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55 result(s) for "Angier, Heather"
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Outpatient Management of COVID-19: Rapid Evidence Review
New COVID-19 variants of concern continue to develop. Incubation period, transmissibility, immune escape, and treatment effectiveness differ by variants of concern. Physicians should be aware that the characteristics of the predominant variants of concern determine aspects of diagnosis and treatment. Multiple testing modalities exist; the most appropriate testing strategy varies depending on the clinical scenario, with factors of test sensitivity, turnaround time, and the expertise required for specimen collection. Three types of vaccines are available in the United States, and all people six months and older should be encouraged to receive one because vaccination is effective in reducing the incidence of and hospitalizations and deaths associated with COVID-19. Vaccination may also reduce the incidence of post-acute sequelae of SARS-CoV-2 infection (i.e., long COVID). Consider medications, such as nirmatrelvir/ritonavir, as first-line treatment for eligible patients diagnosed with COVID-19 unless logistical or supply constraints occur. National Institutes of Health guidelines and local health care partner resources can be used to determine eligibility. Long-term health effects of having COVID-19 are under investigation.
Adults on pre-exposure prophylaxis (tenofovir-emtricitabine) have faster clearance of anti-HIV monoclonal antibody VRC01
Broadly neutralizing monoclonal antibodies (mAbs) are being developed for HIV-1 prevention. Hence, these mAbs and licensed oral pre-exposure prophylaxis (PrEP) (tenofovir-emtricitabine) can be concomitantly administered in clinical trials. In 48 US participants (men and transgender persons who have sex with men) who received the HIV-1 mAb VRC01 and remained HIV-free in an antibody-mediated-prevention trial (ClinicalTrials.gov #NCT02716675), we conduct a post-hoc analysis and find that VRC01 clearance is 0.08 L/day faster ( p  = 0.005), and dose-normalized area-under-the-curve of VRC01 serum concentration over-time is 0.29 day/mL lower ( p  < 0.001) in PrEP users ( n  = 24) vs. non-PrEP users ( n  = 24). Consequently, PrEP users are predicted to have 14% lower VRC01 neutralization-mediated prevention efficacy against circulating HIV-1 strains. VRC01 clearance is positively associated ( r  = 0.33, p   =  0.03) with levels of serum intestinal Fatty Acid Binding protein (I-FABP), a marker of epithelial intestinal permeability, which is elevated upon starting PrEP ( p  = 0.04) and after months of self-reported use ( p  = 0.001). These findings have implications for the evaluation of future HIV-1 mAbs and postulate a potential mechanism for mAb clearance in the context of PrEP. Small molecule drugs can affect clearance of monoclonal antibodies, but this hasn’t been assessed for oral HIV-1 pre-exposure prophylaxis. Here, the authors find that faster serum clearance of an experimental IgG1 monoclonal antibody, VRC01, is associated with use of tenofovir-emtricitabine, possibly explained by increased epithelial intestinal permeability.
Affordable Care Act Medicaid expansion and access to primary-care based smoking cessation assistance among cancer survivors: an observational cohort study
Background Smoking among cancer survivors can increase the risk of cancer reoccurrence, reduce treatment effectiveness and decrease quality of life. Cancer survivors without health insurance have higher rates of smoking and decreased probability of quitting smoking than cancer survivors with health insurance. This study examines the associations of the Affordable Care Act (ACA) Medicaid insurance expansion with smoking cessation assistance and quitting smoking among cancer survivors seen in community health centers (CHCs). Methods Using electronic health record data from 337 primary care community health centers in 12 states that expanded Medicaid eligibility and 273 CHCs in 8 states that did not expand, we identified adult cancer survivors with a smoking status indicating current smoking within 6 months prior to ACA expansion in 2014 and ≥ 1 visit with smoking status assessed within 24-months post-expansion. Using an observational cohort propensity score weighted approach and logistic generalized estimating equation regression, we compared odds of quitting smoking, having a cessation medication ordered, and having ≥6 visits within the post-expansion period among cancer survivors in Medicaid expansion versus non-expansion states. Results Cancer survivors in expansion states had higher odds of having a smoking cessation medication order (adjusted odds ratio [aOR] = 2.54, 95%CI = 1.61-4.03) and higher odds of having ≥6 office visits than those in non-expansion states (aOR = 1.82, 95%CI = 1.22-2.73). Odds of quitting smoking did not differ significantly between patients in Medicaid expansion versus non-expansion states. Conclusions The increased odds of having a smoking cessation medication order among cancer survivors seen in Medicaid expansion states compared with those seen in non-expansion states provides evidence of the importance of health insurance coverage in accessing evidence-based tobacco treatment within CHCs. Continued research is needed to understand why, despite increased odds of having a cessation medication prescribed, odds of quitting smoking were not significantly higher among cancer survivors in Medicaid expansion states compared to non-expansion states.
Impact of LS Mutation on Pharmacokinetics of Preventive HIV Broadly Neutralizing Monoclonal Antibodies: A Cross-Protocol Analysis of 16 Clinical Trials in People without HIV
Monoclonal antibodies are commonly engineered with an introduction of Met428Leu and Asn434Ser, known as the LS mutation, in the fragment crystallizable region to improve pharmacokinetic profiles. The LS mutation delays antibody clearance by enhancing binding affinity to the neonatal fragment crystallizable receptor found on endothelial cells. To characterize the LS mutation for monoclonal antibodies targeting HIV, we compared pharmacokinetic parameters between parental versus LS variants for five pairs of anti-HIV immunoglobin G1 monoclonal antibodies (VRC01/LS/VRC07-523LS, 3BNC117/LS, PGDM1400/LS PGT121/LS, 10-1074/LS), analyzing data from 16 clinical trials of 583 participants without HIV. We described serum concentrations of these monoclonal antibodies following intravenous or subcutaneous administration by an open two-compartment disposition, with first-order elimination from the central compartment using non-linear mixed effects pharmacokinetic models. We compared estimated pharmacokinetic parameters using the targeted maximum likelihood estimation method, accounting for participant differences. We observed lower clearance rate, central volume, and peripheral volume of distribution for all LS variants compared to parental monoclonal antibodies. LS monoclonal antibodies showed several improvements in pharmacokinetic parameters, including increases in the elimination half-life by 2.7- to 4.1-fold, the dose-normalized area-under-the-curve by 4.1- to 9.5-fold, and the predicted concentration at 4 weeks post-administration by 3.4- to 7.6-fold. Results suggest a favorable pharmacokinetic profile of LS variants regardless of HIV epitope specificity. Insights support lower dosages and/or less frequent dosing of LS variants to achieve similar levels of antibody exposure in future clinical applications.
An Exploratory Study of Primary Care Clinicians’ Perspectives on 2021 New and Updated Cancer Screening Guidelines
Background and Objective: Cancer screening rates remain low in rural, racial and ethnic minority, low-income, and uninsured populations. Prior studies showed that cancer screening recommendations vary based on clinicians’ factors. We conducted an exploratory study on primary care clinicians’ beliefs about new or updated cancer screening guidelines according to clinician demographics. Methods: This cross-sectional study involved administering a web-based survey in July and August of 2021 to primary care clinicians practicing in diverse ambulatory settings in the Pacific Northwest belonging to the same health system. The survey assessed clinician demographics, attitudes about the impact of cancer screening on mortality, and how clinicians stay up-to-date with guidelines. Results: Of the 191 clinicians, 81 responded (42.4%), after removing 13 incomplete surveys, we analyzed 68 (35.6%). The majority agreed/strongly agreed that breast (76.1%), colorectal (95.5%), and cervical (90.9%) cancer screening, and HPV vaccination (85.1%) prevent early cancer mortality: there were no differences according to clinician gender or years in practice. Female compared to male clinicians were more likely to agree/strongly agree that tobacco smoking cessation (female: 100% vs male: 86.4%, P = .01) prevents early cancer mortality, whereas male compared to female clinicians were more likely to agree/strongly agree that lung cancer screening (male: 86.4% vs female: 57.8%, P = .04) prevents early cancer mortality. One-third (33.3%) of clinicians were unaware of the 2021 update on lung cancer screening and females were more likely than males to say they did not know about this change (females: 43.2% vs males: 13.6%, P = .02). Conclusions: This study suggests that clinicians’ attitudes are not likely the primary factor affecting low cancer screening rates in some populations and that few differences exist in beliefs based on gender, and none based on years in practice.
Primary and mental health service use in community health center patients before and after cancer diagnosis
Background Cancer survivors face increased risk for chronic diseases resulting from cancer, preexisting conditions, and cancer treatment. Having an established primary care clinic or health insurance may influence patients’ receipt of recommended preventive care necessary to manage, treat, or diagnose new conditions. This study sought to understand receipt of healthcare in community health centers (CHCs) before and after cancer diagnosis among cancer survivors. We also examined the type of care received and assessed whether being established with a CHC or the type of health insurance affected the use of services. Methods Using electronic health record data and linked cancer registries from 5,649 CHC patients in three states from 2012 through 2018, we obtained monthly rates of primary care and mental health/behavioral health (MHBH) visits and the probability of receipt of care before and after a cancer diagnosis. Results Seventy‐five percent of CHC patients diagnosed with cancer returned to their primary CHC for care within 2‐years of their diagnosis. Among those who returned, there was a sharp increase in primary and MHBH care shortly before their diagnosis. Significantly more primary care (pre: 19.6%, post: 21.9%, p < 0.001) and MHBH care (pre: 1.2%, post: 1.6%, p < 0.001) was received after diagnosis than before. However, uninsured patients had fewer visits after their diagnosis than before. Conclusion Use of preventive care for cancer survivors is particularly important. Having an established primary care clinic may help to ensure survivors receive recommended screening and care. In this study on the receipt of preventive healthcare among community health center patients before and after a cancer diagnosis, we found that significantly more primary and mental healthcare was received after diagnosis than before. However, uninsured patients had fewer visits after their diagnosis than before.
Integrating a focus on health equity in implementation science: Case examples from the national cancer institute’s implementation science in cancer control centers (ISC 3 ) network
A Health Equity Task Force (HETF) of members from seven Centers funded by the National Cancer Institute's (NCI) Implementation Science in Cancer Control Centers (ISC ) network sought to identify case examples of how Centers were applying a focus on health equity in implementation science to inform future research and capacity-building efforts. HETF members at each ISC collected information on how health equity was conceptualized, operationalized, and addressed in initial research and capacity-building efforts across the seven ISC Centers funded in 2019-2020. Each Center completed a questionnaire assessing five health equity domains central to implementation science (e.g., community engagement; implementation science theories, models, and frameworks (TMFs); and engaging underrepresented scholars). Data generated illustrative examples from these five domains. Centers reported a range of approaches focusing on health equity in implementation research and capacity-building efforts, including (1) engaging diverse community partners/settings in making decisions about research priorities and projects; (2) applying health equity within a single TMF applied across projects or various TMFs used in specific projects; (3) evaluating health equity in operationalizing and measuring health and implementation outcomes; (4) building capacity for health equity-focused implementation science among trainees, early career scholars, and partnering organizations; and (5) leveraging varying levels of institutional resources and efforts to engage, include, and support underrepresented scholars. Examples of approaches to integrating health equity across the ISC network can inform other investigators and centers' efforts to build capacity and infrastructure to support growth and expansion of health equity-focused implementation science.
Impact of Healthcare Location Concordance on Receipt of Preventive Care Among Children Whose Parents have a Substance Use and/or Mental Health Diagnosis
Aims: Children of parents with substance use and/or other mental health (SU/MH) diagnoses are at increased risk for health problems. It is unknown whether these children benefit from receiving primary care at the same clinic as their parents. Thus, among children of parents with >1 SU/MH diagnosis, we examined the association of parent-child clinic concordance with rates of well-child checks (WCCs) and childhood vaccinations. Design: Retrospective cohort study using electronic health record (EHR) data from the OCHIN network of community health organizations (CHOs), 2010-2018. Setting: 280 CHOs across 17 states. Participants/Cases: 41,413 parents with >1 SU/MH diagnosis, linked to 65,417 children aged 0 to 17 years, each with >1 visit to an OCHIN clinic during the study period. Measurements: Dependent variables: rates of WCCs during (1) the first 15 months of life, and (2) ages 3 to 17 years; vaccine completeness (3) by the age of 2, and (4) before the age of 18. Estimates were attained using generalized estimating equations Poisson or logistic regression. Findings: Among children utilizing the same clinic as their parent versus children using a different clinic (reference group), we observed greater WCC rates in the first 15 months of life [adjusted rate ratio (aRR) = 1.06; 95% confidence interval (CI) = 1.02-1.10]; no difference in WCC rates in ages 3 to 17; higher odds for vaccine completion before age 2 [adjusted odds ratio (aOR) = 1.12; 95% CI = 1.03-1.21]; and lower odds for vaccine completion before age 18 (aOR = 0.88; 95% CI = 0.81-0.95). Conclusion: Among children whose parents have at least one SU/MH diagnosis, parent-child clinic concordance was associated with greater rates of WCCs and higher odds of completed vaccinations for children in the youngest age groups, but not the older children. This suggests the need for greater emphasis on family-oriented healthcare for young children of parents with SU/MH diagnoses; this may be less important for older children.
Medicaid Expansion Produces Long-Term Impact on Insurance Coverage Rates in Community Health Centers
Background:It is crucial to understand the impact of the Affordable Care Act (ACA). This study assesses changes in insurance status of patients visiting community health centers (CHCs) comparing states that expanded Medicaid to those that did not. Methods: Electronic health record data on 875,571 patients aged 19 to 64 years with ≥ 1 visit between 2012 and 2015 in 412 primary care CHCs in 9 expansion and 4 nonexpansion states. We assessed changes in rates of total, uninsured, Medicaid-insured, and privately insured primary care and preventive care visits; immunizations administered, and medications ordered. Results: Rates of uninsured visits decreased pre- to post-ACA, with greater drops in expansion (−57%) versus nonexpansion (−20%) states. Medicaid-insured visits increased 60% in expansion states while remaining unchanged in nonexpansion states. Privately insured visits were 2.7 times higher post-ACA in nonexpansion states with no increase in expansion states. Comparing 2015 with 2014: Uninsured visit rates continued to decrease in expansion (−28%) and nonexpansion states (−19%), Medicaid-insured rates did not significantly increase, and privately insured visits increased in nonexpansion states but did not change in expansion states. Conclusions: Medicaid expansion and subsidies to purchase private coverage likely increased the accessibility of health insurance for patients who had previously not been able to access coverage.
Participatory logic modeling in a multi-site initiative to advance implementation science
Background Logic models map the short-term and long-term outcomes that are expected to occur with a program, and thus are an essential tool for evaluation. Funding agencies, especially in the United States (US), have encouraged the use of logic models among their grantees. They also use logic models to clarify expectations for their own funding initiatives. It is increasingly recognized that logic models should be developed through a participatory approach which allows input from those who carry out the program being evaluated. While there are many positive examples of participatory logic modeling, funders have generally not engaged grantees in developing the logic model associated with their own initiatives. This article describes an instance where a US funder of a multi-site initiative fully engaged the funded organizations in developing the initiative logic model. The focus of the case study is Implementation Science Centers in Cancer Control (ISC 3 ), a multi-year initiative funded by the National Cancer Institute. Methods The reflective case study was collectively constructed by representatives of the seven centers funded under ISC 3 . Members of the Cross-Center Evaluation (CCE) Work Group jointly articulated the process through which the logic model was developed and refined. Individual Work Group members contributed descriptions of how their respective centers reviewed and used the logic model. Cross-cutting themes and lessons emerged through CCE Work Group meetings and the writing process. Results The initial logic model for ISC 3 changed in significant ways as a result of the input of the funded groups. Authentic participation in the development of the logic model led to strong buy-in among the centers, as evidenced by their utilization. The centers shifted both their evaluation design and their programmatic strategy to better accommodate the expectations reflected in the initiative logic model. Conclusions The ISC 3 case study demonstrates how participatory logic modeling can be mutually beneficial to funders, grantees and evaluators of multi-site initiatives. Funded groups have important insights about what is feasible and what will be required to achieve the initiative’s stated objectives. They can also help identify the contextual factors that either inhibit or facilitate success, which can then be incorporated into both the logic model and the evaluation design. In addition, when grantees co-develop the logic model, they have a better understanding and appreciation of the funder’s expectations and thus are better positioned to meet those expectations.