Recommendations for defining treatment outcomes in major psychiatric disorders leveraging real-world data

While information from real-world data (RWD) can be utilized to identify factors able to aid treatment choice, guidelines for the use of RWD are lacking. The aim of this narrative review and expert opinion is to summarize and evaluate definitions of treatment outcomes to antidepressants, antipsychotics, and mood stabilizers using RWD, and to suggest standards for the field. Given that no standards for the use of RWD in estimating treatment outcomes exist, there is a high variability in treatment outcome definitions. We make recommendations for different scenarios of available data and highlight the importance of using other sources of information to validate proxy phenotypes such as continued treatment, switching between medications or polypharmacy of psychotropic medications. Well-defined and validated treatment outcome measures leveraging RWD hold the potential to facilitate the development of precision psychiatry approaches and support regulatory decision-making in psychopharmacological agents.