Evaluation of validity, reliability and ability to detect change for the Hand Eczema Severity Index (HECSI) and evaluation of HECSI-75 and HECSI-90 as within-patient responder definitions.
Chronic Hand Eczema
Clinician‐Reported Outcome
HECSI‐75
HECSI‐90
delgocitinib cream
meaningful change
responder definition
validation
Journal
Contact dermatitis
ISSN: 1600-0536
Titre abrégé: Contact Dermatitis
Pays: England
ID NLM: 7604950
Informations de publication
Date de publication:
13 Oct 2024
13 Oct 2024
Historique:
revised:
11
09
2024
received:
31
05
2024
accepted:
12
09
2024
medline:
14
10
2024
pubmed:
14
10
2024
entrez:
13
10
2024
Statut:
aheadofprint
Résumé
The Hand Eczema Severity Index (HECSI) is a Clinician-Reported Outcome measure of the severity of hand eczema (HE). This study aimed to evaluate the validity, reliability and ability to detect change of the HECSI, and the HECSI-75 and HECSI-90 as responder definitions. Analyses were performed using data from a sample of n = 258 patients with Chronic Hand Eczema (CHE) from a Phase 2b, randomised, double-blind, vehicle-controlled trial of delgocitinib cream, pooled across treatment groups. The measurement properties of the HECSI were assessed and the adequacy of the HECSI-75 and HECSI-90 as responder definitions was explored through cross-tabulation. Inter-item correlations provided support for the scoring, whereby items are grouped by areas of the hand. HECSI demonstrated good test-retest reliability with intra-class correlations >0.70. Construct validity was supported by a logical pattern of correlations with concurrent measures and significant differences in HECSI scores across severity groups (p < 0.001). HECSI was responsive with statistically significant improvements over time and with significant differences (p < 0.001) between improved and stable groups. Data provided support for both HECSI-75 and HECSI-90 as within-patient responder definitions. HECSI has strong validity, reliability and ability to detect change as a measure of CHE severity. HECSI-75 and HECSI-90 are appropriate responder definitions.
Sections du résumé
BACKGROUND
BACKGROUND
The Hand Eczema Severity Index (HECSI) is a Clinician-Reported Outcome measure of the severity of hand eczema (HE).
OBJECTIVES
OBJECTIVE
This study aimed to evaluate the validity, reliability and ability to detect change of the HECSI, and the HECSI-75 and HECSI-90 as responder definitions.
METHODS
METHODS
Analyses were performed using data from a sample of n = 258 patients with Chronic Hand Eczema (CHE) from a Phase 2b, randomised, double-blind, vehicle-controlled trial of delgocitinib cream, pooled across treatment groups. The measurement properties of the HECSI were assessed and the adequacy of the HECSI-75 and HECSI-90 as responder definitions was explored through cross-tabulation.
RESULTS
RESULTS
Inter-item correlations provided support for the scoring, whereby items are grouped by areas of the hand. HECSI demonstrated good test-retest reliability with intra-class correlations >0.70. Construct validity was supported by a logical pattern of correlations with concurrent measures and significant differences in HECSI scores across severity groups (p < 0.001). HECSI was responsive with statistically significant improvements over time and with significant differences (p < 0.001) between improved and stable groups. Data provided support for both HECSI-75 and HECSI-90 as within-patient responder definitions.
CONCLUSIONS
CONCLUSIONS
HECSI has strong validity, reliability and ability to detect change as a measure of CHE severity. HECSI-75 and HECSI-90 are appropriate responder definitions.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : LEO Pharma
Informations de copyright
© 2024 The Author(s). Contact Dermatitis published by John Wiley & Sons Ltd.
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