Development and validation of the Axillary Sweating Daily Diary: a patient-reported outcome measure to assess axillary sweating severity
| العنوان: | Development and validation of the Axillary Sweating Daily Diary: a patient-reported outcome measure to assess axillary sweating severity |
|---|---|
| المؤلفون: | Adelaide A. Hebert, K. K. Gillard, David M. Pariser, J. Drew, Sheri Fehnel, D. Ingolia, H. Hofland, Dana B. DiBenedetti, Lauren Nelson, Dee Anna Glaser |
| المصدر: | Journal of Patient-Reported Outcomes, Vol 3, Iss 1, Pp 1-13 (2019) Journal of Patient-Reported Outcomes |
| بيانات النشر: | SpringerOpen, 2019. |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | medicine.medical_specialty, Intraclass correlation, Sweating severity, Population, Axillary sweating daily diary (ASDD), Health Informatics, Affect (psychology), 03 medical and health sciences, 0302 clinical medicine, Health Information Management, Medicine, Hyperhidrosis, Non-response bias, education, education.field_of_study, business.industry, 030503 health policy & services, Research, lcsh:Public aspects of medicine, Construct validity, lcsh:RA1-1270, Patient reported outcome, Clinical trial, 030220 oncology & carcinogenesis, Physical therapy, Patient-reported outcome, medicine.symptom, 0305 other medical science, business |
| الوصف: | 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 |
| اللغة: | English |
| تدمد: | 2509-8020 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::aeacc0ab1159ff0cb32f720d929bbb92Test http://link.springer.com/article/10.1186/s41687-019-0148-8Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....aeacc0ab1159ff0cb32f720d929bbb92 |
| قاعدة البيانات: | OpenAIRE |
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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. 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