Journal of Clinical and Translational Science最新文献

Medication errors in clinical care and in clinical research are preventable situations requiring quality improvement approaches to mitigate negative safety trends. The "Rights of Medication Administration" framework has existed in hospital and clinic settings for decades to aid clinicians with ensuring medication administration safety for patients. These quality measures such as expanded rights of medication administration, bar coding, and "time outs" have been employed to improve clinical patient safety. In clinical trials, drug accountability standard operating procedures are established standards; however, policies for direct administration of the investigational medical product to the study participant in a trial are lacking. Current administration rights were examined through the lens of clinical research practices, regulations, and case studies leading to proposed revisions for local adaptation. The authors suggest a standard operating procedure for investigational product that includes a "time out" checklist to ensure improved quality study performance and safety for clinical trial participants. This new standard operating procedure considers evolved quality practices suggested in the new "Good Clinical Practice" guidelines, ICH E6 (R3). With safety and quality at the forefront, this newly proposed SOP has been developed for implementation at the local site. Future research is encouraged.

Objective: To provide insights into the motivations, challenges, and preferred methods of contact that influence the recruitment and retention of young adults (YAs) in health research.

Methods: We designed, collected, and analyzed two surveys targeting YAs aged 18-39 years through the Amazon MTurk platform, to assess factors influencing recruitment and retention in health studies. The recruitment survey (n = 477) examined initial engagement motivations, while the retention survey (n = 473) explored factors that sustain long-term participation. Descriptive analyses were stratified by age group and sex.

Results: The recruitment survey indicated that 88% of YAs were willing to participate in health studies, with a preference for online formats (78%). Social media, particularly Facebook (53%), was endorsed as the most common platform for discovering research opportunities. Monetary incentives were reported as the top motivator across all age groups, especially for those aged 35-39 years, with gift cards endorsed as the most appealing to participants aged 18-34. Retention survey results indicated that email (100%) was the most preferred method for maintaining engagement, followed by text messages (78.9%) and social media (62.2%). Text messages (65%), regular updates (56%) and sharing of study results (54%) were identified as key factors for maintaining participant engagement.

Conclusion: Our findings identify that YA participation is driven by a mix of altruistic motivations, such as contributing to the community and research, and personal motivations, including personal health benefits and financial incentives, emphasizing the need for strategies that address both aspects of recruitment and retention motivations.

Introduction: Research ethics consultation services (RECS) provide important ethical guidance to various entities, including investigators and Institutional Review Boards. Established in the late 1980s and influenced by funding requirements from the National Center for Advancing Translational Science, RECS have evolved to address ethical challenges in research. This study aimed to identify key barriers and facilitators affecting the success of RECS, particularly in light of changes in funding and institutional support.

Materials and methods: From a comprehensive list of 55 Clinical and Translational Science Award programs, 20 RECS were purposively sampled for in-depth interviews. Interviews focused on primary functions, accomplishments, barriers, and facilitators of the service. We performed an abductive analysis on transcribed data.

Results: Twenty-two research ethics consultants from 20 institutions participated. Respondents emphasized their services' goal of facilitating ethical research, though many faced barriers such as underutilization and lack of awareness among researchers. Facilitators included institutional support and funding. Support often was contingent on institutional leadership facilitating the service into the university's research enterprise. Participants reported accomplishments, including successful consultations and contributions to institutional policies.

Discussion: Our findings indicate that RECS play a crucial role in supporting ethical research practices, though their effectiveness is often contingent on institutional relationships and funding. Key recommendations include tracking consults, defining consultation outcomes, and fostering the development of new consultants to sustain the field of research ethics.

[This corrects the article DOI: 10.1017/cts.2025.10133.].

Introduction: Historically US-based academic organizations dedicated limited resources, including policies, personnel to ensuring compliance with clinical trials registration and results reporting requirements. A recent follow-up survey finds that 6-years after an initial survey, there is increased attention and dedication of resources to improve compliance rates for clinical trials registration and results reporting.

Methods: Internet-based online survey using Qualtrics between 20 April 2023 and 30 September 2023 distributed to Protocol Registration and Results Reporting (PRS) Administrators at US-based academic organizations with ClinicalTrials.gov organizational accounts. The survey focused on the 249 respondents of the original 2016-2017 survey published in 2018. The overall response rate was 162/249 (65.06%) with 100% participation from National Cancer Center (NCI) Designated Cancer Centers and hubs of the Clinical and Translational Science Awards (CTSA).

Results: Results indicated a marked increase of academic organizations with policies in place for registration (43 to 74%) and results reporting (35 to 68%). The median number of Full-time Equivalent (FTE) staff at responding academic organizations increased (from 0.08 to 0.5) with statistically significant difference between the number of organizational records and FTEs supporting registration and results reporting. Larger gains are seen with NCI-Designated Cancer Centers and/or CTSA hubs.

Conclusions: It appears academic organizations are more equipped to comply with requirements, and demonstrate a trend towards appropriate staffing. In the 6 years since the original survey, US-based academic organizations have significantly increased attention to compliance with clinical trials registration and results reporting requirements, indicated by an increase in institutional policies and dedicated personnel.

Clinical data science, like the broader discipline of all data science, has quickly grown from obscurity only a few decades ago to one of the fastest growing specialties in biomedical research today. Yet, the education and training of the workforce has not kept pace with the growth of the field, the complexity of science, or the needs of the profession. The purpose of this paper is to provide a template for an intensive short course on fundamentals of clinical data science that meets the needs of working professionals in academic, industry, and government research settings. Care will be taken to introduce students to essential roles, responsibilities, and practice patterns within the field, the foundational components from which they come, and many of the soft skills needed for professional practice and advancement in the field today. The course is designed as an evidence-based, immersive learning experience taught over a 5-day period on a university campus, taught using principles of best educational practice and multiple modalities, to assure optimal interaction and engagement throughout the week. This template may be reproduced by any institution interested in and capable of offering such a program.

ASReview is a software that can potentially reduce the workload of literature screening in systematic reviews by ranking the retrieved records. We assessed the tool's feasibility, advantages, and limitations, to populate a database of cancer immunotherapy trials. ASReview is easy to use, and it efficiently identified relevant records. It may save resources compared to traditional systematic reviews using two human reviewers. Predefined procedures are necessary to maintain a transparent and reproducible workflow. Limitations include that adding references to existing projects is difficult and that the algorithm learns from every decision, even when this may not be appropriate.

Cardiovascular disease (CVD) and dementia are leading causes of death in women, with dementia disproportionately affecting females. Both share risk factors such as type 2 and gestational diabetes. While diabetes and CVD risk factors are well studied, gaps remain in understanding dementia's lifespan influences, sex-specific effects, and social determinants. This report advocates a convergence science approach, integrating basic, behavioral, and implementation sciences, to address these gaps. We propose a novel framework to examine shared cardiometabolic risks across the lifespan, enabling targeted early interventions to reduce dementia burden and improve heart-brain health outcomes in women.

Background: The implementation of artificial intelligence (AI) tools into clinical spheres emphasizes the critical need for an AI-competent healthcare workforce that can interpret AI output and identify its limitations. Without comprehensive training, there is a risk of misapplication, mistrust, and underutilization. Workforce skill development events such as workshops and hackathons can increase AI competence and foster interdisciplinary collaboration to promote optimal patient care.

Methods: The University of Florida hosted the AI for Clinical Care (AICC) workshop in April 2024 to address the need for AI-competent healthcare professionals. The hybrid workshop featured a beginner and advanced track with interactive sessions, hands-on skill development, and networking opportunities led by experts. An anonymous, voluntary post-workshop survey asked participants to score their knowledge and skills before and after the AICC workshop. A second, follow-up survey was administered approximately nine months later.

Results: Ninety participants attended the AICC workshop, forty-one attendees completed the post-workshop survey, and six attendees completed the follow-up survey. Paired T-tests of the post-workshop survey revealed statistically significant (P < .001) increases in self-reported knowledge gain across all six beginner track learning objectives and significant (P < .05) increases across all five advanced track objectives. Feedback indicated participants appreciated the interactive format, although communication and networking needed improvement.

Conclusion: The AICC workshop successfully advanced AI literacy among biomedical professionals and promoted collaborative peer networks. Continued efforts are recommended to enhance participant engagement and ensure equitable access to AI education in clinical settings.