Patient-Reported Outcome (PRO): Scalp

DESCRIPTION:
The Scalp Hair Assessment Patient-Reported Outcome (PRO) is a validated, easy-to-use, single-item instrument that assesses percent scalp hair loss in patients with alopecia areata. Patients report their own perception of scalp hair loss using a 5-point Likert-type scale that aligns with the Alopecia Areata Investigator Global Assessment scale (AA-IGA), a clinician-reported outcome (ClinRO) measure.^1,2

DISEASE STATES: 
Alopecia areata

VALIDATED USES: 
Assessment, treatment monitoring

ADMINISTRATION METHOD:
Patient

COMMONLY USED IN:
Clinical trials, clinical practice

DETAILED DESCRIPTION:
Scalp Hair Assessment PRO was developed to align with guidance from the FDA to incorporate PROs in clinical trials. The tool is designed to capture the patient’s voice and perspectives on scalp hair loss as well as their perception of treatment success. Patients agree with the clinical level of hair regrowth representing ≤20% scalp hair loss as a good measure of treatment success. This tool may also be used in clinical practice to facilitate clinician-patient discussions about shared treatment goals.^1,3  

To use the Scalp Hair Assessment PRO tool, patients start by examining all scalp areas with a mirror. Patients then assess the total area of missing scalp hair (note: areas with only vellus hair count as missing hair). Finally, patients assign a percentage of scalp hair loss, aligning with AA-IGA, that ranges from 0% (no hair loss) to 100% (loss of all hair).^1,3

VALUES FOR SCALP HAIR ASSESSMENT PRO^1,3

VALIDITY:
Content validity was established through an iterative feedback process consisting of both clinicians and patients. It was refined through two rounds of qualitative interviews with patients aged 15–72 years, ensuring the tool measures important concepts relevant to the target population.¹

LIMITATIONS:
Reliability has not been established and may require further studies. Only participants with ≥50% scalp hair loss (severe) were included in its development. Participants were recruited from North America and results may not be generalize to other regions or cultures.¹

This resource is intended for educational purposes only and is intended for US healthcare professionals. Healthcare professionals should use independent medical judgment. All decisions regarding patient care must be handled by a healthcare professional and be made based on the unique needs of each patient.

References: 1. Wyrwich KW, Kitchen H, Knight S, et al. Development of the Scalp Hair Assessment PRO™ measure for alopecia areata. Br J Dermatol. 2020;183(6):1065-1072. doi:10.1111/bjd.19024 2. Sun DI, Paller AS. Assessment of alopecia areata disease severity in pediatric patients. Pediatr Dermatol. 2025;42 Suppl 1(Suppl 1):31-35. doi:10.1111/pde.15830 3. Wyrwich KW, Kitchen H, Knight S, et al. The Alopecia Areata Investigator Global Assessment scale: a measure for evaluating clinically meaningful success in clinical trials. Br J Dermatol. 2020;183(4):702-709. doi:10.1111/bjd.18883