基于CT的“斑片状云征”对胸椎黄韧带骨化患者硬脊膜骨化的诊断准确性：一项前瞻性、盲法诊断准确性研究方案
The diagnostic accuracy of CT-based "Banner cloud sign" for dural ossification in patients with thoracic ossification of the ligamentum flavum: a prospective, blinded, diagnostic accuracy study protocol.
作者信息
Chen Guanghui, Zhang Baoliang, Tao Liyuan, Chen Zhongqiang, Sun Chuiguo
机构信息
Department of Orthopedics, Peking University Third Hospital, Beijing, China.
Beijing Key Laboratory of Spinal Disease Research, Beijing, China.
出版信息
Ann Transl Med. 2020 Dec;8(23):1606. doi: 10.21037/atm-20-5439.
BACKGROUND
Ossification of the ligamentum flavum (OLF) is the most common cause of thoracic spinal stenosis, which responds poorly to conservative treatment. Thus, surgery is the only effective treatment for OLF. The existence of dural ossification (DO) makes surgery challenging and increases the risk of intra-/post-operative complications. To date, several methods have been proposed to identify DO, but either the diagnostic accuracy is low or the feasibility is poor. Therefore, the aim of this study was to propose a new imaging sign (Banner cloud sign, BCs), evaluate the accuracy of BCs in the diagnosis of DO, and provide reliable evidence-based data for its application in clinical practice.
METHODS
A prospective, blinded, diagnostic accuracy study will be conducted to assess and compare the accuracy of BCs in the diagnosis of DO with other radiological signs [Tram track sign (TTs) and Comma sign (Cs)]. A total of 120 patients diagnosed with OLF who underwent decompression at the Peking University Third Hospital between January 2018 and June 2019 will be enrolled. Patients' medical records and imaging data will be retrieved from the hospital database server. An observational group consisting of six spine surgeons (with different seniority levels) and two epidemiological researchers will read the patients' images to identify typical imaging signs and determine the presence of DO. Surgical records will be reviewed to confirm the presence of DO, and the results will serve as the reference standard for estimating accuracy. The primary outcome of the study is to determine the accuracy of BCs for DO diagnosis, and the secondary outcome is to compare the sensitivity, specificity, area under the receiver operating characteristic (ROC) curve and inter-observer reliability of each imaging sign. The time taken and level of confidence in DO diagnosis of each observer will also be compared.
DISCUSSION
This study represents the first large-scale investigation of the diagnostic value of BCs, TTs and Cs in the diagnosis of DO, and will provide convincing evidence about their clinical application.
TRIAL REGISTRATION
Registered on 29 February 2020. Trial number is ChiCTR2000030380.
背景
黄韧带骨化（OLF）是胸段脊髓狭窄最常见的原因，保守治疗效果不佳。因此，手术是治疗OLF的唯一有效方法。硬脊膜骨化（DO）的存在使手术具有挑战性，并增加了术中/术后并发症的风险。迄今为止，已提出了几种识别DO的方法，但要么诊断准确性低，要么可行性差。因此，本研究的目的是提出一种新的影像学征象（横幅云征，BCs），评估BCs在诊断DO中的准确性，并为其在临床实践中的应用提供可靠的循证数据。
方法
将进行一项前瞻性、盲法诊断准确性研究，以评估和比较BCs与其他放射学征象[电车轨道征（TTs）和逗号征（Cs）]在诊断DO中的准确性。共有120例2018年1月至2019年6月期间在北京大学第三医院接受减压手术的OLF诊断患者将被纳入研究。患者的病历和影像数据将从医院数据库服务器中检索。由六名脊柱外科医生（不同资历水平）和两名流行病学研究人员组成的观察组将阅读患者的影像，以识别典型的影像学征象并确定DO的存在。将回顾手术记录以确认DO的存在，结果将作为评估准确性的参考标准。本研究的主要结果是确定BCs对DO诊断的准确性，次要结果是比较每个影像学征象的敏感性、特异性、受试者操作特征（ROC）曲线下面积和观察者间可靠性。还将比较每个观察者诊断DO所需的时间和信心水平。
讨论
本研究是首次对BCs、TTs和Cs在诊断DO中的诊断价值进行大规模调查，并将为它们的临床应用提供令人信服的证据。
试验注册
于2020年2月29日注册。试验编号为ChiCTR2000030380。
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