Development of Clinician-Reported Outcome (ClinRO) and Patient-Reported Outcome (PRO) Measures for Eyebrow, Eyelash and Nail Assessment in Alopecia Areata

Wyrwich, Kathleen W.; Kitchen, Helen; Knight, SL; Aldhouse, Natalie; Macey, Jake; Nunes, Fabio P.; Dutronc, Yves; Mesinkovska, Natasha Atanaskova; Ko, Justin; King, Brett

doi:10.1007/s40257-020-00545-9

Cited by 39 publications

(56 citation statements)

References 18 publications

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“…Interview results were aligned with those in North America [ 26 , 27 , 29 ]. All clinicians and nearly all patients confirmed that scalp hair loss was the most important AA sign/symptom and scalp hair regrowth was the greatest treatment priority.…”

Section: Discussionsupporting

confidence: 55%

“…Clinician-reported outcome (ClinRO) and PRO measures [ 29 ] (see Fig. S1 in the “Supplementary Information”) were also developed to assess key secondary AA signs/symptoms [ 30 ], including the ClinRO Measure for Eyebrow Hair Loss™, PRO Measure for Eyebrows™, ClinRO Measure for Eyelash Hair Loss™, PRO Measures for Eyelashes™, ClinRO Measure for Nail Appearance™, PRO Measure for Nail Appearance™, and PRO Measure for Eye Irritation™.…”

Section: Introductionmentioning

confidence: 99%

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Dermatologist and Patient Perceptions of Treatment Success in Alopecia Areata and Evaluation of Clinical Outcome Assessments in Japan

Macey

Kitchen

Aldhouse

et al. 2021

Dermatol Ther (Heidelb)

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Introduction The content validity and treatment success thresholds of clinical outcome assessments (COAs) for alopecia areata (AA)—including the Alopecia Areata-Investigator Global Assessment™ (AA-IGA™), Scalp Hair Assessment Patient-Reported Outcome™ (PRO), and clinician-reported outcome (ClinRO) and PRO measures for eyebrows, eyelashes, eye irritation, and nails—were established in interviews with dermatologists and patients in North America. This study aimed to confirm the content validity and treatment success thresholds of these measures with clinicians and patients in Japan. Methods Qualitative interviews were conducted in Japan with dermatologists with AA expertise and adults with AA who experienced ≥ 50% scalp hair loss. Interviews included concept elicitation and cognitive interview questions. Data were analyzed using thematic and framework techniques. Results Seven dermatologists and 15 patients participated. Scalp hair loss was the most important sign/symptom of AA and the greatest treatment priority. Dermatologists and patients understood the AA-IGA™, Scalp Hair Assessment PRO™, and other COAs, and found these measures to be appropriate, relevant, and clinically meaningful. Dermatologists and patients confirmed that achieving ≤ 20% scalp hair loss (AA-IGA™/Scalp Hair Assessment PRO™ categories 0 or 1) indicated treatment success for patients with ≥ 50% scalp hair loss. Categories 0 or 1 on the other COAs represented treatment success. Conclusion This study confirmed the content validity and treatment success thresholds of the AA-IGA™, Scalp Hair Assessment PRO™, and other ClinRO and PRO measures for AA in Japan. These findings were aligned with interview results in North America and support the use of these measures in AA treatment studies. Supplementary Information The online version contains supplementary material available at 10.1007/s13555-020-00477-6.

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Section: Discussionsupporting

confidence: 55%

Section: Introductionmentioning

confidence: 99%

Dermatologist and Patient Perceptions of Treatment Success in Alopecia Areata and Evaluation of Clinical Outcome Assessments in Japan

Macey

Kitchen

Aldhouse

et al. 2021

Dermatol Ther (Heidelb)

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“…In addition, a comprehensive suite of content-valid clinical outcome assessments of the key physical effects of AA were developed as part of this study. Development of an investigator global assessment [43] and PRO measure [27] for scalp hair loss, along with ClinRO and PRO measures for eyebrow loss, eyelash loss, nail appearance and eye irritation [28] are reported elsewhere.…”

Section: Discussionmentioning

confidence: 99%

“…This qualitative study was designed to elicit the patient experience of AA and to develop and cognitively test PRO measures for key physical AA signs/symptoms (results of this latter objective are reported elsewhere [27,28]). The study protocol was reviewed and approved by Western Institutional Review Board (ref #20171820).…”

Section: Ethicsmentioning

confidence: 99%

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“‘You lose your hair, what’s the big deal?’ I was so embarrassed, I was so self-conscious, I was so depressed:” a qualitative interview study to understand the psychosocial burden of alopecia areata

Aldhouse¹,

Kitchen²,

Knight³

et al. 2020

J Patient Rep Outcomes

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Background Alopecia areata (AA) is characterized by hair loss that can affect the scalp and body. This study describes the psychosocial burden of AA. Methods Participants diagnosed with AA who had experienced ≥50% scalp hair loss according to the Severity of Alopecia Tool (SALT) were identified by clinicians. A semi-structured interview guide, developed with expert clinician input, included open-ended questions to explore patients’ experiences of living with AA. Data were thematically analyzed to identify concepts and relationships. Results Participants (n = 45, 58% female, mean age 33.3 years [range 15–72], mean SALT 67.2 [range 0–100]) described the AA diagnosis as “devastating”. Both males and females reported emotional and psychological impacts of AA including feeling sad/depressed (n = 21), embarrassed/ashamed (n = 10) and angry/frustrated (n = 3). Patients felt helpless (n = 5) due to the unpredictability of disease recurrence, and anxious (n = 19) about judgement from others. Many patients avoided social situations (n = 18), which impaired relationships and increased isolation. Coping strategies included concealment of hair loss through wigs or make-up, although fear of the displacement of these coverings also caused anxiety and the avoidance of activities that could result in scalp exposure (n = 22). Some patients became more accepting of AA over time, which lessened the emotional impact, though efficacious treatment was still desired. A conceptual framework was developed, and a conceptual model was created to depict the relationship between the physical signs/symptoms and the associated psychosocial effects of AA. Conclusion AA impairs patients’ emotional and psychological wellbeing, relationships and lifestyles. Greater disease awareness and effective treatments are needed.

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The Alopecia Areata Severity and Morbidity Index (ASAMI) Study

Moussa,

Bennett,

Wall

et al. 2024

JAMA Dermatol

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ImportanceCurrent measures of alopecia areata (AA) severity, such as the Severity of Alopecia Tool score, do not adequately capture overall disease impact.ObjectiveTo explore factors associated with AA severity beyond scalp hair loss, and to support the development of the Alopecia Areata Severity and Morbidity Index (ASAMI).Evidence ReviewA total of 74 hair and scalp disorder specialists from multiple continents were invited to participate in an eDelphi project consisting of 3 survey rounds. The first 2 sessions took place via a text-based web application following the Delphi study design. The final round took place virtually among participants via video conferencing software on April 30, 2022.FindingsOf all invited experts, 64 completed the first survey round (global representation: Africa [4.7%], Asia [9.4%], Australia [14.1%], Europe [43.8%], North America [23.4%], and South America [4.7%]; health care setting: public [20.3%], private [28.1%], and both [51.6%]). A total of 58 specialists completed the second round, and 42 participated in the final video conference meeting. Overall, consensus was achieved in 96 of 107 questions. Several factors, independent of the Severity of Alopecia Tool score, were identified as potentially worsening AA severity outcomes. These factors included a disease duration of 12 months or more, 3 or more relapses, inadequate response to topical or systemic treatments, rapid disease progression, difficulty in cosmetically concealing hair loss, facial hair involvement (eyebrows, eyelashes, and/or beard), nail involvement, impaired quality of life, and a history of anxiety, depression, or suicidal ideation due to or exacerbated by AA. Consensus was reached that the Alopecia Areata Investigator Global Assessment scale adequately classified the severity of scalp hair loss.Conclusions and RelevanceThis eDelphi survey study, with consensus among global experts, identified various determinants of AA severity, encompassing not only scalp hair loss but also other outcomes. These findings are expected to facilitate the development of a multicomponent severity tool that endeavors to competently measure various disease impact. The findings are also anticipated to aid in identifying candidates for current and emerging systemic treatments. Future research must incorporate the perspectives of patients and the public to assign weight to the domains recognized in this project as associated with AA severity.

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Development of Clinician-Reported Outcome (ClinRO) and Patient-Reported Outcome (PRO) Measures for Eyebrow, Eyelash and Nail Assessment in Alopecia Areata

Cited by 39 publications

References 18 publications

Dermatologist and Patient Perceptions of Treatment Success in Alopecia Areata and Evaluation of Clinical Outcome Assessments in Japan

Dermatologist and Patient Perceptions of Treatment Success in Alopecia Areata and Evaluation of Clinical Outcome Assessments in Japan

“‘You lose your hair, what’s the big deal?’ I was so embarrassed, I was so self-conscious, I was so depressed:” a qualitative interview study to understand the psychosocial burden of alopecia areata

The Alopecia Areata Severity and Morbidity Index (ASAMI) Study

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