Journal of Clinical and Translational Science最新文献

Introduction: There is increasing pressure on the federal research budget and shifting public opinions about the value of the academic enterprise. We must develop and apply metrics that demonstrate the broad benefits of research for health and society. The Translational Science Benefits Model (TSBM) measures the impact of large-scale translational science initiatives, such as the National Cancer Institute's Cancer Moonshot. TSBM provides the scaffolding to illustrate how science has real-world health impacts. We propose an expansion of the TSBM to explicitly include implementation-focused outcomes.

Methods: TSBM includes four categories of benefits, including (1) clinical and medical, (2) community and public health, (3) economic, and (4) policy and legislative. Implementation science outcomes serve as a precursor to the model's established domains of impact and can help to sharpen focus on the translational steps needed to achieve a broad range of impacts. We provide several examples of studies that illustrate these implementation outcomes and other clinical and community benefits.

Conclusions: It is important to consider a broad range of scientific impacts and the conditions that are necessary to achieve them. The expansion of the TSBM to include implementation science outcomes may help to accelerate the cancer community's ability to achieve the goal of preventing 4 million cancer deaths by 2047.

[This corrects the article DOI: 10.1017/cts.2022.381.].

Background: Researchers and research organizations acknowledge the importance of paying research participants but often overlook the process of providing participant payments as a locus for improving equity and inclusion in clinical research. In this conceptual paper, we argue that participants' lived experiences and social context should be recognized and respected when developing these processes.

Methods: We consider how participant payment processes that require specific payment types, delay the timing of payment, or require sharing sensitive information may impose barriers to equitable research. Building on findings from empirical research of participants' perspectives on respect in research and a relational ethics framework of person-oriented research ethics, we explore how researchers and research organizations can better demonstrate respect through the research participation payment process.

Results: We propose five considerations for demonstrating respect when providing payment: (1) practice cultural humility, (2) be mindful of socioeconomic factors, (3) be flexible, (4) be transparent, and (5) maintain open communication. These considerations are intended to address the lack of existing ethical guidance around the process for participant payments and promote more inclusive clinical research. We provide a set of sample questions for research teams to consider how they could modify their payment processes to better demonstrate respect.

Conclusions: By better demonstrating respect for participants when providing payment, researchers can work toward ensuring that their research procedures are more inclusive, respond to the needs of diverse communities, and result in more equitable relationships with participants.

The Master of Science in Clinical Research Management program at Rutgers Biomedical Health Sciences underwent significant restructuring aligned with the Clinical and Translational Science Award funding parameters. This evolution necessitated formal evaluation through accreditation by the Commission on Accreditation of Allied Health Education Programs. The years-long accreditation process posed challenges, particularly regarding the collection of course learning outcomes data aligned with accreditation competency standards. The objective of this special communication is to report the rationale behind pursuing accreditation for clinical research degrees, the data collection challenges during the accreditation process, and a potential solution. In order to address existing university metric data gaps, Research Electronic Data Capture (REDCap) software was used to develop a data collection tool that streamlined the accreditation process and reduced the administrative burden. REDCap was effective in allowing faculty to self-report 3 years of course outcomes data for accreditation. There was an elevated level of user satisfaction compared to alternative data collection methods. A SWOT analysis identified the strengths and weaknesses of using REDCap, emphasizing strengths in functionality that include customizability, data validation, and compliance with regulatory standards. Overall, the advantages of leveraging REDCap for accreditation data collection, including customization, data security, and user-friendliness outweigh the key disadvantage of REDCap, which is its limited reporting capabilities.

Evaluation of benefits beyond quantitative academic outputs is essential in determining translational research value. We used the Translational Science Benefits Model (TSBM) to examine the impact of the QUARTET USA trial using 30 benefits across 4 domains: Clinical, Community, Economic, and Policy. We found that the QUARTET USA trial demonstrated impact in six areas within the Clinical, and Community domains and had potential impact in two additional areas within the Community and Economic domains. Use of the TSBM supports the value of the QUARTET USA trial, which can be used as a template for future cardiovascular trials.

Introduction: Operationalizing multi-site Community Engagement (CE) Studios to inform a research program is valuable for researchers. We describe the process and outcomes of hosting three CE Studios with Community Experts aged 65 years or older with chronic conditions and care partners of older adults. Experts gave feedback about processes for testing the feasibility, efficacy, effectiveness, and implementation of audio recording clinic visits and sharing recordings with patients who have multimorbidity and their care partners.

Methods: The CE Cores of the Clinical and Translational Science Awards Programs at three academic health science centers created a joint CE Studio guide. Studios were conducted iteratively by site. Following receipt of the final reports, responses were compared to find themes, similarities, and differences on four topics in addition to overall commentary: Recruitment and Retention, Study Protocol, Study Reminders and Frequency, and Recording Technology.

Results: Eighteen older adults and care partners in three states provided valuable feedback to inform multi-site trials. Feedback influenced multiple aspects of trials in process or subsequently funded. Experts provided critique on the wording of study invitations, information sheets, and reminders to engage in study procedures. Experts were concerned for participants being disappointed by randomization to a control arm and advised how investigators should prepare to address that.

Conclusions: Multi-site CE Studios should be consecutive, so each team can learn from the previous teams. Using the CES Toolkit ensures that final reports were easily comparable and utilized to develop a research program that now includes three federally funded clinical trials.

Introduction: Essential trace elements and micronutrients are critical in eliciting an effective immune response to combat sepsis, with selenium being particularly noteworthy. The objective of this investigation is to analyze and the levels of serum selenium in neonates within sepsis and control groups.

Methodology: In 2023, a case-control study was carried out involving 66 hospitalized infants - 33 diagnosed with sepsis forming the case group and 33 free from sepsis constituting the control group - along with their mothers, at Children's and Shariati Hospitals in Bandar Abbas. The serum selenium concentrations (expressed in micrograms per deciliter) were quantified utilizing atomic absorption spectrometry. Subsequently, the data were processed and analyzed using IBM SPSS statistical software, version 22.

Results: The average serum selenium level in neonates with sepsis (42.06 ± 20.40 µg/dL) was notably lower compared to the control group (55.61 ± 20.33 µg/dL), a difference that was statistically significant (p-value = 0.009). The levels of serum selenium were comparable between neonates and mothers across both study groups.

Conclusion: The findings of this research indicate that selenium levels in the sepsis group were reduced compared to the control group, despite similar selenium levels in the mothers and neonates in both groups, suggesting that sepsis could be associated with a decrease in selenium levels.

Efficient evidence generation to assess the clinical and economic impact of medical therapies is critical amid rising healthcare costs and aging populations. However, drug development and clinical trials remain far too expensive and inefficient for all stakeholders. On October 25-26, 2023, the Duke Clinical Research Institute brought together leaders from academia, industry, government agencies, patient advocacy, and nonprofit organizations to explore how different entities and influencers in drug development and healthcare can realign incentive structures to efficiently accelerate evidence generation that addresses the highest public health needs. Prominent themes surfaced, including competing research priorities and incentives, inadequate representation of patient population in clinical trials, opportunities to better leverage existing technology and infrastructure in trial design, and a need for heightened transparency and accountability in research practices. The group determined that together these elements contribute to an inefficient and costly clinical research enterprise, amplifying disparities in population health and sustaining gaps in evidence that impede advancements in equitable healthcare delivery and outcomes. The goal of addressing the identified challenges is to ultimately make clinical trials faster, more inclusive, and more efficient across diverse communities and settings.

Research studies involving human subjects require collection of and reporting on demographic data related to race and ethnicity. However, existing practices lack standardized guidelines, leading to misrepresentation and biased inferences and conclusions for underrepresented populations in research studies. For instance, sometimes there is a misconception that self-reported racial or ethnic identity may be treated as a biological variable with underlying genetic implications, overlooking its role as a social construct reflecting lived experiences of specific populations. In this manuscript, we use the We All Count data equity framework, which organizes data projects across seven stages: Funding, Motivation, Project Design, Data Collection, Analysis, Reporting, and Communication. Focusing on data collection and analysis, we use examples - both real and hypothetical - to review common practice and provide critiques and alternative recommendations. Through these examples and recommendations, we hope to provide the reader with some ideas and a starting point as they consider embedding a lens of justice, equity, diversity, and inclusivity from research conception to dissemination of findings.

Background: West Virginia is a rural state with high rates of type 2 diabetes (T2DM) and prediabetes. The Diabetes Prevention and Management (DPM) program was a health coach (HC)-led, 12-month community-based lifestyle intervention.

Objective: The study examined the impact of the DPM program on changes in glycosylated hemoglobin (A1C) and weight over twelve months among rural adults with diabetes and prediabetes. Program feasibility and acceptability were also explored.

Methods: An explanatory sequential quantitative and qualitative one-group study design was used to gain insight into the pre- and 12-month changes to health behavior and clinical outcomes. Trained HCs delivered the educational sessions and provided weekly health coaching feedback. Assessments included demographics, clinical, anthropometric, and qualitative focus groups. Participants included 94 obese adults with diabetes (63%) and prediabetes (37%). Twenty-two participated in three focus groups.

Results: Average attendance was 13.7 ± 6.1 out of 22 sessions. Mean weight loss was 4.4 ± 11.5 lbs at twelve months and clinical improvement in A1C (0.4%) was noted among T2DM adults. Program retention (82%) was higher among older participants and those with poor glycemic control. While all participants connected to a trained HC, only 72% had regular weekly health coaching. Participants reported overall acceptability and satisfaction with the program and limited barriers to program engagement.

Conclusion: Our findings suggest that it is feasible to implement an HC-led DPM program in rural communities and improve A1C in T2DM adults. Trained HCs have the potential to be integrated with healthcare teams in rural regions of the United States.