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. 2019 Sep 5;3(1):59.
doi: 10.1186/s41687-019-0148-8.

Development and validation of the Axillary Sweating Daily Diary: a patient-reported outcome measure to assess axillary sweating severity

L M Nelson  1 , D DiBenedetti  2 , D M Pariser  3 , D A Glaser  4 , A A Hebert  5 , H Hofland  6 , J Drew  6 , D Ingolia  6 , K K Gillard  6 , S Fehnel  2
Affiliations

Development and validation of the Axillary Sweating Daily Diary: a patient-reported outcome measure to assess axillary sweating severity

L M Nelson et al. J Patient Rep Outcomes. .

Abstract

Background: Hyperhidrosis is estimated to affect ~ 4.8% of the US population, and most patients experience a negative psychological impact. Here, we describe development and psychometric evaluation of a patient-reported outcome (PRO) measure to assess severity of axillary hyperhidrosis in clinical trials that meets current U.S. regulatory standards to support product approvals.

Methods: Three rounds of hybrid concept-elicitation/cognitive-debriefing qualitative interviews were conducted in adults with clinician-diagnosed primary axillary hyperhidrosis, followed by similar interviews in children/adolescents. The draft measure included diary items for presence, severity, impact and bothersomeness (basis of the Axillary Sweating Daily Diary [ASDD]), exploratory weekly impact items, and a single-item Patient Global Impression of Change (PGIC). Phase 2 (adults only) and phase 3 (adults and children ≥9 years) clinical trial data were utilized to evaluate measurement properties of the resulting draft measure: floor/ceiling effects, nonresponse bias, test-retest reliability, construct validity, and responsiveness were assessed. The primary concept of interest was axillary sweating severity (ASDD Item 2); however, additional supportive concepts were explored to allow for development of a comprehensive hyperhidrosis measure.

Results: Twenty-nine patient interviews were conducted (N = 21 adult and N = 8 children/adolescents), resulting in the ASDD (4 items, patients ≥16y) and child-specific ASDD-C (2 items ≥9y to <16y), as well as 6 Weekly Impact items and the PGIC (patients ≥16y). No floor/ceiling effects or response biases were identified. Consistency between hypothesized and observed correlation patterns between ASDD/ASDD-C items and other efficacy measures supported construct validity. Intraclass correlation coefficients supported test-retest reliability (0.91-0.93; Item 2). Large effect sizes (- 2.2 to - 2.4) demonstrated that the ASDD/ASDD-C Item 2 could detect changes in hyperhidrosis severity, supporting the measure's responsiveness. Patients perceiving a moderate improvement in symptoms on the PGIC experienced an average 3.8-point improvement on ASDD axillary sweating severity (Item 2); thus, a 4-point responder threshold was defined as a clinically meaningful change.

Conclusions: Qualitative and quantitative evidence support the reliability and validity of the ASDD/ASDD-C and its use in the clinical evaluation of axillary hyperhidrosis treatments. Further evaluation of this measure in future research studies is warranted to demonstrate consistent performance across different axillary hyperhidrosis populations and in different study contexts.

Keywords: Axillary sweating daily diary (ASDD); Hyperhidrosis; Patient reported outcome; Sweating severity.

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Conflict of interest statement

LN, DD, and SF: Employee of RTI Health Solutions. DMP: Consultant (honoraria): Brickell Biotech, Inc.; Biofrontera AG; Celgene; Dermira, Inc.; DUSA Pharmaceuticals, Inc.; LEO Pharma; Novartis; Promius Pharma, LLC; Regeneron Pharmaceuticals, Inc.; Sanofi; TheraVida, Inc.; Valeant Pharmaceuticals International, Inc. Advisory board (honoraria): Pfizer, Inc. Investigator (grants/research funding): Abbott Laboratories; Amgen, Inc.; Brickell Biotech, Inc.; Celgene; Dermavant Sciences; Eli Lilly and Company; LEO Pharma; Merck & Co, Inc.; Novartis; Novo Nordisk A/S; Ortho Dermatologics; Peplin, Inc.; Photocure ASA; Promius Pharma, LLC; Regeneron Pharmaceuticals, Inc.; Stiefel Laboratories; Valeant Pharmaceuticals International, Inc. Investigator (honoraria): LEO Pharma; Pfizer, Inc. DAG: Consultant and investigator: Dermira, Inc. AAH: Investigator (research funding): Dermira, Inc. (paid to the UTHealth McGovern Medical School, Houston). Advisory board (honoraria): Dermira, Inc. Research funding (all monies paid to the UTHealth McGovern Medical School, Houston): Allergan, Plc.; Amgen, Inc.; Cassiopea; Celgene; Dermavant Sciences; Eli Lilly and Company; Galderma S.A.; GSK, Plc.; LEO Pharma; Mayne Pharma; Medimetriks Pharmaceuticals; Novan, Inc.; Promius Pharma, LLC; Vanda Pharmaceuticals. Honoraria: Amgen; GSK, Plc.; Pfizer, Inc.; Valeant Pharmaceutics International, Inc. HH, JD, KKG, and DI: Employee and stockholder of Dermira, Inc.

Figures

Fig. 1
Fig. 1
Overview of the Instrument Development Process. ASDD, Axillary Sweating Daily Diary; HDSS, Hyperhidrosis Disease Severity Scale; IHhS, International Hyperhidrosis Society
Fig. 2
Fig. 2
Areas of bother and impact associated with axillary hyperhidrosis (Adult Patient Interviews; N = 21)
See this image and copyright information in PMC

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