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Objectives: To compare 1-year direct healthcare costs and utilization among children and adolescents initiating non-stimulant medications atomoxetine (ATX) or extended-release guanfacine (GXR).Methods: In this retrospective, observational cohort study, children and adolescents aged 6-17 years with attention deficit/hyperactivity disorder (ADHD) who had ≥1 prescription claim for ATX or GXR between December 31, 2009 and January 1, 2011 were identified in the MarketScan Commercial or Multi-State Medicaid claims databases. The first claim was set as the index. Patients with no claims for other ADHD medications that overlapped with the days' supply for the index therapy during the post-period were classified as initiating monotherapy. All-cause and ADHD-related utilization and costs (2011 US$) and treatment patterns (adherence and persistence) were evaluated during the 12 months following index. Propensity score adjustment accounted for differences in patient characteristics, and bootstrapping was used for comparisons.Results: A total of 13,239 children and adolescents with ADHD met the study criteria (4,411 ATX initiators and 8,828 GXR initiators). There were 2,699 ATX monotherapy patients. In propensity-score-adjusted analyses, mean all-cause total costs were significantly less for monotherapy ATX initiators than for GXR initiators ($7,553 vs $10,639; difference = -$3,086, p < .0001), as were mean ADHD-related total costs ($3,213 vs $4,544; difference = -$1,330, p < .0001). Monotherapy ATX initiators had significantly fewer all-cause and ADHD-related total medical visits and ∼22 days shorter persistence to index therapy (p < .0001). Results were similar for secondary analyses comparing all ATX with all GXR initiators, regardless of monotherapy or combination regimen, and comparing only monotherapy initiators.Conclusions: Children and adolescents with ADHD who initiated ATX monotherapy incurred lower all-cause and ADHD-related total healthcare costs than patients who initiated GXR. This was due in part to less healthcare resource utilization and slightly shorter persistence for ATX patients. These findings may aid decision-making and inform future studies, but must be tempered due to inherent observational research limitations. [ABSTRACT FROM AUTHOR]

Since the introduction of the propensity score (PS), methods for estimating treatment effects with observational data have received growing attention in the literature. Recent research has added substantially to the number of available statistical approaches for controlling confounding in such analyses. However, researchers need guidance to decide on the optimal analytic strategy for any given scenario. To address this gap, we conducted simulations evaluating both well-established methods (regression, PS weighting, stratification, and matching) and more recently proposed approaches (tree-based methods, local control, entropy balancing, genetic matching, prognostic scoring). The simulation scenarios included tree-based and smooth regression models as true data-generation mechanisms. We evaluated an extensive number of analysis strategies combining different treatment choices and outcome models. Key findings include 1) the lack of a single best strategy across all potential scenarios; 2) the importance of appropriately addressing interactions in the treatment choice model and/or outcome model; and 3) a tree-structured treatment choice model and a polynomial outcome model with second-order interactions performed well. One limitation to this initial assessment is the lack of heterogeneous simulation scenarios allowing treatment effects to vary by patient. [ABSTRACT FROM AUTHOR]

Objectives: To compare 30 and 90 day real-world acute myocardial infarction (AMI) and bleeding related rehospitalization rates in acute coronary syndrome (ACS) patients receiving percutaneous coronary intervention (PCI; ACS-PCI) treated with clopidogrel or prasugrel. Research design and methods: Using the Premier hospital database, ACS-PCI patients receiving a drug-eluting (DES) or bare-metal (BMS) stent and clopidogrel or prasugrel from July 2009 to June 2011 were analyzed. Patients were included based on the prasugrel US prescribing information (USPI), excluding patients with a history of transient ischemic attack/stroke and patients ≥75 years without diabetes or prior MI. The primary endpoint was 30 day adjusted AMI rehospitalization rate. Secondary endpoints included 90 day AMI and 30 and 90 day bleeding-related rehospitalization rates. Treatment comparisons were adjusted using propensity score stratification. Results: At the index event, prasugrel patients (N = 9404) differed from clopidogrel patients (N = 74,163) by having a lower risk of comorbid conditions associated with bleeding, being more likely younger and male, having ST-elevation MI and receiving a DES. For clopidogrel and prasugrel, respectively, the observed AMI-related rehospitalization rates were 4.7% and 3.9% at 30 days (p < 0.0001) and 6.3% and 5.1% at 90 days (p < 0.0001). After adjustment, prasugrel was associated with ∼10% lower odds of AMI-related rehospitalization (30 days: OR = 0.892 [95% CI: 0.798, 0.998]; 90 days, OR = 0.901 [95% CI: 0.817, 0.994]). Adjusted bleeding-related rehospitalization rates were similar to each other (OR = 1.035 at 30 days [95% CI: 0.765, 1.399]; OR = 0.922 at 90 days [95% CI: 0.725, 1.172]).Study limitations:Treatment adherence was not assessed. Bleeding events not resulting in a hospitalization (e.g. office, outpatient, or emergency room visits), deaths outside the hospital, or readmissions to a hospital outside of the Premier alliance were not captured in the database. Conclusions: The different patient characteristics between prasugrel- and clopidogrel-treated patients suggest physicians are more selective in choosing patients for prasugrel than recommended in the prasugrel USPI. However, after adjustment for these differences, 30 and 90 day AMI rehospitalization rates were lower for prasugrel-treated patients compared to clopidogrel-treated patients, with no difference in adjusted bleeding-related rehospitalization rates. [ABSTRACT FROM AUTHOR]

Objectives: During a schizophrenia treatment episode, persistence with the initial antipsychotic may indicate optimal pharmacotherapy and be a precursor to longer-term effectiveness and other positive outcomes. The objective of this study was to examine the ability of selected variables to predict antipsychotic persistence among patients receiving olanzapine or risperidone as initial treatment.Research Design and Methods: Data for this analysis, which was not defined in the original study protocol, came from a naturalistic, randomized, open-label trial comparing costs and effectiveness of first-line antipsychotic treatment options in schizophrenia. Predictor variables were as follows: (1) patients' initial antipsychotic (olanzapine [n = 222] or risperidone [n = 218]); (2) current (within 30 days) comorbid diagnosis of substance abuse; and (3) nine self-report items from the Rating of Medication Influence (ROMI) scale, including an item assessing patients' perceptions of the role of their therapeutic alliance in their adherence.Main Outcome Measures: For the primary analysis, a stepwise logistic regression was used in predicting antipsychotic persistence of at least 180 days. Variables found to be significantly predictive were included in a second analysis that assessed persistence at additional thresholds (> 90 days, > 270 days, and completion of the 1-year study).Results: Four variables predicted longer antipsychotic persistence; olanzapine as initial antipsychotic (p = 0.004), absence of comorbid substance abuse (p = 0.025), and two of the ROMI items representing patients' subjective response to treatment--positive relationship with clinical staff (p = 0.048) and fulfillment of life goals (p = 0.050).Conclusions: Within a randomized trial design, this study corroborated the influence of several factors on antipsychotic persistence in schizophrenia. Results support the importance of the initial antipsychotic treatment option, presence of a comorbid substance abuse diagnosis, and the role of patients' subjective responses. Additional research is needed to further explore these and other factors as predictors of antipsychotic persistence, and of subsequent treatment outcomes. [ABSTRACT FROM AUTHOR]

Abstract.There is a growing interest in using observational studies to estimate the effects of treatments on survival or time-to-event outcomes. However, few standard approaches can adequately accommodate multiple treatment levels, which are common in observational comparative effectiveness research. We study the asymptotic properties of the generalized propensity score matching estimators of the marginal hazard ratios between pairs of treatment levels. The estimates are obtained by fitting a marginal Cox proportional hazard model on the matched dataset. We evaluate our approach in a simulation study and a case study where we analyze the IQVIA electronic medical records data. [ABSTRACT FROM AUTHOR]

Describes the rationale, design and analysis of an adaptive clinical trial of fluoxetine hydrochloride in the treatment of out-patients with depressive disorder. Review of related literature; Use of Bayesian analysis methods; Characteristics of subjects in study.