临床评估的软件医疗设备与多发性硬化患者的自我评估:MSCopilot研究结果(p3.2 - 012)
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摘要目的:评估的能力MSCopilot歧视罹患多发性硬化症的病人(pwm)扩大残疾状态量表(eds)得分从0到7从健康对照组(HC)与多发性硬化功能复合(所有)和MSCopilot和所有z得分之间的相关。
背景:评估患者的残疾女士需要执行耗时和昂贵的电池的测试在医院。MSCopilot是一种软件医疗设备设计用于pwm的自我评估,包括4测试:散步、灵巧、认知和低对比度视力。
设计/方法:在这个多中心、非盲、随机病例对照,交叉研究,141 pwm和76 HC配对在年龄、性别、身体质量指数(BMI)和教育入学。参与者执行标准{25英尺走测试(T25FW), 9洞桩测试(9成,节奏的听觉连环任务(PASAT的),符号位模式测试(SDMT),斯隆低对比度信敏度测试(SLCLAT)}和数字测试:{移动行走测试(MWT),移动(MCT)协调测试,移动注意力测试(垫),移动视觉测试(测试)}。
结果:116 pwm(61%的女性,74%的复发缓和女士,女士进步26%)和69 HC进行了分析。MSCopilot的辨别力,量化使用接受者操作特征曲线下面积(AUC),是所有的非劣(分别为0.92和0.89)没有显著差异(ΔAUC = 0.03, p = 0.3)。MSCopilot和所有正确结合z分数歧视pwm和HC的敏感性分别为81%和76%,特异性分别为82%和88%。皮尔逊相关系数的MSCopilot和所有如下:MSCopilot vs所有:r = 0.81, p < 0.001;MSCopilot vs修订的所有(SDMT): r = 0.83, p < 0.001;MSCopilot vs MSFC4 (SDMT SLCLAT): r = 0.85, p < 0.001。
结论:Non-inferiority MSCopilot能力辨别pwm的HC和所有了。强大的数字和标准评分之间的相关性被发现。这些结果表明MSCopilot可用于临床实践为残疾女士进展的监测。
披露:Maillart博士已经收到个人赔偿咨询、担任科学顾问委员会说,或其他活动与广告Scientiam Idec, Genzyme,诺华,默克公司Serono,罗氏公司,赛诺菲,梯瓦制药公司。Maillart博士收到诺华的研究支持,罗氏。Labauge博士已经收到个人赔偿咨询、担任科学顾问委员会说,与生原体或其他活动,Sanofi-Genzyme、拜耳、诺华,Teva, Merck-Serono,罗氏和Medday。Labauge博士已经收到了从生原体研究支持,诺华,Sanofi-Genzyme,罗氏,Medday。。科恩博士没有披露。Maarouf博士没有披露。Vukusic博士已经收到个人赔偿咨询、担任科学顾问委员会说,与生原体或其他活动,Celgene公司,Genzyme,诺华,默克公司Serono,罗氏公司,赛诺菲-安万特和梯瓦制药公司。Vukusic博士已经收到了从生原体研究支持,Genzyme,诺华,默克公司Serono,罗氏公司,赛诺菲-安万特和梯瓦制药公司。Donze博士没有披露。Gallien博士没有披露。 Dr. De Sèze has nothing to disclose. Dr. Bourre has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Merck Serono, Biogen, Novartis, Sanofi-Genzyme and Teva. Dr. Moreau has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Novartis, Biogen, Merck, Roche, MedDay, Teva, and Sanofi-Genzyme. Dr. Moreau has received research support from Novartis, Biogen, Merck, Roche, MedDay, Teva, and Sanofi-Genzyme. Dr. Bieuvelet has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Ad Scientiam. Dr. Vallée has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Ad Scientiam. Dr. Bertillot has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Ad Scientiam. Dr. Argoud has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Ad Scientiam. Dr. Zinai has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Ad Scientiam. Dr. Tourbah has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, Novartis, MedDay, Merck Serono, Roche, Sanofi-Genzyme, Teva. Dr. Tourbah has received research support from Biogen, Novartis, MedDay, Merck Serono, Roche, Sanofi-Genzyme, Teva.
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