Testing a persuasive health communication intervention (PHCI) for emergency department patients who declined rapid HIV/HCV screening: a randomised controlled trial study protocol.

INTRODUCTION: Previous studies have shown that substantial percentages of emergency department (ED) patients in the USA recommended for HIV or hepatitis C (HCV) decline testing. Evidence-based and cost-effective interventions to improve HIV/HCV testing uptake are needed, particularly for people who inject drugs (PWIDs) (currently or formerly), who comprise a group at higher risk for these infections. We developed a brief persuasive health communication intervention (PHCI) designed to convince ED patients who had declined HIV/HCV testing to agree to be tested. In this investigation, we will determine if the PHCI is more efficacious in convincing ED patients to be tested for HIV/HCV when delivered by a video or in person, and whether efficacy is similar among individuals who currently, previously or never injected drugs. METHODS AND ANALYSIS: We will conduct a multisite, randomised controlled trial comparing PHCIs delivered by video versus in person by a health educator to determine which delivery method convinces more ED patients who had declined HIV/HCV testing instead to be tested. We will stratify randomisation by PWID status (current, former or never/non-PWID) to permit analyses comparing the PHCI delivery method by injection-drug use history. We will also perform a cost-effectiveness analysis of the interventions compared with current practice, examining the incremental cost-effectiveness ratio between the two interventions for the ED population overall and within individual strata of PWID. As an exploratory analysis, we will assess if a PHCI video with captions confers increased or decreased acceptance of HIV/HCV testing, as compared with a PHCI video without captions. ETHICS AND DISSEMINATION: The study protocol has been approved by the institutional review board of the Icahn School of Medicine. The results will be disseminated at international conferences and in peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT05968573.

Characterizing the Association Between Traumatic Brain Injury and Discontinuation of Medications for Opioid Use Disorder in a Commercially Insured Adult Population.

OBJECTIVE: Extending prior research that has found that people with traumatic brain injury (TBI) experience worse substance use treatment outcomes, we examined whether history of TBI was associated with discontinuation of medication to treat opioid use disorder (MOUD), an indicator of receiving evidence-based treatment. SETTING: We used MarketScan claims data to capture inpatient, outpatient, and retail pharmacy utilization from large employers in all 50 states from 2016 to 2019. PARTICIPANTS: We identified adults aged 18 to 64 initiating non-methadone MOUD (ie, buprenorphine, injectable naltrexone, and oral naltrexone) in 2016-2019. The exposure was whether an individual had a TBI diagnosis in the 2 years before initiating MOUD. During this period, there were 709 individuals with TBI who were then matched with 709 individuals without TBI. DESIGN: We created a retrospective cohort of matched individuals with and without TBI and used quasi-experimental methods to identify the association between TBI status and MOUD use. We estimated propensity scores by TBI status and created a 1:1 matched cohort of people with and without TBI who initiated MOUD. We used a Cox proportional hazards model to identify the association between TBI and MOUD discontinuation. MAIN MEASURE: The outcome was discontinuation of MOUD (ie, a gap of 14 days or more of MOUD). RESULTS: Among those initiating MOUD, the majority were under 26 years of age, male, and living in an urban setting. Nearly 60% of individuals discontinued medication by 6 months. Adults with TBI had an elevated risk of MOUD discontinuation (hazard ratio [HR] 1.13; 95% confidence interval [CI], 1.01-1.27) compared to those without TBI. Additionally, initiating oral naltrexone was associated with a higher risk of discontinuation (HR 1.63; 95% CI, 1.40-1.90). CONCLUSION: We found evidence of reduced MOUD retention among people with TBI. Differences in MOUD retention may reflect health care inequities, as there are no medical contraindications to using MOUD for people with TBI or other disabilities.

Insurance Instability for Patients With Opioid Use Disorder in the Year After Diagnosis.

Importance: Transitions in insurance coverage may be associated with worse health care outcomes. Little is known about insurance stability for individuals with opioid use disorder (OUD). Objective: To examine insurance transitions among adults with newly diagnosed OUD in the 12 months after diagnosis. Design, Setting, and Participants: Longitudinal cohort study using data from the Massachusetts Public Health Data Warehouse. The cohort includes adults aged 18 to 63 years diagnosed with incident OUD between July 1, 2014, and December 31, 2014, who were enrolled in commercial insurance or Medicaid at diagnosis; individuals diagnosed after 2014 were excluded from the main analyses due to changes in the reporting of insurance claims. Data were analyzed from November 10, 2022, to May 6, 2024. Exposure: Insurance type at time of diagnosis (commercial and Medicaid). Main Outcomes and Measures: The primary outcome was the cumulative incidence of insurance transitions in the 12 months after diagnosis. Logistic regression models were used to generate estimated probabilities of insurance transitions by insurance type and diagnosis for several characteristics including age, race and ethnicity, and whether an individual started medication for OUD (MOUD) within 30 days after diagnosis. Results: There were 20 768 individuals with newly diagnosed OUD between July 1, 2014, and December 31, 2014. Most individuals with newly diagnosed OUD were covered by Medicaid (75.4%). Those with newly diagnosed OUD were primarily male (67% in commercial insurance, 61.8% in Medicaid). In the 12 months following OUD diagnosis, 30.4% of individuals experienced an insurance transition, with adjusted models demonstrating higher transition rates among those starting with Medicaid (31.3%; 95% CI, 30.5%-32.0%) compared with commercial insurance (27.9%; 95% CI, 26.6%-29.1%). The probability of insurance transitions was generally higher for younger individuals than older individuals irrespective of insurance type, although there were notable differences by race and ethnicity. Conclusions and Relevance: This study found that nearly 1 in 3 individuals experience insurance transitions in the 12 months after OUD diagnosis. Insurance transitions may represent an important yet underrecognized factor in OUD treatment outcomes.

Evaluation of Strategies to Enhance Community-Based Naloxone Distribution Supported by an Opioid Settlement.

Importance: Many US states are substantially increasing community-based naloxone distribution, supported in part through settlements from opioid manufacturers and distributors. Objectives: To evaluate the potential impact of increased naloxone availability on opioid overdose deaths (OODs) and explore strategies to enhance this impact by integrating interventions to address solitary drug use. Design, Setting, and Participants: This decision analytical modeling study used PROFOUND (Prevention and Rescue of Fentanyl and Other Opioid Overdoses Using Optimized Naloxone Distribution Strategies), a previously published simulation model, to forecast annual OODs between January 2023 and December 2025. The simulated study population included individuals from Rhode Island who misused opioids and stimulants and were at risk for opioid overdose. Exposures: The study modeled expanded naloxone distribution supported by the state's opioid settlement (50 000 naloxone nasal spray kits each year). Two approaches to expanding naloxone distribution were evaluated: one based on historical spatial patterns of naloxone distribution (supply-based approach) and one based on the spatial distribution of individuals at risk (demand-based approach). In addition, hypothetical interventions to enhance the likelihood of witnessed overdoses in private or semiprivate settings were considered. Main Outcomes and Measures: Annual number of OODs and ratio of fatal to nonfatal opioid overdoses. Results: Modeling results indicated that distributing more naloxone supported by the state's opioid settlement could reduce OODs by 6.3% (95% simulation interval [SI], 0.3%-13.7%) and 8.8% (95% SI, 1.8%-17.5%) in 2025 with the supply-based and demand-based approaches, respectively. However, increasing witnessed overdoses by 20% to 60% demonstrated greater potential for reducing OODs, ranging from 8.5% (95% SI, 0.0%-20.3%) to 24.1% (95% SI, 8.6%-39.3%). Notably, synergistic associations were observed when combining both interventions: increased naloxone distribution with the 2 approaches and a 60% increase in witnessed overdoses could reduce OODs in 2025 by 33.5% (95% SI, 17.1%-50.4%) and 37.4% (95% SI, 19.6%-56.3%), respectively. Conclusions and Relevance: These findings suggest that interventions to address solitary drug use are needed to maximize the impact of continued efforts to increase community-based naloxone distribution, which may be particularly important for jurisdictions that have strong community-based naloxone distribution programs.

The association between naloxone claims and proportion of independent vs. chain pharmacies: A longitudinal analysis of naloxone claims in the US.

BACKGROUND: Expanding access to naloxone through pharmacies is an important policy goal. Our objective was to characterize national county-level naloxone dispensing of chain versus independent pharmacies. METHODS: The primary exposure in our longitudinal analysis was the proportion of chain pharmacies in a county, identified through the US Department of Homeland Security 2010 Infrastructure Foundation-Level Data. We defined counties as having "higher proportion" of chain pharmacies if at least 50% of pharmacies were large national chains. The primary outcome was quarter-year (2016Q1-2019Q2) rate of pharmacy naloxone claims per 100,000 persons from Symphony Health at the county-level. We compared the naloxone dispensing rate between county types using two-sample t-tests. We estimated the association between county-level chain pharmacy proportion and rate of naloxone claims using a linear model with year-quarter fixed effects. RESULTS: Nearly one third of counties (n=946) were higher proportion. Higher proportion counties had a significantly higher rate of naloxone claims across the study period, in 4 of 6 urban-rural classifications, and in counties with and without naloxone access laws. The linear model confirmed that higher proportion counties had a significantly higher rate of naloxone claims, adjusting for urban/rural designation, income, population characteristics, opioid mortality rate, co-prescribing laws and naloxone access laws. CONCLUSION: In this national study, we found an association between naloxone dispensing rates and the county-level proportion of chain (versus independent) pharmacies. Incentivizing naloxone dispensing through educational, regulatory, or legal efforts may improve naloxone availability and dispensing rates - particularly in counties with proportionately high numbers of independent pharmacies.

Changes in Permanent Contraception Procedures Among Young Adults Following the Dobbs Decision.

This cross-sectional study evaluates changes in tubal ligation and vasectomy procedures among younger adults following the Dobbs v Jackson Women's Health Organization decision.

Trends in Attention-Deficit Hyperactivity Disorder Diagnosis and Pharmacotherapy Among Adults With Opioid Use Disorder.

OBJECTIVE: This study aimed to assess nationwide trends in attention-deficit hyperactivity disorder (ADHD) diagnoses and pharmacotherapy among patients with opioid use disorder and ADHD and to examine factors predicting receipt of stimulant medications among patients receiving medications for opioid use disorder (MOUDs). METHODS: A claims-based database of commercially insured patients ages 13-64 was used to conduct two analyses: an annual cross-sectional study of 387,980 patients diagnosed as having opioid use disorder (2007-2017) to estimate the prevalence of ADHD diagnoses and pharmacotherapy, and a retrospective cohort study of 158,591 patients receiving MOUDs to test, with multivariable regression, the association between patient characteristics and receipt of stimulant medication. RESULTS: From 2007 to 2017, the prevalence of ADHD diagnoses increased from 4.6% to 15.1% and the rate of ADHD pharmacotherapy increased from 42.6% to 51.8% among patients with opioid use disorder. Among all patients receiving MOUDs, 10.5% received at least one prescription stimulant during the study period. Female sex; residence in the southern United States; and ADHD, mood, and anxiety disorder diagnoses were associated with increased likelihood of stimulant receipt. Stimulant use disorder and other substance use disorder diagnoses were associated with decreased likelihood of stimulant receipt. CONCLUSIONS: ADHD diagnoses and pharmacotherapy among patients with opioid use disorder have increased. A minority of patients with ADHD and taking MOUDs received a stimulant. Further study is needed of the benefits and risks of ADHD pharmacotherapy for patients with opioid use disorder.

Establishing a Protocol for Determining the Costs of an Integrated Set of Evidence-based Practices Aimed at Reducing Opioid Overdose Deaths.

OBJECTIVES: In the midst of the opioid overdose crisis, local jurisdictions face a choice of public health interventions. A significant barrier when considering evidence-based practices (EBPs) is the lack of information regarding their implementation cost. This protocol paper provides the methodological foundation for the economic cost evaluations of community-wide strategies on the scale of a national study. It can serve as a resource for other communities, local policymakers, and stakeholders as they consider implementing possible public health strategies in their unique settings. METHODS: We present a protocol that details (1) the process of identifying, reviewing, and analyzing individual strategies for study-funded and non-study-funded costs; (2) prospective costing tool designation, and; (3) data collection. To do this, we set up working groups with community stakeholders, reviewed financial invoices, and surveyed individuals with detailed knowledge of their community implementation. DISCUSSION: There were 3 main challenges/limitations. The first was the lack of a standard structure for documenting nonfunded costs associated with each strategy. The second was the need for timely implementation of cost data. The third was generalizability because our study designed its strategies for selected communities due to their high opioid overdose mortality rates. Future steps include more tailored questions to ask during the categorization/filter process and establishing realistic expectations for organizations regarding documenting. CONCLUSIONS: Data collected will provide a critical methodological foundation for costing large community-based EBP strategies and provide clarity for stakeholders on the cost of implementing EBP strategies to reduce opioid overdose deaths.

Indications and Short-Term Outcomes for In-Office Therapeutic Superior Laryngeal Nerve Block.

OBJECTIVE: Superior laryngeal nerve (SLN) block consists of injection of steroid and anesthetic at the internal branch of the SLN entry site. Prior case series have demonstrated beneficial effects on neurogenic cough. SLN blocks have also recently shown benefit for paralaryngeal pain. We describe short-term outcomes for multiple symptoms of irritable larynx syndrome (ILS) including neurogenic cough, dysphonia related to laryngeal hypersensitivity, inducible laryngeal obstruction (ILO), paralaryngeal pain, and isolated globus. METHODS: Retrospective review from 2 institutions of patients undergoing a single SLN block for the indications listed. Variables include age, sex, indication(s), known vagus neuropathy, and patient-reported outcomes at short-term follow-up. RESULTS: A total of 209 patients were included (59 males, 150 females; age: 58 ± 13 years). Twenty-six patients (12%) had a history of a vagus nerve injury. Indications included neurogenic cough (n = 149), dysphonia related to laryngeal hypersensitivity (n = 66), paralaryngeal pain (n = 50), ILO (n = 23), and isolated globus (n = 3). Some patients had multiple indications. Significant improvements in patient-reported measures occurred after a single SLN block within 2 to 4 weeks for neurogenic cough (cough severity index; 25.2 ± 11.2 to 19.0 ± 12.8; P < .001), dysphonia (voice handicap index-10; 22.1 ± 12.2-18.0 ± 13.3; P = .005), and ILO (dyspnea index; 21.0 ± 14.9-14.7 ± 15.7; P = .017). Subjective pain improved in 23 of 39 patients with paralaryngeal pain. There was no observed improvement for isolated globus. Presence of known vagal neuropathy or therapy around the time of SLN block did not affect outcome. CONCLUSION: SLN block can be an effective component of treatment for a variety of ILS symptoms. Patients may experience some improvement after 1 injection. LAY SUMMARY: Symptoms of irritable larynx syndrome, such as neurogenic cough, paralaryngeal pain, inducible laryngeal obstruction, and dysphonia related to laryngeal hypersensitivity can be challenging to manage. In-office Superior Laryngeal Nerve blocks can serve as a quick, well tolerated, adjunctive treatment with positive short-term outcomes. LEVEL OF EVIDENCE: 4.

Utility of Targeted Positron Emission Tomography Imaging to Predict Schwannoma Growth in a Murine Tumor Model.

OBJECTIVE: To identify if targeted positron emission tomography (PET) imaging with radiolabeled antibodies can predict tumor growth rate and ultimate tumor size in a murine flank schwannoma model. STUDY DESIGN: Animal research study. METHODS: Rat schwannoma cells were cultured and implanted into 40 athymic nude mice. Once tumors reached 5 mm in diameter, 30 mice were injected with zirconium-89 labeled antibodies (HER2/Neu, vascular endothelial growth factor receptor 2 (VEGFR2), or IgG isotype). PET/CT was performed, and standardized uptake values (SUV) were recorded. Tumors were serially measured until mice were sacrificed per IACUC protocol. Statistical analysis was performed to measure correlations between SUV values, tumor size, and growth. RESULTS: Mean tumor sizes in mm3 on Day 0 were 144 ± 162 for anti-HER2/Neu, 212 ± 247 for anti-VEGFR2, and 172 ± 204 for IgG isotype groups respectively. Mean growth rates in mm3 /day were 531 ± 250 for HER2, 584 ± 188 for VEGFR2, and 416 ± 163 for the IgG isotype group. For both initial tumor size and growth rates, there was no significant difference between groups. There were significant correlations between maximum tumor volume and both the SUV max in the HER2 group (p = 0.0218, R2 = 0.5020), and we observed significant correlations between growth rate, and SUV values (p = 0.0156, R2 = 0.5394). Respectively, in the anti-VEGFR2 group, there were no significant correlations. CONCLUSION: In a murine schwannoma model, immunotargeted PET imaging with anti-HER2/Neu antibodies predicted tumor growth rate and final tumor size. Laryngoscope, 134:1372-1380, 2024.

Out-of-pocket spending and health care utilization associated with initiation of different medications for opioid use disorder: Findings from a national commercially insured cohort.

INTRODUCTION: Buprenorphine and naltrexone are effective medications for opioid use disorder (MOUD). Naltrexone requires complete detoxification from opioids before initiation while buprenorphine does not, which leads to a differential clinical induction challenge. Few studies have evaluated economic costs associated with MOUD initiation. METHODS: We conducted a retrospective cohort analysis using the 2014-2019 Merative MarketScan database. We included individuals diagnosed with opioid use, abuse, or dependence from 2014 to 2019 who initiated one of three MOUD types: 1) buprenorphine, 2) extended-release naltrexone, or 3) oral naltrexone. We calculated total and monthly out-of-pocket spending, for overall and MOUD-specific claims, for the three months prior through three months after MOUD initiation. We also calculated utilization of detoxification, inpatient, and outpatient services monthly over this period. RESULTS: Our cohort included 27,133 individuals; 19,536, 1886, and 5711 initiated buprenorphine, extended-release naltrexone, and oral naltrexone, respectively. Individuals who initiated naltrexone had the highest out-of-pocket spending over the study period. MOUD-specific spending did not contribute substantially to total out-of-pocket spending. Difference in overall spending by MOUD type was driven by a subset of individuals who initiated naltrexone and had very high out-of-pocket spending in the month prior to MOUD initiation. In this month, mean monthly out-of-pocket spending for high-spenders (above 90th percentile within MOUD type category) was $5734 (95 % confidence interval [CI]: $5181-$6286) and $4622 (95 % CI: $4161-$5082) for those who initiated oral and extended-release naltrexone, respectively, compared with $1852 (95 % CI: $1754-$1950) for those who initiated buprenorphine. In the month prior to MOUD initiation, those who initiated naltrexone also had higher detoxification, inpatient, and outpatient episode/visit frequency. In the month prior to initiation, 28.8 % (95 % CI: 27.7 %-30.0 %) and 25.5 % (95 % CI: 23.6 %-27.5 %) of individuals who initiated oral and extended-release naltrexone had detoxification episodes, compared with 9.7 % (95 % CI: 9.3 %-10.1 %) of those who initiated buprenorphine. CONCLUSION: Findings suggest that individuals who initiated naltrexone utilized more intensive health services, including detoxification, in the period prior to MOUD initiation, resulting in significantly higher out-of-pocket spending. Out-of-pocket spending is a patient-centered outcome reflecting potential patient burden. Our results should be considered as part of the shared decision-making process between patients and providers when choosing treatment for OUD.

Factors Associated With Abrupt Discontinuation of Long-Term High-Dose Opioid Treatment.

This cohort study investigates factors associated with abrupt discontinuation of long-term high-dose opioid treatment at the national level and across US states.

Economic Evaluation of Extended-Release Buprenorphine for Persons With Opioid Use Disorder.

Importance: In 2017, the US Food and Drug Administration (FDA) approved a monthly injectable form of buprenorphine, extended-release buprenorphine; published data show that extended-release buprenorphine is effective compared with no treatment, but its current cost is higher and current retention is lower than that of transmucosal buprenorphine. Preliminary research suggests that extended-release buprenorphine may be an important addition to treatment options, but the cost-effectiveness of extended-release buprenorphine compared with transmucosal buprenorphine remains unclear. Objective: To evaluate the cost-effectiveness of extended-release buprenorphine compared with transmucosal buprenorphine. Design, Setting, and Participants: This economic evaluation used a state transition model starting in 2019 to simulate the lifetime of a closed cohort of individuals with OUD presenting for evaluation for opioid agonist treatment with buprenorphine. The data sources used to estimate model parameters included cohort studies, clinical trials, and administrative data. The model relied on pharmaceutical costs from the Federal Supply Schedule and health care utilization costs from published studies. Data were analyzed from September 2021 to January 2023. Interventions: No treatment, treatment with transmucosal buprenorphine, or treatment with extended-release buprenorphine. Main Outcomes and Measures: Mean lifetime costs per person, discounted quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). Results: The simulated cohort included 100 000 patients with OUD receiving (61% male; mean [SD] age, 38 [11] years) or not receiving medication treatment (58% male, mean [SD] age, 48 [18] years). Compared with no medication treatment, treatment with transmucosal buprenorphine yielded an ICER of $19 740 per QALY. Compared with treatment with transmucosal buprenorphine, treatment with extended-release buprenorphine yielded lower effectiveness by 0.03 QALYs per person at higher cost, suggesting that treatment with extended-release buprenorphine was dominated and not preferred. In probabilistic sensitivity analyses, treatment with transmucosal buprenorphine was the preferred strategy 60% of the time. Treatment with extended-release buprenorphine was cost-effective compared with treatment with transmucosal buprenorphine at a $100 000 per QALY willingness-to-pay threshold only after substantial changes in key parameters. Conclusions and Relevance: In this economic evaluation of extended-release buprenorphine compared with transmucosal buprenorphine for the treatment of OUD, extended-release buprenorphine was not associated with efficient allocation of limited resources when transmucosal buprenorphine was available. Future initiatives should aim to improve retention rates or decrease costs associated with extended-release buprenorphine.

Buprenorphine Out-of-Pocket Costs and Discontinuation in Privately Insured Adults With Opioid Use Disorder.

This cohort study examined the association between out-of-pocket costs for an initial buprenorphine prescription and its discontinuation among commercially insured US adults with opioid use disorder.

Changes to opioid overdose deaths and community naloxone access among Black, Hispanic and White people from 2016 to 2021 with the onset of the COVID-19 pandemic: An interrupted time-series analysis in Massachusetts, USA.

BACKGROUND AND AIMS: The onset of the coronavirus disease 2019 (COVID-19) pandemic was associated with a surge in opioid overdose deaths in Massachusetts, particularly affecting racial and ethnic minority communities. We aimed to compare the impact of the pandemic on opioid overdose fatalities and naloxone distribution from community-based programs across racial and ethnic groups in Massachusetts. DESIGN: Interrupted time-series. SETTING AND CASES: Opioid overdose deaths (OODs) among non-Hispanic White, non-Hispanic Black, Hispanic and non-Hispanic other race people in Massachusetts, USA (January 2016 to June 2021). MEASUREMENTS: Rate of OODs per 100 000 people, rate of naloxone kits distributed per 100 000 people and ratio of naloxone kits per opioid overdose death as a measure of naloxone availability. We applied five imputation strategies using complete data in different periods to account for missingness of race and ethnicity for naloxone data. FINDINGS: Before COVID-19 (January 2016 to February 2020), the rate of OODs declined among non-Hispanic White people [0.2% monthly reduction (95% confidence interval = 0.0-0.4%)], yet was relatively constant among all other population groups. The rate of naloxone kits increased across all groups (0.8-1.2% monthly increase) and the ratio of naloxone kits per OOD death among non-Hispanic White was 1.1% (0.8-1.4%) and among Hispanic people was 1.0% (0.2-1.8%). After the onset of the pandemic (March 2020+), non-Hispanic Black people experienced an immediate increase in the rate of OODs [63.6% (16.4-130%)], whereas rates among other groups remained similar. Trends in naloxone rescue kit distribution did not substantively change among any groups, and the ratio of naloxone kits per OOD death for non-Hispanic Black people did not compensate for the surge in OODs deaths in this group. CONCLUSIONS: With the onset of the COVID-19 pandemic, there was a surge in opioid overdose deaths among non-Hispanic Black people in Massachusetts, USA with no compensatory increase in naloxone rescue kit distribution. For non-Hispanic White and Hispanic people, opioid overdose deaths remained stable and naloxone kit distribution continued to increase.

Comparison of a national commercial pharmacy naloxone data source to state and city pharmacy naloxone data sources-Rhode Island, Massachusetts, and New York City, 2013-2019.

OBJECTIVE: Accurate naloxone distribution data are critical for planning and prevention purposes, yet sources of naloxone dispensing data vary by location, and completeness of local datasets is unknown. We sought to compare available datasets in Massachusetts, Rhode Island, and New York City (NYC) to a commercially available pharmacy national claims dataset (Symphony Health Solutions). DATA SOURCES AND STUDY SETTING: We utilized retail pharmacy naloxone dispensing data from NYC (2018-2019), Rhode Island (2013-2019), and Massachusetts (2014-2018), and pharmaceutical claims data from Symphony Health Solutions (2013-2019). STUDY DESIGN: We conducted a descriptive, retrospective, and secondary analysis comparing naloxone dispensing events (NDEs) captured via Symphony to NDEs captured by local datasets from the three jurisdictions between 2013 and 2019, when data were available from both sources, using descriptive statistics, regressions, and heat maps. DATA COLLECTION/EXTRACTION METHODS: We defined an NDE as a dispensing event documented by the pharmacy and assumed that each dispensing event represented one naloxone kit (i.e., two doses). We extracted NDEs from local datasets and the Symphony claims dataset. The unit of analysis was the ZIP Code annual quarter. PRINCIPAL FINDINGS: NDEs captured by Symphony exceeded those in local datasets for each time period and location, except in RI following legislation requiring NDEs to be reported to the PDMP. In regression analysis, absolute differences in NDEs between datasets increased substantially over time, except in RI before the PDMP. Heat maps of NDEs by ZIP code quarter showed important variations reflecting where pharmacies may not be reporting NDEs to Symphony or local datasets. CONCLUSIONS: Policymakers must be able to monitor the quantity and location of NDEs in order to combat the opioid crisis. In regions where NDEs are not required to be reported to PDMPs, proprietary pharmaceutical claims datasets may be useful alternatives, with a need for local expertise to assess dataset-specific variability.

Optimizing timing of adolescent vaccines: Impact of initiating HPV vaccination before Tdap or meningococcal vaccination on timely completion of the HPV vaccine series.

To explore the impact on timely series completion of initiating the HPV vaccine series prior to other vaccines in the adolescent platform (Tdap or meningococcal vacccines), we created a cohort of children aged 9 in 2015 who were continuously enrolled through the age of 13 (2019) from a national administrative database of employee-sponsored insurance in the United States (MarketScan). Logistic regressions were used to predict the odds of HPV vaccine series completion among those who started the series prior to, concurrent with, or after receiving Tdap or meningococcal vaccination. The cohort included 100,857 eligible children. Compared with adolescents who received their HPV and Tdap or HPV and meningococcal vaccinations concurrently, those who received HPV prior to other vaccines had higher completion (aOR = 1.38 for Tdap, aOR 1.62 for meningococcal), while those who received their HPV vaccination after other vaccines had lower odds of HPV vaccine series completion (aOR = 0.68 for Tdap, aOR = 0.62 for meningococcal). Other factors associated with series completion included female sex, residing in an urban (vs. rural) area, residing in the Northeast, and receiving primary care from a pediatrician (vs. family medicine physician). These data indicate that beginning the HPV vaccine series prior to the adolescent platform may improve on-time series completion.

The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Linkage-to-Care Trial: rationale and design of an emergency department-based randomized clinical trial of linkage-to-care strategies for hepatitis C.

BACKGROUND: Hepatitis C (HCV) poses a major public health problem in the USA. While early identification is a critical priority, subsequent linkage to a treatment specialist is a crucial step that bridges diagnosed patients to treatment, cure, and prevention of ongoing transmission. Emergency departments (EDs) serve as an important clinical setting for HCV screening, although optimal methods of linkage-to-care for HCV-diagnosed individuals remain unknown. In this article, we describe the rationale and design of The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Linkage-to-Care Trial. METHODS: The DETECT Hep C Linkage-to-Care Trial will be a single-center prospective comparative effectiveness randomized two-arm parallel-group superiority trial to test the effectiveness of linkage navigation and clinician referral among ED patients identified with untreated HCV with a primary hypothesis that linkage navigation plus clinician referral is superior to clinician referral alone when using treatment initiation as the primary outcome. Participants will be enrolled in the ED at Denver Health Medical Center (Denver, CO), an urban, safety-net hospital with approximately 75,000 annual adult ED visits. This trial was designed to enroll a maximum of 280 HCV RNA-positive participants with one planned interim analysis based on methods by O'Brien and Fleming. This trial will further inform the evaluation of cost effectiveness, disparities, and social determinants of health in linkage-to-care, treatment, and disease progression. DISCUSSION: When complete, the DETECT Hep C Linkage-to-Care Trial will significantly inform how best to perform linkage-to-care among ED patients identified with HCV. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT04026867 Original date: July 1, 2019 URL: https://clinicaltrials.gov/ct2/show/NCT04026867.