Use of Postoperative Opioid Therapy Following Endoscopic Sleeve Gastroplasty.

INTRODUCTION: There are no established guidelines on periprocedural and postprocedural pain management after endoscopic sleeve gastroplasty (ESG). This study aimed to determine the need for perioperative and postoperative opioid therapy in patients undergoing ESG. METHODS: This retrospective study comprised consecutive patients undergoing ESG. The primary outcome was the percentage of patients requiring postoperative outpatient opioid therapy. Secondary outcomes included frequency and dosage of perioperative pain medications and postoperative pain scores. RESULTS: Of the 67 patients included, 39 (58.2%) required opioids in the perioperative setting. The mean ± SD opioid dose was 12.3 ± 8.4 morphine milligram equivalents. Postoperatively, 17.9% of patients required home opioid prescriptions. More than a third of patients reported no pain. DISCUSSION: In patients undergoing ESG, postoperative opioid therapy should be individualized to attenuate opioid overprescription and the risk of opioid overuse.

Developmental trajectories of late preterm infants and predictors of academic performance.

BACKGROUND: The trajectories of late preterm development from infancy to kindergarten reading and math, and predictors of academic resilience and risk are unknown. METHODS: Sample included 1200 late preterm infants (LPIs) from the Early Childhood Longitudinal Study, Birth Cohort. Objective measurements of development at 9 and 24 months (Bayley-SFR) and reading and math academic achievement at preschool and kindergarten were standardized; trajectories of late preterm development from 9 months to kindergarten reading and math were identified using latent class growth analysis. Multinomial logistic regression [aOR, 95% CI] identified predictors of academic resilience and risk. RESULTS: Four trajectory groups were observed for reading and three for math. More optimal trajectories (in reading and math) and academic resilience were associated with experiencing sensitive parenting and preschool attendance. Suboptimal (at-risk) trajectories (in reading or math) and an increased odds of academic risk were associated with

Risk factors for reduced function in women with a history of breast cancer.

PURPOSE: People with a history of breast cancer are at risk of losing function during and after treatment. Unfortunately, little is known about the individual and additive effects of specific treatment, disease-related, and demographic factors that may contribute to functional decline. This manuscript reports the results of a multi-center study to evaluate the effects of these factors on function. METHODS: In this cross-sectional study, women with a history of breast cancer referred to physical medicine and rehabilitation cancer rehabilitation clinics were administered the PROMIS® Cancer Function Brief 3D Profile to evaluate function in the domains of physical function, fatigue, and social participation. Clinical and demographic information, including treatment history and disease status, was recorded by clinicians. Patients were analyzed in two groups: those with active disease on antineoplastic treatment, and those with no evidence of disease (NED). A multivariable model was constructed to detect associations between clinical and demographic factors. RESULTS: In patients with NED, the presence of chemotherapy-induced peripheral neuropathy (CIPN) was strongly associated with reduced function in all three domains. In those with active disease, having brain metastases was significantly associated with reduced function in all domains and CIPN with reduced physical function. Radiation was associated with improved function in both cohorts. CONCLUSIONS: Among women seeking rehabilitative care, CIPN and the presence of brain metastases were most strongly associated with a decline in function. The effects of radiation on function were unexpected and may be partially explained by the treatment's role in symptom management. Clinicians who treat breast cancer should consider a patient's functional status when providing supportive care.

Frailty Measures of Patient-reported Activity and Fatigue May Predict 1-year Outcomes in Ambulatory Advanced Heart Failure: A Report From the REVIVAL Registry.

BACKGROUND: The Fried Frailty Phenotype predicts adverse outcomes in geriatric populations, but has not been well-studied in advanced heart failure (HF). The Registry Evaluation of Vital Information for Ventricular Assist Devices (VADs) in Ambulatory Life (REVIVAL) study prospectively collected frailty measures in patients with advanced HF to determine relevant assessments and their impact on clinical outcomes. METHODS AND RESULTS: HF-Fried Frailty was defined by 5 baseline components (1 point each): (1) weakness: hand grip strength less than 25% of body weight; (2) slowness based on time to walk 15 feet; (3) weight loss of more than 10 lbs in the past year; (4) inactivity; and (5) exhaustion, both assessed by the Kansas City Cardiomyopathy Questionnaire. A score of 0 or 1 was deemed nonfrail, 2 prefrail, and 3 or greater was considered frail. The primary composite outcome was durable mechanical circulatory support implantation, cardiac transplant or death at 1 year. Event-free survival for each group was determined by the Kaplan-Meier method and the hazard of prefrailty and frailty were compared with nonfrailty with proportional hazards modeling. Among 345 patients with all 5 frailty domains assessed, frailty was present in 17%, prefrailty in 40%, and 43% were nonfrail, with 67% (n = 232) meeting the criteria based on inactivity and 54% (n = 186) for exhaustion. Frail patients had an increased risk of the primary composite outcome (unadjusted hazard ratio [HR] 2.82, 95% confidence interval [CI] 1.52-5.24; adjusted HR 3.41, 95% CI 1.79-6.52), as did prefrail patients (unadjusted HR 1.97, 95% CI 1.14-3.41; adjusted HR 2.11, 95% CI 1.21-3.66) compared with nonfrail patients, however, the predictive value of HF-Fried Frailty criteria was modest (Harrel's C-statistic of 0.603, P = .004). CONCLUSIONS: The HF-Fried Frailty criteria had only modest predictive power in identifying ambulatory patients with advanced HF at high risk for durable mechanical circulatory support, transplant, or death within 1 year, driven primarily by assessments of inactivity and exhaustion. Focus on these patient-reported measures may better inform clinical trajectories in this population.

Evaluation of targeted versus universal prophylaxis for the prevention of invasive fungal infections following lung transplantation.

BACKGROUND: Antifungal prophylaxis to prevent invasive fungal infections (IFI) is widely used following lung transplantation, but the optimal strategy remains unclear. We compared universal with targeted antifungal prophylaxis for effectiveness in preventing IFI. METHODS: Adult patients who underwent lung transplantation at the University of Michigan from /1 July 2014-31 December 2017 were studied for 18 months post-transplant. Universal prophylaxis consisted of itraconazole with or without inhaled liposomal amphotericin B. Using specific criteria, targeted prophylaxis was given with voriconazole for patients at risk for invasive pulmonary aspergillosis (IPA) and with fluconazole or micafungin for patients at risk for invasive candidiasis. Risk factors, occurrence of proven/probable IFI, and mortality were analyzed for the two prophylaxis cohorts. RESULTS: Of 105 lung transplant recipients, 84 (80%) received a double lung transplant, and 38 (36%) of patients underwent transplant for pulmonary fibrosis. Fifty-nine (56%) patients received universal antifungal prophylaxis, and 46 (44%), targeted antifungal prophylaxis. Among 20 proven/probable IFI, there were 14 IPA, 4 invasive candidiasis, 1 cryptococcosis, and 1 deep sternal mold infection. Six (10%) IFI occurred in the universal prophylaxis cohort and 14 (30%) in the targeted prophylaxis cohort. Five of 6 (83%) IFI in the universal prophylaxis cohort, compared with 9/14 (64%) in the targeted prophylaxis cohort, were IPA Candida infections occurred only in the targeted prophylaxis cohort. The development of IFI was more likely in the targeted prophylaxis cohort than the universal prophylaxis cohort, HR = 4.32 (1.51-12.38), P = .0064. CONCLUSIONS: Universal antifungal prophylaxis appears to be more effective than targeted antifungal prophylaxis for prevention of IFI after lung transplant.

Impact of Socioeconomic Factors on Patient Desire for Early LVAD Therapy Prior to Inotrope Dependence.

BACKGROUND: Worsening heart failure (HF) and health-related quality of life (HRQOL) have been shown to impact the decision to proceed with left ventricular assist device (LVAD) implantation, but little is known about how socioeconomic factors influence expressed patient preference for LVAD. METHODS AND RESULTS: Ambulatory patients with advanced systolic HF (n=353) reviewed written information about LVAD therapy and completed a brief survey to indicate whether they would want an LVAD to treat their current level of HF. Ordinal logistic regression analyses identified clinical and demographic predictors of LVAD preference. Higher New York Heart Association (NYHA) class, worse HRQOL measured by Kansas City Cardiomyopathy Questionnaire, lower education level, and lower income were significant univariable predictors of patients wanting an LVAD. In the multivariable model, higher NYHA class (OR [odds ratio]: 1.43, CI [confidence interval]: 1.08-1.90, P = .013) and lower income level (OR: 2.10, CI: 1.18 - 3.76, P = .012 for <$40,000 vs >$80,000) remained significantly associated with wanting an LVAD. CONCLUSION: Among ambulatory patients with advanced systolic HF, treatment preference for LVAD was influenced by level of income independent of HF severity. Understanding the impact of socioeconomic factors on willingness to consider LVAD therapy may help tailor counseling towards individual needs.

Performance of the (1,3)-Beta-D-Glucan Assay on Bronchoalveolar Lavage Fluid for the Diagnosis of Invasive Pulmonary Aspergillosis.

Detection of (1,3)-beta-D-glucan (BDG), a component of the cell wall of many fungi, was studied in bronchoalveolar lavage fluid (BALF) as a possible aid for the diagnosis of proven/probable invasive pulmonary aspergillosis (IPA). BDG was measured on stored BALF from 13 patients with EORTC/MSGERC defined proven/probable IPA and 26 matched control patients without IPA. The median BALF BDG was 80 pg/mL (range < 45-8240 pg/mL) in the IPA cohort and 148 pg/mL (range < 45-5460 pg/mL) in the non-IPA cohort. Using a positive cutoff of ≥ 80 pg/mL, sensitivity was 54% and specificity was 38%. Higher cutoff values led to improvement in specificity but a dramatic decrease in sensitivity. ROC/AUC analysis was unable to identify an optimal cutoff value at which test performance was enhanced: AUC 0.43, 95% CI 0.24-0.63. When the BDG assay was performed on BALF, neither sensitivity nor specificity was sufficient for use in the diagnosis of IPA.

Phase-Contrast Magnetic Resonance Quantification of Aortic Regurgitation in Patients With Turbulent Aortic Flow.

OBJECTIVE: This study aimed to assess variability in measurements and accurately quantify aortic regurgitation in patients with coexisting turbulent aortic flow using phase-contrast magnetic resonance. METHODS: All patients (n = 21) underwent phase-contrast magnetic resonance at 2 or more sites: ascending aorta, sinuses of Valsalva, and left ventricular outflow tract. The net flow/minute (NF), forward flow/minute (FF), regurgitant flow/minute (RF), and regurgitant fraction (RF%) were compared with the sum of superior vena cava and descending aortic flow/minute, left ventricular cardiac output, difference between the 2, and percentage difference, respectively. RESULTS: The NF, FF, and RF were significantly different between each site. The combination of FF in the left ventricular outflow tract and NF from the superior vena cava + descending aorta provided the best reliability of RF and regurgitant fraction (intraclass correlation coefficients, 0.881 [95% confidence interval, 0.882-0.878] and 0.838 [95% confidence interval, 0.837-0.838]). CONCLUSION: Combining flow measurements from more than 1 site provides the most accurate quantification of aortic regurgitation in patients with turbulent aortic flow.

Infant Iron Deficiency and Iron Supplementation Predict Adolescent Internalizing, Externalizing, and Social Problems.

OBJECTIVE: To evaluate associations between iron supplementation and iron deficiency in infancy and internalizing, externalizing, and social problems in adolescence. STUDY DESIGN: The study is a follow-up of infants as adolescents from working-class communities around Santiago, Chile who participated in a preventive trial of iron supplementation at 6 months of age. Inclusionary criteria included birth weight ≥3.0 kg, healthy singleton term birth, vaginal delivery, and a stable caregiver. Iron status was assessed at 12 and 18 months of age. At 11-17 years of age, internalizing, externalizing, and social problems were reported by 1018 adolescents with the Youth Self Report and by parents with the Child Behavior Checklist. RESULTS: Adolescents who received iron supplementation in infancy had greater self-reported attention-deficit/hyperactivity disorder but lower parent-reported conduct disorder symptoms than those who did not (Ps < .05). Iron deficiency with or without anemia at 12 or 18 months of age predicted greater adolescent behavior problems compared with iron sufficiency: more adolescent-reported anxiety and social problems, and parent-reported social, post-traumatic stress disorder, attention-deficit/hyperactivity disorder, oppositional defiant, conduct, aggression, and rule breaking problems (Ps < .05). The threshold was iron deficiency with or without anemia for each of these outcomes. CONCLUSIONS: Iron deficiency with or without anemia in infancy was associated with increased internalizing, externalizing, and social problems in adolescence.

Iron Deficiency, Anemia, and Low Vitamin B-12 Serostatus in Middle Childhood Are Associated with Behavior Problems in Adolescent Boys: Results from the Bogotá School Children Cohort.

BACKGROUND: Iron deficiency (ID) in infancy is related to subsequent behavior problems. The effects of micronutrient status in middle childhood are uncertain. OBJECTIVE: The aim of the study was to examine the associations of micronutrient status biomarkers in middle childhood with externalizing and internalizing behavior problems in adolescence. METHODS: We assessed whether ID (ferritin <15 µg/L), anemia (hemoglobin <12.7 g/dL), or blood concentrations of zinc, vitamins A and B-12, and folate at ages 5-12 y were associated with externalizing or internalizing behavior problems in adolescence in 1042 schoolchildren from Bogotá, Colombia. Behavior problems were assessed with the Youth Self-Report questionnaire after a median 6.2 y of follow-up. Mean problem score differences with 95% CIs were estimated between categories of micronutrient status biomarkers with the use of multivariable linear regression. RESULTS: Mean ± SD externalizing and internalizing problems scores were 52.6 ± 9.6 and 53.8 ± 9.9, respectively. Among boys, middle-childhood ID, anemia, and low plasma vitamin B-12 were associated with 5.9 (95% CI: 1.0, 10.7), 6.6 (95% CI: 1.9, 11.3), and 2.7 (95% CI: 0.4, 4.9) units higher mean externalizing problems scores in adolescence, respectively-after adjustment for baseline age, time spent watching television or playing video games, mother's height, and socioeconomic status. Also in boys, ID was related to an adjusted 6.4 (95% CI: 1.2, 11.6) units higher mean internalizing problems score. There were no associations among girls. Other micronutrient status biomarkers were not associated with behavior problems. CONCLUSIONS: ID, anemia, and low vitamin B-12 in middle childhood are related to behavior problems in adolescent boys.This study was registered at clinicaltrials.gov as NCT03297970.

Early childhood curiosity and kindergarten reading and math academic achievement.

BACKGROUND: Although children's curiosity is thought to be important for early learning, the association of curiosity with early academic achievement has not been tested. We hypothesized that greater curiosity would be associated with greater kindergarten academic achievement in reading and math. METHODS: Sample included 6200 children in the Early Childhood Longitudinal Study, Birth Cohort. Measures at kindergarten included direct assessments of reading and math, and a parent-report behavioral questionnaire from which we derived measures of curiosity and effortful control. Multivariate linear regression examined associations of curiosity with kindergarten reading and math academic achievement, adjusting for effortful control and confounders. We also tested for moderation by effortful control, sex, and socioeconomic status (SES). RESULTS: In adjusted models, greater curiosity was associated with greater kindergarten reading and math academic achievement: breading = 0.11, p < 0.001; bmath = 0.12, p < 0.001. This association was not moderated by effortful control or sex, but was moderated by SES (preading = 0.01; pmath = 0.005). The association of curiosity with academic achievement was greater for children with low SES (breading = 0.18, p < 0.001; bmath = 0.20, p < 0.001), versus high SES (breading = 0.08, p = 0.004; bmath = 0.07, p < 0.001). CONCLUSIONS: Curiosity may be an important, yet under-recognized contributor to academic achievement. Fostering curiosity may optimize academic achievement at kindergarten, especially for children with low SES.

Gestational Age and Kindergarten School Readiness in a National Sample of Preterm Infants.

OBJECTIVE: To examine the association of gestational age with school readiness in kindergarten reading and math skills. We hypothesized that compared with infants born at 39-41 weeks, infants born at lower gestational ages would have poorer school readiness. STUDY DESIGN: The study sample comprised 5250 children from the Early Childhood Longitudinal Study, Birth Cohort, assessed with specialized reading and math assessments at kindergarten. Poor school readiness was characterized by reading and math theta scores ≥1.5 SD below the sample mean. The aOR and 95% CI of poor school readiness were estimated using multivariate logistic regression, examining gestational age continuously and categorically (very preterm [VPT], moderate/late preterm [M/LPT], early term [ET], and term). Pairwise comparisons were performed to test for differences by gestational age category. RESULTS: There was an association between gestational age and poor school readiness for reading and math, with the suggestion of a threshold effect in children born at ≥32 weeks gestation. In adjusted models, in VPT infants, the aORs of poor school readiness in reading and math were 2.58 (95% CI, 1.29-5.15) and 3.38 (95% CI, 1.66-6.91), respectively. For infants born M/LPT and ET, the odds of poor school readiness in reading did not differ from those of children born full-term, however. CONCLUSIONS: Compared with term infants, the highest odds of poor school readiness in reading and math were seen in VPT infants, with lower odds of poor school readiness in children born at ≥32 weeks gestation. Ongoing developmental surveillance before kindergarten is indicated for VPT infants.

Low-Dose Iron Supplementation in Infancy Modestly Increases Infant Iron Status at 9 Mo without Decreasing Growth or Increasing Illness in a Randomized Clinical Trial in Rural China.

BACKGROUND: Previous trials of iron supplementation in infancy did not consider maternal iron supplementation. OBJECTIVE: This study assessed effects of iron supplementation in infancy and/or pregnancy on infant iron status, illnesses, and growth at 9 mo. METHODS: Enrollment occurred from December 2009 to June 2012 in Hebei, China. Infants born to women in a pregnancy iron supplementation trial were randomly assigned 1:1 to iron [∼1 mg Fe/(kg · d) as oral iron proteinsuccynilate] or placebo from 6 wk to 9 mo, excluding infants with cord ferritin <35 µg/L. Study groups were pregnancy placebo/infancy placebo (placebo/placebo), pregnancy placebo/infancy iron (placebo/iron), pregnancy iron/infancy placebo (iron/placebo), and pregnancy iron/infancy iron (iron/iron). The primary outcome was 9-mo iron status: iron deficiency (ID) by cutoff (≥2 abnormal iron measures) or body iron <0 mg/kg and ID + anemia (hemoglobin <110 g/L). Secondary outcomes were doctor visits or hospitalizations and weight or length gain from birth to 9 mo. Statistical analysis by intention to treat and dose-response (between number of iron bottles received and outcome) used logistic regression with concomitant RRs and general linear models, with covariate control as applicable. RESULTS: Of 1482 infants randomly allocated, 1276 had 9-mo data (n = 312-327/group). Iron supplementation in infancy, but not pregnancy, reduced ID risk: RRs (95% CIs) were 0.89 (0.79, 0.998) for placebo/iron compared to placebo/placebo, 0.79 (0.63, 0.98) for placebo/iron compared to iron/placebo, 0.87 (0.77, 0.98) for iron/iron compared to placebo/placebo, and 0.86 (0.77, 0.97) for iron/iron compared to iron/placebo. However, >60% of infants still had ID at 9 mo. Receiving more bottles of iron in infancy was associated with better infant iron status at 9 mo but only among iron-supplemented infants whose mothers were also iron supplemented (i.e., the iron/iron group). There were no group differences in hospitalizations or illnesses and no adverse effects on growth overall or among infants who were iron sufficient at birth. CONCLUSIONS: Iron supplementation in Chinese infants reduced ID at 9 mo without adverse effects on growth or illness. Effects of iron supplementation in pregnancy were observed only when higher amounts of iron were distributed in infancy. This trial was registered at clinicaltrials.gov as NCT00613717.

Iron deficiency (ID) at both birth and 9 months predicts right frontal EEG asymmetry in infancy.

This study considered effects of timing and duration of iron deficiency (ID) on frontal EEG asymmetry in infancy. In healthy term Chinese infants, EEG was recorded at 9 months in three experimental conditions: baseline, peek-a-boo, and stranger approach. Eighty infants provided data for all conditions. Prenatal ID was defined as low cord ferritin or high ZPP/H. Postnatal ID was defined as ≥ two abnormal iron measures at 9 months. Study groups were pre- and postnatal ID, prenatal ID only, postnatal ID only, and not ID. GLM repeated measure analysis showed a main effect for iron group. The pre- and postnatal ID group had negative asymmetry scores, reflecting right frontal EEG asymmetry (mean ± SE: -.18 ± .07) versus prenatal ID only (.00 ± .04), postnatal ID only (.03 ± .04), and not ID (.02 ± .04). Thus, ID at both birth and 9 months was associated with right frontal EEG asymmetry, a neural correlate of behavioral withdrawal and negative emotions.

Prenatal Iron Supplementation Reduces Maternal Anemia, Iron Deficiency, and Iron Deficiency Anemia in a Randomized Clinical Trial in Rural China, but Iron Deficiency Remains Widespread in Mothers and Neonates.

BACKGROUND: Previous trials of prenatal iron supplementation had limited measures of maternal or neonatal iron status. OBJECTIVE: The purpose was to assess effects of prenatal iron-folate supplementation on maternal and neonatal iron status. METHODS: Enrollment occurred June 2009 through December 2011 in Hebei, China. Women with uncomplicated singleton pregnancies at ≤20 wk gestation, aged ≥18 y, and with hemoglobin ≥100 g/L were randomly assigned 1:1 to receive daily iron (300 mg ferrous sulfate) or placebo + 0.40 mg folate from enrollment to birth. Iron status was assessed in maternal venous blood (at enrollment and at or near term) and cord blood. Primary outcomes were as follows: 1) maternal iron deficiency (ID) defined in 2 ways as serum ferritin (SF) <15 µg/L and body iron (BI) <0 mg/kg; 2) maternal ID anemia [ID + anemia (IDA); hemoglobin <110 g/L]; and 3) neonatal ID (cord blood ferritin <75 µg/L or zinc protoporphyrin/heme >118 µmol/mol). RESULTS: A total of 2371 women were randomly assigned, with outcomes for 1632 women or neonates (809 placebo/folate, 823 iron/folate; 1579 mother-newborn pairs, 37 mothers, 16 neonates). Most infants (97%) were born at term. At or near term, maternal hemoglobin was significantly higher (+5.56 g/L) for iron vs. placebo groups. Anemia risk was reduced (RR: 0.53; 95% CI: 0.43, 0.66), as were risks of ID (RR: 0.74; 95% CI: 0.69, 0.79 by SF; RR: 0.65; 95% CI: 0.59, 0.71 by BI) and IDA (RR: 0.49; 95% CI: 0.38, 0.62 by SF; RR: 0.51; 95% CI: 0.40, 0.65 by BI). Most women still had ID (66.8% by SF, 54.7% by BI). Adverse effects, all minor, were similar by group. There were no differences in cord blood iron measures; >45% of neonates in each group had ID. However, dose-response analyses showed higher cord SF with more maternal iron capsules reported being consumed (ß per 10 capsules = 2.60, P < 0.05). CONCLUSIONS: Prenatal iron supplementation reduced anemia, ID, and IDA in pregnant women in rural China, but most women and >45% of neonates had ID, regardless of supplementation. This trial was registered at clinicaltrials.gov as NCT02221752.

Self-Reported Accommodation Needs for Patients with Disabilities in Primary Care.

BACKGROUND: People with disabilities experience barriers to engaging with health care due to inaccessible social and physical environments at primary care clinics. Despite legal mandates, identification and provision of necessary accommodations for this population at primary care clinics are poor. The objective of this cross-sectional study was to assess patient-reported disability status and accommodation needs among patients at a primary care clinic. METHODS: An electronic health record-based Disability and Accommodations Questionnaire assessing disability status, types, and accommodation needs was developed by subject matter experts at Michigan Medicine and the University of Michigan Council for Disability Concerns. The questionnaire underwent multiple rounds of reviews and revisions before its use in clinical settings. A paper-based questionnaire was administered to all patients presenting for a wellness-based visit at an academic health system primary care clinic in southeast Michigan. Data were collected between March 2022 and August 2022. RESULTS: Approximately 13% of the 541 patients self-reported a disability, with 54.2% indicating at least one needed accommodation. The most commonly reported disabilities were mental health and hearing-related disabilities, by 4.8% and 4.6% of patients, respectively. The most frequently requested accommodations were communication- or language-based (for example, presence of an American Sign Language interpreter, assistive listening devices), cognitive-based (for example, inclusion of a support person with care decisions), and mobility-based (for example, assistance with transfers). CONCLUSION: The Disability and Accommodations Questionnaire helped identify the presence of a disability, its types, and any requested accommodations requested at a primary care health center.

Ketogenic Diet Intervention on Metabolic and Psychiatric Health in Bipolar and Schizophrenia: A Pilot Trial.

The ketogenic diet (KD, also known as metabolic therapy) has been successful in the treatment of obesity, type 2 diabetes, and epilepsy. More recently, this treatment has shown promise in the treatment of psychiatric illness. We conducted a 4-month pilot study to investigate the effects of a KD on individuals with schizophrenia or bipolar disorder with existing metabolic abnormalities. Twenty-three participants were enrolled in a single-arm trial. Results showcased improvements in metabolic health, with no participants meeting metabolic syndrome criteria by study conclusion. Adherent individuals experienced significant reduction in weight (12 %), BMI (12 %), waist circumference (13 %), and visceral adipose tissue (36 %). Observed biomarker enhancements in this population include a 27 % decrease in HOMA-IR, and a 25 % drop in triglyceride levels. In psychiatric measurements, participants with schizophrenia showed a 32 % reduction in Brief Psychiatric Rating Scale scores. Overall Clinical Global Impression (CGI) severity improved by an average of 31 %, and the proportion of participants that started with elevated symptomatology improved at least 1-point on CGI (79 %). Psychiatric outcomes across the cohort encompassed increased life satisfaction (17 %) and enhanced sleep quality (19 %). This pilot trial underscores the potential advantages of adjunctive ketogenic dietary treatment in individuals grappling with serious mental illness.

Optimizing Triage of Ambulatory Patients With Advanced Heart Failure: 2-Year Outcomes From REVIVAL.

BACKGROUND: Left ventricular assist device (LVAD) use remains uncommon in advanced heart failure (HF) patients not dependent on inotropes. OBJECTIVES: Before considering a randomized trial comparing a strategy of earlier use of LVAD to continued medical therapy, a better understanding is needed of the clinical trajectory of ambulatory patients with advanced systolic HF on optimal guideline-directed medical therapy (GDMT). METHODS: REVIVAL enrolled 400 patients with advanced ambulatory systolic HF, ≥1 HF mortality risk marker (≥2 HF hospitalizations past year; or HF hospitalization and high natriuretic peptide; or no HF hospitalizations but low peak oxygen consumption, 6-minute walk, serum sodium, HF survival score or Seattle HF model predicted survival), and no LVAD contraindication at 21 LVAD centers from July 2015 to June 2016. Patients were followed for 2 years or until a primary outcome (death, durable ventricular assist device, or urgent transplant). Clinical outcomes and health-related quality of life were evaluated. RESULTS: Mean baseline left ventricular ejection fraction was 21%, median 6-minute walk was 341 m, and 92% were Interagency Registry for Mechanically Assisted Circulatory Support profiles 5 to 7. Adherence to GDMT and electrical device therapies was robust. Composite primary outcome occurred in 22% and 37% at 1 and 2 years, with death alone in 8% and 16%, respectively. Patients surviving for 2 years maintained GDMT intensity and had no decline in health-related quality of life. CONCLUSION: Structured, serial follow-up at programs with expertise in caring for advanced ambulatory systolic HF patients facilitates triage for advanced therapies. Better strategies are still needed to avoid deaths in a small but significant group of patients who die without advanced therapies. REVIVAL patients not selected for VAD or transplant have robust survival and patient-reported outcomes, which challenges advocacy for earlier VAD implantation. (Registry Evaluation of Vital Information for VADs in Ambulatory Life [REVIVAL]; NCT01369407).

Function in Cancer Patients: Disease and Clinical Determinants.

Patients with cancer often experience changes in function during and after treatment but it is not clear what cancer types, and associated clinical factors, affect function. This study evaluated patient-reported functional impairments between specific cancer types and risk factors related to disease status and non-cancer factors. A cross-sectional study evaluating 332 individuals referred to cancer rehabilitation clinics was performed at six U.S. hospitals. The PROMIS Cancer Function Brief 3D Profile was used to assess functional outcomes across the domains of physical function, fatigue, and social participation. Multivariable modeling showed an interaction between cancer type and cancer status on the physical function and social participation scales. Subset analyses in the active cancer group showed an effect by cancer type for physical function (p < 0.001) and social participation (p = 0.008), but no effect was found within the non-active cancer subset analyses. Brain, sarcoma, prostate, and lymphoma were the cancers associated with lower function when disease was active. Premorbid neurologic or musculoskeletal impairments were found to be predictors of lower physical function and social participation in those with non-active cancer; cancer type did not predict low function in patients with no evidence of disease. There was no differential effect of cancer type on fatigue, but increased fatigue was significantly associated with lower age (0.027), increased body mass index (p < 0.001), premorbid musculoskeletal impairment (p < 0.015), and active cancer status (p < 0.001). Anticipatory guidance and education on the common impairments observed with specific cancer types and during specific stages of cancer care may help improve/support patients and their caregivers as they receive impairment-driven cancer rehabilitation care.

Real-World Data Collection from Expanded Access Case Studies for the Treatment of Nontuberculous Mycobacterial Infection with Clofazimine.

Background: Due to its indolent nature, nontuberculous mycobacteria (NTM) are increasing in global prevalence as a cause of pulmonary infections and are difficult to treat with traditional antibiotics. Here, we study the repurposing of clofazimine (CFZ) to treat NTM through expanded access in a single health system. Our main objectives are to describe the feasibility of accessing and analyzing expanded access data and to generate hypotheses regarding CFZ use in NTM treatment. Methods: A retrospective chart review was performed on patients within a single health system who had been approved for expanded access of clofazimine or who received it through an outside hospital for NTM treatment. Data were collected on patients' baseline demographics, details of their NTM infection, concomitant therapies, and results as of 30 June 2021. Results: A total of 55 patients were identified upon initial review as potentially receiving CFZ for NTM infection. After excluding 19 patients who did not initiate CFZ, data from the remaining 36 patients were collected and summarized. The median age at which patients were diagnosed with NTM was 51.3 years old, with a median BMI of 21.2 kg/m2. Patients were more likely to be female (64%), have a baseline lung disease (72%), and 52% were current or former smokers at the time of their diagnosis. The most common species isolated was M. avium complex (47%) followed by M. abscessus (36%), with the most common site of infection being the lung (78%). The majority of patients presented with productive cough with excess sputum production followed by pulmonary nodules and bronchiectasis present on radiograph. Conclusions: This study demonstrated the difficulty of collecting retrospective real-world data via electronic healthcare records on symptoms, side effects, and radiography from patients who obtained a drug through expanded access. Based on the findings of this study, we recommend further research into the potential use of CFZ in patients with M. abscessus pulmonary infections.