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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。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中是不充分的。目前的标准过度代表了皮肤红斑狼疮，有4个标准（而其他器官只有1个标准）。目前的标准需要更新，以反映血清学检测（例如，补体成分、新的自身抗体）、改进的诊断和实验室检测（例如，肾活检结果、尿蛋白与肌酐比率）和更广泛的器官受累定义（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。系统性狼疮国际合作诊所（SLICC）为狼疮临床试验措施的开发和验证制定了合作和生产力标准，包括SLE疾病活动指数（SLDEAI）、SLlCC损伤指数（后来也被ACR采用）和SF-36。SLlCC在全球拥有近30个学术中心。在本研究中，SLlCC将：1)通过频率分析来确定所提出的分类标准的可行性；2)依次将SLE患者及相关疾病患者纳入系统方案，采用传统方法和分类树方法检验提出的分类标准；3)在一组新的患者中参与对生成的分类标准的验证。

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.