Critical Care Medicine Department; Clinical Center, National Institutes of Health, Bethesda, MD, USA.
Department of Transfusion Medicine, National Institutes of Health, Bethesda, MD, USA.
Crit Care Resusc. 2020 Jun;22(2):110-118. doi: 10.51893/2020.2.r1.
Comparative effectiveness research can help guide the use of common, routine medical practices. However, to be safe and informative, such trials must include at least one treatment arm that accurately portrays current practices. While comparative effectiveness research is widely perceived as safe and to involve no or only minimal risks, these assumptions may not hold true if unrecognised deviations from usual care exist in one or more study arms. For critically ill subjects in particular, such practice deviations may increase the risk of death or injury and undermine safety monitoring. Furthermore, unrecognised unusual care seems likely to corrupt informed consent documents, with underappreciated risks shrouded under the reassuring "comparative effectiveness" research label. At present, oversight measures are inadequate to ensure that research subjects enrolled in comparative effectiveness trials are actually receiving usual and not unusual care. Oversight by governmental and non-governmental entities with appropriate expertise, empowered to ensure that current clinical practice has been properly represented, could help prevent occurrences in clinical trials of unusual care masquerading as usual care.
比较疗效研究可以帮助指导常见的常规医疗实践。然而，为了安全和有信息价值，此类试验必须至少包含一个治疗组，准确描述当前的实践。虽然比较疗效研究被广泛认为是安全的，并且没有或只有最小的风险，但如果一个或多个研究组中存在未被识别的常规护理偏离，这些假设可能并不成立。特别是对于危重症患者，这种实践偏差可能会增加死亡或受伤的风险，并破坏安全性监测。此外，未被识别的非常规护理似乎有可能使知情同意文件受到污染，在令人安心的“比较疗效”研究标签下，掩盖了未被充分认识到的风险。目前，监督措施不足以确保参加比较疗效试验的研究对象实际接受的是常规护理，而不是非常规护理。由具有适当专业知识的政府和非政府实体进行监督，并赋予其权力，以确保当前的临床实践得到正确的体现，有助于防止临床试验中出现将非常规护理伪装成常规护理的情况。
