Faculty Bibliography

IMPORTANCE/UNASSIGNED:Obesity affects approximately 42% of US adults and is associated with increased rates of type 2 diabetes, hypertension, cardiovascular disease, sleep disorders, osteoarthritis, and premature death. OBSERVATIONS/UNASSIGNED:A body mass index (BMI) of 25 or greater is commonly used to define overweight, and a BMI of 30 or greater to define obesity, with lower thresholds for Asian populations (BMI ≥25-27.5), although use of BMI alone is not recommended to determine individual risk. Individuals with obesity have higher rates of incident cardiovascular disease. In men with a BMI of 30 to 39, cardiovascular event rates are 20.21 per 1000 person-years compared with 13.72 per 1000 person-years in men with a normal BMI. In women with a BMI of 30 to 39.9, cardiovascular event rates are 9.97 per 1000 person-years compared with 6.37 per 1000 person-years in women with a normal BMI. Among people with obesity, 5% to 10% weight loss improves systolic blood pressure by about 3 mm Hg for those with hypertension, and may decrease hemoglobin A1c by 0.6% to 1% for those with type 2 diabetes. Evidence-based obesity treatment includes interventions addressing 5 major categories: behavioral interventions, nutrition, physical activity, pharmacotherapy, and metabolic/bariatric procedures. Comprehensive obesity care plans combine appropriate interventions for individual patients. Multicomponent behavioral interventions, ideally consisting of at least 14 sessions in 6 months to promote lifestyle changes, including components such as weight self-monitoring, dietary and physical activity counseling, and problem solving, often produce 5% to 10% weight loss, although weight regain occurs in 25% or more of participants at 2-year follow-up. Effective nutritional approaches focus on reducing total caloric intake and dietary strategies based on patient preferences. Physical activity without calorie reduction typically causes less weight loss (2-3 kg) but is important for weight-loss maintenance. Commonly prescribed medications such as antidepressants (eg, mirtazapine, amitriptyline) and antihyperglycemics such as glyburide or insulin cause weight gain, and clinicians should review and consider alternatives. Antiobesity medications are recommended for nonpregnant patients with obesity or overweight and weight-related comorbidities in conjunction with lifestyle modifications. Six medications are currently approved by the US Food and Drug Administration for long-term use: glucagon-like peptide receptor 1 (GLP-1) agonists (semaglutide and liraglutide only), tirzepatide (a glucose-dependent insulinotropic polypeptide/GLP-1 agonist), phentermine-topiramate, naltrexone-bupropion, and orlistat. Of these, tirzepatide has the greatest effect, with mean weight loss of 21% at 72 weeks. Endoscopic procedures (ie, intragastric balloon and endoscopic sleeve gastroplasty) can attain 10% to 13% weight loss at 6 months. Weight loss from metabolic and bariatric surgeries (ie, laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass) ranges from 25% to 30% at 12 months. Maintaining long-term weight loss is difficult, and clinical guidelines support the use of long-term antiobesity medications when weight maintenance is inadequate with lifestyle interventions alone. CONCLUSION AND RELEVANCE/UNASSIGNED:Obesity affects approximately 42% of adults in the US. Behavioral interventions can attain approximately 5% to 10% weight loss, GLP-1 agonists and glucose-dependent insulinotropic polypeptide/GLP-1 receptor agonists can attain approximately 8% to 21% weight loss, and bariatric surgery can attain approximately 25% to 30% weight loss. Comprehensive, evidence-based obesity treatment combines behavioral interventions, nutrition, physical activity, pharmacotherapy, and metabolic/bariatric procedures as appropriate for individual patients.

BACKGROUND:While vaccines have established utility against COVID-19, phase 3 efficacy studies have generally not comprehensively evaluated protection provided by previous infection or hybrid immunity (previous infection plus vaccination). Individual patient data from US government-supported harmonized vaccine trials provide an unprecedented sample population to address this issue. We characterized the protective efficacy of previous SARS-CoV-2 infection and hybrid immunity against COVID-19 early in the pandemic over three-to six-month follow-up and compared with vaccine-associated protection. METHODS:In this post-hoc cross-protocol analysis of the Moderna, AstraZeneca, Janssen, and Novavax COVID-19 vaccine clinical trials, we allocated participants into four groups based on previous-infection status at enrolment and treatment: no previous infection/placebo; previous infection/placebo; no previous infection/vaccine; and previous infection/vaccine. The main outcome was RT-PCR-confirmed COVID-19 >7-15 days (per original protocols) after final study injection. We calculated crude and adjusted efficacy measures. FINDINGS/RESULTS:Previous infection/placebo participants had a 92% decreased risk of future COVID-19 compared to no previous infection/placebo participants (overall hazard ratio [HR] ratio: 0.08; 95% CI: 0.05-0.13). Among single-dose Janssen participants, hybrid immunity conferred greater protection than vaccine alone (HR: 0.03; 95% CI: 0.01-0.10). Too few infections were observed to draw statistical inferences comparing hybrid immunity to vaccine alone for other trials. Vaccination, previous infection, and hybrid immunity all provided near-complete protection against severe disease. INTERPRETATION/CONCLUSIONS:Previous infection, any hybrid immunity, and two-dose vaccination all provided substantial protection against symptomatic and severe COVID-19 through the early Delta period. Thus, as a surrogate for natural infection, vaccination remains the safest approach to protection. FUNDING/BACKGROUND:National Institutes of Health.

BACKGROUND/UNASSIGNED:The transition to telehealth during the COVID-19 pandemic revealed a lack of preexisting telehealth training for clinicians. As a workplace-based simulation methodology designed to improve virtual clinical skills, announced standardized patients (ASPs) may help meet evolving educational needs to sustain quality telehealth care. OBJECTIVE/UNASSIGNED:We describe the development and implementation of an ASP program to assess and provide feedback to resident and faculty clinicians in virtual practice, and report on performance, feasibility, and acceptability. METHODS/UNASSIGNED:From June 2021 to April 2022, resident and faculty clinicians at a VA primary care clinic participated in a video visit in which an ASP portrayed either a 70-year-old man with hearing loss and hypertension or a 60-year-old man with hypertension and financial stress. Following the visit, ASPs provided verbal feedback and completed a behaviorally anchored checklist to rate telehealth and communication skills, chronic disease management, and use of resources. Domain summary scores were calculated as the mean percentage of "well done" items. Participants completed a feedback survey on their experience. RESULTS/UNASSIGNED:Seventy-six televisits (60 primary care residents [postgraduate year 1-3], 16 internal medicine faculty) were conducted from August 2021 to April 2022. Clinicians performed well in communication skills: information gathering (79%, 60 of 76, well done), relationship development (67%, 51 of 76), education and counseling (71%, 54 of 76), and patient satisfaction (86%, 65 of 76). They performed less well in telemedicine skills (38%, 29 of 76). Participants agreed that the experience was a good use of their time (88%, 67 of 76). CONCLUSIONS/UNASSIGNED:An ASP-facilitated training for resident and faculty clinicians assessed telehealth skills and clinical practice and identified areas for intervention. Clinicians responded well to the training and feedback.

IMPORTANCE/UNASSIGNED:Current data identifying COVID-19 risk factors lack standardized outcomes and insufficiently control for confounders. OBJECTIVE/UNASSIGNED:To identify risk factors associated with COVID-19, severe COVID-19, and SARS-CoV-2 infection. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This secondary cross-protocol analysis included 4 multicenter, international, randomized, blinded, placebo-controlled, COVID-19 vaccine efficacy trials with harmonized protocols established by the COVID-19 Prevention Network. Individual-level data from participants randomized to receive placebo within each trial were combined and analyzed. Enrollment began July 2020 and the last data cutoff was in July 2021. Participants included adults in stable health, at risk for SARS-CoV-2, and assigned to the placebo group within each vaccine trial. Data were analyzed from April 2022 to February 2023. EXPOSURES/UNASSIGNED:Comorbid conditions, demographic factors, and SARS-CoV-2 exposure risk at the time of enrollment. MAIN OUTCOMES AND MEASURES/UNASSIGNED:Coprimary outcomes were COVID-19 and severe COVID-19. Multivariate Cox proportional regression models estimated adjusted hazard ratios (aHRs) and 95% CIs for baseline covariates, accounting for trial, region, and calendar time. Secondary outcomes included severe COVID-19 among people with COVID-19, subclinical SARS-CoV-2 infection, and SARS-CoV-2 infection. RESULTS/UNASSIGNED:A total of 57 692 participants (median [range] age, 51 [18-95] years; 11 720 participants [20.3%] aged ≥65 years; 31 058 participants [53.8%] assigned male at birth) were included. The analysis population included 3270 American Indian or Alaska Native participants (5.7%), 7849 Black or African American participants (13.6%), 17 678 Hispanic or Latino participants (30.6%), and 40 745 White participants (70.6%). Annualized incidence was 13.9% (95% CI, 13.3%-14.4%) for COVID-19 and 2.0% (95% CI, 1.8%-2.2%) for severe COVID-19. Factors associated with increased rates of COVID-19 included workplace exposure (high vs low: aHR, 1.35 [95% CI, 1.16-1.58]; medium vs low: aHR, 1.41 [95% CI, 1.21-1.65]; P < .001) and living condition risk (very high vs low risk: aHR, 1.41 [95% CI, 1.21-1.66]; medium vs low risk: aHR, 1.19 [95% CI, 1.08-1.32]; P < .001). Factors associated with decreased rates of COVID-19 included previous SARS-CoV-2 infection (aHR, 0.13 [95% CI, 0.09-0.19]; P < .001), age 65 years or older (aHR vs age <65 years, 0.57 [95% CI, 0.50-0.64]; P < .001) and Black or African American race (aHR vs White race, 0.78 [95% CI, 0.67-0.91]; P = .002). Factors associated with increased rates of severe COVID-19 included race (American Indian or Alaska Native vs White: aHR, 2.61 [95% CI, 1.85-3.69]; multiracial vs White: aHR, 2.19 [95% CI, 1.50-3.20]; P < .001), diabetes (aHR, 1.54 [95% CI, 1.14-2.08]; P = .005) and at least 2 comorbidities (aHR vs none, 1.39 [95% CI, 1.09-1.76]; P = .008). In analyses restricted to participants who contracted COVID-19, increased severe COVID-19 rates were associated with age 65 years or older (aHR vs <65 years, 1.75 [95% CI, 1.32-2.31]; P < .001), race (American Indian or Alaska Native vs White: aHR, 1.98 [95% CI, 1.38-2.83]; Black or African American vs White: aHR, 1.49 [95% CI, 1.03-2.14]; multiracial: aHR, 1.81 [95% CI, 1.21-2.69]; overall P = .001), body mass index (aHR per 1-unit increase, 1.03 [95% CI, 1.01-1.04]; P = .001), and diabetes (aHR, 1.85 [95% CI, 1.37-2.49]; P < .001). Previous SARS-CoV-2 infection was associated with decreased severe COVID-19 rates (aHR, 0.04 [95% CI, 0.01-0.14]; P < .001). CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this secondary cross-protocol analysis of 4 randomized clinical trials, exposure and demographic factors had the strongest associations with outcomes; results could inform mitigation strategies for SARS-CoV-2 and viruses with comparable epidemiological characteristics.

The human vaginal and fecal microbiota change during pregnancy. Because of the proximity of these perineal sites and the evolutionarily conserved maternal-to-neonatal transmission of the microbiota, we hypothesized that the microbiota of these two sites (rectal and vaginal) converge during the last gestational trimester as part of the preparation for parturition. To test this hypothesis, we analyzed 16S rRNA sequences from vaginal introitus and rectal samples in 41 women at gestational ages 6 and 8 months, and at 2 months post-partum. The results show that the human vaginal and rectal bacterial microbiota converged during the last gestational trimester and into the 2nd month after birth, with a significant decrease in Lactobacillus species in both sites, as alpha diversity progressively increased in the vagina and decreased in the rectum. The microbiota convergence of the maternal vaginal-anal sites perinatally might hold significance for the inter-generational transmission of the maternal microbiota.

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.

Objectives: This study examined COVID-19"™s impact in the 2020 compared to 2019 survey years on preventive medical care utilization. Research Design: Using a cross-sectional sample of adults aged 18 years and over (2019; n = 31,997; 2020; n = 31,568), from the National Health Interview Survey, multivariable models compared 2020 to 2019 survey years for receiving diabetes screening blood tests, well-care visits, and physical therapy. An additional multivariable model predicted not having medical care due to the COVID-19 pandemic in the 2020 2020 survey year. Results: In the 2020 versus 2019 survey years, the likelihood lowered for receiving a blood test for diabetes screening (aOR.83 CI =.76,.90). There was a lowered likelihood for a well care visits (aOR =.98 CI =.84, 1.1) and physical therapy (aOR =.97 CI =.89, 1.0). Black (aOR =.62 CI =.51,.75), Hispanic (aOR =.62 CI =.51,.75) and Asian (aOR.67 CI =.53,.86) adults had a lowered likelihood of having physical therapy compared to White adults. Having no insurance coverage lowered the likelihood of getting all three indicators of preventive medical care. There was a higher likelihood of not getting medical care due to COVID-19 in the 2020 survey year (aOR = 1.7 CI = 1.3, 2.1) with Medicaid compared to private coverage. Conclusions: Use of preventive medical care lowered in the pandemic. Race and ethnicity and not having any coverage contributed to not receiving preventive care. Medicaid appeared to increase utilization of preventive medical care but not acute medical care.

OBJECTIVE/UNASSIGNED:Despite intending to eat healthy foods, people often yield to temptation. In environments rife with unhealthy food options, a positive implicit evaluation of unhealthy foods may inadvertently influence unhealthy choices. This study investigates if and under which conditions implicit evaluations of unhealthy and healthy foods can be influenced by a computer-based Go/No-Go (GNG) training. DESIGN/UNASSIGNED: MAIN OUTCOME MEASURE/UNASSIGNED:Implicit evaluations of chips and grapes were assessed using the Extrinsic Affective Simon Task. RESULTS/UNASSIGNED:This GNG training impacted implicit evaluations of chips, but not grapes. GNG training effects were stronger for participants with lower sensitivity for behavioural inhibition measured with the Behavioural Inhibition System scale. CONCLUSION/UNASSIGNED:GNG training might help people change implicit food evaluations. More research is needed to understand how individual and training characteristics affect outcomes with the goal of tailoring and optimising the GNG training to produce the strongest effect.