The design, implementation, and impact of an automated patient-reported outcome data collection and adverse event surveillance tool: a randomized trial.

BACKGROUND: Incorporating patient-reported outcome measures into routine clinical care can improve the patient experience, increase engagement, and establish a structured method for gathering adverse event (AE) data. Systematically collecting this information on a large scale can also inform new solutions for removing treatment barriers like medication nonadherence. This study evaluated whether implementing a patient-reported outcome data collection and adverse event surveillance tool would result in greater treatment continuation for patients receiving care on a telehealth platform. METHODS: We used iterative plan-study-do-act cycles to evaluate how this data collection and surveillance tool-a short prompt for patients to provide information on treatment satisfaction and side effects-impacted treatment continuation, the outcome of interest. We tested two cycles in n = 2,000 patients receiving care for erectile dysfunction on a telehealth platform as a randomized controlled trial, and accounted for incidents where true randomization was not possible during implementation. The first cycle tested the tool alone, while the second cycle tested the tool in conjunction with a messaging template system that provided standardized side effect counseling. RESULTS: Compared to patients in the control group, patients in the intervention group were more likely to refill their prescription over the duration of the study period (75% vs. 71%, Kaplan Meier log-rank test, p = 0.04). Receiving standardized counseling as part of the AE response system was positively associated with treatment continuation (p = 0.0005). CONCLUSIONS: Prompting patients to report side effects and outcomes outside of routine clinical visits has the potential to improve quality of care in virtual treatment. TRIAL REGISTRATION: This trial has been retrospectively registered as a clinical trial (ClinicalTrials.gov Identifier: NCT05895539, registered June 8, 2023).

Brain dopamine responses to ultra-processed milkshakes are highly variable and not significantly related to adiposity in humans.

Ultra-processed foods high in fat and sugar may be addictive, in part, due to their purported ability to induce an exaggerated postingestive brain dopamine response akin to drugs of abuse. Using standard [11C]raclopride positron emission tomography (PET) displacement methods used to measure brain dopamine responses to addictive drugs, we measured postingestive striatal dopamine responses to an ultra-processed milkshake high in fat and sugar in 50 young, healthy adults over a wide body mass index range (BMI 20-45 kg/m2). Surprisingly, milkshake consumption did not result in significant postingestive dopamine response in the striatum (p=0.62) nor any striatal subregion (p>0.33) and the highly variable interindividual responses were not significantly related to adiposity (BMI: r=0.076, p=0.51; %body fat: r=0.16, p=0.28). Thus, postingestive striatal dopamine responses to an ultra-processed milkshake were likely substantially smaller than many addictive drugs and below the limits of detection using standard PET methods.

Characteristics and Weight Loss Practices From a Cohort of 20,000 Patients Using Direct-to-Consumer Telehealth: Observational Cross-sectional Study.

BACKGROUND: Despite the increasing prevalence of obesity, the use of pharmacotherapy treatment remains low. Telehealth platforms have the potential to facilitate access to pharmacotherapy interventions, but little is known about telehealth patients. OBJECTIVE: This study describes a large patient population taking Plenity, an oral superabsorbent hydrogel (OSH) used in the treatment of excess weight or obesity (BMI 25-40 kg/m2). The analysis compared differences in weight loss practices and in-person access to obesity care among telehealth patients with preobesity and obesity. METHODS: This was a cross-sectional assessment of a random sample of 20,000 telehealth patients who completed a structured, web-based visit and received at least one prescription of OSH. Patients were eligible to receive care via telehealth if they were adults, were not pregnant, and had a BMI ≥25 kg/m2. During the visit, patients provided baseline health information including comorbidities, diet, and exercise habits. Their zip code of residence was used to determine their proximity to an obesity medicine provider. Descriptive statistical analysis and tests of differences (chi-square and 2-tailed t tests) were used to compare patients with preobesity (BMI 25-29.9 kg/m2) and obesity (BMI 30-40 kg/m2). RESULTS: Most (15,576/20,000, 77.88%) of the cohort were female, with a mean age of 44 (SD 11) years and a mean BMI of 32.4 (SD 4.1) kg/m2. Among the cohort, 32.13% (6426/20,000) had preobesity, and 40.18% (8036/20,000) of all patients had ≥1 weight-related comorbidity. Almost all (19,732/20,000, 98.66%) patients attempted 1 weight loss method before OSH and half (10,067/20,000, 50.34%) tried ≥4 different methods. Exercise and low-calorie diets were the most attempted weight loss methods, and 28.76% (5752/20,000) of patients reported a prior prescription of weight loss medication. Patients with obesity were more likely than patients with preobesity to have previously tried commercial weight loss plans (7294/13,574, 53.74% vs 2791/6426, 43.43%; P<.001), specialized diets (8493/13,574, 62.57% vs 3799/6426, 59.12%; P<.001), over-the-counter supplements (6807/13,574, 50.15% vs 2876/6426, 44.76%; P<.001), and prescription weight loss medications (4407/13,574, 32.47% vs 1345/6426, 20.93%; P<.001). Females were more likely to seek treatment for preobesity (5332/15,576, 34.23% vs 1094/4424, 24.73% male; P<.001) and reported fewer comorbidities (5992/15,576, 38.47% vs 2044/4424, 46.2% male; P<.001), despite >90% of both sexes reporting the belief that excess weight negatively affected their health (14,247/15,576, 91.47% female participants, 4116/4424, 93.04% male participants). Moreover, 29.25% (5850/20,000) of patients lived in the same zip code and 85.15% (17,030/20,000) lived in the same county as an obesity medicine provider. CONCLUSIONS: Data from this large patient cohort supports the potential for telehealth to provide prescriptive weight management treatment to a population seeking care. Patients with preobesity are an undertreated population who actively seek new weight management options. Female participants sought weight management treatment earlier in the disease continuum than males, despite reporting fewer comorbidities.

Striatal dopamine tone is positively associated with body mass index in humans as determined by PET using dual dopamine type-2 receptor antagonist tracers.

The relationship between adiposity and dopamine type-2 receptor binding potential (D2BP) in the human brain has been repeatedly studied for >20 years with highly discrepant results, likely due to variable methodologies and differing study populations. We conducted a controlled inpatient feeding study to measure D2BP in the striatum using positron emission tomography with both [18F]fallypride and [11C]raclopride in pseudo-random order in 54 young adults with a wide range of body mass index (BMI 20-44 kg/m2). Within-subject D2BP measurements using the two tracers were moderately correlated (r=0.47, p<0.001). D2BP was negatively correlated with BMI as measured by [11C]raclopride (r= -0.51; p<0.0001) but not [18F]fallypride (r=-0.01; p=0.92) and these correlation coefficients were significantly different from each other (p<0.001). Given that [18F]fallypride has greater binding affinity to dopamine type-2 receptors than [11C]raclopride, which is more easily displaced by endogenous dopamine, our results suggest that adiposity is positively associated with increased striatal dopamine tone.

Associations between Diet Quality and Allostatic Load in US Adults: Findings from the National Health and Nutrition Examination Survey, 2015-2018.

BACKGROUND: Allostatic load (AL), the concept of cumulative biological risk from chronic stressful exposures, may provide a framework with which to examine the links between diet, physiological stress, and disease. OBJECTIVE: This study examined the associations between diet quality and AL. DESIGN: This cross-sectional study was conducted using the 2015 through 2018 cycles of the National Health and Nutrition Examination Survey. Dietary intake was assessed using two 24-hour diet recalls. Diet quality was measured using the Healthy Eating Index 2015. AL was measured by a composite score of nine biochemical markers, with three or more dysregulated values signaling elevated AL. All markers were collected during a physical examination. PARTICIPANTS AND SETTING: This study was conducted in a nationally representative population of 5,343 US adults aged 19 years or older who had no prior diagnosis of diabetes (except gestational diabetes), cancer (except skin cancer), or cardiovascular disease; were not pregnant; and had complete dietary intake and AL biomarker data. MAIN OUTCOME MEASURES: The outcome was odds of elevated AL. STATISTICAL ANALYSES PERFORMED: Accounting for the complex survey design of the National Health and Nutrition Examination Survey, multivariable logistic regression was used to examine the associations between Healthy Eating Index 2015 score and elevated AL, adjusting for sociodemographic variables. RESULTS: A significant inverse association between AL and diet quality was observed among adults aged 31 years and older but not among those aged 19 to 30 years. Among adults aged 31 years and older, those in higher quintiles of Healthy Eating Index 2015 score had significantly lower odds of elevated AL compared with the lowest quintile (P for trend < 0.05). CONCLUSIONS: These results suggest that, in adults older than age 30 years, consuming a more healthful diet is inversely associated with AL.

Novel in-home COVID-19 vaccination program for vulnerable populations using public-private collaboration.

Background: The continued emergence of new COVID-19 variants highlights the importance of vaccination in the effort to reduce disease transmission and burden. The objective of this study is to evaluate the processes and outcomes associated with a novel in-home COVID-19 vaccination program aimed at vaccinating high-risk populations in New York, USA. Methods: To evaluate program processes, we described the program itself and reflected on some key lessons learned. To evaluate program outcomes, we analyzed data reported by vaccine recipients. These outcomes included the percentage of vaccine recipients that successfully received the full course of vaccinations, and the demographic and health characteristics of vaccine recipients. We additionally assessed demographic differences in motivations for receiving in-home care, using chi-squared tests to assess statistical significance. Data were collected and reported via dynamic online intake forms. Results: The median age of vaccine recipients was 79 ± SD 9.0 years. The oldest vaccine recipient was 107 years old. Of those with non-missing data, more than half of vaccine recipients were female (63%), identified as part of a racial/ethnic minority (66%), reported an annual income of < $25,000 (58%), and received a high school degree or less (68%). Most vaccine recipients reported having one or more health conditions associated with increased risk of severe COVID-19 disease (72%). Vaccine recipients were most likely to report receiving in-home vaccination because they were home-bound due to disability. Motivations for receiving in-home vaccination differed by demographic subgroup. Conclusion: The population receiving vaccinations from this in-home care delivery program comprised seniors who were mostly female and non-white, indicated socioeconomic vulnerability, and reported one or more COVID-related health conditions; this signified that the program met its goal of vaccinating those most at risk for severe COVID-19 disease.

Household Food Insecurity and the Association with Cumulative Biological Risk among Lower-Income Adults: Results from the National Health and Nutrition Examination Surveys 2007-2010.

Household food insecurity has been associated with adverse health outcomes; however, the mechanisms underlying these associations are not well-defined. Using data from 5005 adults from the 2007-2010 National Health and Nutrition Examination Surveys (NHANES), we examined associations between household food insecurity and cumulative biological risk, a measure of the body's physiological response to chronic stress. Household food security was assessed using the 18-item Household Food Security Survey Module. Marginal food security refers to 1-2 positive responses, and food insecurity refers to ≥3 positive responses. The cumulative biological risk scores were calculated based on the distributions of ten biomarkers from the cardiovascular, metabolic, and immune systems. Elevated biological risk was defined as a risk score of ≥3. Multivariable regression models were used to examine associations between food security and cumulative biological risk scores, adjusting for sociodemographic characteristics. After multivariable adjustment, food insecurity was associated with a 0.14-unit higher cumulative biological risk score (95% CI 0.05-0.22, p-trend = 0.003) and higher odds of elevated biological risk (OR 1.20, 95% CI 1.05-1.37, p-trend = 0.003). These associations differed by gender. Among women, food insecurity was associated with 0.30-unit higher cumulative biological risk score (95% CI 0.14-0.45, p-trend = 0.0004) and higher odds of elevated biological risk (OR 1.61, 95% CI 1.29-2.00, p-trend < 0.0001). These associations were not observed in men. Women experiencing food insecurity demonstrated elevated levels of biological risk. These findings support the hypothesis that food insecurity may be associated with women's chronic health outcomes through the pathway of chronic stress. Further research is needed to understand why these associations were not observed in men.