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.

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.

Citation

Barbarot, S., Rogers, N. K., Abuabara, K., Aubert, H., Chalmers, J., Flohr, C., Hanfin, J., Naldi, L., Margolis, D. J., Paul, C., Ridd, M. J., Schuttelaar, M.-L. A., Simpson, E., Tauber, M., Volke, A., Weidinger, S., Wilkes, S. R., Wollenberg, A., & Thomas, K. S. (2016). Strategies used for measuring long-term control in atopic dermatitis trials: A systematic review. Journal of The American Academy of Dermatology, 75(5), https://doi.org/10.1016/j.jaad.2016.05.043

• 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: 1097-6787
• 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
• Contract Date: Jul 10, 2016