Evaluating patient-perceived control of atopic dermatitis: design,validation, and scoring of the Atopic Dermatitis Control Tool (ADCT) |
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Authors: | David M. Pariser Eric L. Simpson Abhijit Gadkari Thomas Bieber David J. Margolis Michelle Brown |
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Affiliation: | 1. Department of Dermatology, Eastern Virginia Medical School, Norfolk, VA, USA;2. Department of Dermatology, Oregon Health and Science University, Portland, OR, USA;3. Health Economics and Outcomes Research, Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA;4. Department of Dermatology and Allergy, University Hospital Bonn, Bonn, Germany;5. Department of Dermatology, University of Pennsylvania Medical Center, Philadelphia, PA, USA;6. RTI Health Solutions, Research Triangle Park, NC, USA |
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Abstract: | AbstractObjectives: The Atopic Dermatitis Control Tool (ADCT) was designed to evaluate patient-perceived AD control and facilitate patient–physician discussion on long-term disease control.Methods: The study was performed in adult patients with AD. Development of the ADCT followed US Food and Drug Administration (FDA) guidelines on patient-reported outcome measures (PROMs). Qualitative research, including targeted literature review, interviews with clinical experts, and combined concept elicitation/cognitive debriefing with patients with AD, was conducted to provide a list of comprehensive concepts capturing AD control per physician and patient perspectives. Quantitative methods assessed psychometric properties of the instrument and defined the threshold for AD control.Results: The resulting pilot six-item ADCT, reflecting key concepts related to AD control, had 7-day recall and assessed symptoms and impacts on patients’ everyday lives by severity and/or frequency. The ADCT showed good content validity (well understood by adult patients with AD), and quick completion time (<2?min). Psychometric analysis indicated no floor/ceiling effects for response distributions, particularly strong (r?≥?0.80) inter-item correlations for the six ADCT items, robust construct validity (r?>?0.50), and item-level discriminating ability (p?.03); this supported the derivation of a total score based on responses to all items. ADCT total score showed evidence of strong internal consistency reliability (Cronbach’s alpha >0.80). A score ≥7 points was identified as an optimum threshold to identify patients whose AD is “not in control.”Conclusions: No single validated instrument has been available to holistically evaluate patient-perceived AD control. The newly developed ADCT displays good-to-excellent content validity, construct validity, internal consistency, reliability, and discriminating ability. |
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Keywords: | Atopic dermatitis patient-reported outcomes long-term disease control psychometric validation |
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