BILAG 2004. Development and initial validation of an updated version of the British Isles Lupus Assessment Group's disease activity index for patients with systemic lupus erythematosus

BILAG 2004. Development and initial validation of an updated version of the British Isles Lupus Assessment Group's disease activity index for patients with systemic lupus erythematosus
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DOI:
10.1093/rheumatology/keh624
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发表时间:
2005-07-01
期刊:
影响因子:
5.5
通讯作者:
Gordon, C
Gordon, C
中科院分区:
医学1区
文献类型:
--
作者:
Isenberg, DA;Rahman, A;Gordon, C

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Objective.设计一个更具鉴别力的不列颠群岛狼疮评估组(BILAG)疾病活动指数的版本,并表明它是可靠的。BILAG成员采用名义共识方法更新和改进BILAG狼疮疾病活动指数。经过一年多的紧张磋商,对该指数进行了修订。它已经在两个真实的病人练习中进行了评估。这些涉及具有不同SLE临床特征的患者,包括胃肠道、肝脏和眼科问题,早期版本的指数没有充分考虑到这些问题。通过计算组内相关系数来评估区分患者能力的可靠性。医生之间的一致性水平通过计算归因于医生的标准误(SE)与归因于患者的SE的估计值的比值来确定。在体质、粘膜皮肤、神经、心肺、肾脏、眼科和血液系统的一项或两项练习中观察到良好的可靠性和高水平的医生一致性。相比之下,肌肉骨骼系统没有得分以及,虽然提供更明确的词汇定义应该大大改善的情况。BILAG疾病活动指数的一些显着变化,以评估SLE患者的建议。证明有效性和可靠性的过程始于这两个评估真实的患者的练习。正在进行进一步的验证研究。BILAG 2004在评估SLE治疗新疗法的临床试验中可能很有价值,因为它提供了比以前更全面的基于系统的疾病活动性测量。
Objective. To devise a more discriminating version of the British Isles Lupus Assessment Group (BILAG) disease activity index and to show that it is reliable.Methods. A nominal consensus approach was undertaken by members of BILAG to update and improve the BILAG lupus disease activity index. The index has been revised following intense consultations over a 1-yr period. It has been assessed in two real-patient exercises. These involved patients with diverse clinical features of SLE, including gastrointestinal, hepatic and ophthalmic problems, which the earlier versions of the index did not fully take into account. Reliability in terms of the ability to differentiate patients was assessed by calculating intraclass correlation coefficients. The level of agreement between physicians was determined by calculating the ratio of estimates of the standard error (SE) attributable to the physicians to the SE attributable to the patients.Results. Good reliability and high levels of physician agreement were observed in one or both exercises in the constitutional, mucocutaneous, neurological, cardiorespiratory, renal, ophthalmic and haematological systems. In contrast, the musculoskeletal system did not score as well, although providing more clear-cut glossary definitions should greatly improve the situation.Conclusions. Some significant changes in the BILAG disease activity index to assess patients with SLE are proposed. The process of demonstrating validity and reliability has started with these two exercises assessing real patients. Further validation studies are under way. BILAG 2004 is likely to be valuable in clinical trials assessing new therapies for the treatment of SLE, as it provides a more comprehensive system-based disease activity measure than has been available previously.