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.

We assessed the impact of metagenomic next-generation sequencing (mNGS) on patient care using previously established criteria. Among 37 patients receiving mNGS testing, 16% showed results that had a positive clinical impact. While mNGS results may offer valuable supplementary information, results should be interpreted within the broader clinical context and evaluation.

Empowering the Participant Voice (EPV) is an NCATS-funded six-CTSA collaboration to develop, demonstrate, and disseminate a low-cost infrastructure for collecting timely feedback from research participants, fostering trust, and providing data for improving clinical translational research. EPV leverages the validated Research Participant Perception Survey (RPPS) and the popular REDCap electronic data-capture platform. This report describes the development of infrastructure designed to overcome identified institutional barriers to routinely collecting participant feedback using RPPS and demonstration use cases. Sites engaged local stakeholders iteratively, incorporating feedback about anticipated value and potential concerns into project design. The team defined common standards and operations, developed software, and produced a detailed planning and implementation Guide. By May 2023, 2,575 participants diverse in age, race, ethnicity, and sex had responded to approximately 13,850 survey invitations (18.6%); 29% of responses included free-text comments. EPV infrastructure enabled sites to routinely access local and multi-site research participant experience data on an interactive analytics dashboard. The EPV learning collaborative continues to test initiatives to improve survey reach and optimize infrastructure and process. Broad uptake of EPV will expand the evidence base, enable hypothesis generation, and drive research-on-research locally and nationally to enhance the clinical research enterprise.

In 2016, the National Center for Advancing Translational Science launched the Trial Innovation Network (TIN) to address barriers to efficient and informative multicenter trials. The TIN provides a national platform, working in partnership with 60+ Clinical and Translational Science Award (CTSA) hubs across the country to support the design and conduct of successful multicenter trials. A dedicated Hub Liaison Team (HLT) was established within each CTSA to facilitate connection between the hubs and the newly launched Trial and Recruitment Innovation Centers. Each HLT serves as an expert intermediary, connecting CTSA Hub investigators with TIN support, and connecting TIN research teams with potential multicenter trial site investigators. The cross-consortium Liaison Team network was developed during the first TIN funding cycle, and it is now a mature national network at the cutting edge of team science in clinical and translational research. The CTSA-based HLT structures and the external network structure have been developed in collaborative and iterative ways, with methods for shared learning and continuous process improvement. In this paper, we review the structure, function, and development of the Liaison Team network, discuss lessons learned during the first TIN funding cycle, and outline a path toward further network maturity.

Improving the quality and conduct of multi-center clinical trials is essential to the generation of generalizable knowledge about the safety and efficacy of healthcare treatments. Despite significant effort and expense, many clinical trials are unsuccessful. The National Center for Advancing Translational Science launched the Trial Innovation Network to address critical roadblocks in multi-center trials by leveraging existing infrastructure and developing operational innovations. We provide an overview of the roadblocks that led to opportunities for operational innovation, our work to develop, define, and map innovations across the network, and how we implemented and disseminated mature innovations.

New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or “hybrid” trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology.

One challenge for multisite clinical trials is ensuring that the conditions of an informative trial are incorporated into all aspects of trial planning and execution. The multicenter model can provide the potential for a more informative environment, but it can also place a trial at risk of becoming uninformative due to lack of rigor, quality control, or effective recruitment, resulting in premature discontinuation and/or non-publication. Key factors that support informativeness are having the right team and resources during study planning and implementation and adequate funding to support performance activities. This communication draws on the experience of the National Center for Advancing Translational Science (NCATS) Trial Innovation Network (TIN) to develop approaches for enhancing the informativeness of clinical trials. We distilled this information into three principles: (1) assemble a diverse team, (2) leverage existing processes and systems, and (3) carefully consider budgets and contracts. The TIN, comprised of NCATS, three Trial Innovation Centers, a Recruitment Innovation Center, and 60+ CTSA Program hubs, provides resources to investigators who are proposing multicenter collaborations. In addition to sharing principles that support the informativeness of clinical trials, we highlight TIN-developed resources relevant for multicenter trial initiation and conduct.

In the wake of the most recent protests in Belarus following the 2020 Presidential Election, it is useful to explore patterns of satisfaction with the political system, confidence in political institutions, and political participation at different points in time during President Lukashenko’s rule. We utilize Wave 3 of the World Values Study (WVS) and Wave 7 of the Joint European Values Study (EVS)/WVS to (1) analyze whether citizens’ dissatisfaction with the Belarusian government differed between 1996 and 2018, and (2) whether there was a change in political participation during that period. Responses over time suggest that satisfaction with the government and confidence in institutions was not lower in 2018 than it had been in 1996. However, as we discuss in the article, this may be an artifact of authoritarian consolidation and concern/fears about revealing preferences. We also find that the willingness to engage in protests remained more or less the same between these two time periods, especially among those dissatisfied with the political system. These results suggest that once highly dissatisfied citizens took to the streets in 2020, a number of internal and external factors might have triggered a bandwagon effect that pushed other citizens to also join the demonstrations.

OBJECTIVES/GOALS: The Informatics Program in the Wake Forest CTSI is experiencing rapid growth. To accommodate an influx of both staff and clinical investigators this program Invests resources in self-service tools to increase researcher capabilities Automates resource intensive activities Creates transparency of operational processes for researchers. METHODS/STUDY POPULATION: Self-service tools (immediate/automated) The i2b2 tool queries clinical data for feasibility numbers and cohort identification; and provides demographic breakdowns of patient sets The Data Puller tool pulls identified patient data (with IRB approval) The SKAN NLP tool pulls aggregate numbers from over 3 million clinical notes Automation A custom-built tracking system automates parts of tracking requests for data and checking IRB protocols Operational transparency The Data Request Dashboard shows requesters information about their request and where it is in the process of being fulfilled The Data Quote tool was constructed leveraging the integrated CTSA informatics network and uses details of the request to estimate how long it will take to complete. RESULTS/ANTICIPATED RESULTS: i2b2 has had over 300 unique users each year; 80% are faculty or research staff, 20% are clinicians or students. From 2017-2021 there have been an average of 300 i2b2 queries and 45 Data Puller pulls each month. SKAN has had 58 unique users since its implementation in late 2020, averaging 5 new users per month. The automated data request tracking system took approximately 30 staff hours to create and saves an average of 4 hours of staff time per week. It also decreases human error by pulling/pushing information directly between systems. The Informatics program has received positive feedback from researchers who use the Data Request Dashboard. The Data Quote Tool is being used to give standardized quotes to researchers. DISCUSSION/SIGNIFICANCE: Investing resources in developing and implementing self-service tools and operational transparency ultimately reduces overall resource consumption, saving staff and investigator time and effort. This enables the Informatics program to maintain a high standard of service while experiencing rapid growth.

The Trial Innovation Network has established an infrastructure for single IRB review in response to federal policies. The Network’s single IRB (sIRBs) have successfully supported over 70 multisite studies via more than 800 reliance arrangements. This has generated several lessons learned that can benefit the national clinical research enterprise, as we work to improve the conduct of clinical trials. These lessons include distinguishing the roles of the single IRB from institutional Human Research Protections programs, establishing a consistent sIRB review model, standardizing collection of local context and supplemental, study-specific information, and educating and empowering lead study teams to support their sites.

Background: Hospitalized patients may unknowingly carry severe acute respiratory coronavirus virus 2 (SARS-CoV-2), even if they are admitted for other reasons. Because SARS-CoV-2 may remain positive by reverse-transcriptase polymerase chain reaction (RT-PCR) for months after infection, patients with a positive result may not necessarily be infectious. We aimed to determine the frequency of SARS-CoV-2 infections in patients admitted for reasons unrelated to coronavirus disease 2019 (COVID-19). Methods: The University of Iowa Hospitals and Clinics is an 811-bed tertiary-care center. We use a nasopharyngeal SARS-CoV-2 RT-PCR to screen admitted patients without signs or symptoms compatible with COVID-19. Patients with positive tests undergo a repeat test to assess cycle threshold (Ct) value kinetics. We reviewed records for patients with positive RT-PCR screening admitted during July–October 2020. We used a combination of history, serologies, and RT-PCR Ct values to assess and qualify likelihood of infectiousness: (1) likely infectious, if Ct values were <29, or (2) likely not infectious, if 1 or both samples had Cts <30 with or without a positive SARS-CoV-2 antinucleocapsid IgG/IgM test or history of a positive result in the past 90 days. Contact tracing was only conducted for patients likely to be infectious. We describe the isolation duration and contact tracing data. Results: In total, 6,447 patients were tested on hospital admission for any reason (persons under investigation or admitted for reasons other than COVID-19). Of these, 240 (4%) had positive results, but 65 (27%) of these were admitted for reasons other than COVID-19. In total, 55 patients had Ct values available and were included in this analysis. The median age was 56 years (range, 0–91), 28 (51%) were male, and 12 (5%) were children. The most frequent admission syndromes were neurological (36%), gastrointestinal (16%), and trauma (16%). Our assessment revealed 23 likely infections (42%; 14 definite, 9 possible) and 32 cases likely not infectious (58%). The mean Ct for patients who were likely infectious was 22; it was 34 for patients who were likely not infectious. Mean duration of in-hospital isolation was 6 days for those who were likely infectious and 2 days for those who were likely not infectious. We detected 8 individuals (1 healthcare worker and 7 patients) who were exposed to a likely infectious patient. Conclusions: SARS-CoV-2 infection in patients hospitalized for other reasons was infrequent. An assessment of the likelihood of infectiousness including history, RT-PCR Cts, and serology may help prioritize patients in need of isolation and contact investigations.

Funding: No

Disclosures: None