TY - JOUR
T1 - Evaluating patient-perceived control of atopic dermatitis
T2 - design, validation, and scoring of the Atopic Dermatitis Control Tool (ADCT)
AU - Pariser, David M.
AU - Simpson, Eric L.
AU - Gadkari, Abhijit
AU - Bieber, Thomas
AU - Margolis, David J.
AU - Brown, Michelle
AU - Nelson, Lauren
AU - Mahajan, Puneet
AU - Reaney, Matthew
AU - Guillemin, Isabelle
AU - Mallya, Usha G.
AU - Eckert, Laurent
N1 - Publisher Copyright:
© 2019, © 2019 Sanofi Group and Regeneron Pharmaceuticals, Inc. Published by Informa UK Limited, trading as Taylor & Francis Group.
PY - 2020/3/3
Y1 - 2020/3/3
N2 - 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.
AB - 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.
KW - Atopic dermatitis
KW - long-term disease control
KW - patient-reported outcomes
KW - psychometric validation
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U2 - 10.1080/03007995.2019.1699516
DO - 10.1080/03007995.2019.1699516
M3 - Article
C2 - 31778083
AN - SCOPUS:85076422053
SN - 0300-7995
VL - 36
SP - 367
EP - 376
JO - Current Medical Research and Opinion
JF - Current Medical Research and Opinion
IS - 3
ER -