title: The Localized Scleroderma Cutaneous Assessment Tool: responsiveness to change in a pediatric clinical population.
abstract: BACKGROUND
  Lack of agreement on how to accurately capture disease outcomes in localized scleroderma (LS) has hindered the development of efficacious treatment protocols. The LS Cutaneous Assessment Tool (LoSCAT), consisting of the modified LS Skin Severity Index (mLoSSI) and the LS Damage Index, has potential for use in clinical trials.
  
  
  OBJECTIVE
  The goal of this article is to further evaluate the clinical responsiveness of the LoSCAT. Based on the modifiable nature of disease activity versus damage, we expected the mLoSSI to be responsive to change.
  
  
  METHODS
  At 2 study visits, a physician completed the LoSCAT and Physician Global Assessment (PGA) of Disease Activity and of Disease Damage for 29 patients with LS. Spearman correlations were used to examine the relationships between the change in the LoSCAT and the PGA scores. To evaluate contrasted group validity, patients were grouped according to disease activity classification and change scores of groups were compared. Minimal clinically important differences were calculated and compared with the standard error of measurement.
  
  
  RESULTS
  Change in the mLoSSI score correlated strongly with change in the PGA of Disease Activity score, whereas change in the LS Damage Index score correlated weakly with change in the PGA of Disease Damage score. The mLoSSI and PGA of Disease Activity exhibited contrasted group validity. Minimal clinically important differences for the activity measures were greater than the respective standard errors of measurement.
  
  
  CONCLUSIONS
  Only 2 study visits were included in analysis.
  
  
  CONCLUSIONS
  This study gives further evidence that the LoSCAT, specifically the mLoSSI, is a responsive, valid measure of activity in LS and should be used in future treatment studies.
authors.affiliation: Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15224, USA. christina.kelsey@chp.edu
authors.forename: Christina E
authors.initials: CE
authors.lastname: Kelsey
authors.forename: Kathryn S
authors.initials: KS
authors.lastname: Torok
mesh_terms: D000293:Adolescent; D017668:Age of Onset; D001707:Biopsy, Needle; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D018450:Disease Progression; D005260:Female; D006801:Humans; D007150:Immunohistochemistry; D015994:Incidence; D008297:Male; D010372:Pediatrics; D011788:Quality of Life; D015203:Reproducibility of Results; D018570:Risk Assessment; D012594:Scleroderma, Localized / Q000175:diagnosis* / Q000453:epidemiology / Q000523:psychology / Q000628:therapy*; D012720:Severity of Illness Index; D018434:Sickness Impact Profile
keywords: CARRA; CDLQI; Childhood Arthritis and Research Alliance; Children's Dermatology Life Quality Index; ECM; LS; LoSCAT; LoSDI; Localized Scleroderma Cutaneous Assessment Tool; Localized Scleroderma Damage Index; MCID; PGA; PGA-A; PGA-D; Physician Global Assessment; Physician Global Assessment of Disease Activity; Physician Global Assessment of Disease Damage; extracutaneous manifestations; localized scleroderma; mLoSSI; measurement; minimal clinically important difference; modified Localized Scleroderma Skin Severity Index; outcomes; responsiveness to change; validity
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