Measuring What Matters: Development and Dissemination of a Core Outcome Set (COS) for Clinical Trials in Pediatric Anxiety Disorders

Anxiety disorders are common in children and adolescents and cause significant impairment in all aspects of a child's life. Based on the available evidence, no treatment can be recommended as "optimal". The main problem is the wide variability of health outcomes measured across studies making it difficult to compare study results with each other, "pool" data across studies, and make decisions about what is the most effective treatment for various mental health concerns. A "core outcome set (COS)" is an agreed, standardized minimum set of outcomes that should be measured in all trials in specific areas of health. COS development outside of mental health care has resulted in greater standardization across research studies, which has led to enhanced research quality, and ultimately a better understanding of what treatments are best for which patients. There is no COS for trials in pediatric anxiety disorders. This project plans to develop, an evidence- and consensus-based COS for pediatric anxiety disorder trials with active engagement of youth and family members and other stakeholders. We will identify outcomes used in the literature and engage with youth and family through virtual workshops, to understand what they view as important outcomes. With a list of outcomes, we will use a consensus process to help us develop decisions on what to measure across future trials. Once the outcomes of the COS have been established, we will define "how" to measure these outcomes using measurement instruments that are reliable, valid and responsive to measure changes that are important to youth and families. This project will ensure that outcomes that are important to youth and families are part of the final COS. With greater standardization, and more patient-centric outcomes measured across trials in pediatric anxiety disorders, this project and the developed COS will lead to improved research quality and ultimately better mental health outcomes and better health utilization.