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Development of the Scalp Hair Assessment PRO™ measure for alopecia areata
Author(s) -
Wyrwich K.W.,
Kitchen H.,
Knight S.,
Aldhouse N.V.J.,
Macey J.,
Nunes F.P.,
Dutronc Y.,
Mesinkovska N.,
Ko J.M.,
King B.A.
Publication year - 2020
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/bjd.19024
Subject(s) - alopecia areata , scalp , hair loss , dermatology , cabello , medicine , alopecia universalis
Summary Background Valid patient‐reported outcome ( PRO ) measures are required to evaluate alopecia areata ( AA ) treatments. Objectives To develop a content‐valid and clinically meaningful PRO measure to assess AA scalp hair loss with scores comparable with the five‐response‐level Alopecia Areata Investigator Global Assessment ( AA ‐ IGA ™). Methods A draft PRO measure was developed based on input from 10 clinical experts in AA . The PRO measure was cognitively debriefed, modified and finalized through two rounds of qualitative semistructured interviews with patients with AA who had experienced ≥ 50% scalp hair loss. Data were thematically analysed. Results Adults (round 1: n = 25; round 2: n = 15) and adolescents aged 15–17 years (round 1: n = 5) in North America participated. All patients named scalp hair loss as a key AA sign or symptom. Patients demonstrated the ability to self‐report their current amount of scalp hair using percentages. In round 1 not all patients interpreted the measurement concept consistently; therefore, the PRO was modified to clarify the measurement concept to improve usability. Following modifications, patients in round 2 responded without difficulty to the PRO measure. Patients confirmed that they could use the five‐level response scale to rate their scalp hair loss: no missing hair, 0%; limited, 1–20%; moderate, 21–49%; large, 50–94%; nearly all or all, 95–100%. Almost all patients deemed hair regrowth resulting in ≤ 20% scalp hair loss a treatment success. Conclusions The Scalp Hair Assessment PRO ™ is a content‐valid, clinically meaningful assessment of distinct gradations of scalp hair loss for evaluating AA treatment for patients with ≥ 50% hair loss at baseline.