Community advisory boards (CABs) are a valuable strategy for engaging and partnering with communities in research. Eighty-nine percent of Clinical and Translational Science Awardees (CTSA) responding to a 2011 survey reported having a CAB. CTSAs’ experiences with CABs are valuable for informing future practice. This study was conducted to describe common CAB implementation practices among CTSAs; document perceived benefits, challenges, and contributions; and examine their progress toward desirable outcomes. A cross-CTSA collaborative team collected survey data from respondents representing academic and/or community members affiliated with CTSAs with CABs. Data representing 44 CTSAs with CABs were analyzed using descriptive statistics. A majority of respondents reported practices reflecting respect for CAB members’ expertise and input such as compensation (75%), advisory purview beyond their CTSA’s Community Engagement program (88%), and influence over CAB operations. Three-quarters provide members with orientation and training on roles and responsibilities and 89% reported evaluating their CAB. Almost all respondents indicated their CTSA incorporates the feedback of their CABs to some degree; over half do so a lot or completely. This study profiles practices that inform CTSAs implementing a CAB and provide an evaluative benchmark for those with existing CABs.

LGBTQIA2+ patients often experience discrimination and hostility in healthcare spaces. Negative perceptions of healthcare can contribute to poor health outcomes in LGBTQIA2+ patients. This population is rarely included in clinical trials through a lack of inclusion in study protocols, informed consent, and trials not addressing their needs and demographics. Many clinical institutions have created LGBTQIA2+-specific clinics; however, few have successfully developed a free clinic dedicated to this population. A Rainbow Clinic was formed at an established student-run free clinic, utilizing the existing infrastructure. Dissemination of this clinic’s creation can help others replicate similar initiatives.

Explorations of workflow development within primary care allow us to understand initial steps in the pace of knowledge and practice acclimatization within clinics. This study describes use of practice facilitation as an implementation strategy to communicate shared project goals and monitor and support refinement of practice behavior. This study engaged eight health care organizations, including 55 primary care practices, ≈380 clinicians, and ≈620 nursing and support staff in a guideline implementation project regarding United States Preventive Services Task Force use of aspirin recommendations for primary prevention of cardiovascular events.

REAP-2 is an interactive dose-response curve estimation tool for Robust and Efficient Assessment of drug Potency. It provides user-friendly dose-response curve estimation for in vitro studies and conducts statistical testing for model comparisons with a redesigned user interface. We also make a major update of the underlying estimation method with penalized beta regression, which demonstrates great reliability and accuracy in dose estimation and uncertainty quantification. In this note, we describe the method and implementation of REAP-2 with a highlight on potency estimation and drug comparison.

Despite the availability of vaccinations, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to cause Coronavirus Disease 2019 (COVID-19) infection with a spectrum of disease in the acute setting. Transmission, infection, and severe disease remain common. There is a critical need to establish treatment regimens in the ambulatory setting that can reduce symptom burden and potentially prevent progression to severe disease and death. Many existing medicines previously approved for other uses may have benefit but remain unproven in informative clinical trials.

Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-6 is a decentralized, placebo-controlled, double-blind, randomized, platform trial that has now enrolled more than 7500 participants and has reported on the effectiveness of ivermectin at two doses, fluticasone, and fluvoxamine for helping people with COVID-19. With additional repurposed therapies added to the platform, ACTIV-6 continues to enroll symptomatic outpatients aged ≥ 30 years with a confirmed positive PCR or antigen test for SARS-CoV-2. Potential participants are screened and enrolled online, through a call center, or facilitated by local study sites. Participants consent electronically and are randomized to placebo or to one of the open study drugs for which they are eligible at the time of enrollment. A shared, contemporary placebo approach is used. Participants receive study drug in the mail and remain on study for up to 180 days. While enrolled, electronic patient-reported outcome assessments are used to monitor symptoms, healthcare utilization, and mortality. The primary endpoint is time to recovery or a composite of hospitalization and mortality within 28 days. Symptoms, acute healthcare utilization, and the Patient-Reported Outcomes Measurement Information System-29 are collected for up to 180 days.

Using a decentralized trial approach allowed the ACTIV-6 platform to increase both reach and rate of enrollment. The decentralized approach did not simplify regulatory oversight, and we found unanticipated challenges in patient behavior and the study drug delivery process. Despite challenges, ACTIV-6 has enrolled thousands of participants from across the USA and continues to test the effectiveness of repurposed medicines for treating COVID-19. Our lessons learned contribute to the emerging understanding of how to optimize decentralized trials.

Clinical research studies run the risk of being in a deficit leading to premature study termination or a desperate struggle to find new funding to continue the research. It is important for institutions, small or large, to have financial oversight during the research process. We created a financial audit process for a core clinical research department at a pediatric hospital. Understanding where to find your costs, what costs are important, and other elements of the audit process are essential. Knowing how to replicate a financial audit process can help you eliminate the risk of a financial deficit.

Although highly involved in heart failure (HF) patients’ care, home care workers (HCWs) lack HF training and are poorly integrated into the healthcare team. For its potential to address these challenges, we examined the role of technology among HCWs caring for HF patients. We conducted 38 interviews with key stakeholders. Overall, four themes emerged. Participants reported that technology is critical for HF care, but existing systems are outdated and ineffective. HCWs also have limited access to electronic resources. Technology, training, and principles of implementation science can be leveraged to improve HCWs’ experience in caring for HF patients and home healthcare delivery.

The ACT Network was funded by NIH to provide investigators from across the Clinical and Translational Science Award (CTSA) Consortium the ability to directly query national federated electronic health record (EHR) data for cohort discovery and feasibility assessment of multi-site studies. NIH refunded the program for expanded research application to become “Evolve to Next-Gen ACT” (ENACT). In parallel, the US Food and Drug Administration has been evaluating the use of real-world data (RWD), including EHR data, as sources of real-world evidence (RWE) for its regulatory decisions involving drug and biological products. Using insights from implementation science, six lessons learned from ACT for developing and sustaining RWD/RWE infrastructures and networks across the CTSA Consortium are presented in order to inform ENACT’s development from the outset. Lessons include intentional institutional relationship management, end-user engagement, beta-testing, and customer-driven adaptation. The ENACT team is also conducting customer discovery interviews with CTSA hub and investigators using Innovation-Corps@NCATS (I-Corps™) methodology for biomedical entrepreneurs to uncover unmet RWD needs. Possible ENACT value proposition hypotheses are presented by stage of research. Developing evidence about methods for sustaining academically derived data infrastructures and support can advance the science of translation and support our nation’s RWD/RWE research capacity.

The obesity epidemic has continued to rise at an alarming rate and has increased health complications in children, adolescents, and adults. Resistance training, aerobic training, and a combination of the two have been shown to be effective at reducing excess adiposity and improving outcomes of obesity. The continued development of programs, community centers, or medical exercise facilities prescribing these treatments is nearing an absolute necessity to slow the advancing nature of obesity and related metabolic diseases. In this brief review, we summarize the effectiveness of these three training paradigms from a population-centric perspective.

SPARCRequest© (Services, Pricing, & Application for Research Centers) is a web-based research management system that provides a modular and adaptable “electronic storefront” for research-related services. Developed by the South Carolina Clinical & Translational Research Institute at the Medical University of South Carolina, it was released as open source (OS) code in 2014. The adoption of SPARCRequest© accelerated in 2016, when, to ensure responsiveness to the needs of partners, its governance also became open. This governance model enables OS partners to suggest and prioritize features for new releases. As a result, the software code has become more modularized and can be easily customized to meet the diverse needs of adopting hubs. This article describes innovative aspects of the OS governance model, including a multi-institutional committee structure to set strategic vision, make operational decisions, and develop technical solutions; a virtual roadmap that ensures transparency and aligns adopters with release-based goals; and a business process model that provides a robust voting mechanism for prioritizing new features while also enabling fast-paced bug fixes. OS software evolves best in open governance environments. OS governance has made SPARCRequest© more responsive to user needs, attracted more adopters, and increased the proportion of code contributed by adopters.

Well-being is a multifaceted construct that is used across disciplines to portray a state of wellness, health, and happiness. While aspects of well-being seem universal, how it is depicted in the literature has substantial variation. The aim of this scoping review was to identify conceptual and operational definitions of well-being within the field of occupational health. Broad search terms were used related to well-being and scale/assessment. Inclusion criteria were (1) peer-reviewed articles, (2) published in English, (3) included a measure of well-being in the methods and results section of the article, and (4) empirical paper. The searches resulted in 4394 articles, 3733 articles were excluded by reading the abstract, 661 articles received a full review, and 273 articles were excluded after a full review, leaving 388 articles that met our inclusion criteria and were used to extract well-being assessment information. Many studies did not define well-being or link their conceptual definition to the operational assessment tool being used. There were 158 assessments of well-being represented across studies. Results highlight the lack of a consistent definitions of well-being and standardized measurements.

The National Institutes of Health requires data and safety monitoring boards (DSMBs) for all phase III clinical trials. The National Heart, Lung and Blood Institute requires DSMBs for all clinical trials involving more than one site and those involving cooperative agreements and contracts. These policies have resulted in the establishment of DSMBs for many implementation trials, with little consideration regarding the appropriateness of DSMBs and/or key adaptations needed by DSMBs to monitor data quality and participant safety. In this perspective, we review the unique features of implementation trials and reflect on key questions regarding the justification for DSMBs and their potential role and monitoring targets within implementation trials.