Centre for Patient Safety and Service Quality, Imperial College London, UK.
Crit Care Med. 2010 Oct;38(10 Suppl):S642-8. doi: 10.1097/CCM.0b013e3181f20691.
A number of costly trials of interventions for the critically ill have had results that are initially positive, and then subsequent trials are less positive. This has led to uncertainty and a feeling that our scientific approach may need reevaluation. What are we missing when performing these trials? Are there simple, less costly ways of improving outcomes for patients?
Many of the large interventional trials have included patients on the basis of syndromic enrollment criteria. This inevitably leads to a heterogeneous profile of patients, precipitating conditions, and chronic health. The realistic effect of an intervention may vary depending on the individual circumstances of a particular patient, contributing to trial "noise." The assumption that trial size and randomization will deal with this may not hold true and in some circumstances may be biologically questionable. Perhaps we should consider alternatives? In common with other areas of medicine, it is well-known that intensive care outcomes are variable, reflecting differing performance. Until recently, little attention has been focused on a detailed understanding of variation in performance and delivery of care and how such knowledge might be used to improve patient outcomes. A number of recent efforts that have demonstrated positive improvements have been based around understanding and reducing individual and organizational underperformance. This human and organizational factors-based research does not conflict with more pharmacologic-based research and may be complimentary.
By properly understanding the way we do things and the optimal local balance of protocolized and individualized care, we may deliver greater improvements to the outcome of intensive care unit patients than many of the more expensive, pharmacologic, and technological attempts of recent years.
许多针对危重症患者的干预措施的昂贵试验最初结果是积极的，但随后的试验结果则不那么积极。这导致了不确定性，并让人觉得我们的科学方法可能需要重新评估。在进行这些试验时，我们遗漏了什么？是否有简单、成本更低的方法可以改善患者的预后？
许多大型干预性试验都是根据综合征纳入标准来纳入患者的。这不可避免地导致了患者、发病情况和慢性健康状况的异质性。干预措施的实际效果可能因特定患者的个体情况而异，从而导致试验“噪音”。试验规模和随机化可能会解决这个问题的假设可能并不成立，在某些情况下，从生物学角度来看可能是有问题的。也许我们应该考虑其他方法？与医学的其他领域一样，众所周知，重症监护的结果是可变的，反映了不同的表现。直到最近，人们才开始关注对表现和护理提供的差异的详细理解，以及如何利用这些知识来改善患者的预后。最近的一些努力已经证明了积极的改善，这些努力都是基于理解和减少个体和组织的表现不佳。这种基于人力和组织因素的研究与更多基于药理学的研究并不冲突，而是互补的。
通过正确理解我们做事的方式以及协议化和个体化护理的最佳局部平衡，我们可能会比近年来许多更昂贵的、药理学的和技术的尝试更能改善重症监护病房患者的预后。
