确定更好的结果措施来改善痴呆患者的躁动治疗:一份来自欧盟/美国/CTAD工作组的报告

IF 8.5 3区医学 Q1 CLINICAL NEUROLOGY

Jpad-Journal of Prevention of Alzheimers Disease Pub Date : 2018-01-01 DOI:10.14283/jpad.2018.15

Mary Sano, M. Soto, M. Carrillo, J. Cummings, S. Hendrix, J. Mintzer, A. Porsteinsson, P. Rosenberg, L. Schneider, J. Touchon, P. Aisen, B. Vellas, C. Lyketsos, Euusctad Task Force members

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引用次数: 18

摘要

在过去三年中，欧盟-美国CTAD特别工作组第二次解决了与设计痴呆患者躁动的临床试验相关的挑战，这是对患者和护理人员最具破坏性的方面之一。工作队会议提出了六项建议:1 -实施国际音标协会制定的鼓动标准;2 -结合临床医生和护理人员衍生的结局作为主要结局指标;3 -使用全球评级来定义临床有意义的效果和功效研究;4 -通过更好地培训和教育护理人员，提高护理人员报告的准确性;5 -采用新兴技术收集接近实时的行为数据;6 -利用创新的试验设计和增加生物标志物的使用，以最大限度地提高神经精神症状的临床试验的生产率。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Identifying Better Outcome Measures to Improve Treatment of Agitation in Dementia: A Report from the EU/US/CTAD Task Force

For the second time in the past 3 years, the EU-US CTAD Task Force addressed challenges related to designing clinical trials for agitation in dementia, which is one of the most disruptive aspects of the condition for both patients and caregivers. Six recommendations emerged from the Task Force meeting: 1 – Operationalizing agitation criteria established by the IPA; 2 – Combining clinician- and caregiver-derived outcomes as primary outcome measures; 3 – Using global ratings to define clinically meaningful effects and power studies; 4 – Improving the accuracy of caregiver reports by better training and education of caregivers; 5 – Employing emerging technologies to collect near real-time behavioral data; and 6 – Utilizing innovative trial designs and increasing the use of biomarkers to maximize the productivity of clinical trials for neuropsychiatric symptoms.

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来源期刊

Jpad-Journal of Prevention of Alzheimers Disease CLINICAL NEUROLOGY-

自引率

7.80%

发文量

期刊介绍： The JPAD « Journal of Prevention of Alzheimer’Disease » will publish reviews, original research articles and short reports to improve our knowledge in the field of Alzheimer prevention including : neurosciences, biomarkers, imaging, epidemiology, public health, physical cognitive exercise, nutrition, risk and protective factors, drug development, trials design, and heath economic outcomes. JPAD will publish also the meeting abstracts from Clinical Trial on Alzheimer Disease (CTAD) and will be distributed both in paper and online version worldwide.