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Low-fat plant-based diets cause weight loss in clinical trials. However, many foods are highly processed, raising the question as to their effect on body weight. This secondary analysis assessed the associations between changes in processed food intake and weight loss in 244 overweight adults randomly assigned to a vegan ( n  = 122) or control group ( n  = 122) for 16 weeks. Three-day dietary records were analyzed using the NOVA system, which categorizes foods from 1 to 4, based on degree of processing. A repeated measure ANOVA, Pearson correlations, and a multivariate regression model were used for statistical analysis. The consumption of animal foods in categories 1–4 decreased in the vegan group, compared with the control group. Body weight decreased in the vegan group (treatment effect − 5.9 kg [95% CI -6.7 to -5.0]; Gxt, p  < 0.001). Changes in consumption of animal foods in categories 1–4 were positively associated with changes in body weight: r = + 0.34; p  < 0.001 for category 1; r = + 0.18; p  = 0.008 for category 2; r = + 0.17; p  = 0.01 for category 3; and r = + 0.22; p  = 0.001 for category 4. In no NOVA category was the consumption of plant-based processed foods positively and significantly associated with weight gain. The top three independent predictors of weight loss were reduced intakes of processed, unprocessed or minimally processed, and ultra-processed animal foods. These findings suggest that replacing animal products with plant-based foods may be an effective weight-loss strategy, even when processed plant-based foods are included.

Background Thrombotic microangiopathy-induced thrombocytopenia-associated multiple organ failure and hyperinflammatory macrophage activation syndrome are important causes of late pediatric sepsis mortality that are often missed or have delayed diagnosis. The National Institutes of General Medical Science sepsis research working group recommendations call for application of new research approaches in extant clinical data sets to improve efficiency of early trials of new sepsis therapies. Our objective is to apply machine learning approaches to derive computable 24-h sepsis phenotypes to facilitate personalized enrollment in early anti-inflammatory trials targeting these conditions. Methods We applied consensus, k -means clustering analysis to our extant PHENOtyping sepsis-induced Multiple organ failure Study (PHENOMS) dataset of 404 children. 24-hour computable phenotypes are derived using 25 available bedside variables including C-reactive protein and ferritin. Results Four computable phenotypes (PedSep-A, B, C, and D) are derived. Compared to all other phenotypes, PedSep-A patients ( n  = 135; 2% mortality) were younger and previously healthy, with the lowest C-reactive protein and ferritin levels, the highest lymphocyte and platelet counts, highest heart rate, and lowest creatinine ( p  < 0.05); PedSep-B patients ( n  = 102; 12% mortality) were most likely to be intubated and had the lowest Glasgow Coma Scale Score ( p  < 0.05); PedSep-C patients ( n  = 110; mortality 10%) had the highest temperature and Glasgow Coma Scale Score, least pulmonary failure, and lowest lymphocyte counts ( p  < 0.05); and PedSep-D patients ( n  = 56, 34% mortality) had the highest creatinine and number of organ failures, including renal, hepatic, and hematologic organ failure, with the lowest platelet counts ( p  < 0.05). PedSep-D had the highest likelihood of developing thrombocytopenia-associated multiple organ failure (Adj OR 47.51 95% CI [18.83–136.83], p  < 0.0001) and macrophage activation syndrome (Adj OR 38.63 95% CI [13.26–137.75], p  < 0.0001). Conclusions Four computable phenotypes are derived, with PedSep-D being optimal for enrollment in early personalized anti-inflammatory trials targeting thrombocytopenia-associated multiple organ failure and macrophage activation syndrome in pediatric sepsis. A computer tool for identification of individual patient membership ( www.pedsepsis.pitt.edu ) is provided. Reproducibility will be assessed at completion of two ongoing pediatric sepsis studies.

This study examined the role of gut microbiome changes in mediating the effects of a dietary intervention on the frequency and severity of postmenopausal vasomotor symptoms Postmenopausal women (n = 84) reporting ≥2 moderate-to-severe hot flashes daily were randomly assigned, in 2 successive cohorts, to an intervention including a low-fat, vegan diet and cooked soybeans (½ cup [86 g] daily) or to stay on their usual diet. Over a 12-week period, frequency and severity of hot flashes were recorded with a mobile application. In a subset of 11 women, gut microbiome was analyzed at baseline and after 12 weeks of the dietary intervention (low-fat vegan diet with soybeans), using deep shotgun metagenomic sequencing. Differences in the microbiome between baseline and 12 weeks were assessed by comparing alpha diversity with Wilcoxon signed rank tests, beta diversity with permanovaFL, and taxon abundance with Wilcoxon signed rank tests. Pearson correlations were used to assess the association between changes in hot flashes and gut bacteria. In the subset for which microbiome testing was done, total hot flashes decreased by 95 % during the dietary intervention (p = 0.007); severe hot flashes disappeared (from 0.6 to 0.0/day; p = 0.06); and moderate-to-severe hot flashes decreased by 96 % (p = 0.01). Daytime and nighttime hot flashes were reduced by 96 % (p = 0.01) and 94 % (p = 0.004), respectively. Alpha and beta diversity did not significantly differ in the intervention group between baseline and 12 weeks. Two families (Enterobacteriaceae and Veillonellaceae), 5 genera (Erysipelatoclostridium, Fusicatenibacter, Holdemanella, Intestinimonas, and Porphyromonas), and 6 species (Clostridium asparagiforme, Clostridium innocuum, Bacteroides thetaiotaomicron, Fusicatenibacter saccharivorans, Intestinimonas butyriciproducens, Prevotella corporis, and Streptococcus sp.) were differentially abundant, but after correction for multiple comparisons, these differences were no longer significant. Changes in the relative abundance of Porphyromonas and Prevotella corporis were associated with the reduction in severe day hot flashes both unadjusted (r = 0.61; p = 0.047; and r = 0.69; p = 0.02), respectively), and after adjustment for changes in body mass index (r = 0.63; p = 0.049; and r = 0.73; p = 0.02), respectively). Changes in relative abundance of Clostridium asparagiforme were associated with the reduction in total severe hot flashes (r = 0.69; p = 0.019) and severe night hot flashes (r = 0.82; p = 0.002) and the latter association remained significant after adjustment for changes in body mass index (r = 0.75; p = 0.01). This exploratory analysis revealed potential associations between changes in vasomotor symptoms in response to a diet change and changes in the gut microbiome. Larger randomized clinical trials are needed to investigate these findings. [Display omitted] •Total hot flashes decreased by 95 % on the vegan diet.•Changes in Porphyromonas and Prevotella corporis correlated with hot flashes.•Changes in Clostridium asparagiforme correlated with changes in severe hot flashes.

Background A low-fat vegan diet, supplemented with soybeans, has been shown effective in reducing postmenopausal hot flashes. This secondary analysis assessed the association of a plant-based index (PDI), healthful (hPDI), and unhealthful (uPDI), with changes in hot flashes in postmenopausal women. Methods Participants ( n  = 84) were randomly assigned to a low-fat vegan diet supplemented with soybeans ( n  = 42) or a control group ( n  = 42) for 12 weeks. Three-day dietary records were analyzed and PDI indices were calculated. A repeated measures analysis of variance (ANOVA) was used for statistical analysis. Results All three scores increased in the vegan group, compared with no change in the control group; the effect sizes were: PDI + 9.8 (95% CI + 5.8 to + 13.8; p  < 0.001); hPDI + 10.9 (95% CI + 6.4 to + 15.3; p  < 0.001); and uPDI + 3.6 (95% CI + 0.5 to + 6.6; p  = 0.02). The change in all three scores negatively correlated with change in body weight (PDI: r =-0.48; p  < 0.001; hPDI: r =-0.38; p  = 0.002; and uPDI: r =-0.31; p  = 0.01). The changes in PDI and uPDI were negatively associated with changes in severe hot flashes ( r =-0.34; p  = 0.009; and r =-0.43; p  < 0.001, respectively), and associations remained significant after adjustment for changes in body mass index ( r =-0.31; p  = 0.02; and r =-0.41; p  = 0.001, respectively). Conclusions These findings suggest that minimizing the consumption of animal products and oil may be an effective strategy to reduce hot flashes in postmenopausal women, and that categorization of plant foods as “healthful” or “unhealthful” may be unwarranted. Trial registration ClinicalTrials.gov, NCT04587154, registered on Oct 14, 2020.

Background Intensive care unit (ICU) patients on mechanical ventilation often require sedation and analgesia to improve comfort and decrease pain. Prolonged sedation and analgesia, however, may increase time on mechanical ventilation, risk for ventilator associated pneumonia, and delirium. Coordinated interruptions in sedation [spontaneous awakening trials (SATs)] and spontaneous breathing trials (SBTs) increase ventilator-free days and improve mortality. Coordination of SATs and SBTs is difficult with substantial implementation barriers due to difficult-to-execute sequencing between nurses and respiratory therapists. Telehealth-enabled remote care has the potential to overcome these barriers and improve coordinated SAT and SBT adherence by enabling proactive high-risk patient monitoring, surveillance, and real-time assistance to frontline ICU teams. Methods The t elehealth- e nabled, real-time a udit and feedback for c linician ad h erence (TEACH) study will determine whether adding a telehealth augmented real-time audit and feedback to a usual supervisor-led audit and feedback intervention will yield higher coordinated SAT and SBT adherence and more ventilator-free days in mechanically ventilated patients than a usual supervisor-led audit and feedback intervention alone in a type II hybrid effectiveness-implementation cluster-randomized clinical trial in 12 Intermountain Health hospitals with 15 ICUs. In the active comparator control group (six hospitals), the only intervention is the usual supervisor-led audit and feedback implementation. The telehealth-enabled support (TEACH) intervention in six hospitals adds real-time identification of patients eligible for a coordinated SAT and SBT and consultative input from telehealth respiratory therapists, nurses, and physicians to the bedside clinicians to promote adherence including real-time assistance with execution. All intubated and mechanically ventilated patients ≥ 16 years of age are eligible for enrollment except for patients who die on the day of intubation or have preexisting brain death. Based on preliminary power analyses, we plan a 36-month intervention period that includes a 90-day run-in period. Estimated enrollment in the final analysis is up to 9900 mechanically ventilated patients over 33 months. Discussion The TEACH study will enhance implementation science by providing insight into how a telehealth intervention augmenting a usual audit and feedback implementation may improve adherence to coordinated SAT and SBT and increase ventilator-free days. Trial registration Clinicaltrials.gov, NCT05141396 , registered 12/02/2021.

Infants with a first episode of wheezing diagnosed as bronchiolitis are often treated with oral dexamethasone. In this trial, children with bronchiolitis and no history of asthma received oral dexamethasone or placebo. There were no clinically significant differences in outcomes between the two groups. Children with bronchiolitis received oral dexamethasone or placebo. There were no clinically significant differences in outcomes between the two groups. Bronchiolitis is the leading cause of hospitalization for infants in the United States, 1 accounting for 100,000 admissions annually, with hospital charges alone estimated at $700 million. 2 Hospitalization rates for infants with bronchiolitis more than doubled between 1980 and 1996, and the proportion of infant hospitalizations that were due to bronchiolitis more than tripled, from 5% to 16%. 2 Treatment for bronchiolitis is controversial. Bronchodilators are commonly used, 3 , 4 but they have not been shown to have consistent benefits. 5 – 8 Although studies suggest that approximately a quarter of infants hospitalized with bronchiolitis receive corticosteroids, 3 , 4 , 9 the efficacy of these agents has . . .

Background Evidence suggests that changes in advanced glycation end‐products (AGEs) may influence body weight. Previous studies have focused on cooking methods as the primary way how to reduce the dietary AGEs but little is known about the effects of a change in diet composition. Objective The aim of this study was to assess the effects of a low‐fat plant‐based diet on dietary AGEs and test the association with body weight, body composition, and insulin sensitivity. Methods Participants who were overweight (n = 244) were randomly assigned to an intervention (low‐fat plant‐based) (n = 122) or control group (n = 122) for 16 weeks. Before and after the intervention period, body composition was measured by dual X‐ray absorptiometry. Insulin sensitivity was assessed with the predicted insulin sensitivity index (PREDIM). Three‐day diet records were analyzed using the Nutrition Data System for Research software and dietary AGEs were estimated, using a database. Repeated measure ANOVA was used for statistical analysis. Results Dietary AGEs decreased in the intervention group by 8768 ku/day on average (95% −9611 to −7925; p < 0.001), compared with the control group (−1608; 95% CI −2709 to −506; p = 0.005; treatment effect −7161 ku/day [95% CI −8540 to −5781]; Gxt, p < 0.001). Body weight decreased by 6.4 kg in the intervention group, compared with 0.5 kg in the control group (treatment effect −5.9 kg [95% CI −6.8 to −5.0]; Gxt, p < 0.001), largely due to a reduction in fat mass, notably visceral fat. PREDIM increased in the intervention group (treatment effect +0.9 [95% CI + 0.5 to +1.2]; p < 0.001). Changes in dietary AGEs correlated with changes in body weight (r = +0.41; p < 0.001), fat mass (r = +0.38; p < 0.001), visceral fat (r = +0.23; p < 0.001), and PREDIM (r = −0.28; p < 0.001), and remained significant even after adjustment for changes in energy intake (r = +0.35; p < 0.001 for body weight; r = +0.34; p < 0.001 for fat mass; r = +0.15; p = 0.03 for visceral fat; and r = −0.24; p < 0.001 for PREDIM). Conclusions Dietary AGEs decreased on a low‐fat plant‐based diet, and this decrease was associated with changes in body weight, body composition, and insulin sensitivity, independent of energy intake. These findings demonstrate positive effects of qualitative dietary changes on dietary AGEs and cardiometabolic outcomes. Clinical Trial Registry Number NCT02939638.

Aims/Hypothesis This secondary analysis compared the effect of a vegan to a portion-controlled diet on insulin use and insulin costs in people with type 1 diabetes (T1D). Methods Fifty-eight adults with T1D were randomly assigned to a vegan ( n  = 29) or a portion-controlled group ( n  = 29) for 12 weeks. Federal Supply Schedule pharmaceutical pricing was used to assess insulin costs. Results Total dose of insulin decreased by 12.1 units/day in the vegan group ( p  = 0.007), compared to no significant change in the portion-controlled group (treatment effect − 10.7 units/day [95% CI, -21.3 to -0.2]; p  = 0.046). Total insulin costs decreased by 27% ($1.08/day; p  = 0.003) in the vegan group, compared to no significant change in the portion-controlled group (-$0.38/day [95% CI, -$2.13 to +$1.38]; p  = 0.66). Conclusions/Interpretation This study shows that a low-fat vegan diet could reduce insulin use and insulin costs in people with T1D. Larger trials are needed to confirm these findings. Trial registration ClinicalTrials.gov , NCT04944316, registered on June 29, 2021.

Background Retaining participants over time is a frequent challenge in research studies evaluating long-term health outcomes. This study’s objective was to compare the impact of prepaid and postpaid incentives on response to a six-month follow-up survey. Methods We conducted an experiment to compare response between participants randomized to receive either prepaid or postpaid cash card incentives within a multisite study of children under 15 years in age who were hospitalized for a serious, severe, or critical injury. Participants were parents or guardians of enrolled children. The primary outcome was survey response. We also examined whether demographic characteristics were associated with response and if incentive timing influenced the relationship between demographic characteristics and response. We evaluated whether incentive timing was associated with the number of calls needed for contact. Results The study enrolled 427 children, and parents of 420 children were included in this analysis. Follow-up survey response did not differ according to the assigned treatment arm, with the percentage of parents responding to the survey being 68.1% for the prepaid incentive and 66.7% with the postpaid incentive. Likelihood of response varied by demographics. Spanish-speaking parents and parents with lower income and lower educational attainment were less likely to respond. Parents of Hispanic/Latino children and children with Medicaid insurance were also less likely to respond. We found no relationship between the assigned incentive treatment and the demographics of respondents compared to non-respondents. Conclusions Prepaid and postpaid incentives can obtain similar participation in longitudinal pediatric critical care outcomes research. Incentives alone do not ensure retention of all demographic subgroups. Strategies for improving representation of hard-to-reach populations are needed to address health disparities and ensure the generalizability of studies using these results.

Sotalol, a class III antiarrhythmic agent, is used to maintain sinus rhythm in patients with atrial fibrillation or atrial flutter (AFIB/AFL). Despite its efficacy, sotalol's use is limited by its potential to cause life‐threatening ventricular arrhythmias due to QT interval prolongation. Traditionally, sotalol administration required hospitalization to monitor these risks. The FDA approval of intravenous (IV) sotalol for loading before oral maintenance aims to reduce hospitalization duration by facilitating an expedited loading dose, transitioning to oral maintenance therapy. This study evaluates the population pharmacokinetics (PK) and pharmacodynamics (PD) of sotalol using data from the Prospective Evaluation Analysis and Kinetics of IV Sotalol (PEAKS) Registry, which includes patients with atrial arrhythmias undergoing IV sotalol loading. A nonlinear mixed‐effect modeling approach was used to describe sotalol PK, considering covariates such as age, weight, sex, and renal function. The study also examined the correlation between sotalol plasma concentrations and corrected QT interval (QTc) prolongation. Sotalol PK after IV loading and two oral maintenance doses was adequately described by a two‐compartment model with first‐order elimination in patients with atrial arrhythmias. Weight and creatinine clearance (CrCl) were identified as covariates with significant influence on sotalol PK. A linear regression model adequately described the relationship between QTc and plasma sotalol levels (R2 = 0.27). The Monte Carlo simulations showed that the IV loading doses recommended in the prescribing information did not result in significant prolongation of QTc. The data from this study supports the current dosing recommendations of IV sotalol in patients with AFIB/AFL.