Is the implementation of research findings in the critically ill hampered by the lack of universal definitions of illness?
Is the implementation of research findings in the critically ill hampered by the lack of universal definitions of illness?
复制标题
缺乏通用的疾病定义是否会阻碍研究成果在危重病人身上的实施？
DOI：
10.1097/00075198-200308000-00010
复制
发表时间：
2003
影响因子：
3.3
通讯作者：
Shorr,AndrewF
中科院分区：
文献类型：
--
作者：
Carson,ShannonS;Shorr,AndrewF
在临床试验的设计中，明确的疾病定义对于招募同质研究人群至关重要，这些人群更有可能证明干预的益处。适用于标准临床实践的定义可增强临床医生将临床试验结果应用于患者护理的能力。使用普遍接受的定义可以在多项研究中进行有效的比较。脓毒症、急性呼吸窘迫综合征和呼吸机相关性肺炎是专家小组制定的通用定义促进了成功临床试验设计的条件的例子。然而，由于缺乏对疾病定义的理解或接受，或由于其过于包容的性质，其中一些研究结果的实施变得复杂。例如，全身炎症反应综合征（SIRS）的存在将识别大多数脓毒症患者，然而，具有这些临床发现的大量患者将具有其他潜在过程。VAP的批准定义是繁琐的，在临床试验设计中遵守这些定义的情况很差。这导致了临床医生对诊断测试准确性的混淆和对循证指南的接受度差。当研究者和临床医生不遵守疾病的共同定义时，临床试验的结果可能会被不适当地应用或完全被忽视。正在探索使用特定的生化或遗传标记来更具体地识别危重疾病。这种方法也可能对疾病分期有用。
In the design of clinical trials, a clear definition of disease is essential for enrollment of a homogeneous study population with a higher likelihood of demonstrating a benefit of an intervention. A definition that is applicable to standard clinical practice enhances the ability of clinicians to apply results of the clinical trial to patient care. Use of a universally accepted definition allows valid comparisons across multiple studies. Sepsis, the acute respiratory distress syndrome, and ventilator-associated pneumonia are examples of conditions for which universal definitions developed by panels of experts have facilitated the design of successful clinical trials. However, implementation of the results of some of these studies has been complicated by a lack of understanding or acceptance of disease definitions or by their overly inclusive nature. For example, the presence of Systemic Inflammatory Response Syndrome (SIRS) will identify most patients with sepsis, however, a significant number of patients with those clinical findings will have other underlying processes. Approved definitions for VAP are cumbersome, and adherence to those definitions in the design of clinical trials is poor. This has led to confusion regarding the accuracy of diagnostic tests and poor acceptance of evidence based guidelines by clinicians. When investigators and clinicians do not adhere to common definitions of disease, results of clinical trials may be applied inappropriately or ignored altogether. More specific identifiers of critical illnesses using specific biochemical or genetic markers are being explored. This approach may also be useful for staging disease.