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Systematic review of outcome measures in trials of pediatric anaphylaxis treatment
Tamar Rubin, Jacqueline Clayton, Denise Adams
1Department of Pediatrics, University of Alberta, Edmonton, Canada. svohra@ualberta.ca.
Insights
This systematic review found no randomized controlled trials on pediatric anaphylaxis treatments. High-quality studies and consensus on outcome measures are urgently needed to improve care for children with anaphylaxis.
Area of Science:
- Pediatric Allergy and Immunology
- Clinical Trial Methodology
- Evidence-Based Medicine
Background:
- Significant heterogeneity exists in pediatric outcome measures for randomized controlled trials (RCTs), complicating result interpretation.
- Pediatric anaphylaxis trial outcome measures have not been systematically evaluated.
- Anaphylaxis treatment research in children lacks standardized outcome assessment.
Purpose of the Study:
- To systematically identify and assess outcome measures in pediatric anaphylaxis treatment RCTs.
- To evaluate the evidence for current pediatric anaphylaxis treatment modalities.
Main Methods:
- Comprehensive literature search of multiple databases (MEDLINE, EMBASE, Cochrane Library, CENTRAL, CINAHL) from 2001-2012.
- Inclusion of randomized controlled trials involving pediatric patients (0-18 years) with anaphylaxis.
- Independent article assessment by two authors for study eligibility.
Main Results:
- No published studies met the inclusion criteria for the systematic review.
- The search yielded zero randomized controlled trials evaluating treatments for pediatric anaphylaxis.
Conclusions:
- There is a critical lack of high-quality RCTs for pediatric anaphylaxis treatments.
- Development of consensus on appropriate and validated outcome measures is essential.
- Improved research quality is needed to enhance the care of children experiencing anaphylaxis.
Background:
Considerable heterogeneity has been observed in the selection and reporting of disease-specific pediatric outcome measures in randomized controlled trials (RCTs). This makes interpretation of results and comparison across trials challenging. Outcome measures in pediatric anaphylaxis trials have never previously been systematically assessed. This systematic review (SR) identified and assessed outcome measures used in RCTs of anaphylaxis treatment in children. As a secondary objective, this SR assessed the evidence for current treatment modalities for anaphylaxis in the pediatric population.
Methods:
We searched MEDLINE, EMBASE, The Cochrane Library, Cochrane Central Register of Controlled Trials (CENTRAL), and CINAHL from 2001 until December 2012. We also searched websites listing ongoing trials. We included randomized and controlled trials of anaphylaxis treatment in patients 0-18 years of age. Two authors independently assessed articles for inclusion.
Results:
No published studies fulfilled the inclusion criteria.
Conclusions:
There is an alarming absence of RCTs evaluating the treatments for anaphylaxis in children. High quality studies are needed and are possible to design, despite the severe and acute nature of this condition. Consensus about the selection and validation of appropriate outcome measures will enhance the quality of research and improve the care of children with anaphylaxis.
Trial Registration:
CRD42012002685.
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