Isenberg D A, Rahman A, Allen E, Farewell V, Akil M, Bruce I N, D'Cruz D, Griffiths B, Khamashta M, Maddison P, McHugh N, Snaith M, Teh L S, Yee C S, Zoma A, Gordon C
Centre for Rheumatology, University College London, 4th Floor, Arthur Stanley House, 40-50 Tottenham Street, London W1T 4NJ, UK.
Rheumatology (Oxford). 2005 Jul;44(7):902-6. doi: 10.1093/rheumatology/keh624. Epub 2005 Apr 6.
To devise a more discriminating version of the British Isles Lupus Assessment Group (BILAG) disease activity index and to show that it is reliable.
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.
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.
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.
设计一个更具区分度的不列颠群岛狼疮评估组（BILAG）疾病活动指数，并证明其可靠性。
BILAG成员采用名义共识法来更新和改进BILAG狼疮疾病活动指数。该指数在为期1年的密集磋商后进行了修订。在两项真实患者试验中对其进行了评估。这些试验涉及具有系统性红斑狼疮（SLE）各种临床特征的患者，包括胃肠道、肝脏和眼科问题，而该指数的早期版本并未充分考虑这些问题。通过计算组内相关系数评估区分患者的能力方面的可靠性。通过计算医生所致标准误（SE）估计值与患者所致SE的比值来确定医生之间的一致程度。
在一项或两项试验中，在全身、黏膜皮肤、神经、心肺、肾脏、眼科和血液系统中观察到了良好的可靠性和较高的医生一致程度。相比之下，肌肉骨骼系统的评分不佳，不过提供更明确的术语定义应能大大改善这种情况。
提出了BILAG疾病活动指数中一些用于评估SLE患者的重大变化。通过这两项评估真实患者的试验，已经开始了证明有效性和可靠性的过程。进一步的验证研究正在进行中。BILAG 2004在评估SLE新疗法的临床试验中可能很有价值，因为它提供了一个比以前更全面的基于系统的疾病活动度量方法。
