Assessing Heterogeneity of Treatment Effects: Are Authors Misinterpreting Their Results?
Assessing Heterogeneity of Treatment Effects: Are Authors Misinterpreting Their Results?
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DOI：
10.1111/j.1475-6773.2009.01064.x
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发表时间：
2010-02-01
影响因子：
3.4
通讯作者：
Kravitz, Richard L.
中科院分区：
文献类型：
--
作者：
Fernandez y Garcia, Erik;Nguyen, Hien;Kravitz, Richard L.
目的探讨随机对照试验（RCTs）中治疗效果异质性（HTE）的研究是否预先规定，作者对其分析的解释是否与客观证据相一致。资料来源/研究设置1994年、1999年发表在Annals of Internal Medicine、British Medical Journal、Journal of the American Medical Association、Lancet和新英格兰Journal of Medicine上的试验，研究设计我们回顾了87项随机对照试验，这些随机对照试验报告了统计学相互作用或异质性的正式检验（HTE分析），这些研究来自541篇文章的概率样本。数据收集/提取我们记录了进行HTE分析的原因; HTE证据的客观分类（称为“临床统计学差异”[CSD]）;以及作者对结果的解释。作者的解释，与CSD相比，被编码为低估，夸大，或充分stated. PrincipleFindingsFifty-three随机对照试验（61%）声称预先指定的协变量HTE分析。试验显示了强（6）、中等（11）、弱（25）或可忽略不计（16）的CSD证据（29例因信息不足而无法分类）。作者指出，HTE的证据足以支持亚组的差异治疗（10）;需要更多的研究（31）;不存在（21）;或未提供解释（25）。HTE被夸大了22项试验，充分说明在57项试验中，低估了8 trials. ConclusionsIncubation性能和报告可能会限制HTE分析的潜力，作为一种工具，用于确定HTE和个性化的护理在不同的人群。对未来的研究报告和解释的HTE分析的建议。
ObjectiveTo determine whether investigations of heterogeneity of treatment effects (HTE) in randomized-controlled trials (RCTs) are prespecified and whether authors' interpretations of their analyses are consistent with the objective evidence.Data Sources/Study SettingTrials published in Annals of Internal Medicine, British Medical Journal, Journal of the American Medical Association, Lancet, and New England Journal of Medicine in 1994, 1999, and 2004.Study DesignWe reviewed 87 RCTs that reported formal tests for statistical interaction or heterogeneity (HTE analyses), derived from a probability sample of 541 articles.Data Collection/ExtractionWe recorded reasons for performing HTE analysis; an objective classification of evidence for HTE (termed "clinicostatistical divergence" [CSD]); and authors' interpretations of findings. Authors' interpretations, compared with CSD, were coded as understated, overstated, or adequately stated.Principle FindingsFifty-three RCTs (61 percent) claimed prespecified covariates for HTE analyses. Trials showed strong (6), moderate (11), weak (25), or negligible (16) evidence for CSD (29 could not be classified due to inadequate information). Authors stated that evidence for HTE was sufficient to support differential treatment in subgroups (10); warranted more research (31); was absent (21); or provided no interpretation (25). HTE was overstated in 22 trials, adequately stated in 57 trials, and understated in 8 trials.ConclusionsInconsistencies in performance and reporting may limit the potential of HTE analysis as a tool for identifying HTE and individualizing care in diverse populations. Recommendations for future studies on the reporting and interpretation of HTE analyses are provided.