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Journal of the American Academy of Dermatology
Volume 74, n° 2
pages 288-294 (février 2016)
Doi : 10.1016/j.jaad.2015.09.062
accepted : 11 September 2015
Original Articles

A systematic review of Investigator Global Assessment (IGA) in atopic dermatitis (AD) trials: Many options, no standards
 

Masaki Futamura, MD, PhD b, Yael A. Leshem, MD c, Kim S. Thomas, PhD a, Helen Nankervis, PhD a, Hywel C. Williams, DSc, FMedSci a, Eric L. Simpson, MD, MCR c,
a Center of Evidence-based Dermatology, University of Nottingham, Nottingham, United Kingdom 
b Division of Pediatrics, Nagoya Medical Center, Nagoya, Japan 
c Department of Dermatology, Oregon Health and Science University, Portland, Oregon 

Reprint requests: Eric L. Simpson, MD, MCR, Department of Dermatology (Mail Code CH16D), Oregon Health and Science University, 3303 SW Bond Ave, Portland, OR 97239-4501.
Abstract
Background

Investigators often use global assessments to provide a snapshot of overall disease severity in dermatologic clinical trials. Although easy to perform, the frequency of use and standardization of global assessments in studies of atopic dermatitis (AD) is unclear.

Objectives

We sought to assess the frequency, definitions, and methods of analysis of Investigator Global Assessment in randomized controlled trials of AD.

Methods

We conducted a systematic review using all published randomized controlled trials of AD treatments in the Global Resource of Eczema Trials database (2000-2014). We determined the frequency of global scales application and defining features.

Results

Among 317 trials identified, 101 trials (32%) used an investigator-performed global assessment as an outcome measure. There was large variability in global assessments between studies in nomenclature, scale size, definitions, outcome description, and analysis. Both static and dynamic scales were identified that ranged from 4- to 7-point scales. North American studies used global assessments more commonly than studies from other countries.

Limitations

The search was restricted to the Global Resource of Eczema Trials database.

Conclusion

Global assessments are used frequently in studies of AD, but their complete lack of standardized definitions and implementation preclude any meaningful comparisons between studies, which in turn impedes data synthesis to inform clinical decision-making. Standardization is urgently required.

The full text of this article is available in PDF format.

Key words : atopic dermatitis, atopic eczema, global assessment, Investigator Global Assessment, outcome measure, randomized controlled trial, severity, systematic review

Abbreviations used : AD, FDA, GREAT, IGA, RCT



 Funding sources: None.
 Conflicts of interest: None declared.



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