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Curr Med Res Opin. 2019 Dec 12:1-10. doi: 10.1080/03007995.2019.1699516. [Epub ahead of print]

Evaluating patient-perceived control of atopic dermatitis: design, validation, and scoring of the Atopic Dermatitis Control Tool (ADCT).

Author information

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.
7
Health Economics Value Assessment, Sanofi, Bridgewater, NJ, USA.
8
Formerly, Health Economics and Outcomes Research, Sanofi, Guildford, UK.
9
Health Economics Value Assessment, Sanofi, Chilly Mazarin, France.
10
Health Economics Value Assessment, Sanofi Genzyme, Cambridge, MA, USA.

Abstract

Objectives: 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.

KEYWORDS:

Atopic dermatitis; long-term disease control; patient-reported outcomes; psychometric validation

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