The Hidradenitis Suppurativa Quality of Life (HiSQOL) score: development and validation of a measure for clinical trials.
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:
08 2020
08 2020
Historique:
accepted:
07
11
2019
pubmed:
11
11
2019
medline:
15
5
2021
entrez:
10
11
2019
Statut:
ppublish
Résumé
Hidradenitis suppurativa (HS) is a chronic, inflammatory condition that can have a large negative impact on health-related quality of life (HRQOL). A reliable and validated measure of HS-specific HRQOL in clinical studies is needed. To develop and validate the Hidradenitis Suppurativa Quality Of Life (HiSQOL©) scale, for clinical trial measurement of HS-specific HRQOL. In stage 1, qualitative concept elicitation interviews were conducted with patients with HS in Denmark (n = 21) and the U.S.A. (n = 21). In stage 2, cognitive debriefing interviews were performed with U.S. (n = 30) and Danish patients with HS (n = 30). In stage 3 an observational study of 222 patients with HS in the U.S.A. was conducted for item reduction, measure validation and assessment of psychometric properties. In stage 4, an observational study of 215 patients with HS in Denmark was conducted to confirm the psychometric structure derived in stage 3. In both studies the Dermatology Life Quality Index, Hospital Anxiety and Depression Scale and numerical rating scale for pain were also included. In concept elicitation, 99 items were generated, which were reduced to 41 after removing duplicates. In cognitive debriefing, two items were added and one item removed. A 42-item instrument was psychometrically assessed. Based on psychometric analyses and patient input, the instrument was reduced to 17 items that had strong psychometric properties in both the U.S. and Danish samples. The HiSQOL is a reliable and valid instrument to measure HS-specific HRQOL in clinical trials.
Sections du résumé
BACKGROUND
Hidradenitis suppurativa (HS) is a chronic, inflammatory condition that can have a large negative impact on health-related quality of life (HRQOL). A reliable and validated measure of HS-specific HRQOL in clinical studies is needed.
OBJECTIVES
To develop and validate the Hidradenitis Suppurativa Quality Of Life (HiSQOL©) scale, for clinical trial measurement of HS-specific HRQOL.
METHODS
In stage 1, qualitative concept elicitation interviews were conducted with patients with HS in Denmark (n = 21) and the U.S.A. (n = 21). In stage 2, cognitive debriefing interviews were performed with U.S. (n = 30) and Danish patients with HS (n = 30). In stage 3 an observational study of 222 patients with HS in the U.S.A. was conducted for item reduction, measure validation and assessment of psychometric properties. In stage 4, an observational study of 215 patients with HS in Denmark was conducted to confirm the psychometric structure derived in stage 3. In both studies the Dermatology Life Quality Index, Hospital Anxiety and Depression Scale and numerical rating scale for pain were also included.
RESULTS
In concept elicitation, 99 items were generated, which were reduced to 41 after removing duplicates. In cognitive debriefing, two items were added and one item removed. A 42-item instrument was psychometrically assessed. Based on psychometric analyses and patient input, the instrument was reduced to 17 items that had strong psychometric properties in both the U.S. and Danish samples.
CONCLUSIONS
The HiSQOL is a reliable and valid instrument to measure HS-specific HRQOL in clinical trials.
Identifiants
pubmed: 31705538
doi: 10.1111/bjd.18692
pmc: PMC7205560
mid: NIHMS1058982
doi:
Types de publication
Journal Article
Observational Study
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
340-348Subventions
Organisme : NCATS NIH HHS
ID : UL1 TR002014
Pays : United States
Organisme : AHRQ HHS
ID : K08 HS024585
Pays : United States
Organisme : NIAMS NIH HHS
ID : L30 AR072438
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR000127
Pays : United States
Informations de copyright
© 2019 British Association of Dermatologists.
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