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

被引:66
|
作者
Simpson, Eric [1 ]
Eckert, Laurent [2 ]
Gadkari, Abhijit [3 ]
Mallya, Usha G. [4 ]
Yang, Min [5 ]
Nelson, Lauren [6 ]
Brown, Michelle [6 ]
Reaney, Matt [7 ]
Mahajan, Puneet [8 ]
Guillemin, Isabelle [2 ]
Boguniewicz, Mark [9 ]
Pariser, David [10 ]
机构
[1] Oregon Hlth & Sci Univ, Portland, OR 97201 USA
[2] Sanofi, Paris, France
[3] Regeneron Pharmaceut Inc, Tarrytown, NY USA
[4] Sanofi, Cambridge, MA USA
[5] Anal Grp, Boston, MA USA
[6] RTI Hlth Solut, Res Triangle Pk, NC USA
[7] Sanofi, Guildford, Surrey, England
[8] Sanofi, Bridgewater, NJ USA
[9] Univ Colorado, Sch Med, Boulder, CO 80309 USA
[10] Eastern Virginia Med Sch, Norfolk, VA 23501 USA
来源
BMC DERMATOLOGY | 2019年 / 19卷 / 01期
关键词
Atopic dermatitis; tool; control; symptoms; impacts; ADCT (c); reliability; validity; responsiveness; QUALITY-OF-LIFE; DISEASE SEVERITY; OUTCOME MEASURES; BURDEN; ECZEMA; ADULTS; PERSPECTIVES; MULTICENTER; MANAGEMENT; DUPILUMAB;
D O I
10.1186/s12895-019-0095-3
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
Background The Atopic Dermatitis Control Tool (ADCT (c)) is a brief patient self-administered instrument designed and validated to assess atopic dermatitis (AD) control; six AD symptoms and impacts are evaluated over the past week, including overall severity of symptoms, days with intense episodes of itching, intensity of bother, problem with sleep, impact on daily activities, and impact on mood or emotions. This study assessed the reliability, validity, and responsiveness of the ADCT in a longitudinal context, and provided thresholds to identify meaningful within-person change. Methods Data were from a prospective, longitudinal patient survey study of real-world effectiveness of dupilumab in patients with AD. Eligible patients completed a baseline survey before starting dupilumab and were followed at Months 1, 2, 3, and 6 post-initiation as they became eligible. Results Psychometric analyses confirmed internal consistency; Cronbach's alpha coefficients were consistently above the threshold of 0.70 across each follow-up; item-to-total correlations were above the threshold of r >= 0.50. High correlations between the ADCT and the Dermatology Life Quality Index (DLQI) and skin pain supported construct validity, while known-group validity was shown on Patient Global Assessment of Disease (PGAD) overall well-being subgroups with worse AD-related overall well-being having higher mean ADCT total scores at all time points. The ability of the ADCT to detect change was confirmed; the threshold for meaningful within-person change was estimated to be 5 points. Finally, test-retest reliability was confirmed in subgroups of patients with stable PGAD responses. Conclusions Our findings confirm that the ADCT is a valid and reliable tool for assessing AD control.
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页数:10
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