Delirium event and associated treatment modifications among older adults with Alzheimer's disease: An interrupted time-series analysis of Medicare data.

BACKGROUND: Both Alzheimer's disease (AD) and deliriogenic medications increase the risk of delirium in older adults. This study examined the association between delirium and the subsequent monthly use of anticholinergic, sedative, and opioid medications in the 1 year after delirium in older adults with AD. METHODS: This comparative interrupted time series analysis involved adults (aged 65 years and older) with a diagnosis of AD initiating on cholinesterase inhibitors (ChEIs) based on 2013-2017 Medicare data. Separate patient-level segmented regression models were used for each outcome to evaluate changes in the cumulative anticholinergic burden (CAB), sedative load, and opioid load after the delirium/index event using a 12-month baseline and follow-up period among patients who had a delirium event and those without delirium (control group). Propensity score-based stabilized weights were utilized to balance baseline factors in the delirium and control groups. RESULTS: The study included 80,019 older adults with AD with incident ChEI use; 17.11% had delirium. There was an immediate decline in monthly CAB after the delirium event (mean estimate -0.86, p-value: 0.01) compared to the control group. A similar decline was observed when examining the sedative load (-0.06, p-value: 0.002) after the delirium event. However, there was no decline in opioid load (-0.50, p-value: 0.18). In the long term, CAB (0.13; p-value: <0.0001), sedative load (0.01; p-value: <0.001), and opioid load (0.07; p-value: 0.006) increased over the 1-year post-delirium period in the delirium group compared to those without delirium. CONCLUSION: This study found the burden of deliriogenic medications over the 1-year follow-up showed increasing trends in older adults with AD, even though there was some level shift in CAB and sedative load after the delirium event.

Impact of adherence on the cost-effectiveness of apixaban and rivaroxaban in stroke prevention among patients with atrial fibrillation in the United States.

OBJECTIVE: Despite the beneficial effects of DOACs, suboptimal adherence is widely documented, and real-world adherence is lower than in clinical trials. The objective of this study is to compare the cost-effectiveness of apixaban versus rivaroxaban for stroke prevention by incorporating real-world adherence from the US payer's perspective. METHODS: We developed a Markov model with three health states to evaluate the total costs and quality-adjusted life years (QALY) at a willingness to pay threshold of $100,000. The population was a hypothetical cohort of 65-year-old patients with moderate to high stroke risk. The transition probabilities of healthy adherent, nonadherent, and stroke were obtained from a Medicare Advantage Plan. The utilities and costs were obtained from prior clinical studies. Deterministic and probabilistic sensitivity analyses were conducted. RESULTS: Apixaban was cost-effective than rivaroxaban at a willingness to pay threshold of $100,000. Apixaban yielded an additional 0.12 QALYs at a cost of $1904.39, resulting in an incremental cost-effectiveness ratio (ICER) of $16,279.25 per QALY gained. The Monte Carlo simulations indicated that apixaban was cost-effective at 89.67% of simulations. The ICER results were impacted by the medical costs among nonadherent patients. CONCLUSION: After incorporating adherence, apixaban 5 mg was a cost-effective alternative to rivaroxaban 20 mg for stroke prevention among elderly atrial fibrillation (AF) patients.

Due to the improved safety and efficacy profile, DOACs are preferred over warfarin for stroke prevention in AF patients. Suboptimal adherence to DOACs is commonly reported in real-world settings, leading to poorer patient outcomes. Prior pharmacoeconomic analyses have not incorporated real-world adherence data. The findings suggest that apixaban 5 mg is a cost-effective alternative to rivaroxaban 20 mg for stroke prevention. Apixaban was identified as the cost-effective option compared with rivaroxaban for stroke prevention among elderly AF patients after incorporating adherence data in the cost-effectiveness analysis. Healthcare decision-makers can utilize the findings of this study to inform formulary decisions and treatment guidelines.

Racial and Ethnic Disparity in Healthcare Expenditure and Resource Utilization Among Patients with Cardiovascular Diseases.

BACKGROUND: Despite extensive research, significant gaps remain in understanding racial disparity among individuals with cardiovascular diseases (CVD). These disparities, influenced by factors such as access to care and comorbid conditions, necessitate further investigation to develop targeted interventions. AIM: To evaluate the factors contributing to racial and ethnic disparities in healthcare resource utilization and total healthcare expenditure among individuals with CVD. METHODS: Using data from the Medical Expenditure Panel Survey spanning 2014-2021, total healthcare expenditure and having a CVD visit were compared among Hispanic, Black, and White adults with CVD. Descriptive analysis, linear regression, and logistic regression models were used to compare the results. Multivariable models were used to evaluate the effect of demographic and socioeconomic factors on total healthcare expenditure and the likelihood of having a CVD visit among different races. RESULTS: With a weighted sample of 17,722,706, the study found that Hispanic and Black cohorts had 23% and 11% lower healthcare expenditures (both p < 0.001). Hispanic and Black cohorts also had lower odds of having a CVD visit (odds ratio [OR] = 0.61, 95% confidence interval [CI]:0.55-0.68; OR = 0.58, 95% CI: 0.52-0.65, respectively) compared to the White cohort. Key predictors included physical and cognitive limitations, insurance status, income, region, and the year of data collection. CONCLUSION: This study highlights the need for targeted interventions to address healthcare disparities and promote health equity among minority populations with CVD.

Group-based trajectory modeling to identify adherence patterns for direct oral anticoagulants in Medicare beneficiaries with atrial fibrillation: a real-world study on medication adherence.

BACKGROUND: Suboptimal adherence to direct oral anticoagulants (DOACs) among atrial fibrillation (AF) patients remains currently a major concern due to the increased risk of cardiac and thromboembolic events. AIM: To identify longitudinal distinct trajectories of DOAC adherence and sociodemographic and clinical factors associated with each trajectory. METHOD: Patients with AF who were prescribed with DOAC from July 2016-December 2017 were identified among patients enrolled in the Medicare Advantage Plan. Patients were followed up for a year after the index date to calculate the monthly proportion of days covered (PDC). The monthly PDC was incorporated into the logistic group-based trajectory model to evaluate distinct patterns of adherence. A multinomial regression model was carried out to assess various predictors associated with each trajectory. Sub-group analysis was conducted among incident DOAC users. RESULTS: Total of 1969 patients with AF, four distinct trajectories of adherence were selected: adherent 36.8%, gaps in adherence 9.3%, gradual decline in adherence 29.7%, and rapid decline in adherence 24.2%. Significant predictors associated with suboptimal adherence trajectories were age (75 years or older), gender (male vs female), low-income subsidy health plan, prevalent users, and presence of comorbidities. Among 933 incident users, three adherence trajectories were identified: adherent trajectory (31.8%), rapid decline in adherence (32.5%), and gradual decline in adherence (35.6%). The significant predictors among incident users were gender (male vs female), low-income subsidy health plan, HAS-BLED score ≥ 2, and presence of coronary artery disease. CONCLUSION: Adherence to DOACs was suboptimal among the total population and incident users.

Metabolic Monitoring for Children and Adolescents Prescribed Second-Generation Antipsychotics: A Qualitative Study with Child Psychiatrists.

Introduction: Professional guidelines recommend that providers routinely monitor children prescribed second-generation antipsychotics (SGA) to reduce the risk of adverse metabolic events associated with the medication. Despite this guidance, many studies show low rates of monitoring compliance. In this study, we interviewed child psychiatrists for their views of possible barriers to monitoring. Methods: Semi-structured qualitative interviews, developed according to the Regehr model of influences upon patient-provider decision making, were conducted with child and adolescent psychiatrists in current practice and recruited by convenience and snowball sampling. Interviews were conducted through internet video meetings and were recorded. Interview data were analyzed following Framework Analysis qualitative methods. Results: We recruited and completed interviews with 17 psychiatrists. Patient-level barriers included travel difficulties, limited family time for health care appointments, patient fear of blood draws, and more. Provider-level barriers included professional judgment versus guideline guidance, perceived family burden, assumption of low-risk, short-term SGA use, and more. Organizational level barriers included lack of organizational mandates or incentives, limited appointment time per patient, lack of care coordination, lack of co-located labs, personnel turnover, and more. Barriers at the social and cultural level include stigma and low health literacy. Conclusion: These practicing prescribers provided a wide range of possible barriers to metabolic monitoring in children and adolescents prescribed SGAs. The next step is to explore which may be present in certain settings, and to pilot quality improvement interventions. Addressing barriers can reduce risk of metabolic disorders arising from long-term use of SGAs in children and adolescents.

Social Determinants of Health and Other Predictors in Initiation of Treatment with CDK4/6 Inhibitors for HR+/HER2- Metastatic Breast Cancer.

In hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (MBC), cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) have replaced endocrine therapy alone as the standard of care; however, several barriers to treatment initiation still exist. We assessed social determinants of health (SDOH) and other factors associated with the initiation of CDK4/6i for HR+/HER2- MBC in the Medicare population. Using a retrospective cohort design, patients aged ≥65 years and diagnosed during 2015-2017 were selected from the SEER-Medicare database. Time from MBC diagnosis to first CDK4/6i initiation was the study outcome. The effect of SDOH measures and other predictors on the outcome was assessed using the multivariable Fine and Gray hazard modeling. Of 752 eligible women, 352 (46.8%) initiated CDK4/6i after MBC diagnosis (median time to initiation: 27.9 months). In adjusted analysis, SDOH factors significantly associated with CDK4/6i initiation included high versus low median household income (HHI) (hazard ratio [HR] = 1.70; 95% CI = 1.03-2.81) and the percentage of population with high versus low Medicare-only coverage (HR = 1.54; 95% CI = 1.04-2.27). In summary, older Medicare patients with HR+/HER2- MBC residing in areas with high median HHI and a high proportion of Medicare-only coverage had higher rates of initiating CDK4/6i, suggesting inequitable access to these novel, effective treatments and a need for policy intervention.

Immunomodulator adherence in multiple myeloma patients with lower socioeconomic status: a retrospective study.

OBJECTIVE: Poor adherence to oral chemotherapy adversely impacts clinical outcomes and escalates overall healthcare costs. Despite barriers to medication adherence, a significant gap remains in assessing adherence to oral chemotherapy among multiple myeloma (MM) patients with lower socioeconomic status. Hence, our study aims to evaluate immunomodulator adherence in MM patients at a county hospital, primarily serving underrepresented and indigent individuals with low socioeconomic status across the greater Houston area. METHODS: Inclusion criteria composed of patients diagnosed with MM, aged at least 18 years, and treated with lenalidomide or pomalidomide-two widely used immunomodulators-for a minimum of 2 months or having two or more records of dispensation between May 2019 and May 2021. Adherence was gauged using an adjusted version of the medication possession ratio (MPR). RESULTS: Sixty-two patients were enrolled, yielding a mean MPR value of 88% (SD, ± 18.9). Of these, 43 patients (69.3%) demonstrated adherence with an MPR of ≥ 0.90. A significant difference was found in treatment duration between the adherent (mean 8.8 months; SD, ± 7.2) and non-adherent (mean 13.4 months; SD, ± 7.9) groups (p = 0.027). Notably, race/ethnicity demonstrated a significant difference (p = 0.048), driven by disparities in African American and Hispanic representation across adherence levels. CONCLUSION: In summary, our findings highlight race and treatment duration to be predictors of immunomodulator adherence among MM patients with lower socioeconomic status. Further research is imperative to devise and test innovative interventions aimed at enhancing medication adherence, thereby contributing to improved survival and healthcare quality in this population.

Predictors of adherence to direct oral anticoagulants after cardiovascular or bleeding events in Medicare Advantage Plan enrollees with atrial fibrillation.

BACKGROUND: Direct oral anticoagulants (DOACs) are recommended for patients with atrial fibrillation (AF) given their improved safety profile. Suboptimal adherence to DOACs remains a significant concern among individuals with AF. However, the extent of adherence to DOACs following a cardiovascular or bleeding event has not been fully evaluated. OBJECTIVE: To evaluate the pattern of adherence trajectories of DOACs after a cardiovascular or bleeding event and to investigate the sociodemographic and clinical predictors associated with each adherence trajectory by using claims-based data. METHODS: This retrospective study was conducted among patients with AF prescribed with DOACs (dabigatran/apixaban/rivaroxaban) between July 2016 and December 2017 and who were continuously enrolled in the Texas-based Medicare Advantage Plan. Patients who experienced a cardiovascular or bleeding event while using the DOACs were further included in the analysis. The sample was limited to patients who experienced a clinical event such as a cardiovascular or bleeding event while using the DOACs. The clinical events considered in this study were cardiovascular (stroke, congestive heart failure, myocardial infarction, systemic embolism) and bleeding events. To assess adherence patterns, each patient with a DOAC prescription was followed up for a year after experiencing a clinical event. The monthly adherence to DOACs after these events was evaluated using the proportion of days covered (PDC). A group-based trajectory model incorporated the monthly PDC to classify groups of patients based on their distinct patterns of adherence. Predictors associated with each trajectory were assessed using a multinomial logistic regression model, with the adherent trajectory serving as the reference group in the outcome variable. RESULTS: Among the 694 patients with AF who experienced clinical events after the initiation of DOACs, 3 distinct adherence trajectories were identified: intermediate nonadherent (30.50%), adherent (37.7%), and low adherent (31.8%); the mean PDC was 0.47 for the intermediate nonadherent trajectory, 0.93 for the adherent trajectory, and 0.01 for low adherent trajectory. The low-income subsidy was significantly associated with lower adherence trajectories (odds ratio [OR] = 4.81; 95% CI = 3.07-7.51) and with intermediate nonadherent trajectories (OR = 1.57; 95% CI = 1.06-2.34). Also, nonsteroidal anti-inflammatory drug use was significantly associated with lower adherence trajectories (OR = 5.10; 95% CI = 1.95-13.36) and intermediate nonadherent trajectories (OR = 3.17; 95% CI = 1.26-7.93). Other predictors significantly associated with both nonadherent trajectories are type of DOACs (OR = 0.53; 95% CI = 0.35-0.79), presence of coronary artery disease (OR = 1.89; 95% CI = 1.01-3.55), and having 2 or more clinical events (OR = 1.65; 95% CI = 1.09-2.50). CONCLUSIONS: Predictors identified provide valuable insights into the suboptimal adherence of DOACs among Medicare Advantage Plan enrollees with AF, which can guide the development of targeted interventions to enhance adherence in this high-risk patient population.

Cumulative Anticholinergic Burden and its Predictors among Older Adults with Alzheimer's Disease Initiating Cholinesterase Inhibitors.

BACKGROUND: Cumulative anticholinergic burden refers to the cumulative effect of multiple medications with anticholinergic properties. However, concomitant use of cholinesterase inhibitors (ChEIs) and anticholinergic burden can nullify the benefit of the treatment and worsen Alzheimer's disease (AD). A literature gap exists regarding the extent of the cumulative anticholinergic burden and associated risk factors in AD. Therefore, this study evaluated the prevalence and predictors of cumulative anticholinergic burden among patients with AD initiating ChEIs. METHODS: A retrospective longitudinal cohort study was conducted using the Medicare claims data involving parts A, B, and D from 2013 to 2017. The study sample included older adults (65 years and older) diagnosed with AD and initiating ChEIs (donepezil, rivastigmine, or galantamine). The cumulative anticholinergic burden was calculated based on the Anticholinergic Cognitive Burden scale and patient-specific dosing using the defined daily dose over the 1 year follow-up period after ChEI initiation. Incremental anticholinergic burden levels were dichotomized into moderate-high (sum of standardized daily anticholinergic exposure over a year (TSDD) score ≥ 90) versus low-no (score 0-89). The Andersen Behavioral Model was used as the conceptual framework for selecting the predictors under the predisposing, enabling, and need categories. A multivariable logistic regression model was used to evaluate the predictors of high-moderate versus low-no cumulative anticholinergic burden. A multinomial logistic regression model was also used to determine the factors associated with patients having moderate and high burdens compared to low/no burdens. RESULTS: The study included 222,064 older adults with AD with incident ChEI use (mean age 82.24 ± 7.29, 68.9% females, 83.6% White). Overall, 80.48% had some anticholinergic burden during the follow-up, with 36.26% patients with moderate (TSDD scores 90-499), followed by 24.76% high (TSDD score > 500), and 19.46% with low (TSDD score 1-89) burden categories. Predisposing factors such as age; African American, Asian, or Hispanic race; and need factors included comorbidities such as dyslipidemia, syncope, delirium, fracture, pneumonia, epilepsy, and claims-based frailty index were less likely to be associated with the moderate-high anticholinergic burden. The factors that increased the odds of moderate-high burden were predisposing factors such as female sex; enabling factors such as dual eligibility and diagnosis year; and need factors such as baseline burden, behavioral and psychological symptoms of dementia, depression, insomnia, urinary incontinence, irritable bowel syndrome, anxiety, muscle spasm, gastroesophageal reflux disease, heart failure, and dysrhythmia. Most of these findings remained consistent with multinomial logistic regression.  CONCLUSION: Four out of five older adults with AD had some level of anticholinergic burden, with over 60% having moderate-high anticholinergic burden. Several predisposing, enabling, and need factors were associated with the cumulative anticholinergic burden. The study findings suggest a critical need to minimize the cumulative anticholinergic burden to improve AD care.

Trajectories and Predictors for the Development of Clinically Significant Weight Gain in Children and Adolescents Prescribed Second-Generation Antipsychotics.

Background: As many as 60% of pediatric patients taking second-generation antipsychotics (SGA) experience weight gain (antipsychotic-induced weight gain). However, the subgroup that experienced substantial weight increase was poorly understood. This study aimed to identify the development and predictors of clinically significant weight gain (CSWG) among pediatric SGA recipients. Methods: A retrospective analysis of the 2016 to 2021 IQVIA Ambulatory EMR-US database was conducted. The study cohort comprised SGA-naive patients ages 5 to 19, continuously prescribed SGA for ≥90 days. CSWG was defined as a weight gain in BMI z-score >0.5. The development of CSWG was described using the group-based trajectory model approach, and multinomial logistic regression analysis was conducted to examine the risk factors associated with the CSWG trajectories. Results: Of the 16,262 SGA recipients who met the inclusion criteria, 4 distinctive CSWG trajectories were identified: (1) Rapid (14.6%), (2) Gradual (12.6%), (3) Transit (7%), and (4) no CSWG (65.8%). Factors associated with a higher likelihood of having rapid or gradual CSWG versus nonsignificant weight gain were being younger (OR [95% CI] = 12-17 vs. 5-11, Rapid, 0.727 [0.655-0.806]; Gradual, 0.776 [0.668-0.903]), male (Rapid, 1.131 [1.021-1.253]), non-Hispanic White (Black vs. White: Rapid, 0.833 [0.709-0.98]), with lower baseline BMI z-score (Rapid, 0.376 [0.361-0.392]; Gradual, 0.449 [0.424-0.476]), and receiving olanzapine as the initial SGA (Rapid, 1.38 [1.093-1.74]). The Area under the Receiver operating characteristic (ROC) Curve for the comparison of rapid and gradual CSWG with no CSWG trajectory were 0.83 and 0.80, respectively. Conclusions: SGA recipients experienced four distinctive CSWG trajectories (Rapid, Gradual, Transient, and No CSWG). The risk of CSWG could be predicted using patient characteristics at the SGA initiation. This insight highlights the importance of personalized monitoring and timely intervention strategies for at-risk individuals who experienced persistent CSWG in real practice.

Group-Based Trajectory Modeling to Identify Patterns of Antipsychotic-Associated Weight Gain Among Children and Adolescents.

PURPOSE/BACKGROUND: Antipsychotic-associated weight gain (AAWG) is a common adverse effect of second-generation antipsychotic (SGA) medications among children and adolescents. This study applied group-based trajectory modeling to identify latent trajectories of AAWG among children and adolescents and associated risk factors. PROCEDURES: This was a retrospective analysis of the IQVIA Ambulatory EMR-US database from 2016 to 2021. The cohort consisted of patients aged 6 to 19 years who were SGA naive and received at least 90 days of continuous SGA prescriptions. Group-based trajectory modeling was used to identify latent trajectories of AAWG development during a 24-month period since SGA initiation, and multinomial logistic regression analysis was conducted to examine the risk factors associated with the identified AAWG trajectories. FINDINGS/RESULTS: A total of 16,262 patients were included. Group-based trajectory modeling identified the following 4 distinctive AAWG trajectories: persistent severe weight gain (4.2%), persistent moderate weight gain (20.1%), minor weight change (69.6%), and gradual weight loss (6.1%). Compared with the minor weight change group, younger age (12-17 vs 5-11: odds ratio [OR], 0.634; 95% confidence interval [CI], 0.521-0.771), lower baseline body mass index z -score (OR, 0.216; 95% CI, 0.198-0.236), and receiving olanzapine as the initial SGA (olanzapine vs aripiprazole: OR, 1.686; 95% CI, 1.673-1.699) were more likely to follow severe weight gain trajectories. The area under the receiver operating characteristic curves for comparing severe weight gain versus minor weight change groups and moderate weight vs minor weight change groups in the multinomial regression model were 0.91 and 0.8, respectively. IMPLICATIONS/CONCLUSIONS: A quarter of pediatric SGA recipients experienced persistent weight gain during the SGA treatment. The risk of having persistent AAWG can be predicted using patient characteristics collected before SGA initiation and the initial SGA agent.

Adherence to Recommended Metabolic Monitoring of Children and Adolescents Taking Second-Generation Antipsychotics.

OBJECTIVE: Clinical guidelines recommend periodic monitoring for adverse metabolic effects associated with second-generation antipsychotic medications. The authors sought to evaluate adherence to the guideline-recommended metabolic monitoring schedule for children and adolescents prescribed second-generation antipsychotics. METHODS: The authors used a national electronic medical records database for a retrospective study of children and adolescents ages 1-17 years (N=9,620) who were prescribed second-generation antipsychotics in January 2010-December 2018. Adherence to guideline-recommended monitoring of body mass index (BMI), blood glucose, and cholesterol was categorized as full, partial, and no monitoring. Full monitoring of patients was defined as strict metabolic monitoring, following the guideline-recommended schedule. Patients who received any monitoring, but not meeting the full monitoring criteria, were considered partially monitored. Three multinomial logistic regression models were fitted for each metabolic parameter to identify predictors associated with monitoring status. RESULTS: BMI was the metabolic parameter with the highest adherence to guideline-recommended monitoring (full monitoring, 4.7% of patients; partial monitoring, 44.8%), followed by blood glucose (full monitoring, 6.5%; partial monitoring, 29.4%) and cholesterol (full monitoring, 0.8%; partial monitoring, 22.4%). Being Black (vs. non-Black), having a comorbid mood disorder (vs. none), receiving olanzapine as the index second-generation antipsychotic (vs. aripiprazole), and receiving an antidepressant as a concurrent medication (vs. none) were associated with a higher likelihood of receiving both full and partial monitoring of all three metabolic parameters. CONCLUSIONS: Both full and partial adherence to guideline-recommended monitoring of children and adolescents prescribed second-generation antipsychotics were poor. However, children and adolescents at increased metabolic risk tended to be more closely monitored.

Trajectories of adherence to ACEI/ARB medications following a motivational interviewing intervention among Medicare Advantage beneficiaries in Texas.

OBJECTIVES: To assess the impact of student telephone motivational interviewing intervention on angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers (ACEI/ARBs) adherence trajectories and identify predictors of each trajectory. METHODS: The intervention group included continuously enrolled Medicare Advantage Plan patients non-adherent to ACEI/ARBs vs the control group (1:2 ratio). The intervention was tailored by pre-intervention trajectories and included an initial and five follow-up calls. Adherence was measured 6 months after initial calls using the proportion of days covered (PDC). Monthly PDCs were integrated into a group-based trajectory model and categorized patients into 4-groups. A multinomial logistic regression model was used to evaluate trajectory predictors. RESULTS: The study comprised 240 intervention patients and 480 controls with four trajectories: adherent trajectory 44.2%, gradual improvement in adherence 13.4%, slow decline in adherence 24.1%, and discontinuation 18.3%. Patients with the intervention were less likely to experience a slow decline in adherence than controls (OR: 0.627 [0.401-0.981]). Patients with specialty prescribers' visits, ≥ 1 previous hospitalization, rapid decline in adherence as pre-intervention trajectory, and higher CMS risk score were associated with discontinuation trajectory. CONCLUSION: Intervention patients vs controls had a lower likelihood of following a slow decline in adherence pattern. PRACTICE IMPLICATIONS: This study underscores the importance of individualized interventions and the association between past adherence patterns and post-intervention trajectories.

Association Between Abnormal Metabolic Parameters and Receiving Subsequent Interventions in Children and Adolescents Initiating Second-Generation Antipsychotics.

Objectives: This study aimed to examine the association between abnormal readings of metabolic parameters detected during second-generation antipsychotic (SGA) treatment and the likelihood of receiving subsequent adverse drug event interventions. Methods: This was a nested case-control study conducted on patients 1-17 years of age with at least two prescriptions of SGAs between January 2010 and January 2019 using TriNetX EMR data. Following an incident density sampling procedure, patients who received the SGA metabolic adverse event intervention (mAEI) (case) were matched with three nonrecipients (controls). The abnormal readings of metabolic parameters within 30 days before the initiation of mAIEs were further identified. These metabolic parameters include body mass index (BMI) and laboratory parameters such as cholesterol, high-density lipoprotein, low-density lipoprotein, triglycerides, blood glucose, HbA1c, thyroid hormones, liver enzymes, and prolactin. The association of abnormal metabolic parameters with subsequent mAEIs was assessed using a conditional logistic regression model, after adjusting for demographic and other clinical risk factors. Results: One thousand eight hundred eighty-four children and adolescents met the inclusion criteria and were prescribed SGA mAEIs. The most common types of mAEIs prescribed were weight management pharmacotherapy (40.6%), switching from a high or medium metabolic risk profile SGA to a low-risk one (30.9%), nonpharmacological treatment (25.4%), and switching from SGA polytherapy to monotherapy (11.7%). The conditional logistic regression analysis on matched mAEI recipients and nonrecipients showed that patients with an abnormal BMI had 43% higher odds of receiving mAEI (odds ratio [95% confidence interval]: 1.43 [1.13-1.79]). However, the presence of an abnormal laboratory reading was not associated with the initiation of mAEIs. Conclusions: The prescribing of mAEIs were associated with the presence of obesity, but not with abnormal readings of other metabolic parameters, suggesting that additional data are needed to clarify the long-term implication of SGA metabolic adverse events other than weight gain and to inform the appropriate timing for interventions.

Development and internal validation of a risk prediction model for HIV disease severity among people living with HIV and mental illness or substance use disorder.

PURPOSE: Mental illness (MI) and substance use disorders (SUD) are highly prevalent among people living with HIV (PLWH), and have been linked to poor HIV clinical outcomes. Innovative tools for early risk identification can facilitate timely interventions for PLWH and MI/SUD to improve their health outcomes, however, this is currently lacking in Texas, a state with the 4th largest population of PLWH in the United States. To address this gap, we developed a predictive model to estimate the risk of suboptimal HIV clinical outcomes among PLWH and MI/SUD in Texas. METHODS: The Texas Medical Monitoring Project data obtained from June 2015-May 2020 were used to develop and internally validate the predictive model. Univariate descriptive and bivariate inferential statistics were performed to describe the characteristics of the study population and unadjusted associations with HIV clinical outcomes. Multivariable logistic regression was used to develop the prediction model. Internal validation was performed using the bootstrap method. RESULTS: A total of 518 respondents aged 18 years and above, representing 27,255 adults living with HIV and mental illness or substance use disorders in Texas were included. Most participants were male (77.0%), less than 50 years of age (60.0%), and had mild diagnosed mental illness and substance use disorder (54.8%). The risk predictive model contained eight predictors, which together yielded an area under the receiver operating characteristic (ROC) curve of 0.727. Non-retention in care appeared to be the strongest risk predictor for having suboptimal HIV clinical outcome (adjusted odds ratio (aOR) = 3.27; 95% confidence interval (CI) = 1.45, 7.42). CONCLUSIONS: The predictive model had good discrimination between persons at risk of poor HIV clinical outcomes and those not at risk.

Impact of the AACAP practice parameters on the metabolic adverse event monitoring for second-generation antipsychotics (SGAs) in children and adolescents.

INTRODUCTION: The objective of our study was to evaluate the impact of the publication of the American Academy of Child and Adolescent Psychiatry (AACAP) practice parameters for SGA metabolic monitoring in 2011 on SGA metabolic monitoring uptake among pediatric SGA recipients. METHODS: This was a retrospective study of children 1-17 years of age who initiated SGA treatment from Jan 2010 to December 2018 using a national Electronic Medical Records database. A segmented regression of interrupted time-series (ITS) analysis was conducted to analyze the change of metabolic monitoring rates for Body Mass Index (BMI), Blood Glucose (BG), and Total Cholesterol (CHL) 9 quarters pre- and 26 quarters post-the publication of the AACAP practice parameters. RESULTS: The analytical cohort included 9620 children and adolescents who initiated SGA treatment during the study period. The ITS results showed that the publication of the AACAP practice parameter for SGA metabolic monitoring was associated with a 12.61 percentage points (p < 0.0002) immediate increase in BMI monitoring rate, (increased from 29.10% in Q4 2011 to 40.10% in Q3 2012). There was a positive trend of BMI monitoring rate prior to the publication of AACAP practice parameters, which continued during the post-publication period. Neither immediate nor sustained changes in the association of monitoring rates for BG and CHL were observed after the issuance of the guidelines. CONCLUSION: The publication of AACAP practice parameters for SGA monitoring was associated with a significant improvement in the monitoring for BMI, but not for BG and CHL in children and adolescents.

Adherence to oral endocrine therapy in racial/ethnic minority patients with low socioeconomic status before and during the COVID-19 pandemic.

BACKGROUND: Adherence to oral endocrine therapy (OET) is crucial in ensuring its maximum benefit in the prevention and treatment of hormone receptor-positive (HR +) breast cancer (BC). Medication use behavior is suboptimal especially in racial/ethnic minorities with lower socioeconomic status (SES). AIM: We aimed to assess the impact of the coronavirus disease 2019 (COVID-19) pandemic on OET adherence and identify demographic and/or clinical characteristics associated with nonadherence in racial/ethnic minorities with lower SES. METHOD: A retrospective study was conducted at the Harris Health System in Houston, Texas. Data were collected during the 6 months before and 6 months after the start of the pandemic. The adherence was assessed using the prescription refill data using the proportion of days covered. A multivariable logistic regression model was used to identify demographic/clinical characteristics associated with nonadherence. Eighteen years or older patients on appropriate doses of OET for prevention or treatment of BC were included. RESULTS: In 258 patients, adherence was significantly lower during the pandemic (44%) compared to before the pandemic (57%). The demographic/clinical characteristics associated with OET nonadherence before the pandemic were Black/African American, obesity/extreme obesity, prevention setting, tamoxifen therapy, and 4 or more years on OET. During the pandemic, prevention setting and those not using home delivery were more likely to be nonadherent. CONCLUSION: OET adherence was significantly reduced during the COVID-19 pandemic in racial/ethnic minority patients with low SES. Patient-centered interventions are necessary to improve OET adherence in these patients.

Acceptance of COVID-19 vaccination in a sample of Middle Eastern and North African (MENA) Houston residents.

BACKGROUND: COVID-19 vaccination has averted a significant number of deaths in the United States, but vaccination hesitancy continues to be a problem. Therefore, examining vaccination acceptance and/or hesitancy in local communities is critical. METHODS: A quantitative survey and a multivariable logistic regression model was utilized to determine predictors of COVID-19 vaccination in Middle Eastern and North African (MENA) origin Houston residents. The outcome of interest was COVID-19 vaccination status (vaccinated versus not vaccinated). Covariates included: demographics, health, and COVID-19 factors. Statistical analyses included SAS version 9.4 at a priori significance level of 0.05. RESULTS: The overall vaccine acceptance rate was significantly high in this population subset (N = 366), with 77.60% vaccinated, and 22.40% not vaccinated. MENA individuals with some college degrees were less likely to report vaccination than those with a graduate degree [Odds Ratio (OR): 0.18; 95% Confidence Interval (CI): 0.04, 0.77]. Homeowners were more likely to get vaccinated than renters (OR: 2.58; 95%CI: 1.17, 5.68). Individuals practicing Islamic faith were more likely to get vaccinated than other religious affiliations (OR: 3.26; 95%CI: 1.15, 9.19). Individuals with hypertension were less likely to get vaccinated than those without it (OR: 0.34; 95%CI: 0.13, 0.92), and those with anxiety were more likely to get vaccinated than those without anxiety (OR: 4.23; 95%CI: 1.68, 10.64). CONCLUSIONS: Health status, education level, financial stability, and religious affiliation are some of the determining factors that potentially influence vaccination acceptance/hesitancy among the MENA community.

A Motivational Interviewing Intervention to Improve Adherence to ACEIs/ARBs among Nonadherent Older Adults with Comorbid Hypertension and Diabetes.

BACKGROUND: Hypertension and diabetes mellitus are independent risk factors for cardiovascular diseases. Due to the cardioprotective nature of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs), they are recommended for patients with comorbid hypertension and diabetes. However, poor adherence to ACEIs/ARBs among older adults is a major public health concern. This study aimed to assess the effectiveness of a telephonic motivational interviewing (MI) intervention conducted by pharmacy students among a nonadherent older population (≥ 65 years old) with diabetes and hypertension. METHODS: Patients continuously enrolled in a Medicare Advantage Plan who received an ACEI/ARB prescription between July 2017 and December 2017 were identified. Group-based trajectory modeling (GBTM) was used to identify distinct patterns of ACEI/ARB adherence during the 1-year baseline period: adherent, gaps in adherence, gradual decline, and rapid decline in adherence. Patients from the three nonadherent trajectories were randomized into MI intervention or control group. The intervention consisted of an initial call and five follow-up calls administered by MI-trained pharmacy students and tailored to the baseline ACEI/ARB adherence trajectories. The primary outcome was adherence to ACEI/ARB during the 6- and 12-month periods post-MI implementation. The secondary outcome was discontinuation, defined as no refills for ACEI/ARB during the 6- and 12-month periods post-MI implementation. Multivariable regression analyses examined the impact of MI intervention on ACEI/ARB adherence and discontinuation while adjusting for baseline covariates. RESULTS: A total of 240 patients in the intervention group and 480 patients as randomly selected controls were included in this study. At 6 months, patients receiving the MI intervention had significantly better adherence (ß = 0.06; p = 0.03) compared with the controls. Linear and logistic regression models also showed patients in the intervention group were more likely to be adherent than controls within 12 months of intervention implementation (ß = 0.06; p = 0.02 and OR: 1.46; 95% CI 1.05-2.04, respectively). MI intervention did not have any significant impact on the ACEI/ARB discontinuation. CONCLUSION: Patients who received the MI intervention were more likely to be adherent at 6 and 12 months following the intervention initiation, despite gaps in the follow-up calls due to COVID-19. Pharmacist-led MI intervention is an effective behavioral strategy to improve medication adherence among older adults and tailoring the intervention to past adherence patterns may enhance the intervention effectiveness. This study was registered with the United States National Institutes of Health (ClinicalTrials.gov identifier NCT03985098).

Overall survival associated with CDK4/6 inhibitors in patients with HR+/HER2- metastatic breast cancer in the United States: A SEER-Medicare population-based study.

BACKGROUND: Evidence on overall survival (OS) with cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors is generally limited to data from clinical trials or a few observational studies with limited generalizability to Medicare population. The aim of this study was to determine OS benefits associated with CDK4/6 inhibitors in older Medicare patients with hormone receptor (HR)-positive and human epidermal growth factor receptor-2 overexpressing (HER2-) metastatic breast cancer (MBC). METHODS: In a retrospective cohort design, female patients aged ≥65 years with diagnosis of HR+/HER2- MBC from 2015 to 2017 who initiated first-line systemic therapy within 12 months of MBC diagnosis were selected from the Survey Epidemiology and End Results-Medicare database. The effect of treatment type (endocrine therapy [ET]+CDK4/6 inhibitor vs. ET alone) on OS was analyzed using Kaplan-Meier methods and multivariable Cox regression models. Adjusted hazard ratio (aHR) and 95% CIs were estimated. RESULTS: A total of 630 eligible patients were identified (169 patients treated with ET+CDK4/6 inhibitor and 461 patients treated with ET alone). In the Kaplan-Meier analysis, OS rate at 3 years after first-line treatment initiation was 73.0% for ET+CDK4/6 inhibitor versus 49.1% for ET alone (log-rank p < .0001). In Cox regression analysis, first-line ET+CDK4/6 inhibitor therapy was associated with 41% lower rate of mortality versus ET alone (aHR, 0.590; 95% CI, 0.423-0.823). CONCLUSIONS: The findings of this real-world study demonstrate significant OS benefit associated with ET+CDK4/6 inhibitor therapy over ET alone in an older Medicare population of patients with HR+/HER2- MBC, largely consistent with the evidence from clinical trials.