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Systematic Review of Diagnostic Criteria Used in Atopic Dermatitis Randomized Controlled Trials
Paras P Vakharia1, Rishi Chopra1, Jonathan I Silverberg2,3
1Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
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.
Insights
The Hanifin and Rajka criteria were most frequently used in atopic dermatitis clinical trials, but many studies lacked specified diagnostic criteria. Harmonizing criteria is recommended for better research comparison.
Area of Science:
- Dermatology
- Clinical Trials
- Medical Research
Background:
- Atopic dermatitis diagnosis lacks standardized criteria in clinical trials.
- Inconsistent criteria limit the comparability of research findings.
Purpose of the Study:
- To identify the most frequently utilized atopic dermatitis diagnostic criteria in international randomized controlled trials (RCTs).
Main Methods:
- Systematic review of RCTs involving pharmacological interventions from 2007-2016.
- Searched multiple databases including Cochrane Library, EMBASE, MEDLINE, and Scopus.
- Independent study selection and data extraction by two authors.
Main Results:
- Analyzed 212 RCTs, identifying ten distinct diagnostic criteria for atopic dermatitis.
- Hanifin and Rajka criteria were most common (41.0%), followed by UK refinement (9.0%).
- A significant portion (37.3%) of RCTs did not specify diagnostic criteria.
Conclusions:
- Highlights a lack of uniformity and documentation in atopic dermatitis diagnostic criteria across RCTs.
- Recommends harmonizing diagnostic criteria for future atopic dermatitis research.
