Donhauser, Theresa and Gabes, Michaela and Masur, Clarissa and Kamudoni, Paul and Salek, Sam and Abels, Christoph and Apfelbacher, Christian (2025) Longitudinal validity of the Hyperhidrosis Quality of Life Index (HidroQoL©) in a phase IIIb clinical trial population with hyperhidrosis: responsiveness and meaningful change. BRITISH JOURNAL OF DERMATOLOGY, 192 (3). pp. 450-457. ISSN 0007-0963, 1365-2133
Full text not available from this repository. (Request a copy)Abstract
Background The Hyperhidrosis Quality of Life Index (HidroQoL (c)) is a well-developed patient-reported outcome measure assessing the quality of life impacts in hyperhidrosis (HH), which has proven very good measurement properties, such as structural validity and internal consistency.Objectives We aimed to investigate responsiveness over time and estimate values for meaningful within-person change (MWPC) towards symptom improvement for different measurement timepoints (4 and 12 weeks), extending the existing validity evidence in patients with primary axillary HH.Methods Data (from a phase IIIb clinical trial) were collected at baseline, and at weeks 4, 8, 12, 28, 52 and 72. For the assessment of responsiveness, HidroQoL change scores were correlated with corresponding change scores of the Hyperhidrosis Disease Severity Scale (HDSS), the Dermatology Life Quality Index (DLQI) and gravimetric sweat production based on a priori formulated hypotheses. Furthermore, we tested whether the different HDSS change score groups differed significantly from each other over time and whether the HidroQoL was sensitive towards these group differences over time. This was extended by the calculation of matched-pair tests and effect sizes to test significance for each change group separately. For the estimation of MWPC thresholds towards symptom improvement, different anchor-based and integrated approaches were used.Results In total, the sample comprised 357 patients with primary axillary HH. For the assessment of responsiveness, five out of 14 a priori hypotheses regarding the correlation of the change scores could be confirmed, whereas the rejected hypotheses differed only marginally from the expected values. Furthermore, regarding responsiveness, the HidroQoL showed sensitivity towards symptom improvement at each measurement timepoint. Effect sizes were large as expected (d >= 0.806). MWPC thresholds towards symptom improvement were proposed for two measurement timepoints: 5 (week 4) and 6 (week 12). Increasing MWPC values over time were observed.Conclusions This study extends the evidence for the longitudinal validity of the HidroQoL (c) up to 72 weeks and proposed MWPC thresholds for different time intervals (4 and 12 weeks) after baseline, aiding interpretability. Results concur with findings from previous validation studies. Permanent excessive sweating is a medical condition known as 'primary hyperhidrosis', where people sweat a lot more than usual, even when they don't need to. It can affect a person's daily life, and make things like school, sports and social activities difficult. The condition affects about 1-2% of people worldwide. The Hyperhidrosis Quality of Life Index (HidroQoL (c)) questionnaire is used to measure how hyperhidrosis affects a person's life.This study was carried out with patients from Germany, UK, Denmark, Sweden, Poland and Hungary. We looked at how well the questionnaire works over time and how much people's symptoms need to improve after 4 and 12 weeks. The goal of this study was to demonstrate the ability of the HidroQoL (c) to detect change over time and to figure out how much people's symptoms need to improve to make a real difference in their lives. We collected data from 357 patients with hyperhidrosis over 72 weeks. We compared scores from the HidroQoL (c) with scores from other questionnaires that measure sweating and quality of life. We also looked at whether different groups of people with varying symptoms changed over time. We found that the HidroQoL (c) was good at showing changes in symptoms over time. We also figured out how much symptoms needed to improve after 4 and 12 weeks for it to really matter.In summary, our findings suggest that the HidroQoL (c) shows responsiveness over 72 weeks and could help us to understand how much symptoms need to improve for people to feel better. In this study, the longitudinal validity of the Hyperhidrosis Quality of Life Index (HidroQoL (c)) was extended up to 72 weeks. Additionally, meaningful within-person change thresholds were estimated for the time intervals of 4 and 12 weeks after baseline.
| Item Type: | Article |
|---|---|
| Subjects: | 100 Philosophy & psychology > 150 Psychology 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Institut für Epidemiologie und Präventivmedizin Human Sciences > Institut für Psychologie > Lehrstuhl für Klinische Psychologie und Psychotherapie - Lehrstuhl für Psychologie VIII - Prof. Dr. Andreas Mühlberger |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 22 Jan 2026 06:16 |
| Last Modified: | 22 Jan 2026 06:16 |
| URI: | https://pred.uni-regensburg.de/id/eprint/64314 |
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