Measuring long‐term disease control in atopic dermatitis: a validation study of well controlled weeks

Langan, Sinéad M. and Stuart, Beth and Bradshaw, Lucy and Schmitt, Jochen and Williams, Hywel C. and Thomas, Kim S. (2017) Measuring long‐term disease control in atopic dermatitis: a validation study of well controlled weeks. Journal of Allergy and Clinical Immunology . ISSN 1097-6825 (In Press)

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Abstract

Background

Because atopic dermatitis (AD) is a relapsing, remitting disease, assessing long‐term control is important. Well controlled weeks (WCWs) have been used to assess asthma long‐term control, but never validated for AD.

Objectives

To assess feasibility, validity and interpretability of WCWs in AD patients.

Methods

Three studies of patients with moderate‐to‐severe AD including 4‐6 months of daily/weekly symptom and treatment use data were evaluated (Study A: n=336; Study B: n=60; Study C: n=224). WCWs were defined by worsening symptoms and increased medication use. Feasibility, construct validity and interpretability of WCWs were determined by assessing missing data, association with validated AD outcomes, and floor/ceiling effects. Analysis used linear and logistic regression.

Results

WCWs were feasible to collect ‐ 95.2% (study A) and 94.7% (study B) contributed data for at least half of the weekly data‐points, and 93.2% and 88.7% contributed to all data‐points up to 4 months. WCWs were significantly associated with validated AD severity instruments including patient-reported (POEM) and objective signs (EASI, TIS and SASSAD). The odds of experiencing a WCW if AD severity was clear/mild was 5.8 (95% confidence interval (CI) 3.5 to 9.7), 1.9 (95%CI 0.8 to 4.4) and 8.1 (95%CI 4.5 to 14.6) in Studies A, B and C, respectively. WCWs were associated with ceiling effects‐ 31.6% (study A) and 37.5% (study B) of participants had no WCWs for >90% of the time.

Conclusions

WCWs are valid and feasible for measuring long‐term control in AD trials. However, ceiling effects and burden of data collection may limit use.

Item Type: Article
Keywords: AD, long‐term control, outcome measures
Schools/Departments: University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine
University of Nottingham, UK > Faculty of Medicine and Health Sciences > School of Medicine > Units > Clinical Trials Unit
Identification Number: 10.1016/j.jaci.2017.02.043
Depositing User: Eprints, Support
Date Deposited: 13 Feb 2017 15:12
Last Modified: 14 Oct 2017 21:52
URI: http://eprints.nottingham.ac.uk/id/eprint/40565

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