Individual patient- versus group-level data meta-regressions for the investigation of treatment effect modifiers: ecological bias rears its ugly head
Individual patient- versus group-level data meta-regressions for the investigation of treatment effect modifiers: ecological bias rears its ugly head
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DOI：
10.1002/sim.1023
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发表时间：
2002-02-15
影响因子：
2
通讯作者：
Feldman, HI
中科院分区：
文献类型：
--
作者：
Berlin, JA;Santanna, J;Feldman, HI
在进行荟萃分析时，人们的兴趣往往集中在寻找数据异质性的解释上，而不是产生单一的汇总估计。这种探索性分析经常采用已发表的研究级数据，使用元分析回归技术。我们的目标是探索一个真实世界的例子，其中发表的群体水平和个体患者水平的数据都是可用的，并比较两种方法得出的实质性结论。我们在五项随机试验中研究了抗淋巴细胞抗体诱导治疗在肾移植患者中的益处，重点关注是否存在治疗可能被证明特别有益的患者亚组。同种异体移植物在5年内衰竭是研究的终点。我们使用了多种分析方法来处理组水平的数据，包括加权最小二乘回归（N = 5项研究）、逻辑回归（N = 628，受试者总数）和分层贝叶斯方法。我们将逻辑回归模型拟合到患者层面的数据中。在患者水平分析中，我们发现，与无PRA升高的患者相比，面板反应性抗体（PRA）升高的患者（20%或更多）的治疗明显更有效。这些患者是受益于治疗的一小部分患者（约占患者总数的15%）。群体水平的分析未能检测到这种相互作用。我们建议在可行的情况下使用个体患者数据来研究患者特征，以避免群体水平分析带来的潜在生态偏倚。版权所有:John Wiley Sons, Ltd。
When performing a meta-analysis, interest often centres on finding explanations for heterogeneity in the data, rather than on producing a single summary estimate. Such exploratory analyses are frequently under-taken with published, study-level data, using techniques of meta-analytic regression. Our goal was to explore a real-world example for which both published, group-level and individual patient-level data were available, and to compare the substantive conclusions reached by both methods. We studied the benefits of anti-lymphocyte antibody induction therapy among renal transplant patients in five randomized trials, focusing on whether there are subgroups of patients in whom therapy might prove particularly beneficial. Allograft failure within 5 years was the endpoint studied. We used a variety of analytic approaches to the group-level data, including weighted least-squares regression (N = 5 studies), logistic regression (N = 628, the total number of subjects), and a hierarchical Bayesian approach. We fit logistic regression models to the patient-level data. In the patient-level analysis, we found that treatment was significantly more effective among patients with elevated (20 per cent or more) panel reactive antibodies (PRA) than among patients without elevated PRA. These patients comprise a small (about 15 per cent of patients) subgroup of patients that benefited from therapy. The group-level analyses failed to detect this interaction. We recommend using individual patient data, when feasible, to study patient characteristics, in order to avoid the potential for ecological bias introduced by group-level analyses. Copyright (C) 2002 John Wiley Sons, Ltd.