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Treatment of hypoplastic left heart syndrome varies across institutions. This study examined the impact of introducing a standardised programme.
This retrospective cohort study evaluated the effects of a comprehensive strategy on 1-year transplant-free survival with preserved ventricular and atrioventricular valve (AVV) function following a Norwood operation. This strategy included standardised operative and perioperative management and dedicated interstage monitoring. The post-implementation cohort (C2) was compared to historic controls (C1). Outcomes were assessed using logistic regression and Kaplan–Meier analysis.
The study included 105 patients, 76 in C1 and 29 in C2. Groups had similar baseline characteristics, including percentage with preserved ventricular (96% C1 versus 100% C2, p = 0.28) and AVV function (97% C1 versus 93% C2, p = 0.31). Perioperatively, C2 had higher indexed oxygen delivery (348 ± 67 ml/minute/m2 C1 versus 402 ± 102ml/minute/m2 C2, p = 0.015) and lower renal injury (47% C1 versus 3% C2, p = 0.004). The primary outcome was similar in both groups (49% C1 and 52% C2, p = 0.78), with comparable rates of death and transplantation (36% C1 versus 38% C2, p = 0.89) and ventricular (2% C1 versus 0% C2, p = 0.53) and AVV dysfunction (11% C1 versus 11% C2, p = 0.96) at 1-year. When accounting for cohort and 100-day freedom from hospitalisation, female gender (OR 3.7, p = 0.01) increased and ventricular dysfunction (OR 0.21, p = 0.02) and CPR (OR 0.11, p = 0.002) or ECMO use (OR 0.15, p = 001) decreased the likelihood of 1-year transplant-free survival.
Standardised perioperative management was not associated with improved 1-year transplant-free survival. Post-operative ventricular or AVV dysfunction was the strongest predictor of 1-year mortality.
Background: Accurate identification of Clostridioides difficile infections (CDIs) from electronic data sources is important for surveillance. We evaluated how frequently laboratory findings were supported by diagnostic coding and treatment data in the electronic health record. Methods: We analyzed a retrospective cohort of patients in the Veterans’ Affairs Health System from 2006 through 2016. A CDI event was defined as a positive laboratory test for C. difficile toxin or toxin genes in the inpatient, outpatient, or long-term care setting with no prior positive test in the preceding 14 days. Events were classified as incident (no CDI in the prior 56 days), or recurrent (CDI in the prior 56 days) and were evaluated for evidence of clinical diagnosis based on International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9-CM) and ICD-10-CM codes and at least 1 dose of an anti-CDI agent (intravenous or oral metronidazole, fidaxomicin, or oral vancomycin). We further assessed the possibility of treatment without testing by quantifying positive laboratory tests and diagnostic codes among inpatients receiving an anti-CDI agent. A course of anti-CDI therapy was defined as continuous treatment with the same drug. Results: Among 119,063 incident and recurrent CDI events, 70,114 (58.9%) had a diagnosis code and 15,850 (13.3%) had no accompanying treatment. The proportion of patients with ICD codes was highest among patients treated with fidaxomicin (82.6% of 906) or oral vancomycin (74.3% of 30,777) and was lower among patients receiving metronidazole (63.3% of 103,231) and those without treatment (29.9% of 15,850). The proportion of events with ICD codes and treatment was similar between incident and recurrent episodes. During the study period, there were ~470,000 inpatient courses of metronidazole, fidaxomicin, and oral vancomycin. Table 1 shows the presence of ICD codes and positive laboratory tests by anti-CDI agents. Among 51,100 courses of oral vancomycin, 51% had an ICD code and 44% had a positive test for C. difficile within 7 days of treatment initiation. Among 1,013 courses of fidaxomicin, 79% had an ICD code and 56% had a positive laboratory test. Conclusions: In this large cohort, there was evidence of substantial CDI treatment without confirmatory C. difficile testing and, to a lesser extent, some positive tests without accompanying treatment or coding. A combination of data sources may be needed to more accurately identify CDI from electronic health records for surveillance purposes.
Downloading a mobile health (m-health) app on your smartphone does not mean you will ever use it. Telling another person about an app does not mean you like it. Using an online intervention does not mean it has had an impact on your well-being. Yet we consistently rely on downloads, clicks, ‘likes’ and other usage and popularity metrics to measure m-health app engagement. Doing so misses the complexity of how people perceive and use m-health apps in everyday life to manage mental health conditions. This article questions commonly used behavioural metrics of engagement in mental health research and care, and proposes a more comprehensive approach to measuring in-app engagement.
OBJECTIVES/GOALS: There is no objective, biologic tool to detect concussion or guide clinical management. We previously showed that saliva microRNA (miRNA) levels differ in children with concussion and may predict symptom duration. The purpose of this study was to validate the utility of saliva miRNA and define longitudinal trends during the recovery period. METHODS/STUDY POPULATION: We collected concussion symptom burden (SCAT-5), cognitive performance (DANA), balance measures (ClearEdge), and saliva from 150 children (7-21 years) with concussion over 5 time-points: 0-2, 3-6, 7-14, 15-29, and 30-60 days post-injury. Saliva miRNA levels within the 443 concussion samples were quantified with RNA sequencing and compared to 218 samples from age- and sex-matched controls (healthy and post-exercise participants). Non-parametric ANOVA assessed RNA levels across time-points, and between concussions/controls. Machine learning was used to build logistic regression algorithms differentiating concussions/controls, and symptomatic/recovered concussion participants. Relationships between miRNAs and concussion phenotypes were explored with Spearman’s Rank correlations. RESULTS/ANTICIPATED RESULTS: Fifteen miRNAs differed across control and concussion participants (FDR < 0.05). Within concussion participants, all 15 miRNAs trended back toward control levels by 30-60 days post injury. A regression algorithm employing 6 of the 15 miRNAs differentiated control and concussion participants with an area under the curve (AUC) of 0.78 in a training set (n = 244) and 0.84 in a naïve test set (n = 24). Similarly, 6 miRNAs were able to differentiate symptomatic (SCAT-5 symptom score > 7) and asymptomatic concussion participants with an AUC of 0.73 in a training set (n = 219) and 0.76 in a naïve test set (n = 44). Furthermore, 5 miRNAs showed significant (R > 0.3; FDR < 0.05) associations with subjective and/or objective measures of concussion-related symptoms. DISCUSSION/SIGNIFICANCE OF IMPACT: Saliva miRNAs levels are altered in children with concussion, and display predictable longitudinal trends following injury. Saliva miRNA measurement represents a non-invasive, objective tool that could be rapidly assessed to provide biologic evidence for clinicians managing pediatric concussion. CONFLICT OF INTEREST DESCRIPTION: I serve as a paid consultant and scientific advisory board member for Quadrant Biosciences, who has funded a portion of this work and licensed the findings from the Penn State College of Medicine.
The sustainability concept seeks to balance how present and future generations of humans meet their needs. But because nature is viewed only as a resource, sustainability fails to recognize that humans and other living beings depend on each other for their well-being. We therefore argue that true sustainability can only be achieved if the interdependent needs of all species of current and future generations are met, and propose calling this ‘multispecies sustainability’. We explore the concept through visualizations and scenarios, then consider how it might be applied through case studies involving bees and healthy green spaces.
The second and final year of the Erasmus Plus programme ‘Innovative Education and Training in high power laser plasmas’, otherwise known as PowerLaPs, is described. The PowerLaPs programme employs an innovative paradigm in that it is a multi-centre programme, where teaching takes place in five separate institutes with a range of different aims and styles of delivery. The ‘in-class’ time is limited to 4 weeks a year, and the programme spans 2 years. PowerLaPs aims to train students from across Europe in theoretical, applied and laboratory skills relevant to the pursuit of research in laser plasma interaction physics and inertial confinement fusion. Lectures are intermingled with laboratory sessions and continuous assessment activities. The programme, which is led by workers from the Hellenic Mediterranean University and supported by co-workers from the Queen’s University Belfast, the University of Bordeaux, the Czech Technical University in Prague, Ecole Polytechnique, the University of Ioannina, the University of Salamanca and the University of York, has just finished its second and final year. Six Learning Teaching Training activities have been held at the Queen’s University Belfast, the University of Bordeaux, the Czech Technical University, the University of Salamanca and the Institute of Plasma Physics and Lasers of the Hellenic Mediterranean University. The last of these institutes hosted two 2-week-long Intensive Programmes, while the activities at the other four universities were each 5 days in length. In addition, a ‘Multiplier Event’ was held at the University of Ioannina, which will be briefly described. In this second year, the work has concentrated on training in both experimental diagnostics and simulation techniques appropriate to the study of plasma physics, high power laser matter interactions and high energy density physics. The nature of the programme will be described in detail, and some metrics relating to the activities carried out will be presented. In particular, this paper will focus on the overall assessment of the programme.
Recent findings point at novel benefits of specific fibres, like inulin, as their fermentation metabolites can improve mucosal immunity and protect against infections (1,2). This outcome is desirable for athletes, who are at increased exposure to oxidative damage and thus risk of upper respiratory tract infections (URTI). However, whether inulin can improve immune function in athletes is unknown. We investigated the effect of supplementation with inulin-enriched foods on salivary immunoglobulin A (sIgA), a marker of immunity associated with URTI, in rugby players. We hypothesised that inulin supplementation would increase sIgA, and such change would be greater than that observed in a group following a diet without inulin supplementation. Ten rugby players volunteered for this pilot study (24.2 ± 5.4 years, 93.2 ± 18.7 kg). Participants were randomly assigned to either control (CON) or intervention diet (IN) for 3-weeks; and provided with 2% inulin-enriched pasta and bread (IN) or the same products without inulin (CON), to be consumed as part of a prescribed diet plan. sIgA was measured before and after each condition by collecting saliva with validated swabs, and was quantified with enzyme-linked immunoassay. Differences within and between groups were assessed with paired-samples t-test and ANOVA, respectively. Relationships between inulin intake and sIgA were explored with Spearman's correlation and regression analysis. There was a significant increase in sIgA following inulin supplementation (p = 0.002), which was significantly different to CON (+ 53.6 ± 44.7 and 5.8 ± 37.2 mg/dL, p = 0.054). Average inulin intake was 10.9 ± 1.6 g/day, and it was positively associated with sIgA (rs = 0.661, p = 0.038) and correlated with sIgA changes (r2 = 0.438, p = 0.037). There were no significant differences in energy intake between and within groups (p > 0.10). There were no reports of upper-respiratory tract or other infections during the study period (winter). Some IN participants reported improved bowel function. Inulin-enriched products could represent a simple approach to promote mucosal immunity and gut health in athletes. Larger controlled trials are warranted to confirm the dose-response and long-term effects of inulin supplementation including metabolic and performance outcomes.
Identifying risk factors of individuals in a clinical-high-risk state for psychosis are vital to prevention and early intervention efforts. Among prodromal abnormalities, cognitive functioning has shown intermediate levels of impairment in CHR relative to first-episode psychosis and healthy controls, highlighting a potential role as a risk factor for transition to psychosis and other negative clinical outcomes. The current study used the AX-CPT, a brief 15-min computerized task, to determine whether cognitive control impairments in CHR at baseline could predict clinical status at 12-month follow-up.
Baseline AX-CPT data were obtained from 117 CHR individuals participating in two studies, the Early Detection, Intervention, and Prevention of Psychosis Program (EDIPPP) and the Understanding Early Psychosis Programs (EP) and used to predict clinical status at 12-month follow-up. At 12 months, 19 individuals converted to a first episode of psychosis (CHR-C), 52 remitted (CHR-R), and 46 had persistent sub-threshold symptoms (CHR-P). Binary logistic regression and multinomial logistic regression were used to test prediction models.
Baseline AX-CPT performance (d-prime context) was less impaired in CHR-R compared to CHR-P and CHR-C patient groups. AX-CPT predictive validity was robust (0.723) for discriminating converters v. non-converters, and even greater (0.771) when predicting CHR three subgroups.
These longitudinal outcome data indicate that cognitive control deficits as measured by AX-CPT d-prime context are a strong predictor of clinical outcome in CHR individuals. The AX-CPT is brief, easily implemented and cost-effective measure that may be valuable for large-scale prediction efforts.
The Erasmus Plus programme ‘Innovative Education and Training in high power laser plasmas’, otherwise known as PowerLaPs, is described. The PowerLaPs programme employs an innovative paradigm in that it is a multi-centre programme where teaching takes place in five separate institutes with a range of different aims and styles of delivery. The ‘in class’ time is limited to four weeks a year, and the programme spans two years. PowerLaPs aims to train students from across Europe in theoretical, applied and laboratory skills relevant to the pursuit of research in laser–plasma interaction physics and inertial confinement fusion (ICF). Lectures are intermingled with laboratory sessions and continuous assessment activities. The programme, which is led by workers from the Technological Educational Institute (TEI) of Crete, and supported by co-workers from the Queen’s University Belfast, the University of Bordeaux, the Czech Technical University in Prague, Ecole Polytechnique, the University of Ioannina, the University of Salamanca and the University of York, has just completed its first year. Thus far three Learning Teaching Training (LTT) activities have been held, at the Queen’s University Belfast, the University of Bordeaux and the Centre for Plasma Physics and Lasers (CPPL) of TEI Crete. The last of these was a two-week long Intensive Programme (IP), while the activities at the other two universities were each five days in length. Thus far work has concentrated upon training in both theoretical and experimental work in plasma physics, high power laser–matter interactions and high energy density physics. The nature of the programme will be described in detail and some metrics relating to the activities carried out to date will be presented.
We propose a new collection of benchmark problems in mechanizing the metatheory of programming languages, in order to compare and push the state of the art of proof assistants. In particular, we focus on proofs using logical relations (LRs) and propose establishing strong normalization of a simply typed calculus with a proof by Kripke-style LRs as a benchmark. We give a modern view of this well-understood problem by formulating our LR on well-typed terms. Using this case study, we share some of the lessons learned tackling this problem in different dependently typed proof environments. In particular, we consider the mechanization in Beluga, a proof environment that supports higher-order abstract syntax encodings and contrast it to the development and strategies used in general-purpose proof assistants such as Coq and Agda. The goal of this paper is to engage the community in discussions on what support in proof environments is needed to truly bring mechanized metatheory to the masses and engage said community in the crafting of future benchmarks.
Evening-dosed DR/ER-MPH (formerly HLD200), a delayed-release and extended-release methylphenidate, was designed to provide efficacy upon awakening and through the evening. The objective was to evaluate whether treatment with DR/ER-MPH in children with attention-deficit/hyperactivity disorder (ADHD): (1) improves caregiver-rated ADHD symptoms, and (2) reduces caregiver strain, versus placebo.
Caregiver-rated ADHD symptoms (Conners’ Global Index–Parent [CGI-P]) and caregiver strain (Caregiver Strain Questionnaire [CGSQ]) were assessed as secondary endpoints following 3 weeks of treatment in a randomized, double-blind, multicenter, placebo-controlled, parallel-group, phase 3 trial of DR/ER-MPH in children (6-12 years) with ADHD (NCT02520388). Using the 10-item CGI-P, parents rated their child’s ADHD symptoms on a 4-point scale (0=never/seldom; 3=very often/frequently). Caregivers also rated the impact of caring for a child with emotional and behavioral challenges on the 21-item CGSQ (5-point scale: 1=not at all; 5=very much). A reduction on individual item and total scores for both measures indicated an improvement.
Of 163 children enrolled across 22 sites, 161 were included in the intent-to-treat population (DR/ER-MPH, n=81; placebo, n=80) and 138 completed the study. The mean DR/ER-MPH dose after 3 weeks of treatment was 68.1 mg. Mean CGI-P scores at baseline and CGSQ scores at screening (ie, before washout of prior ADHD therapy) were comparable for both DR/ER-MPH (CGI-P: 22.8, CGSQ: 54.5) and placebo (CGI-P: 21.8; CGSQ: 54.9) groups. After 3 weeks of treatment, caregivers of children onDR/ER-MPH reported significant reductions in CGI-P scores versus those on placebo (least-squares [LS] mean: 12.3 vs 17.4; P<0.001). Additionally, there was a significant reduction in CGSQ scores after 3 weeks of treatment with DR/ER-MPH versus placebo (LS mean: 41.2 vs 49.1; P<0.001). Post hoc analyses on the effect of DR/ER-MPHversus placebo on individual items of CGI-P and CGSQ, and the two subscales of CGI-P will be presented. No serious TEAEs were reported and all TEAEs were consistent with those of MPH.
Caregivers reported significant improvements in their child’s ADHD symptoms and these improvements coincided with reductions in caregiver strain after 3 weeks of treatment on evening-dosed DR/ER-MPH versus placebo.
In a phase 3 trial of children with ADHD, DR/ER-MPH (formerly HLD200), a delayed-release and extended-release methylphenidate, improved ADHD symptoms and reduced at-home early morning and late afternoon/evening functional impairments versus placebo, as measured by the validated Parent Rating of Evening andMorning Behaviors-Revised, Morning (PREMB-R AM) and Evening (PREMB-R PM) subscales. This post hoc analysis evaluated the effect of DR/ER-MPH versus placebo onindividual PREMB-R AM/PM item scores.
Data were analyzed from a pivotal, randomized, double-blind, multicenter, placebo-controlled, parallel-group, phase 3 trial of DR/ER-MPH in children (6-12 years) withADHD (NCT02520388). Using the 3-item PREMB-R AM and 8-item PREMB-R PM, both key secondary endpoints, investigators evaluated early morning and lateafternoon/evening functional impairment by scoring each item on a severity scale from 0 (none) to 3 (a lot). For post hoc analyses, treatment comparisons between DR/ER-MPH and placebo at endpoint were determined by using least squares mean changes from baseline on individual PREMB-R AM/PM items score derived from an analysis ofcovariance (ANCOVA) model with treatment as the main effect, and study center and baseline score as covariates.
Of 163 children enrolled across 22 sites, 161 were included in the intent-to-treat population (DR/ER-MPH, n=81; placebo, n=80) and 138 completed the study. The mean DR/ER-MPH dose achieved after 3 weeks of treatment was 68.1 mg. Following 3 weeks of treatment, DR/ER-MPH significantly reduced mean individual item scores from baseline versus placebo on all PREMB-R AM items (all P≤0.002; “getting out of bed”, “getting ready”, and “arguing or struggling in the morning”). Additionally, DR/ER-MPH significantly reduced mean individual item scores from baseline on 5 out of 8 PREMB-R PM items (P<0.01 in 2 items [“sitting through dinner” and “playing quietly”] and P<0.05 in 3 items [“inattentive/distractible”, “transitioning between activities”, and “settling down/getting ready for bed”]). There was a trend towards a reduction on 2 other items of the PREMB-R PM (P<0.09). Distributions of the ratings for each item will be presented. No serious TEAEs were reported; TEAEs were consistent withmethylphenidate.
Post hoc analyses revealed that DR/ER-MPH significantly reduced all PREMB-R AM item scores, including “getting out of bed”, and many PREMB-R PM items, including “getting ready for bed” in children with ADHD. These findings are worth further exploration.
In a phase 3 trial of children with attention-deficit/hyperactivity disorder (ADHD), DR/ER-MPH (formerly HLD200), a delayed-release and extended-release methylphenidate, improved ADHD symptoms and reduced at-home early morning and late afternoon/evening functional impairment versus placebo. The validated Before School Functioning Questionnaire (BSFQ), a key secondary endpoint, was used to measure early morning functional (EMF) impairment. This post hoc analysis evaluated the effect of DR/ER-MPH versus placebo on individual BSFQ item scores from baseline.
Data were analyzed from a pivotal, randomized, double-blind, multicenter, placebo-controlled, parallel-group, phase 3 trial of DR/ER-MPH in children (6-12 years) withADHD (NCT02520388). Using the 20-item BSFQ, investigators evaluated EMF impairment by scoring each item on a severity scale of 0 to 3, with 0 denoting “no impairment” and 3 denoting “severe impairment”. For post hoc analyses, treatment comparisons between DR/ER-MPH and placebo at endpoint were determined by using least squares mean changes from baseline on individual BSFQ items score derived from an analysis of covariance (ANCOVA) model with treatment as the main effect, and study center and baseline score as covariates.
Of 163 children enrolled across 22 sites, 161 were included in the intent-to-treat population (DR/ER-MPH, n=81; placebo, n=80) and 138 completed the study. The mean DR/ER-MPH dose achieved after 3 weeks of treatment was 68.1 mg. Following 3 weeks of treatment, DR/ER-MPH significantly reduced mean BSFQ item scores frombaseline on 18 out of 20 items versus placebo (P<0.001 in 8 items [listening, following directions, attention, forgetfulness, talkativeness, silliness, time awareness, getting to school]; P<0.01 in 7 items [overall organization, being quiet, distraction, interrupt/blurt out, breakfast, hygiene, independence]; P<0.05 in 3 items [procrastination, hyperactivity, awaiting turn]). Only “dressing” and “misplacing/losing items” showed no significant between-group differences (P=0.171 and P=0.175, respectively). Distributions of the severity ratings for each item will be presented. No serious TEAEs were reported; TEAEs were consistent with methylphenidate.
Post hoc analyses revealed that DR/ER-MPH significantly reduced 18 out of 20 individual BSFQ item scores versus placebo in children with ADHD. These findings are worth further exploration.
Difficulties in regulating emotions are linked to the core symptoms of premenstrual dysphoric disorder (PMDD). We therefore investigated the neural substrates of emotion-regulation problems in women with PMDD.
On the basis of self-evaluations over 2 months on the Daily Record of Severity of Problems, eligible participants were assigned to two groups: PMDD and control (18 per group). Functional magnetic resonance imaging (fMRI) and a well-validated task were used to assess brain function during emotion regulation. Participants were tested twice, once during the follicular (asymptomatic) and once in the late luteal (symptomatic) phase of the menstrual cycle.
Women with PMDD gave higher ratings of negative affect in the luteal phase than in the follicular phase, and compared with healthy control participants during the luteal phase. A region-of-interest fMRI analysis indicated that during the late luteal phase, women with PMDD had hypoactivation in right dorsolateral prefrontal cortex (dlPFC) during all conditions of the emotion-regulation task, not only in the contrast that isolated emotion regulation. An exploratory whole-brain, voxel-wise analysis showed that women with PMDD had less activation in the precentral gyrus during the luteal phase than the follicular phase, and less activation in the postcentral gyrus compared with control participants.
During the luteal phase of the menstrual cycle, women with PMDD experience difficulty regulating emotions. Hypoactivation in the right dlPFC may contribute to this problem, but may be related more generally to other affective symptoms of PMDD. Hypofunction in the right pre- and postcentral gyri warrants additional study.
To determine the scope, source, and mode of transmission of a multifacility outbreak of extensively drug-resistant (XDR) Acinetobacter baumannii.
SETTING AND PARTICIPANTS
Residents and patients in skilled nursing facilities, long-term acute-care hospital, and acute-care hospitals.
A case was defined as the incident isolate from clinical or surveillance cultures of XDR Acinetobacter baumannii resistant to imipenem or meropenem and nonsusceptible to all but 1 or 2 antibiotic classes in a patient in an Oregon healthcare facility during January 2012–December 2014. We queried clinical laboratories, reviewed medical records, oversaw patient and environmental surveillance surveys at 2 facilities, and recommended interventions. Pulsed-field gel electrophoresis (PFGE) and molecular analysis were performed.
We identified 21 cases, highly related by PFGE or healthcare facility exposure. Overall, 17 patients (81%) were admitted to either long-term acute-care hospital A (n=8), or skilled nursing facility A (n=8), or both (n=1) prior to XDR A. baumannii isolation. Interfacility communication of patient or resident XDR status was not performed during transfer between facilities. The rare plasmid-encoded carbapenemase gene blaOXA-237 was present in 16 outbreak isolates. Contact precautions, chlorhexidine baths, enhanced environmental cleaning, and interfacility communication were implemented for cases to halt transmission.
Interfacility transmission of XDR A. baumannii carrying the rare blaOXA-237 was facilitated by transfer of affected patients without communication to receiving facilities.
On 16 September 1976, in the neighbourhood of Cite du Havre in Montréal, Québec, a 24-year-old singer and songwriter named Christina ‘Tia’ Blake recorded a demo tape in Studio A of the Canadian Broadcasting Corporation (CBC). Tia had responded to a general request from CBC Radio looking for original songs written by local artists. She recorded three original songs that Thursday, including one song about her father and another written for an old boyfriend. She and the CBC producer listened to the playback together. The producer shook his head. There was nothing there he could use. He gave Tia the tape to keep.