QUALITATIVE AND PSYCHOMETRIC EVALUATION OF THE CLINRO MEASURE FOR EYEBROW HAIR LOSS AND CLINRO MEASURE FOR EYELASH HAIR LOSS IN ADULTS AND ADOLESCENTS WITH SEVERE ALOPECIA AREATA
Author(s)
Arash Mostaghimi, MD1, Ahmed M. Soliman, MS, PhD2, James Twiss, PhD3, Shanshan Qin, PhD4, Matt Ridley, PhD5, Amy L. Fearnhead, MSc3, Henrique Teixeira, MD6, Elektra Papadopoulos, MPH, MD7, Leila Asfour, MD8, Thierry Passeron, MD, PhD9;
1Brigham & Women's Hospital, Boston, MA, USA, 2AbbVie Inc., Vernon Hills, IL, USA, 3RTI- Health Solutions, Manchester, United Kingdom, 4RTI- Health Solutions, Director, Psychometrics, Patient-Centered Outcomes Assessme, Research Triangle Park, NC, USA, 5RTI Health Solutions, Manchester, United Kingdom, 6AbbVie Inc., North Chicago, IL, USA, 7AbbVie, Gaithersburg, MD, USA, 8Chelsea and Westminster NHS Foundation Trust, London, United Kingdom, 9University Côte d’Azur; University Hospital of Nice, Nice, France
1Brigham & Women's Hospital, Boston, MA, USA, 2AbbVie Inc., Vernon Hills, IL, USA, 3RTI- Health Solutions, Manchester, United Kingdom, 4RTI- Health Solutions, Director, Psychometrics, Patient-Centered Outcomes Assessme, Research Triangle Park, NC, USA, 5RTI Health Solutions, Manchester, United Kingdom, 6AbbVie Inc., North Chicago, IL, USA, 7AbbVie, Gaithersburg, MD, USA, 8Chelsea and Westminster NHS Foundation Trust, London, United Kingdom, 9University Côte d’Azur; University Hospital of Nice, Nice, France
OBJECTIVES: The Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss and ClinRO Measure for Eyelash Hair Loss evaluate the extent of eyebrow and eyelash hair loss in patients with Alopecia Areata (AA). The study objectives were to evaluate the content validity of the two ClinROs and to assess their psychometric properties.
METHODS: Cross-sectional, semistructured, individual cognitive debriefing interviews were conducted with clinicians with experience treating adult and adolescent patients with AA to evaluate content validity of the ClinROs. Psychometric analyses used baseline to Week 24 data from a phase 3 upadacitinib trial in adult and adolescent patients with severe AA (NCT06012240; Up‑AA) to evaluate reliability, construct validity, and responsiveness of the measures.
RESULTS: Qualitative feedback from clinicians (n=12) indicated that both ClinROs were appropriate, easy to use, and had suitable response options. The psychometric analysis data sample comprised 1,399 patients (n=1,281 adults; n=118 adolescents; 59% female; median age 35 years). Test-retest reliability weighted kappa coefficients between Weeks 8 and 12 for the overall sample (ClinRO for Eyebrow Hair Loss = 0.90; ClinRO for Eyelash Hair Loss = 0.91) and intra-rater reliability weighted kappa coefficients among clinicians who rated at least 10 identical adult participants (both ClinROs = 0.97) were adequate. Moderate baseline and Week 24 correlations (0.30≤|r|<0.70) were mostly observed with other clinician-reported and patient-reported outcome measures for AA. Both ClinROs distinguished significantly between groups according to Physician Global Impression of Severity of AA (PhGIS-AA) in adults and adolescents at baseline and Week 24 (P<0.01), and ClinRO change scores significantly distinguished between PhGIS-AA response groups (improved/no change/worsened) from baseline to Week 24 in both age groups (P<0.01).
CONCLUSIONS: The results support the ClinROs as reliable, valid, and responsive measures of eyebrow and eyelash hair loss for use in clinical trials of adults and adolescents with severe AA.
METHODS: Cross-sectional, semistructured, individual cognitive debriefing interviews were conducted with clinicians with experience treating adult and adolescent patients with AA to evaluate content validity of the ClinROs. Psychometric analyses used baseline to Week 24 data from a phase 3 upadacitinib trial in adult and adolescent patients with severe AA (NCT06012240; Up‑AA) to evaluate reliability, construct validity, and responsiveness of the measures.
RESULTS: Qualitative feedback from clinicians (n=12) indicated that both ClinROs were appropriate, easy to use, and had suitable response options. The psychometric analysis data sample comprised 1,399 patients (n=1,281 adults; n=118 adolescents; 59% female; median age 35 years). Test-retest reliability weighted kappa coefficients between Weeks 8 and 12 for the overall sample (ClinRO for Eyebrow Hair Loss = 0.90; ClinRO for Eyelash Hair Loss = 0.91) and intra-rater reliability weighted kappa coefficients among clinicians who rated at least 10 identical adult participants (both ClinROs = 0.97) were adequate. Moderate baseline and Week 24 correlations (0.30≤|r|<0.70) were mostly observed with other clinician-reported and patient-reported outcome measures for AA. Both ClinROs distinguished significantly between groups according to Physician Global Impression of Severity of AA (PhGIS-AA) in adults and adolescents at baseline and Week 24 (P<0.01), and ClinRO change scores significantly distinguished between PhGIS-AA response groups (improved/no change/worsened) from baseline to Week 24 in both age groups (P<0.01).
CONCLUSIONS: The results support the ClinROs as reliable, valid, and responsive measures of eyebrow and eyelash hair loss for use in clinical trials of adults and adolescents with severe AA.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
PCR108
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
SDC: Sensory System Disorders (Ear, Eye, Dental, Skin)