Halliday Amy Jean, Lambert Katrina, Bundell Christine, McLean-Tooke Andrew, Gillis David, Prain Kerri M, Bryson Greg, Gillinder Lisa, Brown David, Ramanathan Sudarshini, Dale Russell, Brilot Fabienne, Jordan Nerissa, Lawn Nicholas, Lai Alan, Boyd James, Camacho Ximena, D'Souza Wendyl Jude
Department of Clinical Neurosciences, St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia
Department of Medicine, St Vincent's Hospital Melbourne, The University of Melbourne, Fitzroy, Victoria, Australia.
BMJ Open. 2024 Dec 5;14(12):e084664. doi: 10.1136/bmjopen-2024-084664.
The autoimmune encephalitides (AE) are a heterogeneous group of neurological disorders with significant morbidity and healthcare costs. Despite advancements in understanding their pathophysiology, uncertainties persist regarding long-term prognosis and optimal management. This study aims to address these gaps, focusing on immunotherapeutic strategies, neoplastic associations and functional outcomes.
The Retrospective Linkage Study of Autoimmune Encephalitis project will use data linkage techniques to establish a retrospective 10-year population cohort of Australian patients with AE. Two cohorts will be analysed, the Reference Cohort (clinically confirmed AE cases obtained from hospital medical records, n=145) and the Operationally Defined Cohort (AE cases identified through administrative coding data, n≈5000). Univariate statistical methods will identify candidate coding elements for use in the operational case definition and multivariate models and evaluation methods used to identify and internally validate the optimal coding algorithms. The two study cohorts will be analysed separately due to the high likelihood of overlap. Primary outcomes include relapse rate, prevalence and control of epilepsy, cognitive disability, poor educational attainment, delayed tumour diagnosis and mortality. Statistical analyses, including random mixed-effects regression models, will assess treatment effects, covariates and outcomes.
This project has been approved by the leading investigators' institutional Human Research Ethics Committee (HREC), the St Vincent's Hospital Melbourne HREC, as well as the Australian Institute of Health and Welfare HREC and relevant jurisdictional HRECs where required. The dissemination of findings through peer-reviewed publications and patient advocacy channels will maximise the impact of this research.
自身免疫性脑炎（AE）是一组异质性神经系统疾病，具有较高的发病率和医疗成本。尽管在理解其病理生理学方面取得了进展，但关于长期预后和最佳管理仍存在不确定性。本研究旨在填补这些空白，重点关注免疫治疗策略、肿瘤相关性和功能结局。
自身免疫性脑炎回顾性关联研究项目将使用数据关联技术建立一个澳大利亚AE患者的10年回顾性人群队列。将分析两个队列，参考队列（从医院病历中获取的临床确诊AE病例，n = 145）和操作定义队列（通过行政编码数据识别的AE病例，n≈5000）。单变量统计方法将识别用于操作病例定义的候选编码元素，多变量模型和评估方法将用于识别和内部验证最佳编码算法。由于重叠可能性高，两个研究队列将分别进行分析。主要结局包括复发率、癫痫的患病率和控制情况、认知障碍、教育程度低、肿瘤诊断延迟和死亡率。包括随机混合效应回归模型在内的统计分析将评估治疗效果、协变量和结局。
本项目已获得主要研究者所在机构的人类研究伦理委员会（HREC）、墨尔本圣文森特医院HREC以及澳大利亚卫生与福利研究所HREC的批准，并在需要时获得相关司法管辖区HREC的批准。通过同行评审出版物和患者宣传渠道传播研究结果将使本研究的影响最大化。
