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.

Emotion regulation and functioning have well established links to substance use in adolescents. Yet limited research has investigated emotion regulation in very early substance initiators either on self-report or on behavioral measures (i.e., Emotional Stroop). Similarly, there are few prospective investigations of emotional functioning as a predictor of initiation. Given concerns of emotion difficulties preceding and predicting substance use onset, we aim to investigate emotional functioning difficulties in very early (ages 9–13) substance use initiators relative to sociodemographically matched controls, both after initiation and as a predictor of initiation. We hypothesize that initiators would demonstrate greater emotion dysregulation and decreased emotional functioning relative to controls.

ABCD Study Annual Release 4.0 was used. Participants included those who had data available at Y3 follow-up visit and youth-reported use of any full dose of a substance (n=148). Sociodemographic controls were then matched (n=148). General linear mixed effects models were run to assess emotional functioning at Y3 (Emotional Stroop response time and accuracy performance, youth-reported Emotion Regulation Questionnaire, and parent-reported Difficulties in Emotion Regulation Scale and Child Behavior Checklist externalizing and internalizing symptoms) by substance use group status controlling for random effects of family. Further, hierarchical linear models assessed CBCL emotional functioning from Y0 to Y3 predicting SU initiation at Y3, controlling for within-subject change.

At Y3, early substance use initiation predicted higher parent-reported externalizing symptoms significantly (estimate=5.88, p<.001). Substance use initiation also marginally predicted high parent-reported internalizing symptoms (estimate=2.29, p=.08) and DERS (estimate=0.02, p=.07). ERQ and Stroop performance were not significantly associated with group status (p's>.10). For externalizing symptoms predicting SU initiation, regardless of year (baseline through Y3) was significantly predictive of initiation (p's<.001). HLM demonstrated that externalizing symptoms at all time points resulted in the best predictive model (AIC=392.85, BIC=422.80, relative to models including all data through Y2, AIC=433.63, BIC=458.59).

Here we found externalizing symptoms and, to a lesser extent, internalizing symptoms and emotion dysregulation are associated with early substance use initiation. However, results are limited to parent report, despite the consideration of youth-report and a behavioral measure of emotion regulation, the Emotional Stroop task. Further, while marginal effects were found, downstream externalizing symptoms were a better predictor of later substance use initiation. While other metrics of emotion regulation have been linked to substance use in adolescence, emotion regulation abilities may change as a result of substance use, rather than a predictor of use, and thus needs monitoring over time.

This paper examined whether distinct life-course trajectories of psychological distress from adolescence to midlife were associated with poorer mental health outcomes during the pandemic.

We present a secondary analysis of two nationally representative British birth cohorts, the 1958 National Child Development Study (NCDS) and 1970 British Cohort Study (BCS70). We used latent variable mixture models to identify pre-pandemic longitudinal trajectories of psychological distress and a modified Poisson model with robust standard errors to estimate associations with psychological distress, life satisfaction and loneliness at different points during the pandemic.

Our analysis identified five distinct pre-pandemic trajectories of psychological distress in both cohorts. All trajectories with prior symptoms of psychological distress irrespective of age of onset, severity and chronicity were associated with a greater relative risk of poorer mental health outcomes during the pandemic and the probability of poorer mental health associated with psychological distress trajectories remained fairly constant. The relationship was not fully attenuated when most recent pre-pandemic psychological distress and other midlife factors were controlled for.

Whilst life-course trajectories with any prior symptoms of psychological distress put individuals at greater risk of poor mental health outcomes during the pandemic, those with chronic and more recent occurrences were at highest risk. In addition, prior poor mental health during the adult life-course may mean individuals are less resilient to shocks, such as pandemics. Our findings show the importance of considering heterogeneous mental health trajectories across the life-course in the general population in addition to population average trends.

Clinical guidelines or guidance is an important tool for preventing and treating antimicrobial-resistant (AMR) infections. We sought to understand and support the effective use of guidelines and guidance for AMR infections.

Key informant interviews and a stakeholder meeting on the development and use of guidelines and guidance for management of AMR infections; the interview findings and meeting discussion informed a conceptual framework for AMR infection clinical guidelines.

Interview participants included experts with experience in guidelines development and physician and pharmacist hospital leaders and antibiotic stewardship program leaders. Stakeholder meeting participants included federal and nonfederal participants involved in research, policy, and practice related to prevention and management of AMR infections.

Participants described challenges related to timeliness of guidelines, methodologic limitations of the development process, and issues with usability across a range of clinical settings. These findings, and participants’ suggestions for mitigating the challenges identified, informed a conceptual framework for AMR infection clinical guidelines. The framework components include (1) science and evidence, (2) guideline and guidance development and dissemination, and (3) implementation and real-world practice. These components are supported by engaged stakeholders whose leadership and resources help to improve patient and population AMR infection prevention and management.

Use of guidelines and guidance documents for management of AMR infections can be supported through (1) a robust body of scientific evidence to inform guidelines and guidance; (2) approaches and tools to support timely, transparent guidelines that are relevant and actionable for all clinical audiences; and (3) tools to implement guidelines and guidance effectively.

Millions of people visit US national parks annually to engage in recreational wilderness activities, which can occasionally result in traumatic injuries that require timely, high-level care. However, no study to date has specifically examined timely access to trauma centers from national parks. This study aimed to examine the accessibility of trauma care from national parks by calculating the travel time by ground and air from each park to its nearest trauma center. Using these calculations, the percentage of parks by census region with timely access to a trauma center was determined.

This was a cross-sectional study analyzing travel times by ground and air transport between national parks and their closest adult advanced trauma center (ATC) in 2018. A list of parks was compiled from the National Parks Service (NPS) website, and the location of trauma centers from the 2018 National Emergency Department Inventory (NEDI)-USA database. Ground and air transport times were calculated using Google Maps and ArcGIS, with medians and interquartile ranges reported by US census region. Percentage of parks by region with timely trauma center access—defined as access within 60 minutes of travel time—were determined based on these calculated travel times.

In 2018, 83% of national parks had access to an adult ATC within 60 minutes of air travel, while only 26% had timely access by ground. Trauma center access varied by region, with median travel times highest in the West for both air and ground transport. At a national level, national parks were unequally distributed, with the West housing the most parks of all regions.

While most national parks had timely access to a trauma center by air travel, significant gaps in access remain for ground, the extent of which varies greatly by region. To improve the accessibility of trauma center expertise from national parks, the study highlights the potential that increased implementation of trauma telehealth in emergency departments (EDs) may have in bridging these gaps.

Clinical research staff play a critical role in recruiting families for pediatric research, but their views are not well described. We aimed to describe how pediatric research staff build trusting research relationships with patients and their families.

We interviewed research staff at one pediatric research institution and its affiliated academic medical center between November 2020 and February 2021. Staff were eligible if they conducted participant recruitment, consent, and/or enrollment for clinical research. We developed our semi-structured interview guide based on a framework for trusting researcher-community partnerships.

We interviewed 28 research staff, with a median age of 28 years (range 22–50) and a median of 5 years of experience (range 1–29). Interviewees identified factors relevant to relationship building across three levels: the individual staff member, the relational interaction with the family, and the institutional or other structural backdrop. Individual factors included how staff developed recruitment skills, their perceived roles, and their personal motivations. Relational factors spanned four stages of recruitment: before the approach, forming an initial connection with a family, building the connection, and following up. Structural factors were related to access and diversity, clinical interactions, and the COVID-19 pandemic.

Research staff discussed tensions and supports with various actors, challenges with the integration of research and clinical care, the importance of voluntariness for building trust, and multiple contributors to inequities in research. These findings reveal the importance of ensuring research staff have a voice in institutional policies and are supported to advocate for patients and families.

Publication bias has the potential to adversely impact clinical decision making and patient health if alternative decisions would have been made had there been complete publication of evidence.

The objective of our analysis was to determine if earlier publication of the complete evidence on rosiglitazone’s risk of myocardial infarction (MI) would have changed clinical decision making at an earlier point in time. We tested several methods for adjustment of publication bias to assess the impact of potential time delays to identifying the MI effect. We then performed a cumulative meta-analysis (CMA) for both published studies (published-only data set) and all studies performed (comprehensive data set). We then created an adjusted data set using existing methods of adjustment for publication bias (Harbord regression, Peter’s regression, and the nonparametric trim and fill method) applied to the limited data set. Finally, we compared the time to the decision threshold for each data set using CMA.

Although published-only and comprehensive data sets did not provide notably different final summary estimates [OR = 1.4 (95 percent confidence interval [CI]: .95–2.05) and 1.42 (95 percent CI: 1.03–1.97)], the comprehensive data set reached the decision threshold 36 months earlier than the published-only data set. All three adjustment methods tested did not show a differential time to decision threshold versus the published-only data set.

Complete access to studies capturing MI risk for rosiglitazone would have led to the evidence reaching a clinically meaningful decision threshold 3 years earlier.