The Role of Patients in Alopecia Areata Endpoint Development: Understanding Physical Signs and Symptoms

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

doi:10.1016/j.jisp.2020.05.006

Cited by 5 publications

(17 citation statements)

References 8 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…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%

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)

Self Cite

View full text Add to dashboard Cite

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.

show abstract

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)

Self Cite

View full text Add to dashboard Cite

show abstract

“…Additionally, the findings were generally supportive of similar interviews conducted previously with adults with severe AA. 9,10,29,33 Although this study supports the content validity of the suite of AA PRO measures in adolescents with severe AA, quantitative research to provide evidence of each measure's psychometric properties (e.g. reliability, ability to detect change) 30 is not yet completed.…”

Section: Discussionmentioning

confidence: 67%

A qualitative interview study to explore adolescents’ experience of alopecia areata and the content validity of sign/symptom patient‐reported outcome measures*

et al. 2022

Self Cite

View full text Add to dashboard Cite

Summary Background The content validity (appropriateness and acceptability) of patient‐reported outcome (PRO) measures for scalp hair loss, eyebrow loss, eyelash loss, nail damage and eye irritation has been demonstrated in adults with alopecia areata (AA) but not adolescents. Objectives To explore the content validity of the suite of AA PRO measures and accompanying photoguides in an adolescent sample. Methods Semi‐structured, 90‐min, combined concept elicitation and cognitive interviews were conducted face‐to‐face with adolescents who experienced ≥ 50% AA‐related scalp hair loss. Transcripts underwent thematic and framework analysis. Results Eleven adolescents (aged 12–17 years, 55% female, 45% nonwhite) diagnosed with AA for 5·9 years (mean) participated. Participants had 69·6% scalp hair (mean) and current eyebrow (82%) and/or eyelash loss (82%) and/or nail involvement (36%). Adolescents reported scalp, eyebrow and eyelash hair loss as their top three most bothersome signs/symptoms. Despite mostly accepting their AA, impacts related to visible areas of hair loss were prominent. Participants demonstrated good understanding and appropriate use of the PRO measures, and advocated including hair loss percentages alongside descriptive categories in the Scalp Hair Assessment PRO™. Results confirmed treatment success thresholds established with adults: achievement of ≤ 20% scalp hair loss, no/minimal eyebrow and eyelash loss, no/a little nail damage and eye irritation (PRO measure categories 0 or 1). Conclusions The Scalp Hair Assessment PRO™, PRO Measure for Eyebrows™, PRO Measure for Eyelashes™, PRO Measure for Nail Appearance™ and PRO Measure for Eye Irritation™ and accompanying photoguides are fit‐for‐purpose self‐reported measures of AA signs/symptoms that are impactful to adolescents with AA.

show abstract

“…Scalp hair loss was named as the most bothersome sign/symptom by 77% of the sample (100% of adolescents/72% of adults). Four adults (16%) named eyebrow hair loss as the most bothersome sign/symptom; eyelash, nose and body hair loss each received the most bothersome ranking from one adult patient [29]. The results from this patient ranking exercise con rmed scalp hair loss as the key concept, despite oversampling patients with eyebrow/eyelash hair loss.…”

Section: Ranking Exercisementioning

confidence: 96%

“…Thirty patients with a history of ≥ 50% scalp hair loss were interviewed in October 2017. The patients' demographic and clinical characteristics at the time of the interviews are detailed elsewhere [29], and synopsized here. Five of the patient interviewees were adolescents (ages 15-17 years old; 3 females/2 males) and 25 of the patient interviewees were adults (ages 18-72 years old; 14 females/11 males).…”

Section: Patient Interviewsmentioning

confidence: 99%

See 1 more Smart Citation

Using qualitative methods to establish the clinically meaningful threshold for treatment success for the Severity of Alopecia Tool (SALT) score

Wyrwich¹,

Kitchen²,

Knight³

et al. 2021

Preprint

Self Cite

View full text Add to dashboard Cite

Purpose: Traditionally, appropriate anchors are used to investigate the amount of change on a clinician-reported outcome assessment that is meaningful to individual patients. However, novel qualitative methods can additionally inform the individual improvement threshold for demonstrating the clinical benefit of new treatments. This study aimed to establish a clinically meaningful threshold for treatment success for the clinician-reported Severity of Alopecia Tool (SALT) score for patients with alopecia areata (AA).Methods: A purposive sample of 10 dermatologists expert in the treatment of AA, and 30 adult and adolescent patients with AA and a history of ≥50% scalp hair loss were recruited. Semi-structured interview questions explored thresholds that represented treatment success to clinicians and patients with AA. Findings were analyzed using thematic methods to identify treatment success thresholds.Results: Expert clinicians considered a static threshold of 80% (n=5) or 75% (n=3) of the scalp hair as a treatment success. Patient responses ranged from 70 - 90% (median 80% of the scalp hair). Subsequently, queried patients confirmed that achieving SALT score ≤20 with treatment would be a success. Reflections on the methodology include: clinician perceptions can be informed by current clinical practice and knowledge of existing treatments and research and clinicians easily identified thresholds through qualitative discussions; patients were able to understand and identify thresholds for improvement less than complete absence of disease. Conclusions: This qualitative investigation of expert clinicians and patients with AA confirmed that achieving an amount of 80% or more scalp hair (SALT score ≤20) was an appropriate individual treatment success threshold indicating clinically meaningful improvement for patients with ≥50% scalp hair loss. A qualitative investigation of a quantifiable treatment success is possible through well-designed interview questions for the indication and patient population. Both clinician and patient input plays a critical role in understanding the clinical benefit meaningful to patients.

show abstract

The Role of Patients in Alopecia Areata Endpoint Development: Understanding Physical Signs and Symptoms

Cited by 5 publications

References 8 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

A qualitative interview study to explore adolescents’ experience of alopecia areata and the content validity of sign/symptom patient‐reported outcome measures*

Using qualitative methods to establish the clinically meaningful threshold for treatment success for the Severity of Alopecia Tool (SALT) score

Contact Info

Product

Resources

About