Development and Content Validation of Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) in Adolescents and Adults with Moderate-to-Severe AD - PubMed (original) (raw)

. 2021 Feb;11(1):221-233.

doi: 10.1007/s13555-020-00474-9. Epub 2021 Feb 3.

Mark G Lebwohl 2, Andrew G Bushmakin 3, Eric L Simpson 4, Melinda J Gooderham 5 6, Andreas Wollenberg 7, Adam Gater 8, Jane R Wells 8, Joseph C Cappelleri 9, Ming-Ann Hsu 10, Jocelyn Papacharalambous 11, Elena Peeva 12, Anna M Tallman 11, Weidong Zhang 13, Linda Chen 11

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Development and Content Validation of Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) in Adolescents and Adults with Moderate-to-Severe AD

Rebecca Hall et al. Dermatol Ther (Heidelb). 2021 Feb.

Erratum in

Abstract

Introduction: Most patient-reported outcome (PRO) instruments that measure atopic dermatitis (AD) symptoms do not have sufficient documented evidence of content validity to satisfy regulatory agency guidance for inclusion in product-labelling claims in the USA or Europe. The objective of this study was to develop a PRO instrument in accordance with regulatory agency guidance to assess daily AD symptoms during the course of therapy and to establish its content validity and psychometric properties.

Methods: The Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) daily diary was developed based on qualitative interviews with US adolescents and adults with mild-to-severe AD. Content validity, test-retest reliability, internal consistency reliability, clinically important difference, clinically important responder, convergent validity, and known-group validity were evaluated using correlational and regression methods from phase 2b data from US adults with moderate-to-severe AD who were treated with abrocitinib.

Results: Patient interviews conducted with US adolescents and adults with mild-to-severe AD identified 11 relevant symptoms (itch, dryness, redness, flaking, discolouration, pain, bleeding, cracking, bumps, swelling, and weeping/oozing) for inclusion in the PSAAD instrument. All PSAAD psychometric parameters were acceptable based on phase 2b data from US adults with moderate-to-severe AD. Convergent validity and known-group validity were confirmed by significant correlations between PSAAD and six other PRO measures (r = 0.24-0.91, all p ≤ 0.01) and Dermatology Life Quality Index category (p ≤ 0.0001), respectively.

Conclusions: Evidence supports the PSAAD instrument validity, reliability, responsiveness and definitions of clinically important changes/differences for adults with moderate-to-severe AD.

Keywords: Atopic dermatitis; Daily diary; Eczema; Patient-reported outcomes; Pruritus.

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Figures

Fig. 1

Fig. 1

Summary of concept elicitation and conceptual saturation results for atopic dermatitis symptoms. The number of spontaneous (blue) and probed (orange) reports of each symptom are displayed along with the group of concept elicitation transcripts with which each symptom was spontaneously mentioned (checkmarks) to assess conceptual saturation. Note: Interviews were divided into three equally sized groups (group 1, group 2, group 3)

Fig. 2

Fig. 2

PSAAD diary conceptual framework. AD atopic dermatitis, PSAAD Pruritus and Symptoms Assessment for Atopic Dermatitis

Fig. 3

Fig. 3

Relationship between a PSAAD total score and PGIS, b PSAAD total score and POEM total score and c change from baseline in PSAAD total score and PGIC. PGIC patient global impression of change, PGIS patient global impression of severity, POEM Patient-Oriented Eczema Measure, PSAAD Pruritus and Symptoms Assessment for Atopic Dermatitis

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