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

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.

Validation of the Atopic Dermatitis Control Tool (ADCT©) using a longitudinal survey of biologic-treated patients with atopic dermatitis

“…To confirm known-groups validity, mean ADCT total scores were compared across adjacent subgroups of patients based on PGAD responses (Excellent, Very good, Good, Fair, Poor) and categories of DLQI responses: no effect on patient life (score range: 0-1), a small effect (2-5), a moderate effect (6-10), a very large effect (11)(12)(13)(14)(15)(16)(17)(18)(19)(20), an extremely large effect (21)(22)(23)(24)(25)(26)(27)(28)(29)(30) [36] ( Table 1). Patients in a worse PGAD or DLQI band subgroup were expected to display poorer AD control (i.e., higher mean ADCT total scores, indicating more severe symptoms/greater impact) than patients in a better PGAD or DLQI band subgroup.…”

“…An initial evaluation of the psychometric properties of the instrument in the United States has indicated that the ADCT is valid and reliable for assessing patient-perceived AD control in adults [29]. In addition, a score of ≥7 points was derived as the threshold to identify patients "not in control", based on optimal sensitivity/specificity values [29]. The ADCT© is protected by copyright with all rights reserved to Sanofi, and its development partners.…”

Validation of the Atopic Dermatitis Control Tool (ADCT©) using a longitudinal survey of biologic-treated patients with atopic dermatitis

“…Each of the six ADCT items has a score range from 0 (no problem) to 4 (worst), rating the severity of each concept; the total score ranges from 0 to 24, which is the summation of the responses to all the items. An initial evaluation of the psychometric properties of the instrument in the United States has indicated that the ADCT is valid and reliable for assessing patient-perceived AD control in adults [29]. In addition, a score of ≥7 points was derived as the threshold to identify patients "not in control", based on optimal sensitivity/specificity values [29].…”

Validation of the Atopic Dermatitis Control Tool (ADCT©) using a longitudinal survey of biologic-treated patients with atopic dermatitis

“…The Atopic Dermatitis Control Tool (ADCT©) is a new PROM designed to assess patient-perceived disease control, meeting this current measurement gap in the management of patients with AD (ADCT v1; https://patient-questionnaires.sanofi.com/questionnaires/adct-atopic-dermatitis-controlcommunication-tool) [29]. It is envisaged that the tool will also foster patient-clinician communication regarding disease control.…”

“…An initial evaluation of the psychometric properties of the instrument in the United States has indicated that the ADCT is valid and reliable for assessing patient-perceived AD control in adults. In addition, a score of ≥7 points was derived as the threshold to identify patients "not in control", based on optimal sensitivity/specificity values [29].…”