Trial reportJournal of patient-reported outcomes2023
Hyperhidrosis quality of life index (HidroQoL): further validation by applying classical test theory and item response theory using data from a phase III clinical trial.
Trial report in Journal of patient-reported outcomes, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03658616 (Combined Randomized, Double-blind, Dose-confirming Phase 3a Study in Parallel Design to Assess the Efficacy and Safety of Topical 4-week Treatment With 1% GPB Cream vs Placebo and Open-label Phase 3b Study to Assess Long-term Efficacy and Safety in Patients With Primary Axillary Hyperhidrosis Treated With 1% GPB Cream), which is not on this map. Cited by 5 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Combined Randomized, Double-blind, Dose-confirming Phase 3a Study in Parallel Design to Assess the Efficacy and Safety of Topical 4-week Treatment With 1% GPB Cream vs Placebo and Open-label Phase 3b Study to Assess Long-term Efficacy and Safety in Patients With Primary Axillary Hyperhidrosis Treated With 1% GPB Cream
Who cites it
5 citing papers in PubMed.
- Early onset, genital, and axillary involvement are strongly associated with impaired quality of life in hyperhidrosis patients.Medicine · 2026Article
- Development and Validation of the Japanese Version of the Hyperhidrosis Quality of Life Index.The Journal of dermatology · 2026Article
- Arabic Translation, Cultural Adaptation, and Validation of the Hyperhidrosis Disease Severity Scale (Ar-HDSS).Healthcare (Basel, Switzerland) · 2025Article
- The Creation of the Arabic Version of the Hyperhidrosis Quality of Life Index (HidroQoL©) with Validation and Cross-Cultural Adaptation.Clinical, cosmetic and investigational dermatology · 2025Article
- Iontophoresis Improves the Impact on the Quality of Life of Children with Primary Hyperhidrosis-A Prospective Study and a Short Review.Children (Basel, Switzerland) · 2024Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe Hyperhidrosis Quality of Life Index (HidroQoL ©) is a well-developed and validated patient-reported outcome measure assessing the quality-of-life impacts in hyperhidrosis with 18 items. Our aim was to extend the already existing validity evidence for the HidroQoL, especially in relation to structural validity. Especially Rasch analysis has not been applied to the final 18-item HidroQoL before.
methodsData from a phase III clinical trial were used. Confirmatory factor analysis was conducted to confirm the two a priori HidroQoL scales within classical test theory. Furthermore, the assumptions of the Rasch model (model fit, monotonicity, unidimensionality, local independence) and Differential Item Functioning (DIF) were assessed using item response theory.
resultsThe sample included 529 patients with severe primary axillary hyperhidrosis. The two-factor structure could be confirmed by the confirmatory factor analysis (SRMR = 0.058). The item characteristic curves showed mainly optimally functioning response categories, indicating monotonicity. The overall fit to the Rasch model was adequate and unidimensionality for the HidroQoL overall scale could be confirmed, since the first factor had an eigenvalue of 2.244 and accounted for 18.7%. Local independence was below assumed thresholds (residual correlations ≤ 0.26). DIF analysis, controlling for age or gender, was critical for four and three items, respectively. However, this DIF could be explained.
conclusionUsing classical test theory and item response theory/Rasch analyses, this study provided further evidence for the structural validity of the HidroQoL. This study confirmed several specific (measurement) properties of the HidroQoL questionnaire in patients with physician-confirmed severe primary axillary hyperhidrosis: the HidroQoL is a unidimensional scale allowing the summation of scores to generate a single score, and simultaneously it has a dual structure, also allowing the calculation of separate domain scores for daily activities and psychosocial impacts. With this study, we provided new evidence of the structural validity of the HidroQoL in the context of a clinical trial. Trial registration The study was registered (ClinicalTrials.gov identifier: NCT03658616, 05 September 2018, https://clinicaltrials.gov/ct2/show/NCT03658616?term=NCT03658616&draw=2&rank=1 ).
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