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

Abstract

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 Clinician-Reported Outcome (ClinRO) and Patient-Reported Outcome (PRO) Measures for Eyebrow, Eyelash and Nail Assessment in Alopecia Areata

“…The ClinRO Measure for Eyebrow Hair Loss™, ClinRO Measure of Eyelash Hair Loss™, ClinRO Measure for Nail Appearance™, PRO Measure for Eyebrows™, PRO Measure for Eyelashes™, PRO Measure for Nail Appearance™ and PRO Measure for Eye Irritation™ and accompanying photoguides were developed to provide content-valid, clinically meaningful measures that reflect patients' and dermatologists' perspectives of AA. In conjunction with the Alopecia Areata Investigator Global Assessment™ (AA-IGA™) [11] and Scalp Hair Assessment PRO™ [12] for scalp hair loss, these measures provide a comprehensive suite of assessments for key AA signs/symptoms.…”

“…Fit-for-purpose clinical outcome assessments (COAs) are required to evaluate the efficacy of treatment on these key non-scalp signs/symptoms in AA clinical trials and to complement clinician and patient assessments of scalp hair loss [11,12]. However, to our knowledge, no publicly available outcome measures to evaluate eyebrow hair loss, eyelash hair loss and nail damage have been developed in conjunction with industry guidelines [13].…”

“‘You lose your hair, what’s the big deal?’ I was so embarrassed, I was so self-conscious, I was so depressed:” a qualitative interview study to understand the psychosocial burden of alopecia areata

“…In addition, a comprehensive suite of content-valid clinical outcome assessments of the key physical effects of AA were developed as part of this study. Development of an investigator global assessment [43] and PRO measure [27] for scalp hair loss, along with ClinRO and PRO measures for eyebrow loss, eyelash loss, nail appearance and eye irritation [28] are reported elsewhere.…”

“…This qualitative study was designed to elicit the patient experience of AA and to develop and cognitively test PRO measures for key physical AA signs/symptoms (results of this latter objective are reported elsewhere [27,28]). The study protocol was reviewed and approved by Western Institutional Review Board (ref #20171820).…”

“…During the Round 2 interviews, experience of AA was explored with open-ended questions but probed in less detail. Questions to cognitively test several PRO measures were also included in both rounds; these findings are reported elsewhere [27,28].…”