Publications by authors named "Russell Rothman"

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.

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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.

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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.

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Article Synopsis
  • The study investigates how social capital, specifically caregiver support and neighborhood cohesion, impacts food insecurity in US families with newborns.
  • Out of 881 caregiver-newborn pairs, higher levels of social support and neighborhood cohesion were linked to lower odds of experiencing food insecurity.
  • The findings suggest that enhancing social capital could help mitigate food insecurity in families with young children, and further research is needed to explore these relationships over time.
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  • A study was conducted to evaluate the effectiveness of montelukast versus a placebo in helping outpatients with mild to moderate COVID-19 recover from symptoms more quickly.
  • The trial included 1,250 participants over 30 years old with confirmed COVID-19 symptoms for less than a week, who were randomly assigned to receive either montelukast or a placebo for 14 days.
  • Results showed no significant difference in recovery time between the montelukast and placebo groups, with both groups having a median recovery time of 10 days and no reported deaths.
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  • * There is a significant need for diabetes self-management education and support (DSMES) programs that are tailored to meet the diverse cultural needs of patients, particularly racial and ethnic minorities who are disproportionately impacted by T2D.
  • * Patient-centered care that integrates culturally and literacy-sensitive strategies can lead to better health outcomes, lower healthcare costs, and more effective management of T2D by considering social determinants of health.
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  • The study aimed to assess the effectiveness and safety of low (81 mg) versus high-dose (325 mg) aspirin in patients with established atherosclerotic cardiovascular disease (ASCVD) across different racial groups.
  • Conducted as a secondary analysis of the ADAPTABLE trial, the research involved over 14,000 participants from various racial backgrounds and compared their responses to different aspirin doses over a median follow-up of 26.2 months.
  • The results indicated that race did not significantly alter the effectiveness or safety of aspirin dosing, suggesting that all racial groups responded similarly to the treatment.
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  • The study investigates how different data sources (like electronic health records, insurance claims, and participant reports) contribute to analyzing clinical outcomes in a pragmatic randomized clinical trial (RCT) involving patients with atherosclerotic cardiovascular disease.
  • Conducted from April 2016 to June 2019, the ADAPTABLE study looked at the effects of daily aspirin doses on certain health events, while comparing participant data availability to enhance understanding of outcome rates.
  • The findings revealed a predominance of participant-reported and EHR data, with only a small percentage relying solely on claims data, indicating the need for further study on the varying contributions of each data source to overall clinical results.
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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.

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Article Synopsis
  • - Atherosclerotic cardiovascular disease (ASCVD) is the main health issue in the US, and while aspirin is commonly used for its prevention, a trial (ADAPTABLE) found no significant difference in outcomes between 81 mg and 325 mg doses of aspirin.
  • - The study aimed to investigate whether there are differences in safety and effectiveness of the two aspirin doses based on sex, as previous findings didn't address this.
  • - Conducted across multiple medical centers, the ADAPTABLE trial involved over 15,000 participants with established ASCVD, analyzing outcomes related to major bleeding, heart attacks, and strokes, with a focus on comparing male and female responses to the aspirin doses.
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  • The study investigates how the characteristics and frequency of post-acute sequelae of SARS-CoV-2 infection (PASC) differ between those infected by the ancestral strain in 2020 and the Delta variant in 2021.
  • It analyzes a significant dataset of around 27 million patients across New York and Florida to assess new health conditions arising 31-180 days post COVID-19 infection.
  • Key findings reveal that during the ancestral strain period, issues like pulmonary fibrosis and dyspnea were prominent, while the Delta variant was mainly associated with an increased risk of pulmonary embolism.
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  • - The study aimed to determine the effectiveness of montelukast, a medication, versus a placebo in helping outpatients with mild to moderate COVID-19 recover from their symptoms more quickly.
  • - Conducted as part of the ACTIV-6 trial, 1250 participants aged 30 and older were enrolled from across 104 U.S. sites, receiving either montelukast or a placebo for 14 days.
  • - Results showed no significant difference in recovery times between those taking montelukast and those taking the placebo, with both groups having a median recovery time of 10 days and minimal hospitalizations or adverse events reported.
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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.

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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. 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.

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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.

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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.

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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.

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Article Synopsis
  • In patients with atherosclerotic cardiovascular disease, increased age is linked to higher risks of both ischemic and bleeding events, prompting a study on the effect of aspirin dosage based on age.
  • The ADAPTABLE trial involved nearly 15,100 participants who were randomly assigned to take either 81 mg or 325 mg of aspirin daily, with outcomes measured over an average follow-up of 26.2 months.
  • Results indicated that age did not significantly affect how aspirin dosage influenced clinical outcomes, suggesting that both doses are similarly effective for elderly and younger patients in preventing cardiovascular events.
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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.

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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.

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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.

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Article Synopsis
  • PCORnet is a National Research Network funded by PCORI that uses standardized electronic health records and patient input to facilitate pragmatic health research across 79 health system sites.
  • The network has evolved to include additional data sources such as commercial health plans and federal insurance claims, enhancing its ability to represent patient health and experiences more comprehensively.
  • With amendments allowing the inclusion of economic outcomes in research, PCORnet's phase 3, starting in January 2022, aims to bolster economic patient-centered outcomes through improved data linkages and stakeholder engagement.
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Background: Adults hospitalized for cardiovascular events are at high risk for post-discharge mortality. Hospital-based screening of health-related psychosocial risk factors is now prioritized by the Joint Commission and the National Quality Forum to achieve equitable, high-quality care. We tested our hypothesis that key patient-reported psychosocial and behavioral measures could predict post-hospitalization mortality in a cohort of adults hospitalized for a cardiovascular event.

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  • The ADAPTABLE trial, a large study on aspirin dosing for preventing heart issues, showed no significant difference in efficacy between high- and low-dose aspirin in patients with cardiovascular disease.
  • It explored whether using P2Y12 inhibitors like clopidogrel or prasugrel impacted aspirin's effectiveness or safety; however, results indicated no interaction between aspirin dose and P2Y12 inhibitor use.
  • Participants taking P2Y12 inhibitors had a higher risk of major cardiovascular events but not an increased risk of bleeding, and switching doses was more common in the high-dose group without being influenced by P2Y12 inhibitor status.
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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.

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