People with low socioeconomic status (SES) or serious psychological distress (SPD) in the U.S. face ongoing and future disparities in tobacco smoking. We sought to estimate how smoking disparities contribute to disparities in life expectancy and aggregate life-years in these marginalized subpopulations. We used the Simulation of Tobacco and Nicotine Outcomes and Policy (STOP) microsimulation model to project life expectancy as a function of subpopulation (low SES, higher SES, SPD, or non-SPD) and cigarette smoking status. Low SES was defined as having at least one of the following: income below poverty, less than high school education, or Medicaid insurance. Higher SES individuals belonged to none of these categories. SPD was defined as Kessler-6 score ≥ 13; non-SPD was a Kessler-6 score < 13. To project individual life expectancy losses from smoking, we simulated 40-year-olds stratified by gender, subpopulation (by SES or by SPD, with no change), and smoking status (current/never, with no change). To project time to reach 5

INTRODUCTION:High tobacco smoking prevalence in people with low SES or serious psychological distress in the U.S. may increase cardiovascular disease risk among these marginalized subpopulations. The authors estimate how smoking disparities contribute to cardiovascular disease disparities. METHODS:Using the Simulation of Tobacco and Nicotine Outcomes and Policy model, a validated microsimulation model of tobacco use and clinical outcomes, the authors used 2004-2019 data from the National Health Interview Survey to first compare 20-year cumulative cardiovascular disease incidence for people aged 40 years by sex, smoking status, and marginalized subpopulation membership. Second, the authors simulated the marginalized subpopulations with representative age, sex, and smoking status distributions to estimate 20-year cumulative cardiovascular disease incidence under status quo and counterfactual scenarios. In the counterfactual scenario, smoking prevalence and trends in the low SES and serious psychological distress subpopulations match those in the higher SES and non-SPD subpopulations, respectively. RESULTS:The model-projected impact of smoking on 20-year cumulative cardiovascular disease incidence is considerably larger than the impact of low SES or serious psychological distress; for example, among males aged 40 years, cumulative cardiovascular disease incidence is 28.3% for low SES people who currently smoke, 13.0% for low SES people who never smoke, and 26.2% for higher SES people who currently smoke. In the second analysis, in the status quo scenario, model-projected 20-year cumulative cardiovascular disease incidence is 19.3% for low SES and 22.1% for serious psychological distress; in the counterfactual scenario, it is 18.1% for low SES and 19.6% for serious psychological distress. CONCLUSIONS:Interventions focused on reducing smoking disparities could substantially reduce cardiovascular disease in marginalized subpopulations.

BACKGROUND:Implementation research generally assumes established evidence-based practices and prior piloting of implementation strategies, which may not be feasible during a public health emergency. We describe the use of a simulation model of the effectiveness of COVID-19 mitigation strategies to inform a stakeholder-engaged process of rapidly designing a tailored intervention and implementation strategy for individuals with serious mental illness (SMI) and intellectual/developmental disabilities (ID/DD) in group homes in a hybrid effectiveness-implementation randomized trial. METHODS:We used a validated dynamic microsimulation model of COVID-19 transmission and disease in late 2020/early 2021 to determine the most effective strategies to mitigate infections among Massachusetts group home staff and residents. Model inputs were informed by data from stakeholders, public records, and published literature. We assessed different prevention strategies, iterated over time with input from multidisciplinary stakeholders and pandemic evolution, including varying symptom screening, testing frequency, isolation, contact-time, use of personal protective equipment, and vaccination. Model outcomes included new infections in group home residents, new infections in group home staff, and resident hospital days. Sensitivity analyses were performed to account for parameter uncertainty. Results of the simulations informed a stakeholder-engaged process to select components of a tailored best practice intervention and implementation strategy. RESULTS:The largest projected decrease in infections was with initial vaccination, with minimal benefit for additional routine testing. The initial level of actual vaccination in the group homes was estimated to reduce resident infections by 72.4% and staff infections by 55.9% over the 90-day time horizon. Increasing resident and staff vaccination uptake to a target goal of 90% further decreased resident infections by 45.2% and staff infections by 51.3%. Subsequent simulated removal of masking led to a 6.5% increase in infections among residents and 3.2% among staff. The simulation model results were presented to multidisciplinary stakeholders and policymakers to inform the "Tailored Best Practice" package for the hybrid effectiveness-implementation trial. CONCLUSIONS:Vaccination and decreasing vaccine hesitancy among staff were predicted to have the greatest impact in mitigating COVID-19 risk in vulnerable populations of group home residents and staff. Simulation modeling was effective in rapidly informing the selection of the prevention and implementation strategy in a hybrid effectiveness-implementation trial. Future implementation may benefit from this approach when rapid deployment is necessary in the absence of data on tailored interventions. TRIAL REGISTRATION:ClinicalTrials.gov NCT04726371.

BACKGROUND:More than seven million people with intellectual and/or developmental disabilities (ID/DD) live in the US and may face an elevated risk for COVID-19. OBJECTIVE:To identify correlates of COVID-19 and related hospitalizations among people with ID/DD in group homes in Massachusetts. METHODS:We collected data during March 1, 2020-June 30, 2020 (wave 1) and July 1, 2020-March 31, 2021 (wave 2) from the Massachusetts Department of Public Health and six organizations administering 206 group homes for 1035 residents with ID/DD. The main outcomes were COVID-19 infections and related hospitalizations. We fit multilevel Cox proportional hazards models to estimate associations with observed predictors and assess contextual home- and organizational-level effects. RESULTS:Compared with Massachusetts residents, group home residents had a higher age-adjusted rate of COVID-19 in wave 1 (incidence rate ratio [IRR], 12.06; 95 % confidence interval [CI], 10.51-13.84) and wave 2 (IRR, 2.47; 95 % CI, 2.12-2.88) and a higher age-adjusted rate of COVID-19 hospitalizations in wave 1 (IRR, 17.64; 95 % CI, 12.59-24.70) and wave 2 (IRR, 4.95; 95 % CI, 3.23-7.60). COVID-19 infections and hospitalizations were more likely among residents aged 65+ and in group homes with 6+ resident beds and recent infection among staff and residents. CONCLUSIONS:Aggressive efforts to decrease resident density, staff-to-resident ratios, and staff infections through efforts such as vaccination, in addition to ongoing access to personal protective equipment and COVID-19 testing, may reduce COVID-19 and related hospitalizations in people with ID/DD living in group homes.

Importance:Direct reports of the experiences of staff working in group homes for people with serious mental illness (SMI) and/or intellectual or developmental disabilities (ID/DD) are rarely reported. Hearing from workers about their experiences in the COVID-19 pandemic may inform future workforce and public policy. Objective:To gather baseline data on worker experience with the perceived effects of COVID-19 on health and work in the pandemic prior to initiating an intervention to mitigate the spread of COVID-19 and to measure differences in worker experience by gender, race, ethnicity, education, and resident population served (persons with SMI and/or IDD/DD). Design, Setting, and Participants:This mixed-mode, cross-sectional survey study was conducted using online then paper-based self-administration from May to September 2021 at the end of the first year of the pandemic. Staff working in 415 group homes that provided care within 6 Massachusetts organizations serving adults aged 18 years or older with SMI and/or ID/DD were surveyed. The eligible survey population included a census of staff who were currently employed in participating group homes during the study period. A total of 1468 staff completed or partially completed surveys. The overall survey response rate was 44% (range by organization, 20% to 52%). Main Outcomes and Measures:Self-reported experiential outcomes were measured in work, health, and vaccine completion. Bivariate and multivariate analyses explore experiences by gender, race, ethnicity, education, trust in experts and employers, and population served. Results:The study population included 1468 group home staff (864 [58.9%] women; 818 [55.7%] non-Hispanic Black; 98 [6.7%] Hispanic or Latino). A total of 331 (22.5%) group home staff members reported very serious perceived effects on health; 438 (29.8%) reported very serious perceived effects on mental health; 471 (32.1%) reported very serious perceived effects on health of family and friends; and 414 reported very serious perceived effects (28.2%) on access to health services, with statistically significant differences observed by race and ethnicity. Vaccine acceptance was higher among persons with higher educational attainment and trust in scientific expertise and lower among persons who self-reported as Black or Hispanic/Latino. A total of 392 (26.7%) respondents reported needing support for health needs, and 290 (19.8%) respondents reported needing support for loneliness or isolation. Conclusions and Relevance:In this survey study, approximately one-third of group home workers reported serious personal health and access to health care barriers during the first year of the COVID-19 pandemic in Massachusetts. Addressing unmet health needs and access to health and mental health services, including inequities and disparities by race, ethnicity, and education, should benefit staff health and safety, as well as that of the individuals with disabilities who rely on them for support and care.

This study examined COVID-19 infection and hospitalizations among people with serious mental illness who resided in residential care group homes in Massachusetts during the first year of the COVID-19 pandemic. The authors analyzed data on 2261 group home residents and COVID-19 data from the Massachusetts Department of Public Health. Outcomes included positive COVID-19 tests and COVID-19 hospitalizations March 1, 2020-June 30, 2020 (wave 1) and July 1, 2020-March 31, 2021 (wave 2). Associations between hazard of outcomes and resident and group home characteristics were estimated using multi-level Cox frailty models including home- and city-level frailties. Between March 2020 and March 2021, 182 (8%) residents tested positive for COVID-19, and 51 (2%) had a COVID-19 hospitalization. Compared with the Massachusetts population, group home residents had age-adjusted rate ratios of 3.0 (4.86 vs. 1.60 per 100) for COVID infection and 13.5 (1.99 vs. 0.15 per 100) for COVID hospitalizations during wave 1; during wave 2, the rate ratios were 0.5 (4.55 vs. 8.48 per 100) and 1.7 (0.69 vs. 0.40 per 100). In Cox models, residents in homes with more beds, higher staff-to-resident ratios, recent infections among staff and other residents, and in cities with high community transmission risk had greater hazard of COVID-19 infection. Policies and interventions that target group home-specific risks are needed to mitigate adverse communicable disease outcomes in this population.Clinical Trial Registration Number This study provides baseline (i.e., pre-randomization) data from a clinical trial study NCT04726371.

Luccarelli, James MD, DPhil; Fernandez-Robles, Carlos MD; Wininger, Bryce MD; Becker, Jessica E. MD; Hazen, Eric P. MD; Henry, Michael E. MD Author Information

OBJECTIVE:Autoimmune encephalitis (AE) is a highly treatable neurologic condition that can cause psychosis. Screening for AE is not currently recommended in routine workup for first-episode psychosis (FEP), owing partly to the high cost of testing for AE-associated neuronal autoantibodies.METHODS:This study used a decision-analytic model to estimate the cost-effectiveness of routine serum screening for AE compared with clinically targeted screening in patients with FEP. Model parameters drawn from prior published literature included the prevalence of neuronal autoantibodies in FEP (4.5%), serum autoantibody panel cost (US $291), remission probability with antipsychotics (0.58), and remission probability with immunotherapy for patients diagnosed with AE (0.85). Outcomes included quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness ratios (ICERs), assessed over a 5-year horizon from the US health care sector and societal perspectives. ICER thresholds of $50,000/QALY to $150,000/QALY were used to define cost-effectiveness. The analysis was conducted between June 2018 and January 2020.RESULTS:Routine screening led to mean QALY gains of 0.008 among all patients and 0.174 among the subgroup of patients with neuronal autoantibodies. Mean costs increased by $780 from a societal perspective and $1,150 from a health care sector perspective, resulting in ICERs of $99,330/QALY and $147,460/QALY, respectively. Incorporating joint input data uncertainty, the likelihood routine screening has an ICER ≤ $150,000/QALY was 55% from a societal perspective and 37% from a health care sector perspective. The model parameter with the greatest contribution to overall uncertainty was the effectiveness of immunotherapy relative to antipsychotics.CONCLUSIONS:Routine screening for AE in patients with FEP may be cost-effective in the United States. As further immunotherapy effectiveness data become available, a more definitive recommendation to perform routine screening could be warranted.

Background:In recent years, there has been an increasing burden of child and adolescent mental illness recognized in the United States, and the need for pediatric mental health care is growing. Pediatric consultation-liaison (C-L) psychiatrists are increasingly playing a role in the management of medical and psychiatric disease for pediatric patients. The field is a fast-moving one, with understanding of new neuropsychiatric disease entities; reformulation of prior disease entities; and new interdisciplinary treatments and models of care.Methods:In this study, we aim to review recent advances in the field of pediatric C-L psychiatry, including new diagnostic entities, updated management of frequently encountered clinical presentations, and developments in systems of care.Conclusion:The advances in pediatric C-L psychiatry are broad and serve to promote more streamlined, evidence-based care for the vulnerable population of psychiatrically ill pediatric medical patients. More work remains to determine the most effective interventions for the wide array of presentations seen by pediatric C-L psychiatrists.

We use a large, multi-state Medicaid claims database to delineate the prevalence of mental illness in pediatric patients with a variety of complex medical conditions and to examine the demographic and clinical characteristics of children with a broad range of complex medical conditions co-occurring or not co-occurring with mental health disorders.

Telepsychiatry, the use of real-time video for remote visits, has gained popularity as a means of addressing the growing shortage and uneven distribution of child and adolescent psychiatrists. This chapter reviews the growing role of telepsychiatry in the delivery of care to youth and their families that both mirrors and departs from the traditional in-person encounter. We address the growing research in this area and discuss some of the major considerations when using telepsychiatry, including patient engagement and safety, technology and security, and licensing requirements and regulations.

Mandatory trial registration, and later results reporting, were proposed to mitigate selective clinical trial publication and outcome reporting. The Food and Drug Administration (FDA) Amendments Act (FDAAA) was enacted by Congress on September 27, 2007, requiring the registration of all non-phase I clinical trials involving FDA-regulated medical interventions and results reporting for approved drugs. The association between FDAAA enactment and the registration, results reporting, and publication bias of neuropsychiatric trials has not been studied.

Off-label prescribing of psychiatric drugs is common, despite lacking strong scientific evidence of efficacy and potentially increasing risk for adverse events. The goal of this study was to characterize prevalence of off-label prescriptions of psychiatric drugs and examine patient and clinician predictors of off-label use. This manuscript presents a retrospective, cross-sectional study using data from the 2012 and 2013 National Ambulatory Medical Care Surveys (NAMCS). The study examined all adult outpatient visits to psychiatric practices for chronic care management with a single listed visit diagnosis in which at least one psychiatric drug was prescribed. The main outcome measure was off-label prescribing of at least one psychiatric drug, defined as prescription for a condition for which it has not been approved for use by the FDA. Among our sample representative of 1.85 billion outpatient visits, 18.5 million (1.3%) visits were to psychiatrists for chronic care management in which at least one psychiatric drug was prescribed. Overall, the rate of off-label use was 12.9% (95% CI: 12.2-15.7). The most common off-label uses were for manic-depressive psychosis treated with citalopram and primary insomnia treated with trazodone. Several patient and clinician characteristics were positively associated with off-label prescribing, including seeing a psychiatrist (OR: 1.06, 95% CI, 1.01-1.12; p = 0.03) instead of another type of clinician, the office visit taking place in the Western region of the country (OR: 1.09, 95% CI, 1.01-1.17; p = 0.02), and the patient having 3 or more chronic conditions (OR: 1.12, 95% CI, 1.02-1.14; p = 0.003). In contrast, having Medicare coverage (OR: 0.93, 95% CI, 0.84-0.97; p = 0.04) and receiving payment assistance from a medical charity (OR: 0.91, 95% CI, 0.88-0.96; p = 0.03) instead of private insurance were negatively associated with off-label prescribing. These results suggest that certain classes of psychiatric medications are being commonly prescribed to treat conditions for which they have not been determined by the FDA to be clinically efficacious and/or safe.

Objective: Enhanced HIV prevention interventions, such as pre-exposure prophylaxis for high-risk individuals, require substantial investments. We sought to estimate the medical cost saved by averting 1 HIV infection in the United States.Methods: We estimated lifetime medical costs in persons with and without HIV to determine the cost saved by preventing 1 HIV infection. We used a computer simulation model of HIV disease and treatment (CEPAC) to project CD4 cell count, antiretroviral treatment status, and mortality after HIV infection. Annual medical cost estimates for HIV-infected persons, adjusted for age, sex, race/ethnicity, and transmission risk group, were from the HIV Research Network (range, $1854-$4545/mo) and for HIV-uninfected persons were from the Medical Expenditure Panel Survey (range, $73$628/mo).Results are reported as lifetime medical costs from the US health system perspective discounted at 3% (2012 USD). Results: The estimated discounted lifetime cost for persons who become HIV infected at age 35 is $326,500 (60% for antiretroviral medications, 15% for other medications, 25% nondrug costs). For individuals who remain uninfected but at high risk for infection, the discounted lifetime cost estimate is $96,700. The medical cost saved by avoiding 1 HIV infection is $229,800. The cost saved would reach $338,400 if all HIV-infected individuals presented early and remained in care. Cost savings are higher taking into account secondary infections avoided and lower if HIV infections are temporarily delayed rather than permanently avoided.Conclusions: The economic value of HIV prevention in the United States is substantial given the high cost of HIV disease treatment.

Letters18 November 2014Reporting Discrepancies Between the ClinicalTrials.gov Results Database and Peer-Reviewed PublicationsJessica E. Becker, AB and Joseph S. Ross, MD, MHSJessica E. Becker, ABFrom Yale University School of Medicine, New Haven, Connecticut.Search for more papers by this author and Joseph S. Ross, MD, MHSFrom Yale University School of Medicine, New Haven, Connecticut.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/L14-5022 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:Hartung and colleagues (1) examined a random sample of phase 3 and 4 clinical trials reporting results on Clinical Trials.gov and compared these results with those summarized in corresponding journal publications. They found that the reporting of outcome descriptions, outcome values, and adverse events was highly inconsistent. We did a similar study (2) that had strikingly analogous results, although we explicitly focused on trials registered on Clinical Trials.gov published in high-impact journals.Hartung and colleagues found that 15% of trials reported discrepant primary outcome descriptions between ClinicalTrials.gov and corresponding publications, whereas 20% inconsistently reported primary outcome values. ...References1. Hartung DM, Zarin DA, Guise JM, McDonagh M, Paynter R, Helfand M. Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications. Ann Intern Med. 2014;160:477-83. [PMID: 24687070] doi:10.7326/M13-0480 LinkGoogle Scholar2. Becker JE, Krumholz HM, Ben-Josef G, Ross JS. Reporting of results in ClinicalTrials.gov and high-impact journals. JAMA. 2014;311:1063-5. [PMID: 24618969] doi:10.1001/jama.2013.285634 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAuthors: Jessica E. Becker, AB; Joseph S. Ross, MD, MHSAffiliations: From Yale University School of Medicine, New Haven, Connecticut.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=L14-0306. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoReporting Discrepancies Between the ClinicalTrials.gov Results Database and Peer-Reviewed Publications Daniel M. Hartung , Deborah A. Zarin , Jeanne-Marie Guise , Marian McDonagh , Robin Paynter , and Mark Helfand Metrics Cited byRisk of pneumonitis in cancer patients treated with PARP inhibitors: A meta-analysis of randomized controlled trials and a pharmacovigilance study of the FAERS databaseTargeted Therapies in Trial for Non-Resectable Gallbladder CancerDiagnostic Clinical Trials in Breast Cancer Brain Metastases: Barriers and Innovations10-Year Update on Study Results Submitted to ClinicalTrials.govCurrent state of clinical trials in breast cancer brain metastasesCurrent State of Hypertrophic Cardiomyopathy Clinical TrialsCurrent status and perspectives of interventional clinical trials for glioblastoma – analysis of ClinicalTrials.govPortfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov databaseIs research quality in orthopedic manual therapy trials stagnating? Reflections and pathways for improving research quality and advance our professionComparison of serious adverse events posted at ClinicalTrials.gov and published in corresponding journal articles 18 November 2014Volume 161, Issue 10Page: 760KeywordsAdverse eventsClinical trial reportingClinical trialsDatabasesDisclosureFood and Drug AdministrationSerious adverse events ePublished: 18 November 2014 Issue Published: 18 November 2014 Copyright & PermissionsCopyright © 2014 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...

Understanding HIV transmission dynamics is critical to estimating the potential population-wide impact of HIV prevention and treatment interventions. We developed an individual-based simulation model of the heterosexual HIV epidemic in South Africa and linked it to the previously published Cost-Effectiveness of Preventing AIDS Complications (CEPAC) International Model, which simulates the natural history and treatment of HIV. In this new model, the CEPAC Dynamic Model (CDM), the probability of HIV transmission per sexual encounter between short-term, long-term and commercial sex worker partners depends upon the HIV RNA and disease stage of the infected partner, condom use, and the circumcision status of the uninfected male partner. We included behavioral, demographic and biological values in the CDM and calibrated to HIV prevalence in South Africa pre-antiretroviral therapy. Using a multi-step fitting procedure based on Bayesian melding methodology, we performed 264,225 simulations of the HIV epidemic in South Africa and identified 3,750 parameter sets that created an epidemic and had behavioral characteristics representative of a South African population pre-ART. Of these parameter sets, 564 contributed 90% of the likelihood weight to the fit, and closely reproduced the UNAIDS HIV prevalence curve in South Africa from 1990-2002. The calibration was sensitive to changes in the rate of formation of short-duration partnerships and to the partnership acquisition rate among high-risk individuals, both of which impacted concurrency. Runs that closely fit to historical HIV prevalence reflect diverse ranges for individual parameter values and predict a wide range of possible steady-state prevalence in the absence of interventions, illustrating the value of the calibration procedure and utility of the model for evaluating interventions. This model, which includes detailed behavioral patterns and HIV natural history, closely fits HIV prevalence estimates.