Faculty Bibliography

BACKGROUND:Gender-based differences are reported in inflammatory bowel diseases (IBD) pathogenesis, but their impacts on IBD outcomes are not well known. We determined gender-based differences in response to treatment with tumor necrosis factor inhibitor (TNFi) therapies in individuals with ulcerative colitis (UC). METHODS:We used the Yale University Open Data Access (YODA) platform to abstract individual participant data from randomized clinical trials to study infliximab and golimumab as induction and maintenance therapies in moderately to severely active UC. Using multivariable logistic regression, we examined associations between gender and the endpoints of clinical remission, mucosal healing, and clinical response for each study individually and in a meta-analysis. RESULTS:Of 1639 patients included in induction trials (Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment-Subcutaneous [PURSUIT-SC], active ulcerative colitis trials [ACT] 1 and 2) and 1280 patients included in maintenance trials (Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment-Maintenance [PURSUIT-IM], ACT 1 and 2), 696 (42.5%) and 534 (41.7%) were women, respectively. In a meta-analysis of induction trials, the adjusted odds ratios (aORs) of clinical remission (aOR, 0.55; 95% CI, 0.31-0.97), mucosal healing (aOR, 0.47; 95% CI, 0.27-0.83), and clinical response (aOR, 0.51; 95% CI, 0.29-0.90) in the treatment arm and of clinical remission in the placebo arm (aOR, 0.34; 95% CI, 0.15-0.82) were lower in men compared to women. There were no differences in outcomes by gender in the treatment and placebo arms in the meta-analysis of maintenance trials. CONCLUSIONS:Men are less likely to achieve clinical remission, mucosal healing, and clinical response compared to women during induction treatment with TNFi for UC, but not during the maintenance phase. Future studies delineating the mechanisms underlying these observations would be informative.

IMPORTANCE/UNASSIGNED:Although school-based gardening programs for children have consistently been shown to improve dietary behaviors, no cluster randomized clinical trial (RCT) has evaluated the effects of a school-based gardening intervention on metabolic outcomes. OBJECTIVE/UNASSIGNED:To evaluate the effects of a school-based gardening, nutrition, and cooking intervention (Texas Sprouts) on changes in metabolic outcomes in elementary schoolchildren. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This study was a secondary analysis of a cluster RCT, conducted over 3 years from 2016 to 2019, at low-income elementary schools with majority Hispanic students in the greater Austin, Texas, area. Data were analyzed from January to August 2022. INTERVENTIONS/UNASSIGNED:Texas Sprouts was 1 school year long (9 months) and consisted of (1) Garden Leadership Committee formation; (2) a 0.25-acre outdoor teaching garden; (3) 18 student gardening, nutrition, and cooking lessons taught by trained educators throughout the school year; and (4) 9 monthly parent lessons. The delayed intervention was implemented the following academic year and received an identical intervention. MAIN OUTCOMES AND MEASURES/UNASSIGNED:The following measures were obtained at baseline and postintervention (9 months): demographics via survey; measured height, weight, and body mass index parameters; and glucose, insulin, homeostatic model assessment of insulin resistance, and a lipid panel via an optional fasting blood draw. RESULTS/UNASSIGNED:Sixteen elementary schools were randomly assigned to either Texas Sprouts intervention (8 schools) or to delayed intervention (control, 8 schools). A total of 3302 children (aged 7-12 years) were enrolled in Texas Sprouts, and fasting blood samples were obtained from 1104 children (or 33% of those enrolled) at baseline. The final analytic sample included 695 children (307 boys [44.17%]; mean [SE] age, 9.28 [0.04] years; 480 Hispanic children [69.02%]; 452 [65.03%] eligible for free or reduced lunch) with complete demographic data and baseline and postintervention (9-month) fasting blood draws. Compared with control schools, children from Texas Sprouts schools had a 0.02% reduction in mean hemoglobin A1c (95% CI, 0.03%-0.14%; P = .005) and a 6.40 mg/dL reduction in mean low-density lipoprotein cholesterol (95% CI, 3.82-8.97 mg/dL; P = .048). There were no intervention effects on glucose, insulin, homeostatic model assessment of insulin resistance, or other lipid parameters. CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this cluster RCT, Texas Sprouts improved glucose control and reduced low-density lipoprotein cholesterol in high-risk youth. These findings suggest that elementary schools should incorporate garden-based interventions as a way to improve metabolic parameters in children. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT02668744.

IMPORTANCE/UNASSIGNED:Financial incentives for weight management may increase use of evidence-based strategies while addressing obesity-related economic disparities in low-income populations. OBJECTIVE/UNASSIGNED:To examine the effects of 2 financial incentive strategies developed using behavioral economic theory when added to provision of weight management resources. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:Three-group, randomized clinical trial conducted from November 2017 to May 2021 at 3 hospital-based clinics in New York City, New York, and Los Angeles, California. A total of 1280 adults with obesity living in low-income neighborhoods were invited to participate, and 668 were enrolled. INTERVENTIONS/UNASSIGNED:Participants were randomly assigned to goal-directed incentives, outcome-based incentives, or a resources-only group. The resources-only group participants were given a 1-year commercial weight-loss program membership, self-monitoring tools (digital scale, food journal, and physical activity monitor), health education, and monthly one-on-one check-in visits. The goal-directed group included resources and linked financial incentives to evidence-based weight-loss behaviors. The outcome-based arm included resources and linked financial incentives to percentage of weight loss. Participants in the incentive groups could earn up to $750. MAIN OUTCOMES AND MEASURES/UNASSIGNED:Proportion of patients achieving 5% or greater weight loss at 6 months. RESULTS/UNASSIGNED:The mean (SD) age of the 668 participants enrolled was 47.7 (12.4) years; 541 (81.0%) were women, 485 (72.6%) were Hispanic, and 99 (14.8%) were Black. The mean (SD) weight at enrollment was 98.96 (20.54) kg, and the mean body mass index (calculated as weight in kilograms divided by height in meters squared) was 37.95 (6.55). At 6 months, the adjusted proportion of patients who lost at least 5% of baseline weight was 22.1% in the resources-only group, 39.0% in the goal-directed group, and 49.1% in the outcome-based incentive group (difference, 10.08 percentage points [95% CI, 1.31-18.85] for outcome based vs goal directed; difference, 27.03 percentage points [95% CI, 18.20-35.86] and 16.95 percentage points [95% CI, 8.18-25.72] for outcome based or goal directed vs resources only, respectively). However, mean percentage of weight loss was similar in the incentive arms. Mean earned incentives was $440.44 in the goal-directed group and $303.56 in the outcome-based group, but incentives did not improve financial well-being. CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this randomized clinical trial, outcome-based and goal-directed financial incentives were similarly effective, and both strategies were more effective than providing resources only for clinically significant weight loss in low-income populations with obesity. Future studies should evaluate cost-effectiveness and long-term outcomes. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT03157713.

The need for therapeutic drug monitoring of direct oral anticoagulants (DOACs) remains an area of clinical equipoise. Although routine monitoring may be unnecessary given predictable pharmacokinetics in most patients, there may be altered pharmacokinetics in those with end organ dysfunction, such as those with renal impairment, or with concomitant interacting medications, at extremes of body weight or age, or in those with thromboembolic events in atypical locations. We aimed to assess real-world practices in situations in which DOAC drug-level monitoring was used at a large academic medical center. A retrospective review of the records of patients who had a DOAC drug-specific activity level checked from 2016 to 2019 was included. A total of 119 patients had 144 DOAC measurements (apixaban (n = 62) and rivaroxaban (n = 57)). Drug-specific calibrated DOAC levels were within an expected therapeutic range for 110 levels(76%), with 21 levels (15%) above the expected range and 13 levels (9%) below the expected range. The DOAC levels were checked in the setting of an urgent or emergent procedure in 28 patients (24%), followed by renal failure in 17 patients (14%), a bleeding event in 11 patients (9%), concern for recurrent thromboembolism in 10 patients (8%), thrombophilia in 9 patients (8%), a history of recurrent thromboembolism in 6 patients (5%), extremes of body weight in 7 patients (5%), and unknown reasons in 7 patients (5%). Clinical decision making was infrequently affected by the DOAC monitoring. Therapeutic drug monitoring with DOACs may help predict bleeding events in elderly patients, those with impaired renal function, and in the event of an emergent or urgent procedure. Future studies are needed to target the select patient-specific scenarios where monitoring DOAC levels may impact clinical outcomes.

OBJECTIVE:To evaluate how stress related to the coronavirus disease 2019 (COVID-19) pandemic has affected women's menstrual cycles. We hypothesized that women with high levels of COVID-19-related stress would have more menstrual changes compared with those with lower levels of stress. METHODS:Using a cross-sectional study design, we recruited a representative sample of U.S. adult women of reproductive age (18-45 years) using nonhormonal birth control to participate in an online REDCap (Research Electronic Data Capture, Vanderbilt University) survey. COVID-19-related stress was assessed with the PSS-10-C (COVID-19 Pandemic-related Perceived Stress Scale) and dichotomized as low stress (scores lower than 25) and high stress (scores 25 or higher). Self-reported menstrual outcomes were identified as changes in cycle length, duration, or flow and increased frequency of spotting between cycles. We used χ 2 and Fisher exact tests to compare differences in outcome between the two stress groups and logistic regression models for effect estimates. RESULTS:A total of 354 women of reproductive age across the United States completed both the menstrual and COVID-19-related stress components of our survey. More than half of these women reported at least one change in their menstrual cycles since the start of the pandemic (n=191), and 10.5% reported high COVID-19-related stress (n=37). Compared with those with low COVID-19-related stress, a greater proportion of women with high COVID-19-related stress reported changes in cycle length (shorter or longer; P =.008), changes in period duration (shorter or longer; P <.001), heavier menstrual flow ( P =.035), and increased frequency of spotting between cycles ( P =.006) compared with prepandemic times. After adjusting for age, smoking history, obesity, education, and mental health history, high COVID-19-related stress was associated with increased odds of changes in menstrual cycle length (adjusted odds ratio [aOR] 2.32; 95% CI 1.12-4.85), duration (aOR 2.38; 95% CI 1.14-4.98), and spotting (aOR 2.32; 95% CI 1.03-5.22). Our data also demonstrated a nonsignificant trend of heavier menstrual flow among women with high COVID-19-related stress (aOR 1.61; 95% CI 0.77-3.34). CONCLUSION/CONCLUSIONS:High COVID-19-related stress is associated with significant changes in menstrual cycle length, alterations in period duration, and increased intermenstrual spotting as compared with before the pandemic. Given that menstrual health is frequently an indicator of women's overall well-being, clinicians, researchers, and public health officials must consider the association between COVID-19-related stress and menstrual disturbances.

Background: The introduction of electronic workflows has allowed for the flow of raw uncontextualized clinical data into medical documentation. As a result, many electronic notes have become replete of "noise" and deplete clinically significant "signals." There is an urgent need to develop and implement innovative approaches in electronic clinical documentation that improve note quality and reduce unnecessary bloating. Objective: This study aims to describe the development and impact of a novel set of templates designed to change the flow of information in medical documentation. Methods: This is a multihospital nonrandomized prospective improvement study conducted on the inpatient general internal medicine service across 3 hospital campuses at the New York University Langone Health System. A group of physician leaders representing each campus met biweekly for 6 months. The output of these meetings included (1) a conceptualization of the note bloat problem as a dysfunction in information flow, (2) a set of guiding principles for organizational documentation improvement, (3) the design and build of novel electronic templates that reduced the flow of extraneous information into provider notes by providing link outs to best practice data visualizations, and (4) a documentation improvement curriculum for inpatient medicine providers. Prior to go-live, pragmatic usability testing was performed with the new progress note template, and the overall user experience was measured using the System Usability Scale (SUS). Primary outcome measures after go-live include template utilization rate and note length in characters. Results: In usability testing among 22 medicine providers, the new progress note template averaged a usability score of 90.6 out of 100 on the SUS. A total of 77% (17/22) of providers strongly agreed that the new template was easy to use, and 64% (14/22) strongly agreed that they would like to use the template frequently. In the 3 months after template implementation, general internal medicine providers wrote 67% (51,431/76,647) of all inpatient notes with the new templates. During this period, the organization saw a 46% (2768/6191), 47% (3505/7819), and 32% (3427/11,226) reduction in note length for general medicine progress notes, consults, and history and physical notes, respectively, when compared to a baseline measurement period prior to interventions. Conclusions: A bundled intervention that included the deployment of novel templates for inpatient general medicine providers significantly reduced average note length on the clinical service. Templates designed to reduce the flow of extraneous information into provider notes performed well during usability testing, and these templates were rapidly adopted across all hospital campuses. Further research is needed to assess the impact of novel templates on note quality, provider efficiency, and patient outcomes.

Introduction: Immigration has been identified as an important social determinant of health (SDH), embodying structures and policies that reinforce positions of poverty, stress, and limited social and economic mobility. In the public health literature with regard to diet, immigration is often characterized as an individual-level process (dietary acculturation) and is largely examined in one racial/ethnic subgroup at a time. For this narrative review, we aim to broaden the research discussion by describing SDH common to the immigrant experience and that may serve as barriers to healthy diets. Methods: A narrative review of peer-reviewed quantitative, qualitative, and mixed methods studies on cardiometabolic health disparities, diet, and immigration was conducted. Results: Cardiometabolic disease disparities were frequently described by racial/ethnic subgroups instead of country of origin. While cardiovascular disease and obesity risk differed by country of origin, diabetes prevalence was typically higher for immigrant groups vs United States (US)-born individuals. Common barriers to achieving a healthy diet were food insecurity; lack of familiarity with US food procurement practices, food preparation methods, and dietary guidelines; lack of familiarity and distrust of US food processing and storage methods; alternative priorities for food purchasing (eg, freshness, cultural relevance); logistical obstacles (eg, transportation); stress; and ethnic identity maintenance. Conclusions: To improve the health of immigrant populations, understanding similarities in cardiometabolic health disparities, diet, and barriers to health across immigrant communities"”traversing racial/ethnic subgroups"”may serve as a useful framework. This framework can guide research, policy, and public health practices to be more cohesive, generalizable, and meaningfully inclusive.