Development of Clinician-Reported Outcome (ClinRO) and Patient-Reported Outcome (PRO) Measures for Eyebrow, Eyelash and
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ORIGINAL RESEARCH ARTICLE
Development of Clinician‑Reported Outcome (ClinRO) and Patient‑Reported Outcome (PRO) Measures for Eyebrow, Eyelash and Nail Assessment in Alopecia Areata Kathleen W. Wyrwich1 · Helen Kitchen2 · Sarah Knight2 · Natalie V. J. Aldhouse2 · Jake Macey2 · Fabio P. Nunes3 · Yves Dutronc3 · Natasha Mesinkovska4 · Justin M. Ko5 · Brett A. King6 Published online: 17 August 2020 © The Author(s) 2020
Abstract Background Eyebrow and eyelash hair loss and nail damage—in addition to scalp hair loss—are important signs/symptoms of alopecia areata (AA) to patients and deserve assessment in AA clinical trials. Objectives Our objective was to develop clinician-reported outcome (ClinRO) and patient-reported outcome (PRO) measures and accompanying photoguides to aid in the assessment of AA-related eyebrow, eyelash and nail signs/symptoms. Methods Iterative rounds of qualitative, semi-structured interviews were conducted with US expert dermatologists and North American patients with AA. Patients with eyebrow, eyelash and nail involvement were purposefully sampled. Interview transcripts were qualitatively analyzed. Results Dermatologists (n = 10) described eyebrow and eyelash loss as concerning for affected patients and, along with nail appearance, as deserving assessment. Dermatologist data informed the development of single item, 4-point Likert-type ClinRO and PRO measures of current eyebrow loss, eyelash loss and nail appearance and a PRO measure of eye irritation. Patients (n = 45, age 15–72 years) confirmed the importance and relevance of these signs/symptoms. Interim revision resulted in measures that were understood by and relevant to patients. Dermatologists (n = 5) and patients (n = 10, age 21–54 years) participated in the development of the eyebrow, eyelash and nail photoguides and confirmed that they included photos that appropriately represented different severity levels and were helpful to derive and standardize ratings across raters. Conclusions The ClinRO and PRO measures for eyebrow, eyelash and nail appearance, with their accompanying photoguides and the PRO Measure for Eye Irritation provide clear and meaningful assessments of outcomes important to patients with AA.
1 Introduction Understanding and evaluating the various manifestations of diseases and patients’ treatment experiences is critical for the development and evaluation of new therapies [1]. Current clinical assessment guidelines for alopecia areata (AA) focus on scalp hair loss, with secondary assessment of “body hair loss” and “nail involvement” [2–4]. However, it is known that AA can also cause eyebrow and eyelash hair loss [5, 6] and that the loss of these defining facial features is physically and psychologically bothersome to patients [7, 8]. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s40257-020-00545-9) contains supplementary material, which is available to authorized users. * Brett A. King [email protected] Extended author information available o
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