PSS21 Gap Analysis for Patient-Reported Outcomes Measures for Alopecia

The document presents a gap analysis aimed at identifying a suitable patient-reported outcome (PRO) measure for treatments in alopecia. The search across MEDLINE®, PROQOLID, and PROLabels databases resulted in 45 instruments, of which 23 were patient-reported, 17 were investigator-rated, three were devices, and two were objective hair measures. After applying exclusion criteria, 41 instruments were discarded, leaving four for further consideration: the Kingsley Alopecia Questionnaire (KAP), the Hair Growth Questionnaire, the Hair Problem List, and the Women's Androgenic Alopecia Quality of Life Questionnaire (WAA-QOL). However, none of these instruments fully met the FDA's PRO Guidance requirements. The Hair Growth Questionnaire, developed based on male input only, could potentially be revised for relevance to women with alopecia. The Hair Problem List and the WAA-QOL might be supplemented to include more concepts of interest and tested for relevance to both men and women with alopecia.