Development of the Scalp Hair Assessment PRO™ measure for alopecia areata.
Journal
The British journal of dermatology
ISSN: 1365-2133
Titre abrégé: Br J Dermatol
Pays: England
ID NLM: 0004041
Informations de publication
Date de publication:
12 2020
12 2020
Historique:
accepted:
09
03
2020
pubmed:
13
3
2020
medline:
15
5
2021
entrez:
13
3
2020
Statut:
ppublish
Résumé
Valid patient-reported outcome (PRO) measures are required to evaluate alopecia areata (AA) treatments. 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™). 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. 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. 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.
Sections du résumé
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.
Identifiants
pubmed: 32163589
doi: 10.1111/bjd.19024
pmc: PMC7754291
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1065-1072Subventions
Organisme : NCATS NIH HHS
ID : UL1 TR001414
Pays : United States
Organisme : Eli Lilly and Company
Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2020 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.
Références
Value Health. 2018 Jul;21(7):839-842
pubmed: 30005756
Br J Dermatol. 2019 Jun;180(6):1377-1389
pubmed: 30501016
J Am Acad Dermatol. 2017 Jan;76(1):29-32
pubmed: 27816292
J Am Acad Dermatol. 2016 Oct;75(4):806-812.e3
pubmed: 27436156
Value Health. 2011 Dec;14(8):967-77
pubmed: 22152165
J Am Acad Dermatol. 2017 Jan;76(1):22-28
pubmed: 27816293
J Am Acad Dermatol. 2019 Feb;80(2):e45
pubmed: 30244065
Value Health. 2011 Dec;14(8):978-88
pubmed: 22152166
Br J Dermatol. 2016 Sep;175(3):561-71
pubmed: 26914830
Health Qual Life Outcomes. 2006 Oct 11;4:79
pubmed: 17034633
JCI Insight. 2016 Sep 22;1(15):e89790
pubmed: 27699253
Value Health. 2015 Sep;18(6):741-52
pubmed: 26409600
Autoimmun Rev. 2015 Feb;14(2):81-9
pubmed: 25315746
J Am Acad Dermatol. 2018 Sep;79(3):556-558.e1
pubmed: 29425723
J Am Acad Dermatol. 2004 Sep;51(3):440-7
pubmed: 15337988
Br J Dermatol. 2020 Oct;183(4):702-709
pubmed: 31970750