The MSOAC approach to developing performance outcomes to measure and monitor multiple sclerosis disability.
The MSOAC approach to developing performance outcomes to measure and monitor multiple sclerosis disability.
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DOI：
10.1177/1352458517723718
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发表时间：
2018-10
期刊：
影响因子：
--
通讯作者：
Multiple Sclerosis Outcome Assessments Consortium (MSOAC)
中科院分区：
文献类型：
--
作者：
LaRocca NG;Hudson LD;Rudick R;Amtmann D;Balcer L;Benedict R;Bermel R;Chang I;Chiaravalloti ND;Chin P;Cohen JA;Cutter GR;Davis MD;DeLuca J;Feys P;Francis G;Goldman MD;Hartley E;Kapoor R;Lublin F;Lundstrom G;Matthews PM;Mayo N;Meibach R;Miller DM;Motl RW;Mowry EM;Naismith R;Neville J;Panagoulias J;Panzara M;Phillips G;Robbins A;Sidovar MF;Smith KE;Sperling B;Uitdehaag BM;Weaver J;Multiple Sclerosis Outcome Assessments Consortium (MSOAC)
多发性硬化症结局评估联盟（MSOAC）由国家多发性硬化症协会（MS Society）成立，旨在制定多发性硬化症（MS）相关残疾的改进措施。(1)评估功能表现结局指标（PerfOs）的当前文献和可用数据，（2）确定在MS临床试验中使用PerfOs量化MS残疾的适用性。(1)识别MS中常见的残疾维度;（2）对这些维度的测量进行全面的文献综述;（3）制定MS临床数据交换标准联盟（CDISC）数据标准;（4）创建标准化汇总临床试验数据数据库;（5）分析汇总数据以评估候选测量的心理测量特性;和（6）与监管机构合作，在MS临床试验中使用这些指标作为主要或次要结局。相当多的数据存在支持的功能域的措施amphibia，手动灵活性，视觉和认知。发布了MS的CDISC标准（http：//www.cdisc.org/therapeutic#MS），允许合并临床试验数据。MSOAC成员组织提供了来自16项试验的临床数据，包括14，370例受试者。合格的研究人员可获得安慰剂组受试者的数据。正在对这一综合的标准化数据集进行分析，以支持监管机构对残疾终点的鉴定。
The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) was formed by the National MS Society to develop improved measures of multiple sclerosis (MS)-related disability. (1) To assess the current literature and available data on functional performance outcome measures (PerfOs) and (2) to determine suitability of using PerfOs to quantify MS disability in MS clinical trials. (1) Identify disability dimensions common in MS; (2) conduct a comprehensive literature review of measures for those dimensions; (3) develop an MS Clinical Data Interchange Standards Consortium (CDISC) data standard; (4) create a database of standardized, pooled clinical trial data; (5) analyze the pooled data to assess psychometric properties of candidate measures; and (6) work with regulatory agencies to use the measures as primary or secondary outcomes in MS clinical trials. Considerable data exist supporting measures of the functional domains ambulation, manual dexterity, vision, and cognition. A CDISC standard for MS (http://www.cdisc.org/therapeutic#MS) was published, allowing pooling of clinical trial data. MSOAC member organizations contributed clinical data from 16 trials, including 14,370 subjects. Data from placebo-arm subjects are available to qualified researchers. This integrated, standardized dataset is being analyzed to support qualification of disability endpoints by regulatory agencies.
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影响因子：
5.8
作者：
Rudick, R. A.;Polman, C. H.;Sandrock, A. W.
通讯作者：
Sandrock, A. W.
影响因子：
9.9
作者：
RAO, SM;LEO, GJ;UNVERZAGT, F
通讯作者：
UNVERZAGT, F
影响因子：
2.9
作者：
Goverover, Yael;Strober, Lauren;DeLuca, John
通讯作者：
DeLuca, John
影响因子：
3.9
作者：
Feaster, H. Todd;Bruce, Jared M.
通讯作者：
Bruce, Jared M.
DOI：
10.1177/1352458517690824
发表时间：
2017-04
期刊：
Multiple sclerosis (Houndmills, Basingstoke, England)
影响因子：
--
作者：
Feys P;Lamers I;Francis G;Benedict R;Phillips G;LaRocca N;Hudson LD;Rudick R;Multiple Sclerosis Outcome Assessments Consortium
通讯作者：
Multiple Sclerosis Outcome Assessments Consortium