Long-Term Opioid Therapy and Risk of Opioid Overdose by Derived Clinical Indication in North Carolina, 2006-2018.

Purpose: Long-term opioid therapy (LTOT) has been shown to be associated with opioid overdose, but the definition of LTOT varies widely across studies. We use a rigorous LTOT definition to examine risk of opioid overdose by duration of treatment.

Methods: Data were from a large private health insurance provider in North Carolina linked to mortality records from 2006-2018.

Death ORACL: An Algorithm to Predict Death Using Insurance Claims Data.

The inability to identify dates of death in insurance claims data is the United States is a major limitation to retrospective claims-based research. While deaths result in disenrollment, disenrollment can also occur due to changes in insurance providers. We created an algorithm to differentiate between disenrollment from health plans due to death and disenrollment for other reasons.

Abuse-deterrent formulations and opioid-related harms in North Carolina, 2010-2018.

Abuse-deterrent formulations of opioid analgesics (ADFs) were introduced to reduce opioid-related harms among pain patients, but post-marketing study results have been mixed. However, these studies may be subject to bias from selection criteria, comparator choice, and potential confounding by "indication," highlighting the need for thorough study design considerations. In a sample of privately insured patients prescribed ADF or non-ADF extended-release/long-acting (ER/LA) opioids in North Carolina, we implemented a version of the prevalent new-user design to evaluate the relationship between ADFs and opioid use disorder (OUD, n=235) and opioid overdose (n=18) through six months of follow-up using inverse probability-weighted cumulative incidence functions and Fine-Gray models.

Matching study design to prescribing intention: The prevalent new-user design for studying abuse-deterrent formulations of opioids.

Purpose: In drug studies, research designs requiring no prior exposure to certain drug classes may restrict important populations. Since abuse-deterrent formulations (ADF) of opioids are routinely prescribed after other opioids, choice of study design, identification of appropriate comparators, and addressing confounding by "indication" are important considerations in ADF post-marketing studies.

Methods: In a retrospective cohort study using claims data (2006-2018) from a North Carolina private insurer [NC claims] and Merative MarketScan [MarketScan], we identified patients (18-64 years old) initiating ADF or non-ADF extended-release/long-acting (ER/LA) opioids.

Characterizing Imbalance in the Tails of the Propensity Score Distribution.

Understanding characteristics of patients with propensity scores in the tails of the propensity score (PS) distribution has relevance for inverse-probability-of-treatment-weighted and PS-based estimation in observational studies. Here we outline a method for identifying variables most responsible for extreme propensity scores. The approach is illustrated in 3 scenarios: 1) a plasmode simulation of adult patients in the National Ambulatory Medical Care Survey (2011-2015) and 2) timing of dexamethasone initiation and 3) timing of remdesivir initiation in patients hospitalized for coronavirus disease 2019 from February 2020 through January 2021.

Three-year outcomes for women newly initiated on lifelong antiretroviral therapy during pregnancy - Malawi option B.

Introduction: Antiretroviral therapy (ART) is very effective in preventing vertical transmission of HIV but some women on ART experience different virologic, immunologic, and safety profiles. While most pregnant women are closely monitored for short-term effects of ART during pregnancy, few women receive similar attention beyond pregnancy. We aimed to assess retention in care and clinical and laboratory-confirmed outcomes over 3 years after starting ART under Malawi's Option B + program.

Sample size calculations for pathogen variant surveillance in the presence of biological and systematic biases.

Tracking the emergence and spread of pathogen variants is an important component of monitoring infectious disease outbreaks. To that end, accurately estimating the number and prevalence of pathogen variants in a population requires carefully designed surveillance programs. However, current approaches to calculating the number of pathogen samples needed for effective surveillance often do not account for the various processes that can bias which infections are detected and which samples are ultimately characterized as a specific variant.

Intended and unintended consequences: Changes in opioid prescribing practices for postsurgical, acute, and chronic pain indications following two policies in North Carolina, 2012-2018 - Controlled and single-series interrupted time series analyses.

Background: The potential misapplication of current opioid prescribing policies remains understudied and may have substantial adverse implications for patient safety.

Methods: We used autoregressive integrated moving average models to assess level and trend changes in monthly 1) prescribing rates, 2) days' supply, and 3) daily morphine milligram equivalents (MME) of incident opioid prescriptions relative to 1) a state medical board initiative to reduce high-dose and -volume opioid prescribing and 2) legislation to limit initial opioid prescriptions for acute and postsurgical pain. We examined outcomes by pain indication overall and by cancer history, using prescribing patterns for benzodiazepines to control for temporal trends.

Medicaid Coverage Disruptions Among Children Enrolled in North Carolina Medicaid From 2016 to 2018.

Importance: Brief disruptions in insurance coverage among eligible participants are associated with poorer health outcomes for children.

Objective: To describe factors associated with coverage disruptions among children enrolled in North Carolina Medicaid from 2016 to 2018 and estimate the outcome of preventing such disruptions on medical expenditures.

Design Setting And Participants: This was a retrospective cohort study using North Carolina Medicaid claims data.

Association of Opioid Dose Reduction With Opioid Overdose and Opioid Use Disorder Among Patients Receiving High-Dose, Long-term Opioid Therapy in North Carolina.

Importance: Rapid reduction or discontinuation of long-term opioid therapy may increase risk of opioid overdose or opioid use disorder (OUD). Current guidelines for chronic pain management caution against rapid dose reduction but are based on limited evidence.

Objective: To characterize the association between rapid reduction or abrupt discontinuation of opioid therapy (vs maintained or gradual reduction) and incidence of opioid overdose and OUD among patients prescribed high-dose, long-term opioid therapy (HDLTOT).

A prospective study of asymptomatic SARS-CoV-2 infection among individuals involved in academic research under limited operations during the COVID-19 pandemic.

Background: Early in the pandemic, transmission risk from asymptomatic infection was unclear, making it imperative to monitor infection in workplace settings. Further, data on SARS-CoV-2 seroprevalence within university populations has been limited.

Methods: We performed a longitudinal study of University research employees on campus July-December 2020.

Factors associated with a history of treatment interruption among pregnant women living with HIV in Malawi: A cross-sectional study.

Introduction: Long-term care engagement of women on antiretroviral therapy (ART) is essential to effective HIV public health measures. We sought to explore factors associated with a history of HIV treatment interruption among pregnant women living with HIV presenting to an antenatal clinic in Lilongwe, Malawi.

Methods: We performed a cross-sectional study of pregnant women living with HIV who had a history of ART interruption presenting for antenatal care.

Probable perinatal depression and social support among women enrolled in Malawi's Option B+ Program: A longitudinal analysis.

Background: Malawi's PMTCT Option B+ program has expanded the reach of ART services among pregnant and breastfeeding women, but retention in lifelong HIV care remains challenging. Given that depression can undermine retention, it is important to understand how depression changes over the perinatal period, varies across treatment and retention groups, and could be buffered by social support.

Methods: Data are from an observational study conducted among women enrolled in Malawi's PMTCT Option B+ program.

Association Between Statewide Opioid Prescribing Interventions and Opioid Prescribing Patterns in North Carolina, 2006-2018.

Objective: To examine the impact of three sequential statewide policy and legislative interventions on opioid prescribing practices among privately insured individuals in North Carolina.

Methods: An interrupted time series approach was used to examine level and trajectory changes of new and prevalent opioid prescription rates, days' supply, and daily morphine milligram equivalents before and after implementation of a 1) prescription drug monitoring program, 2) state medical board initiative, and 3) legislative action. Analyses were conducted using individual-level claims data from a large private health insurance provider serving North Carolina residents, ages 18-64 years, from January 2006 to August 2018.

State Medical Board Policy and Opioid Prescribing: A Controlled Interrupted Time Series.

Introduction: In March 2016, the Centers for Disease Control and Prevention issued opioid prescribing guidelines for chronic noncancer pain. In response, in April 2016, the North Carolina Medical Board launched the Safe Opioid Prescribing Initiative, an investigative program intended to limit the overprescribing of opioids. This study focuses on the association of the Safe Opioid Prescribing Initiative with immediate and sustained changes in opioid prescribing among all patients who received opioid and opioid discontinuation and tapering among patients who received high-dose (>90 milligrams of morphine equivalents), long-term (>90 days) opioid therapy.

Antiretroviral Adherence Following Prison Release in a Randomized Trial of the imPACT Intervention to Maintain Suppression of HIV Viremia.

Many people living with HIV (PLWH) pass through correctional facilities each year, a large proportion of whom do not maintain viral suppression following release. We examined the effects of imPACT, an intervention designed to promote post-release viral suppression, on antiretroviral therapy (ART) adherence. PLWH awaiting release from prisons in two southern states were randomized to imPACT (consisting of motivational interviewing, care linkage coordination, and text message medication reminders) versus standard care (SC).

Drug Use Mediates the Relationship Between Depressive Symptoms and Adherence to ART Among Recently Incarcerated People Living with HIV.

Depression is a known risk factor for antiretroviral therapy (ART) non-adherence, but little is known about the mechanisms explaining this relationship. Identifying these mechanisms among people living with HIV (PLHIV) after release from prison is particularly important, as individuals during this critical period are at high risk for both depression and poor ART adherence. 347 PLHIV recently released from prison in North Carolina and Texas were included in analyses to assess mediation of the relationship between depressive symptoms at 2 weeks post-release and ART adherence (assessed by unannounced telephone pill counts) at weeks 9-21 post-release by the hypothesized explanatory mechanisms of alcohol use, drug use, adherence self-efficacy, and adherence motivation (measured at weeks 6 and 14 post-release).

The Depression Treatment Cascade: Disparities by Alcohol Use, Drug Use, and Panic Symptoms Among Patients in Routine HIV Care in the United States.

Little is known about disparities in depression prevalence, treatment, and remission by psychiatric comorbidities and substance use among persons living with HIV (PLWH). We conducted a cross-sectional analysis in a large cohort of PLWH in routine care and analyzed conditional probabilities of having an indication for depression treatment, receiving treatment, receiving indicated treatment adjustments, and achieving remission, stratified by alcohol use, illicit drug use, and panic symptoms. Overall, 34.

Measurement of depression treatment among patients receiving HIV primary care: Whither the truth?

Background: Prescription records, manual chart review, and patient self-report are each imperfect measures of depression treatment in HIV-infected adults.

Methods: We compared antidepressant prescription records in an electronic data warehouse with antidepressant treatment and psychotherapy identified via manual chart review and self-report for patients at 6 academic HIV treatment centers. We examined concordance among these three sources, and used latent class analysis (LCA) to estimate sensitivity and specificity of each measure.

Bone marrow-derived myofibroblasts contribute to the mesenchymal stem cell niche and promote tumor growth.

Carcinoma-associated fibroblasts (CAFs) that express α-smooth muscle actin (αSMA) contribute to cancer progression, but their precise origin and role are unclear. Using mouse models of inflammation-induced gastric cancer, we show that at least 20% of CAFs originate from bone marrow (BM) and derive from mesenchymal stem cells (MSCs). αSMA+ myofibroblasts (MFs) are niche cells normally present in BM and increase markedly during cancer progression.