Optimizing Outcome Assessment in Multicenter TBI Trials: Perspectives From TRACK-TBI and the TBI Endpoints Development Initiative.
Optimizing Outcome Assessment in Multicenter TBI Trials: Perspectives From TRACK-TBI and the TBI Endpoints Development Initiative.
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DOI：
10.1097/htr.0000000000000367
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发表时间：
2018
期刊：
影响因子：
--
通讯作者：
TRACK-TBI Investigators
中科院分区：
文献类型：
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作者：
Bodien YG;McCrea M;Dikmen S;Temkin N;Boase K;Machamer J;Taylor SR;Sherer M;Levin H;Kramer JH;Corrigan JD;McAllister TW;Whyte J;Manley GT;Giacino JT;TRACK-TBI Investigators
Traumatic brain injury (TBI) is a global public health problem that affects the long-term cognitive, physical, and psychological health of patients, while also having a major impact on family and caregivers. In stark contrast to the effective trials that have been conducted in other neurological diseases, nearly 30 studies of interventions employed during acute hospital care for TBI have failed to identify treatments that improve outcome. Many factors may confound the ability to detect true and meaningful treatment effects. One promising area for improving the precision of intervention studies is to optimize the validity of the outcome assessment battery by using well-designed tools and data collection strategies to reduce variability in the outcome data. The Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) study, conducted at 18 sites across the United States, implemented a multi-dimensional outcome assessment battery with 22 measures aimed at characterizing TBI outcome up to one year post-injury. In parallel, through the TBI Endpoints Development (TED) Initiative, federal agencies and investigators have partnered to identify the most valid, reliable, and sensitive outcome assessments for TBI. Here we present lessons learned from the TRACK-TBI and TED initiatives aimed at optimizing the validity of outcome assessment in TBI.
