Sunnybrook Research Institute, Toronto, ON, Canada; Harquail Centre for Neuromodulation, Sunnybrook Health Sciences Centre, Toronto, ON, Canada; Department of Medicine, Division of Neurology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
Sunnybrook Research Institute, Toronto, ON, Canada; Harquail Centre for Neuromodulation, Sunnybrook Health Sciences Centre, Toronto, ON, Canada; Department of Medicine, Division of Neurosurgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
Lancet Psychiatry. 2020 Dec;7(12):1075-1080. doi: 10.1016/S2215-0366(20)30187-5. Epub 2020 Oct 29.
Major depressive disorder is a common and debilitating disorder. Although most patients with this disorder benefit from established treatments, a subset of patients have symptoms that remain treatment resistant. Novel treatment approaches, such as deep brain stimulation, are urgently needed for patients with treatment-resistant major depressive disorder. These novel treatments are currently being tested in clinical trials in which success hinges on how accurately and comprehensively the primary outcome measure captures the treatment effect. In this Personal View, we argue that current measures used to assess outcomes in neurosurgical trials of major depressive disorder might be missing clinically important treatment effects. A crucial problem of continuing to use suboptimal outcome measures is that true signals of efficacy might be missed, thereby disqualifying potentially effective treatments. We argue that a re-evaluation of how outcomes are measured in these trials is much overdue and describe several novel approaches that attempt to better capture meaningful change.
重度抑郁症是一种常见且使人虚弱的疾病。尽管大多数患有这种疾病的患者都受益于既定的治疗方法，但仍有一部分患者的症状对治疗有抵抗力。对于治疗抵抗性重度抑郁症患者来说，急需新的治疗方法，例如深部脑刺激。这些新的治疗方法目前正在临床试验中进行测试，成功与否取决于主要结局测量指标准确而全面地捕捉治疗效果的能力。在这篇个人观点中，我们认为，目前用于评估重度抑郁症神经外科试验结果的措施可能会遗漏临床重要的治疗效果。继续使用不优的结局测量指标的一个关键问题是，可能会错过真正有效的信号，从而使潜在有效的治疗方法失去资格。我们认为，对这些试验中如何衡量结果进行重新评估已经刻不容缓，并描述了几种试图更好地捕捉有意义的变化的新方法。
