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The Impact of a Lifestyle Intervention on Postpartum Cardiometabolic Risk Factors Among Hispanic Women With Abnormal Glucose Tolerance During Pregnancy: Secondary Analysis of a Randomized TrialBackground: Women with abnormal glucose tolerance during pregnancy are at risk for cardiovascular disease (CVD), with higher rates among Hispanics. However, studies on the impact of lifestyle interventions on postpartum CVD profiles are sparse. Methods: This is a secondary analysis of a controlled trial among a subsample of Hispanic women with abnormal glucose tolerance participating in Estudió PARTO (Project Aiming to Reduce Type twO diabetes; mean age = 28.2 y, SD: 5.8) who were randomized to a culturally modified Lifestyle intervention (n = 45) or a comparison Health and Wellness intervention (n = 55). Primary endpoints were biomarkers of cardiovascular risk (lipids, C-reactive protein, fetuin-A, and albumin-to-creatinine ratio) and insulin resistance (fasting insulin, glucose, HbA1c, homeostasis model assessment, leptin, tumor necrosis factor-alpha, and adiponectin) measured at baseline (6-wk postpartum) and 6 and 12 months. Results: In intent-to-treat analyses, there were no significant differences in changes in biomarkers of CVD risk or insulin resistance over the postpartum year. In prespecified sensitivity analyses, women adherent with the Lifestyle Intervention had more favorable improvements in insulin (intervention effect = -4.87, SE: 1.93, P = .01) and HOMA-IR (intervention effect = -1.15, SE: 0.53, P = .03) compared with the Health and Wellness arm. In pooled analyses, regardless of intervention arm, women with higher postpartum sports/exercise had greater increase in HDL-cholesterol (intervention effect = 6.99, SE: 1.72, P = .0001). Conclusions: In this randomized controlled trial among Hispanic women with abnormal glucose tolerance, we did not observe a significant effect on postpartum biomarkers of CVD risk or insulin resistance. Women adherent to the intervention had more favorable changes in insulin and HOMA-IR.
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Equitable reach: Patient and professional recommendations for interventions to prevent perinatal depression and anxietyObjective: Perinatal depression and anxiety are the most common complications in the perinatal period and disproportionately affect those experiencing economic marginalization. Fewer than 15% of individuals at risk for perinatal depression are referred for preventative counseling. The goal of this study was to elicit patient and perinatal care professionals' perspectives on how to increase the reach of interventions to prevent perinatal depression and anxiety among economically marginalized individuals. Methods: We conducted qualitative interviews with perinatal individuals with lived experience of perinatal depression and/or anxiety who were experiencing economic marginalization (n = 12) and perinatal care professionals and paraprofessionals (e.g., obstetrician/gynecologists, midwives, doulas; n = 12) serving this population. Three study team members engaged a "a coding consensus, co-occurrence, and comparison," approach to code interviews. Results: Perinatal individuals and professionals identified prevention intervention delivery approaches and content to facilitate equitable reach for individuals who are economically marginalized. Factors influential included availability of mental health counselors, facilitation of prevention interventions by a trusted professional, digital health options, and options for mental health intervention delivery approaches. Content that was perceived as increasing equitable intervention reach included emphasizing stigma reduction, using cultural humility and inclusive materials, and content personalization. Conclusions: Leveraging varied options for mental health intervention delivery approaches and content could reach perinatal individuals experiencing economic marginalization and address resource considerations associated with preventative interventions.
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Integrating Equity Into Bicycle Infrastructure, Planning, and Programming: A Mixed Methods Exploration of Implementation Among Participants in the Bicycle Friendly Community ProgramIntroduction: Integrating equity considerations into bicycle infrastructure, planning, and programming is essential to increase bicycling and reduce physical inactivity-related health disparities. However, little is known about communities' experiences with activities that promote equity considerations in bicycle infrastructure, planning, and programming or about barriers and facilitators to such considerations. The objective of this project was to gain in-depth understanding of the experiences, barriers, and facilitators that communities encounter with integrating equity considerations into bicycle infrastructure, planning, and programming. Methods: We administered a web-based survey in 2022 to assess communities' experiences with 31 equity-focused activities in 3 areas: 1) community engagement, education, events, and programming (community engagement); 2) data collection, evaluation, and goal setting (data); and 3) infrastructure, facilities, and physical amenities (infrastructure). Respondents were people who represented communities in the US that participated in the League of American Bicyclists' Bicycle Friendly Community (BFC) Program. We then conducted 6 focus groups with a subset of survey respondents to explore barriers and facilitators to implementing equity-focused activities. Results: Survey respondents (N = 194) had experience with a mean (SD) of 5.9 (5.7) equity-focused activities. Focus group participants (N = 30) identified themes related to community engagement (outreach to and engagement of underrepresented communities, cultural perceptions of bicycling, and funding and support for community rides and programs); data (locally relevant data); and infrastructure (political will, community design, and infrastructure). They described barriers and facilitators for each. Conclusion: Communities are challenged with integrating equity into bicycle infrastructure, planning, and programming. Multicomponent strategies with support from entities such as the BFC program will be required to make progress.
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Measuring The Enduring Imprint Of Structural Racism On American NeighborhoodsA long history of discriminatory policies in the United States has created disparities in neighborhood resources that shape ethnoracial health inequities today. To quantify these differences, we organized publicly available data on forty-two variables at the census tract level within nine domains affected by structural racism: built environment, criminal justice, education, employment, housing, income and poverty, social cohesion, transportation, and wealth. Using data from multiple sources at several levels of geography, we developed scores in each domain, as well as a summary score that we call the Structural Racism Effect Index. We examined correlations with life expectancy and other measures of health for this index and other commonly used area-based indices. The Structural Racism Effect Index was more strongly associated with each health outcome than were the other indices. Its domain and summary scores can be used to describe differences in social risk factors, and they provide powerful new tools to guide policies and investments to advance health equity.
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Association of neighborhood-level sociodemographic factors with Direct-to-Consumer (DTC) distribution of COVID-19 rapid antigen tests in 5 US communitiesBackground: Many interventions for widescale distribution of rapid antigen tests for COVID-19 have utilized online, direct-to-consumer (DTC) ordering systems; however, little is known about the sociodemographic characteristics of home-test users. We aimed to characterize the patterns of online orders for rapid antigen tests and determine geospatial and temporal associations with neighborhood characteristics and community incidence of COVID-19, respectively. Methods: This observational study analyzed online, DTC orders for rapid antigen test kits from beneficiaries of the Say Yes! Covid Test program from March to November 2021 in five communities: Louisville, Kentucky; Indianapolis, Indiana; Fulton County, Georgia; O'ahu, Hawaii; and Ann Arbor/Ypsilanti, Michigan. Using spatial autoregressive models, we assessed the geospatial associations of test kit distribution with Census block-level education, income, age, population density, and racial distribution and Census tract-level Social Vulnerability Index. Lag association analyses were used to measure the association between online rapid antigen kit orders and community-level COVID-19 incidence. Results: In total, 164,402 DTC test kits were ordered during the intervention. Distribution of tests at all sites were significantly geospatially clustered at the block-group level (Moran's I: p < 0.001); however, education, income, age, population density, race, and social vulnerability index were inconsistently associated with test orders across sites. In Michigan, Georgia, and Kentucky, there were strong associations between same-day COVID-19 incidence and test kit orders (Michigan: r = 0.89, Georgia: r = 0.85, Kentucky: r = 0.75). The incidence of COVID-19 during the current day and the previous 6-days increased current DTC orders by 9.0 (95% CI = 1.7, 16.3), 3.0 (95% CI = 1.3, 4.6), and 6.8 (95% CI = 3.4, 10.2) in Michigan, Georgia, and Kentucky, respectively. There was no same-day or 6-day lagged correlation between test kit orders and COVID-19 incidence in Indiana. Conclusions: Our findings suggest that online ordering is not associated with geospatial clustering based on sociodemographic characteristics. Observed temporal preferences for DTC ordering can guide public health messaging around DTC testing programs.
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Written testimony of Arlene Ash in Support of S.750 - September 19, 2023, Massachusetts State HouseWritten testimony of Arlene Ash in Support of Massachusetts Bill S.750, "An Act relative to primary care for you."
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Mobile Health Intervention in Patients With Type 2 Diabetes: A Randomized Clinical TrialImportance: Clinical pharmacists and health coaches using mobile health (mHealth) tools, such as telehealth and text messaging, may improve blood glucose levels in African American and Latinx populations with type 2 diabetes. Objective: To determine whether clinical pharmacists and health coaches using mHealth tools can improve hemoglobin A1c (HbA1c) levels. Design, setting, and participants: This randomized clinical trial included 221 African American or Latinx patients with type 2 diabetes and elevated HbA1c (≥8%) from an academic medical center in Chicago. Adult patients aged 21 to 75 years were enrolled and randomized from March 23, 2017, through January 8, 2020. Patients randomized to the intervention group received mHealth diabetes support for 1 year followed by monitored usual diabetes care during a second year (follow-up duration, 24 months). Those randomized to the waiting list control group received usual diabetes care for 1 year followed by the mHealth diabetes intervention during a second year. Interventions: The mHealth diabetes intervention included remote support (eg, review of glucose levels and medication intensification) from clinical pharmacists via a video telehealth platform. Health coach activities (eg, addressing barriers to medication use and assisting pharmacists in medication reconciliation and telehealth) occurred in person at participant homes and via phone calls and text messaging. Usual diabetes care comprised routine health care from patients' primary care physicians, including medication reconciliation and adjustment. Main outcomes and measures: Outcomes included HbA1c (primary outcome), blood pressure, cholesterol, body mass index, health-related quality of life, diabetes distress, diabetes self-efficacy, depressive symptoms, social support, medication-taking behavior, and diabetes self-care measured every 6 months. Results: Among the 221 participants (mean [SD] age, 55.2 [9.5] years; 154 women [69.7%], 148 African American adults [67.0%], and 73 Latinx adults [33.0%]), the baseline mean (SD) HbA1c level was 9.23% (1.53%). Over the initial 12 months, HbA1c improved by a mean of -0.79 percentage points in the intervention group compared with -0.24 percentage points in the waiting list control group (treatment effect, -0.62; 95% CI, -1.04 to -0.19; P = .005). Over the subsequent 12 months, a significant change in HbA1c was observed in the waiting list control group after they received the same intervention (mean change, -0.57 percentage points; P = .002), while the intervention group maintained benefit (mean change, 0.17 percentage points; P = .35). No between-group differences were found in adjusted models for secondary outcomes. Conclusions and relevance: In this randomized clinical trial, HbA1c levels improved among African American and Latinx adults with type 2 diabetes. These findings suggest that a clinical pharmacist and health coach-delivered mobile health intervention can improve blood glucose levels in African American and Latinx populations and may help reduce racial and ethnic disparities. Trial registration: ClinicalTrials.gov Identifier: NCT02990299.
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Paying for Medical and Social Complexity in Massachusetts MedicaidImportance: The first MassHealth Social Determinants of Health payment model boosted payments for groups with unstable housing and those living in socioeconomically stressed neighborhoods. Improvements were designed to address previously mispriced subgroups and promote equitable payments to MassHealth accountable care organizations (ACOs). Objective: To develop a model that ensures payments largely follow observed costs for members with complex health and/or social risks. Design, setting, and participants: This cross sectional study used administrative data for members of the Massachusetts Medicaid program MassHealth in 2016 or 2017. Participants included members who were eligible for MassHealth's managed care, aged 0 to 64 years, and enrolled for at least 183 days in 2017. A new total cost of care model was developed and its performance compared with 2 earlier models. All models were fit to 2017 data (most recent available) and validated on 2016 data. Analyses were begun in February 2019 and completed in January 2023. Exposures: Model 1 used age-sex categories, a diagnosis-based morbidity relative risk score (RRS), disability, serious mental illness, substance use disorder, housing problems, and neighborhood stress. Model 2 added an interaction for unstable housing with RRS. Model 3 added rurality and updated diagnosis-based RRS, medication-based RRS, and interactions between sociodemographic characteristics and morbidity. Main outcome and measures: Total 2017 annual cost was modeled and overall model performance (R2) and fair pricing of subgroups evaluated using observed-to-expected (O:E) ratios. Results: Among 1 323 424 members, mean (SD) age was 26.4 (17.9) years, 53.4% were female (46.6% male), and mean (SD) 2017 cost was $5862 ($15 417). The R2 for models 1, 2, and 3 was 52.1%, 51.5%, and 60.3%, respectively. Earlier models overestimated costs for members without behavioral health conditions (O:E ratios 0.94 and 0.93 for models 1 and 2, respectively) and underestimated costs for those with behavioral health conditions (O:E ratio >1.10); model 3 O:E ratios were near 1.00. Model 3 was better calibrated for members with housing problems, those with children, and those with high morbidity scores. It reduced underpayments to ACOs whose members had high medical and social complexity. Absolute and relative model performance were similar in 2016 data. Conclusions and relevance: In this cross-sectional study of data from Massachusetts Medicaid, careful modeling of social and medical risk improved model performance and mitigated underpayments to safety-net systems.
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Effects of Teacher Training and Continued Support on the Delivery of an Evidence-Based HIV Prevention Program: Findings From a National Implementation Study in the BahamasBackground: Few studies have investigated the effects of teacher training and continued support on teachers' delivery of evidence-based HIV prevention programs. We examined these factors in a national implementation study of an evidence-based HIV risk reduction intervention for adolescents in the sixth grade in the Bahamas. Methods: Data were collected from 126 grade 6 teachers and 3,118 students in 58 government elementary schools in the Bahamas in 2019-2021. This is a Hybrid Type III implementation study guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) model. Teachers attended 2-day training workshops. Trained school coordinators and peer mentors provided biweekly monitoring and mentorship. We used mixed-effects models to assess the effects of teacher training and continued support on implementation fidelity. Results: Teachers who received training in-person or both in-person and online taught the most core activities (27.0 and 27.2 of 35), versus only online training (21.9) and no training (14.9) (F = 15.27, p < .001). Teachers with an "excellent" or "very good" school coordinator taught more core activities than those with a "satisfactory" coordinator or no coordinator (29.2 vs. 27.8 vs. 19.3 vs. 14.8, F = 29.20, p < .001). Teachers with a "very good" mentor taught more core activities and sessions than those with a "satisfactory" mentor or no mentor (30.4 vs. 25.0 vs. 23.1; F = 7.20; p < .01). Teacher training, implementation monitoring, peer mentoring, teachers' self-efficacy, and school-level support were associated with implementation fidelity, which in turn was associated with improved student outcomes (HIV/AIDS knowledge, preventive reproductive health skills, self-efficacy, and intention to use protection). Conclusion: Teachers receiving in-person training and those having higher-rated school coordinator and mentor support taught a larger number of HIV prevention core activities. Effective teacher training, implementation monitoring, and peer mentoring are critical for improving implementation fidelity and student outcomes.
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Toward a more comprehensive understanding of organizational influences on implementation: the organization theory for implementation science frameworkIntroduction: Implementation is influenced by factors beyond individual clinical settings. Nevertheless, implementation research often focuses on factors related to individual providers and practices, potentially due to limitations of available frameworks. Extant frameworks do not adequately capture the myriad organizational influences on implementation. Organization theories capture diverse organizational influences but remain underused in implementation science. To advance their use among implementation scientists, we distilled 70 constructs from nine organization theories identified in our previous work into theoretical domains in the Organization Theory for Implementation Science (OTIS) framework. Methods: The process of distilling organization theory constructs into domains involved concept mapping and iterative consensus-building. First, we recruited organization and implementation scientists to participate in an online concept mapping exercise in which they sorted organization theory constructs into domains representing similar theoretical concepts. Multidimensional scaling and hierarchical cluster analyses were used to produce visual representations (clusters) of the relationships among constructs in concept maps. Second, to interpret concept maps, we engaged members of the Cancer Prevention and Control Research Network (CPCRN) OTIS workgroup in consensus-building discussions. Results: Twenty-four experts participated in concept mapping. Based on resulting construct groupings' coherence, OTIS workgroup members selected the 10-cluster solution (from options of 7-13 clusters) and then reorganized clusters in consensus-building discussions to increase coherence. This process yielded six final OTIS domains: organizational characteristics (e.g., size; age); governance and operations (e.g., organizational and social subsystems); tasks and processes (e.g., technology cycles; excess capacity); knowledge and learning (e.g., tacit knowledge; sense making); characteristics of a population of organizations (e.g., isomorphism; selection pressure); and interorganizational relationships (e.g., dominance; interdependence). Discussion: Organizational influences on implementation are poorly understood, in part due to the limitations of extant frameworks. To improve understanding of organizational influences on implementation, we distilled 70 constructs from nine organization theories into six domains. Applications of the OTIS framework will enhance understanding of organizational influences on implementation, promote theory-driven strategies for organizational change, improve understanding of mechanisms underlying relationships between OTIS constructs and implementation, and allow for framework refinement. Next steps include testing the OTIS framework in implementation research and adapting it for use among policymakers and practitioners.
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Anxiety and Depression Among US Nursing Home Residents with Chronic Obstructive Pulmonary DiseaseBackground: Chronic obstructive pulmonary disease (COPD) is highly prevalent among nursing home residents; however, few studies have focused on the psychological impact of this clinically significant condition on nursing home residents. Objective: We examine the prevalence of, and factors associated with, anxiety and depression in nursing home residents with COPD. Methods: Using the US 2018 Minimum Dataset (MDS), we conducted a cross-sectional study among 239,615 residents aged ≥50 years old in US Medicare/Medicaid certified nursing homes with COPD. Anxiety and depression were diagnosed based on clinical diagnoses, physical examination findings, and treatment orders. Multivariable adjusted Poisson models with a generalized estimating equations approach account for the clustering among residents within nursing homes. Results: The average age of the study population was 79 years (SD: 10.6), 62.0% were women, and 43.7% had five or more comorbid conditions. In this population, 37.2% had anxiety, 57.6% had depression, and 27.5% had both mental health conditions. Women, current tobacco users, persons 50-64 years old, those who reported having moderate or severe pain, and nursing home residents with multimorbidity were more likely to have anxiety or depression than respective comparison groups. Conclusion: Anxiety and depression are common among US nursing home residents with COPD. Women, medically complex patients, and those who report having moderate-to-severe pain appear to be more likely to have anxiety and depression. Clinical teams should be aware of these findings when managing nursing home residents with COPD and use various nonpharmacological and medical interventions for the effective management of anxiety and depression. Longitudinal studies evaluating how anxiety and depression affect the management of COPD and related outcomes, and how best to improve the quality of life of nursing home residents with COPD, are warranted.
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Can psychological interventions prevent or reduce risk for perinatal anxiety disorders? A systematic review and meta-analysisObjective: Little is known about the extent to which interventions can prevent perinatal anxiety disorders. We conducted a systematic review and meta-analysis to examine whether interventions can decrease the onset and symptoms of perinatal anxiety among individuals without an anxiety disorder diagnosis. Method: We conducted a comprehensive literature search across five databases related to key concepts: (1) anxiety disorders/anxiety symptom severity (2) perinatal (3) interventions (4) prevention. We included studies that examined a perinatal population without an anxiety disorder diagnosis, included a comparator group, and assessed perinatal anxiety. We included interventions focused on perinatal anxiety as well as interventions to prevent perinatal depression or influence related outcomes (e.g., physical activity). Results: Thirty-six studies were included. No study assessing the incidence of perinatal anxiety disorder (n = 4) found a significant effect of an intervention. Among studies assessing anxiety symptom severity and included in the quantitative analysis (n = 30), a meta-analysis suggested a small standardized mean difference of -0.31 (95% CI [-0.46, -0.16], p < .001) for anxiety at post intervention, favoring the intervention group. Both mindfulness (n = 6), and cognitive behavioral therapy approaches (n = 10) were effective. Conclusions: Interventions developed for perinatal anxiety were more effective than interventions to prevent perinatal depression. Psychological interventions show promise for reducing perinatal anxiety symptom severity, though interventions specifically targeting anxiety are needed.
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Supporting Veteran's Administration Medical Center Directors' Decisions When Adopting Innovative Practices: Development and Implementation of the "QuickView" and "WishList" ToolsBACKGROUND: Since 2015, the Veterans Health Administration (VHA) Diffusion of Excellence Program has supported spread of practices developed by frontline employees. Shark Tank–style competitions encourage “Sharks” nationwide (VHA medical center/regional directors) to bid for the opportunity to implement practices at their institutions. METHODS: The authors evaluated bidding strategies (2016–2020), developing the “QuickView” practice comparator to promote informed bidding. Program leaders distributed QuickView and revised versions in subsequent competitions. Our team utilized in- person observation, online chats after the competition, bidder interviews, and bid analysis to evaluate QuickView use. Bids were ranked based on demonstrated understanding of resources required for practice implementation. RESULTS: Sharks stated that QuickView supported preparation before the competition and suggested improvements. Our revised tool reported necessary staff time and incorporated a “WishList” from practice finalists detailing minimum requirements for successful implementation. Bids from later years reflected increased review of facilities’ current states before the competition and increased understanding of the resources needed for implementation. Percentage of bids describing local need for the practice rose from 2016 to 2020: 4.7% (6/127); 62.1% (54/87); 78.3% (36/46); 80.6% (29/36); 89.7% (26/29). Percentage of bids committing specific resources rose following QuickView introduction: 81.1% (103/127) in 2016, 69.0% (60/87) in 2017, then 73.9% (34/46) in 2018, 88.9% (32/36) in 2019, and 89.7% (26/29) in 2020. DISCUSSION: In the years following QuickView/WishList implementation, bids reflected increased assessment before the competition of both local needs and available resources. CONCLUSION: Selection of a new practice for implementation requires an understanding of local need, necessary resources, and fit. QuickView and WishList appear to support these determinations.
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Reimagining the Role of Health Departments and Their Partners in Addressing Climate Change: Revising the Building Resilience against Climate Effects (BRACE) FrameworkPublic health departments have important roles to play in addressing the local health impacts of climate change, yet are often not well prepared to do so. The Climate and Health Program (CHP) at the Centers for Disease Control and Prevention (CDC) created the Building Resilience Against Climate Effects (BRACE) framework in 2012 as a five-step planning framework to support public health departments and their partners to respond to the health impacts of climate change. CHP has initiated a process to revise the framework to address learnings from a decade of experience with BRACE and advances in the science and practice of addressing climate and health. The aim of this manuscript is to describe the methodology for revising the BRACE framework and the expected outputs of this process. Development of the revised framework and associated guidance and tools will be guided by a multi-sector expert panel, and finalization will be informed by usability testing. Planned revisions to BRACE will (1) be consistent with the vision of Public Health 3.0 and position health departments as "chief health strategists" in their communities, who are responsible for facilitating the establishment and maintenance of cross-sector collaborations with community organizations, other partners, and other government agencies to address local climate impacts and prevent further harm to historically underserved communities; (2) place health equity as a central, guiding tenet; (3) incorporate greenhouse gas mitigation strategies, in addition to its previous focus on climate adaptation; and (4) feature a new set of tools to support BRACE implementation among a diverse set of users. The revised BRACE framework and the associated tools will support public health departments and their partners as they strive to prevent and reduce the negative health impacts of climate change for everyone, while focusing on improving health equity.
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Pediatric High Blood Pressure Follow-up Guideline Adherence in a Massachusetts Healthcare SystemObjectives: To describe adherence to the American Academy of Pediatrics' (AAP) 2017 clinical practice guidelines for follow-up after high blood pressure (BP) screening by pediatric and family medicine providers in a Massachusetts healthcare system and to assess differences in receipt of follow-up according to child- and clinic-level factors. Methods: Electronic health record data were analyzed for children aged 3-17 years who had an outpatient primary care visit during 2018 with a high BP screening (according to AAP guidelines). We classified AAP guideline adherent follow-up as BP follow-up within 6 months after an elevated finding (+2-week buffer) and within 2 weeks after a hypertensive finding (+2-week buffer). Differences in receipt of guideline adherent follow-up by child- and clinic-level factors were assessed via multilevel mixed effects logistic regression models. Results: The median age of the 4,563 included children was 12 years and 43% were female. Overall, guideline adherent follow-up was received by 17.7% of children within the recommended time interval; 27.4% for those whose index BP was elevated and 5.4% for those whose BP was hypertensive. Modeling revealed older children and those belonging to clinics with more providers, smaller patient panels, and smaller proportion of Medicaid patients were more likely to receive adherent follow-up. Conclusion: Few children received guideline adherent BP follow-up and most differences in adherence were related to clinic resources. System level interventions are needed to improve BP follow-up.
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Performance of Rapid Antigen Tests to Detect Symptomatic and Asymptomatic SARS-CoV-2 Infection : A Prospective Cohort StudyBackground: The performance of rapid antigen tests (Ag-RDTs) for screening asymptomatic and symptomatic persons for SARS-CoV-2 is not well established. Objective: To evaluate the performance of Ag-RDTs for detection of SARS-CoV-2 among symptomatic and asymptomatic participants. Design: This prospective cohort study enrolled participants between October 2021 and January 2022. Participants completed Ag-RDTs and reverse transcriptase polymerase chain reaction (RT-PCR) testing for SARS-CoV-2 every 48 hours for 15 days. Setting: Participants were enrolled digitally throughout the mainland United States. They self-collected anterior nasal swabs for Ag-RDTs and RT-PCR testing. Nasal swabs for RT-PCR were shipped to a central laboratory, whereas Ag-RDTs were done at home. Participants: Of 7361 participants in the study, 5353 who were asymptomatic and negative for SARS-CoV-2 on study day 1 were eligible. In total, 154 participants had at least 1 positive RT-PCR result. Measurements: The sensitivity of Ag-RDTs was measured on the basis of testing once (same-day), twice (after 48 hours), and thrice (after a total of 96 hours). The analysis was repeated for different days past index PCR positivity (DPIPPs) to approximate real-world scenarios where testing initiation may not always coincide with DPIPP 0. Results were stratified by symptom status. Results: Among 154 participants who tested positive for SARS-CoV-2, 97 were asymptomatic and 57 had symptoms at infection onset. Serial testing with Ag-RDTs twice 48 hours apart resulted in an aggregated sensitivity of 93.4% (95% CI, 90.4% to 95.9%) among symptomatic participants on DPIPPs 0 to 6. When singleton positive results were excluded, the aggregated sensitivity on DPIPPs 0 to 6 for 2-time serial testing among asymptomatic participants was lower at 62.7% (CI, 57.0% to 70.5%), but it improved to 79.0% (CI, 70.1% to 87.4%) with testing 3 times at 48-hour intervals. Limitation: Participants tested every 48 hours; therefore, these data cannot support conclusions about serial testing intervals shorter than 48 hours. Conclusion: The performance of Ag-RDTs was optimized when asymptomatic participants tested 3 times at 48-hour intervals and when symptomatic participants tested 2 times separated by 48 hours. Primary funding source: National Institutes of Health RADx Tech program.
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Development and validation of a predictive model for the diagnosis of rheumatic heart disease in low-income countries based on two cross-sectional studiesObjectives: We developed a questionnaire-based risk-scoring system to identify children at risk for rheumatic heart disease (RHD) in rural India. The resulting predictive model was validated in Nepal, in a population with a similar demographic profile to rural India. Methods: The study involved 8646 students (mean age 13.0 years, 46% boys) from 20 middle and high schools in the West Midnapore district of India. The survey asked questions about the presence of different signs and symptoms of RHD. Students with possible RHD who experienced sore throat and joint pain were offered an echocardiogram to screen for RHD. Their findings were compared with randomly selected students without these symptoms. The data were analyzed to develop a predictive model for identifying RHD. Results: Based on our univariate analyses, seven variables were used for building a predictive model. A four-variable model (joint pain plus sore throat, female sex, shortness of breath, and palpitations) best predicted the risk of RHD with a C-statistic of 0.854. A six-point scoring system developed from the model was validated among similarly aged children in Nepal. Conclusions: A simple questionnaire-based predictive instrument could identify children at higher risk for this disease in low-income countries where RHD remains prevalent. Echocardiography could then be used in these high-risk children to detect RHD in its early stages. This may support a strategy for more effective secondary prophylaxis of RHD.
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Unvaccinated Adolescents' COVID-19 Vaccine Intentions: Implications for Public Health MessagingPurpose: COVID-19 vaccine uptake remains low for US adolescents and contributes to excess morbidity and mortality. Most research has assessed parental intention to vaccinate their children. We explored differences between vaccine-acceptant and vaccine-hesitant unvaccinated US adolescents using national survey data. Methods: A nonprobability, quota-based sample of adolescents, aged 13-17 years, was recruited through an online survey panel in April 2021. One thousand nine hundred twenty seven adolescents were screened for participation and the final sample included 985 responses. We assessed responses from unvaccinated adolescents (n = 831). Our primary measure was COVID-19 vaccination intent ("vaccine-acceptant" defined as "definitely will" get a COVID-19 vaccine and any other response classified as "vaccine-hesitant") and secondary measures included reasons for intending or not intending to get vaccinated and trusted sources of COVID-19 vaccine information. We calculated descriptive statistics and chi-square tests to explore differences between vaccine-acceptant and vaccine-hesitant adolescents. Results: Most (n = 831; 70.9%) adolescents were hesitant, with more hesitancy observed among adolescents with low levels of concern about COVID-19 and high levels of concern about side effects of COVID-19 vaccination. Among vaccine-hesitant adolescents, reasons for not intending to get vaccinated included waiting for safety data and having parents who would make the vaccination decision. Vaccine-hesitant adolescents had a lower number of trusted information sources than vaccine-acceptant adolescents. Discussion: Differences identified between vaccine-acceptant and vaccine-hesitant adolescents can inform message content and dissemination. Messages should include accurate, age-appropriate information about side effects and risks of COVID-19 infection. Prioritizing dissemination of these messages through family members, state and local government officials, and healthcare providers may be most effective.
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Disparities in Receipt of Guideline-adherent Blood Pressure Screening: An Observational Examination of Electronic Health Record Data from a Massachusetts Healthcare SystemObjective: To describe the prevalence of blood pressure (BP) screening according to the 2017 American Academy of Pediatrics (AAP) guidelines and differences according to social vulnerability indicators. Study design: We extracted electronic health record data from January 1, 2018, through December 31, 2018, from the largest healthcare system in Central Massachusetts. Outpatient visits for children aged 3-17 years without a prior hypertension diagnosis were included. Adherence was defined by the American Academy of Pediatrics guideline (≥1 BP screening for children with a body mass index [BMI] of <95th percentile) and at every encounter for children with a BMI of ≥95th percentile). Independent variables included social vulnerability indicators at the patient level (insurance type, language, Child Opportunity Index, race/ethnicity) and clinic level (location, Medicaid population). Covariates included child's age, sex, and BMI status, and clinic specialty, patient panel size, and number of healthcare providers. We used direct estimation to calculate prevalence estimates and multivariable mixed effects logistic regression to determine the odds of receiving guideline-adherent BP screening. Results: Our sample comprised 19 695 children (median age, 11 years; 48% female) from 7 pediatric and 20 family medicine clinics. The prevalence of guideline-adherent BP screening was 89%. In our adjusted model, children with a BMI of ≥95th percentile, with public insurance, and who were patients at clinics with larger Medicaid populations and larger patient panels had a lower odds of receiving guideline-adherent BP screening. Conclusions: Despite overall high adherence to BP screening guidelines, patient- and clinic-level disparities were identified.
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A System for Rapidly Yet Rigorously Evaluating the Quality of Randomized Controlled TrialsThis tutorial describes a system for rapidly yet rigorously assessing the quality of randomized controlled trials (RCTs). The system has 7 criteria, represented by the acronym "BIS FOES." The BIS FOES system directs readers to assess RCTs based on the following 7 criteria: the RCT's use (or not) of effective (1) Blinding; the RCT's use (or not) of (2) Intent-to-Treat Analysis; the RCT's (3) Size and other information reflecting the effectiveness of randomization; the amount of sample lost during (4) Follow-up; the (5) Outcomes examined by the RCT (specifically, the outcome measures used by the RCT), the (6) Efects reported (ie, the statistical and clinical significance of the RCT's primary, secondary, and safety findings), and any (7) Special Considerations (ie, additional strengths, limitations, or notable features of the RCT). The first 6 criteria are of basic importance to the assessment of every RCT, whereas the Special Considerations criteria allows the system to be expanded to include virtually any other important aspect of the RCT. This tutorial explains the importance of these criteria and how to assess them. This tutorial also describes how many BIS FOES criteria can be initially assessed from the RCT Abstract while also directing readers to specific locations in the RCT article where additional important information can be found. We hope that the BIS FOES system will help healthcare trainees, but also potentially clinicians, researchers, and the general public, rapidly and thoroughly assess RCTs.
