AI Article Synopsis

  • Clinical trials for primary axillary hyperhidrosis (AHH) need effective ways to measure severity from the patient's viewpoint, leading to the development of the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) scale.
  • The objective of this study was to assess the HDSM-Ax's psychometric performance and determine what constitutes a significant change in AHH severity during a clinical trial for sofpironium bromide gel.
  • Findings show that HDSM-Ax meets psychometric standards and that a change of 1 point on the severity scale is clinically meaningful for patients experiencing AHH.

Article 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.

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Source
http://dx.doi.org/10.36849/JDD.2021.5569DOI Listing

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