Abstract
ObjectivesWe 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.MethodsParticipants, 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”.Results447 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.ConclusionsThe 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.
Highlights
Erythema nodosum leprosum (ENL) is a severe inflammatory complication of borderline lepromatous (BL) leprosy and lepromatous leprosy (LL)
447 participants were assessed with the Erythema Nodosum Leprosum International STudy (ENLIST) ENL Severity Scale
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript
Summary
Erythema nodosum leprosum (ENL) is a severe inflammatory complication of borderline lepromatous (BL) leprosy and lepromatous leprosy (LL). ENL affects up to 50% of individuals with LL and 5–10% of BL leprosy patients [1, 2]. A bacterial index of four or more is a risk factor for developing ENL. ENL may occur before, during or after successful completion of anti-mycobacterial multi-drug therapy (MDT)[2]. ENL causes inflammation in many systems and is characterised by severe pain, tender cutaneous skin lesions, fever, joint and bone pain, iritis, orchitis, lymphadenopathy and neuritis [3]. Most patients have multiple episodes of painful inflammation extending over several years [2, 3]
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