Bipolar disorder (BD) is associated with frequent hospitalizations, a high risk of suicide, and multiple comorbidities. BD pharmacotherapy is often administered by trial and error due to a lack of personalized treatment algorithms accounting for patient age, medical history, and concomitant drugs in use. In addition, BD medications are often poorly tolerated due to adverse effects, which leads to low adherence to treatment. Drug-related long-term comorbidities are still poorly understood, because adverse outcomes vary in their rates and severity, particularly in unique subpopulations. The main question expressed by patients is “What drug is best for me?” Systematic reviews and comparative effectiveness studies addressing this question are still lacking. Randomized clinical trials have provided evidence of limited external validity because they have often excluded youth, patients aged ≥65 years, and patients with mental/medical comorbidities; have had a short follow-up with relatively small sample sizes; and rarely have compared multidrug regimens. We set out to address these gaps in evidence using observational studies, selecting the outcomes most important to patients. Our patient partners identified several primary outcomes of interest for our research: the risks of psychiatric hospitalization (PH), self-harm, metabolic abnormalities, and kidney disorders (KDs). We sought to verify the importance of these outcomes, as well as identify other areas of concern for a larger group of patients, guiding study design and dissemination with iterative feedback.
