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Building a Database of Validated Pediatric Outcomes: An Investigation of Compliance with Established Reporting Standards

Date and Location




Monday 23 September 2013 - 10:30 - 12:00


Presenting author and contact person

Presenting author

Sunita Vohra

Contact person

Denise Adams
Abstract text
Background: Pediatric populations have increasingly been included in clinical research, which relies on the availability and use of appropriate outcome measurement tools. Objectives: i) To develop an inventory of valid and reliable pediatric outcome measurement tools and ii) to identify gaps in outcomes reporting in publications of pediatric randomized controlled trials (RCTs). Methods: Electronic searches of MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials databases were conducted. The top 6 general medicine journals and top 4 pediatric journals were searched for pediatric RCTs published since 2000. RCTs of a single phase/step in a single publication with outcome(s) measured solely in participants under 21 years of age were included. Diagnostic, screening and pilot studies were excluded. Two independent reviewers conducted screening and data extraction. Variables to be extracted included: journal , population age, sample size, condition of interest, intervention, control, primary outcome, outcome measurement tools, and information on psychometric testing. Results: Searches identified 2229 unique references. Most (76%) were identified from pediatric journals, with ages ranging from 23 weeks gestation to 20 years. Half (48.5%) reported one primary outcome, while 27% did not identify a primary outcome, and 24% identified more than one. Of the 100 trials reporting a single primary outcome, 20 used an instrument to measure their primary outcome, but only 7 (35%) reported its psychometric properties. Conclusions: A wide variety of pediatric outcome measurement tools are in use by researchers. Psychometric properties of measurement tools are inconsistently reported in pediatric RCTs, thus it is unclear to readers if the tools are of high quality. Developing a comprehensive database of validated pediatric outcome measures may facilitate use of high quality pediatric research.