1 Interdepartmental Division of Critical Care Medicine.
3 Department of Medicine.
Am J Respir Crit Care Med. 2015 Dec 15;192(12):1416-9. doi: 10.1164/rccm.201410-1832CP.
Most randomized trials in critical care report no mortality benefit; this may reflect competing pathogenic mechanisms, patient heterogeneity, or true ineffectiveness of interventions. We hypothesize that in acute respiratory distress syndrome (ARDS), randomizing only those patients who show a favorable physiological response to an intervention would help ensure that only those likely to benefit would be entered into the study. If true, this would decrease study "noise" and reduce required sample size, thereby increasing the chances of finding true-positive outcomes. It would also lessen the chances of exposing patients to treatments that are unlikely to help or that could cause harm. We present a reanalysis of randomized clinical trials of positive end-expiratory pressure in ARDS that support this hypothesis.
大多数重症监护领域的随机试验并未报告死亡率获益；这可能反映了竞争性的发病机制、患者异质性或干预措施的真正无效性。我们假设，在急性呼吸窘迫综合征（ARDS）中，仅对那些对干预措施表现出有利生理反应的患者进行随机分组，将有助于确保只有那些可能受益的患者被纳入研究。如果这是真的，这将减少研究的“噪声”并降低所需的样本量，从而增加发现真正阳性结果的机会。这也将减少将患者暴露于可能无助益或可能造成伤害的治疗方法的机会。我们对 ARDS 中呼气末正压通气的随机临床试验进行了重新分析，支持这一假设。
