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

BACKGROUND: Atopic dermatitis (AD) is a chronic inflammatory skin disease. There are no standardized methods for capturing long-term control of AD. OBJECTIVE: We sought to identify how long-term control has been captured in published randomized controlled trials (RCTs). Results will initiate consensus discussions on how best to measure long-term control in the core outcome set for AD. METHODS: We conducted a systematic review of RCTs of AD treatments published between 2000 and 2013, with a follow-up period of 3 months or longer, at least 1 outcome measure recorded at 3 or more time points, full article available, and published in English. RESULTS: In all, 101 of 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 used for trials including flare data (21/52). Medication use was recorded based on quantity, potency, and frequency of application. LIMITATIONS: We 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.

Contributors

Barbarot, S. Rogers, N. K. Abuabara, K. Aubert, H. Chalmers, J. Flohr, C. Hanifin, J. Naldi, L. Margolis, D. J. Paul, C. Ridd, M. J. Schuttelaar, M. A. Simpson, E. Tauber, M. Volke, A. Weidinger, S. Wilkes, S. R. Wollenberg, A. Thomas, K. S.

Publication

Journal: J Am Acad Dermatol
Volume: 75
Issue: 5
Pages: 1038 - 1044
Year: 2016
DOI:

Further Study Information

Current Stage: Not Applicable
Date:
Funding source(s):


Health Area

Disease Category: Skin

Disease Name: Eczema

Target Population

Age Range: Unknown

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

Study Type

- Systematic review of outcome measures/measurement instruments

Method(s)

- Systematic review

Linked Studies



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