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Background Children’s responses to medical treatments differ significantly from adults. Appropriately selecting and measuring child and family relevant outcomes when designing pediatric clinical trials is important for decision making with regards to the health of the child. However, outcomes used to measure an intervention’s effectiveness in current pediatric clinical trials often lack child and family relevance, are heterogeneous across and within child health ages and diseases, and are not adequately measured with validated instruments. Furthermore, involvement of patients (children) and their proxies (usually parents) in outcomes selection is minimal. Inconsistent use of outcomes and outcomes measurement in pediatric clinical trials impairs the synthesis of evidence in systematic reviews and leads to outcome reporting bias. This high variability in outcome selection and measurement has led to a situation where child health decisions on treatment of children lack the appropriate underpinning evidence, and a subsequent inability to reach a consensus on the effectiveness and safety of a treatment. Recently, outcome selection initiatives in the general population such as OMERACT and COMET advocate homogeneity of methodology for outcome selection and measurement in trials.

TORCH: Toronto Outcome Research in Child Health - enhancing evidence based outcomes selection in pediatric research