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.
Led by a multi-national team of clinicians, researchers, methodologists, youth and family research partners, the first aim of the project is to identify “what” outcomes are essential to measure in pediatric AD trials. Through a scoping review of outcomes reported in published trials and interactive workshops with youth and families, we will identify a comprehensive candidate outcome list for consideration. In the next phase, we will engage with a diverse sample of clinicians, trialists, and youth and families to identify and prioritize candidate outcomes through an international, web-based Delphi Study.
Identification of candidate outcomes and OMIs through a scoping review of the literature:
review of the literature to systematically identify and synthesize existing candidate outcomes for inclusion for evaluation in the Delphi Study and OMIs.
International Delphi Study
Youth, family members, and professional stakeholders will also be invited to participate in a set of virtual surveys, along with a diverse group of stakeholders all around the world. Outcomes from the scoping review and outcomes from the workshops will be combined in the surveys. After 2 to 3 rounds of the surveys, our goal is to prioritize which outcomes are most important and should be included in the core outcome set.
OMI Identification and Evaluation
In the final phase, we will identify “how” endorsed outcomes should be measured. We will systematically review candidate Outcome Measurement Instruments (OMI) and evaluate their measurement properties, including feasibility, validity, reliability, and responsiveness. Results of this quality appraisal will be shared at an expert meeting where the aim is to reach consensus on final OMI recommendations.
Youth and Family Workshops
We will run a set of virtual workshops -- separate for children/youth and family members -- to get their expertise on what outcomes they think are most important. Engaging youth and family members from across Canada will allow us to identify outcomes that they know to be important from their lived experience, however might be overlooked if researchers or clinicians did the work on their own.
After the surveys are complete, youth and family members will work together with researchers, clinicians and other stakeholders at a consensus meeting to finalize the core outcome set. Finally, we will look at how to measure these outcomes so researchers all around the world can measure outcomes in the same way.
Dissemination of the Final COS
Using integrated knowledge translation and knowledge mobilization approaches, we will widely disseminate and promote uptake of the final COS in pediatric AD trials to key stakeholder and knowledge user groups: clinicians, researchers including trialists, methodologists, systematic reviewers, and youth and family.