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New Core Outcome Set for Pediatric Chronic Pain Clinical Trials: Identifying Domains and Measures
Symposia
Our aim is to update a core outcome set (COS) for pediatric chronic pain interventions. The first phase of our study involved collecting a spectrum of providers’, patients’, and parents’ perspectives about treatment of pediatric chronic pain to understand clinically meaningful outcomes that should be routinely measured. The second phase was to reach consensus of mandatory and optional outcome domains following the OMERACT framework. Results of the Delphi poll and expert consensus conference led to inclusion of 3 mandatory domains for the COS (pain severity, pain interference with daily living, adverse events) and 4 optional domains (overall well-being, emotional functioning, physical functioning, and sleep). A third phase provided recommendations for validated measures to assess each outcome domain using a multi-phase approach : 1) a Delphi study to select candidate measures, 2) a review phase to gather evidence for measurement properties for candidate measures, and 3) a consensus conference with experts to make final recommendations. The selection of measures was guided by the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) initiative, with the greatest weight given to content validity, developmental appropriateness, reliability, responsiveness to change, and usability. Recommendations will be presented and future research gaps and opportunities discussed.