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BACKGROUND: Once-monthly paliperidone palmitate (PP1M) is a long-acting injectable antipsychotic approved for the treatment of schizophrenia and schizoaffective disorder (SCA) in adults. OBJECTIVE: To assess treatment patterns and schizophrenia/SCA-related hospitalization following payer rejection, patient reversal, or payment of an initial PP1M claim. METHODS: This was a retrospective cohort study using the IQVIA Formulary Impact Analyzer database linked to the Medical Claims, Hospital Charge Detail Master, and Experian consumer databases. Patients with schizophrenia/SCA and ≥1 PP1M pharmacy claim from January 1, 2018, to February 28, 2022, were identified and stratified into 3 cohorts based on the transaction status of the initial PP1M claim (index date): rejected (payer not approved), reversed (payer approved, patient abandoned), and paid (payer approved, patient filled). Patient characteristics during the 12 months before the index date, subsequent treatment patterns, and schizophrenia/SCA-related hospitalization for patients with >6 months of follow-up were assessed by cohort. RESULTS: The rejected, reversed, and paid cohorts included 1,260, 1,046, and 1,686 patients, respectively. Across these cohorts, the mean ages ranged between 39.2 and 44.5 years; more than half were male (50.8%-51.6%) and White (50.6%-58.3%); 19.8%-24.6% of patients had a Quan-Charlson Comorbidity Index score of ≥2. Rates of prior atypical oral and long-acting injectable antipsychotic use ranged between 76.4%-80.3% and 7.8%-12.7%, respectively. Among patients with ≥6 months of follow-up, 52.2% in the rejected and 53.1% in the reversed cohorts had a subsequent paid PP1M claim during the study period; the median (quartile 1-quartile 3) time to the first paid PP1M claim was 22 (5-74) days for rejection and 11 (1-41) days for reversal. In the rejected and reversed cohorts, 10.2% (n = 111) and 9.8% (n = 90) of patients, respectively, did not receive any paid claim for an antipsychotic after the initial PP1M rejection/reversal. The prevalence of schizophrenia/SCA-related hospitalization during follow-up was similar between patients with a paid (7.4%) and rejected PP1M claim (7.0%; P = 0.689) but higher among patients with a reversed claim (10.8%; P = 0.004). After adjusting for confounders, patients in the reversed cohort were 39% more likely to have a schizophrenia/SCA-related hospitalization than those in the paid cohort (odds ratio = 1.39; 95% CI = 1.03-1.87). CONCLUSIONS: Payer rejection and patient reversal of initial PP1M claims is a form of primary nonadherence and may influence patient trajectory. Data from this study suggest that patient reversal of PP1M may lead to an increased risk of schizophrenia/SCA-related hospitalizations, potentially caused by missed or delayed treatment. Policy initiatives that remove barriers to primary adherence or fulfillment may help improve patients' clinical outcomes.
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Antipsicóticos , Preparaciones de Acción Retardada , Hospitalización , Palmitato de Paliperidona , Trastornos Psicóticos , Esquizofrenia , Humanos , Palmitato de Paliperidona/administración & dosificación , Palmitato de Paliperidona/economía , Palmitato de Paliperidona/uso terapéutico , Esquizofrenia/tratamiento farmacológico , Esquizofrenia/economía , Masculino , Antipsicóticos/economía , Antipsicóticos/administración & dosificación , Antipsicóticos/uso terapéutico , Femenino , Estudios Retrospectivos , Adulto , Hospitalización/estadística & datos numéricos , Hospitalización/economía , Persona de Mediana Edad , Trastornos Psicóticos/tratamiento farmacológico , Trastornos Psicóticos/economía , Adulto Joven , Inyecciones , Estudios de CohortesRESUMEN
BACKGROUND: Schizophrenia and schizoaffective disorder require long-term antipsychotic treatment with antipsychotic medications, but poor medication adherence can lead to increased health care utilization and costs. Long-acting injectable antipsychotics (LAIs) offer potential therapeutic advantages in that they require less frequent dosing and improved medication adherence. South Carolina has the highest adoption of LAIs among US states, making it an ideal population for comparing the effectiveness of LAIs vs oral antipsychotics (OAPs) in treating schizophrenia or schizoaffective disorder. OBJECTIVE: To evaluate the effect of LAIs compared with OAPs on medication adherence, health care resource utilization, and costs among South Carolina Medicaid beneficiaries with schizophrenia or schizoaffective disorder. METHODS: South Carolina Medicaid beneficiaries with at least 1 claim for an LAI or OAP between January 1, 2015, and December 31, 2018, aged 18 to 65, with at least 2 claims with diagnoses of schizophrenia or schizoaffective disorder were included. Propensity scores (PSs) were calculated using logistic regression adjusting for confounders and predictors of the outcome. We estimated the "average treatment effect on the treated" by employing PS-weighted t-tests and chi-square tests. RESULTS: A total of 3,531 patients met the inclusion criteria, with 1,537 (44.5%) treated with LAIs and 1,994 (56.5%) treated with OAPs. In PS-weighted analyses, the LAI cohort had a greater proportion of days covered than the OAP cohort with a 365-day fixed denominator (69% vs 64%; P < 0.0001), higher medication possession ratio with a variable denominator while on therapy (85% vs 80%; P < 0.0001), and higher persistence (82% vs 64%; P < 0.0001). The average number of inpatient visits and emergency department visits did not significantly differ between cohorts (0.28 hospitalizations, P = 0.90; 3.68 vs 2.96 emergency department visits, P = 0.19). The number of outpatient visits, including visits for medication administration, were greater in the LAI cohort (23.1 [SD 24.2]) vs OAP (16.9 [SD 21.2]; P < 0.0001); however, including the costs for medication administration visits, outpatient costs (per member) were approximately $2,500 lower in the LAI cohort (P < 0.0001). The number of pharmacy visits was greater in the OAP cohort (LAI 21.0 [SD 17.0] vs OAP 23.0 [SD 15.0]; P = 0.006). All-cause total costs were greater in the LAI cohort ($26,025 [SD $29,909]) vs the OAP cohort ($17,291 [SD $25,261]; P < 0.0001) and were driven by the difference in pharmaceutical costs (LAI $15,273 [SD $16,183] vs OAP $4,696 [SD $10,371]; P < 0.0001). CONCLUSIONS: Among South Carolina Medicaid beneficiaries, treatment with LAIs for schizophrenia or schizoaffective disorder was associated with greater medication adherence rates. Patients using LAIs had higher drug costs and total costs, but lower outpatient and total nondrug costs compared with those using OAPs.
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Antipsicóticos , Preparaciones de Acción Retardada , Medicaid , Cumplimiento de la Medicación , Aceptación de la Atención de Salud , Esquizofrenia , Humanos , Antipsicóticos/economía , Antipsicóticos/administración & dosificación , Antipsicóticos/uso terapéutico , Medicaid/economía , Medicaid/estadística & datos numéricos , Esquizofrenia/tratamiento farmacológico , Esquizofrenia/economía , Masculino , Femenino , Adulto , Cumplimiento de la Medicación/estadística & datos numéricos , Estados Unidos , Persona de Mediana Edad , South Carolina , Administración Oral , Adulto Joven , Aceptación de la Atención de Salud/estadística & datos numéricos , Adolescente , Estudios Retrospectivos , Anciano , Inyecciones , Costos de la Atención en Salud/estadística & datos numéricos , Trastornos Psicóticos/tratamiento farmacológico , Trastornos Psicóticos/economíaRESUMEN
Mucoepidermoid carcinoma (MEC) is a common malignancy arising in the parotid gland. The diagnosis of MEC is typically based on its morphological features alone, characteristically containing mucocytes, intermediate cells and epidermoid cells. However, when cystic degeneration is diffuse, it is challenging to distinguish MEC from other benign cystic tumors. This is a case report of a 58-year-old Caucasian man who presented with a parotid mass. H&E sections of the mass reveal multiloculated cysts lined by bland-looking epithelium with only rare papillary architectures. The papillary proliferation contains mucocytes, and epidermoid cells highlighted by the p63 immunohistochemistry study. The diagnosis was confirmed by FISH result of positive MAML2 (11q21) rearrangement. Patient underwent parotidectomy and is disease-free 6 months post-surgery. MEC with cystic degeneration is a common diagnostic pitfall which can mimic many benign lesions in the salivary gland. We present a rare case with MEC with extensive cystic change, its molecular and pathologic findings and review the diagnostic features of MEC, its benign mimickers and useful tools for distinguishing these entities.
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OBJECTIVE: The authors sought to describe out-of-pocket (OOP) costs among beneficiaries with schizophrenia differing in Medicare Part D low-income subsidy (LIS) status. METHODS: National 100% Medicare claims were used to identify all adult fee-for-service Medicare Part D beneficiaries with schizophrenia who used antipsychotics in 2019 (N=283,813). Proportions of patients by LIS status, OOP costs per prescription, and annual OOP costs were reported. Results were stratified by type of antipsychotic received (oral antipsychotic [OAP], first-generation long-acting injectable [FGA-LAI], or second-generation long-acting injectable [SGA-LAI]). RESULTS: In the final sample, 90.3% of beneficiaries had full LIS status, paying minimal copayments (29.6% institutionalized full LIS, paying $0; 42.2% noninstitutionalized full LIS, ≤100% federal poverty level [FPL], paying $1.25-$3.80; and 18.5% noninstitutionalized full LIS, >100% FPL, paying $3.40-$8.50). Only 0.9% of the sample received partial LIS status, and 8.8% had a non-LIS status. Non-LIS beneficiaries had the highest OOP costs, followed by partial LIS beneficiaries. Before entering catastrophic coverage, median OOP costs per prescription for generic OAPs, brand-name OAPs, FGA-LAIs, and SGA-LAIs were $10.85, $171.97, $26.09, and $394.28, respectively, for non-LIS beneficiaries and $3.69, $105.82, $9.35, and $229.20, respectively, for partial LIS beneficiaries. The annual total OOP costs varied substantially by LIS status (full LIS, $0-$130.79; partial LIS, $458.96; non-LIS, $998.81). CONCLUSIONS: Most Medicare beneficiaries with schizophrenia qualified for full LIS and faced minimal OOP costs for both OAPs and LAIs. The remainder (i.e., partial LIS and non-LIS beneficiaries) faced substantial OOP costs, both per prescription and annually, especially for SGA-LAIs.
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Antipsicóticos , Medicare Part D , Esquizofrenia , Anciano , Adulto , Humanos , Estados Unidos , Antipsicóticos/uso terapéutico , Esquizofrenia/tratamiento farmacológico , Gastos en Salud , PobrezaRESUMEN
Air pollution has become a global public health hazard leading to debilitating effects on physical, mental, and emotional health. Management research has just begun to explore the effects of air pollution on employees' work life. Drawing from the transactional theory of stress (Lazarus & Folkman, 1984) and crossover theory (Westman, 2001), we argue that appraisal of air pollution is an important factor that influences leaders and their behavior with subordinates. Specifically, we propose that when leaders appraise severe air pollution, they are more likely to behave abusively toward their subordinates and engage in laissez-faire leadership. We also propose that this relationship is mediated by leaders' experience of somatic complaints and negative affect. We test our model using an experience sampling study in India of leaders and followers who were located in different cities from each other. Overall, our results highlight how air pollution appraisals can harm not only the leader experiencing the pollution but also subordinates of those leaders. In other words, our counterintuitive finding is that subordinates may be harmed by air pollution to which they are not even directly exposed. (PsycInfo Database Record (c) 2024 APA, all rights reserved).
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Contaminación del Aire , Liderazgo , Humanos , Emociones , Evaluación Ecológica Momentánea , Contaminación del Aire/efectos adversosRESUMEN
Classical machine learning and deep learning models for Computer-Aided Diagnosis (CAD) commonly focus on overall classification performance, treating misclassification errors (false negatives and false positives) equally during training. This uniform treatment overlooks the distinct costs associated with each type of error, leading to suboptimal decision-making, particularly in the medical domain where it is important to improve the prediction sensitivity without significantly compromising overall accuracy. This study introduces a novel deep learning-based CAD system that incorporates a cost-sensitive parameter into the activation function. By applying our methodologies to two medical imaging datasets, our proposed study shows statistically significant increases of 3.84% and 5.4% in sensitivity while maintaining overall accuracy for Lung Image Database Consortium (LIDC) and Breast Cancer Histological Database (BreakHis), respectively. Our findings underscore the significance of integrating cost-sensitive parameters into future CAD systems to optimize performance and ultimately reduce costs and improve patient outcomes.
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Aprendizaje Profundo , Humanos , Biología Computacional , Diagnóstico por Computador/métodos , Pulmón , ComputadoresRESUMEN
BACKGROUND: Adherence to antipsychotic medication and care discontinuity remain a challenge to healthcare practitioners providing care to patients with schizophrenia. OBJECTIVE: This study used real-world data from a US hospital-based, all-payer database to examine clinical quality measures among patients with schizophrenia initiated on a long-acting injectable (LAI) or switched to a new oral antipsychotic medication (OAP) following a hospitalization. METHODS: A retrospective cohort study using the PINC AI™ Healthcare Database compared two cohorts of patients with schizophrenia on post-index hospitalization clinical quality and care continuity endpoints. Patients initiated on an LAI (n = 7292) or switched to a new OAP (n = 31,956) during an index hospitalization between April 2017 and April 2020 were included. Propensity score weighting addressed differences in patient, hospital, and clinical characteristics between the two cohorts. RESULTS: Patients who initiated an LAI experienced significantly greater adjusted 30-day antipsychotic medication continuation to index therapy, higher rate of 30-day outpatient follow-up care, longer mean time to discontinuation of index therapy, and lower risk of discontinuing their index treatment compared to patients who switched to a new OAP (all p values < 0.001). Probability of 30-day antipsychotic medication continuation was significantly higher for LAI initiators than for patients who switched to a new OAP, even after controlling for patient, clinical, and hospital characteristics (adjusted odds ratio = 1.2, 95% CI 1.1-1.3, p < 0.001). CONCLUSION: Patients who initiated an LAI in a hospital setting experienced better clinical quality and care continuity outcomes compared to patients who were switched to a new OAP. These findings may be useful in identifying solutions to help improve the quality of medication management post-hospital discharge among patients with schizophrenia.
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This cross-sectional study assesses the racial and ethnic disparities in long-acting injectable antipsychotic use in a national sample of Medicare beneficiaries with schizophrenia.
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Antipsicóticos , Esquizofrenia , Anciano , Estados Unidos , Humanos , Antipsicóticos/uso terapéutico , Esquizofrenia/tratamiento farmacológico , MedicareRESUMEN
BACKGROUND: Maintaining continuity of care after schizophrenia-related hospitalization is challenging for patients and healthcare providers and systems. Prior evidence suggests that second-generation long-acting injectable antipsychotics (SGLAIs) may reduce the risk of treatment nonadherence and readmission versus oral atypical antipsychotics (OAAs). Therefore, quality measures were compared between patients initiated on SGLAIs and OAAs in the United States. METHODS: Adults newly initiated on an SGLAI or OAA during a schizophrenia-related inpatient stay were identified in HealthVerity databases (01/2015-12/2020); the index date was the hospital discharge date. Patients had continuous health insurance coverage for pharmacy and medical services for 6 months pre-admission and post-discharge from the inpatient stay and ≥1 pharmacy or medical claim (i.e. treatment as indicated by the observed insurance claims) for an antipsychotic other than the index SGLAI or OAA in the 6 months pre-admission. Antipsychotic use and adherence, and schizophrenia-related readmissions and outpatient visits were compared during the 6-month period post-discharge. Characteristics between cohorts were balanced using inverse probability weights. RESULTS: Post-discharge, only 36.9% and 40.7% of weighted SGLAI (N = 466) and OAA (N = 517) patients had ≥1 pharmacy or medical claim for the antipsychotic initiated during the inpatient stay, among whom SGLAI patients were 4.4 times more likely to be adherent to that antipsychotic compared to OAA patients (p < .001). Additionally, SGLAI patients were 2.3 and 3.0 times more likely to have a pharmacy or medical claim for and be adherent to any antipsychotic relative to OAA patients (including index antipsychotic; all p < .001). Within 7 and 30 days post-discharge, 1.7% and 13.0% of SGLAI patients and 4.1% and 12.6% of OAA patients had a readmission. Further, SGLAI patients were 51% more likely to have an outpatient visit compared to OAA patients (p = .044). CONCLUSIONS: Less than half of patients initiated on antipsychotics during a schizophrenia-related inpatient stay continued the same treatment post-discharge. However, SGLAI patients were more likely to be adherent to the initiated antipsychotic and to have an outpatient visit, which may suggest improved continuity of care post-discharge relative to OAA patients.
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Antipsicóticos , Esquizofrenia , Adulto , Humanos , Estados Unidos , Antipsicóticos/uso terapéutico , Esquizofrenia/tratamiento farmacológico , Palmitato de Paliperidona/uso terapéutico , Cuidados Posteriores , Pacientes Internos , Estudios Retrospectivos , Alta del Paciente , Medicaid , Preparaciones de Acción Retardada/uso terapéuticoRESUMEN
Consumer-based voice assistants have the ability to deliver evidence-based treatment, but their therapeutic potential is largely unknown. In a pilot trial of a virtual voice-based coach, Lumen, delivering problem-solving treatment, adults with mild-to-moderate depression and/or anxiety were randomized to the Lumen intervention (n = 42) or waitlist control (n = 21). The main outcomes included changes in neural measures of emotional reactivity and cognitive control, and Hospital Anxiety and Depression Scale [HADS] symptom scores over 16 weeks. Participants were 37.8 years (SD = 12.4), 68% women, 25% Black, 24% Latino, and 11% Asian. Activation of the right dlPFC (neural region of interest in cognitive control) decreased in the intervention group but increased in the control group, with an effect size meeting the prespecified threshold for a meaningful effect (Cohen's d = 0.3). Between-group differences in the change in activation of the left dlPFC and bilateral amygdala were observed, but were of smaller magnitude (d = 0.2). Change in right dlPFC activation was also meaningfully associated (r ≥ 0.4) with changes in self-reported problem-solving ability and avoidance in the intervention. Lumen intervention also led to decreased HADS depression, anxiety, and overall psychological distress scores, with medium effect sizes (Cohen's d = 0.49, 0.51, and 0.55, respectively), compared with the waitlist control group. This pilot trial showed promising effects of a novel digital mental health intervention on cognitive control using neuroimaging and depression and anxiety symptoms, providing foundational evidence for a future confirmatory study.
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Depresión , Distrés Psicológico , Adulto , Humanos , Femenino , Masculino , Depresión/terapia , Depresión/psicología , Ansiedad/terapia , Trastornos de Ansiedad , EncéfaloRESUMEN
BACKGROUND: Exercise may improve executive function among people living with all-cause dementia (PWD), but more evidence is needed. The aim of this pilot randomized controlled trial (RCT) is to examine whether exercise plus usual care improves the primary outcome of executive function, and secondary physiological (inflammation, metabolic aging, epigenetics) and behavioral (cognition, psychological health, physical function, and falls) outcomes compared to usual care alone among PWD. METHODS AND STUDY DESIGN: The strEngth aNd BaLance exercise on Executive function in people living with Dementia (ENABLED) protocol is a pilot parallel, 6-month assessor-blinded RCT (1:1) in residential care facilities, including n = 21 receiving exercise plus usual care and n = 21 usual care alone [NCT05488951]. We will collect primary (Color-Word Stroop Test) and secondary physiological (inflammation, metabolic aging, epigenetics) and behavioral (cognition, psychological health, physical function, and falls) outcomes at baseline and 6 months. We will obtain falls monthly from medical charts. We will collect physical activity, sedentary behavior, and sleep via wrist-worn accelerometers over 7 days at baseline and 6 months. The physical therapist-led adapted Otago Exercise Program will involve 1-h of strength, balance and walking 3×/week for 6 months in groups of 5-7. We will use generalized linear mixed models to examine differences over time in primary and secondary outcomes between groups and examine potential interactions with sex and race. DISCUSSION: This pilot RCT will examine the direct effects and potential underlying physiological mechanisms of exercise on executive function and other behavioral outcomes in PWD, which may have implications for clinical care management.
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Demencia , Función Ejecutiva , Humanos , Terapia por Ejercicio/métodos , Inflamación , Proyectos Piloto , Equilibrio Postural , Ensayos Clínicos Controlados Aleatorios como Asunto , Masculino , FemeninoRESUMEN
BACKGROUND: No research to date has examined antipsychotic (AP) use, healthcare resource use (HRU), costs, and quality of care among those with schizophrenia in the Medicare program despite it serving as the primary payer for half of individuals with schizophrenia in the US. OBJECTIVES: To provide national estimates and assess regional variation in AP treatment utilization, HRU, costs, and quality measures among Medicare beneficiaries with schizophrenia. METHODS: Cross-sectional descriptive analysis of 100% Medicare claims data from 2019. The sample included all adult Medicare beneficiaries with continuous fee-for-service coverage and ≥1 inpatient and/or ≥2 outpatient claims with a diagnosis for schizophrenia in 2019. Summary statistics on AP use; HRU and cost; and quality measures were reported at the national, state, and county levels. Regional variation was measured using the coefficient of variation (CoV). RESULTS: We identified 314,888 beneficiaries with schizophrenia. About 91% used any AP; 20% used any long-acting injectable antipsychotic (LAI); and 14% used atypical LAIs. About 28% of beneficiaries had ≥1 hospitalization and 47% had ≥1 emergency room (ER) visits, the vast majority of which were related to mental health (MH). Total annual all-cause, MH, and schizophrenia-related costs were $23,662, $15,000 and $12,109, respectively. Among those with hospitalizations, 18.4% and 27.3% had readmission within 7 and 30 days and 56% and 67% had a physician visit and AP fill within 30 days post-discharge, respectively. Overall, 81% of beneficiaries were deemed adherent to their AP medications. Larger interstate variations were observed in LAI use than AP use (CoV: 0.21 vs 0.02). County-level variations were larger than state-level variations for all measures. CONCLUSIONS: In this first study examining a national sample of Medicare beneficiaries with schizophrenia, we found low utilization rates of LAIs and high levels of hospital admissions/readmissions and ER visits. State and county-level variations were also found in these measures.
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Antipsicóticos , Esquizofrenia , Anciano , Adulto , Humanos , Estados Unidos , Antipsicóticos/uso terapéutico , Esquizofrenia/tratamiento farmacológico , Cuidados Posteriores , Estudios Transversales , Medicare , Estudios Retrospectivos , Alta del Paciente , Atención a la SaludRESUMEN
This retrospective study evaluated the benefit of following different long-acting injectable (LAI) initiation strategies based on the timing of behavioral and clinical events among Medicaid beneficiaries with schizophrenia. Adults with schizophrenia initiating oral antipsychotics (OAPs) after 12 months without antipsychotic use or schizophrenia-related inpatient/emergency room (ER) visits (index date) were identified. Patients were categorized into four event-driven LAI initiation strategy cohorts based on observed sequences of behavioral (i.e., OAP adherence) and clinical (i.e., schizophrenia-related inpatient/ER visits) events between index and LAI initiation or censoring-strategy #1: adherent to OAPs without schizophrenia-related inpatient/ER visits; strategy #2: nonadherent to OAPs without schizophrenia-related inpatient/ER visits; strategy #3: one schizophrenia-related inpatient/ER visit; strategy #4: ≥2 schizophrenia-related inpatient/ER visits. Clinical outcomes (i.e., all-cause inpatient/ER visits) were evaluated between OAP initiation and end of follow-up. Comparisons between LAI initiation strategy cohorts were conducted using a dynamic marginal structural model adjusting for baseline characteristics and time-varying confounders. Among 13,444 eligible patients, 13.1%, 53.6%, 15.7%, and 17.6% were following strategies #1-4, respectively; of these, 21.9%, 4.3%, 9.2%, and 6.5% started an LAI (the remaining were censored). Strategy #1 was associated with a greater clinical benefit, with 43%, 69%, and 80% fewer inpatient days (all p < 0.05); and 57%, 59%, and 79% fewer ER visits (all p < 0.01) vs strategies #2-4, respectively; the clinical benefit was also observed for strategy #2 vs #3-4. Therefore, starting an LAI prior to OAP nonadherence or occurrence of a schizophrenia-related inpatient/ER visit was associated with fewer all-cause inpatient days of inpatient stay and ER visits.
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BACKGROUND: The Disease Recovery Evaluation and Modification study (DREaM; NCT02431702) assessed the benefit of initiating paliperidone palmitate (PP), a long-acting injectable antipsychotic, in patients with recent-onset schizophrenia or schizophreniform disorder. OBJECTIVE: To determine whether reductions in psychiatric hospitalizations with early initiation of PP vs oral antipsychotic (OAP) therapy observed in a DREaM post hoc analysis are transportable to a real-world population of patients with recent-onset schizophrenia. METHODS: Patients enrolled in DREaM were randomized to receive OAP or PP for 9 months, after which OAP recipients were re-randomized to receive OAP or PP for another 9 months. We used this design to form treatment arms: OAP-OAP, OAP-PP, and PP-PP. Inclusion/exclusion criteria were used to identify a Medicaid Managed Care (MMC) OAP-treated cohort of 1,000 patients diagnosed with schizophrenia using IBM Truven databases from 2015 to 2019. The MMC cohort was combined with the subset of patients diagnosed with schizophrenia enrolled in DREaM from US sites (N = 45, 43, and 44 for OAP-OAP, OAP-PP, and PP-PP, respectively). Propensity scores for the MMC cohort were estimated using baseline variables identified via double-lasso regression. Estimated propensity scores were used to weight psychiatric hospitalizations in the DREaM OAP-OAP group and compared with observed MMC OAP cohort psychiatric hospitalizations. After the successful calibration of the DREaM OAP-OAP group, similar approaches were taken for the OAP-PP and PP-PP groups to transport DREaM effects to MMC data. RESULTS: Standardized mean differences in baseline covariates between DREaM treatment arms and MMC groups were substantially reduced after calibration. The 18-month cumulative numbers of psychiatric hospitalizations per patient (SE) were 0.83 (0.14) for the MMC cohort, 0.43 (0.14) for the unweighted OAP-OAP, and 0.80 (0.37) for the calibrated OAP-OAP. The difference between the calibrated OAP-OAP and MMC was not statistically significant (difference, 0.03 [95% CI = -0.67 to 0.81]), indicating successful calibration. The mean difference in 18-month cumulative psychiatric hospitalizations relative to the MMC cohort was -0.77 (95% CI = -1.08 to -0.47) for OAP-PP and -0.83 (95% CI = -1.15 to -0.60) for PP-PP. CONCLUSIONS: Our study demonstrates that results from the DREaM OAP-OAP group reflect psychiatric hospitalizations in a real-world population when calibrated using specific baseline characteristics. Transporting the DREaM effects, we find that using OAP-PP and PP-PP treatment strategies for patients with recent-onset schizophrenia in the MMC population could reduce psychiatric hospitalizations compared with the use of OAP. These findings, along with the potential reduction in associated costs, should be considered when assessing the value of PP formulations. DISCLOSURES: Dr Basu reports consulting fees through Salutis Consulting LLC related to this work. Dr Mavros is a former employee of the Janssen Pharmaceutical Companies of Johnson & Johnson, Inc, and holds stock in the company. Ms Benson, Dr Fu, Ms Patel, and Dr Brown are employees of Janssen Scientific Affairs, LLC, and hold stock in Johnson & Johnson. This research was funded by Janssen Scientific Affairs, LLC. The sponsor was involved in the study design; collection, analysis, and interpretation of data; and development and review of the manuscript. All authors had full access to the study data and take responsibility for data integrity and the accuracy of the analyses. All authors provided direction and comments on the manuscript, reviewed and approved the final version prior to submission, made the final decision about where to publish these data, and approved submission to this journal.
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Antipsicóticos , Esquizofrenia , Estados Unidos , Humanos , Adulto , Esquizofrenia/tratamiento farmacológico , Antipsicóticos/uso terapéutico , Medicaid , Calibración , Costos de la Atención en Salud , Palmitato de Paliperidona , Estudios RetrospectivosRESUMEN
Background: Life sciences research often turns out to be ineffective. Our aim was to develop a method for mapping repetitive research processes, detecting practice variations, and exploring inefficiencies. Methods: Three samples of R&I projects were used: companion diagnostics of cancer treatments, identification of COVID-19 variants, and COVID-19 vaccine development. Major steps involved: defined starting points, desired end points; measurement of transition times and success rates; exploration of variations, and recommendations for improved efficiency. Results: Over 50% of CDX developments failed to reach market simultaneously with new drugs. There were significant variations among phases of co-development (Bartlett test P<0.001). Length of time in vaccine development also shows variations (P<0.0001). Similarly, subject participation indicates unexplained variations in trials (Phase I: 489.7 (±461.8); Phase II: 857.3 (±450.1); Phase III: 35402 (±18079). Conclusion: Analysis of repetitive research processes can highlight inefficiencies and show ways to improve quality and productivity in life sciences.
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INTRODUCTION: Long-acting injectable antipsychotic agents have been suggested to improve adherence and patient outcomes in schizophrenia or schizoaffective disorder. The purpose of this study was to assess medication use patterns (i.e., medication adherence, persistence), hospital and emergency department readmissions, and total direct medical costs of Oklahoma Medicaid members with schizophrenia or schizoaffective disorder switching from an oral antipsychotic (OAP) to once-monthly paliperidone palmitate (PP1M) or to another OAP (OAP-switch). METHODS: A historical cohort analysis was conducted from 1 January 2016 to 31 December 2020 among adults aged ≥ 18 and ≤ 64 years with schizophrenia or schizoaffective disorder who were previously treated with an OAP. The first claim for PP1M or a new OAP defined the study index date. Members who transitioned from PP1M to 3-month formulation (PP3M) were included (i.e., PP1M/PP3M). Proportion of days covered (PDC), 45-day treatment gaps, 30-day readmissions to hospitals or emergency department, and total direct medical costs were assessed using multivariable, machine-learning least absolute shrinkage, and selection operator (Lasso) regressions controlling for numerous demographic, clinical, mental health, and provider characteristics. RESULTS: Among 295 Medicaid members meeting full inclusion criteria, 183 involved PP1M/PP3Ms (44 PP1M cases transitioned to PP3M) and 112 involved an OAP-switch. The multivariable-adjusted odds of readmission were significantly associated with a 45-day treatment gap (p < 0.05) and non-adherence (i.e., PDC < 80%) (p < 0.05). Relative to PP1M/PP3Ms, the multivariable analyses also indicated that OAP-switch was associated with an 18.5% lower PDC, 92.3% higher number of 45-day treatment gaps, and an approximately 90% higher odds of all-cause 30-day readmission (p < 0.05). The adjusted pre- to post-index change in cost was approximately 49% lower for OAP-switches versus PP1M/PP3Ms (p < 0.001), although unadjusted post-index costs did not differ between groups (p = 0.440). CONCLUSION: This real-world investigation of adult Medicaid members with schizophrenia or schizoaffective disorder observed improved adherence and persistence with fewer readmissions with PP1M/PP3Ms versus OAP-switches.
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Antipsicóticos , Trastornos Psicóticos , Esquizofrenia , Adulto , Estados Unidos , Humanos , Palmitato de Paliperidona/uso terapéutico , Antipsicóticos/uso terapéutico , Esquizofrenia/tratamiento farmacológico , Readmisión del Paciente , Estudios Retrospectivos , Medicaid , Administración Oral , Trastornos Psicóticos/tratamiento farmacológicoRESUMEN
BACKGROUND: Given relapse frequency early in the course of schizophrenia, recently diagnosed patients may benefit from longacting injectable antipsychotics, which are associated with reduced risk of relapse and hospitalization compared with oral antipsychotics (OAPs). OBJECTIVE: To compare health care resource utilization (HCRU) and costs in patients with recent-onset schizophrenia treated with continuous paliperidone palmitate (PP) or continuous OAP or who switched from OAP to PP. METHODS: In this analysis, we combined the 2 randomized phases of the prospective, open-label Disease Recovery Evaluation and Modification (DREaM) clinical study using the principal stratification method to generate 3 treatment strategies: continuous PP for 18 months (PP-PP), continuous OAP for 18 months (OAP-OAP), and initial OAP switched to PP after 9 months (OAP-PP). HCRU metrics included psychiatric hospitalizations, psychiatric and nonpsychiatric emergency department visits, and ambulatory visits. Costs were analyzed using generalized linear models with inverse-probability weighting based on time-varying probabilities of exposure. Robust SEs were estimated using individual-level clustered bootstrapping. Subgroup analyses were performed by region and prior antipsychotic use (< 6 vs ≥ 6 months). RESULTS: A total of 181 patients were included in the PP-PP (n = 61), OAP-OAP (n = 61), and OAP-PP (n = 59) groups. The majority of patients (73%) were enrolled at study sites in the United States, and 48% had received an antipsychotic for less than 6 months prior to study entry. Baseline characteristics were well balanced, and no significant differences in discontinuation rates were observed across treatment strategies. Compared with OAP-OAP, significantly lower cumulative HCRU and costs were apparent before 9 months in the PP-PP group and after 9 months in the OAP-PP group. The cumulative 18-month effects of PP-PP and OAP-PP vs OAP-OAP on the number of psychiatric hospitalizations were â0.28 (95% CI = â0.51 to â0.08) and â0.27 (95% CI = â0.50 to 0.04), respectively, and those on cumulative mean per-patient total health care costs (in 2020 USD) were -$2,867 (95% CI = â$5,133 to â$750) and â$2,789 (95% CI = â$5,155 to â$701), respectively. Subgroup analyses indicated a greater reduction in psychiatric hospitalizations and costs with PP-PP or OAP-PP relative to OAP-OAP in patients with less than 6 vs 6 or more months of prior antipsychotic therapy. CONCLUSIONS: Continuous early use of PP in adults with recentonset schizophrenia significantly reduced psychiatric hospitalizations and associated estimated costs compared with OAP; these effects were particularly notable for patients with a shorter duration of prior antipsychotic use. As this was a post hoc analysis of a study that was not powered for HCRU assessments, future studies calibrating these effects to larger real-world populations will be useful. DISCLOSURES: Dr Basu reports consulting fees through Salutis Consulting LLC related to this work. Ms Benson, Dr Turkoz, Ms Patel, Dr Baker, and Dr Brown are employees of Janssen Scientific Affairs, LLC, and stockholders of Johnson & Johnson, Inc. This research was funded by Janssen Scientific Affairs, LLC. The sponsor was involved in the study design; collection, analysis, and interpretation of data; development and review of the manuscript; and decision to submit the manuscript for publication.
Asunto(s)
Antipsicóticos , Administración Oral , Adulto , Preparaciones de Acción Retardada , Humanos , Palmitato de Paliperidona , Aceptación de la Atención de Salud , Estudios Prospectivos , Recurrencia , Estudios Retrospectivos , Estados UnidosRESUMEN
AIMS: Provide the first national description across the US of variations in healthcare measures in 2018 among Medicaid beneficiaries with schizophrenia. MATERIALS AND METHODS: Adult beneficiaries with ≥2 diagnoses for schizophrenia, and continuous enrollment with consistent geographical data in all of 2018 were identified from Transformed Medicaid Statistical Information System (T-MSIS) Analytic Files (TAF) data for 45 of 50 states. Antipsychotic (AP) utilization rates, including long-acting injectable APs (LAIs), quality metrics, and all-cause healthcare resource utilization and costs for claims submitted to Medicaid were reported nationally and by state. Pearson correlation evaluated associations between LAI utilization and total healthcare costs at state and county levels. RESULTS: Across the US 688,437 patients with schizophrenia were identified. The AP utilization rate was 51% (state range: 24-77%), while the LAI utilization rate was 13% (range: 4-26%). The proportion of patients adherent to any AP was 56% (range: 19-73%). Within 30 days post-discharge from an inpatient admission, 22% (range: 8-58%) of patients had an outpatient visit, and 12% (range: 4-48%) had a readmission. The proportion of patients with ≥1 inpatient admission and ≥1 emergency room visit was 34% (range: 19-82%) and 45% (range: 20-70%). Per-patient-per-year total healthcare costs averaged $32,920 (range: $717-$93,972). At the county level, a weak negative correlation was observed between LAI utilization and total healthcare costs. LIMITATIONS: This study included Medicaid beneficiaries enrolled with pharmacy and medical benefits, including beneficiaries dually eligible for Medicare; results cannot be generalized to the overall schizophrenia population or those with other payer coverage. CONCLUSIONS: In 2018, half of beneficiaries with schizophrenia did not submit any claims for APs to Medicaid, nearly half had an emergency room visit, and one-third had an inpatient admission. Moreover, healthcare measures varied considerably across states. These findings may indicate unmet treatment needs for Medicaid beneficiaries with schizophrenia.
Schizophrenia is a severe mental disorder that poses a large health, social, and cost burden to patients and society. While treatment with antipsychotic medications can reduce the number of relapses and hospitalizations, many patients do not adhere to treatment, which can lead to poor symptom control and further use of healthcare services. Interestingly, these measures of schizophrenia care seem to vary across US states. Therefore, we ran the first study to describe the regional differences in antipsychotic use, measures of quality of care, healthcare use, and healthcare costs among Medicaid-insured patients across the US in 2018.Our results showed that only half of patients used antipsychotics in 2018 (with a range of 2477% across states) and the proportion of patients adherent to antipsychotic treatment was low (range of 1973%). Additionally, nearly half of all patients had an emergency room visit (range of 2070%), and one-third had an inpatient admission (range of 1982%). These findings highlight large variations in antipsychotic use, performance measures, and healthcare use, possibly due to regional differences in unmet needs in schizophrenia care for Medicaid-insured patients in the US. Since use of inpatient and emergency room services was consistently high in specific states or regions, and yearly healthcare costs per patient varied from $717$93,972 (mean = $32,920), there may be a particularly high burden in certain areas of the country where patients with schizophrenia may potentially be experiencing multiple relapses. Further research is needed to identify policies that may help narrow these regional differences.
Asunto(s)
Antipsicóticos , Esquizofrenia , Adulto , Cuidados Posteriores , Anciano , Antipsicóticos/uso terapéutico , Preparaciones de Acción Retardada , Costos de la Atención en Salud , Humanos , Medicaid , Medicare , Alta del Paciente , Estudios Retrospectivos , Esquizofrenia/diagnóstico , Esquizofrenia/tratamiento farmacológico , Estados UnidosRESUMEN
Clinical practice guidelines (CPGs) translate evidence into recommendations to improve patient care and outcomes. To provide an overview of schizophrenia CPGs, we conducted a systematic literature review of English-language CPGs and synthesized current recommendations for the acute and maintenance management with antipsychotics. Searches for schizophrenia CPGs were conducted in MEDLINE/Embase from 1/1/2004-12/19/2019 and in guideline websites until 06/01/2020. Of 19 CPGs, 17 (89.5%) commented on first-episode schizophrenia (FES), with all recommending antipsychotic monotherapy, but without agreement on preferred antipsychotic. Of 18 CPGs commenting on maintenance therapy, 10 (55.6%) made no recommendations on the appropriate maximum duration of maintenance therapy, noting instead individualization of care. Eighteen (94.7%) CPGs commented on long-acting injectable antipsychotics (LAIs), mainly in cases of nonadherence (77.8%), maintenance care (72.2%), or patient preference (66.7%), with 5 (27.8%) CPGs recommending LAIs for FES. For treatment-resistant schizophrenia, 15/15 CPGs recommended clozapine. Only 7/19 (38.8%) CPGs included a treatment algorithm.