Bodien Yelena G, McCrea Michael, Dikmen Sureyya, Temkin Nancy, Boase Kim, Machamer Joan, Taylor Sabrina R, Sherer Mark, Levin Harvey, Kramer Joel H, Corrigan John D, McAllister Thomas W, Whyte John, Manley Geoffrey T, Giacino Joseph T
Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston (Dr Bodien); Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Charlestown, Massachusetts (Drs Bodien and Giacino); Departments of Neurosurgery and Neurology, Medical College of Wisconsin, Milwaukee (Dr McCrea); Departments of Rehabilitation Medicine (Dr Dikmen and Mss Boase and Machamer) and Neurological Surgery and Biostatistics (Dr Temkin), University of Washington, Seattle; Department of Neurological Surgery, Brain and Spinal Injury Center (Dr Taylor), and Department of Neurology, Memory and Aging Center (Dr Kramer), University of California, San Francisco; TIRR Memorial Hermann, Houston, Texas (Dr Sherer); Department of Physical Medicine and Rehabilitation, Baylor College of Medicine, Houston, Texas (Drs Sherer and Levin); Department of Physical Medicine & Rehabilitation, The Ohio State University, Columbus (Dr Corrigan); Department of Psychiatry, University of Indiana School of Medicine, Indianapolis (Dr McAllister); and Moss Rehabilitation Research Institute, Elkins Park, Pennsylvania (Dr Whyte).
J Head Trauma Rehabil. 2018 May/Jun;33(3):147-157. doi: 10.1097/HTR.0000000000000367.
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 multidimensional outcome assessment battery with 22 measures aimed at characterizing TBI outcome up to 1 year postinjury. 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.
创伤性脑损伤（TBI）是一个全球性的公共卫生问题，它会影响患者的长期认知、身体和心理健康，同时也对家庭和护理人员产生重大影响。与在其他神经系统疾病中进行的有效试验形成鲜明对比的是，近30项针对TBI急性住院治疗期间采用的干预措施的研究未能确定能改善预后的治疗方法。许多因素可能会混淆检测真正有意义的治疗效果的能力。提高干预研究精度的一个有前景的领域是通过使用精心设计的工具和数据收集策略来优化结局评估指标的有效性，以减少结局数据的变异性。在美国18个地点开展的创伤性脑损伤转化研究与临床知识（TRACK-TBI）研究实施了一个多维结局评估指标，包含22项测量指标，旨在描述受伤后长达1年的TBI结局。与此同时，通过创伤性脑损伤终点开发（TED）倡议，联邦机构和研究人员合作确定了用于TBI的最有效、可靠和敏感的结局评估方法。在此，我们介绍从TRACK-TBI和TED倡议中吸取的经验教训，旨在优化TBI结局评估的有效性。
