Marisa Elena Domino

Contrasting Measures of Adherence with Simple Drug Use, Medication Switching, and Therapeutic Duplication

BACKGROUND Multiple measures of adherence have been reported in the research literature and it is difficult to determine which is best, as each is nuanced. Occurrences of medication switching and polypharmacy or therapeutic duplication can substantially complicate adherence calculations when adherence to a therapeutic class is sought. OBJECTIVE To contrast the Proportion of Days Covered (PDC) adherence metric with 2 variants of the Medication Possession Ratio (MPR, truncated MPR). METHODS This study was a retrospective analysis of the North Carolina Medicaid administrative claims data from July 1999 to June 2000. Data for patients with schizophrenia (ICD-9-CM code 295.xx) who were not part of a health maintenance organization, not hospitalized, and not pregnant, taking at least one antipsychotic, were aggregated for each person into person-quarters. The numerator for PDC was defined as the number of days one or more antipsychotics was available and the MPR numerator was defined as the total days’ supply of antipsychotics; both were divided by the total days in each person-quarter. Adherence rates were estimated for subjects who used only one antipsychotic, switched medications, or had therapeutic duplication in the quarter. RESULTS The final sample consisted of 25,200 person-quarters from 7069 individuals. For person-quarters with single antipsychotic use, adherence to antipsychotics as a class was: PDC 0.607, truncated MPR 0.640, and MPR 0.695 (p < 0.001). For person-quarters with switching, the average MPR was 0.690, truncated MPR was 0.624, and PDC was 0.562 (p < 0.001). In the presence of therapeutic duplication, the PDC was 0.669, truncated MPR was 0.774, and MPR was 1.238 (p < 0.001). CONCLUSIONS 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.

Treatment for Adolescents with Depression Study (TADS): Rationale, design, and methods

OBJECTIVES A rapidly growing empirical literature on the treatment of major depressive disorder (MDD) in youth supports the efficacy of short-term treatment with depression-specific cognitive-behavioral therapy or medication management with a selective serotonin reuptake inhibitor. These studies also identify a substantial probability of partial response and of relapse, which might be addressed by more intensive, longer-term treatments. METHOD Funded by the National Institute of Mental Health, the Treatment for Adolescents With Depression Study (TADS) is a multicenter, randomized, masked effectiveness trial designed to evaluate the short-term (12-week) and long-term (36-week) effectiveness of four treatments for adolescents with MDD: fluoxetine, cognitive-behavioral therapy, their combination, and, acutely, pill placebo. A volunteer sample of 432 subjects aged 12-17 years (inclusive) with a primary DSM-IV diagnosis of MDD who are broadly representative of patients seen in clinical practice will enter the study. The primary dependent measures rated blindly by an independent evaluator are the Childrens Depression Rating Scale and, for responder analysis, a dichotomized Clinical Global Impressions-Improvement score. Consistent with an intent-to-treat analysis, all patients, regardless of treatment status, return for all scheduled assessments. RESULTS This report describes the design of the trial, the rationale for the design choices made, and the methods used to carry out the trial. CONCLUSION When completed, TADS will improve our understanding of how best to initiate treatment for adolescents with MDD.

The Treatment for Adolescents With Depression Study (TADS): outcomes over 1 year of naturalistic follow-up.

OBJECTIVE The Treatment for Adolescents With Depression Study (TADS) evaluates the effectiveness of fluoxetine, cognitive-behavioral therapy (CBT), and their combination in adolescents with major depressive disorder. The authors report effectiveness outcomes across a 1-year naturalistic follow-up period. METHOD The randomized, controlled trial was conducted in 13 academic and community sites in the United States. Stages I, II, and III consisted of 12, 6, and 18 weeks of acute, consolidation, and continuation treatment, respectively. Following discontinuation of TADS treatments at the end of stage III, stage IV consisted of 1 year of naturalistic follow-up. The participants were 327 subjects between the ages of 12 and 17 with a primary DSM-IV diagnosis of major depressive disorder. No TADS treatment was provided during the follow-up period; treatment was available in the community. The primary dependent measures, rated by an independent evaluator blind to treatment status, were the total score on the Childrens Depression Rating Scale-Revised and the rate of response, defined as a rating of much or very much improved on the Clinical Global Impressions improvement measure. RESULTS Sixty-six percent of the eligible subjects participated in at least one stage IV assessment. The benefits seen at the end of active treatment (week 36) persisted during follow-up on all measures of depression and suicidality. CONCLUSIONS In contrast to earlier reports on short-term treatments, in which worsening after treatment is the rule, the longer treatment in the TADS was associated with persistent benefits over 1 year of naturalistic follow-up.

Retirement and physical activity: analyses by occupation and wealth.

BACKGROUND Older adults close to retirement age show the lowest level of physical activity. Changes in lifestyle with retirement may alter physical activity levels. This study investigated whether retirement changes physical activity and how the effect differs by occupation type and wealth level. METHODS This longitudinal study used the Health and Retirement Study (1996-2002), U.S. population-based data. Analyses were conducted in 2007 and 2008. Physical activity was measured by a composite indicator of participation in either work-related or leisure-time physical activity. Fixed-effects regression models were used to account for confounders and unobserved heterogeneity. The dependent variable was a composite indicator of participation in regular physical activity either at work or during nonworking hours. RESULTS Physical activity decreased with retirement from a physically demanding job but increased with retirement from a sedentary job. Occupation type interacted with wealth level, with the negative impact on physical activity of retirement exacerbated by lack of wealth and the positive effect of retirement on physical activity enhanced by wealth. CONCLUSIONS Substantial differences in the effect of retirement on physical activity occurred across subgroups. As the number of people approaching retirement age rapidly increases, findings suggest that a growing segment of the nations population may not sustain an adequate level of physical activity.

Cost-Effectiveness of Treatments for Adolescent Depression: Results From TADS

OBJECTIVE While the evidence base for treatments for adolescent depression is building, little is known about the relative efficiency of such treatments. Treatment costs are a relevant concern given the competing demands on family and health care budgets. The authors evaluated the cost-effectiveness of three active treatments among adolescents with major depressive disorder. METHOD Volunteers (N=439) ages 12 to 18 with a primary diagnosis of major depressive disorder participated in a randomized, controlled trial conducted at 13 U.S. academic and community clinics from 2000 to 2004. Subjects included those participants who did not drop out and had evaluable outcome and cost data at 12 weeks (N=369). Subjects were randomly assigned to 12 weeks of either fluoxetine alone (10-40 mg/day), CBT alone, CBT combined with fluoxetine (10-40 mg/day), or placebo (equivalent to 10-40 mg/day). Both placebo and fluoxetine were administered double-blind; CBT alone and CBT in combination with fluoxetine were administered unblinded. Societal cost per unit of improvement on the Childrens Depression Rating Scale-Revised and cost per quality-adjusted life year (QALY) were compared. RESULTS Results ranged from an incremental cost over placebo of

Relative cost-effectiveness of treatments for adolescent depression: 36-week results from the tads randomized trial

24,000 per QALY for treatment with fluoxetine to

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123,000 per QALY for combination therapy treatment. The cost-effectiveness ratio for CBT treatment was not evaluable due to negative clinical effects. The models were robust on a variety of assumptions. CONCLUSIONS 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

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125,000/QALY). Fluoxetine is more cost-effective than combination therapy after 12 weeks of treatment.

Effect of Retirement on Eating Out and Weight Change: An Analysis of Gender Differences

OBJECTIVE The cost-effectiveness of three active interventions for major depression in adolescents was compared after 36 weeks of treatment in the Treatment of Adolescents with Depression Study. METHOD Outpatients aged 12 to 18 years with a primary diagnosis of major depression participated in a randomized controlled trial conducted at 13 U.S. academic and community clinics from 2000 to 2004. Three hundred twenty-seven participants randomized to 1 of 3 active treatment arms, fluoxetine alone (n = 109), cognitive-behavioral therapy (n = 111) alone, or their combination (n = 107), were evaluated for a 3-month acute treatment and a 6-month continuation/maintenance treatment period. Costs of services received for the 36 weeks were estimated and examined in relation to the number of depression-free days and quality-adjusted life-years. Cost-effectiveness acceptability curves were also generated. Sensitivity analyses were conducted to assess treatment differences on the quality-adjusted life-years and cost-effectiveness measures. RESULTS Cognitive-behavioral therapy was the most costly treatment component (mean

The agency for healthcare research and quality multiple chronic conditions research network: Overview of research contributions and future priorities

1,787 [in monotherapy] and