Multicenter clinical trials are essential for evaluating interventions but often face significant challenges in study design, site coordination, participant recruitment, and regulatory compliance. To address these issues, the National Institutes of Health’s National Center for Advancing Translational Sciences established the Trial Innovation Network (TIN). The TIN offers a scientific consultation process, providing access to clinical trial and disease experts who provide input and recommendations throughout the trial’s duration, at no cost to investigators. This approach aims to improve trial design, accelerate implementation, foster interdisciplinary teamwork, and spur innovations that enhance multicenter trial quality and efficiency. The TIN leverages resources of the Clinical and Translational Science Awards (CTSA) program, complementing local capabilities at the investigator’s institution. The Initial Consultation process focuses on the study’s scientific premise, design, site development, recruitment and retention strategies, funding feasibility, and other support areas. As of 6/1/2024, the TIN has provided 431 Initial Consultations to increase efficiency and accelerate trial implementation by delivering customized support and tailored recommendations. Across a range of clinical trials, the TIN has developed standardized, streamlined, and adaptable processes. We describe these processes, provide operational metrics, and include a set of lessons learned for consideration by other trial support and innovation networks.

Recent changes to US research funding are having far-reaching consequences that imperil the integrity of science and the provision of care to vulnerable populations. Resisting these changes, the BJPsych Portfolio reaffirms its commitment to publishing mental science and advancing psychiatric knowledge that improves the mental health of one and all.

Increased temporal variability in the gut microbiome is associated with intestinal conditions such as ulcerative colitis and Crohn’s disease, leading to the recently established concept of microbial volatility (1). Increased physiological stress has been shown to increase microbial volatility indicating that microbial volatility is susceptible to external interventions(1). Dietary fibre positively affects the gut microbiome, but it is unclear if it impacts microbial volatility. The gut microbiota influences hypertension, and high-fibre intake reduces blood pressure (BP)(2). However, not all individuals exhibit a response to these fibre-based dietary changes, and the reasons for this variability remain unclear. Similarly, it is unknown whether the degree of stability of the gut microbiota consortium could be a determining factor in individual responsiveness to dietary interventions. Here, we aimed to identify: i) whether gut microbiome volatility differs when dietary fibre vs placebo interventions, and ii) whether microbiome volatility discriminates between BP responders and non-responders to a high fibre intervention. Twenty treatment-naive participants with hypertension received either placebo or 40g per day of prebiotic acetylated and butyrylated high amylose maize starch (HAMSAB) supplementation for 3 weeks in a phase II randomised cross-over double-blind placebo-controlled trial(3). Blood pressure was monitored at baseline and each endpoint by 24-hour ambulatory BP monitoring, with those experiencing a reduction between timepoints of ≥ 2 mmHg classified as responders. Baseline stool samples were collected, and the V4 region of the 16S gene was sequenced. Taxonomy was assigned by reference to the SILVA database. Microbial volatility between timepoints (e.g., pre- and post-intervention) was calculated as the Euclidian distance of centred log-ratio transformed genera counts (Aitchison distance). No difference was observed in microbial volatility between individuals when they received the dietary fibre intervention or the placebo (21.5 ± 5.5 vs 20.5 ± 7.7, p = 0.51). There was no significant difference between microbial volatility on the dietary intervention between responders and non-responders (21.8 ± 4.9 vs 20.9 ± 7.2, p = 0.84). There was no association between the change in BP during intervention and microbial volatility during intervention (r2 = −0.09, p = 0.72). These data suggest that temporal volatility of the gut microbiota does not change with fibre intake or contribute to the BP response to dietary fibre intervention trials in people with hypertension.

This review aims to highlight the relative importance of cardiovascular disease (CVD) lifestyle-associated risk factors among individuals with inflammatory bowel disease (IBD) and examine the effectiveness of lifestyle interventions to improve these CVD risk factors. Adults with IBD are at higher risk of CVD due to systemic and gut inflammation. Besides that, tobacco smoking, dyslipidaemia, hypertension, obesity, physical inactivity and poor diet can also increase CVD risk. Typical IBD behavioural modification including food avoidance and reduced physical activity, as well as frequent corticosteroid use, can further increase CVD risk. We reviewed seven studies and found that there is insufficient evidence to conclude the effects of diet and/or physical activity interventions on CVD risk outcomes among populations with IBD. However, the limited findings suggest that people with IBD can adhere to a healthy diet or Mediterranean diet (for which there is most evidence) and safely participate in moderately intense aerobic and resistance training to potentially improve anthropometric risk factors. This review highlights the need for more robust controlled trials with larger sample sizes to assess and confirm the effects of lifestyle interventions to mitigate modifiable CVD risk factors among the IBD population.

This editorial considers the value and nature of academic psychiatry by asking what defines the specialty and psychiatrists as academics. We frame academic psychiatry as a way of thinking that benefits clinical services and discuss how to inspire the next generation of academics.

Invasive plants can gain a foothold in new environments by manipulating soil conditions through allelopathy or through the disruption of associations between native plants and their mycorrhizal associates. The resulting changes in soil conditions can affect the recovery of habitats long after the invasive plant has been removed. We conducted a series of greenhouse experiments to examine the effects of soil conditioned by pale swallow-wort [Vincetoxicum rossicum (Kleopow) Barbarich; Apocynaceae], on the growth of native plants. Additionally, we tested the effects of aqueous extracts of common milkweed (Asclepias syriaca L.; Apocynaceae), a related plant with known allelopathic effects, on the regrowth of V. rossicum from transplanted root crowns. Soil from a 15-yr-old V. rossicum infestation reduced seedling emergence in A. syriaca as well as in V. rossicum itself. Conversely, the same soil had no effect on the growth of mature A. syriaca plants. Soil conditioned by V. rossicum growth in the greenhouse had no effect on the biomass and percentage cover generated by two restoration seed mixes. Soil conditioned by A. syriaca, however, yielded lower biomass and percentage cover from both seed mixes. In contrast to the allelopathic effects of A. syriaca on seedlings, aqueous extracts of A. syriaca increased aboveground plant growth in V. rossicum. Our results suggest that the effects of V. rossicum–conditioned soil on native plants are concentrated at the seedling establishment phase. Additionally, the use of diverse native seed mixes shows great potential for restoring productivity to ecosystems affected by V. rossicum.

The consumption of healthy foods such as whole grains, vegetables, fruits, nuts, legumes, dairy, and fish is associated with decreased risk of cardiovascular disease (CVD). CVD is an inflammatory disease caused by atherosclerosis. Inflammation is measured clinically using hsCRP, however hsCRP is not specific to CVD. Novel pro-inflammatory markers, such as platelet-activating factor (PAF) and lipoprotein-associated phospholipase A2 (Lp-PLA2), have garnered attention due to their specific roles in endothelial dysfunction and CVD risk. During the COVID 19 outbreak research highlighted a potential interaction between PAF and Lp-PLA2 and the SARS COVID 19 virus(1-3) and related adenovirus-vector and mRNA vaccines.4 This cross-sectional study investigated the association between PAF, Lp-PLA2, hsCRP, and intake of healthy food groups including fruit, cruciferous and other vegetables, grains, meat and poultry, fish and seafood, nuts and legumes, and dairy in 100 adults (49 ± 13 years, 31% male) with variable CVD risk. Data were collected across four groups during May and July 2021 (Groups 1 and 2 - CVD risk factors) and January and April 2022 (Groups 3 and 4 - no CVD risk factors). Fasting PAF, Lp-PLA2 and hsCRP and usual dietary intake (food frequency questionnaire) were measured. Food intake was converted into serves and classified into food groups. Correlations and multiple regressions were performed. Contrary to expectations, mean PAF was lower for groups 1 and 2 (n = 46, mean PAF 3.31 ± 1.66 ng/mL) compared to groups 3 and 4 (n = 54, mean PAF 19.82 ± 12.95 ng/mL) p < 0.001 with a large effect size (eta squared 0.665). Cruciferous vegetables were associated with lower levels of PAF (β = -.27, CI [−0.41, −0.14], p < .001) with a one serve increase in cruciferous vegetables per day associated with an 24% reduction in PAF. Nuts and legumes were associated with lower levels of hsCRP (β = -.51, CI [−0.81, −0.22], p<.001) with an increase of one serve per day associated with a 40% reduction in hsCRP. There were small inverse associations between cheese and both PAF (β = -.15, CI [−0.27, −0.03], p = .017) and Lp-PLA2 (β = -.26, CI [−0.47, −0.04], p = .024), however these were not significant at the Bonferroni-adjusted P<.005 level. In conclusion, cruciferous vegetables and nut and legume consumption were associated with lower levels of inflammation. The lack of associations between PAF and Lp-PLA2 and other healthy foods may be due to confounding by COVID-19 infection and vaccination programs which prevents any firm conclusion on the relationship between PAF, Lp-PLA2 and food groups. Future research should aim to examine the relationship with these novel markers and healthy food groups in a non-pandemic setting.

Patients with inflammatory bowel disease (IBD) have higher risk of developing cardiometabolic diseases due to chronic gut and systemic inflammation which promotes atherogenesis. Adopting healthy lifestyle habits can prevent development of cardiometabolic diseases, but can be challenging for people with IBD. The IBD exercise and diet (IBDeat) habits study describes the lifestyle habits and cardiometabolic disease risk factors of adults with IBD in Aotearoa, New Zealand (NZ).

This is a cross-sectional study including adult NZ IBD patients recruited online via Crohn’s and Colitis NZ and Dunedin hospital from 2021 to 2022. An online questionnaire collected demographics, smoking status, comorbidities, medications, disease severity scores, quality of life, physical activity, and dietary intake. The Dunedin cohort had physical measurements taken including anthropometrics, handgrip strength, blood pressure, body composition (bioelectrical impedance), blood nutritional markers, and faecal calprotectin. Data were compared to established reference values and linear regression analysis investigated associations between lifestyle habits and cardiometabolic risk factors. The study received University of Otago ethical approval (reference: H21/135). A total of 213 adults with IBD (54% Crohn’s disease; 46% ulcerative colitis) completed the online questionnaire and a subset of 102 from Dunedin provided physical measurements. Participants characteristics were: median age 37 (IQR 25, 51) years, 71% female, 82% NZ European, 4% smokers, and 1.4% had active IBD. Thirty-five percent of participants had at least one comorbidity and 34% of participants had poor quality of life. Known dietary risk factors associated with cardiometabolic diseases were common: low intakes of vegetables (77%), fruit (51%), fibre (35%) and high intakes of total fat (84%) and saturated fat (98%). Physical activity recommendations were met by 61% of participants and 63% reported barriers to being more active from fatigue (63%) and joint pain (54%). Other cardiometabolic risk factors were common in the Dunedin cohort: high LDL (79%) and total cholesterol (76%), central adiposity (64%), high body fat percentage (44%), high blood pressure (26%), and low handgrip strength (25%). Regression analysis showed that vegetable (per serve) and carbohydrate (per 5% of total daily energy intake (TE)) were associated with 0.22 mmol/L (95%CI 0.43, 0.013) and 0.20 mmol/L (95%CI 0.34, 0.057) lower LDL cholesterol. Discretionary food items were associated with higher LDL cholesterol, 0.11 mmol/L per daily serve (95%CI 0.028, 0.19). A 5% difference in TE intake from carbohydrate was associated with 1.11% (95%CI 2.22%, 0.0038%) lower body fat percentage while protein was associated with 3.1% (95%CI 0.81%, 5.39%) higher body fat percentage. Physical activity had weak associations with cardiometabolic disease risk factors. Adults with IBD have multiple modifiable risk factors for cardiometabolic diseases. Vegetable and carbohydrate intake were associated with lower LDL cholesterol concentration while discretionary food items showed otherwise. Protein intake was associated with higher body fat percentage.

Odd Radio Circles (ORCs) are a class of low surface brightness, circular objects approximately one arcminute in diameter. ORCs were recently discovered in the Australian Square Kilometre Array Pathfinder (ASKAP) data and subsequently confirmed with follow-up observations on other instruments, yet their origins remain uncertain. In this paper, we suggest that ORCs could be remnant lobes of powerful radio galaxies, re-energised by the passage of a shock. Using relativistic hydrodynamic simulations with synchrotron emission calculated in post-processing, we show that buoyant evolution of remnant radio lobes is alone too slow to produce the observed ORC morphology. However, the passage of a shock can produce both filled and edge-brightnened ORC-like morphologies for a wide variety of shock and observing orientations. Circular ORCs are predicted to have host galaxies near the geometric centre of the radio emission, consistent with observations of these objects. Significantly offset hosts are possible for elliptical ORCs, potentially causing challenges for accurate host galaxy identification. Observed ORC number counts are broadly consistent with a paradigm in which moderately powerful radio galaxies are their progenitors.

We present and evaluate the prospects for detecting coherent radio counterparts to gravitational wave (GW) events using Murchison Widefield Array (MWA) triggered observations. The MWA rapid-response system, combined with its buffering mode ($\sim$4 min negative latency), enables us to catch any radio signals produced from seconds prior to hours after a binary neutron star (BNS) merger. The large field of view of the MWA ($\sim$$1\,000\,\textrm{deg}^2$ at 120 MHz) and its location under the high sensitivity sky region of the LIGO-Virgo-KAGRA (LVK) detector network, forecast a high chance of being on-target for a GW event. We consider three observing configurations for the MWA to follow up GW BNS merger events, including a single dipole per tile, the full array, and four sub-arrays. We then perform a population synthesis of BNS systems to predict the radio detectable fraction of GW events using these configurations. We find that the configuration with four sub-arrays is the best compromise between sky coverage and sensitivity as it is capable of placing meaningful constraints on the radio emission from 12.6% of GW BNS detections. Based on the timescales of four BNS merger coherent radio emission models, we propose an observing strategy that involves triggering the buffering mode to target coherent signals emitted prior to, during or shortly following the merger, which is then followed by continued recording for up to three hours to target later time post-merger emission. We expect MWA to trigger on $\sim$$5-22$ BNS merger events during the LVK O4 observing run, which could potentially result in two detections of predicted coherent emission.

We present the Cosmological Double Radio Active Galactic Nuclei (CosmoDRAGoN) project: a large suite of simulated AGN jets in cosmological environments. These environments sample the intra-cluster media of galaxy clusters that form in cosmological smooth particle hydrodynamics (SPH) simulations, which we then use as inputs for grid-based hydrodynamic simulations of radio jets. Initially conical jets are injected with a range of jet powers, speeds (both relativistic and non-relativistic), and opening angles; we follow their collimation and propagation on scales of tens to hundreds of kiloparsecs, and calculate spatially resolved synthetic radio spectra in post-processing. In this paper, we present a technical overview of the project, and key early science results from six representative simulations which produce radio sources with both core- (Fanaroff-Riley Type I) and edge-brightened (Fanaroff-Riley Type II) radio morphologies. Our simulations highlight the importance of accurate representation of both jets and environments for radio morphology, radio spectra, and feedback the jets provide to their surroundings.

Infants and children born with CHD are at significant risk for neurodevelopmental delays and abnormalities. Individualised developmental care is widely recognised as best practice to support early neurodevelopment for medically fragile infants born premature or requiring surgical intervention after birth. However, wide variability in clinical practice is consistently demonstrated in units caring for infants with CHD. The Cardiac Newborn Neuroprotective Network, a Special Interest Group of the Cardiac Neurodevelopmental Outcome Collaborative, formed a working group of experts to create an evidence-based developmental care pathway to guide clinical practice in hospital settings caring for infants with CHD. The clinical pathway, “Developmental Care Pathway for Hospitalized Infants with Congenital Heart Disease,” includes recommendations for standardised developmental assessment, parent mental health screening, and the implementation of a daily developmental care bundle, which incorporates individualised assessments and interventions tailored to meet the needs of this unique infant population and their families. Hospitals caring for infants with CHD are encouraged to adopt this developmental care pathway and track metrics and outcomes using a quality improvement framework.