Smolen J S, Strand V, Cardiel M, Edworthy S, Furst D, Gladman D, Gordon C, Isenberg D A, Klippel J H, Petri M, Simon L, Tugwell P, Wolfe F
University of Vienna, Austria.
J Rheumatol. 1999 Feb;26(2):504-7.
The OMERACT module on systemic lupus erythematosus (SLE) dealt with the definition of preliminary core sets of outcome domains for randomized clinical trials (RCT) and longitudinal observational studies (LOS). After lectures introducing the problems and addressing the key issues, 6 discussion groups, 3 each for LOS and RCT, discussed and weighted more than a dozen possible items for use as outcome domains. The means of the respective 3 groups were calculated. For both RCT and LOS the same outcome domains received more than 10 of a total maximum of 100 points: disease activity, health related quality of life (HRQOL), damage, and toxicity/adverse events. However, the weights for HRQOL and damage were different for LOS and RCT. A final vote led to the acceptance of these 4 variables as a preliminary core set for outcome in SLE by more than 80% of the participants. This core set will allow for improved design, performance, and evaluation of future studies in SLE. However, a number of domains not included in the core set were regarded as important for further analysis and research.
系统性红斑狼疮（SLE）的OMERACT模块涉及为随机临床试验（RCT）和纵向观察性研究（LOS）确定初步核心结局领域的定义。在介绍了相关问题并阐述了关键要点的讲座之后，6个讨论小组（LOS和RCT各3个）对十多个可能用作结局领域的项目进行了讨论和加权。计算了各自3个小组的平均值。对于RCT和LOS而言，相同的结局领域在总分100分中获得了超过10分：疾病活动度、健康相关生活质量（HRQOL）、损伤以及毒性/不良事件。然而，LOS和RCT中HRQOL和损伤的权重有所不同。最终投票结果是，超过80%的参与者接受这4个变量作为SLE结局的初步核心集。该核心集将有助于改进未来SLE研究的设计、实施和评估。然而，一些未包含在核心集中的领域被认为对进一步分析和研究很重要。
