Strategies used for measuring long-term control in atopic dermatitis trials: A systematic review - 15/10/16

Doi : 10.1016/j.jaad.2016.05.043

Sebastien Barbarot, PhD ^a,^b, Natasha K. Rogers, PhD ^a, Katrina Abuabara, MD ^c, Helene Aubert, MD ^b, Joanne Chalmers, PhD ^a, Carsten Flohr, PhD ^d, Jon Hanifin, MD ^e, Luigi Naldi, MD ^f, David J. Margolis, MD ^g, Carle Paul, MD ^h, Matthew J. Ridd, PhD ⁱ, Marie-Louise Anna Schuttelaar, PhD ^j, Eric Simpson, MD ^e, Marie Tauber, MD ^h, Annika Volke, MD ^k, Stephan Weidinger, MD ^l, Sally R. Wilkes, PhD ^a, Andreas Wollenberg, PhD ^m, Kim S. Thomas, PhD ^a,^⁎
^a Center of Evidence-based Dermatology, University of Nottingham, Nottingham, United Kingdom
^b Department of Dermatology, Centre Hospitalier Universitaire (CHU) de Nantes, Nantes, France
^c Department of Dermatology, University of California, San Francisco, California
^d Population-based Dermatology Research Unit, St John's Institute of Dermatology, Guy's and St Thomas' National Health Service Foundation Trust and King's College London, London, United Kingdom
^e Department of Dermatology, Oregon Health and Science University, Portland, Oregon
^f Study Center Italian Group for Epidemiologic Research in Dermatology and Department of Dermatology, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy
^g Departments of Dermatology and Biostatistics and Epidemiology, University of Pennsylvania, Perelman School of Medicine, Philadelphia, Pennsylvania
^h Dermatology, Paul Sabatier University and Hôpital Larrey, Toulouse, France
ⁱ School of Social and Community Medicine, University of Bristol, Bristol, United Kingdom
^j Department of Dermatology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands
^k Department of Dermatology, University of Tartu, Tartu, Estonia
^l Department of Dermatology, Venereology, and Allergy, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
^m Department of Dermatology and Allergy, Ludwig-Maximilian University Munich, Munich, Germany

^∗Reprint requests: Kim S. Thomas, PhD, University of Nottingham, King's Meadow Campus, Lenton Lane Nottingham, NG7 2NR United Kingdom.University of NottinghamKing's Meadow CampusLenton Lane NottinghamNG7 2NRUnited Kingdom

Abstract

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.

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Graphical abstract

Le texte complet de cet article est disponible en PDF.

Key words : atopic dermatitis, atopic eczema, flares, long-term control, outcome measures, randomized controlled trials, systematic review

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

Plan

Methods

Eligibility criteria and search strategy

Study selection and data extraction

Results

Types of long-term control outcomes used

Discussion

Main findings

Strengths and limitations

What does this mean for the HOME initiative and for future research?

	Dr Ridd is funded by National Institute for Health Research (NIHR) Post Doctoral Fellowship (PDF-2014-07-013). The views expressed in this publication are those of the authors and not necessarily those of the National Health Service, the NIHR, or the Department of Health.
	Conflicts of interest: None declared.

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Vol 75 - N° 5

P. 1038-1044 - novembre 2016 Retour au numéro

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Strategies used for measuring long-term control in atopic dermatitis trials: A systematic review - 15/10/16

Abstract

Background

Objective

Methods

Results

Limitations

Conclusion

Graphical abstract

Plan

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