Develop initial candidate list of IN-ROADS outcomes to include in the COS for adolescent MDD clinical trials with input from key stakeholders.
The development of IN-ROADS will employ COS methodology recommended by COMET, with innovative adaptations to ensure engagement of patients and families and involves a) conducting a scoping review of all adolescent MDD clinical trials published in the English language between 2008 and 2017 and b) setting up an international advisory group of key stakeholders, focus groups of patients and caregivers and an expert advisory committee of a subgroup of focus group participants.
Prioritization of candidate outcomes for inclusion in the IN-ROADS COS will be achieved by holding an international advisory group meeting, conducting focus groups of adolescents with MDD and caregivers, and engaging the expert advisory committee. An international web-based Delphi study - an iterative multistage process that allows for consensus to be reached from a selection of disparate opinions - will allow engagement of a diverse and international group of professional stakeholders.
Consensus regarding outcomes for inclusion in the COS will be reached through structured rounds of surveys coupled with controlled feedback. After completion of the Delphi study, patient, caregiver, and professional stakeholder input will be brought together at a consensus meeting with the goal of establishing a recommended COS through discussion.
Prioritization and Consensus
Outcomes will be evaluated and prioritized based on the shared input of patients, caregivers, clinicians, researchers and other key stakeholders, ensuring that the COS is usable and relevant.
Report and disseminate the final COS worldwide to ensure that all key stakeholders are aware of the newly developed COS. Stakeholders attending the in-person consensus meeting will be actively engaged in the dissemination and uptake of the COS.
Our knowledge translation plan for IN-ROADS includes a strategy that targets each stakeholder group with the goal of identifying champions, the type of change required, and necessary specific endorsement and enforcement strategies. Publication of the COS development work in appropriate journals and presentations at important international/national conferences will also ensure appropriate uptake and implementation of the new COS, at each stage of future adolescent MDD clinical trials.