Department of Neurosciences, University of California, San Diego School of Medicine, La Jolla, CA, USA.
Ann Neurol. 2010 Apr;67(4):434-40. doi: 10.1002/ana.21997.
Evidence from well-designed clinical trials may guide clinicians, reduce regional variation, and lead to improved outcomes. Many physicians choose to ignore evidence-based practice guidelines. Using unproven therapies outside of a randomized trial slows recruitment in clinical trials that could yield information on clinical and economic efficacy. Using acute stroke therapy as an illustration, we present an ethical hierarchy for therapeutic decision making during medical emergencies. First, physicians should offer standard care. If no standard care option exists, the physician should consider enrollment in a randomized clinical trial. If no trial is appropriate, the physician should consider a nonrandomized registry, or consensus-based guidelines. Finally, only after considering the first 3 options, the physician should use best judgment based on previous personal experience and any published case series or anecdotes. Given the paucity of quality randomized clinical trial data for most medical decisions, the "best judgment" option will be used most frequently. Nevertheless, such a hierarchy is needed because of the limited time during medical emergencies for consideration of general principles of clinical decision making. There should be general agreement in advance as to the hierarchy to follow in selecting treatment for critically ill patients. Were more clinicians to follow this hierarchy, and choose to participate in clinical trials, the generation of new knowledge would accelerate, yielding rigorous data supporting or refuting the efficacy and safety of new interventions more quickly, thus benefiting far more patients over time.
来自精心设计的临床试验的证据可以为临床医生提供指导,减少区域差异,并提高治疗效果。然而,许多医生选择忽视基于证据的临床实践指南。在随机试验之外使用未经证实的治疗方法会减缓临床试验的招募速度,而这些试验可能会提供有关临床和经济疗效的信息。我们以急性脑卒中治疗为例,提出了医疗急救期间治疗决策的伦理层次。首先,医生应提供标准护理。如果没有标准护理选择,医生应考虑参加随机临床试验。如果没有合适的试验,医生应考虑非随机登记或基于共识的指南。最后,只有在考虑了前 3 个选择后,医生才应根据以前的个人经验和任何已发表的病例系列或轶事来运用最佳判断。由于大多数医疗决策缺乏高质量的随机临床试验数据,因此“最佳判断”选项将被最频繁地使用。然而,由于在医疗急救期间考虑临床决策的一般原则的时间有限,因此需要这样的层次结构。在为危重病患者选择治疗方法时,应该事先就遵循的层次结构达成普遍共识。如果有更多的临床医生遵循这一层次结构,并选择参与临床试验,那么新知识的产生速度将会加快,从而更快地提供严格的数据来支持或反驳新干预措施的疗效和安全性,从而使更多的患者长期受益。