The Alopecia Areata Investigator Global Assessment scale: a measure for evaluating clinically meaningful success in clinical trials

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

doi:10.1111/bjd.18883

Cited by 68 publications

(76 citation statements)

References 20 publications

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“…The ClinRO Measure for Eyebrow Hair Loss™, ClinRO Measure of Eyelash Hair Loss™, ClinRO Measure for Nail Appearance™, PRO Measure for Eyebrows™, PRO Measure for Eyelashes™, PRO Measure for Nail Appearance™ and PRO Measure for Eye Irritation™ and accompanying photoguides were developed to provide content-valid, clinically meaningful measures that reflect patients' and dermatologists' perspectives of AA. In conjunction with the Alopecia Areata Investigator Global Assessment™ (AA-IGA™) [11] and Scalp Hair Assessment PRO™ [12] for scalp hair loss, these measures provide a comprehensive suite of assessments for key AA signs/symptoms.…”

Section: Resultsmentioning

confidence: 99%

“…Fit-for-purpose clinical outcome assessments (COAs) are required to evaluate the efficacy of treatment on these key non-scalp signs/symptoms in AA clinical trials and to complement clinician and patient assessments of scalp hair loss [11,12]. However, to our knowledge, no publicly available outcome measures to evaluate eyebrow hair loss, eyelash hair loss and nail damage have been developed in conjunction with industry guidelines [13].…”

Section: Introductionmentioning

confidence: 99%

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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

Wyrwich

Kitchen²,

Knight³

et al. 2020

Am J Clin Dermatol

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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.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Wyrwich

Kitchen²,

Knight³

et al. 2020

Am J Clin Dermatol

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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%

“‘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 development of the AA-IGA TM and the corresponding five-level ordinal response scale for the draft Scalp Hair Assessment PRO were previously reported. 15…”

Section: Clinician Interviewsmentioning

confidence: 99%

“…It is also beneficial for clinician-reported outcomes and PRO response scales to be similar to allow for comparison of data from each rater. Therefore, the first step in developing the PRO content was to develop the Alopecia Areata Investigator Global Assessment (AA-IGA TM ), 15 which builds from the SALT assessment.…”

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confidence: 99%

Development of the Scalp Hair Assessment PRO™ measure for alopecia areata

et al. 2020

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Summary Background Valid patient‐reported outcome (PRO) measures are required to evaluate alopecia areata (AA) treatments. Objectives To develop a content‐valid and clinically meaningful PRO measure to assess AA scalp hair loss with scores comparable with the five‐response‐level Alopecia Areata Investigator Global Assessment (AA‐IGA™). Methods A draft PRO measure was developed based on input from 10 clinical experts in AA. The PRO measure was cognitively debriefed, modified and finalized through two rounds of qualitative semistructured interviews with patients with AA who had experienced ≥ 50% scalp hair loss. Data were thematically analysed. Results Adults (round 1: n = 25; round 2: n = 15) and adolescents aged 15–17 years (round 1: n = 5) in North America participated. All patients named scalp hair loss as a key AA sign or symptom. Patients demonstrated the ability to self‐report their current amount of scalp hair using percentages. In round 1 not all patients interpreted the measurement concept consistently; therefore, the PRO was modified to clarify the measurement concept to improve usability. Following modifications, patients in round 2 responded without difficulty to the PRO measure. Patients confirmed that they could use the five‐level response scale to rate their scalp hair loss: no missing hair, 0%; limited, 1–20%; moderate, 21–49%; large, 50–94%; nearly all or all, 95–100%. Almost all patients deemed hair regrowth resulting in ≤ 20% scalp hair loss a treatment success. Conclusions The Scalp Hair Assessment PRO™ is a content‐valid, clinically meaningful assessment of distinct gradations of scalp hair loss for evaluating AA treatment for patients with ≥ 50% hair loss at baseline.

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The Alopecia Areata Investigator Global Assessment scale: a measure for evaluating clinically meaningful success in clinical trials

Cited by 68 publications

References 20 publications

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

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

“‘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

Development of the Scalp Hair Assessment PRO™ measure for alopecia areata

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