1. A leprosy clinical severity scale for erythema nodosum leprosum: An international, multicentre validation study of the ENLIST ENL Severity Scale
- Author
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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 AC, 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 NJ, and Erythema Nodosum Leprosum International STudy Group
- Subjects
Bacterial Diseases ,Male ,Medical Doctors ,Health Care Providers ,Pathology and Laboratory Medicine ,Severity of Illness Index ,Geographical Locations ,030207 dermatology & venereal diseases ,0302 clinical medicine ,Erythema Nodosum ,Medicine and Health Sciences ,Young adult ,Immune Response ,Musculoskeletal System ,health care economics and organizations ,Bangladesh ,lcsh:Public aspects of medicine ,Middle Aged ,Leprosy, Lepromatous ,Erythema nodosum leprosum ,Professions ,Infectious Diseases ,Scale (social sciences) ,Female ,Leprosy ,Anatomy ,Research Article ,Neglected Tropical Diseases ,Adult ,medicine.medical_specialty ,lcsh:Arctic medicine. Tropical medicine ,Asia ,lcsh:RC955-962 ,030231 tropical medicine ,Immunology ,MEDLINE ,India ,macromolecular substances ,Dermatology ,03 medical and health sciences ,Young Adult ,Signs and Symptoms ,Cronbach's alpha ,Diagnostic Medicine ,Physicians ,Severity of illness ,medicine ,Humans ,Inflammation ,Receiver operating characteristic ,business.industry ,Public Health, Environmental and Occupational Health ,Biology and Life Sciences ,lcsh:RA1-1270 ,medicine.disease ,Tropical Diseases ,Health Care ,Joints (Anatomy) ,Erythema ,People and Places ,Physical therapy ,Lesions ,Population Groupings ,business - Abstract
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., Author summary Erythema nodosum leprosum (ENL) is a severe, painful complication of leprosy, which can occur before, during or after successful treatment of the infection. ENL is characterised by severe pain and the development of new painful skin lesions. Other organ systems are often affected. ENL may continue to affect people for many years leading to disability, significant loss of income and sometimes death. ENL often requires prolonged treatment with corticosteroids, thalidomide or other drugs that modulate the immune system. Thalidomide is the most effective treatment but is not widely available or affordable in many leprosy endemic settings. This results in many people taking high doses of corticosteroids for prolonged periods and being at risk of severe adverse effects. In order to assess the efficacy of different treatments for ENL it is important to be able to compare individuals before and after treatment. This is difficult to do in a complex, multi-system disorder such as ENL. To overcome this problem we have developed a scale, which is easy to use, to measure the severity of ENL. In this article, we describe the validation of this scale, which ensures that it is a useful measure of ENL severity.
- Published
- 2017