The PDC provides a more conservative estimate of adherence than the MPR across all types of users; however, the differences between the 2 methods are more substantial for persons switching therapy and prescribed therapeutic duplication, where MPR may overstate true adherence. The PDC should be considered when a measure of adherence to a class of medications is sought, particularly in clinical situations in which multiple medications within a class are often used concurrently.
Context:The Treatment for Adolescents With Depression Study evaluates the effectiveness of fluoxetine hydrochloride therapy, cognitive behavior therapy (CBT), and their combination in adolescents with major depressive disorder.Objective: To report effectiveness outcomes across 36 weeks of randomized treatment.Design and Setting: Randomized, controlled trial conducted in 13 academic and community sites in the United States. Cognitive behavior and combination therapies were not masked, whereas administration of placebo and fluoxetine was double-blind through 12 weeks, after which treatments were unblinded. Patients assigned to placebo were treated openly after week 12, and the placebo group is not included in these analyses by design.Participants: Three hundred twenty-seven patients aged 12 to 17 years with a primary DSM-IV diagnosis of major depressive disorder.Interventions: All treatments were administered per protocol.
Main Outcome Measures:The primary dependent measures rated blind to treatment status by an independent evaluator were the Children's Depression Rating ScaleRevised total score and the response rate, defined as a Clinical Global Impressions-Improvement score of much or very much improved.Results: Intention-to-treat analyses on the Children's Depression Rating Scale-Revised identified a significant time ϫ treatment interaction (P Ͻ .001). Rates of response were 73% for combination therapy, 62% for fluoxetine therapy, and 48% for CBT at week 12; 85% for combination therapy, 69% for fluoxetine therapy, and 65% for CBT at week 18; and 86% for combination therapy, 81% for fluoxetine therapy, and 81% for CBT at week 36. Suicidal ideation decreased with treatment, but less so with fluoxetine therapy than with combination therapy or CBT. Suicidal events were more common in patients receiving fluoxetine therapy (14.7%) than combination therapy (8.4%) or CBT (6.3%).
Conclusions:In adolescents with moderate to severe depression, treatment with fluoxetine alone or in combination with CBT accelerates the response. Adding CBT to medication enhances the safety of medication. Taking benefits and harms into account, combined treatment appears superior to either monotherapy as a treatment for major depression in adolescents.
Objective
To estimate the effect of two separate policy changes in the North Carolina Medicaid program; the first reduced prescription lengths from 100 to 34 days' supply and the second increased copayments for brand name medications.
Data Sources/Study Setting
Medicaid claims data were obtained from the Centers for Medicare and Medicaid Services for January 1, 2000 – December 31, 2002.
Study Design
We used a pre-post controlled partial difference-in-difference-in-differences (DDD) design to examine the effect of the policy change on adults in North Carolina; adult Medicaid recipients from Georgia served as controls. Outcomes examined include medication adherence and Medicaid expenditures.
Data Collection/Extraction Methods
Data were aggregated to the person-quarter level. Individuals in HMOs, nursing homes, pregnant or deceased in the quarter were excluded.
Principal Findings
Both policies decreased medication adherence. The days' supply policy had a much larger effect on adherence than did the copayment increase. Total Medicaid spending declined from the days' supply policy but the copayment policy resulted in a net increase in Medicaid expenditures.
Conclusions
Although Medicaid costs decreased with the change in days supply policy, these savings were due to reduced adherence to these chronic medications. Additional research should examine the effect of these policy changes from the perspective of Medicaid enrollees.
Both fluoxetine and combination therapy are at least as cost-effective in the short-term as other treatments commonly used in primary care (using a threshold of $125,000/QALY). Fluoxetine is more cost-effective than combination therapy after 12 weeks of treatment.
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