Journal of Clinical and Translational Science最新文献

{"title":"Unveiling readability challenges: An extensive analysis of consent document accessibility in clinical trials.","authors":"Adrian H Zai, Jamie M Faro, Jeroan Allison","doi":"10.1017/cts.2024.595","DOIUrl":"https://doi.org/10.1017/cts.2024.595","url":null,"abstract":"<p><strong>Background: </strong>Clinical research trials rely on informed consent forms (ICFs) to explain all aspects of the study to potential participants. Despite efforts to ensure the readability of ICFs, concerns about their complexity and participant understanding persist. There is a noted gap between Institutional Review Board (IRB) standards and the actual readability levels of ICFs, which often exceed the recommended 8th-grade reading level. This study evaluates the readability of over five thousand ICFs from ClinicalTrials.gov in the USA to assess their literacy levels.</p><p><strong>Methods: </strong>We analyzed 5,239 US-based ICFs from ClinicalTrials.gov using readability metrics such as the Flesch Reading Ease, Flesch-Kincaid Grade Level, Gunning Fog Index, and the percentage of difficult words. We examined trends in readability levels across studies initiated from 2005 to 2024.</p><p><strong>Results: </strong>Most ICFs exceeded the recommended 8th-grade reading level, with an average Flesch-Kincaid Grade Level of 10.99. While 91% of the ICFs were written above the 8th-grade level, there was an observable improvement in readability, with fewer studies exceeding a 10th-grade reading level in recent years.</p><p><strong>Conclusions: </strong>The study reveals a discrepancy between the recommended readability levels and actual ICFs, highlighting a need for simplification. Despite a trend toward improvement in more recent years, ongoing efforts are necessary to ensure ICFs are comprehensible to participants of varied educational backgrounds, reinforcing the ethical integrity of the consent process.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e125"},"PeriodicalIF":2.1,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11428065/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142347682","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacotherapy guideline concordance for major depressive disorder and its link to functioning via symptom change.","authors":"Mason T Breitzig, Fan He, Lan Kong, Guodong Liu, Daniel A Waschbusch, Jeff D Yanosky, Duanping Liao, Erika F H Saunders","doi":"10.1017/cts.2024.562","DOIUrl":"https://doi.org/10.1017/cts.2024.562","url":null,"abstract":"<p><strong>Introduction: </strong>Alleviation of symptom severity for major depressive disorder (MDD) is known to be associated with a lagged improvement of functioning. Pharmacotherapy guidelines support algorithms for MDD treatment. However, it is currently unclear whether concordance with guidelines influences functional recovery. A guideline concordance algorithm (GCA-8) was used to measure this pathway in a naturalistic clinical setting.</p><p><strong>Methods: </strong>Data from 1403 adults (67% female, 84% non-Hispanic/Latino White, mean age of 43 years) with nonpsychotic MDD from the Penn State Psychiatry Clinical Assessment and Rating Evaluation System registry (visits from 02/01/2015 to 04/13/2021) were evaluated. Multivariable linear regression measured associations between GCA-8 and World Health Organization Disability Assessment Schedule 2.0 (WHODAS) scores. Mediation by MDD symptom severity using the Patient Health Questionnaire depression module (PHQ-9) was also evaluated.</p><p><strong>Results: </strong>This study found a statistically significant improvement in WHODAS scores (functioning) between baseline and final measures (-2 points, <i>P</i> < .001) within one year. A one standard deviation increase in the GCA-8 score was associated with a 0.48-point reduction in mean disability score (total effect; <i>P</i> = .02) with significant mediation by the change in MDD symptom severity (coefficient = -0.51, <i>P</i> < .001) and a nonsignificant natural direct effect of the GCA-8 independent of PHQ-9 change (coefficient = -0.02, <i>P</i> = .92).</p><p><strong>Conclusions: </strong>Higher pharmacotherapy guideline concordance is associated with better functioning for MDD patients; this association likely occurs through improvement in MDD symptom severity rather than directly.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e123"},"PeriodicalIF":2.1,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11428114/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142347678","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"SEED: A novel web-based data visualization platform to visualize, communicate, and explore social, environmental, and equity drivers of health.","authors":"Nrupen A Bhavsar, Jessica Sperling, Raquel Ruiz, Dinushika Mohottige, Perusi Muhigaba, Mina Silberberg, Anthony Leiro, Pamela Maxson, Michelle Lyn, L Ebony Boulware","doi":"10.1017/cts.2024.569","DOIUrl":"https://doi.org/10.1017/cts.2024.569","url":null,"abstract":"<p><p>Multisector stakeholders, including, community-based organizations, health systems, researchers, policymakers, and commerce, increasingly seek to address health inequities that persist due to structural racism. They require accessible tools to visualize and quantify the prevalence of social drivers of health (SDOH) and correlate them with health to facilitate dialog and action. We developed and deployed a web-based data visualization platform to make health and SDOH data available to the community. We conducted interviews and focus groups among end users of the platform to establish needs and desired platform functionality. The platform displays curated SDOH and de-identified and aggregated local electronic health record data. The resulting Social, Environmental, and Equity Drivers (SEED) Health Atlas integrates SDOH data across multiple constructs, including socioeconomic status, environmental pollution, and built environment. Aggregated health prevalence data on multiple conditions can be visualized in interactive maps. Data can be visualized and downloaded without coding knowledge. Visualizations facilitate an understanding of community health priorities and local health inequities. SEED could facilitate future discussions on improving community health and health equity. SEED provides a promising tool that members of the community and researchers may use in their efforts to improve health equity.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e121"},"PeriodicalIF":2.1,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11428061/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142347680","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Factors associated with clinician willingness to adopt HPV self-sampling and self-testing for cervical cancer screening.","authors":"Luke Brennan, Tiwaladeoluwa Adekunle, Monica Kasting, Michele R Forman, Victoria Champion, Natalia M Rodriguez","doi":"10.1017/cts.2024.604","DOIUrl":"10.1017/cts.2024.604","url":null,"abstract":"<p><strong>Background: </strong>Cervical cancer screening rates in the USA fall behind national targets, requiring innovation to circumvent screening barriers. Cervical cancer screening where human papillomavirus (HPV) testing is performed on vaginal samples collected by the patients themselves (self-sampling) are effective and acceptable, and patient-operated rapid HPV tests (self-testing) are currently under development. It is unclear why there is ambivalence toward HPV self-sampling and self-testing among clinicians, an important stakeholder group. We conducted a mixed convergent quantitative and qualitative study to identify the factors influencing clinicians' attitudes toward self-sampling and self-testing.</p><p><strong>Methods: </strong>A survey of Midwest clinicians distributed by professional group media and a market research firm between May and November 2021 was analyzed (<i>n</i> = 248) alongside in-depth interviews with Midwest clinicians from professional groups (<i>n</i> = 23). Logistic regression models examined willingness to support self-sampling and self-testing across respondent characteristics.</p><p><strong>Results: </strong>We report that family practice physicians and those in rural areas were more willing to adopt HPV self-sampling (adjusted OR (aOR) = 3.16 [1.43-6.99]; aOR = 2.17 [1.01-4.68]). Clinician willingness to support self-testing was positively associated with current use of self-testing for other conditions and negatively associated with performing 10 or more monthly cervical cancer screenings (aOR = 2.02 [1.03-3.95], aOR = 0.42 [0.23-0.78]). Qualitative data contextualize how clinical specialty and experience with self-sampling and self-testing for other conditions inform clinician perspectives.</p><p><strong>Conclusion: </strong>These data suggest clinician populations most accepting of initiatives to implement self-sampling and self-testing for cervical cancer screening and highlight that experience with other forms of self-testing could facilitate more widespread adoption for cervical cancer.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e118"},"PeriodicalIF":2.1,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11428071/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142347673","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Supporting students from underrepresented minority backgrounds in graduate school: A mixed-methods formative study to inform post-baccalaureate design.","authors":"Jessica B Sperling, Noelle E Wyman Roth, Whitney E Welsh, Allison T McElvaine, Sallie R Permar, Rasheed A Gbadegesin","doi":"10.1017/cts.2024.590","DOIUrl":"https://doi.org/10.1017/cts.2024.590","url":null,"abstract":"<p><p>The US biomedical research workforce suffers from systemic barriers causing insufficient diversity and perpetuating inequity. To inform programming enhancing graduate program access, we implemented a formative mixed-method study to identify needed supports for program applications and graduate program success. Overall, results indicate value in added supports for understanding application needs, network development, critical thinking, time management, and reading academic/scientific literature. We find selected differences for underrepresented minority (URM) students compared to others, including in the value of psychosocial supports. This work can inform broader efforts to enhance graduate school access and provides foundation for further understanding of URM students' experiences.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e124"},"PeriodicalIF":2.1,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11428063/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142347681","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Developing decision support tools for high-risk women and healthcare providers to increase chemoprevention informed choice and uptake: A retrospective translational science case study","authors":"Leah G. Pope, Zainab Abedin, Katherine D. Crew, Rita Kukafka, Harold Alan Pincus","doi":"10.1017/cts.2024.565","DOIUrl":"https://doi.org/10.1017/cts.2024.565","url":null,"abstract":"Retrospective case studies are one approach to help identify processes underlying the translation of successful health interventions. This case study investigates the development of <jats:italic>RealRisks</jats:italic> and <jats:italic>Breast Cancer Risk Navigation</jats:italic> (<jats:italic>BNAV</jats:italic>), decision support tools for breast cancer risk assessment, and risk-stratified prevention. Following a recently developed protocol for retrospective translational science case studies, we examined the career trajectory of Dr Katherine Crew as she expanded from basic science to interdisciplinary, patient-oriented research in oncology and began collaboration with Dr Rita Kukafka, a public health informatician focused on communicating risk. Data collection methods included key informant interviews and examination of peer-reviewed publications, funded grants, and news articles associated with the research. Data were analyzed to identify key milestones in the development of <jats:italic>RealRisks</jats:italic> and <jats:italic>BNAV</jats:italic> and to elucidate facilitators and barriers to the translational process. Facilitators to translation included funding and infrastructure provided by a Clinical and Translational Science Award (CTSA), the creation of an interdisciplinary team, and broad support from stakeholders including patient advocacy groups. Barriers to translation included limited mid-career support, ongoing costs for technology, and the time required to establish interdisciplinary, team science efforts. The findings reported here can be used to inform ongoing efforts to develop a more robust science of translation.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"62 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142183235","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The adolescent health network: A unique approach to sustained adolescent stakeholder engagement","authors":"Deepa L. Sekhar, Alicia M. Hoke, Marwa Khan, Patricia L. Gordon, Erin K. Conahan, Jennifer L. Kraschnewski","doi":"10.1017/cts.2024.567","DOIUrl":"https://doi.org/10.1017/cts.2024.567","url":null,"abstract":"At least 70% of premature adult deaths result from behaviors starting and reinforced in adolescence. The use of adolescent-centered outcomes and the necessity of creating space for the adolescent voice regarding research that directly impacts them is often overlooked. These omissions result in proposals and solutions that lack consideration of adolescent ingenuity, preferences, and needs. In 2021, Penn State PRO Wellness was awarded a Patient-Centered Outcomes Research Institute Engagement Award with the goal of addressing the gap in the inclusion of adolescents in research focused on teenage health. The resultant Adolescent Health Network (AHN) was developed in partnership with a stakeholder advisory board comprised of adolescents, parents, health researchers, and school staff. The AHN currently consists of 12 schools and 43 adolescents who have completed stakeholder training. For adolescents, the AHN simulates a school club or career enrichment activity with incoming freshmen replacing graduating seniors over time. For health researchers, the AHN provides rapid, easy access to a pool of adolescents with stakeholder training who are available to provide input on various aspects of a study from recruitment plans, to survey tools to dissemination strategies. This manuscript details the development, execution, and data from this novel program.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"3 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142183234","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of TRACER: A Translational Research Accomplishments Cataloguer for Clinical and Translational Science Award hub activity tracking, evaluation, and decision-making","authors":"Jessica Sperling, Stella Quenstedt, Anthony Leiro, Perusi B. Muhigaba, F. Joseph McClernon","doi":"10.1017/cts.2024.545","DOIUrl":"https://doi.org/10.1017/cts.2024.545","url":null,"abstract":"Organizations supporting translational research and translational science, including Clinical and Translational Science Award (CTSA) hubs, provide a diverse and often changing array of resources, support, and services to a myriad of researchers and research efforts. While a wide-ranging scope of programs is essential to the advancement of translational research and science, it also complicates a systematic and unified process for tracking activities, studying research processes, and examining impact. To overcome these challenges, the Duke University School of Medicine’s CTSA hub created a data platform, Translational Research Accomplishment Cataloguer (TRACER), that provides capacity to enhance strategic decision-making, impact assessment, and equitable resource distribution. This article reviews TRACER development processes, provides an overview of the TRACER platform, addresses challenges in the development process, and describes avenues for addressing or overcoming these challenges. TRACER development allowed our hub to conceptually identify key processes and goals within programs and linkages between programs, and it sets the stage for advancing evidence-based improvement across our hub. This platform development provides key insight into facilitators that can inform other initiatives seeking to collect and align organizational data for strategic decision-making and impact assessment. TRACER or similar platforms are additionally well positioned to advance the study of translational science.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"62 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142183284","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Connecting with the community: Perceptions of a community tour","authors":"Christopher Jones, Kandice Reilly, Brian Peacock, Nancy Denizard-Thompson, Alicia Walters-Stewart, Leslie Doroski McDowell, Jessica Valente, Aylin A. Aguilar, Michael Lischke, Kimberly Montez","doi":"10.1017/cts.2024.588","DOIUrl":"https://doi.org/10.1017/cts.2024.588","url":null,"abstract":"Introduction: This study explores the transformative effects of the Community Plunge, an educational program at the Wake Forest University School of Medicine (WFUSOM), on healthcare delivery, community engagement, and trainee perspectives. It addresses the broader context of health outcomes, where clinical care only accounts for 20%, emphasizing the critical role of social determinants of health (SDOH) and individual behaviors in the remaining 80%. Methods: WFUSOM’s Community Plunge, established in 2002, involves a guided tour of the community, discussions with residents, and debriefing sessions. Qualitative interviews with 20 clinicians were conducted to extract key themes and insights. Results: The study identified several key outcomes. First, participants gained crucial insights into the community’s history, structural challenges, and prevalent SDOH, enhancing their understanding of the diverse patient populations they serve. Second, the program positively influenced clinician attitudes, fostering empathy, reducing paternalism, and promoting holistic patient care. Third, participants expressed a desire for increased community involvement and reported career trajectory changes toward advocacy and volunteerism. However, challenges such as time constraints were acknowledged. Conclusions: The study advocates for collaborative efforts to enhance the program’s impact, including proactive measures to ensure respectful engagement during community tours. It positions the Community Plunge as an innovative, scalable, and transformative strategy for experiential SDOH exposure, crucial for the evolving social consciousness of healthcare learners.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"17 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142183236","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The role of the adenylate kinase 5 gene in various diseases and cancer","authors":"M. Sarim Siddiqui, Mehdi H. Shahi, Javier S. Castresana","doi":"10.1017/cts.2024.536","DOIUrl":"https://doi.org/10.1017/cts.2024.536","url":null,"abstract":"Adenylate kinases (AKs) are important enzymes involved in cellular energy metabolism. Among AKs, AK5 (adenylate kinase 5), a cytosolic protein, is emerging as a significant contributor to various diseases and cellular processes. This comprehensive review integrates findings from various research groups on AK5 since its discovery, shedding light on its multifaceted roles in nucleotide metabolism, energy regulation, and cellular differentiation. We investigate its implications in a spectrum of diseases, including autoimmune encephalitis, epilepsy, neurodegenerative disorders such as Alzheimer’s and Parkinson’s, diabetes, lower extremity arterial disease, celiac disease, and various cancers. Notably, AK5’s expression levels and methylation status have been associated with cancer progression and patient outcomes, indicating its potential as a prognostic indicator. Furthermore, AK5 is implicated in regulating cellular processes in breast cancer, gastric cancer, colorectal carcinoma, prostate cancer, and colon adenocarcinoma, suggesting its relevance across different cancer types. However, a limitation lies in the need for more robust clinical validation and a deeper understanding of AK5’s precise mechanisms in disease pathogenesis, despite its association with various pathophysiological conditions. Nonetheless, AK5 holds promise as a therapeutic target, with emerging evidence suggesting its potential in therapy development.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"30 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142183146","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}