核心实验室应力超声心动图解读的价值：来自缺血性心脏病改善临床结果评价（ISCHEMIA）试验的观察结果
The value of core lab stress echocardiography interpretations: observations from the ISCHEMIA Trial.
作者信息
Kataoka Akihisa, Scherrer-Crosbie Marielle, Senior Roxy, Gosselin Gilbert, Phaneuf Denis, Guzman Gabriela, Perna Gian, Lara Alfonso, Kedev Sasko, Mortara Andrea, El-Hajjar Mohammad, Shaw Leslee J, Reynolds Harmony R, Picard Michael H
机构信息
Cardiac Ultrasound Laboratory, Massachusetts General Hospital and Harvard Medical School, 55 Fruit Street Yawkey 5E, Boston, MA, 02114, USA.
Department of Cardiovascular Medicine, Division of Cardiology, National Heart and Lung Institute, Imperial College, Sydney Street, London, SW3 6NP, UK.
出版信息
Cardiovasc Ultrasound. 2015 Dec 18;13:47. doi: 10.1186/s12947-015-0043-2.
BACKGROUND
Stress echocardiography (SE) is dependent on subjective interpretations. As a prelude to the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) Trial, potential sites were required to submit two SE, one with moderate or severe left ventricular (LV) myocardial ischemia and one with mild ischemia. We evaluated the concordance of site and core lab interpretations.
METHODS
Eighty-one SE were submitted from 41 international sites. Ischemia was classified by the number of new or worsening segmental LV wall motion abnormalities (WMA): none, mild (1 or 2) or moderate or severe (3 or more) by the sites and the core lab.
RESULTS
Core lab classified 6 SE as no ischemia, 35 mild and 40 moderate or greater. There was agreement between the site and core in 66 of 81 total cases (81%, weighted kappa coefficient [K] =0.635). Agreement was similar for SE type - 24 of 30 exercise (80%, K = 0.571) vs. 41 of 49 pharmacologic (84%, K = 0.685). The agreement between poor or fair image quality (27 of 36 cases, 75%, K = 0.492) was not as good as for the good or excellent image quality cases (39 of 45 cases, 87%, K = 0.755). Differences in concordance were noted for degree of ischemia with the majority of discordant interpretations (87%) occurring in patients with no or mild LV myocardial ischemia.
CONCLUSIONS
While site SE interpretations are largely concordant with core lab interpretations, this appears dependent on image quality and the extent of WMA. Thus core lab interpretations remain important in clinical trials where consistency of interpretation across a range of cases is critical.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01471522.
背景
负荷超声心动图（SE）依赖主观解读。作为医学与侵入性方法比较健康效果国际研究（ISCHEMIA）试验的前奏，要求潜在研究地点提交两份SE报告，一份存在中度或重度左心室（LV）心肌缺血，另一份存在轻度缺血。我们评估了研究地点与核心实验室解读的一致性。
方法
来自41个国际研究地点的81份SE报告被提交。缺血情况根据新出现或加重的节段性左心室壁运动异常（WMA）数量进行分类：研究地点和核心实验室均分为无、轻度（1或2个）或中度或重度（3个或更多）。
结果
核心实验室将6份SE报告分类为无缺血，35份为轻度，40份为中度或更严重。81例总病例中，有66例（81%）研究地点与核心实验室的分类一致（加权kappa系数[K]=0.635）。SE类型的一致性相似——30例运动负荷SE中有24例（80%，K=0.571），49例药物负荷SE中有41例（84%，K=0.685）。图像质量差或一般的病例一致性（36例中的27例，75%，K=0.492）不如图像质量好或优秀的病例（45例中的39例，87%，K=0.755）。缺血程度的一致性存在差异，大多数不一致的解读（8
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