Walker Stephen L, Sales Anna M, Butlin C Ruth, Shah Mahesh, Maghanoy Armi, Lambert Saba M, Darlong Joydeepa, Rozario Benjamin Jewel, Pai Vivek V, Balagon Marivic, Doni Shimelis N, Hagge Deanna A, Nery José A C, Neupane Kapil D, Baral Suwash, Sangma Biliom A, Alembo Digafe T, Yetaye Abeba M, Hassan Belaynesh A, Shelemo Mohammed B, Nicholls Peter G, Lockwood Diana N J
Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.
Leprosy Laboratory, Oswaldo Cruz Institute, Fiocruz, Rio de Janeiro, Brazil.
PLoS Negl Trop Dis. 2017 Jul 3;11(7):e0005716. doi: 10.1371/journal.pntd.0005716. eCollection 2017 Jul.
We wished to validate our recently devised 16-item ENLIST ENL Severity Scale, a clinical tool for measuring the severity of the serious leprosy associated complication of erythema nodosum leprosum (ENL). We also wished to assess the responsiveness of the ENLIST ENL Severity Scale in detecting clinical change in patients with ENL.
Participants, recruited from seven centres in six leprosy endemic countries, were assessed using the ENLIST ENL Severity Scale by two researchers, one of whom categorised the severity of ENL. At a subsequent visit a further assessment using the scale was made and both participant and physician rated the change in ENL using the subjective categories of "Much better", "somewhat better", "somewhat worse" and "much worse" compared with "No change" or "about the same".
447 participants were assessed with the ENLIST ENL Severity Scale. The Cronbach alpha of the scale and each item was calculated to determine the internal consistency of the scale. The ENLIST ENL Severity Scale had good internal consistency and this improved following removal of six items to give a Cronbach's alpha of 0.77. The cut off between mild ENL and more severe disease was 9 determined using ROC curves. The minimal important difference of the scale was determined to be 5 using both participant and physician ratings of change.
The 10-item ENLIST ENL Severity Scale is the first valid, reliable and responsive measure of ENL severity and improves our ability to assess and compare patients and their treatments in this severe and difficult to manage complication of leprosy. The ENLIST ENL Severity Scale will assist physicians in the monitoring and treatment of patients with ENL. The ENLIST ENL Severity Scale is easy to apply and will be useful as an outcome measure in treatment studies and enable the standardisation of other clinical and laboratory ENL research.
我们希望验证我们最近设计的16项ENLIST ENL严重程度量表，这是一种用于测量麻风结节性红斑（ENL）这种严重麻风相关并发症严重程度的临床工具。我们还希望评估ENLIST ENL严重程度量表在检测ENL患者临床变化方面的反应性。
从六个麻风流行国家的七个中心招募参与者，由两名研究人员使用ENLIST ENL严重程度量表进行评估，其中一名研究人员对ENL的严重程度进行分类。在随后的一次访视中，再次使用该量表进行评估，参与者和医生根据“好多了”“稍好一些”“稍差一些”和“差得多”这些主观类别对ENL的变化进行评分，并与“无变化”或“大致相同”进行比较。
447名参与者使用ENLIST ENL严重程度量表进行了评估。计算该量表及其每个项目的克朗巴哈系数，以确定量表的内部一致性。ENLIST ENL严重程度量表具有良好的内部一致性，在去除六个项目后有所改善，克朗巴哈系数为0.77。使用ROC曲线确定轻度ENL与更严重疾病之间的临界值为9。使用参与者和医生对变化的评分确定该量表的最小重要差异为5。
10项ENLIST ENL严重程度量表是首个有效、可靠且具有反应性的ENL严重程度测量工具，提高了我们评估和比较患有这种严重且难以管理的麻风并发症患者及其治疗效果的能力。ENLIST ENL严重程度量表将有助于医生对ENL患者进行监测和治疗。ENLIST ENL严重程度量表易于应用，将作为治疗研究中的一项结局指标，并使其他临床和实验室ENL研究实现标准化。
