In response to the COVID-19 pandemic, we rapidly implemented a plasma coordination center, within two months, to support transfusion for two outpatient randomized controlled trials. The center design was based on an investigational drug services model and a Food and Drug Administration-compliant database to manage blood product inventory and trial safety.

A core investigational team adapted a cloud-based platform to randomize patient assignments and track inventory distribution of control plasma and high-titer COVID-19 convalescent plasma of different blood groups from 29 donor collection centers directly to blood banks serving 26 transfusion sites.

We performed 1,351 transfusions in 16 months. The transparency of the digital inventory at each site was critical to facilitate qualification, randomization, and overnight shipments of blood group-compatible plasma for transfusions into trial participants. While inventory challenges were heightened with COVID-19 convalescent plasma, the cloud-based system, and the flexible approach of the plasma coordination center staff across the blood bank network enabled decentralized procurement and distribution of investigational products to maintain inventory thresholds and overcome local supply chain restraints at the sites.

The rapid creation of a plasma coordination center for outpatient transfusions is infrequent in the academic setting. Distributing more than 3,100 plasma units to blood banks charged with managing investigational inventory across the U.S. in a decentralized manner posed operational and regulatory challenges while providing opportunities for the plasma coordination center to contribute to research of global importance. This program can serve as a template in subsequent public health emergencies.

Post-procedural antimicrobial prophylaxis is not recommended by professional guidelines but is commonly prescribed. We sought to reduce use of post-procedural antimicrobials after common endoscopic urologic procedures.

A before-after, quasi-experimental trial with a baseline (July 2020–June 2022), an implementation (July 2022), and an intervention period (August 2022–July 2023).

Three participating medical centers.

We assessed the effect of a bundled intervention on excess post-procedural antimicrobial use (ie, antimicrobial use on post-procedural day 1) after three types of endoscopic urologic procedures: ureteroscopy and transurethral resection of bladder tumor or prostate. The intervention consisted of education, local champion(s), and audit-and-feedback of data on the frequency of post-procedural antimicrobial-prescribing.

1,272 procedures were performed across all 3 sites at baseline compared to 525 during the intervention period; 644 (50.6%) patients received excess post-procedural antimicrobials during the baseline period compared to 216 (41.1%) during the intervention period. There was no change in the use of post-procedural antimicrobials at sites 1 and 2 between the baseline and intervention periods. At site 3, the odds of prescribing a post-procedural antimicrobial significantly decreased during the intervention period relative to the baseline time trend (0.09; 95% CI 0.02–0.45). There was no significant increase in post-procedural unplanned visits at any of the sites.

Implementation of a bundled intervention was associated with reduced post-procedural antimicrobial use at one of three sites, with no increase in complications. These findings demonstrate both the safety and challenge of guideline implementation for optimal perioperative antimicrobial prophylaxis.

This trial was registered on clinicaltrials.gov, NCT04196777.

Decades of evidence have elucidated associations between early adversity and risk for negative outcomes. However, traditional conceptualizations of the biologic embedding of adversity ignore neuroscientific principles which emphasize developmental plasticity. Dimensional models suggest that separate dimensions of experiences shape behavioral development differentially. We hypothesized that deprivation would be associated with higher psychopathology and lower academic achievement through executive function and effortful control, while threat would do so through observed, and parent reported emotional reactivity.

In this longitudinal study of 206 mother–child dyads, we test these theories across the first 7 years of life. Threat was measured by the presence of domestic violence, and deprivation by the lack of cognitive stimulation within the parent–child interaction. We used path analyses to test associations between deprivation and threat with psychopathology and school outcomes through cognition and emotional reactivity.

We show that children who experienced more deprivation showed poor academic achievement through difficulties with executive function, while children who experienced more threat had higher levels of psychopathology through increased emotional reactivity.

These observations are consistent with work in adolescence and reflect how unique adverse experiences have differential effects on children’s behavior and subsequently long-term outcomes.

The New Jersey Kids Study (NJKS) is a transdisciplinary statewide initiative to understand influences on child health, development, and disease. We conducted a mixed-methods study of project planning teams to investigate team effectiveness and relationships between team dynamics and quality of deliverables.

Ten theme-based working groups (WGs) (e.g., Neurodevelopment, Nutrition) informed protocol development and submitted final reports. WG members (n = 79, 75%) completed questionnaires including de-identified demographic and professional information and a modified TeamSTEPPS Team Assessment Questionnaire (TAQ). Reviewers independently evaluated final reports using a standardized tool. We analyzed questionnaire results and final report assessments using linear regression and performed constant comparative qualitative analysis to identify central themes.

WG-level factors associated with greater team effectiveness included proportion of full professors (β = 31.24, 95% CI 27.65–34.82), team size (β = 0.81, 95% CI 0.70–0.92), and percent dedicated research effort (β = 0.11, 95% CI 0.09–0.13); age distribution (β = −2.67, 95% CI –3.00 to –2.38) and diversity of school affiliations (β = –33.32, 95% CI –36.84 to –29.80) were inversely associated with team effectiveness. No factors were associated with final report assessments. Perceptions of overall initiative leadership were associated with expressed enthusiasm for future NJKS participation. Qualitative analyses of final reports yielded four themes related to team science practices: organization and process, collaboration, task delegation, and decision-making patterns.

We identified several correlates of team effectiveness in a team science initiative's early planning phase. Extra effort may be needed to bridge differences in team members' backgrounds to enhance the effectiveness of diverse teams. This work also highlights leadership as an important component in future investigator engagement.

We assessed the effectiveness of heterologous vaccination strategy in immunocompromised individuals regarding COVID-19 outcomes, comparing it to homologous approaches.

Systematic literature review/meta-analysis.

We searched PubMed, CINAHL, EMBASE, Cochrane Central Register of Controlled Trials, Scopus, and Web of Science from January 1, 2020 to September 29, 2023. We included studies that evaluated the heterologous vaccination strategy on immunocompromised individuals through outcomes related to COVID-19 (levels of anti-SARS-CoV-2 spike protein IgG, neutralizing antibodies, symptomatic COVID-19 infection, hospitalization, and death) in comparison to homologous schemes. We also used random-effect models to produce pooled odds ratio estimates. Heterogeneity was investigated with I2 estimation.

Eighteen studies met the inclusion criteria for this systematic review. Fourteen of them provided quantitative data for inclusion in the meta-analysis on vaccine response, being four of them also included in the vaccine effectiveness meta-analysis. The vaccination strategies (heterologous vs homologous) showed no difference in the odds of developing anti-SARS-CoV-2 spike protein IgG (odds ratio 1.12 [95% Cl: 0.73–1.72]). Heterologous schemes also showed no difference in the production of neutralizing antibodies (odds ratio 1.48 [95% Cl: 0.72–3.05]) nor vaccine effectiveness in comparison to homologous schemes (odds ratio 1.52 [95% CI: 0.66–3.53]).

Alternative heterologous COVID-19 vaccinations have shown equivalent antibody response rates and vaccine effectiveness to homologous schemes, potentially aiding global disparity of vaccine distribution.

A clinical tool to estimate the risk of treatment-resistant schizophrenia (TRS) in people with first-episode psychosis (FEP) would inform early detection of TRS and overcome the delay of up to 5 years in starting TRS medication.

To develop and evaluate a model that could predict the risk of TRS in routine clinical practice.

We used data from two UK-based FEP cohorts (GAP and AESOP-10) to develop and internally validate a prognostic model that supports identification of patients at high-risk of TRS soon after FEP diagnosis. Using sociodemographic and clinical predictors, a model for predicting risk of TRS was developed based on penalised logistic regression, with missing data handled using multiple imputation. Internal validation was undertaken via bootstrapping, obtaining optimism-adjusted estimates of the model's performance. Interviews and focus groups with clinicians were conducted to establish clinically relevant risk thresholds and understand the acceptability and perceived utility of the model.

We included seven factors in the prediction model that are predominantly assessed in clinical practice in patients with FEP. The model predicted treatment resistance among the 1081 patients with reasonable accuracy; the model's C-statistic was 0.727 (95% CI 0.723–0.732) prior to shrinkage and 0.687 after adjustment for optimism. Calibration was good (expected/observed ratio: 0.999; calibration-in-the-large: 0.000584) after adjustment for optimism.

We developed and internally validated a prediction model with reasonably good predictive metrics. Clinicians, patients and carers were involved in the development process. External validation of the tool is needed followed by co-design methodology to support implementation in early intervention services.

Although the link between alcohol involvement and behavioral phenotypes (e.g. impulsivity, negative affect, executive function [EF]) is well-established, the directionality of these associations, specificity to stages of alcohol involvement, and extent of shared genetic liability remain unclear. We estimate longitudinal associations between transitions among alcohol milestones, behavioral phenotypes, and indices of genetic risk.

Data came from the Collaborative Study on the Genetics of Alcoholism (n = 3681; ages 11–36). Alcohol transitions (first: drink, intoxication, alcohol use disorder [AUD] symptom, AUD diagnosis), internalizing, and externalizing phenotypes came from the Semi-Structured Assessment for the Genetics of Alcoholism. EF was measured with the Tower of London and Visual Span Tasks. Polygenic scores (PGS) were computed for alcohol-related and behavioral phenotypes. Cox models estimated associations among PGS, behavior, and alcohol milestones.

Externalizing phenotypes (e.g. conduct disorder symptoms) were associated with future initiation and drinking problems (hazard ratio (HR)⩾1.16). Internalizing (e.g. social anxiety) was associated with hazards for progression from first drink to severe AUD (HR⩾1.55). Initiation and AUD were associated with increased hazards for later depressive symptoms and suicidal ideation (HR⩾1.38), and initiation was associated with increased hazards for future conduct symptoms (HR = 1.60). EF was not associated with alcohol transitions. Drinks per week PGS was linked with increased hazards for alcohol transitions (HR⩾1.06). Problematic alcohol use PGS increased hazards for suicidal ideation (HR = 1.20).

Behavioral markers of addiction vulnerability precede and follow alcohol transitions, highlighting dynamic, bidirectional relationships between behavior and emerging addiction.

Therapeutics targeting frontotemporal dementia (FTD) are entering clinical trials. There are challenges to conducting these studies, including the relative rarity of the disease. Remote assessment tools could increase access to clinical research and pave the way for decentralized clinical trials. We developed the ALLFTD Mobile App, a smartphone application that includes assessments of cognition, speech/language, and motor functioning. The objectives were to determine the feasibility and acceptability of collecting remote smartphone data in a multicenter FTD research study and evaluate the reliability and validity of the smartphone cognitive and motor measures.

A diagnostically mixed sample of 207 participants with FTD or from familial FTD kindreds (CDR®+NACC-FTLD=0 [n=91]; CDR®+NACC-FTLD=0.5 [n=39]; CDR®+NACC-FTLD>1 [n=39]; unknown [n=38]) were asked to remotely complete a battery of tests on their smartphones three times over two weeks. Measures included five executive functioning (EF) tests, an adaptive memory test, and participant experience surveys. A subset completed smartphone tests of balance at home (n=31) and a finger tapping test (FTT) in the clinic (n=11). We analyzed adherence (percentage of available measures that were completed) and user experience. We evaluated Spearman-Brown split-half reliability (100 iterations) using the first available assessment for each participant. We assessed test-retest reliability across all available assessments by estimating intraclass correlation coefficients (ICC). To investigate construct validity, we fit regression models testing the association of the smartphone measures with gold-standard neuropsychological outcomes (UDS3-EF composite [Staffaroni et al., 2021], CVLT3-Brief Form [CVLT3-BF] Immediate Recall, mechanical FTT), measures of disease severity (CDR®+NACC-FTLD Box Score & Progressive Supranuclear Palsy Rating Scale [PSPRS]), and regional gray matter volumes (cognitive tests only).

Participants completed 70% of tasks. Most reported that the instructions were understandable (93%), considered the time commitment acceptable (97%), and were willing to complete additional assessments (98%). Split-half reliability was excellent for the executive functioning (r’s=0.93-0.99) and good for the memory test (r=0.78). Test-retest reliabilities ranged from acceptable to excellent for cognitive tasks (ICC: 0.70-0.96) and were excellent for the balance (ICC=0.97) and good for FTT (ICC=0.89). Smartphone EF measures were strongly associated with the UDS3-EF composite (ß's=0.6-0.8, all p<.001), and the memory test was strongly correlated with total immediate recall on the CVLT3-BF (ß=0.7, p<.001). Smartphone FTT was associated with mechanical FTT (ß=0.9, p=.02), and greater acceleration on the balance test was associated with more motor features (ß=0.6, p=0.02). Worse performance on all cognitive tests was associated with greater disease severity (ß's=0.5-0.7, all p<.001). Poorer performance on the smartphone EF tasks was associated with smaller frontoparietal/subcortical volume (ß's=0.4-0.6, all p<.015) and worse memory scores with smaller hippocampal volume (ß=0.5, p<.001).

These results suggest remote digital data collection of cognitive and motor functioning in FTD research is feasible and acceptable. These findings also support the reliability and validity of unsupervised ALLFTD Mobile App cognitive tests and provide preliminary support for the motor measures, although further study in larger samples is required.

Performance validity tests (PVTs) are included in neuropsychological testing to ensure examinees are performing to the best of their abilities. There are two types of PVTs: embedded and free standing. Embedded PVTs are tests that are derived from standard neuropsychological tests of various cognitive domains. Freestanding PVTs are tests that are designed with the intention of being a PVT. Research studies show that undergraduate samples do not always performed to the best of their abilities. The purpose of this study was to cross-validate previous research on the topic of performance validity in a college sample. It was predicted that the non-credible group would demonstrate higher failure rates on embedded PVTs compared to the credible group.

The sample consisted of 198 neurologically and psychologically healthy undergraduate students with a mean age of 19.69 (SD = 2.11). Participants were broken into two groups: non-credible (i.e., participants that failed two or more PVTs) and credible (i.e., participants that did not failed two or more PVTs). The Rey-Osterrith copy test, Comalli Stroop part A (CSA), B (CSB), and C (CSC), Trail Making Test part A and B, Symbol Digit Modalities Test written (SDMT-W) and oral (SDMT-O) parts, Controlled Oral Word Association Test (COWAT) letter fluency, and Finger Tapping Test were used to evaluate failure rates in our sample. PVT cutoff scores were use from previously validated in the literature. Chi-square analysis was used to evaluate failure rates between the groups.

Chi-square analysis revealed significant failure rate differences between groups on several PVTs. Results revealed that 15% of the non-credible group failed the CSA compared to 1% of the credible group, X2=14.77, p=.000. Meanwhile, 26% of the non-credible group failed the CSB compared to 2% of the credible group, X2=24.72, p=.000. Furthermore, results showed that 11% of the non-credible group failed the CSC compared to 1% of the credible group, X2=13.05, p=.000.Next, 48% of the non-credible group failed the Trail Making Test part A compared to 8% of the credible group, X2=31.61, p=.000. We also found that 15% of the non-credible group failed the SDMT-W part compared to 1% of the credible group,X2=19.18, p=.000. Meanwhile, on the SDMT-O part 19% of the non-credible group failed compared to 1% of the credible group, X2=25.52, p =.000. On the COWAT letter fluency task 74% of the non-credible group failed compared to 19% of the credible group, X2=36.90, p=.000. Finally, results revealed on the Finger Tapping Test 19% of the non-credible group failed compared to 3% of the credible group, X2=10.01, p=.002.

As expected, the non-credible participants demonstrated significantly higher PVT failure rates compared to credible participants. A possible explanation driving higher failure rates in our sample can be due to cultural variables (e.g., bilingualism). It was suggested by researchers that linguistic factors may be impacting higher PVT failure rates and developing a false-positive error. Future research using undergraduate samples need to identify which PVT’s are being impacted by linguist factors.

We identify a set of essential recent advances in climate change research with high policy relevance, across natural and social sciences: (1) looming inevitability and implications of overshooting the 1.5°C warming limit, (2) urgent need for a rapid and managed fossil fuel phase-out, (3) challenges for scaling carbon dioxide removal, (4) uncertainties regarding the future contribution of natural carbon sinks, (5) intertwinedness of the crises of biodiversity loss and climate change, (6) compound events, (7) mountain glacier loss, (8) human immobility in the face of climate risks, (9) adaptation justice, and (10) just transitions in food systems.

The Intergovernmental Panel on Climate Change Assessment Reports provides the scientific foundation for international climate negotiations and constitutes an unmatched resource for researchers. However, the assessment cycles take multiple years. As a contribution to cross- and interdisciplinary understanding of climate change across diverse research communities, we have streamlined an annual process to identify and synthesize significant research advances. We collected input from experts on various fields using an online questionnaire and prioritized a set of 10 key research insights with high policy relevance. This year, we focus on: (1) the looming overshoot of the 1.5°C warming limit, (2) the urgency of fossil fuel phase-out, (3) challenges to scale-up carbon dioxide removal, (4) uncertainties regarding future natural carbon sinks, (5) the need for joint governance of biodiversity loss and climate change, (6) advances in understanding compound events, (7) accelerated mountain glacier loss, (8) human immobility amidst climate risks, (9) adaptation justice, and (10) just transitions in food systems. We present a succinct account of these insights, reflect on their policy implications, and offer an integrated set of policy-relevant messages. This science synthesis and science communication effort is also the basis for a policy report contributing to elevate climate science every year in time for the United Nations Climate Change Conference.

We highlight recent and policy-relevant advances in climate change research – with input from more than 200 experts.

Researchers have identified genetic and neural risk factors for externalizing behaviors. However, it has not yet been determined if genetic liability is conferred in part through associations with more proximal neurophysiological risk markers.

Participants from the Collaborative Study on the Genetics of Alcoholism, a large, family-based study of alcohol use disorders were genotyped and polygenic scores for externalizing (EXT PGS) were calculated. Associations with target P3 amplitude from a visual oddball task (P3) and broad endorsement of externalizing behaviors (indexed via self-report of alcohol and cannabis use, and antisocial behavior) were assessed in participants of European (EA; N = 2851) and African ancestry (AA; N = 1402). Analyses were also stratified by age (adolescents, age 12–17 and young adults, age 18–32).

The EXT PGS was significantly associated with higher levels of externalizing behaviors among EA adolescents and young adults as well as AA young adults. P3 was inversely associated with externalizing behaviors among EA young adults. EXT PGS was not significantly associated with P3 amplitude and therefore, there was no evidence that P3 amplitude indirectly accounted for the association between EXT PGS and externalizing behaviors.

Both the EXT PGS and P3 amplitude were significantly associated with externalizing behaviors among EA young adults. However, these associations with externalizing behaviors appear to be independent of each other, suggesting that they may index different facets of externalizing.