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Importance: Infant growth predicts long-term obesity and cardiovascular disease. Previous interventions designed to prevent obesity in the first 2 years of life have been largely unsuccessful. Obesity prevalence is high among traditional racial and ethnic minority groups., Objective: To compare the effectiveness of adding a digital childhood obesity prevention intervention to health behavior counseling delivered by pediatric primary care clinicians., Design, Setting, and Participants: Individually randomized, parallel-group trial conducted at 6 US medical centers and enrolling patients shortly after birth. To be eligible, parents spoke English or Spanish, and children were born after 34 weeks' gestational age. Study enrollment occurred between October 2019 and January 2022, with follow-up through January 2024., Interventions: In the clinic-based health behavior counseling (clinic-only) group, pediatric clinicians used health literacy-informed booklets at well-child visits to promote healthy behaviors (n = 451). In the clinic + digital intervention group, families also received health literacy-informed, individually tailored, responsive text messages to support health behavior goals and a web-based dashboard (n = 449)., Main Outcomes and Measures: The primary outcome was child weight-for-length trajectory over 24 months. Secondary outcomes included weight-for-length z score, body mass index (BMI) z score, and the percentage of children with overweight or obesity., Results: Of 900 randomized children, 86.3% had primary outcome data at the 24-month follow-up time point; 143 (15.9%) were Black, non-Hispanic; 405 (45.0%) were Hispanic; 185 (20.6%) were White, non-Hispanic; and 165 (18.3%) identified as other or multiple races and ethnicities. Children in the clinic + digital intervention group had a lower mean weight-for-length trajectory, with an estimated reduction of 0.33 kg/m (95% CI, 0.09 to 0.57) at 24 months. There was also an adjusted mean difference of -0.19 (95% CI, -0.37 to -0.02) for weight-for-length z score and -0.19 (95% CI, -0.36 to -0.01) for BMI z score. At age 24 months, 23.2% of the clinic + digital intervention group compared with 24.5% of the clinic-only group had overweight or obesity (adjusted risk ratio, 0.91 [95% CI, 0.70 to 1.17]) based on the Centers for Disease Control and Prevention criteria of BMI 85th percentile or greater. At that age, 7.4% of the clinic + digital intervention group compared with 12.7% of the clinic-only group had obesity (adjusted risk ratio, 0.56 [95% CI, 0.36 to 0.88])., Conclusions and Relevance: A health literacy-informed digital intervention improved child weight-for-length trajectory across the first 24 months of life and reduced childhood obesity at 24 months. The intervention was effective in a racially and ethnically diverse population that included groups at elevated risk for childhood obesity., Trial Registration: ClinicalTrials.gov Identifier: NCT04042467.

Objective: To examine the association between social capital and household food insecurity among US families with newborns., Study Design: This cross-sectional analysis used enrollment data from 881 newborn-caregiver dyads at 6 geographically-diverse US academic sites enrolled in the Greenlight Plus Trial, a comparative effectiveness trial to prevent childhood obesity. Ordinal proportional-odds models were used to characterize the associations of 2 self-reported measures of social capital: (1) caregiver social support and (2) neighborhood social cohesion, with household food insecurity after controlling for sociodemographic characteristics., Results: Among 881 newborn-caregiver dyads (49% Hispanic, 23% non-Hispanic White, 17% non-Hispanic Black; 49% with annual household income <$50 000), food security was high for 75%, marginal for 9%, low for 11% and very low for 4%. In covariate-adjusted analyses, caregivers with a low social support score of 18 had 5 times the odds (aOR = 5.03 95% CI = 3.28-7.74) of greater food insecurity compared with caregivers with a high social support score of 30. Caregivers with a low neighborhood social cohesion score of 10 had nearly 3 times the odds (aOR = 2.87 95% CI 1.61-5.11) of greater food insecurity compared with caregivers with a high neighborhood social cohesion score of 20. These associations remained robust when both social capital measures were included in one model., Conclusions: Caregiver social support and neighborhood social cohesion each appear to be inversely associated with food insecurity among US families with newborns. Longitudinal research is needed to determine the directionality of these relationships and whether improving social capital for families with young children reduces household food insecurity., Competing Interests: Declaration of Competing Interest This secondary analysis utilized data from the Greenlight Plus Trial which was supported by the Patient Centered Outcomes Research Institute (PCORI) [contract number AD-2018C1-11238]. Study data were collected and managed using REDCap electronic data capture tools hosted by Vanderbilt University Medical Center and supported by NCATS/NIH grant number: UL1 TR000445. The funders of the Greenlight Plus Trial, PCORI, and NCATS/NIH, had no role in the design and conduct of the study, collection and analysis of the data, preparation of the manuscript, or the decision to submit the manuscript for publication. J. O. L. is a postdoctoral fellow supported by NIH-NIDDKT32DK062707 grant. K. B. F. previously reviewed abstracts for Patient Centered Outcomes Research Institute funded studies unrelated to this study. L. M. S. reported serving as a paid advisor to Medeloop.ai, an artificial intelligence-driven platform that supports clinical research, but this activity was unrelated to this study. The authors have no other conflicts of interest to disclose., (Copyright © 2024 Elsevier Inc. All rights reserved.)

This manuscript addresses a critical topic: navigating complexities of conducting clinical trials during a pandemic. Central to this discussion is engaging communities to ensure diverse participation. The manuscript elucidates deliberate strategies employed to recruit minority communities with poor social drivers of health for participation in COVID-19 trials. The paper adopts a descriptive approach, eschewing analysis of data-driven efficacy of these efforts, and instead provides a comprehensive account of strategies utilized. The Accelerate COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership launched early in the COVID-19 pandemic to develop clinical trials to advance SARS-CoV-2 treatments. In this paper, ACTIV investigators share challenges in conducting research during an evolving pandemic and approaches selected to engage communities when traditional strategies were infeasible. Lessons from this experience include importance of community representatives' involvement early in study design and implementation and integration of well-developed public outreach and communication strategies with trial launch. Centralization and coordination of outreach will allow for efficient use of resources and the sharing of best practices. Insights gleaned from the ACTIV program, as outlined in this paper, shed light on effective strategies for involving communities in treatment trials amidst rapidly evolving public health emergencies. This underscores critical importance of community engagement initiatives well in advance of the pandemic., Competing Interests: None., (© The Author(s) 2024.)

Type 2 Diabetes (T2D) is a chronic multifaceted metabolic condition characterized by elevated blood glucose levels with varying degrees of insulin resistance and abnormal insulin production. Lifestyle modifications, such as those defined by the guidelines for diabetes self-management education and support (DSMES), are foundational for glycemic control. A current gap in T2D management is addressing DSMES which is tailored to best serve the diversity of patients with this disease. The purpose of this narrative review is to discuss the current literature related to lifestyle modification for T2D, the importance of culturally sensitive T2D management programs, and the impact culturally sensitive and diverse T2D management programs have on cardiometabolic health. Despite being disproportionately affected by T2D, racial and ethnic minorities have low referral rates for DSMES. This growing disparity may be exacerbated by a lack of awareness of how to adapt lifestyle modifications in a culturally competent manner and how social determinants of health (SDOH) may affect the infrastructure and resources available to diverse patient populations. Currently, there is limited research on how DSMES is addressed to include culturally and literacy-sensitive recommendations in the United States. Patient-centered care, emphasizing personalized DSMES, can lead to improved glycemic control, reduced healthcare costs, and improved cardiometabolic health. A key component of effective DSMES should include culturally and literacy-sensitive approaches with an awareness of the impact of SDOH. Understanding how ethnicity, race, and culture influence experiences with T2D management can help providers prescribe more patient-centered and sustainable recommendations.

Background: The relative contributions of common patient-reported social determinants of health on 30- and 90-day post-discharge outcomes among patients with acute coronary syndromes (ACS) is unclear., Objective: The aim of this article is to examine the independent associations of social determinants with readmission or death, accounting for medical history., Methods: Participants included adults who were hospitalized with ACS at an academic medical center. Domains measured were social support, health literacy/numeracy, and socioeconomic status (SES) (including education and difficulty paying bills). We employed multivariable Cox proportional hazard models to study associations with time to all-cause readmission or death, up to 30 or 90 days after discharge, and adjusted for demographics and medical history (prior admissions and Elixhauser comorbidity index)., Key Results: Among 1,168 patients with ACS and no history of heart failure, more prior admissions, and higher comorbidity index (the medical history domain) were associated with higher rates of 30- and 90-day readmission or death (domain p values <.01 and <.0001, respectively). The social support domain was not associated with outcomes. Higher health literacy and numeracy were associated with lower rates of 30- and 90-day readmission or death (domain p values .016 and .002, respectively). Higher education and less difficulty paying bills (the SES domain) was marginally associated with lower rates of 90-day readmission or death (domain, p = .052)., Conclusions: In addition to medical history, the domain of health literacy and numeracy was independently associated with readmission or death of patients with ACS during the 90 days after hospital discharge. [ HLRP: Health Literacy Research and Practice . 2024;8(4):e212-e223. ]., Competing Interests: Disclosure: ASM has served as a data safety and monitoring board member for the Clinical Science Research and Development Veterans Affairs Merit Grant: Personalizing Veteran Lung Cancer Screening and Diagnosis. RLR has received support for travel through the Engel Research Award from the Academy for Communication in Healthcare; and has received grants from the National Institutes of Health, Patient-Centered Outcomes Research Institute, Agency for Healthcare Research and Quality, Duke Clinical Research Institute/Novartis, Centers for Disease Control and Prevention Global Health Foundation, Centers for Medicare and Medicaid Services/Center for Medicare and Medicaid Innovation, paid to the institution. EEV has received grants from the National Heart, Lung, and Blood Institute and National Institute of Nursing Research (UG3HL165740), and the National Institutes of Health/National Institute on Aging (R01-AG065249), and served on a COVID-19 Advisory Board for Gilead Sciences. LSM has received grants from the National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases through the University of Utah (R01 DK124719), the Helmsley Charitable Trust (R-2203-05822), and the National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases (R01 DK119282 and R01 DK119282-S), paid to the institution. SPB has received grants from the National Institutes of Health/National Institute of Aging (1K23AG048347-A101), National Institutes of Health/Eunice Kennedy Shriver National Institute of Child Health and Human Development (K12-HD043483), paid to the institution. SK has received grants from the National Institutes of Health, Patient-Centered Outcomes Research Institute, Agency for Healthcare Research and Quality, Centers for Medicare and Medicaid Services, and Esperion Therapeutics, paid to the institution; and has served as a consultant to Gilead Sciences and Bayer. The remaining authors have disclosed no potential conflicts of interest, financial or otherwise.

Importance: The effect of montelukast in reducing symptom duration among outpatients with mild to moderate COVID-19 is uncertain., Objective: To assess the effectiveness of montelukast compared with placebo in treating outpatients with mild to moderate COVID-19., Design, Setting, and Participants: This randomized clinical trial (Accelerating COVID-19 Therapeutic Interventions and Vaccines [ACTIV]-6) was conducted from January 27 through June 23, 2023, during the circulation of Omicron subvariants. Participants aged 30 years or older with confirmed SARS-CoV-2 infection and 2 or more acute COVID-19 symptoms for less than 7 days were included across 104 US sites., Interventions: Participants were randomized 1:1 to receive montelukast, 10 mg once daily, or matched placebo for 14 days., Main Outcomes and Measures: The primary outcome was time to sustained recovery (defined as ≥3 consecutive days without symptoms). Secondary outcomes included time to death; time to hospitalization or death; a composite of health care utilization events (hospitalization, urgent care clinic visit, emergency department visit, or death); COVID-19 clinical progression scale score; and difference in mean time unwell. A modified intention-to-treat approach was used for the analysis., Results: Among 1250 participants who were randomized and received the study drug or placebo, the median age was 53 years (IQR, 42-62 years), 753 (60.2%) were female, and 704 (56.3%) reported receiving 2 or more doses of a SARS-CoV-2 vaccine. Among 628 participants who received montelukast and 622 who received placebo, differences in time to sustained recovery were not observed (adjusted hazard ratio [AHR], 1.02; 95% credible interval [CrI], 0.92-1.12; P = .63 for efficacy). Unadjusted median time to sustained recovery was 10 days (95% CI, 10-11 days) in both groups. No deaths occurred, and hospitalizations were reported for 2 participants (0.3%) in each group; the composite of health care utilization events was reported for 18 participants (2.9%) in the montelukast group and 18 (2.9%) in the placebo group (AHR, 1.01; 95% CrI, 0.45-1.84; P = .48 for efficacy). Five participants (0.4%) experienced serious adverse events (3 [0.5%] in the montelukast group and 2 [0.3%] in the placebo group)., Conclusions and Relevance: In this randomized clinical trial of outpatients with mild to moderate COVID-19, treatment with montelukast did not reduce duration of COVID-19 symptoms. These findings do not support the use of montelukast for the treatment of mild to moderate COVID-19., Trial Registration: ClinicalTrials.gov Identifier: NCT04885530.

The limitations of the explanatory clinical trial framework include the high expense of implementing explanatory trials, restrictive entry criteria for participants, and redundant logistical processes. These limitations can result in slow evidence generation that is not responsive to population health needs, yielding evidence that is not generalizable. Clinically integrated trials, which integrate clinical research into routine care, represent a potential solution to this challenge and an opportunity to support learning health systems. The operational and design features of clinically integrated trials include a focused scope, simplicity in design and requirements, the leveraging of existing data structures, and patient participation in the entire trial process. These features are designed to minimize barriers to participation and trial execution and reduce additional research burdens for participants and clinicians alike. Broad adoption and scalability of clinically integrated trials are dependent, in part, on continuing regulatory, healthcare system, and payer support. This analysis presents a framework of the strengths and challenges of clinically integrated trials and is based on a multidisciplinary expert "Think Tank" panel discussion that included representatives from patient populations, academia, non-profit funding agencies, the U.S. Food and Drug Administration, and industry., Competing Interests: Disclosures Dr. Peters is supported by the National Heart Lung and Blood Institute (T32HL069749) and has received honoraria from Cytokinetics. Dr. Jones has received grants from Bayer, Boehringer Ingelheim, and Merck. Dr. Broedl is an employee of Boehringer Ingelheim. Dr. Hornik received a research grant from Before Brands and consulting fees from SC Pharma. Dr. Knowlton received a salary from Intermountain Health Care. Dr. Krofah had leadership roles in Protas, the Reagan Udall Foundation, Clinical Trials Transformation Initiative (CTTI), Duke Margolis Center for Health Policy, Alliance for a Stronger FDA, Patient Focused Medicines Development (PFMD), and Medical Device Innovation Consortium (MDIC). Dr. Landray received grants from Janssen, FluLab, Schmidt Futures, Google Ventures, the National Institute for Health Research, UK Research & Innovation, Wellcome, and the Bill & Melinda Gates Foundation, as well as study drugs from Regeneron, Roche, AbbVie, and GSK. Dr. Rockhold received grants from the NIH, PCORI, BMS, AstraZeneca, American Regent, the Gates Foundation, and Eidos and consulting fees from Janssen, Clover, Doctor Evidence, and Intercept. He also participated on Data Safety Monitoring Boards for Lilly, AstraZeneca, Merck, Gilead, Novartis, Icosavax, Sanofi, UCB, Amgen, Biogen, BMS, Pulmocide, Alkermes, and Diurnal. He had an unpaid leadership role for the Frontier Science Foundation. He has stock or stock options for GSK, Clover, Athira, Doctor Evidence, DataVant, Spencer Health Solutions, and Adaptic Health. Dr. Roessig is a full-time employee of Bayer AG. Dr. Rothman has received grants from PCORI, the CDC, NIH, and AHRQ. Lesley Schofield is an employee of Novartis and has stock or stock options from Novartis. Dr. Tenaerts is an employee of Medable, Inc., and has a stock option grant with Medable, Inc. Dr. Tenaerts also received an honorarium for participation on a data monitoring committee., (Copyright © 2024. Published by Elsevier Inc.)

Importance: Pragmatic randomized clinical trials (RCTs) often use multiple data sources to examine clinical events, but the relative contribution of data sources to clinical end-point rates is understudied., Objective: To assess the contribution of data sources (electronic health records [EHRs], public/private insurance claims, and/or participant-reported data) to clinical end points among ADAPTABLE participants who had available data., Design, Setting, and Participants: The ADAPTABLE study was an open-label, pragmatic RCT from April 2016 through June 2019 conducted in research networks within clinical practice. Participants had existing atherosclerotic cardiovascular disease and available data to analyze. The characteristics of patients by combinations of data source availability were compared to examine the contribution of each of the data sources to end-point ascertainment. Data for this prespecified analysis were examined from January 2022 to June 2023., Exposures: Randomized exposure to 81 mg or 325 mg of aspirin daily., Main Outcomes and Measures: Number of events for the primary end point (composite of death, hospitalization for myocardial infarction, and hospitalization for stroke) that were contributed by EHR or claims data and then number of events contributed by each additional data source., Results: Of 15 006 participants randomized with at least 1 other source of data available beyond participant-reported data, there were 8756 (58.3%) with participant-reported and EHR data; 4291 (28.6%) with participant-reported, EHR, and claims data; 1412 (9.4%) with EHR-only data; 262 (1.7%) with participant-reported and claims data; 202 (1.3%) with EHR and claims data; and 83 (0.6%) with claims-only data. Participants with EHR-only data were younger (median age, 63.7 years; IQR, 55.8-71.4) compared with the other groups (range, 65.6-71.9 years). Among participants with both EHR and claims data, with or without participant-reported data (n = 4493), for each outcome, most events (92%-100%) were identified in the EHR or in claims data. For all clinical end points, participant-reported data contributed less than 10% of events not otherwise available from claims or EHR data., Conclusions and Relevance: In this analysis of a pragmatic RCT, claims and EHR data provided the most clinical end-point data when compared with participant-reported events. These findings provide a framework for collecting end points in pragmatic clinical trials. Further work is needed to understand the data source combinations that most effectively provide clinical end-point data in RCTs.

Importance: Atherosclerotic cardiovascular disease (ASCVD) remains the leading cause of morbidity and mortality in the US. Although aspirin is recommended for secondary prevention of ASCVD, there was no difference in safety and effectiveness of aspirin dosed daily at 81 mg or 325 mg in the ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) randomized clinical trial. However, it is unknown whether differences by sex exist in the safety and effectiveness of the different aspirin doses., Objective: To evaluate sex-specific differences in the safety and effectiveness of 2 aspirin doses in the ADAPTAPLE trial., Design, Setting, and Participants: The ADAPTABLE study was an open-label, pragmatic, randomized clinical trial that randomly assigned participants with chronic, stable ASCVD to 81 mg vs 325 mg of aspirin daily. Using Cox proportional-hazard models, male and female participants were compared for outcomes. In addition, it was assessed whether sex was an effect modifier in the association between aspirin dose and outcomes. The ADAPTABLE trial was conducted at 40 medical centers and 1 health plan. Eligible patients were 18 years and older and had established ASCVD. Study data were analyzed from December 2021 to March 2024., Interventions: Patients received 81 mg or 325 mg of aspirin daily for the secondary prevention of ASCVD., Main Outcomes and Measures: The primary effectiveness outcomes included all-cause death and hospitalization for myocardial infarction (MI) or stroke. The primary safety outcome was hospitalization for major bleeding requiring transfusion., Results: A total of 15 076 patients (median [IQR] age, 67.6 [60.7-73.6] years; 10 352 male [68.7%]) were followed up for a median (IQR) of 26.2 (19.0-34.9) months. Overall, 4724 (31.3%) were female, and 2307 of the female participants (48.8%) received aspirin 81 mg. Compared with males, female participants were younger (median [IQR] age, 66.3 [59.4-72.6] years vs 68.2 (61.4-73.9) years, less likely to self-report White race (3426 [72.5%] vs 8564 [82.7%]), more likely to smoke (564 [12.9%] vs 818 [8.4%]), and more likely to have a history of peripheral arterial disease (1179 [25.7%] vs 2314 [23.0%]). The primary effectiveness outcome of all-cause death and hospitalization for MI or stroke occurred in 379 female participants (8.1%) and 780 male participants (7.1%). There was no significant interaction by sex for the primary effectiveness end point between the 2 aspirin doses (female adjusted hazard ratio [aHR], 1.01; 95% CI, 0.82-1.26 and male aHR, 1.06; 95% CI, 0.91-1.23; P interaction term for sex = .74). During the trial, female participants had fewer revascularization procedures (237 [5.0%] vs 680 [6.6%]; aHR, 0.79; 95% CI, 0.68-0.92; P = .002) but had a higher risk of hospitalization for stroke (aHR, 1.72; 95% CI, 1.27-2.33; P < .001). Among female participants, there was a slightly higher rate of bleeding in the 81-mg aspirin cohort compared with the 325-mg cohort (20 [0.83%] vs 13 [0.52%]; aHR, 2.21; 95% CI, 1.04-4.70; P interaction term for sex = .07). There were no significant differences between female and male participants regarding aspirin dose adherence., Conclusions and Relevance: In this secondary analysis of the ADAPTABLE trial, there were no significant sex-specific differences in the effectiveness and safety of 2 aspirin doses for secondary prevention of ASCVD events., Trial Registration: ClinicalTrials.gov Identifier: NCT02697916.

Objective: This study aimed to describe caregiver satisfaction with physician communication over the first two years of life and examine differences by preferred language and the relationship to physician continuity., Methods: Longitudinal data were collected at well visits (2 months to 2 years) from participants in a randomized controlled trial to prevent childhood obesity. Satisfaction with communication was assessed using the validated Communication Assessment Tool (CAT) questionnaire. Changes in the odds of optimal scores were estimated in mixed-effects logistic regression models to evaluate the associations between satisfaction over time and language, interpreter use, and physician continuity., Results: Of 865 caregivers, 35% were Spanish-speaking. Spanish-speaking caregivers without interpreters had lower odds of an optimal satisfaction score compared with English speakers during the first 2 years, beginning at 2 months [OR 0.64 (95% CI: 0.43, 0.95)]. There was no significant difference in satisfaction between English-speaking caregivers and Spanish-speaking caregivers with an interpreter. The odds of optimal satisfaction scores increased over time for both language groups. For both language groups, odds of an optimal satisfaction score decreased each time a new physician was seen for a visit [OR 0.82 (95% CI: 0.69, 0.97)]., Conclusion: Caregiver satisfaction with physician communication improves over the first two years of well-child visits for both English- and Spanish-speakers. A loss of physician continuity over time was also associated with lower satisfaction. Future interventions to ameliorate communication disparities should ensure adequate interpreter use for primarily Spanish-speaking patients and address continuity issues to improve communication satisfaction., Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to disclose., (Copyright © 2024 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.)

Background: SARS-CoV-2-infected patients may develop new conditions in the period after the acute infection. These conditions, the post-acute sequelae of SARS-CoV-2 infection (PASC, or Long COVID), involve a diverse set of organ systems. Limited studies have investigated the predictability of Long COVID development and its associated risk factors., Methods: In this retrospective cohort study, we used electronic healthcare records from two large-scale PCORnet clinical research networks, INSIGHT (~1.4 million patients from New York) and OneFlorida+ (~0.7 million patients from Florida), to identify factors associated with having Long COVID, and to develop machine learning-based models for predicting Long COVID development. Both SARS-CoV-2-infected and non-infected adults were analysed during the period of March 2020 to November 2021. Factors associated with Long COVID risk were identified by removing background associations and correcting for multiple tests., Results: We observed complex association patterns between baseline factors and a variety of Long COVID conditions, and we highlight that severe acute SARS-CoV-2 infection, being underweight, and having baseline comorbidities (e.g., cancer and cirrhosis) are likely associated with increased risk of developing Long COVID. Several Long COVID conditions, e.g., dementia, malnutrition, chronic obstructive pulmonary disease, heart failure, PASC diagnosis U099, and acute kidney failure are well predicted (C-index > 0.8). Moderately predictable conditions include atelectasis, pulmonary embolism, diabetes, pulmonary fibrosis, and thromboembolic disease (C-index 0.7-0.8). Less predictable conditions include fatigue, anxiety, sleep disorders, and depression (C-index around 0.6)., Conclusions: This observational study suggests that association patterns between investigated factors and Long COVID are complex, and the predictability of different Long COVID conditions varies. However, machine learning-based predictive models can help in identifying patients who are at risk of developing a variety of Long COVID conditions., (© 2024. The Author(s).)

Background: While several studies examine the relationship between screen time and dietary practices in children and teenagers, there is limited research in toddlers. This study evaluates the association between television (TV) exposure and dietary practices in 2-year-old children., Methods: We conducted a cross-sectional, secondary data analysis from the Greenlight Intervention Study. Toddlers' daily TV watching time, mealtime TV, and dietary practices were assessed by caregiver report at the 24-month well-child visit. Separate regression models were used and adjusted for sociodemographic/household characteristics and clinic site., Results: Five hundred and thirty-two toddlers were included (51% Latino; 30% non-Latino Black; 59% ≤$20,000 annual household income). Median daily TV watching time was 42 minutes (interquartile range: 25, 60); 25% reported the TV was "usually on" during mealtimes. After adjustment, toddlers who watched more TV daily had higher odds of consuming sugar-sweetened beverages, fast food, and more junk food; those watching less TV had higher odds of consuming more fruits/vegetables. Those with the TV "usually on" during mealtimes were more likely to consume sugar-sweetened beverages (aOR 3.72 [95% confidence interval {CI} 2.16-6.43]), fast food (aOR 2.83 [95%CI 1.54-5.20]), and more junk food (aOR 4.25 [95%CI 2.71-6.65])., Conclusions: Among toddlers from primarily minoritized populations and of lower socioeconomic status, those who watched more TV daily and usually had the TV on during meals had significantly less healthy dietary practices, even after adjusting for known covariates. This study supports the current American Academy of Pediatrics screen time guidelines and underscores the importance of early counseling on general and mealtime TV., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.)

Importance: The frequency and characteristics of post-acute sequelae of SARS-CoV-2 infection (PASC) may vary by SARS-CoV-2 variant., Objective: To characterize PASC-related conditions among individuals likely infected by the ancestral strain in 2020 and individuals likely infected by the Delta variant in 2021., Design: Retrospective cohort study of electronic medical record data for approximately 27 million patients from March 1, 2020-November 30, 2021., Setting: Healthcare facilities in New York and Florida., Participants: Patients who were at least 20 years old and had diagnosis codes that included at least one SARS-CoV-2 viral test during the study period., Exposure: Laboratory-confirmed COVID-19 infection, classified by the most common variant prevalent in those regions at the time., Main Outcome(s) and Measure(s): Relative risk (estimated by adjusted hazard ratio [aHR]) and absolute risk difference (estimated by adjusted excess burden) of new conditions, defined as new documentation of symptoms or diagnoses, in persons between 31-180 days after a positive COVID-19 test compared to persons without a COVID-19 test or diagnosis during the 31-180 days after the last negative test., Results: We analyzed data from 560,752 patients. The median age was 57 years; 60.3% were female, 20.0% non-Hispanic Black, and 19.6% Hispanic. During the study period, 57,616 patients had a positive SARS-CoV-2 test; 503,136 did not. For infections during the ancestral strain period, pulmonary fibrosis, edema (excess fluid), and inflammation had the largest aHR, comparing those with a positive test to those without a COVID-19 test or diagnosis (aHR 2.32 [95% CI 2.09 2.57]), and dyspnea (shortness of breath) carried the largest excess burden (47.6 more cases per 1,000 persons). For infections during the Delta period, pulmonary embolism had the largest aHR comparing those with a positive test to a negative test (aHR 2.18 [95% CI 1.57, 3.01]), and abdominal pain carried the largest excess burden (85.3 more cases per 1,000 persons)., Conclusions and Relevance: We documented a substantial relative risk of pulmonary embolism and a large absolute risk difference of abdomen-related symptoms after SARS-CoV-2 infection during the Delta variant period. As new SARS-CoV-2 variants emerge, researchers and clinicians should monitor patients for changing symptoms and conditions that develop after infection., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Varma et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Adults hospitalized for cardiovascular events are at high risk for postdischarge mortality. Screening of psychosocial risk is prioritized by the Joint Commission. We tested whether key patient-reported psychosocial and behavioral measures could predict posthospitalization mortality in a cohort of adults hospitalized for a cardiovascular event., Methods: We conducted a prospective cohort study to test the prognostic utility of validated patient-reported measures, including health literacy, social support, health behaviors and disease management, and socioeconomic status. Cox survival analyses of mortality were conducted over a median of 3.5 years., Results: Among 2977 adults hospitalized for either acute coronary syndrome or acute decompensated heart failure, the mean age was 53 years, and 60% were male. After adjusting for demographic, clinical, and other psychosocial factors, mortality risk was greatest among patients who reported being unemployed (hazard ratio [HR]: 1.99, 95% confidence interval [CI]): 1.30-3.06), retired (HR: 2.14, 95% CI: 1.60-2.87), or unable to work due to disability (HR: 2.36, 95% CI: 1.73-3.21), as compared to those who were employed. Patient-reported perceived health competence (PHCS-2) and exercise frequency were also associated with mortality risk after adjusting for all other variables (HR: 0.86, 95% CI: 0.73-1.00 per four-point increase in PHCS-2; HR: 0.86, 95% CI: 0.77-0.96 per 3-day increase in exercise frequency, respectively)., Conclusions: Patient-reported measures of employment status, perceived health competence, and exercise frequency independently predict mortality after a cardiac hospitalization. Incorporating these brief, valid measures into hospital-based screening may help with prognostication and targeting patients for resources during post-discharge transitions of care., (© 2024 The Authors. Journal of Hospital Medicine published by Wiley Periodicals LLC on behalf of Society of Hospital Medicine.)

Background: Understanding how different populations respond to a childhood obesity intervention could help optimize personalized treatment strategies, especially with the goal to reduce disparities in obesity. Methods: We conducted a secondary analysis of the Greenlight Cluster Randomized Controlled Trial, a health communication focused pediatric obesity prevention trial, to evaluate for heterogeneity of treatment effect (HTE) by child biological sex, caregiver BMI, caregiver reported race and ethnicity, primary language, and health literacy. To examine HTE on BMI z-score from 2 to 24 months of age, we fit linear mixed effects models. Results: We analyzed 802 caregiver-child pairs, of which 52% of children were female, 58% of households reported annual family income of <$20,000, and 83% did not have a college degree. We observed evidence to suggest HTE by primary language ( p  = 0.047 for Spanish vs. English) and the combination of primary language and health literacy ( p  = 0.01). There was insufficient evidence to suggest that the Greenlight intervention effect differed by biological sex, caregiver BMI, or by race/ethnicity. Conclusions: This HTE analysis found that the Greenlight obesity prevention intervention had a more beneficial effect on child BMI z-score over 2 years for children of caregivers with limited health literacy and for caregivers for whom Spanish was the primary language.

Background and Objectives: The American Academy of Pediatrics designed The Injury Prevention Program (TIPP) in 1983 to help pediatricians prevent unintentional injuries, but TIPP's effectiveness has never been formally evaluated. We sought to evaluate the impact of TIPP on reported injuries in the first 2 years of life., Methods: We conducted a stratified, cluster-randomized trial at 4 academic medical centers: 2 centers trained their pediatric residents and implemented TIPP screening and counseling materials at all well-child checks (WCCs) for ages 2 to 24 months, and 2 centers implemented obesity prevention. At each WCC, parents reported the number of child injuries since the previous WCC. Proportional odds logistic regression analyses with generalized estimating equation examined the extent to which the number of injuries reported were reduced at TIPP intervention sites compared with control sites, adjusting for baseline child, parent, and household factors., Results: A total of 781 parent-infant dyads (349 TIPP; 432 control) were enrolled and had sufficient data to qualify for analyses: 51% Hispanic, 28% non-Hispanic Black, and 87% insured by Medicaid. Those at TIPP sites had significant reduction in the adjusted odds of reported injuries compared with non-TIPP sites throughout the follow-up (P = .005), with adjusted odds ratios (95% CI) of 0.77 (0.66-0.91), 0.60 (0.44-0.82), 0.32 (0.16-0.62), 0.26 (0.12-0.53), and 0.27 (0.14-0.52) at 4, 6, 12, 18, and 24 months, respectively., Conclusions: In this cluster-randomized trial with predominantly low-income, Hispanic, and non-Hispanic Black families, TIPP resulted in a significant reduction in parent-reported injuries. Our study provides evidence for implementing the American Academy of Pediatrics' TIPP in routine well-child care., (Copyright © 2024 by the American Academy of Pediatrics.)

Objective: Understand the patient's decision-making process regarding colectomy for recurrent diverticulitis., Background: The decision to pursue elective colectomy for recurrent diverticulitis is highly preference-sensitive. Little is known about the patient's perspective in this decision-making process., Methods: We performed a qualitative study utilizing focus groups of patients with recurrent diverticulitis at 3 centers across the United States. Using an iterative inductive/deductive approach, we developed a conceptual framework to capture the major themes identified in the coded data., Results: From March 2019 to July 2020, 39 patients were enrolled across 3 sites and participated in 6 focus groups. After coding the transcripts using a hierarchical coding system, a conceptual framework was developed. Major themes identified included participants' beliefs about surgery, such as normative beliefs (eg, subjective, value placed on surgery), control beliefs (eg, self-efficacy, stage of change), and anticipated outcomes (eg, expectations, anticipated regret); the role of behavioral management strategies (eg, fiber, eliminate bad habits); emotional experiences (eg, depression, embarrassment); current symptoms (eg, severity, timing); and quality of life (eg, cognitive load, psychosocial factors). Three sets of moderating factors influencing patient choice were identified: clinical history (eg, source of diagnosis, multiple surgeries), clinical protocols (eg, pre-op and post-op education), and provider-specific factors (eg, specialty, choice of surgeon)., Conclusions: Patients view the decision to undergo colectomy through 3 major themes: their beliefs about surgery, their psychosocial context, and moderating factors that influence participant choice to undergo surgery. This knowledge is essential both for clinicians counseling patients who are considering colectomy and for researchers studying the process to optimize care for recurrent diverticulitis., Competing Interests: The authors report no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: Infants with high birthweight have increased risk for adverse outcomes at birth and across childhood. Prenatal risks to healthy food access may increase odds of high birthweight. We tested whether having a poor neighborhood food environment and/or food insecurity had associations with high birthweight., Methods: We analyzed cross-sectional baseline data in Greenlight Plus, an obesity prevention trial across six US cities (n = 787), which included newborns with a gestational age greater than 34 weeks and a birthweight greater than 2500 g. We assessed neighborhood food environment using the Place-Based Survey and food insecurity using the US Household Food Security Module. We performed logistic regression analyses to assess the individual and additive effects of risk factors on high birthweight. We adjusted for potential confounders: infant sex, race, ethnicity, gestational age, birthing parent age, education, income, and study site., Results: Thirty-four percent of birthing parents reported poor neighborhood food environment and/or food insecurity. Compared to those without food insecurity, food insecure families had greater odds of delivering an infant with high birthweight (adjusted odds ratios [aOR] 1.96, 95% confidence intervals [CI]: 1.01, 3.82) after adjusting for poor neighborhood food environment, which was not associated with high birthweight (aOR 1.35, 95% CI: 0.78, 2.34). Each additional risk to healthy food access was associated with a 56% (95% CI: 4%-132%) increase in high birthweight odds., Conclusions: Prenatal risks to healthy food access may increase high infant birthweight odds. Future studies designed to measure neighborhood factors should examine infant birthweight outcomes in the context of prenatal social determinants of health., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.)

Background: In patients with atherosclerotic cardiovascular disease, increasing age is concurrently associated with higher risks of ischemic and bleeding events. The objectives are to determine the impact of aspirin dose on clinical outcomes according to age in atherosclerotic cardiovascular disease., Methods and Results: In the ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) trial, patients with atherosclerotic cardiovascular disease were randomized to daily aspirin doses of 81 mg or 325 mg. The primary effectiveness end point was death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke. The primary safety end point was hospitalization for bleeding requiring transfusion. A total of 15 076 participants were randomized to aspirin 81 mg (n=7540) or 325 mg (n=7536) daily (median follow-up: 26.2 months; interquartile range: 19.0-34.9 months). Median age was 67.6 years (interquartile range: 60.7-73.6 years). Among participants aged <65 years (n=5841 [38.7%]), a primary end point occurred in 226 (7.54%) in the 81 mg group, and in 191 (6.80%) in the 325 mg group (adjusted hazard ratio [HR], 1.23 [95% CI, 1.01-1.49]). Among participants aged ≥65 years (n=9235 [61.3%]), a primary end point occurred in 364 (7.12%) in the 81 mg group, and in 378 (7.96%) in the 325 mg group (adjusted HR, 0.95 [95% CI, 0.82-1.10]). The age-dose interaction was not significant ( P =0.559). There was no significant interaction between age and the randomized aspirin dose for the secondary effectiveness and the primary safety bleeding end points ( P >0.05 for all)., Conclusions: Age does not modify the impact of aspirin dosing (81 mg or 325 mg daily) on clinical end points in secondary prevention of atherosclerotic cardiovascular disease.

Objective: Patients with diabetes mellitus (DM) and concomitant atherosclerotic cardiovascular disease (ASCVD) must be on the most effective dose of aspirin to mitigate risk of future adverse cardiovascular events., Research Design and Methods: ADAPTABLE, an open-label, pragmatic study, randomized patients with stable, chronic ASCVD to 81 mg or 325 mg of daily aspirin. The effects of aspirin dosing was assessed on the primary effectiveness outcome, a composite of all-cause death, hospitalization for myocardial infarction, or hospitalization for stroke, and the primary safety outcome of hospitalization for major bleeding. In this prespecified analysis, we used Cox proportional hazards models to compare aspirin dosing in patients with and without DM for the primary effectiveness and safety outcome., Results: Of 15,076 patients, 5,676 (39%) had DM of whom 2,820 (49.7%) were assigned to 81 mg aspirin and 2,856 (50.3%) to 325 mg aspirin. Patients with versus without DM had higher rates of the composite cardiovascular outcome (9.6% vs. 5.9%; P < 0.001) and bleeding events (0.78% vs. 0.50%; P < 0.001). When comparing 81 mg vs. 325 mg of aspirin, patients with DM had no difference in the primary effectiveness outcome (9.3% vs. 10.0%; hazard ratio [HR] 0.98 [95% CI 0.83-1.16]; P = 0.265) or safety outcome (0.87% vs. 0.69%; subdistribution HR 1.25 [95% CI 0.72-2.16]; P = 0.772)., Conclusions: This study confirms the inherently higher risk of patients with DM irrespective of aspirin dosing. Our findings suggest that a higher dose of aspirin yields no added clinical benefit, even in a more vulnerable population., (© 2023 by the American Diabetes Association.)

Importance: The effect of higher-dose fluvoxamine in reducing symptom duration among outpatients with mild to moderate COVID-19 remains uncertain., Objective: To assess the effectiveness of fluvoxamine, 100 mg twice daily, compared with placebo, for treating mild to moderate COVID-19., Design, Setting, and Participants: The ACTIV-6 platform randomized clinical trial aims to evaluate repurposed medications for mild to moderate COVID-19. Between August 25, 2022, and January 20, 2023, a total of 1175 participants were enrolled at 103 US sites for evaluating fluvoxamine; participants were 30 years or older with confirmed SARS-CoV-2 infection and at least 2 acute COVID-19 symptoms for 7 days or less., Interventions: Participants were randomized to receive fluvoxamine, 50 mg twice daily on day 1 followed by 100 mg twice daily for 12 additional days (n = 601), or placebo (n = 607)., Main Outcomes and Measures: The primary outcome was time to sustained recovery (defined as at least 3 consecutive days without symptoms). Secondary outcomes included time to death; time to hospitalization or death; a composite of hospitalization, urgent care visit, emergency department visit, or death; COVID-19 clinical progression scale score; and difference in mean time unwell. Follow-up occurred through day 28., Results: Among 1208 participants who were randomized and received the study drug, the median (IQR) age was 50 (40-60) years, 65.8% were women, 45.5% identified as Hispanic/Latino, and 76.8% reported receiving at least 2 doses of a SARS-CoV-2 vaccine. Among 589 participants who received fluvoxamine and 586 who received placebo included in the primary analysis, differences in time to sustained recovery were not observed (adjusted hazard ratio [HR], 0.99 [95% credible interval, 0.89-1.09]; P for efficacy = .40]). Additionally, unadjusted median time to sustained recovery was 10 (95% CI, 10-11) days in both the intervention and placebo groups. No deaths were reported. Thirty-five participants reported health care use events (a priori defined as death, hospitalization, or emergency department/urgent care visit): 14 in the fluvoxamine group compared with 21 in the placebo group (HR, 0.69 [95% credible interval, 0.27-1.21]; P for efficacy = .86) There were 7 serious adverse events in 6 participants (2 with fluvoxamine and 4 with placebo) but no deaths., Conclusions and Relevance: Among outpatients with mild to moderate COVID-19, treatment with fluvoxamine does not reduce duration of COVID-19 symptoms., Trial Registration: ClinicalTrials.gov Identifier: NCT04885530.

PCORnet, the National Patient-Centered Clinical Research Network, provides the ability to conduct prospective and observational pragmatic research by leveraging standardized, curated electronic health records data together with patient and stakeholder engagement. PCORnet is funded by the Patient-Centered Outcomes Research Institute (PCORI) and is composed of 8 Clinical Research Networks that incorporate at total of 79 health system "sites." As the network developed, linkage to commercial health plans, federal insurance claims, disease registries, and other data resources demonstrated the value in extending the networks infrastructure to provide a more complete representation of patient's health and lived experiences. Initially, PCORnet studies avoided direct economic comparative effectiveness as a topic. However, PCORI's authorizing law was amended in 2019 to allow studies to incorporate patient-centered economic outcomes in primary research aims. With PCORI's expanded scope and PCORnet's phase 3 beginning in January 2022, there are opportunities to strengthen the network's ability to support economic patient-centered outcomes research. This commentary will discuss approaches that have been incorporated to date by the network and point to opportunities for the network to incorporate economic variables for analysis, informed by patient and stakeholder perspectives. Topics addressed include: (1) data linkage infrastructure; (2) commercial health plan partnerships; (3) Medicare and Medicaid linkage; (4) health system billing-based benchmarking; (5) area-level measures; (6) individual-level measures; (7) pharmacy benefits and retail pharmacy data; and (8) the importance of transparency and engagement while addressing the biases inherent in linking real-world data sources., Competing Interests: The authors declare no conflict of interest., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Importance: Clinicians recommend enteric-coated aspirin to decrease gastrointestinal bleeding in secondary prevention of coronary artery disease even though studies suggest platelet inhibition is decreased with enteric-coated vs uncoated aspirin formulations., Objective: To assess whether receipt of enteric-coated vs uncoated aspirin is associated with effectiveness or safety outcomes., Design, Setting, and Participants: This is a post hoc secondary analysis of ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness), a pragmatic study of 15 076 patients with atherosclerotic cardiovascular disease having data in the National Patient-Centered Clinical Research Network. Patients were enrolled from April 19, 2016, through June 30, 2020, and randomly assigned to receive high (325 mg) vs low (81 mg) doses of daily aspirin. The present analysis assessed the effectiveness and safety of enteric-coated vs uncoated aspirin among those participants who reported aspirin formulation at baseline. Data were analyzed from November 11, 2019, to July 3, 2023., Intervention: ADAPTABLE participants were regrouped according to aspirin formulation self-reported at baseline, with a median (IQR) follow-up of 26.2 (19.8-35.4) months., Main Outcomes and Measures: The primary effectiveness end point was the cumulative incidence of the composite of myocardial infarction, stroke, or death from any cause, and the primary safety end point was major bleeding events (hospitalization for a bleeding event with use of a blood product or intracranial hemorrhage). Cumulative incidence at median follow-up for primary effectiveness and primary safety end points was compared between participants taking enteric-coated or uncoated aspirin using unadjusted and multivariable Cox proportional hazards models. All analyses were conducted for the intention-to-treat population., Results: Baseline aspirin formulation used in ADAPTABLE was self-reported for 10 678 participants (median [IQR] age, 68.0 [61.3-73.7] years; 7285 men [68.2%]), of whom 7366 (69.0%) took enteric-coated aspirin and 3312 (31.0%) took uncoated aspirin. No significant difference in effectiveness (adjusted hazard ratio [AHR], 0.94; 95% CI, 0.80-1.09; P = .40) or safety (AHR, 0.82; 95% CI, 0.49-1.37; P = .46) outcomes between the enteric-coated aspirin and uncoated aspirin cohorts was found. Within enteric-coated aspirin and uncoated aspirin, aspirin dose had no association with effectiveness (enteric-coated aspirin AHR, 1.13; 95% CI, 0.88-1.45 and uncoated aspirin AHR, 0.99; 95% CI, 0.83-1.18; interaction P = .41) or safety (enteric-coated aspirin AHR, 2.37; 95% CI, 1.02-5.50 and uncoated aspirin AHR, 0.89; 95% CI, 0.49-1.64; interaction P = .07)., Conclusions and Relevance: In this post hoc secondary analysis of the ADAPTABLE randomized clinical trial, enteric-coated aspirin was not associated with significantly higher risk of myocardial infarction, stroke, or death or with lower bleeding risk compared with uncoated aspirin, regardless of dose, although a reduction in bleeding with enteric-coated aspirin cannot be excluded. More research is needed to confirm whether enteric-coated aspirin formulations or newer formulations will improve outcomes in this population., Trial Registration: ClinicalTrials.gov Identifier: NCT02697916.

Background The ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) was a large, pragmatic, randomized controlled trial that found no difference between high- versus low-dose aspirin for secondary prevention of atherosclerotic cardiovascular disease. Whether concomitant P2Y12 inhibitor therapy modifies the effect of aspirin dose on clinical events remains unclear. Methods and Results Participants in ADAPTABLE were stratified according to baseline use of clopidogrel or prasugrel (P2Y12 group). The primary effectiveness end point was a composite of death, myocardial infarction, or stroke; and the primary safety end point was major bleeding requiring blood transfusions. We used multivariable Cox regression to compare the relative effectiveness and safety of aspirin dose within P2Y12 and non-P2Y12 groups. Of 13 815 (91.6%) participants with available data, 3051 (22.1%) were receiving clopidogrel (2849 [93.4%]) or prasugrel (203 [6.7%]) at baseline. P2Y12 inhibitor use was associated with higher risk of the primary effectiveness end point (10.86% versus 6.31%; adjusted hazard ratio [HR], 1.40 [95% CI, 1.22-1.62]) but was not associated with bleeding (0.95% versus 0.53%; adjusted HR, 1.42 [95% CI, 0.91-2.22]). We found no interaction in the relative effectiveness and safety of high- versus low-dose aspirin by P2Y12 inhibitor use. Overall, dose switching or discontinuation was more common in the high-dose compared with low-dose aspirin group, but the pattern was not modified by P2Y12 inhibitor use. Conclusions In this prespecified analysis of ADAPTABLE, we found that the relative effectiveness and safety of high- versus low-dose aspirin was not modified by baseline P2Y12 inhibitor use. Registration https://www.clinical.trials.gov. Unique identifier: NCT02697916.

Background: Among patients with established cardiovascular disease, the ADAPTABLE trial found no significant differences in cardiovascular events and bleeding rates between 81 mg and 325 mg of aspirin (ASA) daily. In this secondary analysis from the ADAPTABLE trial, we studied the effectiveness and safety of ASA dosing in patients with a history of chronic kidney disease (CKD)., Methods: ADAPTABLE participants were stratified based on the presence or absence of CKD, defined using ICD-9/10-CM codes. Within the CKD group, we compared outcomes between patients taking ASA 81 mg and 325 mg. The primary effectiveness outcome was defined as a composite of all cause death, myocardial infarction, or stroke and the primary safety outcome was hospitalization for major bleeding. Adjusted Cox proportional hazard models were utilized to report differences between the groups., Results: After excluding 414 (2.7%) patients due to missing medical history, a total of 14,662 patients were included from the ADAPTABLE cohort, of whom 2,648 (18%) patients had CKD. Patients with CKD were older (median age 69.4 vs 67.1 years; P < .0001) and less likely to be white (71.5% vs 81.7%; P < .0001) when compared to those without CKD. At a median follow-up of 26.2 months, CKD was associated with an increased risk of both the primary effectiveness outcome (adjusted HR 1.79 [1.57, 2.05] P < .001 and the primary safety outcome (adjusted HR 4.64 (2.98, 7.21), P < .001 and P < .05, respectively) regardless of ASA dose. There was no significant difference in effectiveness (adjusted HR 1.01 95% CI 0.82, 1.23; P = .95) or safety (adjusted HR 0.93; 95% CI 0.52, 1.64; P = .79) between ASA groups., Conclusions: Patients with CKD were more likely than those without CKD to have adverse cardiovascular events or death and were also more likely to have major bleeding requiring hospitalization. However, there was no association between ASA dose and study outcomes among these patients with CKD., Competing Interests: Disclosures The authors have no competing interests to declare regarding the current publication. The authors are solely responsible for the design and conduct of this study; all study analyses, the drafting and editing of the paper and its final contents., (Copyright © 2023. Published by Elsevier Inc.)

Objective: To assess if 100% fruit juice intake prior to 6 months is associated with juice and sugar-sweetened beverage (SSB) intake at 24 months and whether this differs by sociodemographic factors., Methods: We used longitudinal data from infants enrolled in the control (no obesity intervention) arm of Greenlight, a cluster randomized trial to prevent childhood obesity which included parent-reported child 100% fruit juice intake at all well child checks between 2 and 24 months. We studied the relationship between the age of juice introduction (before vs after 6 months) and juice and SSB intake at 24 months using negative binomial regression while controlling for baseline sociodemographic factors., Results: We report results for 187 participants (43% Hispanic, 39% non-Hispanic Black), more than half (54%) of whom had reported 100% fruit juice intake before 6 months. Average 100% fruit juice intake at 24 months was greater than the recommended amount (of 4 oz) and was 8.2 oz and 5.3 oz for those who had and had not, respectively, been introduced to juice before 6 months. In adjusted models, early introduction of juice was associated with a 43% (95% confidence interval: 5%-96%) increase in juice intake at 24 months., Conclusions: 100% fruit juice intake exceeding recommended levels at 6 and 24 months in this diverse cohort was prevalent. Introducing 100% fruit juice prior to 6 months may put children at greater risk for more juice intake as they age. Further research is necessary to determine if early guidance can reduce juice intake., (Copyright © 2023 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.)

Background Internet-based participation has the potential to enhance pragmatic and decentralized trials, where representative study populations and generalizability to clinical practice are key. We aimed to study the differences between internet and noninternet/telephone participants in a large remote, pragmatic trial. Methods and Results In a subanalysis of the ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) study, we compared internet participants with those who opted for noninternet participation. Study process measures examined included participant characteristics at consent, study medication adherence, and study retention. The clinical outcome examined was a composite of all-cause mortality, hospitalization for myocardial infarction, or hospitalization for stroke. Noninternet participants were older (mean 69.4 versus 67.4 years), more likely to be female (38.9% versus 30.2%), more likely to be Black (27.3% versus 6.0%) or Hispanic (11.1% versus 2.0%), and had a higher number of comorbid conditions. The composite clinical outcome was more than twice as high in noninternet participants. The hazard of nonadherence to the assigned aspirin dosage was 46% higher in noninternet participants than internet participants. Conclusions Noninternet participants differed from internet participants in notable demographic characteristics while having poorer baseline health. Over the course of ADAPTABLE, they also had worse clinical outcomes and greater likelihood of study drug nonadherence. These results suggest that trials focused on internet participation select for younger, healthier participants with a higher proportion of traditionally overrepresented patients. Allowing noninternet participation enhances diversity; however, additional steps may be needed to promote study retention and study medication adherence. Registration Information clinicaltrials.gov. Identifier: NCT02697916.

Importance: The COVID-19 pandemic stressed the healthcare field, resulting in a worker exodus at the onset and throughout the pandemic and straining healthcare systems. Female healthcare workers face unique challenges that may impact job satisfaction and retention. It is important to understand factors related to healthcare workers' intent to leave their current field., Objective: To test the hypothesis that female healthcare workers were more likely than male counterparts to report intention to leave., Design: Observational study of healthcare workers enrolled in the Healthcare Worker Exposure Response and Outcomes (HERO) registry. After baseline enrollment, two HERO 'hot topic' survey waves, in May 2021 and December 2021, ascertained intent to leave. Unique participants were included if they responded to at least one of these survey waves., Setting: HERO registry, a large national registry that captures healthcare worker and community member experiences during the COVID-19 pandemic., Participants: Registry participants self-enrolled online and represent a convenience sample predominantly composed of adult healthcare workers., Exposure(s): Self-reported gender (male, female)., Main Outcome: Primary outcome was intention to leave (ITL), defined as having already left, actively making plans, or considering leaving healthcare or changing current healthcare field but with no active plans. Multivariable logistic regression models were performed to examine the odds of intention to leave with adjustment for key covariates., Results: Among 4165 responses to either May or December surveys, female gender was associated with increased odds of ITL (42.2% males versus 51.4% females reported intent to leave; aOR 1.36 [1.13, 1.63]). Nurses had 74% higher odds of ITL compared to most other health professionals. Among those who expressed ITL, three quarters reported job-related burnout as a contributor, and one third reported experience of moral injury., Conclusions and Relevance: Female healthcare workers had higher odds of intent to leave their healthcare field than males. Additional research is needed to examine the role of family-related stressors., Trial Registration: ClinicalTrials.gov identifier NCT04342806., Competing Interests: The authors declare competing financial interests as follows. Dr. Linzer is supported through his employer Hennepin Healthcare for work by large healthcare organizations to reduce burnout (ABIM, ACP, AMA, IHI, Optum Office for Provider Advancement, Essentia Health Systems, Gillette Children’s Hospital and California AHEC). He is supported for other scholarly work by NIH and AHRQ, and consults for Harvard University on a grant to assess relationships between work conditions and diagnostic accuracy (consulting funds donated to Hennepin Healthcare). This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2023 Apple et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Recent studies have investigated post-acute sequelae of SARS-CoV-2 infection (PASC, or long COVID) using real-world patient data such as electronic health records (EHR). Prior studies have typically been conducted on patient cohorts with specific patient populations which makes their generalizability unclear. This study aims to characterize PASC using the EHR data warehouses from two large Patient-Centered Clinical Research Networks (PCORnet), INSIGHT and OneFlorida+, which include 11 million patients in New York City (NYC) area and 16.8 million patients in Florida respectively. With a high-throughput screening pipeline based on propensity score and inverse probability of treatment weighting, we identified a broad list of diagnoses and medications which exhibited significantly higher incidence risk for patients 30-180 days after the laboratory-confirmed SARS-CoV-2 infection compared to non-infected patients. We identified more PASC diagnoses in NYC than in Florida regarding our screening criteria, and conditions including dementia, hair loss, pressure ulcers, pulmonary fibrosis, dyspnea, pulmonary embolism, chest pain, abnormal heartbeat, malaise, and fatigue, were replicated across both cohorts. Our analyses highlight potentially heterogeneous risks of PASC in different populations., (© 2023. The Author(s).)

Objective: The purpose of this study is to understand how families from diverse sociodemographic backgrounds perceived the impact of the pandemic on the development of their children., Methods: We used a multimethod approach guided by Bronfenbrenner's Ecological Systems Theory, which identifies 5 developmental systems (micro, meso, exo, macro, and chrono). Semistructured interviews were conducted in English or Spanish with parents living in 5 geographic regions of the United States between July and September 2021. Participants also completed the COVID-19 Exposure and Family Impact Survey., Results: Forty-eight families participated, half of whose preferred language was Spanish, with a total of 99 children ages newborn to 19 years. Most qualitative themes pertained to developmental effects of the microsystem and macrosystem. Although many families described negative effects of the pandemic on development, others described positive or no perceived effects. Some families reported inadequate government support in response to the pandemic as causes of stress and potential negative influences on child development. As context for their infant's development, families reported a variety of economic hardships on the COVID-19 Exposure and Family Impact Survey, such as having to move out of their homes and experiencing decreased income., Conclusion: In addition to negative impacts, many parents perceived positive pandemic-attributed effects on their child's development, mainly from increased time for parent-child interaction. Families described economic hardships that were exacerbated by the pandemic and that potentially affect child development and insufficient government responses to these hardships. These findings hold important lessons for leaders who wish to design innovative solutions that address inequities in maternal, family, and child health., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objectives: To determine whether hydroxychloroquine (HCQ) is safe and effective at preventing COVID-19 infections among health care workers (HCWs)., Methods: In a 1: 1 randomized, placebo-controlled, double-blind, parallel-group, superiority trial at 34 US clinical centers, 1360 HCWs at risk for COVID-19 infection were enrolled between April and November 2020. Participants were randomized to HCQ or matched placebo. The HCQ dosing included a loading dose of HCQ 600 mg twice on day 1, followed by 400 mg daily for 29 days. The primary outcome was a composite of confirmed or suspected COVID-19 clinical infection by day 30, defined as new-onset fever, cough, or dyspnea and either a positive SARS-CoV-2 polymerase chain reaction test (confirmed) or a lack of confirmatory testing due to local restrictions (suspected)., Results: Study enrollment closed before full accrual due to recruitment challenges. The primary end point occurred in 41 (6.0%) participants receiving HCQ and 53 (7.8%) participants receiving placebo. No difference in the proportion of participants experiencing clinical infection (estimated difference of -1.8%, 95% confidence interval -4.6-0.9%, P = 0.20) was identified nor any significant safety issues., Conclusion: Oral HCQ taken as prescribed appeared safe among HCWs. No significant clinical benefits were observed. The study was not powered to detect a small but potentially important reduction in infection., Trial Registration: NCT04334148., Competing Interests: Declaration of competing interest All authors have completed the International Committee of Medical Journal Editors uniform disclosure form and declare: support from the Patient-Centered Outcomes Research Institute (PCORI) for the reported work; Vir Biotechnology (SC); AstraZeneca, GSK, Novartis, Pulmatric, Sanofi-Aventis, Genentech, Teva (MC); Vir Biotechnology (KA); Centers for Disease Control, Infection Control Education for Major Sports, LLC, UpToDate, AHRQ, NIAID (DA); NIH (KA); Pfizer (EO); Abbott (RR)., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background: Compared to white individuals, Black and Hispanic individuals have higher rates of COVID-19 hospitalization and death. Less is known about racial/ethnic differences in post-acute sequelae of SARS-CoV-2 infection (PASC)., Objective: Examine racial/ethnic differences in potential PASC symptoms and conditions among hospitalized and non-hospitalized COVID-19 patients., Design: Retrospective cohort study using data from electronic health records., Participants: 62,339 patients with COVID-19 and 247,881 patients without COVID-19 in New York City between March 2020 and October 2021., Main Measures: New symptoms and conditions 31-180 days after COVID-19 diagnosis., Key Results: The final study population included 29,331 white patients (47.1%), 12,638 Black patients (20.3%), and 20,370 Hispanic patients (32.7%) diagnosed with COVID-19. After adjusting for confounders, significant racial/ethnic differences in incident symptoms and conditions existed among both hospitalized and non-hospitalized patients. For example, 31-180 days after a positive SARS-CoV-2 test, hospitalized Black patients had higher odds of being diagnosed with diabetes (adjusted odds ratio [OR]: 1.96, 95% confidence interval [CI]: 1.50-2.56, q<0.001) and headaches (OR: 1.52, 95% CI: 1.11-2.08, q=0.02), compared to hospitalized white patients. Hospitalized Hispanic patients had higher odds of headaches (OR: 1.62, 95% CI: 1.21-2.17, q=0.003) and dyspnea (OR: 1.22, 95% CI: 1.05-1.42, q=0.02), compared to hospitalized white patients. Among non-hospitalized patients, Black patients had higher odds of being diagnosed with pulmonary embolism (OR: 1.68, 95% CI: 1.20-2.36, q=0.009) and diabetes (OR: 2.13, 95% CI: 1.75-2.58, q<0.001), but lower odds of encephalopathy (OR: 0.58, 95% CI: 0.45-0.75, q<0.001), compared to white patients. Hispanic patients had higher odds of being diagnosed with headaches (OR: 1.41, 95% CI: 1.24-1.60, q<0.001) and chest pain (OR: 1.50, 95% CI: 1.35-1.67, q < 0.001), but lower odds of encephalopathy (OR: 0.64, 95% CI: 0.51-0.80, q<0.001)., Conclusions: Compared to white patients, patients from racial/ethnic minority groups had significantly different odds of developing potential PASC symptoms and conditions. Future research should examine the reasons for these differences., (© 2023. The Author(s).)

Post-acute sequelae of SARS-CoV-2 infection (PASC) affects a wide range of organ systems among a large proportion of patients with SARS-CoV-2 infection. Although studies have identified a broad set of patient-level risk factors for PASC, little is known about the association between "exposome"-the totality of environmental exposures and the risk of PASC. Using electronic health data of patients with COVID-19 from two large clinical research networks in New York City and Florida, we identified environmental risk factors for 23 PASC symptoms and conditions from nearly 200 exposome factors. The three domains of exposome include natural environment, built environment, and social environment. We conducted a two-phase environment-wide association study. In Phase 1, we ran a mixed effects logistic regression with 5-digit ZIP Code tabulation area (ZCTA5) random intercepts for each PASC outcome and each exposome factor, adjusting for a comprehensive set of patient-level confounders. In Phase 2, we ran a mixed effects logistic regression for each PASC outcome including all significant (false positive discovery adjusted p-value < 0.05) exposome characteristics identified from Phase I and adjusting for confounders. We identified air toxicants (e.g., methyl methacrylate), particulate matter (PM 2.5 ) compositions (e.g., ammonium), neighborhood deprivation, and built environment (e.g., food access) that were associated with increased risk of PASC conditions related to nervous, blood, circulatory, endocrine, and other organ systems. Specific environmental risk factors for each PASC condition and symptom were different across the New York City area and Florida. Future research is warranted to extend the analyses to other regions and examine more granular exposome characteristics to inform public health efforts to help patients recover from SARS-CoV-2 infection., Competing Interests: We declare that we have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 The Author(s).)

Importance: It is unknown whether ivermectin, with a maximum targeted dose of 600 μg/kg, shortens symptom duration or prevents hospitalization among outpatients with mild to moderate COVID-19., Objective: To evaluate the effectiveness of ivermectin at a maximum targeted dose of 600 μg/kg daily for 6 days, compared with placebo, for the treatment of early mild to moderate COVID-19., Design, Setting, and Participants: The ongoing Accelerating COVID-19 Therapeutic Interventions and Vaccines 6 (ACTIV-6) platform randomized clinical trial was designed to evaluate repurposed therapies among outpatients with mild to moderate COVID-19. A total of 1206 participants older than 30 years with confirmed COVID-19 experiencing at least 2 symptoms of acute infection for less than or equal to 7 days were enrolled at 93 sites in the US from February 16, 2022, through July 22, 2022, with follow-up data through November 10, 2022., Interventions: Participants were randomly assigned to receive ivermectin, with a maximum targeted dose of 600 μg/kg (n = 602) daily, or placebo (n = 604) for 6 days., Main Outcomes and Measures: The primary outcome was time to sustained recovery, defined as at least 3 consecutive days without symptoms. The 7 secondary outcomes included a composite of hospitalization, death, or urgent/emergent care utilization by day 28., Results: Among 1206 randomized participants who received study medication or placebo, the median (IQR) age was 48 (38-58) years, 713 (59.1%) were women, and 1008 (83.5%) reported receiving at least 2 SARS-CoV-2 vaccine doses. The median (IQR) time to sustained recovery was 11 (11-12) days in the ivermectin group and 11 (11-12) days in the placebo group. The hazard ratio (posterior probability of benefit) for improvement in time to recovery was 1.02 (95% credible interval, 0.92-1.13; P = .68). Among those receiving ivermectin, 34 (5.7%) were hospitalized, died, or had urgent or emergency care visits compared with 36 (6.0%) receiving placebo (hazard ratio, 1.0 [95% credible interval, 0.6-1.5]; P = .53). In the ivermectin group, 1 participant died and 4 were hospitalized (0.8%); 2 participants (0.3%) were hospitalized in the placebo group and there were no deaths. Adverse events were uncommon in both groups., Conclusions and Relevance: Among outpatients with mild to moderate COVID-19, treatment with ivermectin, with a maximum targeted dose of 600 μg/kg daily for 6 days, compared with placebo did not improve time to sustained recovery. These findings do not support the use of ivermectin in patients with mild to moderate COVID-19., Trial Registration: ClinicalTrials.gov Identifier: NCT04885530.

Introduction: Social support is a modifiable social determinant of health that shapes breastfeeding outcomes and may contribute to racial and ethnic breastfeeding disparities. This study characterizes the relationship between social support and early breastfeeding., Methods: This is a cross-sectional analysis of baseline data collected in 2019-2021 for an RCT. Social support was measured using the Enhancing Recovery in Coronary Heart Disease Social Support Instrument. Outcomes, collected by self-report, included (1) early breastfeeding within the first 21 days of life, (2) planned breastfeeding duration, and (3) confidence in meeting breastfeeding goals. Each outcome was modeled using proportional odds regression, adjusting for covariates. Analysis was conducted in 2021-2022., Results: Self-reported race and ethnicity among 883 mothers were 50% Hispanic, 17% Black, 23% White, and 10% other. A large proportion (88%) of mothers were breastfeeding. Most breastfeeding mothers (82%) planned to breastfeed for at least 6 months, with more than half (58%) planning to continue for 12 months or more. Most women (65%) were confident or very confident in meeting their breastfeeding duration goal. In adjusted models, perceived social support was associated with planned breastfeeding duration (p=0.042) but not with early breastfeeding (p=0.873) or confidence in meeting breastfeeding goals (p=0.427). Among the covariates, maternal depressive symptoms were associated with lower breastfeeding confidence (p<0.001)., Conclusions: The associations between perceived social support and breastfeeding outcomes are nuanced. In this sample of racially and ethnically diverse mothers, social support was associated with longer planned breastfeeding duration but not with early breastfeeding or breastfeeding confidence., (Copyright © 2022 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose: This manuscript aims to compare and contrast acceptability and perceived benefits of yoga-skills training (YST) and an empathic listening attention control (AC) in the Pro-You study, a randomized pilot trial of YST vs. AC for adults receiving chemotherapy infusions for gastrointestinal cancer., Methods: Participants were invited for a one-on-one interview at week 14 follow-up, after completing all intervention procedures and quantitative assessments. Staff used a semi-structured guide to elicit participants' views on study processes, the intervention they received, and its effects. Qualitative data analysis followed an inductive/deductive approach, inductively identifying themes and deductively guided by social cognitive theory., Results: Some barriers (e.g., competing demands, symptoms), facilitators (e.g., interventionist support, the convenience of clinic-based delivery), and benefits (e.g., decreased distress and rumination) were common across groups. YST participants uniquely described the importance of privacy, social support, and self-efficacy for increasing engagement in yoga. Benefits specific to YST included positive emotions and greater improvement in fatigue and other physical symptoms. Both groups described some self-regulatory processes, but through different mechanisms: self-monitoring in AC and the mind-body connection in YST., Conclusions: This qualitative analysis demonstrates that participant experiences in a yoga-based intervention or an AC condition reflect social cognitive and mind-body frameworks of self-regulation. Findings can be used to develop yoga interventions that maximize acceptability and effectiveness and to design future research that elucidates the mechanisms by which yoga is efficacious., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

The post-acute sequelae of SARS-CoV-2 infection (PASC) refers to a broad spectrum of symptoms and signs that are persistent, exacerbated or newly incident in the period after acute SARS-CoV-2 infection. Most studies have examined these conditions individually without providing evidence on co-occurring conditions. In this study, we leveraged the electronic health record data of two large cohorts, INSIGHT and OneFlorida+, from the national Patient-Centered Clinical Research Network. We created a development cohort from INSIGHT and a validation cohort from OneFlorida+ including 20,881 and 13,724 patients, respectively, who were SARS-CoV-2 infected, and we investigated their newly incident diagnoses 30-180 days after a documented SARS-CoV-2 infection. Through machine learning analysis of over 137 symptoms and conditions, we identified four reproducible PASC subphenotypes, dominated by cardiac and renal (including 33.75% and 25.43% of the patients in the development and validation cohorts); respiratory, sleep and anxiety (32.75% and 38.48%); musculoskeletal and nervous system (23.37% and 23.35%); and digestive and respiratory system (10.14% and 12.74%) sequelae. These subphenotypes were associated with distinct patient demographics, underlying conditions before SARS-CoV-2 infection and acute infection phase severity. Our study provides insights into the heterogeneity of PASC and may inform stratified decision-making in the management of PASC conditions., (© 2022. The Author(s).)

Background: Healthy lifestyle behaviors that can prevent adverse health outcomes, including obesity, are formed in early childhood. This study describes feeding, television, and sleep behaviors among one-year-old infants and examines differences by sociodemographic factors., Methods: Caregivers of one-year-olds presenting for well care at two clinics, control sites for the Greenlight Study, were queried about feeding, television time, and sleep. Adjusted associations between sociodemographic factors and behaviors were performed by modified Poisson (binary), multinomial logistic (multi-category), or linear (continuous) regression models., Results: Of 235 one-year-olds enrolled, 81% had Medicaid, and 45% were Hispanic, 36% non-Hispanic Black, 19% non-Hispanic White. Common behaviors included 20% exclusive bottle use, 32% put to bed with bottle, mean daily juice intake of 4.1 ± 4.6 ounces, and active television time 45 ± 73 min. In adjusted analyses compared to Hispanic caregivers, non-Hispanic Black caregivers were less likely to report exclusive bottle use (odds ratio: 0.11, 95% confidence interval [CI] 0.03-0.39), reported 2.4 ounces more juice (95% CI 1.0-3.9), 124 min more passive television time (95% CI 60-188), and 37 min more active television time (95% CI 10-64). Increased caregiver education and higher income were associated with 0.4 (95% CI 0.13-0.66) and 0.3 (95% CI 0.06-0.55) more servings of fruits and vegetables per day, respectively., Conclusion: In a diverse sample of one-year-olds, caregivers reported few protective behaviors that reduce the risk for adverse health outcomes including obesity. Differences in behavior by race/ethnicity, income, and education can inform future interventions and policies. Future interventions should strive to create culturally effective messaging to address common adverse health behaviors., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2022 The Authors.)

Background: The first 1000 days of a child's life are increasingly recognized as a critical window for establishing a healthy growth trajectory to prevent childhood obesity and its associated long-term comorbidities. The purpose of this manuscript is to detail the methods for a multi-site, comparative effectiveness trial designed to prevent childhood overweight and obesity from birth to age 2 years., Methods: This study is a multi-site, individually randomized trial testing the comparative effectiveness of two active intervention arms: 1) the Greenlight intervention; and 2) the Greenlight Plus intervention. The Greenlight intervention is administered by trained pediatric healthcare providers at each well-child visit from 0 to 18 months and consists of a low health literacy toolkit used during clinic visits to promote shared goal setting. Families randomized to Greenlight Plus receive the Greenlight intervention plus a health information technology intervention, which includes: 1) personalized, automated text-messages that facilitate caregiver self-monitoring of tailored and age-appropriate child heath behavior goals; and 2) a web-based, personalized dashboard that tracks child weight status, progress on goals, and electronic Greenlight content access. We randomized 900 parent-infant dyads, recruited from primary care clinics across six academic medical centers. The study's primary outcome is weight for length trajectory from birth through 24 months., Conclusions: By delivering a personalized and tailored health information technology intervention that is asynchronous to pediatric primary care visits, we aim to achieve improvements in child growth trajectory through two years of age among a sample of geographically, socioeconomically, racially, and ethnically diverse parent-child dyads., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objective: To examine racial and ethnic differences in maternal social support in infancy and the relationship between social support and mother-infant health behaviors., Methods: Secondary analysis of baseline data from a multisite obesity prevention trial that enrolled mothers and their 2-month-old infants. Behavioral and social support data were collected via questionnaire. We used modified Poisson regression to determine association between health behaviors and financial and emotional social support, adjusted for sociodemographic characteristics., Results: Eight hundred and twenty-six mother-infant dyads (27.3% non-Hispanic Black, 18.0% Non-Hispanic White, 50.1% Hispanic and 4.6% Non-Hispanic Other). Half of mothers were born in the United States; 87% were Medicaid-insured. There were no racial/ethnic differences in social support controlling for maternal nativity. US-born mothers were more likely to have emotional and financial support (rate ratio [RR] 1.14 95% confidence interval [CI]: 1.07, 1.21 and RR 1.23 95% CI: 1.11, 1.37, respectively) versus mothers born outside the United States. Mothers with financial support were less likely to exclusively feed with breast milk (RR 0.62; 95% CI: 0.45, 0.87) yet more likely to have tummy time ≥12min (RR 1.28; 95% CI: 1.02, 1.59) versus mothers without financial support. Mothers with emotional support were less likely to report feeding with breast milk (RR 0.82; 95% CI: 0.69, 0.97) versus mothers without emotional support., Conclusions: Nativity, not race or ethnicity, is a significant determinant of maternal social support. Greater social support was not universally associated with healthy behaviors. Interventions may wish to consider the complex nature of social support and population-specific social support needs., (Copyright © 2022 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.)

Introduction: The learning health system (LHS) aligns science, informatics, incentives, stakeholders, and culture for continuous improvement and innovation. The Agency for Healthcare Research and Quality and the Patient-Centered Outcomes Research Institute designed a K12 initiative to grow the number of LHS scientists. We describe approaches developed by 11 funded centers of excellence (COEs) to promote partnerships between scholars and health system leaders and to provide mentored research training., Methods: Since 2018, the COEs have enlisted faculty, secured institutional resources, partnered with health systems, developed and implemented curricula, recruited scholars, and provided mentored training. Program directors for each COE provided descriptive data on program context, scholar characteristics, stakeholder engagement, scholar experiences with health system partnerships, roles following program completion, and key training challenges., Results: To date, the 11 COEs have partnered with health systems to train 110 scholars. Nine (82%) programs partner with a Veterans Affairs health system and 9 (82%) partner with safety net providers. Clinically trained scholars (n = 87; 79%) include 70 physicians and 17 scholars in other clinical disciplines. Non-clinicians (n = 29; 26%) represent diverse fields, dominated by population health sciences. Stakeholder engagement helps scholars understand health system and patient/family needs and priorities, enabling opportunities to conduct embedded research, improve outcomes, and grow skills in translating research methods and findings into practice. Challenges include supporting scholars through roadblocks that threaten to derail projects during their limited program time, ranging from delays in access to data to COVID-19-related impediments and shifts in organizational priorities., Conclusions: Four years into this novel training program, there is evidence of scholars' accomplishments, both in traditional academic terms and in terms of moving along career trajectories that hold the potential to lead and accelerate transformational health system change. Future LHS training efforts should focus on sustainability, including organizational support for scholar activities., Competing Interests: With the exception of Francis D. Chesley, Jr., all authors are grantees of the program that is the subject of this paper., (© 2022 The Authors. Learning Health Systems published by Wiley Periodicals LLC on behalf of University of Michigan.)

Objective: Examine factors impacting U.S. parents' intention to vaccinate their children against COVID-19., Methods: Data were collected February-May 2021 from parents living in six geographically diverse locations. The COVID-19 Exposure and Family Impact Survey assessed perceived susceptibility and severity to adverse outcomes from the pandemic. Semi-structured interviews assessed perceptions about benefits and risks of vaccinating children., Results: Fifty parents of 106 children (newborn-17 years) were included; half were Spanish-speaking and half English-speaking. 62% were hesitant about vaccinating their children against COVID-19. Efficacy and safety were the main themes that emerged: some parents perceived them as benefits while others perceived them as risks to vaccination. Parent hesitancy often relied on social media, and was influenced by narrative accounts of vaccination experiences. Many cited the lower risk of negative outcomes from COVID-19 among children, when compared with adults. Some also cited inaccurate and constantly changing information about COVID-19 vaccines., Conclusion: Main drivers of parent hesitancy regarding child COVID-19 vaccination include perceived safety and efficacy of the vaccines and lower severity of illness in children., Practice Implications: Many vaccine-hesitant parents may be open to vaccination in the future and welcome additional discussion and data., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Objective: We examined users' preferences for and engagement with text messages delivered as part of an emergency department (ED)-based intervention to improve antihypertensive medication adherence., Methods: We recruited ED patients with elevated blood pressure for a pilot randomized trial evaluating a medication adherence intervention with text messages. Intervention participants chose text content and frequency, received texts for 45 days, and completed a feedback survey. We defined engagement via responses to texts. We examined participant characteristics associated with text preferences, engagement, and feedback., Results: Participants (N = 101) were 57% female and 46% non-White. Most participants (71%) chose to receive both reminder and informational texts; 94% chose reminder texts once per day and 97% chose informational texts three times per week. Median text message response rate was 56% (IQR 26-80%). Participants who were Black (p < 0.01), had lower income (p = 0.03), or had lower medication adherence (p < 0.01) rated the program as more helpful and wanted additional functionalities for adherence support., Conclusions and Practice Implications: While overall engagement was modest, participants at risk of worse health outcomes expressed more value and interest in the program. Findings inform the design of text messaging interventions for antihypertensive medication adherence and support targeting vulnerable patients to reduce health disparities., Clinical Trials Registration: NCT02672787., (Copyright © 2021 Elsevier B.V. All rights reserved.)