Volume 10 Supplement 1

Canadian Society of Allergy and Clinical Immunology Annual Scientific Meeting 2013

Open Access

Systematic review of outcome measures in randomised controlled trials of pediatric eosinophilic esophagitis (EoE) treatment

  • Tamar Rubin1,
  • Jacqueline Clayton1,
  • Denise Adams1, 2,
  • Rabin Persad1, 4 and
  • Sunita Vohra1, 2, 3Email author
Allergy, Asthma & Clinical Immunology201410(Suppl 1):A70

https://doi.org/10.1186/1710-1492-10-S1-A70

Published: 3 March 2014

Background

Heterogeneity has been noted in the selection and reporting of disease-specific pediatric outcomes in randomized controlled trials (RCTs) [1]. The consequence may be invalid results from RCTs, or difficulty in comparing results across trials [2, 3]. The primary objective of this systematic review was to assess the heterogeneity of outcome measures selection and reporting in recent pediatric EoE treatment trials. As secondary objectives, we assessed the heterogeneity of disease definition and resolution across studies compared to established concensus guidelines, as well as the evidence for current EoE treatments.

Methods

We searched MEDLINE, EMBASE, The Cochrane Library, Cochrane Central Register of Controlled Trials (CENTRAL), and CINAHL from the last ten years, including randomized controlled trials of EoE treatment in patients 0-18 years. Two authors independently assessed articles for inclusion.

Results

A total of 11 studies met inclusion criteria (Fig 1). Numerous outcome measures were selected and reported in these trials, with certain measures, such as esophageal eosinophilia, clinical symptoms, safety, histologic features, and endoscopic features, re-occurring frequently, but not universally. Uptake of consensus-established diagnostic criteria for EoE (FIGER criteria) was 30% in trials published after 2007. Due to the small number and heterogeneity of studies obtained, no conclusions regarding treatment efficacy could be made.
Figure 1

Flow Diagram

Conclusions

The results of this study confirm the need for universally reported, pediatric-specific, standardized outcome measures in EoE trials. Adherence to standardized disease definitions will enhance the utility of outcome measures. Consistent disease definition and standardized outcome reporting will allow for meta-analyses across similar trials and thus inform future clinical decision-making in pediatric EoE.

Systematic review registration

CRD42013003798

Authors’ Affiliations

(1)
Department of Pediatrics, University of Alberta
(2)
CARE Program, University of Alberta
(3)
Department of Public Health Sciences, University of Alberta
(4)
Department of Pediatric Gastroenterology, University of Alberta

References

  1. Clarke M: Standardising outcomes for clinical trials and systematic reviews. Trials. 2007, 8: 39-PubMed CentralView ArticlePubMedGoogle Scholar
  2. Sinha I, Jones L, Smith RL, Williamson PR: A systematic review of studies that aim to determine which outcomes to measure in clinical trials in children. PLoS Med. 2008, 5 (4): e96-PubMed CentralView ArticlePubMedGoogle Scholar
  3. Williamson PR, Gamble C, Altman DG, Hutton JL PR: Outcome selection bias in meta-analysis. Stat Methods Med Res. 2005, 14: 515-524.View ArticlePubMedGoogle Scholar

Copyright

© Rubin et al; licensee BioMed Central Ltd. 2014

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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