3 years ago

Severity assessments used for inclusion criteria and baseline severity evaluation in atopic dermatitis clinical trials: a systematic review

Rishi Chopra, Jonathan I. Silverberg, Amy S. Paller, Eric L. Simpson, Paras P. Vakharia
Background Numerous inclusion criteria and baseline severity assessments are used in clinical trials of atopic dermatitis (AD), which may limit comparison of results. Objective We sought to characterize the inclusion criteria and baseline severity assessments used in randomized controlled trials (RCT) of AD internationally. Methods We performed a systematic review of RCT with a pharmacological intervention from 2007-2016. Cochrane Library, EMBASE, GREAT, LILACS, MEDLINE and Scopus were searched. Two authors independently performed study selection and data extraction. Results Overall, 212 RCT met inclusion/exclusion criteria. Target population and inclusion criteria based on AD severity were not documented in 78 (36.8%) and 25 (18.7%) studies, respectively. Thirty and 58 severity assessments were used for inclusion criteria and baseline severity, respectively, with only 60.3% concordance between their use. Global assessments were most frequently used for both inclusion criteria and baseline severity assessment in North America (39.5% and 32.1%), while SCORing AD (SCORAD) or objective SCORAD index was most frequently used in Europe (23.5% and 23.0%) and Asia (34.2% and 43.5%). Minimum and maximum thresholds of severity assessments were inconsistently used between studies for inclusion criteria, even within similar target populations. SCORAD, global assessments and body surface area were most frequently used for both inclusion criteria and baseline severity assessment. IGA was particularly used in trials of topical agents. Conclusions There was considerable variability and poor documentation of inclusion criteria and baseline severity assessments in RCT for AD. These differences may limit interpretation of a study and comparison of results between studies. This article is protected by copyright. All rights reserved.

Publisher URL: http://onlinelibrary.wiley.com/resolve/doi

DOI: 10.1111/jdv.14483

You might also like
Discover & Discuss Important Research

Keeping up-to-date with research can feel impossible, with papers being published faster than you'll ever be able to read them. That's where Researcher comes in: we're simplifying discovery and making important discussions happen. With over 19,000 sources, including peer-reviewed journals, preprints, blogs, universities, podcasts and Live events across 10 research areas, you'll never miss what's important to you. It's like social media, but better. Oh, and we should mention - it's free.

  • Download from Google Play
  • Download from App Store
  • Download from AppInChina

Researcher displays publicly available abstracts and doesn’t host any full article content. If the content is open access, we will direct clicks from the abstracts to the publisher website and display the PDF copy on our platform. Clicks to view the full text will be directed to the publisher website, where only users with subscriptions or access through their institution are able to view the full article.