Content-Valid Patient-Reported Outcome Measure Developed for Alopecia Areata

woman with alopecia shows her bald spot
30 year old Caucasian woman with spot alopecia, bald spot on her head
A novel patient-reported outcome measure allows scalp hair loss to be characterized into clinically meaningful gradations from 0% to 100% missing scalp hair.

The Scalp Hair Assessment Patient-Reported Outcome™ (PRO) may be a clinically meaningful measure of scalp hair loss for use in the treatment of alopecia areata, according to study results published in the British Journal of Dermatology.

The assessment of scalp hair in clinical trials for alopecia areata has relied mainly on clinician-reported outcomes; however, PROs may provide a more comprehensive measurement approach. The objective of this study was to develop a content-valid and clinically meaningful PRO measure to comprehensively assess scalp hair loss in patients with alopecia areata.

In the study, researchers conducted interviews with 10 clinical experts on alopecia areata to develop a draft PRO measure. Researchers then performed 2 rounds of interviews with patients with alopecia areata (30 patients in round 1 and 15 patients in round 2) who had experienced ≥50% scalp hair loss. Data collected from the interviews included patients’ accounts about their personal experiences with areata alopecia and hair improvements they considered meaningful. Patient interviews lasted 90 minutes each and took place from October 2017 through March 2018. Researchers then used the interview transcripts to perform thematic analysis.

Results revealed that 78% of patients (n=35) considered scalp hair loss the most bothersome symptom of alopecia areata and that the single most important factor for determining meaningful growth was hair quantity. Percentages were used by patients to determine the amount of scalp hair they felt equated to a successful treatment. In round 1, many patients misinterpreted the meaning of hair loss, which led to the modification of the PRO to clarify the measurement and improve usability. This modification led to a more accurate response to the PRO measure in round 2. Most patients considered hair regrowth resulting in scalp hair loss of 20% or less a treatment success and confirmed they could use the 5-level percentage response scale to accurately rate scalp hair loss.

The main limitations to this study were that participants were from North America and findings could not be generalized to other populations, and additional novel measures may be required for other bothersome symptoms of alopecia areata, such as hair loss of eyebrows and eyelashes.

Related Articles

The study researchers concluded that the Scalp Hair Assessment PRO may be a content-valid and clinically meaningful measure for obtaining patient and clinician perspectives and treatment expectations in alopecia areata.

Disclosure: This clinical trial was supported by Eli Lilly and Company. Please see the original reference for a full list of authors’ disclosures.

Follow @DermAdvisor


Wyrwich KW, Kitchen H, Knight S, et al. Development of the Scalp Hair Assessment Patient-Reported Outcome™ (PRO) measure for alopecia areata [published online March 12, 2020]. Br J Dermatol. doi: 10.1111/bjd.19024