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Active-control trials: how would a new agent compare with placebo? A method illustrated with clopidogrel, aspirin, and placebo.活性对照试验:新型药物与安慰剂相比如何?以氯吡格雷、阿司匹林和安慰剂为例说明的一种方法。
Am Heart J. 2001 Jan;141(1):26-32. doi: 10.1067/mhj.2001.111262.
2
Indirect comparison in evaluating relative efficacy illustrated by antimicrobial prophylaxis in colorectal surgery.通过结直肠手术中的抗菌预防措施说明评估相对疗效时的间接比较。
Control Clin Trials. 2000 Oct;21(5):488-97. doi: 10.1016/s0197-2456(00)00055-6.
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Publication and related biases.发表偏倚及相关偏倚
Health Technol Assess. 2000;4(10):1-115.
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Users' Guides to the Medical Literature: XIX. Applying clinical trial results B. Guidelines for determining whether a drug is exerting (more than) a class effect.医学文献用户指南:第十九篇。应用临床试验结果 B. 判断一种药物是否产生(超过)类效应的指南。
JAMA. 1999 Oct 13;282(14):1371-7. doi: 10.1001/jama.282.14.1371.
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The role of randomization in clinical studies: myths and beliefs.随机化在临床研究中的作用:误解与观念
J Clin Epidemiol. 1999 Jun;52(6):487-97. doi: 10.1016/s0895-4356(99)00041-4.
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The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials.随机对照试验荟萃分析中直接和间接治疗比较的结果。
J Clin Epidemiol. 1997 Jun;50(6):683-91. doi: 10.1016/s0895-4356(97)00049-8.
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Borrowing strength from external trials in a meta-analysis.在荟萃分析中借鉴外部试验的优势。
Stat Med. 1996 Dec 30;15(24):2733-49. doi: 10.1002/(SICI)1097-0258(19961230)15:24<2733::AID-SIM562>3.0.CO;2-0.
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Large trials vs meta-analysis of smaller trials: how do their results compare?大型试验与小型试验的荟萃分析:它们的结果如何比较?
JAMA. 1996;276(16):1332-8.
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Why we need observational studies to evaluate the effectiveness of health care.为什么我们需要观察性研究来评估医疗保健的有效性。
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Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials.偏倚的实证证据。与对照试验中治疗效果估计相关的方法学质量维度。
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间接比较在评估竞争性干预措施疗效方面的有效性:来自已发表的荟萃分析的实证证据。

Validity of indirect comparison for estimating efficacy of competing interventions: empirical evidence from published meta-analyses.

作者信息

Song Fujian, Altman Douglas G, Glenny Anne-Marie, Deeks Jonathan J

机构信息

Department of Public Health and Epidemiology, University of Birmingham, Birmingham B15 2TT.

出版信息

BMJ. 2003 Mar 1;326(7387):472. doi: 10.1136/bmj.326.7387.472.

DOI:10.1136/bmj.326.7387.472
PMID:12609941
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC150178/
Abstract

OBJECTIVE

To determine the validity of adjusted indirect comparisons by using data from published meta-analyses of randomised trials.

DESIGN

Direct comparison of different interventions in randomised trials and adjusted indirect comparison in which two interventions were compared through their relative effect versus a common comparator. The discrepancy between the direct and adjusted indirect comparison was measured by the difference between the two estimates.

DATA SOURCES

Database of abstracts of reviews of effectiveness (1994-8), the Cochrane database of systematic reviews, Medline, and references of retrieved articles.

RESULTS

44 published meta-analyses (from 28 systematic reviews) provided sufficient data. In most cases, results of adjusted indirect comparisons were not significantly different from those of direct comparisons. A significant discrepancy (P<0.05) was observed in three of the 44 comparisons between the direct and the adjusted indirect estimates. There was a moderate agreement between the statistical conclusions from the direct and adjusted indirect comparisons (kappa 0.51). The direction of discrepancy between the two estimates was inconsistent.

CONCLUSIONS

Adjusted indirect comparisons usually but not always agree with the results of head to head randomised trials. When there is no or insufficient direct evidence from randomised trials, the adjusted indirect comparison may provide useful or supplementary information on the relative efficacy of competing interventions. The validity of the adjusted indirect comparisons depends on the internal validity and similarity of the included trials.

摘要

目的

利用已发表的随机试验荟萃分析数据确定调整间接比较的有效性。

设计

随机试验中不同干预措施的直接比较以及通过两种干预措施相对于共同对照的相对效应进行比较的调整间接比较。通过两种估计值之间的差异来衡量直接比较和调整间接比较之间的差异。

数据来源

有效性综述摘要数据库(1994 - 1998年)、Cochrane系统评价数据库、Medline以及检索文章的参考文献。

结果

44项已发表的荟萃分析(来自28项系统评价)提供了足够的数据。在大多数情况下,调整间接比较的结果与直接比较的结果无显著差异。在44项直接估计值与调整间接估计值的比较中,有3项观察到显著差异(P<0.05)。直接比较和调整间接比较的统计结论之间存在中度一致性(kappa值为0.51)。两种估计值之间差异的方向不一致。

结论

调整间接比较通常但并非总是与直接头对头随机试验的结果一致。当随机试验没有直接证据或直接证据不足时,调整间接比较可能会提供关于相互竞争干预措施相对疗效的有用或补充信息。调整间接比较的有效性取决于纳入试验的内部有效性和相似性。