Measurement properties of primary outcome measures in pediatric RCTs: inadequate reporting, insufficient validation, or both?

Abstract: Randomized controlled trials (RCTs) are the gold standard for high quality evidence generation pertaining to treatment effectiveness. RCT results are used in knowledge synthesis and evidence-based practice. The validity of RCT results is dependent upon the validity of the primary outcome measures. Primary outcomes and the measurement properties of the primary outcome measures should be clearly reported to enable confident interpretation of results. A systematic review of pediatric RCTs published in high impact journals found inadequate reporting of primary outcomes and the measurement properties of their outcome measures. Furthermore, quality assessments of the measurement properties and the methodology of the studies in which the properties are evaluated suggest a need for further validation. The issue is thus twofold: inadequate reporting paired with insufficient validation. The awareness of this dual issue can encourage higher reporting standards and improved conduct of trials to ultimately enhance the quality of primary research.