy and to assess whether summary estimates of accuracy differ between meta-analyses of noncomparative and comparative studies.

DATA SOURCES

Systematic reviews in any language from the Database of Abstracts of Reviews of Effects and the Cochrane Database of Systematic Reviews from 1994 to October 2012.

STUDY SELECTION

1 of 2 assessors selected reviews that evaluated at least 2 tests and identified meta-analyses that included both noncomparative studies and comparative studies.

DATA EXTRACTION

1 of 3 assessors extracted data about review and study characteristics and test performance.

DATA SYNTHESIS

248 reviews compared test accuracy; of the 6915 studies, 2113 (31%) were comparative. Thirty-six reviews (with 52 meta-analyses) had adequate studies to compare results of noncomparative and comparative studies by using a hierarchical summary receiver-operating characteristic meta-regression model for each test comparison. In 10 meta-analyses, noncomparative studies ranked tests in the opposite order of comparative studies. A total of 25 meta-analyses showed more than a 2-fold discrepancy in the relative diagnostic odds ratio between noncomparative and comparative studies. Differences in accuracy estimates between noncomparative and comparative studies were greater than expected by chance (P < 0.001).

LIMITATION

A paucity of comparative studies limited exploration of direction in bias.

CONCLUSION

Evidence derived from noncomparative studies often differs from that derived from comparative studies. Robustly designed studies in which all patients receive all tests or are randomly assigned to receive one or other of the tests should be more routinely undertaken and are preferred for evidence to guide test selection.

PRIMARY FUNDING SOURCE

National Institute for Health Research (United Kingdom).

摘要

背景

系统评价“比较”两种或更多种检验方法的准确性时,通常会为每种检验方法纳入不同的研究。

目的

调查是否存在检验准确性的直接比较研究,并评估非比较研究和比较研究的汇总准确性估计值是否存在差异。

数据来源

从 1994 年至 2012 年 10 月,使用任何语言的数据库的评价摘要(Database of Abstracts of Reviews of Effects)和 Cochrane 系统评价数据库(Cochrane Database of Systematic Reviews)进行系统评价。

研究选择

2 名评估人员中的 1 名选择了评估至少 2 种检验方法的综述,并确定了纳入非比较研究和比较研究的荟萃分析。

数据提取

3 名评估人员中的 1 名提取了关于综述和研究特征以及检验性能的数据。

数据综合

248 项综述比较了检验准确性;在 6915 项研究中,有 2113 项(31%)为比较研究。36 项综述(有 52 项荟萃分析)有足够的研究,可以使用每个检验比较的分层汇总受试者工作特征元回归模型来比较非比较研究和比较研究的结果。在 10 项荟萃分析中,非比较研究对检验的排序与比较研究相反。共有 25 项荟萃分析显示,非比较研究和比较研究之间的相对诊断比值比差异超过 2 倍。非比较研究和比较研究之间的准确性估计值差异大于偶然发生的差异(P < 0.001)。

局限性

比较研究的缺乏限制了对偏倚方向的探索。

结论

来自非比较研究的证据往往与来自比较研究的证据不同。应更常规地进行所有患者接受所有检验或随机分配接受一种或另一种检验的稳健设计研究,并且首选这些研究为检验选择提供依据。

主要资金来源

英国国家卫生研究院(National Institute for Health Research,United Kingdom)。

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