• Despina G Contopoulos-Ioannidis, Iva Seto, Michele P Hamm, Denise Thomson, Lisa Hartling, John P A Ioannidis, Sarah Curtis, Evelyn Constantin, Gitanjali Batmanabane, Terry Klassen, and Katrina Williams.
• Department of Pediatrics, Division of Infectious Diseases, Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, California 94305, USA. dcontop@stanford.edu
• Pediatrics. 2012 Jun 1; 129 Suppl 3: S161-84.

BackgroundAn important step toward improvement of the conduct of pediatric clinical research is the standardization of the ages of children to be included in pediatric trials and the optimal age-subgroups to be analyzed.MethodsWe set out to evaluate empirically the age ranges of children, and age-subgroup analyses thereof, reported in recent pediatric randomized clinical trials (RCTs) and meta-analyses. First, we screened 24 RCTs published in Pediatrics during the first 6 months of 2011; second, we screened 188 pediatric RCTs published in 2007 in the Cochrane Central Register of Controlled Trials; third, we screened 48 pediatric meta-analyses published in the Cochrane Database of Systematic Reviews in 2011. We extracted information on age ranges and age-subgroups considered and age-subgroup differences reported.ResultsThe age range of children in RCTs published in Pediatrics varied from 0.1 to 17.5 years (median age: 5; interquartile range: 1.8-10.2) and only 25% of those presented age-subgroup analyses. Large variability was also detected for age ranges in 188 RCTs from the Cochrane Central Register of Controlled Trials, and only 28 of those analyzed age-subgroups. Moreover, only 11 of 48 meta-analyses had age-subgroup analyses, and in 6 of those, only different studies were included. Furthermore, most of these observed differences were not beyond chance.ConclusionsWe observed large variability in the age ranges and age-subgroups of children included in recent pediatric trials and meta-analyses. Despite the limited available data, some age-subgroup differences were noted. The rationale for the selection of particular age-subgroups deserves further study.

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