In order to fill this significant void, the Tufts Clinical and Translational Science Institute established a series of regular training sessions for clinical research coordinators and other research staff, focusing on the practical aspects of obtaining informed consent through role-playing scenarios with community members acting as simulated patients. We analyze the influence and range of these training sessions and delineate the consequences of utilizing community members as simulated patients. therapeutic mediations Community members embedded in the trainings facilitate clinical research coordinators' exposure to a broad spectrum of patient perspectives, a wide range of patient reactions, and the profound lived experience of the communities the research serves. The act of utilizing community members as trainers effectively dismantles traditional power dynamics, a demonstration of the organization's commitment to inclusivity and community engagement. Following these observations, we recommend augmenting informed consent training with simulated consent exercises, enabling interactions with community members providing real-time feedback to coordinators.
SARS-CoV-2 rapid antigen detection tests (Ag-RDTs) granted emergency use authorization often mandate assessment of their performance on asymptomatic individuals using a serial testing approach. A novel study protocol is presented, designed to create data of regulatory standards, evaluating the serial implementation of Ag-RDTs to identify the presence of SARS-CoV-2 among asymptomatic individuals.
Longitudinal performance of Ag-RDT was assessed by this prospective cohort study, utilizing a siteless, digital method. Participants from throughout the United States, who were at least two years old and did not report COVID-19 symptoms for the 14 days leading up to study enrollment, qualified to join this study. Between October 18, 2021, and February 15, 2022, a digital enrollment platform was used to include participants from across the mainland USA. Participants underwent Ag-RDT and molecular comparator testing every 48 hours, for a period of 15 days. Data on enrollment demographics, geographic distribution, and SARS-CoV-2 infection rates are presented.
A study encompassing 7361 participants saw 492 individuals test positive for SARS-CoV-2, including 154 who were initially asymptomatic and tested negative upon study entry. This result went beyond the anticipated enrollment of 60 positive participants. Enrolment of participants spanned 44 US states, and the spatial distribution of these individuals adapted to the evolving national COVID-19 situation.
The site-less digital methodology implemented in the Test Us At Home study facilitated a swift, efficient, and rigorous assessment of COVID-19 rapid diagnostics. This approach can be seamlessly adapted across other research fields to enhance study recruitment and participant accessibility.
In the Test Us At Home study, the digital, site-free methodology accelerated, streamlined, and rigorously evaluated rapid COVID-19 diagnostic testing. Its adaptable structure allows for integration into various research areas, enhancing study enrollment and broadening access.
To cultivate bidirectional communication and resource development for participant recruitment in the DNA integrity study, a partnership between the community advisory board (CAB) and the research community engagement team (CE Team) was forged. Involving a minoritized community, this partnership prioritized respect, accessibility, and broadened engagement.
Through an iterative design process, a ten-member CAB, separated into two groups based on meeting schedules, supplied insights and feedback to the CE Team in the development of recruitment and consent materials. One group reviewed and improved the materials, while the other group rigorously tested and further refined them. The CE Team's meticulous analysis of CAB meeting notes provided essential insights for refining materials and executing CAB-recommended actions.
In partnership, recruitment and consent materials were co-produced, leading to the enrollment of 191 individuals in the study. The CAB fostered and facilitated increased participation, encompassing community leaders. Community decision-makers received details regarding the DNA integrity study through this extensive engagement, along with solutions to their questions and worries concerning the research project. Liproxstatin-1 concentration The researchers' investigation of topics and interests connected to the current study and the community's concerns, was prompted by the reciprocal communication between the CAB and the CE Team.
Through the guidance of the CAB, the CE Team developed a more nuanced appreciation for the language of partnership and respect. This partnership's approach enabled wider community engagement and improved communication with those who might take part in the study.
The CAB's support enabled the CE Team to acquire a more nuanced understanding of the language of partnership and respect. This partnership, consequently, unlocked avenues for intensified community engagement and efficient communication with would-be study participants.
In 2017, the Michigan Institute for Clinical and Health Research (MICHR) and community partners in Flint, Michigan, initiated a research funding program, and undertook a comprehensive analysis of how the research partnerships that received funding functioned and interacted. Despite the existence of validated metrics for community-engaged research (CEnR) collaborations, the research team found that none were adequately applicable to the particular requirements of the CEnR work currently being conducted. MICHR faculty and staff, collaborating with community members and workers in Flint, used a community-based participatory research (CBPR) methodology to develop and implement a Flint-specific evaluation of active CEnR partnerships in 2019 and 2021.
Over a dozen partnerships, sponsored by MICHR, were given annual surveys. These assessments were made by community and academic associates to evaluate the evolving relationships and effects within their research teams.
Based on the outcomes, partners considered their partnerships to be engaging and significantly impactful on their projects. Many notable disparities in the perspectives of community and academic partners evolved over time; however, the most conspicuous difference concerned the financial administration of the partnerships.
This study investigates how financial management strategies of community-engaged health research partnerships in Flint, a locally relevant context, affect the scientific productivity and impact of these teams, with implications for CEnR at the national level. Evaluation strategies for clinical and translational research centers seeking to implement and assess their community-based participatory research (CBPR) practices are provided in this work.
This research investigates the financial management of community-engaged health research partnerships in Flint, with the aim of identifying their association with scientific productivity and impact, presenting implications for CEnR on a national scale. Clinical and translational research centers aiming to implement and measure their use of CBPR approaches can leverage the evaluation methods presented in this work.
While mentorship is essential for a successful career, underrepresented minority (URM) faculty are often underserved by mentoring opportunities. A study of the NHLBI-funded PRIDE-FTG program evaluated the effect of peer mentoring on career success outcomes for early-career URM faculty in functional and translational genomics of blood disorders. Evaluation of the peer mentoring program's efficacy employed the Mentoring Competency Assessment (MCA), a brief qualitative survey with open-ended questions, and a semi-structured exit interview. Baseline surveys (Time 1) were conducted, alongside surveys at six months and at the culmination of PRIDE-FTG participation (Time 2). The research produced the following results. From Time 1 to Time 2, the MCA self-assessment scores of mentees revealed a substantial increase (p < 0.001). This increase was particularly evident in their ability to communicate effectively (p < 0.0001), establish expectations (p < 0.005), evaluate understanding (p < 0.001), and handle diversity issues (p < 0.0002). Mentees' MCA ratings for peer mentors showed a statistically significant correlation with developmental promotion (p < 0.027). Data from the PRIDE-FTG program indicate a successful improvement in MCA competencies for URM junior faculty participants through peer mentoring, wherein mentors held higher faculty rankings compared to their mentees. To bolster early-career scholar development among underrepresented minority faculty, peer mentoring programs deserve consideration as a strategic imperative.
Clinical trials often feature diverse strategies for conducting interim analyses. Frequently, Data and Safety Monitoring Boards (DSMBs) leverage these resources to provide study teams with recommendations regarding recruitment targets for substantial, later-phase clinical trials. We, as collaborative biostatisticians, teaching and working in multiple research areas and spanning various trial phases, acknowledge the substantial disparity and ambiguity in the implementation of interim analyses within clinical trials. Subsequently, this paper aims to provide a broad overview and practical guidance for interim analyses, specifically tailored for those with no statistical background. We meticulously delineate the following interim analysis types: efficacy, futility, safety, and sample size re-estimation, offering justifications, illustrations, and consequences for each. While the methods for interim analysis might differ across studies, we consistently advocate for pre-specifying the interim analysis approach, to the maximum degree feasible, and prioritizing the protection against risk and the integrity of the trial. zoonotic infection Finally, we suggest that interim analyses function as valuable tools enabling the DSMB to make well-considered decisions, all within the context of the overarching study.