TY - JOUR
T1 - Validation of five patient-reported outcomes for atopic dermatitis severity in adults
AU - Silverberg, J. I.
AU - Margolis, D. J.
AU - Boguniewicz, M.
AU - Fonacier, L.
AU - Grayson, M. H.
AU - Ong, P. Y.
AU - Fuxench, Z. C.
AU - Simpson, E. L.
N1 - Funding Information:
The Atopic Dermatitis in America Study is an independent research project of the Asthma and Allergy Foundation of America in partnership with the National Eczema Association (NEA) and sponsored by Sanofi Genzyme and Regeneron.
Funding Information:
Conflicts of interest. J.I.S. has served as a consultant and/or advisory board member for AbbVie, Asana, Eli Lilly, Galderma, GlaxoSmithKline, Glenmark, Kiniksa, LEO, Menlo, Pfizer, Realm, Regeneron-Sanofi and Roivant, receiving honoraria; has served as a speaker for Regeneron-Sanofi; has received research grants from GlaxoSmithKline and Regeneron-Sanofi; and is supported by the Dermatology Foundation. D.J.M. is the chair of the data monitoring committee for all Sunovion clinical trials of dupilumab; and has received independent research funding to his institution from the National Institute of Health and Valeant. M.B. has received research funding from Anacor and Regeneron and has consulted for Regeneron, Sanofi Genzyme and Pfizer. L.F. has served as a consultant for Regeneron, receiving honoraria; has served as a speaker for Regeneron; and has received research and educational grants from Genentech, Baxter and Pfizer. M.H.G. is a board member of the Asthma and Allergy Foundation of America (AAFA) and chair for the AAFA Medical Scientific Council, and has been on advisory boards for AstraZeneca, Genentech and Novartis. P.Y.O. is a coinvestigator of the Atopic Dermatitis Research Network and has consulted for Pfizer and Theravance. Z.C.F. has served as a consultant for the National Eczema Association and the Asthma and Allergy Foundation, receiving honoraria; receives or has received research grants (to the Trustees of the University of Pennsylvania) from Regeneron, Sanofi, Tioga, Vanda Pharmaceuticals and Realm Therapeutics for work in atopic dermatitis; and has received payment for continuing medical education work related to atopic dermatitis that was supported indirectly by Regeneron and/or Sanofi. E.L.S. has served as a consultant and/or advisory board member for Regeneron-Sanofi.
Publisher Copyright:
© 2019 British Association of Dermatologists
PY - 2020/1/1
Y1 - 2020/1/1
N2 - Background: Structured patient-reported outcomes of atopic dermatitis (AD) severity are not standardized in clinical practice. Objectives: To determine the construct validity, internal consistency, cross-cultural validity and floor or ceiling effects of multiple AD severity assessments. Methods: This is a cross-sectional, population-based study of 2893 adults, including 602 adults who met a modified set of U.K. diagnostic criteria for AD. AD severity was assessed using self-reported global AD severity, Patient-Oriented Eczema Measure (POEM), Patient-Oriented Scoring Atopic Dermatitis (PO-SCORAD) and its objective and subjective components, and numerical rating scale (NRS)-itch. Quality of life was assessed using Short-Form (SF)-12 mental and physical health scores, Short-Form Six Dimensions (SF-6D) health utility scores and Dermatology Life Quality Index (DLQI). Mental health was assessed with the Hospital Anxiety and Depression Scale (HADS). Results: PO-SCORAD, PO-SCORAD objective and subjective subscores, NRS-itch and POEM all had moderate-to-strong correlations with each other and DLQI, fair-to-moderate correlations with HADS-anxiety and HADS-depression, and inverse correlations with SF-12 mental component score and SF-6D (Pearson correlations, P < 0·001). All scores showed good criterion validity as judged by anova and receiver operator characteristics. PO-SCORAD, PO-SCORAD objective subscore and POEM had similarly good internal consistency (Cronbach's alpha = 0·84, 0·82 and 0·86); the PO-SCORAD subjective subscore was less internally consistent (alpha = 0·57). All scores showed potentially poor cross-cultural validity as demonstrated by uniform and nonuniform differential item functioning by age, sex and/or race/ethnicity for multiple items. There were floor effects for POEM, but not for the other assessments. Conclusions: PO-SCORAD, PO-SCORAD objective and subjective subscores, NRS-itch and POEM appear to be valid for assessing AD severity in clinical practice. What's already known about this topic?. Few studies have demonstrated the validity of the atopic dermatitis severity assessments Patient-Oriented Scoring Atopic Dermatitis (PO-SCORAD), PO-SCORAD subscores, numerical rating scale (NRS)-itch and Patient-Oriented Eczema Measure (POEM). What does this study add?. This study demonstrates that PO-SCORAD, PO-SCORAD subscores, NRS-itch and POEM all had good construct validity in the assessment of atopic dermatitis severity in adults. Only POEM demonstrated floor effects. What are the clinical implications of this work?. PO-SCORAD, PO-SCORAD subscores, NRS-itch and POEM all appear to have sufficient validity to be used as assessments of atopic dermatitis severity in clinical practice.
AB - Background: Structured patient-reported outcomes of atopic dermatitis (AD) severity are not standardized in clinical practice. Objectives: To determine the construct validity, internal consistency, cross-cultural validity and floor or ceiling effects of multiple AD severity assessments. Methods: This is a cross-sectional, population-based study of 2893 adults, including 602 adults who met a modified set of U.K. diagnostic criteria for AD. AD severity was assessed using self-reported global AD severity, Patient-Oriented Eczema Measure (POEM), Patient-Oriented Scoring Atopic Dermatitis (PO-SCORAD) and its objective and subjective components, and numerical rating scale (NRS)-itch. Quality of life was assessed using Short-Form (SF)-12 mental and physical health scores, Short-Form Six Dimensions (SF-6D) health utility scores and Dermatology Life Quality Index (DLQI). Mental health was assessed with the Hospital Anxiety and Depression Scale (HADS). Results: PO-SCORAD, PO-SCORAD objective and subjective subscores, NRS-itch and POEM all had moderate-to-strong correlations with each other and DLQI, fair-to-moderate correlations with HADS-anxiety and HADS-depression, and inverse correlations with SF-12 mental component score and SF-6D (Pearson correlations, P < 0·001). All scores showed good criterion validity as judged by anova and receiver operator characteristics. PO-SCORAD, PO-SCORAD objective subscore and POEM had similarly good internal consistency (Cronbach's alpha = 0·84, 0·82 and 0·86); the PO-SCORAD subjective subscore was less internally consistent (alpha = 0·57). All scores showed potentially poor cross-cultural validity as demonstrated by uniform and nonuniform differential item functioning by age, sex and/or race/ethnicity for multiple items. There were floor effects for POEM, but not for the other assessments. Conclusions: PO-SCORAD, PO-SCORAD objective and subjective subscores, NRS-itch and POEM appear to be valid for assessing AD severity in clinical practice. What's already known about this topic?. Few studies have demonstrated the validity of the atopic dermatitis severity assessments Patient-Oriented Scoring Atopic Dermatitis (PO-SCORAD), PO-SCORAD subscores, numerical rating scale (NRS)-itch and Patient-Oriented Eczema Measure (POEM). What does this study add?. This study demonstrates that PO-SCORAD, PO-SCORAD subscores, NRS-itch and POEM all had good construct validity in the assessment of atopic dermatitis severity in adults. Only POEM demonstrated floor effects. What are the clinical implications of this work?. PO-SCORAD, PO-SCORAD subscores, NRS-itch and POEM all appear to have sufficient validity to be used as assessments of atopic dermatitis severity in clinical practice.
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U2 - 10.1111/bjd.18002
DO - 10.1111/bjd.18002
M3 - Article
C2 - 30972740
AN - SCOPUS:85069842976
SN - 0007-0963
VL - 182
SP - 104
EP - 111
JO - British Journal of Dermatology
JF - British Journal of Dermatology
IS - 1
ER -