Table 2.
Clinicians’ and patients’ definitions of treatment success for clinician-reported and patient-reported outcome measures for alopecia areata in Japan
| Clinician definition of treatment successa | Patient definition of treatment successc |
|---|---|
| AA-IGA™ | |
|
0—None (no missing hair) 1—Limited (1–20% missing hair) (n = 5/6) 2—Moderate (21–49% missing hair) (n = 1/6) |
0—None (no missing hair) 1—Limited (1–20% missing hair) (n = 15/15) |
| Scalp Hair Assessment PRO™ | |
| – |
0—No missing hair (0% missing hair; I have a full head of hair) 1—A limited area (1–20% missing hair) (n = 11/15) 2—A moderate area (21–49% missing hair) (n = 4/15) |
| ClinRO Measure for Eyebrow Hair Loss™ | |
|
0—Full coverage and no areas of hair loss (n = 1/5) 1—Minimal gaps in eyebrow hair and distribution is even (n = 4/5) |
0—Full coverage and no areas of hair loss (n = 3/15) 1—Minimal gaps in eyebrow hair and distribution is even (n = 12/15) |
| PRO Measure for Eyebrows™ | |
| – |
0—Full eyebrows on each eye (n = 3/9) 1—Minimal gap(s) or a minimal amount of thinning (n = 6/9) |
| ClinRO Measure for Eyelash Hair Loss™ | |
|
0—Eyelashes form a continuous line (n = 2/5) 1—Minimal gaps and the eyelashes are evenly spaced (n = 3/5) |
0—Eyelashes form a continuous line (n = 4/15) 1—Minimal gaps and the eyelashes are evenly spaced (n = 9/15) 2—Significant gaps or the eyelashes are not evenly spaced (n = 2/15) |
| PRO Measures for Eyelashes™ | |
| – |
0—Full eyelashes on each eyelid (n = 2/9) 1—Minimal gap or minimal gaps along the eyelids (n = 6/9) 2—Large gap or large gaps along the eyelids (n = 1/9) |
| ClinRO Measure for Nail Appearance™ | |
|
0—Nails are not at all damaged (n = 3/6)b 1—At least one nail is a little damaged (n = 3/6)b |
0—Nails are not at all damaged (n = 4/15) 1—At least one nail is a little damaged (n = 9/15) 2—At least one nail is moderately damaged (n = 2/15) |
| PRO Measure for Nail Appearance™ | |
| – |
0—Nails are not at all damaged 1—At least one nail is a little damaged (n = 6/6) |
| PRO Measure for Eye Irritation™ | |
| – |
0—My eyes have not been irritated (n = 2/4) 1—My eyes have been a little irritated (n = 2/4) |
The AA-IGA™/Scalp Hair Assessment PRO™ comprises five severity categories: 0—none/no scalp hair missing (0% missing hair) to 4—very severe/nearly all or all scalp hair missing (95–100% missing hair). ClinRO and PRO eyebrow, eyelash, eye irritation, and nail measures comprise four severity categories: 0—normal presentation of eyebrows/eyelashes/nails or no eye irritation to 3—no or barely any eyebrows/eyelashes, very damaged nails, or severe eye irritation. Clinicians and patients were asked to define treatment success considering 9 months of treatment
AA-IGA™ Alopecia Areata-Investigator Global Assessment, ClinRO clinician-reported outcome, PRO patient-reported outcome
aClinicians were only asked about their definition of treatment success of the ClinRO measures, and not all clinicians were asked (n = 5–6) because of interview time constraints. For the AA-IGA™, clinicians defined clinically meaningful change from category 3—severe (50–94% missing hair) on the AA-IGA™. For the ClinRO Measure for Eyebrow Hair Loss™, Eyelash Hair Loss™ and Nail Appearance™, clinicians were asked which category would indicate treatment success
bTwo of the six clinicians did not assess severity of nail damage in clinical practice
cFor the PRO measures, patients reported meaningful change from their current category. Only patients who rated themselves as having at least “1” on the PRO Measures for Eyebrows™, Eyelashes™, Eye Irritation™, and/or Nail Appearance™, indicating some level of AA involvement in these locations, were asked about treatment success. For the ClinRO measures, patients were asked which category they would need to be rated as by their doctor