[Critical reading of cardiovascular trials with neutral or negative findings].

IF 0.7 Q4 CARDIAC & CARDIOVASCULAR SYSTEMS Giornale italiano di cardiologia Pub Date : 2023-10-01 DOI:10.1714/4100.40982
Alberto Aimo, Vincenzo Castiglione, Iacopo Fabiani, Paolo Morfino, Michele Emdin, Roberto Ferrari, Luigi Tavazzi, Aldo Pietro Maggioni, Claudio Rapezzi
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Abstract

Randomized controlled trials showing a significant benefit are met with enthusiasm because they may change the standard of care for patients who share the clinical and pathophysiologic characteristics of trial participants. Nonetheless, a well-designed and fully executed trial with neutral or negative findings also represents a critically important investigation deserving careful scientific scrutiny. In this paper we propose a 10-step approach to the interpretation of neutral or negative trials to exclude important methodological issues before concluding that the treatment really does not work. We will discuss this approach using the most classic trials of the past and some notable examples among superiority trials (mostly phase 3 trials) published over the last years.

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[对中性或阴性结果的心血管试验的批评性解读]。
显示出显著益处的随机对照试验受到了热烈欢迎,因为它们可能会改变具有试验参与者临床和病理生理特征的患者的护理标准。尽管如此,一项设计良好、执行充分、结果中立或消极的试验也代表着一项至关重要的调查,值得仔细的科学审查。在本文中,我们提出了一种10步方法来解释中性或阴性试验,以排除重要的方法学问题,然后得出治疗确实不起作用的结论。我们将使用过去最经典的试验和过去几年发表的优势试验(主要是第三阶段试验)中的一些显著例子来讨论这种方法。
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Giornale italiano di cardiologia
Giornale italiano di cardiologia CARDIAC & CARDIOVASCULAR SYSTEMS-
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