Patient-Reported Outcome (PRO): Eyebrow and Eyelash
DESCRIPTION:
Patient-reported outcome (PRO) measures examining eyebrow and eyelash involvement are validated, easy-to-use, single-item instruments that help evaluate two important manifestations of alopecia areata that place a unique psychological burden on patients. Patients report their own perception of hair loss across their eyebrows and eyelashes using a 4-point Likert-type scale that aligns with the clinician-reported outcome (ClinRO) measures for eyebrows and eyelashes.1
DISEASE STATES:
Alopecia areata
VALIDATED USES:
Treatment monitoring
ADMINISTRATION METHOD:
Patient
COMMONLY USED IN:
Clinical trials
DETAILED DESCRIPTION:
The FDA requires fit-for-purpose clinical outcome assessments (COAs) that evaluate the efficacy of key non-scalp signs/symptoms to complement scalp hair loss assessments in alopecia areata (AA) clinical trials. The PRO measure was developed in conjunction with the ClinRO tool for eyebrow and eyelash involvement in AA. Thus, the eyebrow and eyelash PRO tool is designed to complement the ClinRO tool in AA clinical trials.1
Photo guides may accompany the PRO tool, helping aid in patient training and standardize severity ratings. Patients are shown images representing severity levels of hair loss across both the eyebrow and eyelash domains. The PRO measure works by having patients look at their eyebrows or eyelashes (both upper and lower, both eyes) and rate their current appearance on a 4-point Likert-type scale (0–3). Patients rate their eyebrows based on the most bothersome type of hair loss for them. Unlike a PRO for scalp hair loss, ratings are not percentage based. Three is the highest rating for either eyebrow or eyelash.1
In a clinical study examining the concordance between ClinRO and PRO treatment outcomes for eyebrow and eyelash hair loss, measurements occurred at Weeks 36 and 52 and were compared with baseline measures.2
PRO MEASURE FOR EYEBROWS™ AND CLINRO MEASURE FOR EYEBROW HAIR LOSS™
| Rating | PRO* Assessment (one choice) |
|---|---|
| 0 | I have full eyebrows on each eye |
| 1 | I have a minimal gap(s) or a minimal amount of thinning in at least one of my eyebrows |
| 2 | I have a large gap(s) or a large amount of thinning in at least one of my eyebrows |
| 3 | I have no or barely any eyebrow hairs |
| Rating | ClinRO† Assessment (one choice) |
|---|---|
| 0 | The eyebrows have full coverage and no areas of hair loss |
| 1 | There are minimal gaps in eyebrow hair and distribution is even |
| 2 | There are significant gaps in eyebrow hair or distribution is not even |
| 3 | No notable eyebrow hair |
*Patients rate their eyebrows on the day of the self-assessment. †Clinicians must examine both eyebrows from 2 feet away.
PRO MEASURE FOR EYELASHES™ AND CLINRO MEASURE FOR EYELASH HAIR LOSS™
| Rating | PRO* Assessment (one choice) |
|---|---|
| 0 | I have full eyelashes on each eyelid |
| 1 | I have a minimal gap or minimal gaps along the eyelids |
| 2 | I have a large gap or large gaps along the eyelids |
| 3 | I have no or barely any eyelash hair |
| Rating | ClinRO† Assessment (one choice) |
|---|---|
| 0 | The eyelashes form a continuous line along the eyelids on both eyes |
| 1 | There are minimal gaps and the eyelashes are evenly spaced along the eyelids on both eyes |
| 2 | There are significant gaps or the eyelashes are not evenly spaced along the eyelids |
| 3 | No notable eyelashes |
‡Examine upper and lower eyelashes of both eyes.
VALIDITY:
Content validity was established through multiple rounds of qualitative concept elicitation, cognitive debriefing and iterative revisions. Optional photo guides were shown to improve consistency and patients’ interpretation of severity.1 In a clinical trial, the concordance between ClinRO and PRO measures for eyebrow and eyelash hair loss demonstrated positive correlations Spearman’s rank correlation coefficients (0.83 to 0.87) and high concordance rates.2
LIMITATIONS:
The original study was conducted in North American populations and may not be generalized to other cultures, countries, and skin types. It was designed for clinical trials in severe AA populations and may not apply to milder forms of AA or for use in clinical practice.1 Subjectivity may be introduced, concordance rates were lower for intermediate scores (1–2).2 There is insufficient evidence to support the reliability of these ClinRO measures.
This resource is intended for educational purposes only and is intended for US healthcare professionals. Healthcare professionals should use independent medical judgment. All decisions regarding patient care must be handled by a healthcare professional and be made based on the unique needs of each patient.
References: 1. Wyrwich KW, Kitchen H, Knight S, et al. Development of Clinician-Reported Outcome (ClinRO) and Patient-Reported Outcome (PRO) measures for eyebrow, eyelash and nail assessment in alopecia areata. Am J Clin Dermatol. 2020;21(5):725-732. doi:10.1007/s40257-020-00545-9 2. Mostaghimi A, Ko J, Tosti A, et al. Concordance between clinician-reported and patient-reported outcomes of eyebrow and eyelash hair loss in patients with severe alopecia areata: Results from BRAVE-AA1 and BRAVE-AA2 studies. J Am Acad Dermatol. 2024;91(4):729-732. doi:10.1016/j.jaad.2024.05.077
Explore more clinical tools to improve dermatologic care for your patients.