Prevalence and Trends in Cardiovascular Risk Factors Among Middle Aged Persons from Five Race and Ethnic Groups in the United States: A Longitudinal Analysis of Two Cohort Studies.

Importance: It is well established that people of South Asian background have a high burden of atherosclerotic cardiovascular disease (ASCVD). However, few studies have comprehensively examined if South Asian adults in the United States (US) develop cardiovascular risk factors at younger ages than adults from other race and ethnic groups. Objective: To compare the prevalence and change in ASCVD risk factors across age strata by race and ethnic group. Design: We combined data from the Mediators of Atherosclerosis in South Asians Living in America (MASALA) and the Multi-Ethnic Study of Atherosclerosis (MESA) cohort studies. Longitudinal data from all eligible participants at all available exam visits were used to estimate the prevalence of risk factors at ages 45 and 55 years for each race and ethnic group. Setting: Multicenter longitudinal cohort study in 7 field centers across the U.S. Participants: The baseline study sample included individuals free of clinical ASCVD; 554 South Asians, 796 White, 588 Black, 517 Hispanic/Latino, and 245 Chinese adults aged 45-55 years were included. Exposures: Self-identified race (Black, Chinese, South Asian, or White) or ethnic group (Hispanic/Latino). Main Outcomes and Measures: Prevalence of clinical (prediabetes & diabetes, hypertension, dyslipidemia, BMI) and behavioral (diet quality, alcohol use, exercise) ASCVD risk factors at age 45 and age 55. Results: At age 45, South Asian men and women had the highest prevalence of pre-diabetes and diabetes and higher prevalence of hypertension compared to White, Chinese, and Hispanic/Latino men and women. South Asian men had a higher prevalence of dyslipidemia than White, Chinese, and Black men, and South Asian women had a higher prevalence than Chinese and Black women. All groups had worse diet quality than South Asian men and women at age 45, and most also had higher rates of alcohol use. Conclusions and Relevance: We observed significant differences in the prevalence of risk factors for South Asian adults compared to adults from other U.S. race and ethnic groups at age 45 years. Understanding trends and disparities in cardiovascular risk and protective factors across the life course can help equitably improve prevention and treatment strategies for US populations. Key Points: Question: Do South Asian adults have a higher burden of cardiovascular risk factors at age 45 years compared adults from other race and ethnic groups?Findings: In this study of 2754 adults from two cohort studies, the prevalence of prediabetes and diabetes at age 45 years was higher among South Asians than in Black, Chinese, Hispanic and White adults; hypertension prevalence was higher among South Asians than all groups except Black adults.Meaning: South Asian adults have a higher prevalence of several clinical cardiovascular risk factors at a younger age.

Culturally Adapted Lifestyle Intervention for South Asian Adults With Cardiovascular Risk Factors: The SAHELI Randomized Clinical Trial.

Importance: South Asian adults in the US experience excess cardiovascular disease (CVD) compared with other racial and ethnic groups. The effectiveness and reach of guideline-recommended lifestyle interventions have not been evaluated in this population. Objective: To evaluate whether a culturally adapted, group lifestyle intervention will improve CVD risk factors more effectively than written health education materials among US South Asian adults. Design, Setting, and Participants: This single-blind randomized clinical trial was conducted from March 6, 2018, to February 11, 2023 at community sites in the Chicago, Illinois, metropolitan area. South Asian adults aged 18 to 65 years who were overweight or obese, had no history of CVD events, and had at least 1 additional CVD risk factor (hypertension, dyslipidemia, prediabetes, or diabetes) were eligible for inclusion. Intervention: A 16-week, culturally adapted, group-based lifestyle intervention led by community health coaches. Lifestyle modification counseling was delivered in English, Gujarati, Hindi, and Urdu. Participants tracked their diet and physical activity (PA) and received 4 optional group maintenance sessions between months 5 and 11 of follow-up. The intervention was delivered in person prior to the onset of the COVID-19 pandemic and via videoconference starting in March 2020. The control group received written health education materials, delivered monthly. Main Outcomes and Measures: Primary outcomes were the between-group differences in CVD risk factor changes from baseline to 12 months, including weight, systolic blood pressure (SBP), diastolic blood pressure (DBP), glycated hemoglobin (HbA1c), and total cholesterol, estimated using multivariate mixed-effects regression models. Secondary outcomes were self-reported diet quality, PA, and self-efficacy, estimated using univariate mixed-effects regression models. Results: Among 549 randomized participants, 318 (57.9%) were women, and mean (SD) participant age was 49.2 (9.5) years. Mean differences in CVD risk factor changes from baseline to 12 months in the intervention vs control group were calculated for weight (mean difference, -0.07 kg; 95% CI, -0.55 to 0.42), SBP (mean difference, 0.47 mm Hg; 95% CI, -1.85 to 2.79), DBP (mean difference, 0.44 mm Hg; 95% CI, -1.06 to 1.95), cholesterol (mean difference, -2.47 mg/dL; 95% CI, -8.51 to 3.57), and HbA1c (mean difference, -0.07%; 95% CI -0.20% to 0.07%). Intervention participation was associated with greater improvements in dietary quality, PA, and self-efficacy than control. Conclusions and Relevance: In the SAHELI randomized clinical trial, a culturally adapted, group lifestyle intervention was not more effective than written health education materials for CVD risk factor reduction among US South Asian adults, but the intervention was associated with small improvements in self-reported health behaviors. Effective CVD prevention interventions for this elevated-risk population require further investigation. Trial Registration: ClinicalTrials.gov Identifier: NCT03336255.

A mixed-methods, theory-driven assessment of the sustainability of a multi-sectoral preventive intervention for South Asian Americans at risk for cardiovascular disease.

BACKGROUND: South Asian Americans bear a high burden of atherosclerotic cardiovascular disease (ASCVD), but little is known about the sustainability of evidence-based interventions (EBI) to prevent ASCVD in this population. Using community-based participatory research, we previously developed and implemented the South Asian Healthy Lifestyle Intervention (SAHELI), a culturally-adapted EBI targeting diet, physical activity, and stress management. In this study, we use the Integrated Sustainability Framework to investigate multisectoral partners' perceptions of organizational factors influencing SAHELI sustainability and strategies for ensuring sustainability. METHODS: From 2022 to 2023, we conducted a mixed-methods study (quant- > QUAL) with 17 SAHELI partners in the Chicago area. Partners' settings included: community organization, school district, public health department, and healthcare system. Descriptive statistics summarized quantitative results. Two coders used a hybrid thematic analysis approach to identify qualitative themes. Qualitative and quantitative data were integrated and analyzed using mixed methods. RESULTS: Surveys (score range 1-5: higher scores indicate facilitators; lower scores indicate barriers) indicated SAHELI sustainability facilitators to be its "responsiveness to community values and needs" (mean = 4.9). Barriers were "financial support" (mean = 3.5), "infrastructure/capacity to support sustainment" (mean = 4.2), and "implementation leadership" (mean = 4.3). Qualitative findings confirmed quantitative findings that SAHELI provided culturally-tailored cardiovascular health education responsive to the needs of the South Asian American community, increased attention to health issues, and transformed perceptions of research among community members. Qualitative findings expanded upon quantitative findings, showing that the organizational fit of SAHELI was a facilitator to sustainability while competing priorities were barriers for partners from the public health department and health system. Partners from the public health department and health system discussed challenges in offering culturally-tailored programming exclusively for one targeted population. Sustainability strategies envisioned by partners included: transitioning SAHELI to a program delivered by community members; integrating components of SAHELI into other programs; and expanding SAHELI to other populations. Modifications made to SAHELI (i.e., virtual instead of in-person delivery) had both positive and negative implications for sustainability. DISCUSSION: This study identifies common sustainability barriers and facilitators across different sectors, as well as those specific to certain settings. Aligning health equity interventions with community needs and values, organizational activities, and local context and resources is critical for sustainability. Challenges also arise from balancing the needs of specific populations against providing programming for broader audiences.

Risk of significant functional impairment across cancer diagnosis and care continuum.

BACKGROUND: The authors examined baseline physical functional (PF) impairment among cancer outpatients in the National Cancer Institute Cancer Moonshot study Northwestern University Improving the Management of Symptoms During and Following Cancer Treatment (NU IMPACT). They hypothesized that PF impairment, measured with the Patient Reported Outcome Measurement Information System-Physical Function (PROMIS-PF) survey, would (1) be common and more prevalent for patients receiving treatment compared with no treatment and (2) differ across tumor types, independent of cancer continuum phase. METHODS: Adults who were diagnosed with cancer in NU IMPACT (n = 2273) were sampled, and their PROMIS-PF scores were compared across tumor types and cancer continuum (curative, noncurative, or no treatment), with scores ≤40 indicating moderate-severe impairment. Multivariable logistic regression models were used to evaluate the relation among patient and cancer factors and PF scores using a 95% confidence interval. RESULTS: Forty percent of the surveyed patients reported moderate-severe PF impairment. Patients with melanoma reported the least impairment, and those with lung cancer were 6.5 times more likely to have moderate-severe impairment (95% confidence interval, 2.393-17.769). The noncurative group was 1.5 times more likely to have moderate-severe impairment (95% confidence interval, 1.045-2.145; mean score, 43; p < .001) than the curative (mean score, 6) and no treatment (mean score, 48) groups. One-third of those who reported PF impairment also had significant pain and/or fatigue. CONCLUSIONS: A sizeable minority experienced PF impairment across tumor types for which pain and/or fatigue co-occurred, particularly in the noncurative group. The PROMIS-PF survey effectively identified variations in physical function. Future studies will explore how screening for PF impairment can be used to refer patients for appropriate cancer rehabilitation services.

Early Endoscopic Retrograde Cholangiopancreatography in Gallstone Pancreatitis Is Safe: Results From a Large Single-Center Retrospective Study.

OBJECTIVES: There is concern that performing early endoscopic retrograde cholangiopancreatography (ERCP) in the setting of gallstone pancreatitis (GSP) with choledocholithiasis can worsen underlying pancreatitis. This study was designed to assess outcomes of early versus delayed ERCP in patients with GSP with choledocholithiasis in the absence of cholangitis. MATERIALS AND METHODS: In this single-center retrospective study, we identified 124 patients who underwent ERCP for choledocholithiasis in the setting of GSP without cholangitis between 2012 and 2022. Timing of ERCP was categorized as early (<48 hours after time of diagnosis) versus delayed (>48 hours). Data on patient demographics, complications, length of stay (LOS), and mortality were collected. RESULTS: Cannulation success rates were similar for early and delayed ERCP (97% vs 100%). The adverse event rate for early ERCP was 15% compared to 29% for delayed ERCP. LOS for patients with predicted mild pancreatitis was shorter for early versus delayed ERCP (4.2 vs 7.1 days, P = 0.007). There were no deaths in either group. CONCLUSIONS: There was a trend toward fewer adverse events and there was a shorter LOS among patients with GSP with choledocholithiasis undergoing early versus delayed ERCP. Early ERCP should be considered, particularly in patients with predicted mild pancreatitis.

Association between high-density mapping of atypical atrial flutter, clinical outcomes and healthcare utilization.

BACKGROUND: Success of atypical atrial flutter (AAFL) ablation has historically been limited by difficulty mapping the complex re-entrant circuits involved. While high-density (HD) mapping has become commonplace in clinical practice, there are limited data on outcomes of HD versus non-HD mapping for AAFL ablation. OBJECTIVE: To compare clinical outcomes and healthcare utilization using HD mapping versus non-HD mapping for AAFL ablation. METHODS: Retrospective analysis of all AAFL procedures between 2005 and 2022 at an academic medical center was conducted. Procedures utilizing a 16-electrode HD Grid catheter and Precision mapping system were compared to procedures using prior generation 10-20 electrode spiral catheters and the Velocity system (Abbott, IL). Cox regression models and Poisson regression models were utilized to examine procedural and healthcare utilization outcomes. Models were adjusted for left ventricular ejection fraction, CHA2DS2-VASc, and history of prior ablation. RESULTS: There were 108 patients (62% HD mapping) included in the analysis. Baseline clinical characteristics were similar between groups. Use of HD mapping was associated with a higher rate of AAFL circuit delineation (92.5% vs. 76%; p = .014) and a greater adjusted procedure success rate, defined as non-inducibility at procedure end, (aRR (95% CI) 1.26 (1.02-1.55) p = .035) than non-HD mapping. HD mapping was also associated with a lower rate of ED visits (aIRR (95% CI) 0.32 (0.14-0.71); p = .007) and hospitalizations (aIRR (95% CI) 0.32 (0.14-0.68); p = .004) for AF/AFL/HF through 1 year. While there was a lower rate of recurrent AFL through 1 year among HD mapping cases (aHR (95% CI) 0.60 (0.31-1.16) p = .13), statistical significance was not met likely due to the low sample size and higher rate of ambulatory rhythm monitoring in the HD group (61% vs. 39%, p = .025). CONCLUSION: Compared to non-HD mapping, AAFL ablation with HD mapping is associated with improvements in the ability to define the AAFL circuit, greater procedural success, and a reduction in the number of ED visits and hospitalization for AF/AFL/HF.

Evolution of the Umbilical Cord Blood Proteome Across Gestational Development.

Neonatal health is dependent on early risk stratification, diagnosis, and timely management of potentially devastating conditions, particularly in the setting of prematurity. Many of these conditions are poorly predicted in real-time by clinical data and current diagnostics. Umbilical cord blood may represent a novel source of molecular signatures that provides a window into the state of the fetus at birth. In this study, we comprehensively characterized the cord blood proteome of infants born between 24 to 42 weeks using untargeted mass spectrometry and functional enrichment analysis. We determined that the cord blood proteome at birth varies significantly across gestational development. Proteins that function in structural development and growth (e.g., extracellular matrix organization, lipid particle remodeling, and blood vessel development) are more abundant earlier in gestation. In later gestations, proteins with increased abundance are in immune response and inflammatory pathways, including complements and calcium-binding proteins. Furthermore, these data contribute to the knowledge of the physiologic state of neonates across gestational age, which is crucial to understand as we strive to best support postnatal development in preterm infants, determine mechanisms of pathology causing adverse health outcomes, and develop cord blood biomarkers to help tailor our diagnosis and therapeutics for critical neonatal conditions.

Statistical analysis plan for the NU IMPACT stepped-wedge cluster randomized trial.

BACKGROUND: As part of the IMPACT Consortium of three effectiveness-implementation trials, the NU IMPACT trial was designed to evaluate implementation and effectiveness outcomes for an electronic health record (EHR)-embedded symptom monitoring and management program for outpatient cancer care. NU IMPACT uses a unique stepped-wedge cluster randomized design, involving six clusters of 26 clinics, for evaluation of implementation outcomes with an embedded patient-level randomized trial to evaluate effectiveness outcomes. Collaborative, consortium-wide efforts to ensure use of the most robust and recent analytic methodologies for stepped-wedge trials motivated updates to the statistical analysis plan for implementation outcomes in the NU IMPACT trial. METHODS: In the updated statistical analysis plan for NU IMPACT, the primary implementation outcome patient adoption, as measured by clinic-level monthly proportions of patient engagement with the EHR-based cancer symptom monitoring system, will be analyzed using generalized least squares linear regression with auto-regressive errors and adjustment for cluster and time effects (underlying secular trends). A similar strategy will be used for secondary patient and provider implementation outcomes. DISCUSSION: The analytic updates described here resulted from highly iterative, collaborative efforts among statisticians, implementation scientists, and trial leads in the IMPACT Consortium. This updated statistical analysis plan will serve as the a priori specified approach for analyzing implementation outcomes for the NU IMPACT trial.

Impact of hypertensive disorders of pregnancy and gestational diabetes mellitus on offspring cardiovascular health in early adolescence.

BACKGROUND: Adverse pregnancy outcomes, including hypertensive disorders of pregnancy and gestational diabetes mellitus, influence maternal cardiovascular health long after pregnancy, but their relationship to offspring cardiovascular health following in-utero exposure remains uncertain. OBJECTIVE: To examine associations of hypertensive disorders of pregnancy or gestational diabetes mellitus with offspring cardiovascular health in early adolescence. STUDY DESIGN: This analysis used data from the prospective Hyperglycemia and Adverse Pregnancy Outcome Study from 2000 to 2006 and the Hyperglycemia and Adverse Pregnancy Outcome Follow-Up Study from 2013 to 2016. This analysis included 3317 mother-child dyads from 10 field centers, comprising 70.8% of Hyperglycemia and Adverse Pregnancy Outcome Follow-Up Study participants. Those with pregestational diabetes and chronic hypertension were excluded. The exposures included having any hypertensive disorders of pregnancy or gestational diabetes mellitus vs not having hypertensive disorders of pregnancy or gestational diabetes mellitus, respectively (reference). The outcome was offspring cardiovascular health when aged 10-14 years, on the basis of 4 metrics: body mass index, blood pressure, total cholesterol level, and glucose level. Each metric was categorized as ideal, intermediate, or poor using a framework provided by the American Heart Association. The primary outcome was defined as having at least 1 cardiovascular health metric that was nonideal vs all ideal (reference), and the second outcome was the number of nonideal cardiovascular health metrics (ie, at least 1 intermediate metric, 1 poor metric, or at least 2 poor metrics vs all ideal [reference]). Modified poisson regression with robust error variance was used and adjusted for covariates at pregnancy enrollment, including field center, parity, age, gestational age, alcohol or tobacco use, child's assigned sex at birth, and child's age at follow-up. RESULTS: Among 3317 maternal-child dyads, the median (interquartile) ages were 30.4 (25.6-33.9) years for pregnant individuals and 11.6 (10.9-12.3) years for children. During pregnancy, 10.4% of individuals developed hypertensive disorders of pregnancy, and 14.6% developed gestational diabetes mellitus. At follow-up, 55.5% of offspring had at least 1 nonideal cardiovascular health metric. In adjusted models, having hypertensive disorders of pregnancy (adjusted risk ratio, 1.14 [95% confidence interval, 1.04-1.25]) or having gestational diabetes mellitus (adjusted risk ratio, 1.10 [95% confidence interval, 1.02-1.19]) was associated with a greater risk that offspring developed less-than-ideal cardiovascular health when aged 10-14 years. The above associations strengthened in magnitude as the severity of adverse cardiovascular health metrics increased (ie, with the outcome measured as ≥1 intermediate, 1 poor, and ≥2 poor adverse metrics), albeit the only statistically significant association was with the "1-poor-metric" exposure. CONCLUSION: In this multinational prospective cohort, pregnant individuals who experienced either hypertensive disorders of pregnancy or gestational diabetes mellitus were at significantly increased risk of having offspring with worse cardiovascular health in early adolescence. Reducing adverse pregnancy outcomes and increasing surveillance with targeted interventions after an adverse pregnancy outcome should be studied as potential avenues to enhance long-term cardiovascular health in the offspring exposed in utero.

Disparities in electronic health record portal access and use among patients with cancer.

BACKGROUND: Electronic health record-linked portals may improve health-care quality for patients with cancer. Barriers to portal access and use undermine interventions that rely on portals to reduce cancer care disparities. This study examined portal access and persistence of portal use and associations with patient and structural factors before the implementation of 3 portal-based interventions within the Improving the Management of symPtoms during And following Cancer Treatment (IMPACT) Consortium. METHODS: Portal use data were extracted from electronic health records for the 12 months preceding intervention implementation. Sociodemographic factors, mode of accessing portals (web vs mobile), and number of clinical encounters before intervention implementation were also extracted. Rurality was derived using rural-urban commuting area codes. Broadband access was estimated using the 2015-2019 American Community Survey. Multiple logistic regression models tested the associations of these factors with portal access (ever accessed or never accessed) and persistence of portal use (accessed the portal ≤20 weeks vs ≥21 weeks in the 35-week study period). RESULTS: Of 28 942 eligible patients, 10 061 (35%) never accessed the portal. Male sex, membership in a racial and ethnic minority group, rural dwelling, not working, and limited broadband access were associated with lower odds of portal access. Younger age and more clinical encounters were associated with higher odds of portal access. Of those with portal access, 25% were persistent users. Using multiple modalities for portal access, being middle-aged, and having more clinical encounters were associated with persistent portal use. CONCLUSION: Patient and structural factors affect portal access and use and may exacerbate disparities in electronic health record-based cancer symptom surveillance and management.

Association of American Identity with Cardiovascular Health in South Asian Americans: The MASALA Study.

Background: Ethnic and national identity may influence cardiovascular health (CVH)-related behaviors, such as dietary preference. To better understand how acculturation is related to CVH among South Asian American adults, we evaluated the association of self-rated American identity with CVH factors among participants of the Mediators of Atherosclerosis in South Asians Living in America (MASALA) Study. Methods: Multivariable linear regression quantified the associations of self-rated American identity [1 (low American identity) to 10 (high American identity)] with CVH factors, including measures of cholesterol, blood pressure, and blood glucose. The role of diet quality, physical activity, and social support in mediating these associations was evaluated. Results: Participants (n = 771) lived in the United States for an average of 27 (SD 11) years. The mean self-rated American identity score was 5.5 (2.4). After adjustment, a 5-point higher American identity score was associated with 6.5 mg/dL higher low-density lipoprotein cholesterol, 6.6 mg/dL higher total cholesterol, 2.9 mmHg higher systolic blood pressure, and 1.4 mmHg higher diastolic blood pressure. Accounting for diet quality, physical activity, or social support does not alter these associations. Conclusions: Higher self-rated American identity is associated with worse CVH factors among South Asian American adults.

Implementation and evaluation of an expanded electronic health record-integrated bilingual electronic symptom management program across a multi-site Comprehensive Cancer Center: The NU IMPACT protocol.

BACKGROUND: People with cancer experience symptoms that adversely affect quality of life. Despite existing interventions and clinical guidelines, timely symptom management remains uneven in oncology care. We describe a study to implement and evaluate an electronic health record (EHR)-integrated symptom monitoring and management program in adult outpatient cancer care. METHODS: Our cancer patient-reported outcomes (cPRO) symptom monitoring and management program is a customized EHR-integrated installation. We will implement cPRO across all Northwestern Memorial HealthCare (NMHC) hematology/oncology clinics. We will conduct a cluster randomized modified stepped-wedge trial to evaluate patient and clinician engagement with cPRO. Further, we will embed a patient-level randomized clinical trial to evaluate the impact of an additional enhanced care (EC; cPRO plus web-based symptom self-management intervention) relative to usual care (UC; cPRO alone). The project uses a Type 2 hybrid effectiveness-implementation approach. The intervention will be implemented across seven regional clusters within the healthcare system comprising 32 clinic sites. A 6-month prospective pre-implementation enrollment period will be followed by a post-implementation enrollment period, during which newly enrolled, consenting patients will be randomly assigned (1:1) to EC or UC. We will follow patients for 12 months post-enrollment. Patients randomized to EC will receive evidence-based symptom-management content on cancer-related concerns and approaches to enhance quality of life, using a web-based tool ("MyNM Care Corner"). This design allows for within- and between-site evaluation of implementation plus a group-based comparison to demonstrate effectiveness on patient-level outcomes. DISCUSSION: The project has potential to guide implementation of future healthcare system-level cancer symptom management programs. http://ClinicalTrials.gov # NCT03988543.

Inflammatory Activity After Diverse Fertility Treatments: A Multicenter Analysis in the Modern Multiple Sclerosis Treatment Era.

BACKGROUND AND OBJECTIVES: Patients with multiple sclerosis (MS) may seek fertility treatment (FT)-including in vitro fertilization (IVF). Variable relapse risk after IVF has been reported in small historical cohorts, with more recent studies suggesting no change in annualized relapse rate (ARR). The objective of this study was to evaluate ARR 12 months pre-FT and 3 months post-FT in a multicenter cohort and identify factors associated with an increased risk of relapse. METHODS: Patients with clinically isolated syndrome (CIS) or MS aged 18-45 years with at least 1 FT from January 1, 2010, to October 14, 2021, were retrospectively identified at 4 large academic MS centers. The exposed period of 3 months after FT was compared with the unexposed period of 12 months before FT. FTs included controlled ovarian stimulation followed by fresh embryo transfer (COS-ET), COS alone, embryo transfer (ET) alone, and oral ovulation induction (OI). The Wilcoxon signed rank test and mixed Poisson regression models with random effects were used to compare ARR pre-FT vs post-FT, with the incidence rate ratio (IRR) and 95% CI reported. RESULTS: One hundred twenty-four FT cycles among 65 patients with MS (n = 56) or CIS (n = 9) were included: 61 COS-ET, 19 COS alone, 30 ET alone, and 14 OI. The mean age at FT was 36.5 ± 3.8 years, and the mean disease duration was 8.2 ± 5.0 years. Across 80 cycles with COS, only 5 relapses occurred among 4 unique patients within 3 months of treatment. The mean ARR after COS and before was not different (0.26 vs 0.25, p = 0.37), and the IRR was 0.95 (95% CI: 0.52-1.76, p = 0.88). No cycles with therapeutic disease-modifying therapies (DMTs) during COS had 3 months relapse (ARR 0 post-COS vs 0.18 pre-COS, p = 0.02, n = 34). Relapse rates did not vary by COS protocol. Among COS-ET cycles that achieved pregnancy (n = 43), ARR decreased from 0.26 to 0.09 (p = 0.04) within the first trimester of pregnancy. There were no relapses 3 months after ET alone and 1 relapse after OI. DISCUSSION: In this modern multicenter cohort of patients with MS undergoing diverse FTs, which included 43% on DMTs, we did not observe an elevated relapse risk after FT.

Comparative cardiovascular effects of GLP-1 agonists using real-world data.

AIMS: There is limited research using real-world data to evaluate protective cardiovascular effects of glucagon-like peptide-1 (GLP-1) agonists among adults with type 2 diabetes (T2D) early in treatment. MATERIALS AND METHODS: We conducted a retrospective, active comparator cohort study using 2011-2015 administrative claims data to compare cardiovascular disease (CVD) event rates following initiation of exenatide extended-release (E-ER), exenatide immediate-release (E-IR) or liraglutide in T2D adults who previously received no other antidiabetic medication (ADM) except metformin. The primary outcome was time to first major adverse CVD event (ischaemic heart disease, stroke, congestive heart failure or peripheral arterial disease) after starting GLP-1. Cox proportional hazards regression was used to model the association between index GLP-1 and CVD events, adjusting for baseline patient, prescriber and plan characteristics. Primary analyses included all patients with ≥2 prescription fills for the index GLP-1, regardless of subsequent refill adherence or initiation of other ADM after index date. RESULTS: Compared with liraglutide, neither E-ER nor E-IR was associated with risk of composite major CVD events (hazard ratios [HRs] for E-ER and E-IR: 1.33 [95% C.I. 0.73-2.39] and 1.30 [0.81-2.09]). No associations were observed between event rates for individual CVD components. The HR for an ischaemic event with E-IR relative to liraglutide was 1.85 (95% C.I. 0.97-3.53). Adjusting for time-varying exposure to other ADM and CVD medications after index date produced similar results. CONCLUSIONS: Initiating either immediate or extended-release exenatide rather than liraglutide was not associated with significant differences in CVD risk in this observational real-world study.

DOAC compared with warfarin for VTE in patients with obesity: a retrospective cohort study conducted through the VENUS network.

The effectiveness and safety of direct oral anticoagulants (DOAC) compared with warfarin remains uncertain in obese patients. We assessed the comparative effectiveness and safety of DOACs with warfarin for the treatment of VTE among obese patients. This multi-center retrospective cohort study included adults with a BMI ≥ 35 kg/m2 or weight ≥ 120 kg prescribed either DOAC (apixaban, dabigatran, edoxaban, rivaroxaban) or warfarin for a VTE diagnosis. The primary outcome was the 12-month rate of recurrent VTE. The secondary outcome was the 12-month rate of major bleeding. Among 5626 patients, 67% were prescribed warfarin and 33% were prescribed a DOAC. The 12-month VTE recurrence rate was 3.6% (67/1823) for patients treated with DOAC compared with 3.8% (143/3664) for patients treated with warfarin [odds ratio for recurrent VTE on warfarin versus DOAC (OR) (95% CI).07 (0.80, 1.45)]. The 12-month major bleeding rate was 0.5% (10/1868) for patients on DOAC versus 2.4% (89/3758) on warfarin [OR 4.25 (2.19, 8.22)]. Similar proportions of recurrent VTE occurred across BMI thresholds on DOAC and warfarin: for BMI ≥ 35 kg/m2 (N = 5412), 3.6% versus 3.8%, respectively [OR 1.08 (0.80, 1.46)]; for BMI ≥ 40 kg/m2 (N = 2321), 4.4% versus 3.5%, respectively [OR 0.80 (0.51, 1.26)]; and for BMI ≥ 50 kg/m2 (N = 560), 3.1% versus 3.7%, respectively [OR 1.18 (0.39, 3.56)]. Similar proportions of recurrent VTE occurred in patients with obesity treated for VTE with DOACs and warfarin. DOACs were associated with lower major bleeding compared to warfarin in patients with obesity and VTE.

Telehealth utilization and patient satisfaction in an ambulatory movement disorders center during the COVID-19 pandemic.

INTRODUCTION: Studies suggest that patients are satisfied with telehealth in ambulatory settings. However, tele-neurology satisfaction data are limited by a small sample size and COVID-19-era data is not specific to movement disorders clinics. In this prospective observational study, telehealth utilization during the COVID-19 pandemic was assessed, and patient satisfaction was compared between telehealth and in-person visits in an outpatient movement disorders center. METHODS: Patients ≥18 years who completed an appointment at Northwestern's Movement Disorders Clinic were invited to complete a post-visit Medallia survey. The primary outcomes of the survey were likelihood to recommend (LTR) provider, LTR location, and 'spent enough time,' on a 0-10 scale. Responses were categorized into in-person vs. telehealth groups. RESULTS: Telehealth utilization significantly increased from a pre-COVID timeframe rate of 0.3% (Nov 2019 to Feb 2020) to 39.5% during the COVID-19 pandemic (March 2020 through April 2021) (p-value < 0.001). During the COVID-19 pandemic, 621 patients responded to the post-visit Medallia survey (response rate = 30%), including 365 in-person and 256 telehealth visits. No significant differences were observed between in-person and telehealth encounters in LTR provider (p = 0.892), LTR location (p = 0.659), and time spent (p = 0.395). Additional subgroup multivariable analysis did not support differences in satisfaction between different age groups. DISCUSSION: With its large sample size, our study demonstrates that in the setting of increased TH utilization in movement disorders clinic during the COVID-19 pandemic, patients reported similar satisfaction with telehealth compared to in-person visits. This study supports the utility of telehealth to provide specialized neurologic clinic care.

Examining changes in clinical management and postpartum readmissions for hypertensive disorders of pregnancy over time.

OBJECTIVE: In response to 2013 guidelines for hypertensive disorders of pregnancy (HDP), our study examined changes in antenatal management and postpartum readmission (PPR) over time. STUDY DESIGN: This is a retrospective cohort study of individuals diagnosed antenatally with HDP who delivered at a tertiary care center from 2012 to 2017. MAIN OUTCOME MEASURES: The primary outcome was postpartum readmission for HDP in 2012-2013 vs 2014-2017. Secondary outcomes included intravenous magnesium administration and prescription for oral (PO) antihypertensive medication during delivery admission. Multivariable logistic regression models assessed differences in outcomes over time, adjusted for age, race, and payer status, for HDP with and without severe features, defined by ACOG criteria. RESULTS: Of 5,300 eligible individuals, 73.5 % had HDP without severe features and 26.5 % had severe features. The PPR frequency in this cohort was 1.1 % (N = 59). There was no difference in PPR for individuals with HDP without severe features (aOR 0.73; 95 % CI 0.28-1.88) or with severe features (aOR 1.30; 95 % CI 0.50-3.39) by epoch. Magnesium administration for HDP with severe features remained below 80 % over time. Magnesium administration for HDP without severe features and discharge prescriptions for PO medications for HDP with severe features were lower after 2013. Neither magnesium administration nor discharge prescriptions were associated with decreased odds of PPR. CONCLUSION: Although there was no difference in PPR for HDP after 2013, there were changes in antenatal management of HDP, including decreased magnesium administration for individuals with HDP without severe features and PO medication for individuals with severe features.

South Asians Active Together (SAATH): Protocol for a multilevel physical activity intervention trial for South Asian American mother and daughter dyads.

South Asian (SA), including Asian Indian and Pakistani Americans, have a high burden of cardiometabolic risk factors and low levels of physical activity (PA). Increasing PA in the U.S. population is a national priority; however, SA American women and girls experience unique barriers to PA that are not addressed by current promotion efforts. To address this gap, our community-based participatory research partnership developed the South Asians Active Together (SAATH) intervention. This study is a two-arm randomized clinical trial to evaluate the effects, mediators, and implementation of the 18-week SAATH intervention. A total of 160 mother-daughter dyads will be randomized in a 1:1 ratio to the SAATH intervention and control groups. The intervention was designed for mother-daughter dyads and targets individual, interpersonal, and family levels through (1) group exercise classes, (2) mother-daughter discussions, and (3) peer group discussions. The intervention targets the environment level through community partner meetings aimed at creating environment changes to enhance PA opportunities for SA women and girls. The control group will receive PA education materials. We hypothesize that dyads who receive the intervention will have significantly greater increases in moderate- and vigorous-intensity PA (MVPA) from baseline to 4 months, compared to the control group. MVPA will be measured at 12 months in intervention participants to examine if changes are sustained. A process evaluation will use the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework. This study will fill knowledge gaps about the effectiveness and implementation of culturally adapted, community-based PA interventions for SA women and girls.