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Background: Depot antipsychotics are a treatment option for medication nonadherence in patients with schizophrenia. Nonadherence can lead to increased relapse and hospitalization rates. This article reports hospitalization data before and after initiation of olanzapine long-acting injection (LAI), a depot antipsychotic. Methods: Data were assessed from an ongoing, multinational, prospective, observational post-authorisation safety study being conducted to evaluate post-injection delirium/sedation syndrome (PDSS), an adverse reaction that can occur following injection of olanzapine LAI. Eligible patients were aged =18 years, diagnosed with schizophrenia, were prescribed olanzapine LAI, and lived outside the United States. Psychiatric hospitalization and medication data were collected retrospectively for the 6-month period before study entry and prospectively throughout the study. Paired t-tests and McNemar's tests were used to assess changes in hospitalization incidence and duration. Stepwise Cox proportional hazards models assessed factors associated with hospitalizations. Analyses were based on data from the first 3 years of the continuously enrolling study (N = 668). Results: The average duration of olanzapine LAI exposure for all patients was 0.768 years. Of the 529 patients who received at least 1 injection of olanzapine LAI and were not hospitalized at study entry, 8.1 % had at least 1 subsequent psychiatric hospitalization with a mean duration of 2.0 days. Of the 288 patients who had a >6- month follow-up, 8.3 % had at least 1 post-baseline psychiatric hospitalization with a mean duration of 2.3 days. The incidence of hospitalizations in the 6-month period after treatment was significantly lower than that in the 6-month period prior to treatment (8.3 vs 32.6 %, respectively; P < 0.001). Furthermore, mean hospitalization duration decreased from 11.5 days in the 6-month period before treatment to 2.3 days in the 6-month period after treatment (P < 0.001). Psychiatric hospitalization in the prior 12 months (P < 0.0001) and recreational drug use within 24 h of baseline visit (P = 0.015) were identified as potential predictors of time to first psychiatric hospitalization after beginning to take olanzapine LAI. At the time of interim analysis, 5 PDSS events had occurred, which was too few for a full analysis of those events. Conclusions: Results indicate a significant reduction in the incidence and days of hospitalization from the 6-month period before to the 6-month period after olanzapine LAI initiation, which suggests reduced relapse and hospitalization during treatment. Results should be interpreted with caution due to the observational nature of the study and use of retrospective baseline data. [ABSTRACT FROM AUTHOR]

Background: The Provisional Diagnostic Instrument (PDI-4) is a brief, adult self-report instrument for 4 common psychiatric diagnoses in primary care patients: major depressive episode (MDE), generalized anxiety disorder (GAD), attention deficit hyperactivity disorder (ADHD), and bipolar I disorder based on past or present mania. Our objective was to assess validity of the PDI-4 in a population independent of the study population originally used to develop the scale. Methods: An online version of the 17-item PDI-4 was administered to 1,047 adults in the US; respondents also completed the PHQ-9, HADS-A, CAARS-S, and MDQ within the online survey. Respondents self-reported diagnosis by a healthcare professional with the terms depression (n=221), anxiety (n=218), attention deficit disorder (n=206), bipolar or manic depressive disorder (n=195), or none of these (n=207). Statistical analyses examined convergent and discriminant validity, and operating characteristics of the PDI-4 relative to the individual, validated, self-rated scales PHQ-9, HADS-A, CAARS-S, and MDQ, for each PDI-4 diagnosis. Results: Convergent validity of the PDI-4 was supported by strong correlations with the corresponding individual scales (range of 0.63 [PDI-4 and MDQ] to 0.87 [PDI-4 and PHQ-9]). Operating characteristics of the PDI-4 were similar to results in the previous site-based study. The scale exhibited moderate sensitivities (0.52 [mania] to 0.70 [ADHD]) and strong specificities (0.86 [mania] to 0.92 [GAD]) using the individual scales as the gold standards. ANOVAs demonstrated that PDI-4 discriminated between subsets of patients defined by pre-specified severity level cutoff scores of the individual scales. However, overlapping symptoms and co-morbidities made differentiation between mental diagnoses much weaker than differentiation from the control group with none of the diagnoses. Conclusions: The PDI-4 appears to be a suitable, brief, self-rated tool for provisional diagnoses of common mental disorders. However, the high level of symptom overlap between these diagnoses emphasizes that such brief scales are not a replacement for thorough diagnostic evaluation by trained medical providers. [ABSTRACT FROM AUTHOR]

Background: To identify patient characteristics and early changes in patients' clinical status that best predict subsequent switching of antipsychotic agents in the long-term treatment of schizophrenia. Methods: This post-hoc analysis used data from a one-year randomized, open-label, multisite study of antipsychotics in the treatment of schizophrenia. The study protocol permitted switching of antipsychotics when clinically warranted after the first eight weeks. Baseline patient characteristics were assessed using standard psychiatric measures and reviews of medical records. The prediction model included baseline sociodemographics, comorbid psychiatric and non-psychiatric conditions, body weight, clinical and functional variables, as well as change scores on standard efficacy and tolerability measures during the first two weeks of treatment. Cox proportional hazards modeling was used to identify the best predictors of switching from the initially assigned antipsychotic medication. Results: About one-third of patients (29.5%, 191/648) switched antipsychotics before the end of the one-year study. There were six variables identified as the best predictors of switching: lack of antipsychotic use in the prior year, pre-existing depression, female gender, lack of substance use disorder, worsening of akathisia (as measured by the Barnes Akathisia Scale), and worsening of symptoms of depression/anxiety (subscale score on the Positive and Negative Syndrome Scale) during the first two weeks of antipsychotic therapy. Conclusions: Switching antipsychotics appears to be prevalent in the naturalistic treatment of schizophrenia and can be predicted by a small and distinct set of variables. Interestingly, worsening of anxiety and depressive symptoms and of akathisia following two weeks of treatment were among the more robust predictors of subsequent switching of antipsychotics. [ABSTRACT FROM AUTHOR]

Background: Individuals with schizophrenia may have a higher risk of encounters with the criminal justice system than the general population, but there are limited data on such encounters and their attendant costs. This study assessed the prevalence of encounters with the criminal justice system, encounter types, and the estimated cost attributable to these encounters in the one-year treatment of persons with schizophrenia. Methods: This post-hoc analysis used data from a prospective one-year cost-effectiveness study of persons treated with antipsychotics for schizophrenia and related disorders in the United States. Criminal justice system involvement was assessed using the Schizophrenia Patients Outcome Research Team (PORT) client survey and the victimization subscale of the Lehman Quality of Life Interview (QOLI). Direct cost of criminal justice system involvement was estimated using previously reported costs per type of encounter. Patients with and without involvement were compared on baseline characteristics and direct annual health care and criminal justice systemrelated costs. Results: Overall, 278 (46%) of 609 participants reported at least 1 criminal justice system encounter. They were more likely to be substance users and less adherent to antipsychotics compared to participants without involvement. The 2 most prevalent types of encounters were being a victim of a crime (67%) and being on parole or probation (26%). The mean annual per-patient cost of involvement was $1,429, translating to 6% of total annual direct health care costs for those with involvement (11% when excluding crime victims). Conclusions: Criminal justice system involvement appears to be prevalent and costly for persons treated for schizophrenia in the United States. Findings highlight the need to better understand the interface between the mental health and the criminal justice systems and the related costs, in personal, societal, and economic terms. [ABSTRACT FROM AUTHOR]

Background: To assess the direct cost of relapse and the predictors of relapse during the treatment of patients with schizophrenia in the United States. Methods: Data were drawn from a prospective, observational, noninterventional study of schizophrenia in the United States (US-SCAP) conducted between 7/1997 and 9/2003. Patients with and without relapse in the prior 6 months were compared on total direct mental health costs and cost components in the following year using propensity score matching method. Baseline predictors of subsequent relapse were also assessed. Results: Of 1,557 participants with eligible data, 310 (20%) relapsed during the 6 months prior to the 1-year study period. Costs for patients with prior relapse were about 3 times the costs for patients without prior relapse. Relapse was associated with higher costs for inpatient services as well as for outpatient services and medication. Patients with prior relapse were younger and had onset of illness at earlier ages, poorer medication adherence, more severe symptoms, a higher prevalence of substance use disorder, and worse functional status. Inpatient costs for patients with a relapse during both the prior 6 months and the follow-up year were 5 times the costs for patients with relapse during the follow-up year only. Prior relapse was a robust predictor of subsequent relapse, above and beyond information about patients' functioning and symptom levels. Conclusions: Despite the historical decline in utilization of psychiatric inpatient services, relapse remains an important predictor of subsequent relapse and treatment costs for persons with schizophrenia. [ABSTRACT FROM AUTHOR]

Background: Schizophrenia is a severe, chronic, and costly illness that adversely impacts patients' lives and health care payer budgets. Cost comparisons of treatment regimens are, therefore, important to health care payers and researchers. Pre-Post analyses ("mirror-image"), where outcomes prior to a medication switch are compared to outcomes post-switch, are commonly used in such research. However, medication changes often occur during a costly crisis event. Patients may relapse, be hospitalized, have a medication change, and then spend a period of time with intense use of costly resources (post-medication switch). While many advantages and disadvantages of Pre-Post methodology have been discussed, issues regarding the attributability of costs incurred around the time of medication switching have not been fully investigated. Methods: Medical resource use data, including medications and acute-care services (hospitalizations, partial hospitalizations, emergency department) were collected for patients with schizophrenia who switched antipsychotics (n = 105) during a 1-year randomized, naturalistic, antipsychotic cost-effectiveness schizophrenia trial. Within-patient changes in total costs per day were computed during the pre- and post-medication change periods. In addition to the standard Pre-Post analysis comparing costs pre- and post-medication change, we investigated the sensitivity of results to varying assumptions regarding the attributability of acute care service costs occurring just after a medication switch that were likely due to initial medication failure. Results: Fifty-six percent of all costs incurred during the first week on the newly initiated antipsychotic were likely due to treatment failure with the previous antipsychotic. Standard analyses suggested an average increase in cost-per-day for each patient of $2.40 after switching medications. However, sensitivity analyses removing costs incurred post-switch that were potentially due to the failure of the initial medication suggested decreases in costs in the range of $4.77 to $9.69 per day post-switch. Conclusion: Pre-Post cost analyses are sensitive to the approach used to handle acute-service costs occurring just after a medication change. Given the importance of quality economic research on the cost of switching treatments, thorough sensitivity analyses should be performed to identify the impact of crisis events around the time of medication change. [ABSTRACT FROM AUTHOR]

Background: Adherence to antipsychotics for schizophrenia is associated with favorable clinical outcomes. This study compared annual mental-health service utilization by recent medication adherence levels for patients treated for schizophrenia, and assessed whether adherence levels change from pre- to post-psychiatric hospitalization. Methods: We analyzed data from a large prospective, non-interventional study of patients treated for schizophrenia in the United States, conducted between 7/1997 and 9/2003. Detailed mental-health resource utilization was systematically abstracted from medical records and augmented with patients' self report. Medication possession ratio (MPR) with any antipsychotic in the 6 months prior to enrollment was used to categorize patients as: adherent (MPR ≥ 80%, N = 1758), partially adherent (MPR ≥ 60% < 80%, N = 36), or non-adherent (MPR < 60%, N = 216). Group comparisons employed propensity score-adjusted bootstrap re-sampling methods with 1000 iterations, adjusting for baseline patient demographic and clinical characteristics identified a priori. Results: Adherent patients had a lower rate of psychiatric hospitalization compared with partially adherent and non-adherent patients (p < 0.001) and were more likely than non-adherent to engage in group therapy, individual therapy, and medication management. Most patients (92.0%) who were adherent in the 6 months prior to hospital admission continued to be adherent 6 months following hospitalization. However, 75.0% of previously partially adherent became adherent, and 38.7% of previously non-adherent became adherent following hospitalization. Conclusion: Adherence is associated with lower utilization of acute care services and greater engagement in outpatient mental-health treatment. Adherence is a potentially dynamic phenomenon, which may improve, at least temporarily, following patients' psychiatric hospitalizations. [ABSTRACT FROM AUTHOR]

Background: Relatively little is known about the relationship between psychosocial crises and treatment costs for persons with schizophrenia. This naturalistic prospective study assessed the association of recent crises with mental health treatment costs among persons receiving treatment for schizophrenia. Methods: Data were drawn from a large multi-site, non-interventional study of schizophrenia patients in the United States, conducted between 1997 and 2003. Participants were treated at mental health treatment systems, including the Department of Veterans Affairs (VA) hospitals, community mental health centers, community and state hospitals, and university health care service systems. Total costs over a 1-year period for mental health services and component costs (psychiatric hospitalizations, antipsychotic medications, other psychotropic medications, day treatment, emergency psychiatric services, psychosocial/rehabilitation group therapy, individual therapy, medication management, and case management) were calculated for 1557 patients with complete medical information. Direct mental health treatment costs for patients who had experienced 1 or more of 5 recent crisis events were compared to propensity-matched samples of persons who had not experienced a crisis event. The 5 non-mutually exclusive crisis event subgroups were: suicide attempt in the past 4 weeks (n = 18), psychiatric hospitalization in the past 6 months (n = 240), arrest in the past 6 months (n = 56), violent behaviors in the past 4 weeks (n = 62), and diagnosis of a co-occurring substance use disorder (n = 413). Results: Across all 5 categories of crisis events, patients who had a recent crisis had higher average annual mental health treatment costs than patients in propensity-score matched comparison samples. Average annual mental health treatment costs were significantly higher for persons who attempted suicide ($46,024), followed by persons with psychiatric hospitalization in the past 6 months ($37,329), persons with prior arrests ($31,081), and persons with violent behaviors ($18,778). Total cost was not significantly higher for those with co-occurring substance use disorder ($19,034). Conclusion: Recent crises, particularly suicide attempts, psychiatric hospitalizations, and criminal arrests, are predictive of higher mental health treatment costs in schizophrenia patients. [ABSTRACT FROM AUTHOR]

Background: This study compared the costs of antipsychotic polypharmacy for patients who initiated on 1 of the 3 most commonly prescribed atypical antipsychotics -- olanzapine, quetiapine, or risperidone. Methods: Data were drawn from a large, prospective, naturalistic, multi-site, nonrandomized study of treatment for schizophrenia in the United States conducted between July 1997 and September 2003. Participants who were initiated on olanzapine (N = 405), quetiapine (N = 115), or risperidone (N = 276) were followed for 1 year post initiation and compared on: (a) average daily cost of the index antipsychotic while on the index antipsychotic, (b) average daily cost of the coprescribed antipsychotics while on the index antipsychotic, (c) average daily cost of the index antipsychotic and the coprescribed antipsychotics while on the index antipsychotic, (d) total annual cost of antipsychotic medications prescribed in the year following initiation on the index antipsychotic, using propensity score-adjusted bootstrap resampling method. Average daily antipsychotic costs and total annual antipsychotic costs were also estimated using more recent (2004) antipsychotic drug prices. Results: During the 1 year following initiation on the index antipsychotic, the total average daily cost of the index antipsychotic was higher for quetiapine ($15.33) than olanzapine ($13.90, p < .05) and risperidone ($11.04, p < .01), although the average daily cost of the index antipsychotic was higher for olanzapine ($10.08) than risperidone ($6.74, p < .01) or quetiapine ($6.63, p < .01). Lower total average daily costs were observed in risperidone than olanzapine or quetiapine. Significantly lower average daily cost of concomitant antipsychotic medications for olanzapine ($3.82) compared to quetiapine ($8.70, p < .01) or risperidone-initiated patients ($4.30, p < .01) contributed to the lower average daily cost of all antipsychotic medication for olanzapine-initiated patients. Each dollar spent on the index antipsychotic was accompanied by spending an additional $1.31 on concomitant antipsychotics for quetiapine compared to $0.64 for risperidone and $0.38 for olanzapine-initiated patients. A separate intent-to-treat analysis of the total annual antipsychotic cost found a significantly higher total annual antipsychotic cost for quetiapine-initiated patients ($5320) compared to olanzapine ($4536, p < .01) or risperidone ($3813, p < .01). Conclusion: Prevalent antipsychotic polypharmacy adds substantial cost to the treatment of schizophrenia. Comparison of medication costs need to address the costs of all antipsychotics. A better understanding of concomitant antipsychotic costs provides a more accurate portrayal of antipsychotic medication costs in the treatment of schizophrenia. [ABSTRACT FROM AUTHOR]

Background: This study of chronically ill patients with schizophrenia aimed to identify patients who achieve sustained favorable long-term outcome - when the outcome incorporates severity of symptoms, level of functioning, and use of acute care services - and to identify the best baseline predictors of achieving this sustained favorable long-term outcome., Methods: Using data from the United States Schizophrenia Care and Assessment Program (US-SCAP) (N = 2327), a large 3-year prospective, multisite, observational study of individuals treated for schizophrenia in the US, a hierarchical cluster analysis was performed to group patients based upon baseline symptom severity. Symptom severity was assessed using the Positive and Negative Syndrome Scale (PANSS) scores, level of functioning, and use of acute care services. Level of functioning reflected patient-reported productivity and clinician-rated occupational role functioning. Use of acute care services reflected self-reported psychiatric hospitalization and emergency service use. Change of health state was determined over the 3-year period. A patient was classified as having a sustained favorable long-term outcome if their health state values had the closest distance to the defined "best baseline cluster" at each point over the length of the study. Stepwise logistic regression was used to determine baseline predictors of sustained favorable long-term outcome., Results: At baseline, 5 distinct health state clusters were identified, ranging from "best" to "worst." Of 1635 patients with sufficient data, only 157 (10%) experienced sustained favorable long-term outcome during the 2-years postbaseline. The baseline predictors associated with sustained favorable long-term outcome included better quality of life, more daily activities, patient-reported clearer thinking from medication, better global functioning, being employed, not being a victim of a crime, not having received individual therapy, and not having received help with shopping and leisure activities., Conclusions: Only a small percentage of patients achieved sustained favorable long-term outcome in this study, suggesting there continues to be a great need for improvement in the treatment of schizophrenia. Findings suggest that clinicians could make early projections of health states and identify those patients more likely to achieve favorable long-term outcomes enabling early therapeutic interventions to enhance benefits for patients.

Background: Switching between antipsychotic medications is common in the treatment of schizophrenia. However, data on clinical and economic outcomes from antipsychotic switching, in particular acute care service use, is fairly limited. The goal of this research was to assess the clinical and economic ramifications of switching antipsychotics during outpatient management of schizophrenia., Methods: Data from a 1-year randomized, open-label cost-effectiveness study involving typical and atypical antipsychotics were assessed. The study protocol permitted switching of antipsychotics when clinically warranted. The risk of crisis-related events, use of acute-care services, and the time to the initial use of such services were determined in outpatients who switched antipsychotics compared with those who continued with their initial medications. Health care resource utilization data were abstracted from medical records and other sources (e.g., patient self-report), and direct costs were estimated using previously published benchmarks., Results: Almost one-third of patients (29.3%) underwent a switch from their initial antipsychotic agent, with an average duration of 100 days before such treatment alterations. Compared with their counterparts who remained on their initial therapies, individuals who switched antipsychotics experienced a significantly higher risk of acute-care services, including hospitalization (p = .013) and crisis services (p = .011). Patients undergoing medication switches also used acute-care services significantly sooner (p = .004) and accrued an additional $3,000 (a 25% increase) in annual total health care costs per patient, most of which was due to acute-care expenditures., Conclusion: Switching antipsychotic medications was found to be associated with considerably poorer clinical and economic outcomes, as reflected by, more frequent and more rapid use of acute-care services compared with persons remaining on their initial treatments., Trial Registration: Trial ID 2325 in LillyTrials.com (also accessible via ClinicalStudyResults.org).

Background: Relatively little is known about the relationship between psychosocial crises and treatment costs for persons with schizophrenia. This naturalistic prospective study assessed the association of recent crises with mental health treatment costs among persons receiving treatment for schizophrenia., Methods: Data were drawn from a large multi-site, non-interventional study of schizophrenia patients in the United States, conducted between 1997 and 2003. Participants were treated at mental health treatment systems, including the Department of Veterans Affairs (VA) hospitals, community mental health centers, community and state hospitals, and university health care service systems. Total costs over a 1-year period for mental health services and component costs (psychiatric hospitalizations, antipsychotic medications, other psychotropic medications, day treatment, emergency psychiatric services, psychosocial/rehabilitation group therapy, individual therapy, medication management, and case management) were calculated for 1557 patients with complete medical information. Direct mental health treatment costs for patients who had experienced 1 or more of 5 recent crisis events were compared to propensity-matched samples of persons who had not experienced a crisis event. The 5 non-mutually exclusive crisis event subgroups were: suicide attempt in the past 4 weeks (n = 18), psychiatric hospitalization in the past 6 months (n = 240), arrest in the past 6 months (n = 56), violent behaviors in the past 4 weeks (n = 62), and diagnosis of a co-occurring substance use disorder (n = 413)., Results: Across all 5 categories of crisis events, patients who had a recent crisis had higher average annual mental health treatment costs than patients in propensity-score matched comparison samples. Average annual mental health treatment costs were significantly higher for persons who attempted suicide ($46,024), followed by persons with psychiatric hospitalization in the past 6 months ($37,329), persons with prior arrests ($31,081), and persons with violent behaviors ($18,778). Total cost was not significantly higher for those with co-occurring substance use disorder ($19,034)., Conclusion: Recent crises, particularly suicide attempts, psychiatric hospitalizations, and criminal arrests, are predictive of higher mental health treatment costs in schizophrenia patients.