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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.

Development of the Scalp Hair Assessment PRO™ measure for alopecia areata