In addition to scalp hair loss, brow and eyelash hair loss, and nail damage are key signs/symptoms of alopecia areata (AA) to patients and should be evaluated in AA clinical studies. The goal of this study was to create clinician-reported outcome (ClinRO) and patient-reported outcome (PRO) assessments, as well as supporting photoguides, to help in the assessment of AA-related eyebrow, eyelash, and nail signs/symptoms. Patients with brow, eyelash and nail involvement were sampled on purpose. The transcripts of the interviews were examined qualitatively. Dermatologists identified brow and eyelash loss as alarming for afflicted individuals and, along with nail appearance, as worthy of evaluation. Dermatologist data was used to construct single-item, 4-point Likert-type ClinRO and PRO measures of current eyebrow loss, eyelash loss, and nail appearance, as well as a PRO measure of eye discomfort. These signs/symptoms were confirmed as important and relevant by patients. The interim modification resulted in measurements that patients understood and found meaningful. Dermatologists and patients collaborated on the development of the brow, eyelash, and nail photoguides, and it was validated that they featured images that accurately depicted different severity levels and were useful in generating and standardizing ratings among raters.
The ClinRO and PRO measures for brow, eyelash, and nail appearance, as well as their supporting photoguides, and the PRO Measure for Eye Irritation, give clear and relevant assessments of outcomes essential to AA patients.