How useful are unpublished data from the Food and Drug Administration in meta-analysis?
How useful are unpublished data from the Food and Drug Administration in meta-analysis?
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DOI：
10.1016/s0895-4356(02)00520-6
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发表时间：
2003-01-01
影响因子：
7.2
通讯作者：
Shekelle, PG
中科院分区：
文献类型：
--
作者：
MacLean, CH;Morton, SC;Shekelle, PG
这项系统性综述和荟萃分析的目的是确定FDA综述中总结的非类固醇抗炎药(NSAID)研究是否最终发表，比较FDA综述中总结的研究的方法学和人群特征与同行评审文献中报告的研究，并比较每个数据源中非类固醇抗炎药导致消化不良的汇集相对风险。风险差异的汇总测量用随机效应模型计算；研究协变量的影响用Meta回归来评估。在FDA综述中描述的37项研究中，有一项已经发表。在发表的数据和FDA的数据中，样本大小、性别分布、药物使用适应症和方法学质量没有显著差异。使用已发表的数据(1.21)或FDA数据(1.07)获得的消化不良合并风险比没有显著或实际差异。来自FDA综述的数据可能是系统评价和荟萃分析的一个可行的数据源，但只有在受到与已发表数据相同的方法学审查之后。(C)2003 Elsevier Science Inc.保留所有权利。
The goals of this systematic review and meta-analysis were to ascertain whether studies of nonsteroidal anti-inflammatory drugs (NSAIDs) summarized in the FDA reviews are ultimately published, to compare the methodologic and population characteristics of studies summarized in the FDA reviews with those reported in peer reviewed literature, and to compare the pooled relative risk of dyspepsia from NSAIDs in each data source. Summary measures of risk difference were calculated with a random effects model; meta-regression was used to assess the effect of study covariates. Among 37 studies described in the FDA reviews, one was published. Sample size, gender distribution, indication for drug use, and methodologic quality did not vary significantly between the published and FDA data. The pooled risk ratio for dyspepsia obtained using published data (1.21) or FDA data (1.07) did not differ significantly or practically. Data from FDA reviews may be a viable data source for systematic reviews and meta-analyses but only after being subjected to the same methodologic scrutiny as published data. (C) 2003 Elsevier Science Inc. All rights reserved.