The Static Physician’s Global Assessment of Genitalia: A Clinical Outcome Measure for the Severity of Genital Psoriasis
August 2017 | Volume 16 | Issue 8 | Original Article | 793 | Copyright © August 2017
Joseph F. Merola MD MMSc,a Alison Potts Bleakman PhD,b Alice B. Gottlieb MD PhD,c Alan Menter MD,d April N. Naegeli PhD,b Robert Bissonnette MD MS FAAD FRCPC,e Lyn Guenther MD FRCPC,f John Sullivan MBBS MS,g Kim Meeuwis MD PhD,h Kyoungah See PhD,b and Kristina Callis Duffin MD MSi
aDepartment of Dermatology and Medicine, Division of Rheumatology, Harvard Medical School, Brigham and Women’s Hospital, Boston, MA, USA bEli Lilly and Company, Indianapolis, IN, USA cDepartment of Dermatology, New York Medical College at Metropolitan Hospital, New York, NY, USA dDepartment of Dermatology, Baylor University Medical Center, Dallas, TX, USA eInnovaderm Research, Montreal, QC, Canada fThe Guenther Dermatology Research Centre, London, ON, Canada gDepartment of Medicine, UNSW, Sydney, New South Wales, Australia hDepartment of Dermatology, Radboud University Medical Center, Nijmegen, The Netherlands iDepartment of Dermatology, University of Utah, Salt Lake City, UT, USA
Introduction: Genital psoriasis is a common but frequently overlooked manifestation of psoriasis with a considerable impact on patients’ quality of life. Currently no validated clinical trial outcome measures exist to assess genital psoriasis severity that meet regulatory agency requirements.
Methods: This study describes the development of the static Physician’s Global Assessment of Genitalia (sPGA-G) scale, a clinical outcome measure for the assessment of genital psoriasis severity that accounts for the erythematous clinical presentation of genital psoriasis. The reliability of the sPGA-G was evaluated using scores collected from clinician assessments of photographs of genital psoriasis cases. Scores were collected from 10 academic and clinical experts in genital psoriasis and 95 clinician assessors who participated in either in-person (n=28) or online (n=67) sPGA-G training modules.
Results: The sPGA-G had a high inter-rater reliability (IRR, measured by Kendall’s W) for expert raters (W=0.856, P less than 0.0001), in-person assessors (W=0.822, P less than 0.0001), and online assessors (W=0.678, P less than 0.0001). IRR was also high for all clinical assessors combined, (W=0.714, P less than 0.0001).
Discussion: This study demonstrates that the sPGA-G is an intuitive and reliable clinical outcome measure that specifically measures the severity of genital psoriasis.
J Drugs Dermatol. 2017;16(8):793-799.
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