Publications

BACKGROUND: Lecanemab, an anti-amyloid monoclonal antibody for Alzheimer's disease, was approved for use in the Veteran's Health Administration (VHA) in 2023. Little is known about the real-world use and outcomes of lecanemab.

METHODS: This retrospective cohort study included Veterans who initiated lecanemab in the VHA between October 2023 and September 2024. Data on demographics, healthcare utilization, medication exposures, and neuroimaging were extracted from the VA Corporate Data Warehouse. Chart review was used to collect information on dementia diagnosis, Montreal Cognitive Assessments (MoCA), and Apolipoprotein E (APOE) genotype. We examined medication adherence, brain MRIs, 6-month MoCAs, amyloid-related imaging abnormalities (ARIA), and healthcare utilization from initiation to study end (12/31/24).

RESULTS: Overall, 32 Veterans (mean [SD] age 75 [6] years, 100% male, 97% white, 84% urban-dwelling) initiated lecanemab; 53% had mild cognitive impairment and 47% mild dementia. The baseline mean MoCA score was 21 (SD 3). Half were heterozygous for APOE ε4 and half non-carriers. The median days of follow-up was 172 (range 62-349), and the median number of lecanemab infusions received was 11 (2-24). Brain MRI follow-up occurred regularly, with all eligible patients receiving an MRI between the 4th and 5th infusion, 92% (22/24) between the 6th and 7th infusions, and 92% (11/12) between the 13th and 14th infusions. However, of the 28 patients with 6 months follow-up, only 9 (32%) had a MoCA completed and the mean change in MoCA was -0.2 (SD 4.2). During follow-up, 25% of patients had imaging abnormalities: 2 (6.2%) experienced acute stroke and 6 (18.8%) experienced ARIA (3 ARIA-edema, 3 ARIA-hemorrhage, and 1 both). Three patients (9.4%) stopped lecanemab for ≥30 days by the end of the study period. Reasons for discontinuation included ARIA, side effects, and patient preference. During follow-up, 0 patients died, 3 (9.4%) were hospitalized within VHA, and 11 (34.4%) had VHA emergency department or urgent care visits.

CONCLUSIONS: In the first year lecanemab was available in VHA, the few patients initiated on treatment were mostly white, male, and urban residents. The finding that 25% of patients experienced ARIA or stroke underscores the importance of monitoring the lecanemab safety and effectiveness long-term.

INTRODUCTION: Medicaid provides access to care for low-income patients facing life-threatening illnesses who are cared for in intensive care units (ICUs). Despite the growth of Medicaid coverage with the Affordable Care Act, little is known about Medicaid's role in critical care for the Medicaid Expansion population, adults ages 19-64.

METHODS: Using hospital discharge data from Virginia, we examined payer composition between 2016 and 2023 and analyzed 2023 demographic and clinical data for adults ages 19-64.

RESULTS: Medicaid's share of ICU stays more than doubled from 2016 (14.1%) to 2023 (31.8%). While only 25.6% of Medicaid hospitalizations involved ICU care, these stays account disproportionately for charges (51.7%), hospital days (36.9%), and readmissions (32.3%). Common reasons for admission include potentially preventable conditions: sepsis, diabetes, heart failure, and alcohol use. Medicaid patients, despite being younger than their commercially insured counterparts, have more comorbidities (4+ comorbidities: 49.9% vs 38.9%) and are more likely to be readmitted in adjusted models (29.7% [95% Confidence Interval: 29.1-30.4] vs 24.3% [95% Confidence Interval: 23.6%-25.1%]).

CONCLUSIONS: This work demonstrates the crucial role of Medicaid as a payer for seriously ill adults and the need for increased attention by Medicaid programs to ICU patients before, during, and after hospitalization.

BACKGROUND AND AIMS: Comparative effectiveness research studies commonly restrict cohorts to individuals who initiate a medication and do not have evidence of prior treatment. This is particularly challenging in research on medications for opioid use disorder (MOUD) because of sporadic use or intermittent adherence. We examined the impact of different lookback windows and washout criteria to identify MOUD initiator cohorts on sample size, cohort characteristics, and misclassification of treatment initiation.

DESIGN AND SETTING: Cohort study using the Merative™ MarketScan® Multi-State Medicaid Database (2011-2022).

PARTICIPANTS: Medicaid-insured adults aged 18-64 with an MOUD prescription from 01/01/2022 to 12/31/2022 and a history of opioid use disorder (OUD) with at least 3 months of continuous enrollment.

MEASUREMENTS: We created treatment initiator cohorts with increasingly restrictive lookback windows for inclusion (6-, 12-, 24-, 36-months, all-available). During each lookback window, we required [1] continuous enrollment; [2] continuous enrollment and OUD diagnosis; or [3] continuous enrollment, OUD diagnosis, and no prior treatment with MOUD. We defined prior treatment with MOUD as: (a) ≥ 30 days use (less restrictive definition; allowed for some prior treatment); or (b) ≥ 1 day use (more restrictive definition; did not allow prior treatment). We quantified changes in cohort sample size, demographic characteristics, and proportion of prevalent use episodes misclassified as MOUD treatment initiation (gold standard: 36-month lookback window).

FINDINGS: We identified 103 794 eligible MOUD initiators (64.8% buprenorphine, 24.8% methadone, 10.4% naltrexone). Sample size of the cohorts decreased with increasingly restrictive lookback windows and washout criteria: [1] continuous enrollment (range, 96.9% for 6 months to 51.8% for 36 months); [2] continuous enrollment and less restrictive washout (range, 29.7% to 8.4%); and [3] continuous enrollment and more restrictive washout (range, 22.2% to 5.8%). All-available lookback performed similarly to a 12-month lookback. Longer lookback windows resulted in initiator cohorts with a greater proportion of individuals who were older, female, and of a minoritized race/ethnicity. The proportion of people with prevalent MOUD use misclassified as treatment initiation increased steadily with decreasing duration of lookback windows (24-, 12-, and 6-month); we observed misclassification among 16.1% to 49.2% of individuals (less restrictive washout), and 16.8% to 53.2% of individuals (more restrictive washout).

CONCLUSIONS: The choice of lookback window duration and washout criteria in research on medications for opioid use disorder (MOUD) presents tradeoffs between cohort sample size, demographic characteristics, and misclassification of treatment initiation. This study offers practical guidance for researchers planning to perform comparative studies in MOUD.

Background/Objectives: The Developing and Evaluating a Machine Learning Opioid Prediction & Risk-Stratification E-Platform (DEMONSTRATE) trial aims to assess the usability, acceptability, feasibility, and effectiveness of implementing a machine learning (ML)-based clinical decision support (CDS) tool-the Overdose Prevention Alert-which predicts a patient's risk of opioid overdose within three months. Methods: This single-arm study uses a pre-post implementation design with mixed-methods evaluation in 13 University of Florida Health, Gainesville, internal medicine and family medicine clinics. Eligible patients are aged ≥18 years, received an opioid prescription within the year prior to their upcoming primary care visit, are not receiving hospice care, do not have a malignant cancer diagnosis, and are identified by the ML algorithm as high risk for overdose. The Overdose Prevention Alert triggers when a primary care provider (PCP) signs an opioid order in electronic health records. We will evaluate effectiveness by comparing pre- and post-implementation outcomes using a composite patient-level measure defined by the presence of any of the following 6 favorable indicators: (1) evidence of naloxone access; (2) absence of opioid overdose diagnoses and naloxone administration; (3) absence of emergency department (ED) visits or hospitalizations due to opioid overdose or opioid use disorder (OUD); (4) absence of overlapping opioid and benzodiazepine use within a 7-day window; (5) absence of opioid use ≥50 morphine milligram equivalent daily average; (6) receipt of referrals to non-pharmacological pain management. Additional quantitative metrics will include alert penetration, usage patterns, and clinical actions taken. Usability and acceptability will be assessed using a 12-item questionnaire for PCPs and semi-structured interviews. Expected Results: The trial will provide insights into real-world ML-driven CDS implementation and inform future strategies to reduce opioid-related harm.

Background/Objectives: While lecanemab (Leqembi) and several amyloid targeting therapies were approved for Alzheimer's disease, questions remain on real-world implementation, safety, and effectiveness. The objective of this study was to describe the uptake and early outcomes of Veterans initiating lecanemab. Methods: This retrospective cohort study included Veterans who initiated lecanemab in the Veteran's Health Administration (VHA) between October 2023 and July 2024. Treatment persistence and monitoring, change in Montreal Cognitive Assessment (MoCA) score, incidence of adverse events, including amyloid-related imaging abnormalities (ARIA), and healthcare utilization were analyzed at 7 months. Results: Overall, 32 Veterans (mean [SD] age 75.3 [6.0] years, 100% male, 97% white, 84% urban dwelling) initiated lecanemab. Seventeen patients (53%) had mild cognitive impairment, 15 (47%) had mild dementia; mean baseline MoCA score was 21.3 (SD 3.4). At 7 months following treatment initiation, we assessed process, safety, and effectiveness outcomes. Process outcomes: In all, 25 patients (78%) were persistent with treatment. Safety outcomes: Three patients (9%) experienced a stroke, and 7 (22%) experienced ARIA. Effectiveness outcomes: Only 12 (38%) patients had a MoCA completed by 7 months, and the mean change in MoCA was 0.0 (SD 3.7, p = 1.0). A follow-up amyloid positron emission tomography (PET) scan was completed by 9 (28%) patients, and 5 had reductions in amyloid. Conclusions: Initial observations in a small VHA cohort suggest that uptake of lecanemab was limited, and the finding that nearly 30% of patients experienced ARIA or stroke within 7 months of initiation underscores the importance of monitoring the lecanemab safety and effectiveness long-term. These early findings should be interpreted cautiously given the limited sample size and very limited follow-up MoCA data.

Aggregated counts from electronic health records (EHRs) provide a rich source of real-world data that can be leveraged to investigate critical medical conditions such as postpartum hemorrhage (PPH). We used the Evolve to Next-Gen Accrual to Clinical Trials (ENACT) network, a large, federated network of EHRs, and conducted repeated annual cross-sectional analyses on PPH incidence, risk factors, and maternal comorbidities in a large cohort of 591,375 delivery hospitalizations during the period 2005 to 2022. During this time, there was a statistically significant increasing trend in the incidence of PPH, which is consistent with previous studies. Native Hawaiian or Other Pacific Islander women had the highest incidence of PPH (12.14%), followed by Asian (11.04%) and Black or African American (9.36%) women. In PPH deliveries, the top-ranked risk factor was placenta previa or accreta (19.58%), the top-ranked comorbidity was primary cesarean delivery (41.08%), and the commonest cause was uterine atony (76.5%).

OBJECTIVE: To evaluate trends in outpatient visits among Medicare beneficiaries with established AF before and after the pandemic and to investigate differences in outpatient care utilization patterns based on baseline utilization levels.

RESULTS: We analyzed 2018-2022 Medicare data to assess outpatient visit trends among 124,483 beneficiaries with atrial fibrillation (AF), categorizing them into quartiles based on pre-pandemic in-person visit frequency. We found that in-person visits declined while telehealth use increased across all groups during the pandemic. After the pandemic, total visits remained below pre-pandemic levels for higher-utilizing groups after the pandemic.