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首页> 外文期刊>Statistical methods in medical research >Reflections on meta-analyses involving trials stopped early for benefit: Is there a problem and if so, what is it?
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Reflections on meta-analyses involving trials stopped early for benefit: Is there a problem and if so, what is it?

机译：对涉及试验的荟萃分析的思考出于利益的考虑而早日停止：是否存在问题，如果存在，那是什么？

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摘要

We review controversies associated with randomized controlled trials (RCTs) stopped early for apparent benefit (truncated RCTs or tRCTs) and present our groups' perspective. Long-established theory, simulations and recent empirical evidence demonstrate that tRCTs will on average overestimate treatment effects, and this overestimation may be large, particularly when tRCTs have small number of events. Theoretical considerations and simulations demonstrate that on average, meta-analyses of RCTs with appropriate stopping rules will lead to only trivial overestimation of treatment effects. However, tRCTs will disproportionally contribute to meta-analytic estimates when tRCTs occur early in the sequence of trials with few subsequent studies, publication of nontruncated RCTs is delayed, there is publication bias, or tRCTs result in a 'freezing' effect in which 'correcting' trials are never undertaken. To avoid applying overestimates of effect to clinical decision-making, clinicians should view the results of individual tRCTs with small sample sizes and small number of events with skepticism. Pooled effects from meta-analyses including tRCTs are likely to overestimate effect when there is a substantial difference in effect estimates between the tRCTs and the nontruncated RCTs, and in which the tRCTs have a substantial weight in the meta-analysis despite themselves having a relatively small number of events. Such circumstances call for sensitivity analyses omitting tRCTs.
机译：我们回顾了为尽早获益而停止的随机对照试验（RCT）的争议（截断的RCT或tRCT），并提出了我们小组的观点。悠久的理论，模拟和最新的经验证据表明，tRCT会平均高估治疗效果，这种高估可能很大，尤其是在tRCT发生事件少的情况下。理论上的考虑和模拟表明，具有适当停止规则的RCT的荟萃分析平均只会导致对治疗效果的高估。但是，如果tRCT在试验序列的早期出现且随后的研究很少，未截短的RCT的发布被延迟，出现发表偏倚或tRCT导致“冻结”效应，其中“校正”会大大超出比例，从而对荟萃分析估计值做出贡献。审判从未进行。为避免将过高的效果评估应用于临床决策，临床医生应以较小的样本量和较少的怀疑事件来查看单个tRCT的结果。当tRCT与未截短的RCT之间的效果估算值存在显着差异，并且尽管tRCT尽管相对较小，但它们在荟萃分析中的权重却很大，因此，包括tRCT在内的荟萃分析可能会高估效果。事件数。在这种情况下，需要进行敏感性分析而忽略tRCT。

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