Department of Biokinesiology and Physical Therapy and Department of Neurology, 5116 University of Southern California , Los Angeles, USA.
Int J Stroke. 2018 Feb;13(2):112-116. doi: 10.1177/1747493017743061. Epub 2017 Dec 7.
Over the past decade, ATTEND is one of only a handful of moderate to large-scale nonpharmacologic stroke recovery trials with a focus on rehabilitation. While unique in some respects, its test of superiority for the experimental intervention returned negative/neutral results, with no differences in outcome between the experimental intervention and an appropriate control group - a result not uncommon to the majority of moderate to large stroke rehabilitation intervention trials (i.e. six out of eight conducted in the past decade). The authors offer a number of potential explanations for the negative outcome, all of which have merit. We choose not to dwell on these possibilities, but rather offer a radically different explanation, one which has implications for future rehabilitation clinical trials. Our premise is that the process of neurorehabilitation is complex and multifaceted, but most importantly, for success, it requires a genuine collaboration between the patient and the clinician or caregiver to effect optimal recovery. This collaborative relationship must be defined by the unique perspective of each patient. By doing so, we acknowledge the importance of the individual patient's values, goals, perspectives, and capacity. Rehabilitation scientists can design what arguably is a scientifically sound intervention that is evidence-based and even with preliminary data supporting its efficacy, but if the patient does not value the target outcome, does not fully engage in the therapy, or does not expect the intervention to succeed, the likelihood of success is poor. We offer this opinion, not to be critical, but to suggest a paradigm shift in the way in which we conduct stroke recovery and rehabilitation trials.
在过去的十年中，ATTEND 是少数几个专注于康复的中等规模至大规模非药物性中风恢复试验之一。虽然在某些方面具有独特性，但其实验性干预措施的优越性测试结果为阴性/中性，实验组与适当的对照组之间在结果上没有差异——这一结果在大多数中等规模至大规模中风康复干预试验中并不罕见（即过去十年中进行的八项试验中有六项）。作者提出了一些可能导致阴性结果的潜在解释，这些解释都有其合理性。我们选择不深究这些可能性，而是提供一个截然不同的解释，这一解释对未来的康复临床试验具有重要意义。我们的前提是，神经康复的过程是复杂和多方面的，但最重要的是，为了取得成功，患者与临床医生或护理人员之间必须建立真正的合作关系，以实现最佳康复。这种合作关系必须由每位患者的独特视角来定义。通过这种方式，我们承认患者个人的价值观、目标、观点和能力的重要性。康复科学家可以设计出一种从科学角度来看合理的、基于证据的干预措施，即使有初步数据支持其疗效，但如果患者不重视目标结果、不完全参与治疗，或者不期望干预措施取得成功，那么成功的可能性就很小。我们提出这个观点，不是为了批评，而是为了建议在进行中风康复和康复试验的方式上进行范式转变。
