C J Kushner1,2, M Tarazi1,2, R G Gaffney1,2, R Feng3, K Ardalan4, H A Brandling-Bennett5, L Castelo-Soccio6, J C Chang7, Y E Chiu8, S Gmuca7, R D Hunt9, P J Kahn10, A M Knight7, J Mehta7, D R Pearson1,2, J R Treat6, J Wan6, A C Yeguez1, J S S Concha1,2, B Patel1,2, J Okawa1,2, L M Arkin11, V P Werth1,2. 1. Department of Dermatology, University of Pennsylvania, Perelman Center for Advanced Medicine, Suite 1-330A, 3400 Civic Center Boulevard, Philadelphia, PA, 19104, U.S.A. 2. Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, U.S.A. 3. Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania, Philadelphia, PA, U.S.A. 4. Department of Pediatrics and Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, U.S.A. 5. Department of Pediatrics and Dermatology, University of Washington School of Medicine, Seattle, WA, U.S.A. 6. Section of Dermatology, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, U.S.A. 7. Division of Rheumatology, Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, U.S.A. 8. Departments of Dermatology and Pediatrics, Medical College of Wisconsin, Milwaukee, WI, U.S.A. 9. Departments of Dermatology and Pediatrics, Baylor College of Medicine, Houston, TX, U.S.A. 10. Department of Pediatrics, Division of Rheumatology, NYU Langone Medical Center, New York, NY, U.S.A. 11. Departments of Dermatology and Pediatrics, University of Wisconsin School of Medicine, Madison, WI, U.S.A.
Abstract
BACKGROUND: The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a reliable outcome measure for cutaneous lupus erythematosus (CLE) in adults used in clinical trials. However, it has not been validated in children, limiting clinical trials for paediatric CLE. OBJECTIVES: This study aimed to validate the CLASI in paediatrics. METHODS: Eleven paediatric patients with CLE, six dermatologists and six rheumatologists participated. The physicians were trained to use the CLASI and Physician's Global Assessment (PGA), and individually rated all patients using both tools. Each physician reassessed two randomly selected patients. Within each physician group, the intraclass correlation coefficient (ICC) was calculated to assess the reliability of each measure. RESULTS: CLASI activity scores demonstrated excellent inter- and intrarater reliability (ICC > 0·90), while the PGA activity scores had good inter-rater reliability (ICC 0·73-0·77) among both specialties. PGA activity scores showed excellent (ICC 0·89) and good intrarater reliability (ICC 0·76) for dermatologists and rheumatologists, respectively. Limitations of this study include the small sample size of patients and potential recall bias during the physician rerating session. CONCLUSIONS: CLASI activity measurement showed excellent inter- and intrarater reliability in paediatric CLE and superiority over the PGA. These results demonstrate that the CLASI is a reliable and valid outcome instrument for paediatric CLE.
BACKGROUND: The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a reliable outcome measure for cutaneous lupus erythematosus (CLE) in adults used in clinical trials. However, it has not been validated in children, limiting clinical trials for paediatric CLE. OBJECTIVES: This study aimed to validate the CLASI in paediatrics. METHODS: Eleven paediatric patients with CLE, six dermatologists and six rheumatologists participated. The physicians were trained to use the CLASI and Physician's Global Assessment (PGA), and individually rated all patients using both tools. Each physician reassessed two randomly selected patients. Within each physician group, the intraclass correlation coefficient (ICC) was calculated to assess the reliability of each measure. RESULTS: CLASI activity scores demonstrated excellent inter- and intrarater reliability (ICC > 0·90), while the PGA activity scores had good inter-rater reliability (ICC 0·73-0·77) among both specialties. PGA activity scores showed excellent (ICC 0·89) and good intrarater reliability (ICC 0·76) for dermatologists and rheumatologists, respectively. Limitations of this study include the small sample size of patients and potential recall bias during the physician rerating session. CONCLUSIONS: CLASI activity measurement showed excellent inter- and intrarater reliability in paediatric CLE and superiority over the PGA. These results demonstrate that the CLASI is a reliable and valid outcome instrument for paediatric CLE.
Authors: Josef Symon S Concha; Aikaterini Patsatsi; Ann Marshak-Rothstein; Ming-Lin Liu; Animesh A Sinha; Lela A Lee; Joseph F Merola; Ali Jabbari; Johann E Gudjonsson; François Chasset; Paul Jarrett; Benjamin Chong; Lisa Arkin; Anthony P Fernandez; Marzia Caproni; Steven A Greenberg; Hee Joo Kim; David R Pearson; Alisa Femia; Ruth Ann Vleugels; David Fiorentino; Manabu Fujimoto; Joerg Wenzel; Victoria P Werth Journal: J Invest Dermatol Date: 2018-09-19 Impact factor: 8.551
Authors: Srita Chakka; Rebecca L Krain; Josef Symon S Concha; Benjamin F Chong; Joseph F Merola; Victoria P Werth Journal: Ann Transl Med Date: 2021-03