Risks for Anaphylaxis With Intravenous Iron Formulations: A Retrospective Cohort Study

Chintan V. Dave, Gary M. Brittenham, Jeffrey Carson, Soko Setoguchi 2022

BACKGROUND: The risks for anaphylaxis among intravenous (IV) iron products currently in use have not been assessed. OBJECTIVE: To compare risks for anaphylaxis among 5 IV iron products that are used frequently. DESIGN: Retrospective cohort study using a target trial emulation framework. SETTING: Medicare fee-for-service data with Part D coverage between July 2013 and December 2018…


Benzodiazepine and Stimulant Prescriptions Before Overdose in Youth

Greta Bushnell, Hillary Samples, Tobias Gerhard, Diane P. Calello, Mark Olfson 2022

In 2019, 4777 youth died of a drug overdose in the United States.1 Seven-hundred and twenty-seven youth died of overdoses involving benzodiazepines (BZDs) and 902 from overdoses involving psychostimulants.2 Opioid-related overdose deaths frequently involve other substances, and in youth, stimulants and BZDs are the most commonly involved substances.3 Overdoses can involve prescription drugs accessed through […]


Non–prescribed buprenorphine preceding treatment intake and clinical outcomes for opioid use disorder

Arthur Robin Williams, Christine M. Mauro, Tianshu Feng, Amanda Wilson, Angelo Cruz, Mark Olfson, Stephen Crystal, Hillary Samples, Lisa Chiodo 2022

Objective: Successful retention on buprenorphine improves outcomes for opioid use disorder (OUD); however, we know little about associations between use of non–prescribed buprenorphine (NPB) preceding treatment intake and clinical outcomes. Methods: The study conducted observational retrospective analysis of abstracted electronic health record (EHR) data from a multi-state nationwide office-based opioid treatment program. The study observed a random sample of 1000 newly admitted patients with OUD for buprenorphine maintenance (2015–2018) for up to 12 months following intake. We measured use of NPB by mandatory intake drug testing and manual EHR coding…


Psychosocial and behavioral therapy in conjunction with medication for opioid use disorder: Patterns, predictors, and association with buprenorphine treatment outcomes

Hillary Samples, Arthur Robin Williams, Stephen Crystal, Mark Olfson 2022

Introduction: Current evidence indicates that buprenorphine is a highly effective treatment for opioid use disorder (OUD), though premature medication discontinuation is common. Research on concurrent psychosocial and behavioral therapy services and related outcomes is limited. The goal of this study was to define patterns of OUD-related psychosocial and behavioral therapy services received in the first 6 months after buprenorphine initiation, identify patients’ characteristics associated with service patterns, and examine the course of buprenorphine treatment, including the association of therapy with medication treatment duration…


Pandemic vaccine testing: Combining conventional and challenge studies

Tobias Gerhard, Brian L. Strom, Nir Eyal 2022

Abstract: Early into COVID, human challenge trials were considered, but usually as alternatives to conventional randomized controlled trials. Instead, assessment of authorized COVID vaccines, of further COVID vaccines, and of vaccines …


Longitudinal analysis of the prevalence and correlates of heavy episodic drinking and self-reported opioid use among a national cohort of patients with HIV

Benjamin J. Oldfield, Yu Li, Rachel Vickers-Smith, Declan T. Barry, Stephen Crystal, Kirsha S. Gordon, Robert D. Kerns, Emily C. Williams, Brandon D.L. Marshall, E. Jennifer Edelman 2022

Background: Heavy episodic drinking (HED) is a risk factor for opioid-related overdose and negatively impacts HIV disease progression. Among a national cohort of patients with HIV (PWH), we examined sociodemographic and clinical correlates of concomitant HED and self-reported opioid use. Methods: We used data collected from 2002 through 2018 from the Veterans Aging Cohort Study, a prospective cohort including PWH in care at eight US Veterans Health Administration sites. HED was defined as consuming six or more drinks at least once in the year prior to survey collection. We examined the relationship between HED and self-reported opioid use and created a 4-level composite variable of HED and opioid use…


Opioid overdose survivors: Medications for opioid use disorder and risk of repeat overdose in Medicaid patients

Stephen Crystal, Molly Nowels, Hillary Samples, Mark Olfson, Arthur Robin Williams, Peter Treitler 2022

Background: Patients with medically-treated opioid overdose are at high risk for subsequent adverse outcomes, including repeat overdose. Understanding factors associated with repeat overdose can aid in optimizing post-overdose interventions. Methods: We conducted a longitudinal, retrospective cohort study using NJ Medicaid data from 2014 to 2019. Medicaid beneficiaries aged 12–64 with an index opioid overdose from 2015 to 2018 were followed for one year for subsequent overdose. Exposures included patient demographics; co-occurring medical, mental health, and substance use disorders; service and medication use in the 180 days preceding the index overdose; and MOUD following index overdose. Results: Of 4898 individuals meeting inclusion criteria, 19.6% had repeat opioid overdoses within one year…


Cross-substance patterns of alcohol, cigarette, and cannabis use initiation in Black and White adolescent girls

Carolyn E. Sartor, Feifei Ye, Patricia Simon, Zu Wei Zhai, Alison E. Hipwell, Tammy Chung 2022

Characterizing variations in the timing of alcohol, cigarette, and cannabis use onset both among and between Black and White youth can inform targeted prevention. The current study aimed to capture cross-substance initiation patterns in Black and White girls and characterize these patterns with respect to substance use related socioeconomic, neighborhood, family, community, and individual level factors. Data were drawn from interviews conducted at ages 8 through 17 in an urban sample of girls (n = 2172; 56.86% Black, 43.14% White). Discrete-time multiple event process survival mixture modeling was used to identify patterns (i.e., classes) representing timing of alcohol, cigarette, and cannabis use initiation, separately by race. Class characteristics were compared using multinomial logistic regression. Among both Black and White girls, four classes, including abstainer and cross-substance early onset classes, emerged. Two classes characterized by mid-adolescence onset (Black girls) and variation in onset by substance (White girls) were also observed. Class differences centered around cannabis for Black girls (e.g., preceding or following cigarette use) and alcohol for White girls (e.g., (in)consistency over time in greater likelihood of initiation relative to cigarette and cannabis use). Several factors distinguishing the classes were common across race (e.g., externalizing behaviors, friends’ cannabis use); some were specific to Black girls (e.g., intentions to smoke cigarettes) or White girls (e.g., primary caregiver problem drinking). Findings underscore the need to recognize a more complex picture than a high-risk/low-risk dichotomy for substance use initiation and to attend to nuanced differences in markers of risky onset pathways between Black and White girls…


Climate Change, Health, and Health Care Systems: A Global Perspective

Soko Setoguchi, Desmond Leddin, Geoffrey Metz, M. Bishr Omary 2022

Many of us who have served in health care long enough witnessed a transition from cloth gowns, sheets, and reusable surgical trays to disposal plastic replacements decades ago. However, we have rarely connected a pair of gloves and equipment that were discarded after each use to melting ice caps and dying polar bears…


Consent Requirements for Testing Health Policies: An Intercontinental Comparison of Expert Opinions

Astrid Berner-Rodoreda, Shannon McMahon, Nir Eyal, Puspita Hossain, Atonu Rabbani, Mrittika Barua, Malabika Sarker, Emmy Metta, Elia Mmbaga, Melkizedeck Leshabari, Daniel Wikler, Till Bärnighausen 2022

Abstract: Individual informed consent is a central requirement for clinical research on human subjects, yet whether and how consent requirements should apply to health policy experiments (HPEs) remains unclear. HPEs test and evaluate public health policies prior to implementation. We interviewed 58 health experts in Tanzania, Bangladesh and Germany on informed consent requirements for HPEs…


“The research assistants kept coming to follow me up; I counted myself as a lucky person”: Social support arising from a longitudinal HIV cohort study in Uganda

Jeffrey I. Campbell, Angella Musiimenta, Sylvia Natukunda, Nir Eyal, Jessica E. Haberer 2022

Abstract: Background Participation in longitudinal research studies in resource-limited settings often involves frequent interactions with study staff and other participants, as well as receipt of incentives and transportation reimbursements. Social support—receipt of material and emotional resources from one’s social network—has been linked to antiretroviral adherence in sub-Saharan Africa. The extent to which social support arises from study participation, its range and depth, and its implications for observational study conduct, have not been extensively described. Methods We conducted individual open-ended and semi-structured interviews with participants in a longitudinal, observational antiretroviral therapy adherence monitoring study in Mbarara, Uganda.


Regulator-Requested Non-Interventional Postauthorization Safety and Effectiveness Studies for Oncology Drugs: A Systematic Review

Xiao Zhang, Lei Chen, Oswaldo L. Bracco, Soko Setoguchi, Wei Zhou, Mehmet Burcu 2022

Abstract: There has been a growing number of oncology drug approvals. Non-interventional postauthorization safety/effectives studies (PASSs/PAESs) aim to provide real-world evidence on the safety/effectiveness of oncology drugs postapproval. To understand the current landscape, a comprehensive search as of March 1, 2021, was conducted in major register/databases…


Perspectives of opioid use disorder treatment providers during COVID-19: Adapting to flexibilities and sustaining reforms

Peter C. Treitler, Cadence F. Bowden, James Lloyd, Michael Enich, Amesika N. Nyaku, Stephen Crystal 2022

Objective: The COVID-19 pandemic led to unprecedented temporary federal and state regulatory flexibilities that rapidly transformed medication for opioid use disorder (MOUD) treatment delivery. This study aimed to understand changes in treatment providers’ care during COVID-19, provider experiences with the adaptations, and perceptions of which changes should be sustained long-term. Methods: We conducted in-depth, semi-structured interviews with 20 New Jersey MOUD providers, purposively sampled to reflect diversity in provider setting, specialty, and other characteristics. Using a rapid analysis approach, we summarized content within interview domains and analyzed domains across participants for recurring concepts and themes…


Increased risk for binge drinking among college students with disability who report sexual violence

Carla D. Chugani, Kelley A. Jones, Robert W.S. Coulter, Jocelyn C. Anderson, Janine Talis, Tina R. Goldstein, Tammy Chung, Elizabeth Miller 2022

Objective This study investigated binge drinking in college students with and without disabilities and sexual violence (SV). Participants: This analysis includes 2,113 college students recruited from campus health or counseling centers between 2015 and 2017, aged 18-24. Method: Multinomial logistic regression procedures were used to estimate adjusted odds ratios (AOR) for past month binge drinking days (BDD). Results: Among students with disabilities, 68% endorsed SV, compared with 53% of those without disability. Disability was not significantly associated with BDD; SV was significantly associated with BDD (p <.0001). Students with SV, regardless of disability status, had 1.7- to 2.1-fold greater odds of having 4+ past month BDD. Conclusions: While disability alone is not a risk factor for binge drinking, novel findings include that students with disabilities binge drink at similarly high rates to their nondisabled peers, and are at elevated risk for SV, which is closely associated with binge drinking...


Medically treated opioid overdoses among New Jersey Medicaid beneficiaries: Rapid growth and complex comorbidity amid growing fentanyl penetration

Stephen Crystal, Molly Nowels, Mark Olfson, Hillary Samples, Arthur Robinson Williams, Peter Treitler 2021

Objective: Medically treated opioid overdoses identify a population at high risk of subsequent mortality and need for treatment. This study reports on medically treated opioid overdose trends in a state with rapid fentanyl spread. Methods: We conducted stratified trend analysis of medically treated overdose due to heroin, synthetic opioids, methadone, or other natural opioids among New Jersey Medicaid beneficiaries aged 12–64 years (2014–2019); evaluated associations with demographics and co-occurring conditions; and examined trends in fentanyl penetration in suspected heroin seizures from New Jersey State Police data. Results: Overdose risk more than tripled from 2014 to 2019, from 120.5 to 426.8 per 100,000 person-years, respectively…


Considerations when assessing the effect of nightshifts on hypertension prevalence

Maxwell Everett, Soko Setoguchi, Aayush Visaria 2021

Considerations when assessing the effect of nightshifts on hypertension prevalence …


Brief original report: Does smoking status provide information relevant to screening for other substance use among US adults?

Maria R. Khan, Kaoon Ban, Ellen C. Caniglia, Jennifer E. Edelman, Julie Gaither, Stephen Crystal, Natalie E. Chichetto, Kailyn E. Young, Janet Tate, Amy C. Justice, R. Scott Braithwaite 2021

Abstract: We assessed whether tobacco screening provides clinically meaningful information about other substance use, including alcohol and other drug use, potentially facilitating targeting of screening for substance use. Using data from the Veterans Aging Cohort Study survey sample (VACS; N = 7510), we calculated test performance characteristics of tobacco use screening results for identification of other substance use including sensitivity, specificity, positive-likelihood-ratio (+LR = [sensitivity/(1-specificity)]: increase in odds of substance use informed by a positive tobacco screen), and negative-likelihood-ratio (-LR: [(1-sensitivity)/specificity]: reduction in odds of substance use informed by a negative tobacco screen). The sample was 95% male, 75% minority, and 43% were current and 33% were former smokers. Never smoking, versus any history, indicated an approximate four-fold decrease in the odds of injection drug use (-LR = 0.26), an approximate 2.5-fold decrease in crack/cocaine (-LR = 0.35) and unhealthy alcohol use (-LR = 0.40), an approximate two-fold decrease in marijuana (-LR = 0.51) and illicit opioid use (-LR = 0.48), and an approximate 30% decrease in non-crack/cocaine stimulant use (-LR = 0.75)…


Validation of a claims-based algorithm to identify cases of ulcerative colitis in Japan

Haruei Ogino, Hiromu Morikubo, Keita Fukaura, Tasuku Okui, Sean Gardiner, Naonobu Sugiyama, Noritoshi Yoshii, Tsutomu Kawaguchi, Haoqian Chen, Edward Nonnenmacher, Soko Setoguchi, Naoki Nakashima, Taku Kobayashi 2021

Background and Aim: The prevalence of ulcerative colitis (UC) is increasing in Japan. Validated claims-based definitions are required to investigate the epidemiology of UC and its treatment and disease course in clinical practice. This study aimed to develop a claims-based algorithm for UC in Japan…


Where to begin? Thirty must-read papers for newcomers to pharmacoepidemiology

Anton Pottegård, Lucas Morin, Jesper Hallas, Tobias Gerhard, Almut G. Winterstein, Susanna Perez-Gutthann, Mina Tadrous 2021

Pharmacoepidemiology, the study of use and effects of medications, devices, diagnostics, and other medical interventions in large populations, is a science under constant development. New study designs are added to the armamentarium, new data sources are being leveraged, and new approaches are developed. All are changing the conduct of pharmacoepidemiological studies…


Prescription Opioid Laws and Opioid Dispensing in US Counties: Identifying Salient Law Provisions with Machine Learning

Silvia S. Martins, Emilie Bruzelius, Jeanette A. Stingone, Katherine Wheeler-Martin, Hanane Akbarnejad, Christine M. Mauro, Megan E. Marziali, Hillary Samples, Stephen Crystal, Corey S. Davis, Kara E. Rudolph, Katherine M. Keyes, Deborah S. Hasin, Magdalena Cerdá 2021

Background: Hundreds of laws aimed at reducing inappropriate prescription opioid dispensing have been implemented in the United States, yet heterogeneity in provisions and their simultaneous implementation have complicated evaluation of impacts. We apply a hypothesis-generating, multistage, machine-learning approach to identify salient law provisions and combinations associated with dispensing rates to test in future research…


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