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A leprosy clinical severity scale for erythema nodosum leprosum: An international, multicentre validation study of the ENLIST ENL Severity Scale

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 dete...

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Autores principales: 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.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5510881/
https://www.ncbi.nlm.nih.gov/pubmed/28671966
http://dx.doi.org/10.1371/journal.pntd.0005716
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author 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.
author_facet 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.
author_sort Walker, Stephen L.
collection PubMed
description 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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spelling pubmed-55108812017-08-07 A leprosy clinical severity scale for erythema nodosum leprosum: An international, multicentre validation study of the ENLIST ENL Severity Scale 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. PLoS Negl Trop Dis Research Article 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. Public Library of Science 2017-07-03 /pmc/articles/PMC5510881/ /pubmed/28671966 http://dx.doi.org/10.1371/journal.pntd.0005716 Text en © 2017 Walker et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
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.
A leprosy clinical severity scale for erythema nodosum leprosum: An international, multicentre validation study of the ENLIST ENL Severity Scale
title A leprosy clinical severity scale for erythema nodosum leprosum: An international, multicentre validation study of the ENLIST ENL Severity Scale
title_full A leprosy clinical severity scale for erythema nodosum leprosum: An international, multicentre validation study of the ENLIST ENL Severity Scale
title_fullStr A leprosy clinical severity scale for erythema nodosum leprosum: An international, multicentre validation study of the ENLIST ENL Severity Scale
title_full_unstemmed A leprosy clinical severity scale for erythema nodosum leprosum: An international, multicentre validation study of the ENLIST ENL Severity Scale
title_short A leprosy clinical severity scale for erythema nodosum leprosum: An international, multicentre validation study of the ENLIST ENL Severity Scale
title_sort leprosy clinical severity scale for erythema nodosum leprosum: an international, multicentre validation study of the enlist enl severity scale
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5510881/
https://www.ncbi.nlm.nih.gov/pubmed/28671966
http://dx.doi.org/10.1371/journal.pntd.0005716
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