Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax): Evaluation of Measurement Performance
dc.contributor.author | Hobart, J | |
dc.date.accessioned | 2020-12-21T13:39:47Z | |
dc.date.issued | 2021-04 | |
dc.identifier.issn | 1545-9616 | |
dc.identifier.uri | http://hdl.handle.net/10026.1/16764 | |
dc.description.abstract |
BACKGROUND: Clinical trials of primary axillary hyperhidrosis (AHH) require rigorous measurement of AHH severity from the patient’s perspective. Previously, we reported conceptualization and item content development for the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) scale. OBJECTIVE: To evaluate the psychometric performance and estimate clinically meaningful change scores for the HDSM-Ax in a Phase IIb clinical study of sofpironium bromide gel for AHH. METHOD: HDSM-Ax measurement performance was analyzed in trial response data using two psychometric paradigms: Classical Test and Rasch Measurement Theories (CTT; RMT). HDSM-Ax meaningful change scores were estimated from anchor-based methods using two global summary questions of hyperhidrosis severity and the Hyperhidrosis Disease Severity Score (HDSS). RESULTS: HDSM-Ax satisfied CTT and RMT criteria as a fit-for-purpose outcome measure in AHH clinical trials. Within-person anchor-based analyses indicated a 1-point change in HDSM-Ax severity score (range, 0–4) represents a clinically meaningful change in AHH severity. CONCLUSION: HDSM-Ax is a well-defined and reliable measure of AHH severity. A 1-point change in HDSM-Ax score is clinically meaningful. J Drugs Dermatol.20(4):410-418. doi:10.36849/JDD.5569. | |
dc.format.extent | 410-418 | |
dc.format.medium | ||
dc.language | eng | |
dc.language.iso | en | |
dc.publisher | Journal of Drugs in Dermatology, Inc. | |
dc.subject | Administration, Cutaneous | |
dc.subject | Adult | |
dc.subject | Axilla | |
dc.subject | Cholinergic Antagonists | |
dc.subject | Clinical Trials, Phase II as Topic | |
dc.subject | Female | |
dc.subject | Gels | |
dc.subject | Humans | |
dc.subject | Hyperhidrosis | |
dc.subject | Male | |
dc.subject | Middle Aged | |
dc.subject | Multicenter Studies as Topic | |
dc.subject | Psychometrics | |
dc.subject | Quality of Life | |
dc.subject | Randomized Controlled Trials as Topic | |
dc.subject | Reproducibility of Results | |
dc.subject | Severity of Illness Index | |
dc.subject | Treatment Outcome | |
dc.subject | Young Adult | |
dc.title | Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax): Evaluation of Measurement Performance | |
dc.type | journal-article | |
dc.type | Article | |
plymouth.author-url | https://www.ncbi.nlm.nih.gov/pubmed/33852243 | |
plymouth.issue | 4 | |
plymouth.volume | 20 | |
plymouth.publication-status | Published | |
plymouth.journal | Journal of drugs in dermatology : JDD | |
dc.identifier.doi | 10.36849/JDD.5569 | |
plymouth.organisational-group | /Plymouth | |
plymouth.organisational-group | /Plymouth/Faculty of Health | |
plymouth.organisational-group | /Plymouth/Faculty of Health/Peninsula Medical School | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA/UoA03 Allied Health Professions, Dentistry, Nursing and Pharmacy | |
plymouth.organisational-group | /Plymouth/Research Groups | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED) | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)/CCT&PS | |
plymouth.organisational-group | /Plymouth/Users by role | |
plymouth.organisational-group | /Plymouth/Users by role/Academics | |
dc.publisher.place | United States | |
dcterms.dateAccepted | 2020-10-21 | |
dc.rights.embargodate | 2021-7-6 | |
dc.rights.embargoperiod | Not known | |
rioxxterms.versionofrecord | 10.36849/JDD.5569 | |
rioxxterms.licenseref.uri | http://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.licenseref.startdate | 2021-04 | |
rioxxterms.type | Journal Article/Review |