The CONSORT Statement says that data‐driven early stopping of a clinical trial is likely to weaken the inferences that can be drawn from the trial. The GRADE guidelines go further, saying that early stopping is a study limitation that carries the risk of bias, and recommending sensitivity analyses in which trials stopped early are omitted from evidence synthesis. Despite extensive debate in the literature over these issues, the existence of clear recommendations in high profile guidelines makes it inevitable that systematic reviewers will consider sensitivity analyses investigating the impact of early stopping. The purpose of this article is to assess methodologies for conducting such sensitivity analyses, and to make recommendations about how the guidelines should be interpreted. We begin with a clarifying overview of the impacts of early stopping on treatment effect estimation in single studies and meta‐analyses. We then warn against naive approaches for conducting sensitivity analyses, including simply omitting trials stopped early from meta‐analyses. This approach underestimates treatment effects, which may have serious implications if cost‐effectiveness analyses determine whether treatments are made widely available. Instead, we discuss two unbiased approaches to sensitivity analysis, one of which is straightforward but statistically inefficient, and the other of which achieves greater statistical efficiency by making use of recent methodological developments in the analysis of clinical trials. We end with recommendations for interpreting: (a) the CONSORT Statement on reporting of reasons for early stopping, and (b) the GRADE guidelines on sensitivity analyses assessing the impact of early stopping.

中文翻译：

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敏感性分析评估了尽早停止对系统评价的影响：解释指南的建议。

CONSORT声明说，以数据为依据的临床试验的早期停止可能会削弱从临床试验中得出的推论。GRADE指南走得更远，认为早期停止是一项研究局限性，存在偏倚风险，建议在敏感性分析中推荐将早期停止的试验从证据综合中删除。尽管文献中对这些问题进行了广泛的辩论，但备受关注的指南中存在明确的建议，使得不可避免的是，系统的审阅者会考虑进行敏感性分析以调查早期停止的影响。本文的目的是评估进行此类敏感性分析的方法，并就应如何解释指南提出建议。我们首先对单项研究和荟萃分析中的早期停药对治疗效果评估的影响进行清晰的概述。然后，我们警告您不要进行幼稚的方法来进行敏感性分析，包括简单地省略从荟萃分析中提早终止的试验。这种方法低估了治疗效果，如果成本效益分析确定是否可以广泛使用治疗方法，则可能会产生严重的影响。取而代之的是，我们讨论了两种无偏见的敏感性分析方法，一种简单明了，但统计上效率低下，另一种通过在临床试验分析中利用最新方法学的发展而获得了更高的统计效率。最后，我们提出了以下解释的建议：（a）CONSORT关于报告提前停止原因的声明，