title: Reliability and convergent validity of the cutaneous sarcoidosis activity and morphology instrument for assessing cutaneous sarcoidosis.
abstract: OBJECTIVE
  A validated scoring system is essential to assess the effect of therapeutic interventions on a disease. The instrument introduced here captures sarcoidosis disease activity in a reliable, reproducible manner, which will help standardize clinical trial outcomes and allow comparative efficacy studies in the future and may help lead to more robust data regarding the effect of different treatments on cutaneous sarcoidosis.
  
  
  OBJECTIVE
  To assess the reliability and convergent validity of the Cutaneous Sarcoidosis Activity and Morphology Instrument (CSAMI) and Sarcoidosis Activity and Severity Index (SASI) for evaluating cutaneous sarcoidosis outcomes.
  
  
  METHODS
  Cross-sectional study evaluating cutaneous sarcoidosis disease severity using CSAMI, SASI, and Physician's Global Assessment (PGA) as reference in the dedicated cutaneous sarcoidosis clinic of a teaching hospital.
  
  
  METHODS
  Eight dermatologists evaluating cutaneous sarcoidosis in 11 patients.
  
  
  METHODS
  Evaluation using the study instruments.
  
  
  METHODS
  Primary outcomes included interrater and intrarater reliability and convergent validity; secondary outcomes, correlation with quality-of-life measures and time required for completion.
  
  
  RESULTS
  All instruments demonstrated good to excellent intrarater reliability. Interrater reliability was excellent for CSAMI Activity scores (intraclass correlation coefficient, 0.82 [95% CI, 0.66-0.94]) and fair to poor for CSAMI Damage scores (0.42 [0.21-0.72]), modified Facial SASI (0.40 [0.17-0.72]), and PGA scores (0.40 [0.18-0.70]). CSAMI Activity and Damage scores and modified Facial SASI all demonstrated convergent validity with statistically significant correlations with PGA scores. Trends for correlations were seen between CSAMI scores and specific Skindex-29 quality-of-life domains. Although CSAMI required longer time to complete than SASI, both were scored within adequate time for use in clinical trials.
  
  
  CONCLUSIONS
  CSAMI appears to be a reliable and valid outcome instrument to measure cutaneous sarcoidosis and may capture a wide range of body surface and cutaneous morphologic types. This instrument can be adopted into clinical practice and clinical trials to allow physicians to assess the intensity of their patients' cutaneous sarcoidosis disease activity. Widespread use of one metric for disease severity assessment can help standardize the evaluation of the effect of various treatments on the disease. Future research is necessary to demonstrate its sensitivity to change and to confirm its correlation with quality-of-life measures.
authors.affiliation: Department of Dermatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
authors.forename: Misha
authors.initials: M
authors.lastname: Rosenbach
authors.affiliation: Department of Dermatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
authors.forename: Howa
authors.initials: H
authors.lastname: Yeung
authors.affiliation: Department of Dermatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
authors.forename: Emily Y
authors.initials: EY
authors.lastname: Chu
authors.affiliation: Department of Dermatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
authors.forename: Ellen J
authors.initials: EJ
authors.lastname: Kim
authors.affiliation: Department of Dermatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
authors.forename: Aimee S
authors.initials: AS
authors.lastname: Payne
authors.affiliation: Department of Dermatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
authors.forename: Junko
authors.initials: J
authors.lastname: Takeshita
authors.affiliation: Department of Dermatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
authors.forename: Carmela C
authors.initials: CC
authors.lastname: Vittorio
authors.affiliation: Department of Dermatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
authors.forename: Karolyn A
authors.initials: KA
authors.lastname: Wanat
authors.affiliation: Department of Dermatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
authors.forename: Victoria P
authors.initials: VP
authors.lastname: Werth
authors.affiliation: Department of Dermatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.|Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
authors.forename: Joel M
authors.initials: JM
authors.lastname: Gelfand
mesh_terms: D000328:Adult; D016001:Confidence Intervals; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015588:Observer Variation; D011788:Quality of Life; D015203:Reproducibility of Results; D012507:Sarcoidosis / Q000473:pathology*; D012720:Severity of Illness Index; D012871:Skin Diseases / Q000473:pathology*; D011795:Surveys and Questionnaires