03223nas a2200433 4500000000100000008004100001653001200042653003600054653003000090100001400120700001200134700001400146700001100160700001600171700001400187700001400201700001400215700001000229700001400239700001100253700001200264700001200276700001500288700001200303700001400315700001400329700001300343700001400356700001400370700001600384700001600400700005700416245015000473856009800623300001300721490000700734520203400741022001402775 2017 d10aleprosy10aErythema nodosum leprosum (ENL)10aENLIST ENL Severity Scale1 aWalker SL1 aSales A1 aButlin CR1 aShah M1 aMaghanoy AA1 aLambert S1 aDarlong J1 aRozario B1 aPai V1 aBalagon M1 aDoni S1 aHagge D1 aNery JA1 aNeupane KD1 aBaral S1 aSangma BA1 aAlembo DT1 aYetaye A1 aHassan BA1 aShelemo M1 aNicholls PG1 aLockwood DN1 aErythema Nodosum Leprosum International STudy Group 00aA leprosy clinical severity scale for erythema nodosum leprosum: An international, multicentre validation study of the ENLIST ENL Severity Scale. uhttp://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0005716&type=printable ae00057160 v113 a

OBJECTIVES: 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.

METHODS: 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".

RESULTS: 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.

CONCLUSIONS: 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.

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