ACR RE-CLASSIFICATION OF SLE CRITERIA (AROSE) ORIG GRANT REVISION OF ACR CLASSIF

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。目前美国风湿病学会(ACR)对系统性红斑狼疮(SLE)的分类标准已被证明在当前的研究环境下是不合适的。目前的标准过多地代表了皮肤狼疮，有4个标准(而其他器官只有1个)。目前的标准需要更新，以反映血清学测试(例如补体成分、新的自身抗体)、改进的诊断和实验室测试(例如肾活检结果、尿蛋白与肌酐的比率)以及器官受累的更广泛定义(例如，将神经受累重新定义为不仅仅是“癫痫”或“精神病”)方面的进展。系统性红斑狼疮国际协作诊所(SLICC)在开发和验证SLE临床试验措施方面为合作和生产力制定了标准，包括SLE疾病活动指数(SLDEAI)、SLlCC损害指数(后来也被ACR采用)和SF-36。SLLCC在全球拥有近30个学术中心。在这项研究中，SLLCC将：1)通过频率分析确定建议分类标准的可行性；2)顺序地将SLE患者和有相关疾病的患者纳入系统方案，以使用传统和分类树方法测试建议的分类标准；以及3)在新的一组患者中参与验证所生成的分类标准。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The current American College of Rheumatology (ACR) classification criteria for systemic lupus erythematosus (SLE) have proven to be inadequate in the current research climate. The current criteria over-represent cutaneous lupus, with 4 criteria (whereas every other organ receives only 1). The current criteria need to be updated to represent advances in serologic testing (e.g., complement components, new autoantibodies), improved diagnostic and laboratory testing (e.g., renal biopsy findings, urine protein to creatinine ratios) and broader definitions of organ involvement (e.g., redefining neurologic involvement as more than "seizures" or "psychosis"). The Systemic Lupus International Collaborating Clinics (SLICC) has set a standard for cooperation and productivity in the development and validation of clinical trial measures for SLE, including the SLE Disease Activity lndex (SLDEAI), the SLlCC Damage lndex (later also adopted by the ACR), and the SF-36. SLlCC consists of nearly 30 academic centers world-wide. In this study, SLlCC will: 1)identify, by frequency analysis, the feasibility of proposed classification criteria; 2) sequentially enroll SLE patients and those with related diseases into a systematic protocol to test proposed classification criteria using traditional and classification tree methodology; and 3) participate in a validation exercise of the generated classification criteria in a new set of patients.