Abstract
Background
Numerous diagnostic criteria for atopic dermatitis are used in clinical trials, which may limit comparison of results.
Objective
We sought to determine the most commonly used atopic dermatitis diagnostic criteria in randomized controlled trials internationally.
Methods
We performed a systematic review of randomized controlled trials with a pharmacological intervention from 2007 to 2016. Cochrane Library, EMBASE, GREAT, LILACS, MEDLINE, and Scopus were searched. Two authors independently performed the study selection and data extraction.
Results
Two hundred and twelve randomized controlled trials met inclusion/exclusion criteria. Overall, ten different diagnostic criteria were used. The Hanifin and Rajka criteria were most commonly used (41.0%), followed by the UK refinement of the Hanifin and Rajka criteria (9.0%), Japanese Dermatological Association criteria (4.2%), and American Academy of Dermatology criteria (3.8%). No diagnostic criteria were specified in 37.3% of randomized controlled trials. The Hanifin and Rajka criteria were the most commonly used atopic dermatitis diagnostic criteria in clinical trials of topical and systemic interventions, across all years between 2007 and 2016, in pediatric and adult populations, in most countries and regions internationally.
Conclusions
The results highlight the lack of uniformity and documentation of atopic dermatitis diagnostic criteria in randomized controlled trials for atopic dermatitis. We recommend harmonizing the diagnostic criteria for atopic dermatitis in future randomized controlled trials.
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Acknowledgements
The authors thank Yufan Yan, BS, Northwestern University Feinberg School of Medicine for providing assistance with translation services.
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JIS had full access to all the data in the study and takes responsibility for the integrity of the data and accuracy of the data analysis. Study concept and design: JIS. Acquisition of data: PPV, RC. Analysis and interpretation of data: JIS, PPV, RC. Drafting of the manuscript: JIS, PPV, RC. Critical revision of the manuscript for important intellectual content: JIS, PPV, RC. Statistical analysis: PPV, JIS. Obtained funding: JIS.
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This publication was made possible with support from the Agency for Healthcare Research and Quality, Grant No. K12 HS023011, and the Dermatology Foundation.
Conflict of interest
Jonathan I. Silverberg, Paras P. Vakharia, and Rishi Chopra have no conflicts of interest directly relevant to the contents of this study.
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This study was exempt from institutional review board approval.
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Vakharia, P.P., Chopra, R. & Silverberg, J.I. Systematic Review of Diagnostic Criteria Used in Atopic Dermatitis Randomized Controlled Trials. Am J Clin Dermatol 19, 15–22 (2018). https://doi.org/10.1007/s40257-017-0299-4
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DOI: https://doi.org/10.1007/s40257-017-0299-4