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Strategies used for measuring long-term control in atopic dermatitis trials: A systematic review

Barbarot, Sebastien; Rogers, Natasha K.; Abuabara, Katrina; Aubert, Helene; Chalmers, Joanne; Flohr, Carsten; Hanfin, Jon; Naldi, Luigi; Margolis, David J.; Paul, Carle; Ridd, Matthew J.; Schuttelaar, Marie-Louise Anna; Simpson, Eric; Tauber, Marie; Volke, Annika; Weidinger, Stephan; Wilkes, Sally R.; Wollenberg, Andreas; Thomas, Kim S.

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Authors

Sebastien Barbarot

Natasha K. Rogers

Katrina Abuabara

Helene Aubert

Joanne Chalmers

Carsten Flohr

Jon Hanfin

Luigi Naldi

David J. Margolis

Carle Paul

Matthew J. Ridd

Marie-Louise Anna Schuttelaar

Eric Simpson

Marie Tauber

Annika Volke

Stephan Weidinger

Sally R. Wilkes

Andreas Wollenberg



Abstract

Background: Atopic dermatitis (AD) is a chronic inflammatory skin disease. There are no standardised methods for capturing long-term control of AD.

Objective: To identify how long-term control has been captured in published randomised controlled trials (RCTs). Resultswill initiate consensus discussions on how best to measure long-term control in the core outcome set for AD.

Methods: Systematic review of RCTs of AD treatments published between 2000 and 2013, with a follow-up period of ?3 months, at least one outcome measure recorded at ?3 time-points, full paper available, and published in English.

Results: 101/ 353 RCTs were eligible. Methods to capture long-term control included: repeated measurement of AD outcomes (92 RCTs; 91%), use of AD medication (29 RCTs; 28.7%); and AD flares/remissions (26 RCTs; 25.7%). Repeated measurements of AD outcomes were typically collected 3 to 5 times during a trial, but analysis methods often failed to make best use of the data. Time to first flare was most commonly for trials including flare data (21/52). Medication-use was recorded based on quantity, potency and frequency of application. Limitations: Included RCT data only

Conclusion: This review illustrates the difficulties in measuring long-term control, and points to the need for improved harmonization of outcomes.

Journal Article Type Article
Acceptance Date May 31, 2016
Online Publication Date Aug 10, 2016
Publication Date Nov 30, 2016
Deposit Date Jul 10, 2016
Publicly Available Date Aug 10, 2016
Journal Journal of the American Academy of Dermatology
Print ISSN 0190-9622
Electronic ISSN 1523-1747
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 75
Issue 5
DOI https://doi.org/10.1016/j.jaad.2016.05.043
Keywords Atopic eczema; Atopic dermatitis; Long-term control; Outcome measures; RCTs; Systematic review; Flares.
Public URL https://nottingham-repository.worktribe.com/output/826041
Publisher URL http://www.sciencedirect.com/science/article/pii/S0190962216303255

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