The Hyperhidrosis Disease Severity Measure-Axillary: Conceptualization and Development of Item Content

Area of Science:

• Dermatology
• Medical device development
• Patient-reported outcomes

Background:

• Primary axillary hyperhidrosis (AHH) significantly impacts patients' lives.
• Current assessment tools, like the Hyperhidrosis Disease Severity Scale (HDSS), are limited in capturing the full spectrum of AHH symptom severity.
• There is a need for improved patient-reported outcome (PRO) measures for AHH.

Purpose of the Study:

• To develop and validate a new patient-reported outcome measure for assessing the severity of primary axillary hyperhidrosis (AHH).
• To create a more comprehensive tool than the existing HDSS for AHH symptom assessment.

Main Methods:

• The Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) was developed through concept elicitation interviews with 58 AHH patients, literature review, and expert input.
• Cognitive debriefing interviews (n=26, n=27, n=5) assessed the clarity, relevance, and content of the HDSM-Ax.
• Rasch Measurement Theory (RMT) analyses were employed to evaluate content validity and cross-sectional measurement properties.

Main Results:

• The 11-item HDSM-Ax scale ranges from 0 (no sweating) to 44 (worst possible sweating).
• Content validity was established through interviews demonstrating saturation of AHH symptom concepts.
• Cognitive debriefing confirmed the item content's completeness, comprehensibility, meaningfulness, and relevance. RMT analysis indicated adequate targeting, item fit, and stability.

Conclusions:

• The HDSM-Ax is a well-developed PRO measure for axillary hyperhidrosis severity.
• It surpasses the HDSS in its ability to quantify symptom severity.
• The HDSM-Ax is suitable for use in clinical research and practice to monitor treatment response.