Department of Neurology and Clinical Neurophysiology, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam Neuroscience, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands
Department of Neurology and Clinical Neurophysiology, Amsterdam University Medical Centre, University of Amsterdam, Amsterdam Neuroscience, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands.
BMJ Open. 2021 Dec 13;11(12):e053594. doi: 10.1136/bmjopen-2021-053594.
Idiopathic inflammatory myopathies (IIMs) excluding inclusion body myositis (IBM) are a group of heterogeneous autoimmune disorders characterised by subacute-onset and progressive proximal muscle weakness, which are frequently part of a multisystem autoimmune disorder. Reaching the diagnosis can be challenging, and no gold standard for the diagnosis of IIM exists. Diagnostic modalities include serum creatine kinase activity, muscle imaging (MRI or ultrasound (US)), electromyography (EMG), myositis autoantibody testing and muscle biopsy. Several diagnostic criteria have been developed for IIMs, varying in reported sensitivity and specificity.
We hypothesise that an evidence-based diagnostic strategy, using fewer and preferably the least invasive diagnostic modalities, can achieve the accuracy of a complete panel of diagnostic tests, including MRI, US, EMG, myositis-specific autoantibody testing and muscle biopsy.
The OptimizAtion of Diagnostic Accuracy in idioPathic inflammaTory myopathies study is a prospective diagnostic accuracy study with an over-complete study design. 100 patients suspected of an IIM excluding IBM will be included. A reference diagnosis will be assigned by an expert panel using all clinical information and all results of all ancillary tests available, including 6 months of follow-up. Several predefined diagnostic strategies will be compared against the reference diagnosis to find the optimal diagnostic strategy.
Ethical approval was obtained from the medical ethics committee of the Academic Medical Centre, University of Amsterdam, The Netherlands (2019-814). The results will be distributed through conference presentations and peer-reviewed publications.
Netherlands trial register; NL8764.
特发性炎性肌病（IIM）不包括包涵体肌炎（IBM），是一组异质性自身免疫性疾病，其特征为亚急性发作和进行性近端肌无力，这些通常是多系统自身免疫性疾病的一部分。诊断可能具有挑战性，目前还没有 II M 的金标准诊断方法。诊断方法包括血清肌酸激酶活性、肌肉影像学（MRI 或超声（US））、肌电图（EMG）、肌炎自身抗体检测和肌肉活检。已经为 IIM 制定了几种诊断标准，其报告的敏感性和特异性各不相同。
我们假设使用较少的、最好是无创的诊断方法的基于证据的诊断策略，可以达到包括 MRI、US、EMG、肌炎特异性自身抗体检测和肌肉活检在内的完整诊断检测组合的准确性。
特发性炎性肌病中诊断准确性的优化研究（OptimizAtion of Diagnostic Accuracy in idioPathic inflammaTory myopathies study）是一项前瞻性诊断准确性研究，采用过度完整的研究设计。将纳入 100 例疑似 IBM 以外的 IIM 的患者。将由一个专家小组根据所有临床信息和所有辅助检查的结果（包括 6 个月的随访），使用参考诊断来分配。将比较几种预先定义的诊断策略与参考诊断，以找到最佳的诊断策略。
已从荷兰阿姆斯特丹学术医学中心医学伦理委员会获得伦理批准（2019-814）。结果将通过会议演讲和同行评议的出版物分发。
荷兰试验注册处；NL8764。
