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Background: Pilot data suggest that off-label, unmonitored antiepileptic drug prescribing for behavioral and psychological symptoms of dementia is increasing, replacing other psychotropic medications targeted by purposeful reduction efforts. This trend accelerated during the COVID-19 pandemic. Although adverse outcomes related to this trend remain unknown, preliminary results hint that harms may be increasing and concentrated in vulnerable populations., Objective: Using a mixed methods approach including both a retrospective secondary data analysis and a national clinician survey, this study aims to describe appropriate and potentially inappropriate antiepileptic and other psychoactive drug prescribing in US nursing homes (NHs), characteristics and patient-oriented outcomes associated with this prescribing, and how these phenomena may be changing under the combined stressors of the COVID-19 pandemic and the pressure of reduction initiatives., Methods: To accomplish the objective, resident-level, mixed-effects regression models and interrupted time-series analyses will draw on cohort elements linked at an individual level from the Centers for Medicare and Medicaid Services' (CMS) Minimum Data Set, Medicare Part D, Medicare Provider Analysis and Review, and Outpatient and Public Use Files. Quarterly cohorts of NH residents (2009-2021) will incorporate individual-level data, including demographics; health status; disease variables; psychotropic medication claims; comprehensive NH health outcomes; hospital and emergency department adverse events; and NH details, including staffing resources and COVID-19 statistics. To help explain and validate findings, we will conduct a national qualitative survey of NH prescribers regarding their knowledge and beliefs surrounding changing approaches to dementia care and associated outcomes., Results: Funding was obtained in September 2022. Institutional review board exemption approval was obtained in January 2023. The CMS Data Use Agreement was submitted in May 2023 and signed in March 2024. Data access was obtained in June 2024. Cohort creation is anticipated by January 2025, with crosswalks finalized by July 2025. The first survey was fielded in October 2023 and published in July 2024. The second survey was fielded in March 2024. The results are in review as of July 2024. Iterative survey cycles will continue biannually until December 2026. Multidisciplinary dissemination of survey analysis results began in July 2023, and dissemination of secondary data findings is anticipated to begin January 2025. These processes are ongoing, with investigation to wrap up by June 2027., Conclusions: This study will detail appropriate and inappropriate antiepileptic drug use and related outcomes in NHs and describe disparities in long-stay subpopulations treated or not treated with psychotropics. It will delineate the impact of the pandemic in combination with national policies on dementia management and outcomes. We believe this mixed methods approach, including processes that link multiple CMS data sets at an individual level and survey-relevant stakeholders, can be replicated and applied to evaluate a variety of patient-oriented questions in diverse clinical populations., International Registered Report Identifier (irrid): DERR1-10.2196/64446., (©Jonathan D Winter, J William Kerns, Nicole Brandt, Linda Wastila, Danya Qato, Roy T Sabo, Stephen Petterson, YoonKyung Chung, Sarah Reves, Christopher Winter, Katherine M Winter, Eposi Elonge, Craig Ewasiuk, Yu-Hua Fu, Adam Funk, Alex Krist, Rebecca Etz. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 19.09.2024.)

(1) Background: Pulmonary hypertension (PH) increases pulmonary vascular resistance and right ventricular (RV) afterload. Assessment of RV systolic function in PH using RV fractional area change (RV FAC) as a marker directly correlates with mortality and the need for extracorporeal membrane oxygenation (ECMO). However, few studies have assessed neurodevelopmental outcomes. We hypothesize that cardiac RV systolic dysfunction with lower RV FAC is associated with worse neurodevelopmental impairment (NI). (2) Methods: Retrospective study of 42 subjects with PH to evaluate neurodevelopmental outcomes in the first two years of life based on (i) subjective assessment of RV systolic function and (ii) RV FAC, a specific echocardiographic marker for RV function. (3) Results: Subjects from the initial study cohort ( n = 135) with PH who had long-term follow-up were divided into RV dysfunction (study, n = 20) and non-RV dysfunction (control, n = 22) groups. RV FAC in the study vs. control group (0.18 vs. 0.25) was lower ( p = 0.00017). There was no statistically significant difference in NI either with RV dysfunction or lower RV FAC. Although not significant, RV dysfunction was associated with longer mean duration of mechanical ventilation, time on ECMO, and length of stay. In the initial cohort (135), mortality was 16.3% and the percentage of NI was 62%. (4) Conclusions: Neonatal pulmonary hypertension is associated with a high degree of neurodevelopment impairment. Early RV systolic dysfunction, as identified by RV FAC, was not an optimal predictive biomarker for infants with PH and neurodevelopmental impairment.

Objectives. To estimate state-level excess death rates during 2020 to 2023 and examine differences by region and partisan orientation. Methods. We modeled death and population counts from the Centers for Disease Control and Prevention to estimate excess death rates for the United States, 9 census divisions, and 50 states. We compared excess death rates for states with different partisan orientations, measured by the party of the seated governor and the level of partisan representation in state legislatures. Results. The United States experienced 1 277 697 excess deaths between March 2020 and July 2023. Almost 90% of these deaths were attributed to COVID-19, and 51.5% occurred after vaccines were available. The highest excess death rates first occurred in the Northeast and then shifted to the South and Mountain states. Between weeks ending June 20, 2020, through March 19, 2022, excess death rates were higher in states with Republican governors and greater Republican representation in state legislatures. Conclusions. Excess death rates during the COVID-19 pandemic varied considerably across the US states and were associated with partisan representation in state government, although the influence of confounding variables cannot be excluded. ( Am J Public Health . 2024;114(9):882-891. https://doi.org/10.2105/AJPH.2024.307731).

Importance: Unhealthy alcohol use (UAU) is the fourth most preventable cause of death in the US. The US Preventive Services Task Force recommends that primary care clinicians routinely screen all adults 18 years and older for UAU; however, this preventive service is poorly implemented., Objective: To determine if practice facilitation improved delivery of the recommended care for UAU compared to usual care., Design, Setting, and Participants: This practice-level cluster randomized clinical trial was conducted across diverse and representative primary care practices throughout Virginia. A total of 76 primary care practices enrolled between October 2019 and January 2023., Intervention: Practices received immediate (intervention) or 6-month delayed (control) practice facilitation, which included tailored educational sessions, workflow management, and tools for addressing UAU., Main Outcomes and Measures: Outcomes included the increase in recommended screening for UAU, brief interventions, referral for counseling, and medication treatment. Data were collected via medical record review (structured and free text data) and transcripts of practice facilitator sessions and exits interviews., Results: Of the 76 primary care practices enrolled, 32 were randomized to intervention and 35 to control; 11 789 patients (mean [SD] age, 50.1 [16.3] years; 61.1% women) were randomly selected for analysis, with patient demographics similar to Virginia at large. From baseline to 6 months after intervention, screening with a validated instrument increased from 2.1% (95% CI, 0.5%-8.4%) to 35.5% (95% CI, 11.5%-69.9%) in the intervention group compared to 0.4% (95% CI, 0.1%-1.8%) to 1.4% (95% CI, 0.3%-5.8%) in the control group (P < .001). Brief office-based interventions for the intervention group increased from 26.2% (95% CI, 14.2%-45.8%) to 62.6% (95% CI, 43.6%-78.3%) vs 45.5% (95% CI, 28.0%-64.1%) to 55.1% (95% CI, 36.5%-72.3%) in the control group (P = .008). Identification of UAU, referral for counseling, and medication treatment had similar changes for both groups. Qualitative analyses of transcripts revealed that few clinicians understood the preventive service prior to practice facilitation, but at the end most felt much more competent and confident with screening and brief intervention for UAU., Conclusions and Relevance: This cluster randomized clinical trial demonstrated that practice facilitation can help primary care practices to better implement screening and counseling for UAU into their routine workflow. Effective primary care practice implementation interventions such as this can have a profound effect on the health of communities. Given the number of people that the participating practices care for, this intervention resulted in an additional 114 604 patients being screened annually for UAU who would not have been otherwise., Trial Registration: ClinicalTrials.gov Identifier: NCT04248023.

It is not known how school closure affected child maltreatment. We conducted a retrospective cohort, linear mixed-models study of 133 counties (comprising 8,582,479 children) in Virginia between 2018 and 2021. Exposure was the opening of schools at least 2 days a week. Outcomes were referrals and incidence of child maltreatment reported to the Department of Social Services. In 2020-2021, there were descriptively more referrals (in-person: 50.9 per 10,000 [95% CI: 47.9, 54.0]; virtual: 45.8 per 10,000 [95% CI: 40.7, 50.9]) and incidence (in-person: 3.7 per 10,000 [95% CI: 3.3, 4.2]; virtual: 2.9 per 10,000 [95% CI: 2.3, 3.5]) of child maltreatment in counties with in-person schooling, though these differences did not reach statistical significance. The referral rate variations (between pandemic and pre-pandemic eras) of counties with in-person schooling was significantly greater than rate changes in counties with virtual schooling during the summer period. There were no differences in incidence in any quarter. Higher poverty within a county was associated with both higher referrals and incidence. Our findings suggest that child maltreatment is driven primarily by underlying differences in counties (namely, poverty) rather than the type of schooling children receive., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The Centers for Medicare & Medicaid Services (CMS) grades nursing home performance in antipsychotic prescribing quarterly, publishing findings as a quality measure. While scores have improved since 2011, marked performance variation between facilities persists. To assess quality gap changes between best- and worst-performing deciles, we compared quarterly prescribing changes between these groups pre-pandemic (April 2011 to March 2020) and during the pandemic (April 2020 to March 2022). Antipsychotic quality measure scores, improving pre-pandemic, deteriorated during the pandemic. The pre-pandemic quality gap between the best- and worst-performing deciles narrowed as the worst-performing decile improved faster than the best-performing decile. During the pandemic, the quality gap widened as the worst-performing decile relapsed more than the best-performing decile ( p  < .0001). The pandemic disrupted quality performance gains and compounded disparities between facilities. A better understanding of the factors allowing high performers to weather pandemic stressors better than poor performers may reveal opportunities to improve nursing home quality and equity for all residents., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2024.)

Introduction: Unhealthy alcohol use increases the risk for and exacerbation of chronic health conditions. As such, screening, prevention, and management of unhealthy alcohol use is especially critical to improving health outcomes for patients with multiple chronic health conditions. It is unclear to what extent multiple chronic condition status is a barrier to screening for unhealthy alcohol use in the primary care setting. The authors hypothesized that patients with multiple chronic conditions would be at lower odds of being screened for unhealthy alcohol use than patients without multiple chronic conditions., Methods: The authors performed a secondary analysis of electronic health record data for patients from 67 primary care practices in Virginia (2020-2023). Using the Center for Medicare and Medicaid Services' chronic disease framework, they classified patients by multiple chronic condition status: no multiple chronic conditions, physical multiple chronic conditions, mental health multiple chronic conditions, and physical and mental health multiple chronic conditions. They used multiple logistic regressions with an added practice-level random effect to analyze the relationship between multiple chronic condition status and the odds of receiving an alcohol-related assessment, of being screened for unhealthy alcohol use with a U.S. Preventive Services Task Force-recommended instrument, and of screening positive for unhealthy alcohol use within the past 2 years., Results: Within a final cohort of n =11,789, a total of 6,796 patients (58%) had multiple chronic conditions (29% physical multiple chronic conditions, 4% mental health multiple chronic conditions, and 25% physical and mental health multiple chronic conditions). In all, 69% of patients were screened for unhealthy alcohol use, whereas 16% were screened with a U.S. Preventive Services Task Force-recommended instrument, and 7% screened positive for unhealthy alcohol use. Patients with physical and mental health multiple chronic conditions had 0.9 times lower odds of receiving any screening for unhealthy alcohol use than those with no multiple chronic conditions (95% CI=0.8, 1.0; p =0.0240), whereas patients with only physical multiple chronic conditions or only mental health multiple chronic conditions had similar odds. There was no difference in the odds of being screened with a U.S. Preventive Services Task Force-recommended instrument on the basis of multiple chronic condition status. Patients with mental health multiple chronic conditions and physical and mental health multiple chronic conditions had 1.8 and 1.5 times greater odds of screening positive for unhealthy alcohol use, respectively (95% CI=1.3, 2.7; p =0.0014 and 95% CI=1.2, 1.8; p =0.0003)., Conclusions: Although patients with chronic mental health conditions were more likely to screen positive for unhealthy alcohol use than patients without multiple chronic conditions, Virginia primary care patients with physical and mental health multiple chronic conditions were less likely to receive an alcohol-related assessment during the past 2 years. Given the overall modest rate of screening with a U.S. Preventive Services Task Force-recommended instrument, further efforts are needed to create the conditions for high-quality alcohol-related preventive service delivery in primary care, particularly for patients with high complexity and/or mental health conditions., (© 2024 The Authors.)

Purpose: Women and children continue to miss preventive visits. Which neighborhood factors predict inadequate prenatal care (PNC) and well-child visit (WCV) attendance remain unclear., Description: In a retrospective case-control study at Virginia Commonwealth University Health System, mothers with less than 50% adherence or initiation after 5 months gestation were eligible as cases and those with ≥ 80% adherence and initiation before 5 months were eligible as controls. Children in the lowest quintile of adherence were eligible as cases and those with ≥ 80% of adherence were eligible as controls. Cases and controls were randomly selected at a 1:2 ratio and matched on birth month. Covariates were derived from the 2018 American Community Survey. A hotspot was defined as a zip code tabulation area (ZCTA) with a proportion of controls less than 0.66. ZCTAs with fewer than 5 individuals were excluded. Weighted quantile regression was used to determine which covariates were most associated with inadequate attendance., Assessment: We identified 38 and 35 ZCTAs for the PNC and WCV analyses, respectively. Five of 11 hotspots for WCV were also hotspots for PNC. Education and income predicted 51% and 34% of the variation in missed PNCs, respectively; language, education and transportation difficulties explained 33%, 29%, and 17% of the variation in missed WCVs, respectively. Higher proportions of Black residents lived in hotspots of inadequate PCV and WCV attendance., Conclusion: Neighborhood-level factors performed well in predicting inadequate PCV and WCV attendance. The disproportionate impact impact of inadequate PCV and WCV in neighborhoods where higher proportions of Black people lived highlights the potential influence of systemic racism and segregation on healthcare utilization., (© 2023. The Author(s).)

Background: Primary care is the foundation of health care, resulting in longer lives and improved equity. Primary care was the frontline of the COVID-19 pandemic public response and essential for access to care. Yet primary care faces substantial structural and systemic challenges. As part of a longitudinal analysis to track the capacity and health of primary care, we surveyed every primary care practice in Virginia in 2018 and again in 2022., Methods: Surveys were emailed or mailed up to 6 times and nonresponders received a phone call. Questions assessed organizational characteristics, scope of care, capacity, and organizational stress in the prior year. From respondents, 39 clinicians, nurses, staff, administrators, and practice managers were interviewed., Results: 526 out of 2296 primary care practices (23% response rate) completed the survey, with broad representation across geography, ownership, and payer mix. Compared with 2018, in 2022 there were increases in practices owned by health systems (25% vs 43%, P < .0001 ) and average percent of patients with Medicaid per practice (12% vs 22%, P < .0001 ). The percent of practices reporting any major stressor increased from 34% to 53% ( P < .0001 ). The main increased stress was losing a clinician, with 13% of practices in 2018 versus 42% in 2022 reporting losing a clinician ( P < .0001 )., Conclusions: Primary care practices are resilient and continue to serve their communities, including a broad scope of services and care for underserved people. However, the COVID-19 pandemic caused significant stress. With an increase in clinicians leaving clinical practice, we anticipate worsening access to primary care., Competing Interests: Conflict of interest: Dr. Britz is a JABFM Fellow., (© Copyright by the American Board of Family Medicine.)

Policy Points The increasing political polarization of states reached new heights during the COVID-19 pandemic, when response plans differed sharply across party lines. This study found that states with Republican governors and larger Republican majorities in legislatures experienced higher death rates during the COVID-19 pandemic-and in preceding years-but these associations often lost statistical significance after adjusting for the average income and health status of state populations and for the policy orientations of the states. Future research may help clarify whether the higher death rates in these states result from policy choices or have other explanations, such as the tendency of voters with lower incomes or poorer health to elect Republican candidates., Context: Increasing polarization of states reached a high point during the COVID-19 pandemic, when the party affiliation of elected officials often predicted their policy response. The health consequences of these divisions are unclear. Prior studies compared mortality rates based on presidential voting patterns, but few considered the partisan orientation of state officials. This study examined whether the partisan orientation of governors or legislatures was associated with mortality outcomes during the COVID-19 pandemic., Methods: Data on deaths and the partisan orientation of governors and legislators were obtained from the Centers for Disease Control and Prevention and the National Conference of State Legislatures, respectively. Linear regression was used to measure the association between Republican representation (percentage of seats held) in legislatures and (1) age-adjusted, all-cause mortality rates (AAMRs) in 2015-2021 and (2) excess death rates during three phases of the COVID-19 pandemic, controlling for median household income, the prevalence of four risk factors (obesity, chronic obstructive pulmonary disease, heart attack, stroke), and state policy orientation. Associations between excess death rates and the governor's party were also examined., Findings: States with Republican governors or greater Republican representation in legislatures experienced higher AAMRs during 2015-2021, lower excess death rates during Phase 1 of the COVID-19 pandemic (weeks ending March 28, 2020, through June 13, 2020), and higher excess death rates in Phases 2 and 3 (weeks ending June 20, 2020, through April 30, 2022; p < 0.05). Most associations lost statistical significance after adjustment for control variables., Conclusions: Mortality was higher in states with Republican governors and greater Republican legislative representation before and during much of the pandemic. Observed associations could be explained by the adverse effects of policy choices, reverse causality (e.g., popularity of Republican candidates in states with lower socioeconomic and health status), or unmeasured factors that predominate in states with Republican leaders., (© 2023 The Authors. The Milbank Quarterly published by Wiley Periodicals LLC on behalf of The Milbank Memorial Fund.)

The US Preventive Services Task Force (USPSTF) recommends screening and behavioral counseling for adults over 18 years for unhealthy alcohol use. Recommended screening instruments include the Alcohol Use Disorders Identification Test-Concise and or Single Alcohol Screening Question. Behavioral counseling is feasible in primary care, taking on average 30 minutes. Baseline data for a practice facilitation trial demonstrated clinicians appropriately screened only 10.8% of patients and only identified 9.6% as having risky drinking. Yet, 24% of patients reported risky drinking on a survey, demonstrating the implementation gap of the USPSTF recommendation and opportunity to improve health., Competing Interests: Disclosure Consent for publication: Consent provided by authors; not required by funders. Availability of data and material: Data not available due to participant consent. Conflict of Interest: None. Funding: Funding for this study is provided by the Agency for Health care Research and Quality (1R18HS027077–01, ahrq.gov) and in part by the Community Engagement Core and the Biostatistics, Epidemiology, and Research Design Core (BERD) of the C. Kenneth and Dianne Wright Center for Clinical and Translational Research (CTSA award No. UL1TR002649 from the National Center for Advancing Translational Sciences). The opinions expressed in this article are those of the authors and do not necessarily reflect those of the funders. The funders and sponsors approved of the study design, collection, management, analysis and interpretation of data but were not involved in the construction of these elements, nor in the preparation of this article or decision to report for publication., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objectives: Evaluate current prevalence and changes in prescribing of antiseizure medications (ASMs) in Virginia nursing homes for residents with and without seizures., Methods: Retrospective cohort. De-identified claims extracted from the Virginia All-Payers-Claims-Database defined annual and biennial cohorts of all insured long-stay residents with and without any claims-based seizure diagnoses. ASM prescribing prevalence rates for these cohorts were analyzed from 2011 to 2016. Multiple logistic regression compared prescribing prevalence rates within and between these 2 groups., Results: Annual cohorts averaged 57,190. 65.6% Female, 38% white. 80% public insurance, 20% commercial secondary. Between 2011 and 2016, the claims-based prevalence of seizure diagnoses decreased (17.1% to 10.5%). However, ASM prescribing prevalence increased (10.4% to 11.6%). Increases were entirely among residents who never had any seizure-epilepsy claim, whereas ASM prescribing among residents with seizures decreased. Different drugs were used for patients with and without seizures. For residents without seizures, 85% of ASMs prescribed have alternative indications for mood or pain symptoms, and large gains in gabapentin and modest but significant increases in valproate, lamotrigine, carbamazepine, and topiramate prescribing were detected. Among residents with seizures, ASMs without alternative indications were more common (59%), with marked reductions in phenobarbital and phenytoin but significant increases in levetiracetam and lacosamide use observed., Conclusions: Long-stay ASM use is changing. ASM gains are unrelated to seizure-epilepsy prevalence. ASM prescribing increased only among residents without seizures, where ASMs with expanded indications were preferred. Long-stay ASM prescribing and prescribing indication should be included in mandatory CMS reporting similar to other CNS-active medications., Competing Interests: The authors declare no conflict of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Purpose: Cancer treatment nonadherence is associated with higher rates of cancer recurrence and decreased survival. Rural patients with cancer experience a 10% higher mortality rate compared with their nonrural counterparts; geographic differences in nonadherence may contribute to this increased mortality. The goal of this study was to assess for geographic disparities and determine sociodemographic and clinical factors associated with radiation therapy (RT) nonadherence and survival among rural and nonrural patients with cancer., Methods and Materials: We examined cancer registry, medical records, and billing claims data at a safety net academic medical center. Geographic residence was defined as rural versus nonrural by US Department of Agriculture 2013 Rural-Urban Continuum Codes. Other factors assessed were age, sex, race, marital status, insurance type, employment, area median household income, residential distance to cancer treatment center, clinical stage, cancer type, treatment modality, total radiation dose received, and radiation dose per fraction. We used Cox proportional hazards modeling to examine 7 ways of operationalizing nonadherence and selected the definition that resulted in the best model fit statistics and prediction of mortality. Overall survival rates were estimated with the Kaplan-Meier method. We then examined nonadherence as the main exposure along with additional covariates in least absolute shrinkage and selection operator penalized survival analyses and as the outcome in our multivariable generalized linear regression analyses predicting nonadherence. We considered 2-way interaction terms with the main exposure, geographic residence., Results: We identified 3,077 patients with cancer who averaged 62 years old, were 59% female, 34% Black, and 14% rural. Twenty-two percent of patients missed at least 2 fractions and missed an average of 10% of their treatment plan. Rural patients experienced a higher mortality rate than nonrural patients (53% vs 42%, P < .0001). Survival was assessed through December 31, 2021, with a mean follow-up of 4.5 years. Proportion of missed fractions as the indicator of nonadherence provided the best model fit statistics and prediction of survival. Marital status, employment status, tumor, nodes, metastases stage, cancer type, and age at diagnosis significantly affected survival, in addition to a treatment delay by geographic residence interaction effect. Specifically, patients residing in rural areas who experienced a treatment delay were more than twice as likely to die as nonrural residents who also experienced a treatment delay, and nearly twice as likely to die as rural residents who did not experience a treatment delay. The 2-year survival rate was 76% for nonrural residents who did not experience a treatment delay versus 27% for rural residents who experienced a treatment delay. Patients who were widowed, had stage 4 cancer, or lung cancer were more likely to be nonadherent. Finally, patients residing in rural areas who experienced a treatment delay were more likely to subsequently be nonadherent., Conclusions: In a geographically and racially diverse population, RT nonadherence is a significant concern that affects survival, yet it is a modifiable risk factor. We demonstrated that rural residence was associated with both RT nonadherence and poorer overall survival. Rural patients with a treatment delay had the lowest overall survival, compared with both nonrural survivors and rural survivors without delay. Rural residents who are delayed in starting treatment are at heightened risk for poor outcomes and should receive targeted support to mitigate the observed disparities. Additional patient populations that may benefit from targeted treatment adherence support include widowed patients and those with stage 4 cancer or lung cancer., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Clinical trials are constantly evolving in the context of increasingly complex research questions and potentially limited resources. In this review article, we discuss the emergence of "adaptive" clinical trials that allow for the preplanned modification of an ongoing clinical trial based on the accumulating evidence with application across translational research. These modifications may include terminating a trial before completion due to futility or efficacy, re-estimating the needed sample size to ensure adequate power, enriching the target population enrolled in the study, selecting across multiple treatment arms, revising allocation ratios used for randomization, or selecting the most appropriate endpoint. Emerging topics related to borrowing information from historic or supplemental data sources, sequential multiple assignment randomized trials (SMART), master protocol and seamless designs, and phase I dose-finding studies are also presented. Each design element includes a brief overview with an accompanying case study to illustrate the design method in practice. We close with brief discussions relating to the statistical considerations for these contemporary designs., Competing Interests: The authors have no conflicts of interest to declare., (© The Author(s) 2023.)

Introduction: There were more than 100,000 fatal drug overdoses in the U.S. in 2021 alone. In recent years, there has been a shift in opioid mortality from predominantly White rural communities to Black urban communities. This study aimed to identify the Virginia communities disproportionately affected by the overdose crisis and to better understand the systemic factors contributing to disparities in opioid mortality., Methods: Using the state all-payer claims database, state mortality records, and census data, we created a multivariate model to examine the community-level factors contributing to racial disparities in opioid mortality. We used generalized linear mixed models to examine the associations between socioecologic factors and fatal opioid overdoses, opioid use disorder diagnoses, opioid-related emergency department visits, and mental health diagnoses., Results: Between 2015 and 2020, racial disparities in mortality widened. In 2020, Black males were 1.5 times more likely to die of an opioid overdose than White males (47.3 vs 31.6 per 100,000; p <0.001). The rate of mental health disorders strongly correlated with mortality (β=0.53, p <0.001). Black individuals are not more likely to be diagnosed with opioid use disorder (β=0.01, p =0.002) or with mental health disorders (β= -0.12, p <0.001), despite higher fatal opioid overdoses., Conclusions: There are widening racial disparities in opioid mortality. Untreated mental health disorders are a major risk factor for opioid mortality. Findings show pathways to address inequities, including early linkage to care for mental health and opioid use disorders. This analysis shows the use of comprehensive socioecologic data to identify the precursors to fatal overdoses, which could allow earlier intervention and reallocation of resources in high-risk communities., (© 2023 The Authors.)

Background: Recruiting underrepresented people and communities in research is essential for generalizable findings. Ensuring representative participants can be particularly challenging for practice-level dissemination and implementation trials. Novel use of real-world data about practices and the communities they serve could promote more equitable and inclusive recruitment., Methods: We used a comprehensive primary care clinician and practice database, the Virginia All-Payers Claims Database, and the HealthLandscape Virginia mapping tool with community-level socio-ecological information to prospectively inform practice recruitment for a study to help primary care better screen and counsel for unhealthy alcohol use. Throughout recruitment, we measured how similar study practices were to primary care on average, mapped where practices' patients lived, and iteratively adapted our recruitment strategies., Results: In response to practice and community data, we adapted our recruitment strategy three times; first leveraging relationships with residency graduates, then a health system and professional organization approach, followed by a community-targeted approach, and a concluding approach using all three approaches. We enrolled 76 practices whose patients live in 97.3% (1844 of 1907) of Virginia's census tracts. Our overall patient sample had similar demographics to the state for race (21.7% vs 20.0% Black), ethnicity (9.5% vs 10.2% Hispanic), insurance status (6.4% vs 8.0% uninsured), and education (26.0% vs 32.5% high school graduate or less). Each practice recruitment approach uniquely included different communities and patients., Discussion: Data about primary care practices and the communities they serve can prospectively inform research recruitment of practices to yield more representative and inclusive patient cohorts for participation., Competing Interests: Drs. Krist and Epling served on the U.S. Preventive Services Task Force for the 2020 Recommendation for Unhealthy Alcohol Use in Adolescents and Adults: Screening and Behavioral Counseling Interventions Recommendation. The remaining authors have no conflicts of interest to declare., (© The Author(s) 2023.)

Background: Buprenorphine treatment has been associated with reduced non-prescribed opioid use and opioid related overdose (OD). We evaluated initial outcomes of rapid induction onto extended-release injectable buprenorphine (BUP-XR) within 7 days of emergency department presentation for unintentional OD., Methods: Between February 2019-February 2021, N  = 19 patients with opioid use disorder received buprenorphine/naloxone (4/1 mg), followed by BUP-XR (300 mg) at induction and continued BUP-XR outpatient for 6 months. Primary outcomes included adverse events, repeat OD, and death., Results: For patients who received at least one dose of BUP-XR, there were no treatment related serious adverse events or symptoms of precipitated withdrawal. In addition, there were no repeat visits for ODs or deaths within 6 months of the initial OD., Discussion: These preliminary findings support the need for larger controlled clinical trials to examine the safety and efficacy of rapid induction of BUP-XR in patients with opioid use disorder at high risk of opioid OD. Rapid induction onto long-lasting injectable buprenorphine may be a promising and protective treatment approach in the future., Competing Interests: Dr. F. Gerard Moeller consults for Boehringer Ingelheim and AstraZeneca. He received past grant support from Indivior and Nektar and was a past consultant for Indivior and Astellas. No other disclosures were reported., (© 2023 The Author(s).)

Background: Developmental disabilities (DD) affect over 10% of children 0 to 5 years of age, and early interventions are known to improve outcomes, yet barriers remain in connecting children to these services., Objective: To identify gaps in services for young children with DD and established risk conditions in Virginia., Methods: Data from the 2018 Virginia All Payers Claim Database and the American Community Survey were used to estimate the proportion of children with DD, and among those children, the proportion that received at least one intervention service. Logistic and binomial regression models were used to examine the socio-demographic associations with having developmental needs met, at the individual and zip code tabulation (ZCTA) level., Results: Approximately 12% of children 0 to 5 years were found to have DD or established risk condition diagnosis, and only 54% of these received intervention services during that year. Individual-level analyses suggest that odds of having developmental needs met are higher among older children, boys, and children with public insurance. ZCTA-level analyses suggested higher odds of developmental needs being met in areas with higher levels of unemployment, while areas with high proportions of people with limited English proficiency and a high school education or less had lower odds of having needs met., Conclusions: Receiving early childhood developmental services in Virginia is associated with having public insurance and living in an area with higher levels of unemployment, higher education, and English-proficiency. Efforts are needed to improve delivery of services overall, specifically targeted to those areas with high levels of unmet need., (Copyright © 2022 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.)

Background: Cell-free next-generation sequencing (cfNGS) may have a unique role in the diagnosis of infectious complications in immunocompromised hosts. The rapid turnaround time and non-invasive nature make it a promising supplement to standard of care., Methods: This retrospective, observational single-center study at a tertiary care medical center in Virginia investigated the use of cfNGS in clinical practice. Patients over age 18 years with cfNGS performed for any indication were included. The primary outcome was detection of bacteria and/or fungi on cfNGS. The secondary outcomes were concordance, and abundance of fungal and bacterial organism concentration detected over time from symptom onset, and clinical impact., Results: Thirty-six patients (92% immunosuppressed) were identified and included. Twenty-one (58%) tests detected one to five organisms (14/21 bacteria, 8/21 fungi, and 6/21 viruses). The clinical impact of cfNGS was positive in 52.8% of cases, negative in 2.8%, and negligible in 44.4%. Positive tests prompted therapy changes in 12 of 21 patients; six of 20 bacteria and seven of eight fungi identified were considered clinically pathogenic. Three bacteria identifications and six fungi identifications prompted targeted treatment. When fungal species were not identified by cNFGS, antifungal de-escalation occurred in seven patients., Conclusion: cfNGS assisted in critical management changes, including initiation of treatment for identified organisms and antimicrobial de-escalation. Its non-invasive nature and rapid turnaround time make this an important adjunct to standard of care testing that may assist in providing earlier, targeted therapy, especially when opportunistic pathogens remain high on the differential diagnosis., (© 2023 The Authors. Transplant Infectious Disease published by Wiley Periodicals LLC.)

Introduction: Cytomegalovirus (CMV) is one of the most common and clinically significant viral infections following allogeneic hematopoietic cell transplantation (HCT). Currently available options for CMV prophylaxis and treatment present challenges related to side effects and cost., Methods: In this retrospective medical record review, the incidence of clinically significant CMV infection (CMV disease or reactivation requiring preemptive treatment) following allogeneic HCT was compared in patients receiving valacyclovir 1 g three times daily versus acyclovir 400 mg every 12 h for viral prophylaxis., Results: Forty-five patients who received valacyclovir were matched based on propensity scoring to 35 patients who received acyclovir. All patients received reduced-intensity conditioning regimens containing anti-thymocyte globulin. Clinically significant CMV infection by day + 180 was lower in the valacyclovir group compared to the acyclovir group (18% vs. 57%, p  = 0.0004). Patients receiving valacyclovir prophylaxis also had less severe infection evidenced by a reduction in CMV disease, lower peak CMV titers, delayed CMV reactivation, and less secondary neutropenia., Conclusion: Prospective evaluation of valacyclovir 1 g three times daily for viral prophylaxis following allogeneic HCT is warranted. Due to valacyclovir's favorable toxicity profile and affordable cost, it has the potential to benefit patients on a broad scale as an option for CMV prophylaxis.

Our primary objectives are to empirically identify distinct childhood groups based on trajectories of waist circumference (WC) and waist circumference index measurements, and then to estimate associations between these groups and adult diabetes incidence, as well as other outcomes, including blood pressure, body size, body composition, and hemoglobin levels. Childhood WC and height measurements as well as various adult measurements are taken from participants in the Fels Longitudinal Study. Childhood groups are identified using group-based trajectory modeling. Associations between the resulting group probabilities and adult outcomes are examined using mixed models. Our results show that distinct childhood groups are identifiable for both waist size measurements, with growth curves exhibited by these groups becoming distinguishably separate at around 4 years of age. Higher probabilities for groups exhibiting the larger waist size for either measurement were estimated to have higher risks of developing diabetes in adulthood. Associations were also observed between group probabilities and systolic blood pressure, diastolic blood pressure, and various anthropomorphic measurements, with most associations consistently occurring in early adulthood. These findings expand upon the existing literature, showing that childhood trends in waist size, distinguishable at ages as early as 4 years, are associated with adult Type-2 diabetes.

Objectives: Compare Virginia nursing homes in the top- and bottom-quintiles of antipsychotic use for variation in community, social, and facility factors., Methods: 2018 CMS data ascertained Virginia nursing homes in the top and bottom quintiles for antipsychotic use. The Virginia Health Department provided social determinant of health (SDOH) statistics for each facility's county/city while claims identified facility demographics. Chi square and independent two-sample t -tests compared quintiles for regional, social, and demographic differences., Results: Quintiles averaged 3000 residents and 56 facilities. Facilities with the lowest rates of antipsychotic use were more likely to be privately owned and had fewer African-American and minority residents and more white residents. All 18 SDOH statistics were superior for the communities of facilities with the lowest antipsychotic rates. Nine of these differences were statistically significant, including the aggregated "Health Opportunity Index.", Conclusions: The antipsychotic prevalence rate for facilities in the top-quintile of antipsychotic use is fivefold the bottom-quintile's rate. Antipsychotic prescribing in nursing homes is associated with regional, demographic, and social factors not addressed by existing antipsychotic reduction measures, with vulnerable populations at greatest risk., Clinical Implications: The efficacy of measures aimed at curbing long-stay antipsychotic prescribing could be improved by addressing SDOH including economic opportunities.

Background: Screening for food insecurity (FI) and providing nutrition care are important management strategies for chronic diseases, but rates are low. Aspects of team-based care and providers' nutrition competence may help inform interventions to improve these services. The objectives of this study were to describe US primary care providers' FI screening and nutrition care practices (counselling, referrals, and time spent counselling) and test for associations with scored measures of their perceptions of team-based care (care continuity, patient-centredness, coordination with external providers and resources) and nutrition competence (confidence counselling and attitudes towards nutrition)., Methods: Cross-sectional online survey data of primary care providers were described and analysed for associations using Wilcoxon rank sum tests., Results: Of provider respondents (N = 92), 35% (n = 32) worked in clinics that screen for FI and had higher team perceptions (P = 0.006) versus those who do not. Those who reported counselling >30% patients about nutrition (57%, n = 52) and referring >10% patients to nutrition professionals (24%, n = 22) had significantly better attitudes towards nutrition (P = 0.013 and P = 0.04, respectively) compared with those with lower counselling and referral rates. Half (n = 46) of the providers reported spending >3-min counselling each patient about nutrition and had higher patient-centred care (P = 0.004) and nutrition competence (P < 0.001) compared with those who spent less time counselling., Conclusion: Providers in clinics that screen for FI had higher overall perceptions of team-based care, but their nutrition competence was not significantly different. Meanwhile, reported more time counselling was associated with a culture of patient-centredness. Promoting team-based care may be a mechanism for improving FI screening and nutrition care., (© The Author(s) 2022. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Purpose: Primary care is the foundation of the health care workforce and the only part that extends life and improves health equity. Previous research on the geographic and specialty distribution of physicians has relied on the American Medical Association's Masterfile, but these data have limitations that overestimate the workforce., Methods: We present a pragmatic, systematic, and more accurate method for identifying primary care physicians using the National Plan and Provider Enumeration System (NPPES) and the Virginia All-Payer Claims Database (VA-APCD). Between 2015 and 2019, we identified all Virginia physicians and their specialty through the NPPES. Active physicians were defined by at least 1 claim in the VA-APCD. Specialty was determined hierarchically by the NPPES. Wellness visits were used to identify non-family medicine physicians who were providing primary care., Results: In 2019, there were 20,976 active physicians in Virginia, of whom 5,899 (28.1%) were classified as providing primary care. Of this primary care physician workforce, 52.4% were family medicine physicians; the remaining were internal medicine physicians (18.5%), pediatricians (16.8%), obstetricians and gynecologists (11.8%), and other specialists (0.5%). Over 5 years, the counts and relative percentages of the workforce made up by primary care physicians remained relatively stable., Conclusions: Our novel method of identifying active physicians with a primary care scope provides a realistic size of the primary care workforce in Virginia, smaller than some previous estimates. Although the method should be expanded to include advanced practice clinicians and to further delineate the scope of practice, this simple approach can be used by policy makers, payers, and planners to ensure adequate primary care capacity., (© 2022 Annals of Family Medicine, Inc.)

Background: To exchange the type of subjective Bayesian prior selection for assumptions more directly related to statistical decision making in clinician studies and trials, the decreasingly informative prior (DIP) is considered. We expand standard Bayesian early termination methods in one-parameter statistical models for Phase II clinical trials to include decreasingly informative priors (DIP). These priors are designed to reduce the chance of erroneously adapting trials too early by parameterize skepticism in an amount always equal to the unobserved sample size., Method: We show how to parameterize these priors based on effective prior sample size and provide examples for common single-parameter models, include Bernoulli, Poisson, and Gaussian distributions. We use a simulation study to search through possible values of total sample sizes and termination thresholds to find the smallest total sample size (N) under admissible designs, which we define as having at least 80% power and no greater than 5% type I error rate., Results: For Bernoulli, Poisson, and Gaussian distributions, the DIP approach requires fewer patients when admissible designs are achieved. In situations where type I error or power are not admissible, the DIP approach yields similar power and better-controlled type I error with comparable or fewer patients than other Bayesian priors by Thall and Simon., Conclusions: The DIP helps control type I error rates with comparable or fewer patients, especially for those instances when increased type I error rates arise from erroneous termination early in a trial., Competing Interests: Conflict of interest: None declared

Background: Filipino Americans (FAs) are the third-largest Asian American subgroup in the United States (US). Some studies showed that FAs experience more cardiometabolic diseases (CMDs) than other Asian subgroups and non-Hispanic Whites. The increased prevalence of CMD observed in FAs could be due to genetics and social/dietary lifestyles. While FAs are ascribed as an Asian group, they have higher burdens of CMD, and adverse social determinants of health compared to other Asian subgroups. Therefore, studies to elucidate how FAs might develop CMD and respond to medications used to manage CMD are warranted. The ultimate goals of this study are to identify potential mechanisms for reducing CMD burden in FAs and to optimize therapeutic drug selection. Collectively, these investigations could reduce the cardiovascular health disparities among FAs., Rationale and Design: This is a cross-sectional epidemiological design to enroll 300 self-identified Filipino age 18 yrs. or older without a history of cancer and/or organ transplant from Virginia, Washington DC, and Maryland. Once consented, a health questionnaire and disease checklist are administered to participants, and anthropometric data and other vital signs are collected. When accessible, we collect blood samples to measure basic blood biochemistry, lipids, kidney, and liver functions. We also extract DNA from the blood or saliva for genetic and pharmacogenetic analyses. CMD prevalence in FAs will be compared to the US population. Finally, we will conduct multivariate analyses to ascertain the role of genetic and non-genetic factors in developing CMD in FAs. Virginia Commonwealth University IRB approved all study materials (Protocol HM20018500)., Summary: This is the first community-based study to involve FAs in genomics research. The study is actively recruiting participants. Participant enrollment is ongoing. At the time of this publication, the study has enrolled 97 participants. This ongoing study is expected to inform future research to reduce cardiovascular health disparities among FAs.

Objective: To determine whether cascade reporting is associated with a change in meropenem and fluoroquinolone consumption., Design: A quasi-experimental study was conducted using an interrupted time series to compare antimicrobial consumption before and after the implementation of cascade reporting., Setting: A 399-bed, tertiary-care, Veterans' Affairs medical center., Participants: Antimicrobial consumption data across 8 inpatient units were extracted from the Center for Disease Control and Prevention (CDC) National Health Safety Network (NHSN) antimicrobial use (AU) module from April 2017 through March 2019, reported as antimicrobial days of therapy (DOT) per 1,000 days present (DP)., Intervention: Cascade reporting is a strategy of reporting antimicrobial susceptibility test results in which secondary agents are only reported if an organism is resistant to primary, narrow-spectrum agents. A multidisciplinary team developed cascade reporting algorithms for gram-negative bacteria based on local antibiogram and infectious diseases practice guidelines, aimed at restricting the use of fluoroquinolones and carbapenems. The algorithms were implemented in March 2018., Results: Following the implementation of cascade reporting, mean monthly meropenem (P =.005) and piperacillin/tazobactam (P = .002) consumption decreased and cefepime consumption increased (P < .001). Ciprofloxacin consumption decreased by 2.16 DOT per 1,000 DP per month (SE, 0.25; P < .001). Clostridioides difficile rates did not significantly change., Conclusion: Ciprofloxacin consumption significantly decreased after the implementation of cascade reporting. Mean meropenem consumption decreased after cascade reporting was implemented, but we observed no significant change in the slope of consumption. cascade reporting may be a useful strategy to optimize antimicrobial prescribing.

Objectives: To help better control chronic conditions we need to address root causes of poor health like unhealthy behaviors, mental health, and social needs. However, addressing these needs in primary care is difficult. One solution may be connecting patients with a navigator for support creating a personal care goal., Methods: As part of an RCT to evaluate a feasible approach to care planning, 24 clinicians from 12 practices in the Virginia Ambulatory Care Outcomes Research Network (ACORN) and 87 intervention patients with uncontrolled chronic conditions participated in a care planning intervention. We had a structured process to guide patients, train navigators, and adapt the navigation process to meet the needs of each practice., Results: Only 1 practice had bandwidth for staff to serve as a patient navigator, even for extra pay. For the other 11 practices, a research team member needed to provide navigation services. On average, patients wanted 25 weeks of support to complete care plans. The average time patients needed to speak with navigators on the phone was 7 min and 3 s. In exit interviews, patients consistently shared how motivational it was to have a caring person check in on them, offer help, and hold them accountable., Conclusion: Patient navigation to address care plans should be feasible. The time commitment is minimal. It does not require intensive training, and primary care is already doing much of this work. Yet, given the burden and competing demands in primary care, this help cannot be offered without additional resources.

During July 2021, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) B.1.617.2 variant infections, including vaccine breakthrough infections, occurred after large public gatherings in Provincetown, Massachusetts, USA, prompting a multistate investigation. Public health departments identified primary and secondary cases by using coronavirus disease surveillance data, case investigations, and contact tracing. A primary case was defined as SARS-CoV-2 detected <14 days after travel to or residence in Provincetown during July 3-17. A secondary case was defined as SARS-CoV-2 detected <14 days after close contact with a person who had a primary case but without travel to or residence in Provincetown during July 3-August 10. We identified 1,098 primary cases and 30 secondary cases associated with 26 primary cases among fully and non-fully vaccinated persons. Large gatherings can have widespread effects on SARS-CoV-2 transmission, and fully vaccinated persons should take precautions, such as masking, to prevent SARS-CoV-2 transmission, particularly during substantial or high transmission.

Background and Objectives: The American Academy of Pediatrics recommends against the routine use of β-agonists, corticosteroids, antibiotics, chest radiographs, and viral testing in bronchiolitis, but use of these modalities continues. Our objective for this study was to determine the patient, provider, and health care system characteristics that are associated with receipt of low-value services., Methods: Using the Virginia All-Payers Claims Database, we conducted a retrospective cross-sectional study of children aged 0 to 23 months with bronchiolitis (code J21, International Classification of Diseases, 10th Revision ) in 2018. We recorded medications within 3 days and chest radiography or viral testing within 1 day of diagnosis. Using Poisson regression, we identified characteristics associated with each type of overuse., Results: Fifty-six percent of children with bronchiolitis received ≥1 form of overuse, including 9% corticosteroids, 17% antibiotics, 20% β-agonists, 26% respiratory syncytial virus testing, and 18% chest radiographs. Commercially insured children were more likely than publicly insured children to receive a low-value service (adjusted prevalence ratio [aPR] 1.21; 95% confidence interval [CI]: 1.15-1.30; P < .0001). Children in emergency settings were more likely to receive a low-value service (aPR 1.24; 95% CI: 1.15-1.33; P < .0001) compared with children in inpatient settings. Children seen in rural locations were more likely than children seen in cities to receive a low-value service (aPR 1.19; 95% CI: 1.11-1.29; P < .0001)., Conclusions: Overuse in bronchiolitis remains common and occurs frequently in emergency and outpatient settings and rural locations. Quality improvement initiatives aimed at reducing overuse should include these clinical environments., Competing Interests: POTENTIAL CONFLICT OF INTEREST: Dr Krist is a member of the US Preventive Services Task Force. This article does not necessarily represent the views and policies of the US Preventive Services Task Force., (Copyright © 2021 by the American Academy of Pediatrics.)

Introduction: Clinical preventive services can reduce mortality and morbidity, but Americans receive only half of the recommended care. Although wellness visits protect time for clinicians to review needs and discuss care with patients, studies have not shown that having a wellness visit improves health outcomes. This study seeks to understand the types of discussions and volume of care delivered during wellness visits., Methods: Using a sample of 1,008 patients scheduled for a wellness visit from 22 primary care clinicians across 3 states from 2018 to 2019, electronic health records were reviewed, and a subset of visits was audio recorded. The discussion and delivery of clinical preventive services, as recommended by the U.S. Preventive Services Task Force, were measured, and new diagnoses were identified from the clinical preventive services. Analyses were completed in 2020., Results: Even though patients were up to date with 80% of the recommended clinical preventive services 3 months after the visit, only 0.5% of patients were up to date with all the recommended clinical preventive services. On average, 6.9 clinical preventive service discussions occurred during each wellness visit on the basis of electronic health records review, and 7.7 clinical preventive services discussions occurred on the basis of audio recordings. An average of 0.4 new diagnoses was identified, including cancer diagnoses, cardiovascular risks, and infections., Conclusions: Wellness visits are an important time for patients and clinicians to discuss prevention strategies and to deliver recommended clinical preventive services, leading to the identification of previously unrecognized diagnoses. This will improve patients' health. Policies and incentives that promote wellness visits are important, and efforts are needed to deliver them to those most in need., (Published by Elsevier Inc.)

During July 2021, 469 cases of COVID-19 associated with multiple summer events and large public gatherings in a town in Barnstable County, Massachusetts, were identified among Massachusetts residents; vaccination coverage among eligible Massachusetts residents was 69%. Approximately three quarters (346; 74%) of cases occurred in fully vaccinated persons (those who had completed a 2-dose course of mRNA vaccine [Pfizer-BioNTech or Moderna] or had received a single dose of Janssen [Johnson & Johnson] vaccine ≥14 days before exposure). Genomic sequencing of specimens from 133 patients identified the B.1.617.2 (Delta) variant of SARS-CoV-2, the virus that causes COVID-19, in 119 (89%) and the Delta AY.3 sublineage in one (1%). Overall, 274 (79%) vaccinated patients with breakthrough infection were symptomatic. Among five COVID-19 patients who were hospitalized, four were fully vaccinated; no deaths were reported. Real-time reverse transcription-polymerase chain reaction (RT-PCR) cycle threshold (Ct) values in specimens from 127 vaccinated persons with breakthrough cases were similar to those from 84 persons who were unvaccinated, not fully vaccinated, or whose vaccination status was unknown (median = 22.77 and 21.54, respectively). The Delta variant of SARS-CoV-2 is highly transmissible (1); vaccination is the most important strategy to prevent severe illness and death. On July 27, CDC recommended that all persons, including those who are fully vaccinated, should wear masks in indoor public settings in areas where COVID-19 transmission is high or substantial.* Findings from this investigation suggest that even jurisdictions without substantial or high COVID-19 transmission might consider expanding prevention strategies, including masking in indoor public settings regardless of vaccination status, given the potential risk of infection during attendance at large public gatherings that include travelers from many areas with differing levels of transmission., Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Stacey B. Gabriel reports receiving grants from CDC. Bronwyn MacInnis, Katherine Siddle, and Daniel Park report receiving grants from CDC and the National Institutes of Health. Taylor Brock-Fisher reports receiving a grant from the Community Tracing Collaborative. No other potential conflicts of interest were disclosed.

Objective: Prenatal care (PNC) and well child visit (WCV) attendance are associated with improved health outcomes. We aimed to determine if the factors affecting maternal and child attendance are similar or different., Methods: We conducted a retrospective case control study at Virginia Commonwealth University Health System. We used the Adequacy of Prenatal Care Utilization Index and the American Academy of Pediatrics recommendations to assess the adequacy of PNC and WCV attendance, respectively. Mothers with less than 50% visit adherence or initiation after 5 months gestation were eligible as cases and those with 80% or more adherence and initiation before 5 months were eligible as controls. Children in the lowest quintile of adherence were eligible as cases and those with 80% or more adherence were eligible as controls. Cases and controls were randomly selected at a 1:2 ratio from the eligible subjects and frequency matched on birth month., Results: In adjusted analyses, mothers and children who were publicly insured or who were uninsured had higher odds of poor preventive visit attendance. Mothers who experienced intimate partner violence and had more living children were more likely to have poor attendance. Children whose mothers had younger age, greater number of pregnancies and transportation difficulties had poorer attendance., Conclusions: While lack of insurance and public insurance remained significantly associated with both poor PNC and WCV attendance, other factors varied between groups. Expanding eligibility requirements and streamlining enrollment and renewal processes may improve two generations of preventive visit attendance., (Copyright © 2020 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.)

The 2020 Sturgis motorcycle rally resulted in widespread transmission of severe acute respiratory syndrome coronavirus 2 across the United States. At least 649 coronavirus disease 2019 cases were identified, including secondary and tertiary spread to close contacts. To limit transmission, persons attending events should be vaccinated or wear masks and practice physical distancing if unvaccinated. Persons with a known exposure should be managed according to their coronavirus disease 2019 vaccination or prior infection status and may include quarantine and coronavirus disease 2019 testing., (Published by Oxford University Press for the Infectious Diseases Society of America 2021.)

Objective: Excluded from reporting to CMS's Percentage of long-stay residents who got an antipsychotic medication quality-measure are antipsychotics prescribed to nursing home patients with schizophrenia, Tourette's, or Huntington's. Over the 4 years following its 2012 debut, the quality-measure calculated a 27% reduction in inappropriate antipsychotic use but also an 18.3% increase in exclusion claims. This study evaluated the impact of these exclusions on the measure's findings., Methods: Claims data for the years 2011-2016 retrospectively identified the prevalence of schizophrenia, Tourette's, and Huntington's in quarterly cohorts of Virginia long-stay residents prescribed antipsychotics. Annualized diagnoses in 2011 were compared with subsequent years using simple logistic regression., Results: In 2016, 29% of the antipsychotics prescribed in Virginia nursing homes were to residents with diagnoses of schizophrenia, Tourette's, and Huntington's, a significant 32% increase from 2011., Conclusion: Almost 30% of the antipsychotics employed in Virginia nursing homes are excluded from CMS's long-stay antipsychotic quality-measure., (Copyright © 2020 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.)

Objectives: Lung cancer remains the leading cause of cancer-related deaths in the United States. In 2013, the US Preventive Services Task Force recommended annual screening for lung cancer with low-dose computed tomography in adults meeting certain criteria. This study seeks to assess lung cancer screening uptake in three health systems., Setting: This study was part of a randomized controlled trial to engage underserved populations in preventive care and includes 45 primary care practices in eight states., Methods: Practice and clinician characteristics were manually collected. Lung cancer was measured from electronic health record data. A generalized linear mixed model was used to assess characteristics associated with screening., Results: Patient records between 2012 and 2016 were examined. Lung cancer screening uptake overall increased only slightly after the guideline change (2.8-5.6%, p < 0.01). One health system did not show an increase in uptake (0.2-0.1%, p = 0.32), another had a clinically insignificant increase (1.5-2.9%, p < 0.01), and the third nearly doubled its higher baseline screening rate (10.4-19.1%, p < 0.01). Within the third health system, patients more likely to be screened were older, male, had more comorbid conditions, visited the office more frequently, were seen in practices closer to the screening clinic, or were uninsured or covered by Medicare or Medicaid., Conclusions: Certain patients appeared more likely to be screened. The only health system with increased lung cancer screening explicitly promoted screening rather than relying on clinicians to implement the new guideline. Systems approaches may help increase the low uptake of lung cancer screening.

Response-adaptive (RA) allocation designs can skew the allocation of incoming subjects toward the better performing treatment group based on the previously accrued responses. While unstable estimators and increased variability can adversely affect adaptation in early trial stages, Bayesian methods can be implemented with decreasingly informative priors (DIP) to overcome these difficulties. DIPs have been previously used for binary outcomes to constrain adaptation early in the trial, yet gradually increase adaptation as subjects accrue. We extend the DIP approach to RA designs for continuous outcomes, primarily in the normal conjugate family by functionalizing the prior effective sample size to equal the unobserved sample size. We compare this effective sample size DIP approach to other DIP formulations. Further, we considered various allocation equations and assessed their behavior utilizing DIPs. Simulated clinical trials comparing the behavior of these approaches with traditional Frequentist and Bayesian RA as well as balanced designs show that the natural lead-in approaches maintain improved treatment with lower variability and greater power., (© 2021 John Wiley & Sons Ltd.)

Introduction: In December 2013, cholesterol treatment guidelines changed the approach to statin therapy by recommending fixed doses of low-, medium-, or high-intensity statins based on cardiovascular risk. We sought to evaluate the guideline's adoption in a diverse group of practices., Methods: Using a mixed-methods approach, we analyzed electronic health record data the year before and 2 years following guideline publication in 45 practices across 8 states. We examined associations based on patient, clinician, and practice characteristics and interviewed 24 clinicians and practice leaders to inform findings., Results: The proportion of patients adherent with all recommendations 2 years after the guideline only increased from 18.5% to 20.3% ( P < .01 ). There were clinically insignificant increases in statin use across risk strata (1.7% to 3.5%) and small increases in high-intensity statin use (2.6% to 4.6%). Only half of patients with cardiovascular disease (52.9%) were on any statin, not much different from patients at moderate (49.6% to 50.9%) or low (41.6% to 48.7%) risk. Multiple patient (risk, use of health care), clinician (age), and practice (type, rurality) factors were associated with statin use. Clinicians reported patient resistance to statins but liked having a risk calculator to guide discussions., Conclusion: Despite general agreement with statin benefit, the guideline was poorly implemented. Marginal differences in statin use between the highest and lower risk strata of patients is concerning. Rather than intensifying statin potency and recommending more patients take statins, guidelines may want to focus on ensuring that those who will benefit most get treatment., Competing Interests: Conflict of interest: STT is an employee of the Agency for Healthcare Research and Quality. He contributed to this article in his personal capacity. The opinions expressed are the author’s own and do not reflect the view of the Agency for Healthcare Research and Quality, the Department of Health and Human Services or the Federal government. AHK is the chair of the U.S. Preventive Services Task Force (USPSTF) and helped to make the USPSTF’s statin preventive medication guidelines. This article represents the opinions of the authors and does not necessarily represent the views and policies of the USPSTF., (© Copyright 2021 by the American Board of Family Medicine.)

Introduction: Screening for colorectal cancer is beneficial. Yet, screening remains suboptimal, and underserved populations are at greater risk for not being appropriately screened. Although many barriers to screening are understood, less is known about how the decision-making process on whether to receive colonoscopy or stool testing influences screening., Methods: As part of a randomized controlled trial to test engaging underserved populations in preventive care through online, personalized, educational material, 2417 patients aged 50 to 74 years were randomly selected from the 70,998 patients with an office visit the year prior and mailed a survey to assess decision-making for colorectal cancer screening. Twenty practices in practice-based research networks from 5 diverse states participated. Survey data were supplemented with electronic health record data., Results: Among respondents, 64% were or became up to date with screening within 3 months of their office visit. The main factor associated with being up to date was the length of the patient-clinician relationship (<6 months vs 5+ years: odds ratio [OR], 0.49; 95% CI, 0.30-0.80). Sharing the decision about screening options with the clinician was a predictor for being up to date compared with patients who made the decision for themselves (OR, 1.75; 95% CI, 1.27-2.44). Only 36% of patients reported being given a choice about screening options. Traditional factors like race, employment, insurance, and education were not associated with screening., Conclusions: Having a long-term relationship with a primary care clinician and sharing decisions may be key drivers to ensure evidence-based preventive care for underserved populations., Competing Interests: Conflict of interest: Dr. Krist is a member of the United States Preventive Services Task Force (USPSTF)., (© Copyright 2020 by the American Board of Family Medicine.)

Background: Previous research demonstrated that registries are effective for improving clinical guideline adherence for the care of patients with type 2 diabetes. However, registry implementation has typically relied on intensive support (such as practice facilitators) for practice change and care improvement., Objective: To determine whether a remotely delivered, low-intensity organizational change intervention supports implementation and use of diabetes registries in primary care., Design: Cluster-randomized controlled effectiveness trial of providing limited external support leveraging internal practice resources and problem-solving capacities for driving diabetes registry implementation in 32 practices in Virginia., Intervention: All practices identified local implementation champions who participated in an in-person education session on the value and use of diabetes registries, while intervention practices were also paired with peer mentors and had access to a physician informaticist, who worked remotely to assist practices with implementation., Main Measures: Practice champions reported progress on registry implementation milestone achievement, and reported practice-level organizational capacity by using a modified version of the Assessment of Chronic Illness Care (ACIC)., Key Results: Intervention practices were significantly more likely to have implemented a registry (44% vs 6%, P = .04) and to have achieved more implementation milestones (5.5 vs 2.6, P < .0001) than control practices. Baseline ACIC scores indicated room for organizational improvement with regard to chronic illness care (overall median, 6.4; range, 3.8 to 10.8) and clinical information systems use (median, 6.0; range, 0 to 11) with no significant differences between intervention and control practices., Conclusions: Remotely provided guidance paired with limited in-person assistance can support rapid implementation of diabetes registries in typical primary care practices., Competing Interests: Conflict of interest: The authors declare that they do not have a conflict of interest., (© Copyright 2020 by the American Board of Family Medicine.)

Background: Many patients with poorly controlled multiple chronic conditions (MCC) also have unhealthy behaviors, mental health challenges, and unmet social needs. Medical management of MCC may have limited benefit if patients are struggling to address their basic life needs. Health systems and communities increasingly recognize the need to address these issues and are experimenting with and investing in new models for connecting patients with needed services. Yet primary care clinicians, whose regular contact with patients makes them more familiar with patients' needs, are often not included in these systems., Methods: We are starting a clinician-level cluster-randomized controlled trial to evaluate how primary care clinicians can participate in these community and hospital solutions and whether doing so is effective in controlling MCC. Sixty clinicians in the Virginia Ambulatory Care Outcomes Research Network will be matched by age and sex and randomized to usual care (control condition) or enhanced care planning with clinical-community linkage support (intervention). From the electronic health record we will identify all patients with MCC, including cardiovascular disease or risks, diabetes, obesity, or depression. A baseline assessment will be mailed to up to 50 randomly selected patients for each clinician (3000 total). Ten respondents per clinician (600 patients total) with uncontrolled MCC will be randomly selected for study inclusion, with oversampling of minorities. The intervention includes two components. First, we will use an enhanced care planning tool, My Own Health Report (MOHR), to screen patients for health behavior, mental health, and social needs. Patients will be supported by a patient navigator, who will help patients prioritize needs, create care plans, and write a personal narrative to guide the care team. Patients will update care plans every 1 to 2 weeks. Second, we will create community-clinical linkage to help address patients' needs. The linkage will include community resource registries, personnel to span settings (patient navigators and a community health worker), and care team coordination across team members through MOHR., Discussion: This study will help inform efforts by primary care clinicians to help address unhealthy behaviors, mental health needs, and social risks as a strategy to better control MCC., Trial Registration: ClinicalTrials.gov: NCT03885401. Registered on 19 September 2019.

Background: Unhealthy alcohol use is the third leading cause of preventable death in the United States. Evidence demonstrates that screening for unhealthy alcohol use and providing persons engaged in risky drinking with brief behavioral and counseling interventions improves health outcomes, collectively termed screening and brief interventions. Medication assisted therapy (MAT) is another effective method for treatment of moderate or severe alcohol use disorder. Yet, primary care clinicians are not regularly screening for or treating unhealthy alcohol use., Methods and Analysis: We are initiating a clinic-level randomized controlled trial aimed to evaluate how primary care clinicians can impact unhealthy alcohol use through screening, counseling, and MAT. One hundred and 25 primary care practices in the Virginia Ambulatory Care Outcomes Research Network (ACORN) will be engaged; each will receive practice facilitation to promote screening, counseling, and MAT either at the beginning of the trial or at a 6-month control period start date. For each practice, the intervention includes provision of a practice facilitator, learning collaboratives with three practice champions, and clinic-wide information sessions. Clinics will be enrolled for 6-12 months. After completion of the intervention, we will conduct a mixed methods analysis to identify changes in screening rates, increase in provision of brief counseling and interventions as well as MAT, and the reduction of alcohol intake for patients after practices receive practice facilitation., Discussion: This study offers a systematic process for dissemination and implementation of the evidence-based practice of screening, counseling, and treatment for unhealthy alcohol use. Practices will be asked to implement a process for screening, counseling, and treatment based on their practice characteristics, patient population, and workflow. We propose practice facilitation as a robust and feasible intervention to assist in making changes within the practice. We believe that the process can be replicated and used in a broad range of clinical settings; we anticipate this will be supported by our evaluation of this approach., Trial Registration: ClinicalTrials.gov, ClinicalTrials.gov Identifier: NCT04248023, Registered 5 February 2020.

The medical school admissions process seeks to assess a core set of cognitive and non-cognitive competencies that reflect professional readiness and institutional mission alignment. The standardized format of multiple mini-interviews (MMIs) can enhance assessments, and thus many medical schools have switched to this for candidate interviews. However, because MMIs are resource-intensive, admissions deans use a variety of interviewers from different backgrounds/professions. Here, we analyze the MMI process for the 2018 admissions cycle at the VCU School of Medicine, where 578 applicants were interviewed by 126 raters from five distinct backgrounds: clinical faculty, basic science faculty, medical students, medical school administrative staff, and community members. We found that interviewer background did not significantly influence MMI evaluative performance scoring, which eliminates a potential concern about the consistency and reliability of assessment.

Background: Adult opioid use and neonatal abstinence syndrome (NAS) are growing public health problems in the United States (U.S.). Our objective was to determine how opioid use disorder treatment access impacts the relationship between adult opioid use and NAS., Methods: We conducted a cross-sectional state-level ecologic study using 36 states with available Healthcare Cost and Utilization Project State Inpatient Databases in 2014. Opioid use disorder treatment access was determined by the: 1) proportion of people needing but not receiving substance use treatment, 2) density of buprenorphine-waivered physicians, and 3) proportion of individuals in outpatient treatment programs (OTPs). The incidence of NAS was defined as ICD-9 code 779.5 (drug withdrawal syndrome in newborn) from any discharge diagnosis field per 1000 live births in that state., Results: Unmet need for substance use disorder treatment correlated with NAS (r = 0.54, 95% CI: 0.26-0.73). The correlation between adult illicit drug use/dependence and NAS was higher in states with a lower density of buprenorphine-waivered physicians and individuals in OTPs., Conclusions: Measures of opioid use disorder treatment access dampened the correlation between illicit drug use/dependence and NAS. Future studies using community- or individual-level data may be better poised to answer the question of whether or not opioid use disorder treatment access improves NAS relative to adult opioid use.

A novel antimicrobial consumption metric designed to identify the proportion of carbapenem consumption (PoCC) among broad-spectrum antipseudomonal antimicrobials has been shown to vary significantly by US Census Bureau region. This retrospective surveillance study identified significant total PoCC variability (27%; P = .001) across 8 inpatient units from January 2017 through June 2018. This metric may be useful in identifying and comparing inpatient units that may be overusing antipseudomonal carbapenems., (Copyright © 2019 Association for Professionals in Infection Control and Epidemiology, Inc. All rights reserved.)

Background: Providers have expressed concern about patient access to clinical notes. There is the possibility that providers may linguistically censor notes knowing that patients have access., Purpose: Qualitative interviews and a pre- and post- linguistic analysis of the implementation of OpenNotes was performed to determine whether oncologists changed the content and style of their notes., Methods: Mixed methods were utilized, including 13 semi-structured interviews with oncologists and random effects modeling of over 500 clinical notes. The Linguistic Inquiry and Word Count program was used to evaluate notes for emotions, thinking styles, and social concerns., Results: No significant differences from pre- and post-implementation of OpenNotes was found. Thematic analysis revealed that oncologists were concerned that changing their notes would negatively impact multidisciplinary communication. However, oncologists acknowledged that notes could be more patient-friendly and may stimulate patient-provider communication., Conclusions: Although oncologists were aware that patients could have access, they felt strongly about not changing the content of notes. A comparison between pre- and post-implementation confirmed this view and found that notes did not change., Practice Implications: Patient access to oncologist's notes may serve as an opportunity to reinforce important aspects of the consultation., (Copyright © 2019 Elsevier B.V. All rights reserved.)