This review tackles a key challenge in psychiatric research: the absence of standardised guidelines for defining treatment outcomes using real-world data (RWD). As RWD becomes increasingly valuable for informing treatment decisions, especially in routine clinical settings, inconsistencies in how outcomes are measured can undermine the reliability and comparability of findings.
Focusing on antidepressants, antipsychotics, and mood stabilisers, the authors analyse how treatment outcomes have been defined in existing studies and highlight the considerable variability in approaches. To address this, the review proposes a set of practical recommendations tailored to different types of data sources, ranging from prescription records to broader health registries.
A central message is the importance of validating commonly used proxy measures, such as continued treatment, medication switching, or the use of multiple psychotropic medications, by integrating additional sources of information.
The proposed standards aim to improve the quality and interpretability of RWD studies, paving the way for precision psychiatry and supporting more robust regulatory decision-making in the development and assessment of psychopharmacological treatments.
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