Tracking medication changes to assess outcomes in comparative effectiveness research: A bipolar CHOICE study.

Area of Science:

• Psychiatry
• Clinical Research
• Health Services Research

Background:

• Comparative effectiveness research requires outcome measures for large datasets like electronic medical records.
• Medication adjustments based on clinical need can serve as a surrogate outcome measure.
• The Medication Recommendation Tracking Form (MRTF) was developed to quantify medication adjustments and their reasons.

Purpose of the Study:

• To evaluate the feasibility and utility of the MRTF in a randomized trial.
• To assess the relationship between Necessary Clinical Adjustments (NCAs) and treatment response in bipolar disorder.
• To explore NCAs as a potential surrogate outcome measure in large-scale data analyses.

Main Methods:

• The MRTF was administered to 482 adult patients during a 6-month randomized comparative effectiveness trial (Bipolar CHOICE).
• Data collected included frequency, types, and reasons for medication adjustments to calculate NCAs.
• Statistical analyses examined the association between NCAs and treatment response, symptom severity, comorbidities, side effects, and quality of life.

Main Results:

• Fewer NCAs were observed in treatment responders compared to non-responders.
• Each additional NCA decreased the odds of subsequent response by approximately 30%.
• Higher symptom severity, comorbid anxiety, and problematic side effects were associated with increased NCAs; fewer NCAs correlated with better quality of life and function.

Conclusions:

• The MRTF is a feasible tool for assessing clinical outcomes and can serve as a proxy for treatment response.
• Medication changes, as captured by NCAs, may be a valuable surrogate outcome measure for analyzing large electronic health and claims data.
• Findings have implications for clinical training, decision-making, and the development of novel outcome measures in mental health research.