Zafar Sahar F, Westover M Brandon, Gaspard Nicolas, Gilmore Emily J, Foreman Brandon P, OʼConnor Kathryn L, Rosenthal Eric S
*Department of Neurology, Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, U.S.A.; †Department of Neurology, Université Libre de Bruxelles, Brussels, Belgium; ‡Department of Neurology, Yale University School of Medicine, New Haven, Connecticut, U.S.A.; and §Department of Neurology and Rehabilitation Medicine, UC College of Medicine, Cincinnati, Ohio, U.S.A.
J Clin Neurophysiol. 2016 Jun;33(3):235-40. doi: 10.1097/WNP.0000000000000276.
Thirty percent of patients with subarachnoid hemorrhage experience delayed cerebral ischemia or delayed ischemic neurologic decline (DIND). Variability in the definitions of delayed ischemia makes outcome studies difficult to compare. A recent consensus statement advocates standardized definitions for delayed ischemia in clinical trials of subarachnoid hemorrhage. We sought to evaluate the interrater agreement of these definitions.
Based on consensus definitions, we assessed for: (1) delayed cerebral infarction, defined as radiographic cerebral infarction; (2) DIND type 1 (DIND1), defined as focal neurologic decline; and (3) DIND2, defined as a global decline in arousal. Five neurologists retrospectively reviewed electronic records of 58 patients with subarachnoid hemorrhage. Three reviewers had access to and reviewed neuroradiology imaging. We assessed interrater agreement using the Gwet kappa statistic.
Interrater agreement statistics were excellent (95.83%) for overall agreement on the presence or absence of any delayed ischemic event (DIND1, DIND2, or delayed cerebral infarction). Agreement was "moderate" for specifically identifying DIND1 (56.58%) and DIND2 (48.66%) events. We observed greater agreement for DIND1 when there was a significant focal motor decline of at least 1 point in the motor score. There was fair agreement (39.20%) for identifying delayed cerebral infarction; CT imaging was the predominant modality.
Consensus definitions for delayed cerebral ischemia yielded near-perfect overall agreement and can thus be applied in future large-scale studies. However, a strict process of adjudication, explicit thresholds for determining focal neurologic decline, and MRI techniques that better discriminate edema from infarction seem critical for reproducibility of determination of specific outcome phenotypes, and will be important for successful clinical trials.
30%的蛛网膜下腔出血患者会经历延迟性脑缺血或延迟性缺血性神经功能衰退(DIND)。延迟性缺血定义的差异使得结果研究难以比较。最近的一项共识声明主张在蛛网膜下腔出血的临床试验中对延迟性缺血采用标准化定义。我们试图评估这些定义的评分者间一致性。
基于共识定义,我们评估了:(1)延迟性脑梗死,定义为影像学上的脑梗死;(2)1型DIND(DIND1),定义为局灶性神经功能衰退;以及(3)2型DIND(DIND2),定义为意识水平的整体下降。五位神经科医生回顾性地查阅了58例蛛网膜下腔出血患者的电子病历。三位审阅者有权限并审阅了神经放射学影像。我们使用Gwet卡方统计量评估评分者间一致性。
对于是否存在任何延迟性缺血事件(DIND1、DIND2或延迟性脑梗死)的总体一致性,评分者间一致性统计结果极佳(95.83%)。对于具体识别DIND1(56.58%)和DIND2(48.66%)事件,一致性为“中等”。当运动评分中至少有1分的显著局灶性运动下降时,我们观察到DIND1的一致性更高。对于识别延迟性脑梗死,一致性一般(39.20%);CT成像是主要的检查方式。
延迟性脑缺血的共识定义产生了近乎完美的总体一致性,因此可应用于未来的大规模研究。然而,严格的判定过程、确定局灶性神经功能衰退的明确阈值以及能更好地区分水肿和梗死的MRI技术,对于特定结果表型判定的可重复性似乎至关重要,并且对成功开展临床试验也很重要。