PT  - JOURNAL ARTICLE
AU  - Katrina Abuabara
AU  - Jonathan I Silverberg
AU  - Eric L Simpson
AU  - Amy S Paller
AU  - Lawrence F. Eichenfield
AU  - Robert Bissonnette
AU  - James Krueger
AU  - John E. Harris
AU  - Laura Dalfonso
AU  - Stephanie E Watkins
AU  - Julie M Crawford
AU  - D Thaçi
AU  - Emma Guttman-Yassky
TI  - International observational atopic dermatitis cohort to follow natural history and treatment course: TARGET-DERM AD study design and rationale
AID  - 10.1136/bmjopen-2020-039928
DP  - 2020 Nov 01
TA  - BMJ Open
PG  - e039928
VI  - 10
IP  - 11
4099  - http://bmjopen.bmj.com/content/10/11/e039928.short
4100  - http://bmjopen.bmj.com/content/10/11/e039928.full
SO  - BMJ Open2020 Nov 01; 10
AB  - Introduction As new topical and systemic treatments become available for atopic dermatitis (AD), there is a need to understand how treatments are being used in routine clinical practice, their comparative effectiveness and their long-term safety in diverse clinical settings.Methods and analysis The TARGET-DERM AD cohort is a longitudinal, observational study of patients with AD of all ages, designed to provide practical information on long-term effectiveness and safety unobtainable in traditional registration trials. Patients with physician-diagnosed AD receiving prescription treatment (topical or systemic) will be enrolled at academic and community clinical centres. Up to 3 years of retrospective medical records, 5 years of prospective medical records, and optional biological samples and patient-reported outcomes will be collected. The primary aims include characterisation of AD treatment regimens, evaluation of response to therapy, and description of adverse events.Ethics and dissemination TARGET-DERM has been approved by a central IRB (Copernicus Group IRB, 5000 Centregreen Way Suite 200, Cary, North Carolina 27513) as well as local and institutional IRBs. No additional Ethics Committee reviews. Results will be reviewed by a publications committee and submitted to peer-reviewed journals.Trial registration number NCT03661866, pre-results.