Applying comparative effectiveness research methods in bipolar disorders.

Area of Science:

• Pharmacoeconomics
• Health Services Research
• Clinical Epidemiology

Background:

• Randomized clinical trials (RCTs) are the gold standard for medical evidence.
• Observational comparative effectiveness research (CER) using real-world data addresses gaps left by RCTs.
• This study presents a CER example in bipolar disorder treatment.

Purpose of the Study:

• To demonstrate how observational CER can supplement RCTs.
• To analyze real-world drug therapy episodes in bipolar disorder.
• To highlight the importance of patient treatment history in CER.

Main Methods:

• Utilized paid claims data from a large commercial insurer.
• Defined drug therapy episodes based on continuous days of medication use (15-day gap).
• Included 105,440 episodes of antipsychotic, antidepressant, or mood stabilizer therapy.

Main Results:

• Mood stabilizers and antidepressants initiated most episodes (40% each).
• Over 59% of episodes were for augmentation therapy.
• Patient outcomes (therapy duration, cost) varied significantly with treatment history, particularly episode type.

Conclusions:

• Observational CER can evaluate outcomes across diverse clinical scenarios, considering treatment history.
• Patient treatment history significantly impacts compliance and future costs.
• Failure to account for treatment history introduces bias; observational CER can identify research gaps.