Journal of Clinical and Translational Science最新文献

Introduction: The 2018 Common Rule revision intended to improve informed consent by recommending a concise key information (KI) section, yet provided little guidance about how to describe KI. We developed innovative, visual KI templates with attention to health literacy and visual design principles. We explored end users' attitudes, beliefs, and institutional policies that could affect implementing visual KI pages.

Materials and methods: From October 2023 to April 2024, we conducted semi-structured interviews with principal investigators, research staff, and Institutional Review Board (IRB) personnel, including those in oversight/management, and community partners. Forty participants from three academic institutions (in the Midwest, Southeast, and Mountain West) viewed example KI pages and completed interviews. We coded written transcripts inductively and deductively based on the capability, opportunity, and motivation to change behavior (COM-B) framework. Data were analyzed using content analysis and organized thematically.

Results: Participants responded positively to the visual KI examples. They discussed potential benefits, including improving information processing and understanding of study procedures, diversity in research, trust in research, and study workflow. They also described potential challenges to consider before widespread implementation: IRBs' interpretations of federal guidelines, possible impacts on IRB submission processes, the effort/skill required to develop visuals, and difficulty succinctly communicating study risks. There was no consensus about when to use visual KI during consent, and some wondered if they were feasible for all study types.

Discussion: Visual KI offers a promising solution to long-standing informed consent challenges. Future work can explore resources and training to address challenges and promote widespread use.

Recruiting and retaining research participants is challenging because it often requires overcoming structural barriers and addressing how histories of mistrust and individuals' lived experiences affect their research engagement. We describe a pilot workshop designed to educate clinical research professionals on using empathy skills to recognize and mitigate bias to improve recruitment and retention. In a post-workshop survey (22/31 participants completed), 94% agreed the workshop helped them practice perspective-taking, recognize implicit bias, and identify opportunities for empathy. Participants reported increased confidence in key recruitment and retention skills (p < 0.05). Future studies will evaluate whether this translates into improved recruitment.

As funding for large translational research consortia increases across the National Institutes of Health (NIH), focused working groups provide an opportunity to leverage the power of unique networks to conduct high-impact science and offer a strategy for building collaborative infrastructure to sustain networks long-term. This sustainment leverages the existing NIH investments, amplifying the impact and creating conditions for future innovative translational research. However, few resources exist that detail practical strategies for establishing and sustaining working groups in consortia. Here, we describe how the Coordinating Center for the National Cancer Institute-funded Cancer Center Cessation Initiative (C3I) utilized principles derived from the Science of Team Science to develop replicable strategies for building and sustaining an effective working group-led consortium. These strategies include continually engaging community members in strategic planning, prioritizing diversity in leadership and membership, creating multi-level opportunities for leadership and participation, providing intensive community management and facilitation, and incentivizing projects that support the consortium sustainment. When assessing the impact of these interventions through qualitative exit interviews, four key themes emerged: through the C3I working group consortium, members co-created new dissemination products, gained new insights and innovations, enhanced local program implementation, and invested in cross-network collaboration to support sustained engagement in the initiative.

Introduction: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Background: All IN for Health is a well-established community-academic partnership dedicated to helping improve the lives of Indiana residents by increasing health research literacy and promoting health resources, as well as opportunities to participate in research. It is sponsored by the Indiana Clinical and Translational Science Institute (I-CTSI). The study's purpose was to measure trust in biomedical research and healthcare organizations among research volunteers.

Methods: The Relationship of Trust and Research Engagement (RTRE) survey was developed utilizing 3 validated scales. The RTRE consisted of 36 items in a 5-point Likert scale with three open-text questions. We conducted 3 focus groups with a total of 24 individuals ahead of the survey's launch. Recruitment was done through the All IN for Health newsletter. The survey was administered in the summer of 2022.

Results: Six hundred and sixty-three individuals participated in the survey. Forty-one percent agreed that doctors do medical research for selfish reasons. Moreover, 50% disagree that patients get the same medical treatment regardless of race/ethnicity. Sixty-seven percent think it is safe to participate in medical research, yet 79% had never been asked to participate. Ten percent believe that researchers select minorities for their most dangerous studies and expose minoritized groups to diseases.

Conclusion: The utilization of tools to measure trust will facilitate participant recruitment and will assist institutions and investigators alike in accountability. It is imperative, we work toward understanding our communities' trust in medical research, assessing our own trustworthiness, and critically reflect on the authenticity of our efforts.

[This corrects the article DOI: 10.1017/cts.2023.571.].

Introduction: The avoidance of asthma triggers, like tobacco smoke, facilitates asthma management. Reliance upon caregiver report of their child's environmental tobacco smoke (ETS) exposure may result in information bias and impaired asthma management. This analysis aimed to characterize the chronicity of ETS exposure, assess the validity of caregiver report of ETS exposure, and investigate the relationship between ETS exposure and asthma attack.

Methods: A secondary data analysis was performed on data from a longitudinal study of 162 children aged 7-12 years with asthma living in federally subsidized housing in three US cities (Boston, Cincinnati, and New Orleans). Data were collected at three time points over 1 year.

Results: Over 90% of children were exposed to ETS (≥0.25 ng/ml of urine cotinine (UC)). Exposure was consistent over 1 year. Questionnaire data had a sensitivity of 28-34% using UC ≥0.25 ng/ml as the gold standard. High ETS exposure (UC ≥ 30 ng/ml) was significantly associated with asthma attack (aOR 2.97, 0.93-9.52, p = 0.07). Lower levels (UC 0.25-30 ng/ml) were not statistically significant (aOR 1.76, 0.71- 4.38, p = 0.22). No association was found using caregiver-reported ETS exposure.

Conclusion: Relying on questionnaire data to assess children's exposure to tobacco smoke may lead to substantial information bias. For children with asthma, incorrect characterization may substantially impact asthma morbidity.

Objective/goals: Cognitive decline is intricately linked to various factors such as obesity, stress, poor sleep, and circadian rhythm misalignment, which are interrelated in their impact on cognitive health. Irregular food-intake timing further compounds these issues. The practice of prolonged nightly fasting (PNF) may help synchronize food intake with circadian rhythms, potentially mitigating adverse effects of cognitive decline and associated factors.

Methods: A pilot nationwide, remotely delivered, 2-arm randomized controlled trial was conducted to assess the 8-week outcomes of cognition, stress, and sleep, after a PNF intervention (14-hr nightly fast, 6 nights/week, no calories after 8 pm) compared to a health education (HED) control condition. Participants were living with memory decline, stress, and obesity and had weekly check-in calls to report fasting times (PNF) or content feedback (HED).

Results: Participants were enrolled from 37 states in the US; N = 58, 86% women, 71% white, 93% non-Latinx, mean (SD) age 50.1 (5.1) years and BMI 35.6 (3.6) kg/m². No group differences existed at baseline. Linear mixed-effects models were used to compare outcome change differences between groups. Compared to the HED control, the PNF intervention was associated with improved sleep quality (B = -2.52; SE = 0.90; 95% CI -4.30--0.74; p = 0.006). Perceived stress and everyday cognition significantly changed over time (p < 0.02), without significant difference by group.

Discussion: Changing food intake timing to exclude nighttime eating and promote a fasting period may help individuals living with obesity, memory decline, and stress to improve their sleep. Improved sleep quality may lead to additional health benefits.

Long-term health and developmental impact after in utero opioid and other substance exposures is unclear. There is an urgent need for well-designed, prospective, long-term observational studies. The HEALthy Brain and Child Development Study aims to address this need. It will require optimizing recruitment and retention of caregivers and young children in long-term research. Therefore, a scoping review of original research articles, indexed in the PubMed database and published in English between January 1, 2010, and November 23, 2023, was conducted on recruitment and retention strategies of caregiver-child (≤6 years old) dyads in observational, cohort studies. Among 2,902 titles/abstracts reviewed, 37 articles were found eligible. Of those, 29 (78%) addressed recruitment, and 18 (49%) addressed retention. Thirty-four (92%) articles focused on strategies for facilitating recruitment and/or retention, while 18 (49%) described potentially harmful approaches. Recruitment and retention facilitators included face-to-face and regular contact, establishing a relationship with study personnel, use of technology and social platforms, minimizing inconveniences, and promoting incentives. This review demonstrates that numerous factors can affect engagement of caregivers and their children in long-term cohort studies. Better understanding of these factors can inform researchers about optimal approaches to recruitment and retention of caregiver-child dyads in longitudinal research.