Co-Design of a Novel Desirability of Outcome Ranking for Medication Trials in Psychosis.

Background: Clinical trials of medication for psychosis focus on symptom reduction or relapse as the primary outcome. Broader consumer definitions of recovery that emphasize quality of life, functioning, and treatment tolerability are rarely incorporated into primary trial outcomes. The aim was to co-design a Desirability of Outcome Ranking (DOOR), a novel primary outcome that integrates multiple consumer and clinician priorities in relation to antipsychotic medication trials. Study Design: Through an iterative co-design process, clinicians and consumers (young people and families with lived experience of psychosis) first rated outcomes of greatest personal and clinical importance for medication trials. The top three were quality of life, clinical symptoms, and side effects. Consumers then completed a preliminary survey, co-design focus groups, and written feedback to create the DOOR. Study Results: A final DOOR with 48 ordinal levels was created. Consumers prioritized quality of life, but only when symptoms and/or side effects remained within tolerable (mild-moderate) ranges. Levels 1-12 represented the most desirable outcomes, characterized by high/moderate quality of life with minimal-to-mild symptoms/side effects. Levels 13-24 reflected moderate/high quality of life with a mixture of symptom/side-effect outcomes. Levels 25-36 reflected low/moderate quality of life with generally lower symptoms/side effects. Levels 37-48 were least desirable, characterized by low/moderate quality of life with generally moderate/severe symptoms/side effects. Conclusions: This co-designed novel DOOR integrates multiple consumer and clinician preferred constructs into a single holistic outcome. Examining its performance and interpretability in clinical trials of medication for psychosis is warranted.