{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,26]],"date-time":"2026-10-26T19:30:58Z","timestamp":1793043058934,"version":"4.5.0"},"reference-count":26,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2023,6,6]],"date-time":"2023-06-06T00:00:00Z","timestamp":1686009600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,6,6]],"date-time":"2023-06-06T00:00:00Z","timestamp":1686009600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Dr. August Wolff GmbH & Co. KG Arzneimittel"},{"DOI":"10.13039\/501100012320","name":"Otto-von-Guericke-Universit\u00e4t Magdeburg","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100012320","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Patient Rep Outcomes"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>The Hyperhidrosis Quality of Life Index (HidroQoL \u00a9) 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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Data 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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>The sample included 529 patients with severe primary axillary hyperhidrosis. The two-factor structure could be confirmed by the confirmatory factor analysis (SRMR\u2009=\u20090.058). 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\u2009\u2264\u20090.26). DIF analysis, controlling for age or gender, was critical for four and three items, respectively. However, this DIF could be explained.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Using 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.<\/jats:p>\n                <jats:p><jats:italic>Trial registration<\/jats:italic> The study was registered (ClinicalTrials.gov identifier: NCT03658616, 05 September 2018, <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03658616?term=NCT03658616&amp;draw=2&amp;rank=1\">https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03658616?term=NCT03658616&amp;draw=2&amp;rank=1<\/jats:ext-link>).<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s41687-023-00596-6","type":"journal-article","created":{"date-parts":[[2023,6,6]],"date-time":"2023-06-06T19:44:42Z","timestamp":1686080682000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["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"],"prefix":"10.1186","volume":"7","clinical-trial-number":[{"clinical-trial-number":"nct03658616","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0640-1169","authenticated-orcid":false,"given":"Theresa","family":"Donhauser","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Apfelbacher","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gesina","family":"Kann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clarissa","family":"Masur","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Kamudoni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sam","family":"Salek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christoph","family":"Abels","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michaela","family":"Gabes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,6,6]]},"reference":[{"issue":"4","key":"596_CR1","doi-asserted-by":"publisher","first-page":"863","DOI":"10.1016\/S0733-8635(05)70062-0","volume":"16","author":"LP Stolman","year":"1998","unstructured":"Stolman LP (1998) Treatment of hyperhidrosis. Dermatol Clin 16(4):863\u2013869. https:\/\/doi.org\/10.1016\/S0733-8635(05)70062-0","journal-title":"Dermatol Clin"},{"issue":"10","key":"596_CR2","doi-asserted-by":"publisher","first-page":"743","DOI":"10.1007\/s00403-016-1697-9","volume":"308","author":"J Doolittle","year":"2016","unstructured":"Doolittle J, Walker P, Mills T, Thurston J (2016) Hyperhidrosis: an update on prevalence and severity in the United States. Arch Dermatol Res 308(10):743\u2013749. https:\/\/doi.org\/10.1007\/s00403-016-1697-9","journal-title":"Arch Dermatol Res"},{"issue":"2","key":"596_CR3","doi-asserted-by":"publisher","first-page":"241","DOI":"10.1016\/j.jaad.2003.12.040","volume":"51","author":"DR Strutton","year":"2004","unstructured":"Strutton DR, Kowalski JW, DA PharmD G, Stang PE (2004) US prevalence of hyperhidrosis and impact on individuals with axillary hyperhidrosis: results from a national survey. J Am Acad Dermatol 51(2):241\u2013248. https:\/\/doi.org\/10.1016\/j.jaad.2003.12.040","journal-title":"J Am Acad Dermatol"},{"issue":"4","key":"596_CR4","doi-asserted-by":"publisher","first-page":"467","DOI":"10.1016\/j.det.2014.06.004","volume":"32","author":"H Hamm","year":"2014","unstructured":"Hamm H (2014) Impact of hyperhidrosis on quality of life and its assessment. Dermatol Clin 32(4):467\u2013476. https:\/\/doi.org\/10.1016\/j.det.2014.06.004","journal-title":"Dermatol Clin"},{"key":"596_CR5","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-021-02958-3","author":"M Gabes","year":"2021","unstructured":"Gabes M, Kn\u00fcttel H, Kann G, Tischer C, Apfelbacher CJ (2021) Measurement properties of patient-reported outcome measures (PROMs) in hyperhidrosis: a systematic review. Qual Life Res. https:\/\/doi.org\/10.1007\/s11136-021-02958-3","journal-title":"Qual Life Res"},{"key":"596_CR6","doi-asserted-by":"publisher","DOI":"10.1097\/01.jnr.0000387485.78685.1e","author":"C-H Kuo","year":"2004","unstructured":"Kuo C-H, Yen M, Lin P-C (2004) Developing an instrument to measure quality of life of patients with hyperhidrosis. J Nurs Res. https:\/\/doi.org\/10.1097\/01.jnr.0000387485.78685.1e","journal-title":"J Nurs Res"},{"issue":"3","key":"596_CR7","doi-asserted-by":"publisher","first-page":"393","DOI":"10.1007\/s10862-010-9211-8","volume":"33","author":"MG Wheaton","year":"2011","unstructured":"Wheaton MG, Braddock AE, Abramowitz JS (2011) The sweating cognitions inventory: a measure of cognitions in hyperhidrosis. J Psychopathol Behav Assess 33(3):393\u2013402. https:\/\/doi.org\/10.1007\/s10862-010-9211-8","journal-title":"J Psychopathol Behav Assess"},{"key":"596_CR8","volume-title":"Development, validation and clinical application of a patient-reported outcome measure in hyperhidrosis: the hyperhidrosis quality of life index (HidroQoL \u00a9)","author":"P Kamudoni","year":"2014","unstructured":"Kamudoni P (2014) Development, validation and clinical application of a patient-reported outcome measure in hyperhidrosis: the hyperhidrosis quality of life index (HidroQoL \u00a9). Cardiff University, Cardiff"},{"issue":"4","key":"596_CR9","doi-asserted-by":"publisher","first-page":"1017","DOI":"10.1007\/s11136-014-0825-2","volume":"24","author":"P Kamudoni","year":"2015","unstructured":"Kamudoni P, Mueller B, Salek MS (2015) The development and validation of a disease-specific quality of life measure in hyperhidrosis: the hyperhidrosis quality of life index (HidroQOL\u00a9). Qual Life Res 24(4):1017\u20131027. https:\/\/doi.org\/10.1007\/s11136-014-0825-2","journal-title":"Qual Life Res"},{"issue":"3","key":"596_CR10","doi-asserted-by":"publisher","first-page":"473","DOI":"10.1111\/bjd.19300","volume":"184","author":"M Gabes","year":"2021","unstructured":"Gabes M, Jourdan C, Schramm K, Masur C, Abels C, Kamudoni P, Salek S, Apfelbacher C (2021) Hyperhidrosis quality of life index (HidroQoL\u00a9): further validation and clinical application in patients with axillary hyperhidrosis using data from a phase III randomized controlled trial. Br J Dermatol 184(3):473\u2013481. https:\/\/doi.org\/10.1111\/bjd.19300","journal-title":"Br J Dermatol"},{"issue":"1","key":"596_CR11","doi-asserted-by":"publisher","first-page":"229","DOI":"10.1111\/bjd.18234","volume":"182","author":"C Masur","year":"2020","unstructured":"Masur C, Soeberdt M, Kilic A, Knie U, Abels C (2020) Safety and efficacy of topical formulations containing 0\u00b75, 1 and 2% glycopyrronium bromide in patients with primary axillary hyperhidrosis: a randomized, double-blind, placebo-controlled study. Br J Dermatol 182(1):229\u2013231. https:\/\/doi.org\/10.1111\/bjd.18234","journal-title":"Br J Dermatol"},{"issue":"8","key":"596_CR12","doi-asserted-by":"publisher","first-page":"2197","DOI":"10.1007\/s11136-021-02822-4","volume":"30","author":"JJ Gagnier","year":"2021","unstructured":"Gagnier JJ, Lai J, Mokkink LB, Terwee CB (2021) COSMIN reporting guideline for studies on measurement properties of patient-reported outcome measures. Qual Life Res 30(8):2197\u20132218. https:\/\/doi.org\/10.1007\/s11136-021-02822-4","journal-title":"Qual Life Res"},{"issue":"5","key":"596_CR13","doi-asserted-by":"publisher","first-page":"1147","DOI":"10.1007\/s11136-018-1798-3","volume":"27","author":"CAC Prinsen","year":"2018","unstructured":"Prinsen CAC, Mokkink LB, Bouter LM, Alonso J, Patrick DL, de Vet HCW, Terwee CB (2018) COSMIN guideline for systematic reviews of patient-reported outcome measures. Qual Life Res 27(5):1147\u20131157. https:\/\/doi.org\/10.1007\/s11136-018-1798-3","journal-title":"Qual Life Res"},{"issue":"2","key":"596_CR14","first-page":"103","volume":"3","author":"JM Linacre","year":"1999","unstructured":"Linacre JM (1999) Investigating rating scale category utility. J Outcome Meas 3(2):103\u2013122","journal-title":"J Outcome Meas"},{"key":"596_CR15","doi-asserted-by":"publisher","DOI":"10.1007\/978-981-10-8414-0","volume-title":"Living with chronic disease: measuring important patient-reported outcomes","author":"P Kamudoni","year":"2018","unstructured":"Kamudoni P, Nutjaree J, Salek S (2018) Living with chronic disease: measuring important patient-reported outcomes. Springer, Singapore"},{"issue":"1","key":"596_CR16","doi-asserted-by":"publisher","first-page":"21","DOI":"10.1186\/1471-244X-9-21","volume":"9","author":"TL Shea","year":"2009","unstructured":"Shea TL, Tennant A, Pallant JF (2009) Rasch model analysis of the depression, anxiety and stress scales (DASS). BMC Psychiatr 9(1):21. https:\/\/doi.org\/10.1186\/1471-244X-9-21","journal-title":"BMC Psychiatr"},{"key":"596_CR17","volume-title":"Rating scale analysis","author":"BD Wright","year":"1982","unstructured":"Wright BD, Masters GN (1982) Rating scale analysis. MESA press, San Diego"},{"issue":"3","key":"596_CR18","doi-asserted-by":"publisher","first-page":"441","DOI":"10.1007\/s11136-011-9980-x","volume":"21","author":"C Gorecki","year":"2012","unstructured":"Gorecki C, Lamping DL, Nixon J, Brown JM, Cano S (2012) Applying mixed methods to pretest the pressure ulcer quality of life (PU-QOL) instrument. Qual Life Res 21(3):441\u2013451. https:\/\/doi.org\/10.1007\/s11136-011-9980-x","journal-title":"Qual Life Res"},{"key":"596_CR19","unstructured":"Bond TG, Fox CM, Lacey H (Hrsg) (2007) Applying the Rasch model: Fundamental measurement. Citeseer"},{"issue":"4","key":"596_CR20","doi-asserted-by":"publisher","first-page":"309","DOI":"10.1177\/0146621612441858","volume":"36","author":"D Andrich","year":"2012","unstructured":"Andrich D, Humphry SM, Marais I (2012) Quantifying local, response dependence between two polytomous items using the rasch model. Appl Psychol Meas 36(4):309\u2013324. https:\/\/doi.org\/10.1177\/0146621612441858","journal-title":"Appl Psychol Meas"},{"issue":"1","key":"596_CR21","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1111\/j.1745-3984.1999.tb00543.x","volume":"36","author":"R Zwick","year":"1999","unstructured":"Zwick R, Thayer DT, Lewis C (1999) An Empirical bayes approach to Mantel-Haenszel DIF analysis. J Educ Meas 36(1):1\u201328. https:\/\/doi.org\/10.1111\/j.1745-3984.1999.tb00543.x","journal-title":"J Educ Meas"},{"key":"596_CR22","doi-asserted-by":"publisher","first-page":"864","DOI":"10.3389\/fpsyt.2019.00864","volume":"10","author":"HL Quittkat","year":"2019","unstructured":"Quittkat HL, Hartmann AS, D\u00fcsing R, Buhlmann U, Vocks S (2019) Body dissatisfaction, importance of appearance, and body appreciation in men and women over the lifespan. Front Psych 10:864. https:\/\/doi.org\/10.3389\/fpsyt.2019.00864","journal-title":"Front Psych"},{"issue":"4","key":"596_CR23","doi-asserted-by":"publisher","first-page":"283","DOI":"10.2190\/AG.66.4.b","volume":"66","author":"P Basevitz","year":"2008","unstructured":"Basevitz P, Pushkar D, Chaikelson J, Conway M, Dalton C (2008) Age-related differences in worry and related processes. Int J Aging Human Dev 66(4):283\u2013305. https:\/\/doi.org\/10.2190\/AG.66.4.b","journal-title":"Int J Aging Human Dev"},{"issue":"4","key":"596_CR24","doi-asserted-by":"publisher","first-page":"254","DOI":"10.1016\/S0197-0070(84)80127-8","volume":"5","author":"PM Levenson","year":"1984","unstructured":"Levenson PM, Morrow JR, Pfefferbaum BJ (1984) Attitudes toward health and illness: a comparison of adolescent, physician, teacher, and school nurse views. J Adolesc Health Care 5(4):254\u2013260. https:\/\/doi.org\/10.1016\/S0197-0070(84)80127-8","journal-title":"J Adolesc Health Care"},{"issue":"4","key":"596_CR25","doi-asserted-by":"publisher","first-page":"465","DOI":"10.1111\/j.1745-3984.1996.tb00502.x","volume":"33","author":"JA Douglas","year":"1996","unstructured":"Douglas JA, Roussos LA, Stout W (1996) Item-bundle DIF hypothesis testing: identifying suspect bundles and assessing their differential functioning. J Educ Meas 33(4):465\u2013484. https:\/\/doi.org\/10.1111\/j.1745-3984.1996.tb00502.x","journal-title":"J Educ Meas"},{"issue":"1","key":"596_CR26","first-page":"6","volume":"78","author":"LB Mokkink","year":"2018","unstructured":"Mokkink LB, Prinsen C, Patrick DL, Alonso J, Bouter LM, de Vet HC, Terwee CB, Mokkink L (2018) COSMIN methodology for systematic reviews of patient-reported outcome measures (PROMs). User Manual 78(1):6\u20133","journal-title":"User Manual"}],"container-title":["Journal of Patient-Reported Outcomes"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s41687-023-00596-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s41687-023-00596-6\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s41687-023-00596-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,6,6]],"date-time":"2023-06-06T19:46:08Z","timestamp":1686080768000},"score":1,"resource":{"primary":{"URL":"https:\/\/jpro.springeropen.com\/articles\/10.1186\/s41687-023-00596-6"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,6,6]]},"references-count":26,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2023,12]]}},"alternative-id":["596"],"URL":"https:\/\/doi.org\/10.1186\/s41687-023-00596-6","relation":{},"ISSN":["2509-8020"],"issn-type":[{"value":"2509-8020","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,6,6]]},"assertion":[{"value":"16 December 2022","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"23 May 2023","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"6 June 2023","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Ethical approval was obtained by the corresponding ethics committees of the different countries.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Christian Apfelbacher has received institutional funding from Dr. August Wolff GmbH & Co. KG Arzneimittel, and consultancy fees from Dr. August Wolff GmbH & Co. KG Arzneimittel, LEO Pharma, RHEACELL and Sanofi Genzyme. Clarissa Masur is and Christoph Abels was an employee of Dr. August Wolff GmbH & Co. KG Arzneimittel. Paul Kamudoni is a developer of the HidroQoL and is an employee of Merck Healthcare KgaA. Sam Salek is a joint developer of the HidroQoL, has received unrestricted educational grants from GlaxoSmithKline, European Hematology Association, Novartis, Bristol Meyer Squib, Sanofi, Celgene and consultancy fees from Pfizer and Agios.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"55"}}