Journal of Clinical and Translational Science最新文献

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Community partner coauthorship for increased implementation science impact: Strengthening capacity and engagement. 社区合作伙伴共同参与,提高实施科学的影响力:加强能力和参与。
IF 2.1
Journal of Clinical and Translational Science Pub Date : 2024-09-20 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.574
Rebekka M Lee, Cristina Huebner Torres, James G Daly, Annette Thomas, Peggy A Hannon, Sonja Likumahuwa-Ackman, Karen M Emmons
{"title":"Community partner coauthorship for increased implementation science impact: Strengthening capacity and engagement.","authors":"Rebekka M Lee, Cristina Huebner Torres, James G Daly, Annette Thomas, Peggy A Hannon, Sonja Likumahuwa-Ackman, Karen M Emmons","doi":"10.1017/cts.2024.574","DOIUrl":"https://doi.org/10.1017/cts.2024.574","url":null,"abstract":"<p><p>Engaging diverse partners in each phase of the research process is the gold standard of community-engaged research and adds value to the impact of implementation science. However, partner engagement in dissemination, particularly meaningful involvement in developing peer-reviewed manuscripts, is lacking. The Implementation Science Centers in Cancer Control are using the Translational Science Benefits Model to demonstrate the impact of our work beyond traditional metrics, including building capacity and promoting community engagement. This paper presents a case example of one center that has developed a policy for including community partners as coauthors. Standard practices are used to foster clear communications and bidirectional collaboration. Of published papers focused on center infrastructure and implementation research pilots, 92% have community partner coauthors. This includes 21 individuals in roles ranging from physician assistant to medical director to quality manager. Through this intentional experience of co-creation, community partners have strengthened implementation science expertise. Community coauthors have also ensured that data interpretation and dissemination reflect real-world practice environments and offer sustainable strategies for rapid translation to practice improvements. Funders, academic journals, and researchers all have important roles to play in supporting community coauthors as critical thought partners who can help to narrow the gap between research and practice.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e129"},"PeriodicalIF":2.1,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11428058/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142347669","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}
引用次数: 0
Addressing social determinants of health in the field of ophthalmology: In response to: Identifying and addressing social determinants of health to improve patient-centered care - Kalsi N, Gordon D, Geske J. 在眼科领域解决健康的社会决定因素:回应:识别并解决健康的社会决定因素,改善以患者为中心的护理 - Kalsi N、Gordon D、Geske J。
IF 2.1
Journal of Clinical and Translational Science Pub Date : 2024-09-20 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.596
Imani Nwokeji, Chisom Madu, Jin Ming Lin
{"title":"Addressing social determinants of health in the field of ophthalmology: In response to: Identifying and addressing social determinants of health to improve patient-centered care - Kalsi N, Gordon D, Geske J.","authors":"Imani Nwokeji, Chisom Madu, Jin Ming Lin","doi":"10.1017/cts.2024.596","DOIUrl":"https://doi.org/10.1017/cts.2024.596","url":null,"abstract":"","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e130"},"PeriodicalIF":2.1,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11428056/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142347667","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}
引用次数: 0
Lifestyle intervention and support preferences to maximize health outcomes in adolescent bariatric surgery patients. 对青少年减肥手术患者进行生活方式干预和支持,最大限度地提高他们的健康水平。
IF 2.1
Journal of Clinical and Translational Science Pub Date : 2024-09-19 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.553
Marlyn A Allicock, Rashon King, Jackson Francis, M Sunil Mathew, Dhatri Polavarapu, Alicia Wheelington, Maral Misserian, Bethany R Cartwright, Adejumoke Adewunmi, Aparajita Chandrasekhar, Faisal G Qureshi, Sarah E Barlow, Sarah E Messiah
{"title":"Lifestyle intervention and support preferences to maximize health outcomes in adolescent bariatric surgery patients.","authors":"Marlyn A Allicock, Rashon King, Jackson Francis, M Sunil Mathew, Dhatri Polavarapu, Alicia Wheelington, Maral Misserian, Bethany R Cartwright, Adejumoke Adewunmi, Aparajita Chandrasekhar, Faisal G Qureshi, Sarah E Barlow, Sarah E Messiah","doi":"10.1017/cts.2024.553","DOIUrl":"10.1017/cts.2024.553","url":null,"abstract":"<p><strong>Introduction: </strong>Metabolic and bariatric surgery (MBS) is safe and efficacious for adolescents with severe obesity. Pairing MBS with behavioral lifestyle interventions may be effective for optimizing treatment outcomes. However, no standardized program exists. Adolescent perspectives are critical to understanding how to design interventions to enhance engagement, sustain motivation, and meet informational needs for pre- and post-MBS self-management behaviors. The aim of this study was to develop an MBS lifestyle support intervention built on evidence-based content with input from adolescents and their families.</p><p><strong>Methods: </strong>A mixed-methods design identified adolescent preferences for MBS lifestyle support. Data were collected from a racially and ethnically diverse sample of adolescents (<i>N</i> = 17, 76% females, 24% males 41.2% non-Hispanic Black, 41.2% Hispanic/Latino, 11.8% non-Hispanic White, 5.8% Other) and their mothers (<i>N</i> = 13, 38.4% Hispanic) recruited from an MBS clinic. Quantitative surveys and qualitative interviews assessed preferred types of pre-post MBS content, modality, frequency, and delivery platforms to inform the design of the intervention. Mixed methods data were triangulated to provide a comprehensive understanding of adolescent/parent preferences.</p><p><strong>Results: </strong>Adolescents prioritized eating well, managing stress, and maintaining motivation as desired support strategies. Parents identified parental support groups and nutrition guidance as priorities. Peer support and social media platforms were identified as key approaches for boosting motivation and engagement.</p><p><strong>Conclusions: </strong>The patient voice is an important first step in understanding how, and whether behavioral lifestyle programs combined with MBS for weight management can be optimized. Adolescent preferences may enhance program fit and identify health behavior supports needed to sustain behavior change.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e127"},"PeriodicalIF":2.1,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11440570/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142347676","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}
引用次数: 0
"Join the team" clinical research workforce development model: A new paradigm in healthcare career opportunities. "加入团队 "临床研究人才培养模式:医疗保健职业机会的新典范。
IF 2.1
Journal of Clinical and Translational Science Pub Date : 2024-09-19 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.577
Kate Marusina, Olga Kishchenko, Angela Griffiths
{"title":"\"Join the team\" clinical research workforce development model: A new paradigm in healthcare career opportunities.","authors":"Kate Marusina, Olga Kishchenko, Angela Griffiths","doi":"10.1017/cts.2024.577","DOIUrl":"https://doi.org/10.1017/cts.2024.577","url":null,"abstract":"<p><p>The University of California (UC) Davis Clinical and Translational Science Center has established the \"Join the Team\" model, a Clinical Research Coordinator workforce pipeline utilizing a community-based approach. The model has been extensively tested at UC Davis and demonstrated to generate a viable pathway for qualified candidates for employment in clinical research. The model combines the following elements: community outreach; professional training materials created by the Association for Clinical Research Professionals and adapted to the local environment; financial support to trainees to encourage ethnic and socioeconomic diversity; and internship/shadowing opportunities. The program is tailored for academic medical centers (AMCs) in recognition of administrative barriers specific to AMCs. UC Davis's model can be replicated at other locations using information in this article, such as key program features and barriers faced and surmounted. We also discuss innovative theories for future program iterations.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e128"},"PeriodicalIF":2.1,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11428055/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142347651","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}
引用次数: 0
Returning individual research results to participants: Values, preferences, and expectations 将个人研究成果返还给参与者:价值观、偏好和期望
IF 2.6
Journal of Clinical and Translational Science Pub Date : 2024-09-18 DOI: 10.1017/cts.2024.568
Denise A. Kent, Michelle Villegas-Downs, Marina Del Rios, Michael Freedman, Jerry A. Krishnan, Martha G. Menchaca, Crystal L. Patil, Jenny Sculley, Nathan Tintle, Lynn B. Gerald
{"title":"Returning individual research results to participants: Values, preferences, and expectations","authors":"Denise A. Kent, Michelle Villegas-Downs, Marina Del Rios, Michael Freedman, Jerry A. Krishnan, Martha G. Menchaca, Crystal L. Patil, Jenny Sculley, Nathan Tintle, Lynn B. Gerald","doi":"10.1017/cts.2024.568","DOIUrl":"https://doi.org/10.1017/cts.2024.568","url":null,"abstract":"Background/objective: Disclosing individual research results to participants is not standard practice. The return of individual research results to participants may increase recruitment, retention, and engagement in research. This study’s objective was to explore the preferences, expectations, and experiences of research participants receiving individual research results. Methods: A mixed-methods approach, consisting of semi-structured interviews and a health literacy assessment, was used with participants enrolled in a cohort study. The interviews were analyzed to produce an understanding of current experiences. Using descriptive analyses, responses were compared to identify alignments and divergences among participants. Results: Forty-three English-speaking and 16 Spanish-speaking participants enrolled. Ninety-eight percent of participants wanted to receive their individual research results. Seventy-five percent of participants reported they shared results with their healthcare providers. More participants aged 18–65 reported the need to follow up with their provider (70%) as compared to participants &gt; 65 (20%). Two-thirds of participants reported a positive experience receiving their research results; however, 22% reported anxiety and worry. Most participants (69%) described the electronic medical record (EMR) as their preferred method for receiving their results. Yet only 50% of Spanish speakers preferred receiving research results through the EMR compared to 77% of English speakers. Participants with low health literacy preferred receiving study results in person or by phone. Conclusion: Research participants value receiving their individual research results, and this may increase recruitment and retention within the research enterprise. While more research is needed, the lessons learned from this study lay the groundwork for developing best practices and policies around the return of individual research results.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"3 1","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142250937","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}
引用次数: 0
Just Research: Evaluation findings of an educational program to promote inclusive research among investigators and research staff. 公正研究:在调查人员和研究人员中推广包容性研究的教育计划的评估结果。
IF 2.1
Journal of Clinical and Translational Science Pub Date : 2024-09-16 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.592
Susan Racine Passmore, Gina Green-Harris, Peter Kirschmann, Amarette Filut, Katrina Phelps, Mariana Garcia, Dorothy Farrar Edwards
{"title":"Just Research: Evaluation findings of an educational program to promote inclusive research among investigators and research staff.","authors":"Susan Racine Passmore, Gina Green-Harris, Peter Kirschmann, Amarette Filut, Katrina Phelps, Mariana Garcia, Dorothy Farrar Edwards","doi":"10.1017/cts.2024.592","DOIUrl":"https://doi.org/10.1017/cts.2024.592","url":null,"abstract":"<p><p>Educational opportunities for investigators and staff to promote inclusive research practices are a critical piece of the effort to increase diversity in study participation and promote health equity. However, few trainings to date have empirically been shown to result in behavior changes. We present preliminary evaluation findings for the <i>Just Research</i> workshop offered at the University of Wisconsin-Madison between October 2022 and August 2023. These sessions included 80 participants who made up 4 cohorts. Data was collected through a retrospective pre/post-test survey administered 0-7 days following the workshop (<i>n</i> = 70), and a follow-up survey administered 9-12 months following the workshop (<i>n</i> = 21). Participants demonstrate significant increases in knowledge and self-efficacy regarding implementing inclusive practices post-intervention (<i>p</i> < .001). 85.7% of participants who completed the follow-up survey reported implementing inclusive practices.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e120"},"PeriodicalIF":2.1,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11428049/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142347674","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}
引用次数: 0
Mentoring up: How mentorship training influences mentee intent to change behavior. 指导向上:导师培训如何影响被指导者改变行为的意愿。
IF 2.1
Journal of Clinical and Translational Science Pub Date : 2024-09-16 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.589
Jonathan Orsini, So Hee Hyun, Fatima Sancheznieto
{"title":"Mentoring up: How mentorship training influences mentee intent to change behavior.","authors":"Jonathan Orsini, So Hee Hyun, Fatima Sancheznieto","doi":"10.1017/cts.2024.589","DOIUrl":"https://doi.org/10.1017/cts.2024.589","url":null,"abstract":"<p><strong>Introduction: </strong>The purpose of this study was to evaluate data from different implementations of the <i>Mentoring Up</i> curriculum, designed by the Center for the Improvement of Mentored Experiences in Research. The study investigated the relationship between participants' self-reported change in mentoring competence and the behaviors they intended to implement post-training.</p><p><strong>Methods: </strong>The data set included 401 respondents who consented to participate after 59 <i>Mentoring Up</i> training events hosted by 34 institutions between 2015 and 2022. Responses to the Mentoring Competency Assessment (MCA) were analyzed to determine which factors were related to self-reported changes in participants' mentoring competencies post-training.</p><p><strong>Results: </strong>Quantitative analysis showed that intent to change, perceived value of training, training modality, and prior mentor training were all significantly associated with the magnitude of change in MCA scores between pre- and post-tests. Further, participants who engaged in face-to-face training found significantly more value in the training than those who participated online. Analysis of open-ended questions demonstrated that participants with larger changes in MCA scores were more likely to address core principles of <i>Mentoring Up</i> curriculum when discussing their behavior change plans post-training.</p><p><strong>Conclusion: </strong>Participants improved their mentoring competence by participating in the <i>Mentoring Up</i> curriculum, and this change was significantly and practically associated with an intent to modify their behavior in their mentoring relationships.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e119"},"PeriodicalIF":2.1,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11428057/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142347677","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}
引用次数: 0
Evaluation of a peer-led research best practices training for community health workers and promotoras. 对针对社区卫生工作者和宣传员的同伴引导研究最佳做法培训进行评估。
IF 2.1
Journal of Clinical and Translational Science Pub Date : 2024-09-16 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.593
Susan L Murphy, Alexandra E Harper, Gina M Jay, Vanessa I Trujillo, Kristen Weeks-Norton, Elias Samuels, Jonathan P Troost, Brenda Eakin, Gretchen Piatt, Catherine Striley, Analay Perez, Shannen McIntosh, Daphne C Watkins, Sergio Aguilar-Gaxiola, Linda Cottler
{"title":"Evaluation of a peer-led research best practices training for community health workers and promotoras.","authors":"Susan L Murphy, Alexandra E Harper, Gina M Jay, Vanessa I Trujillo, Kristen Weeks-Norton, Elias Samuels, Jonathan P Troost, Brenda Eakin, Gretchen Piatt, Catherine Striley, Analay Perez, Shannen McIntosh, Daphne C Watkins, Sergio Aguilar-Gaxiola, Linda Cottler","doi":"10.1017/cts.2024.593","DOIUrl":"https://doi.org/10.1017/cts.2024.593","url":null,"abstract":"<p><strong>Introduction: </strong>Community health workers and promotoras (CHW/Ps) increasingly support research conducted in communities but receive variable or no training. We developed a culturally and linguistically tailored research best practices course for CHW/Ps that can be taken independently or in facilitated groups. The purpose of this study was to evaluate the facilitated training.</p><p><strong>Methods: </strong>CHW/Ps were recruited from communities and partners affiliated with study sites in Michigan, Florida, and California. They participated in virtual or in-person training facilitated by a peer in English or Spanish and then completed a survey about their abilities (i.e., knowledge and skills for participating in research-related work) and perceptions of the training. Linear regression analyses were used to examine differences in training experience across several factors.</p><p><strong>Results: </strong>A total of 394 CHW/Ps, mean age 41.6 ± 13.8 years, completed the training and survey (<i>n</i> = 275 English; 119 Spanish). Most CHW/Ps were female (80%), and 50% identified as Hispanic, Latino, or Spanish. Over 95% of CHW/Ps rated their abilities as improved after training; 98% agreed the course was relevant to their work and felt the training was useful. Small differences were observed between training sites.</p><p><strong>Discussion: </strong>Most CHW/Ps rated the training positively and noted improved knowledge and skills for engaging in research-related work. Despite slight site differences, the training was well received, and CHW/Ps appreciated having a facilitator with experience working in community-based settings. This course offers a standard and scalable approach to training the CHW/P workforce. Future studies can examine its uptake and effect on research quality.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e117"},"PeriodicalIF":2.1,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11428051/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142347672","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}
引用次数: 0
Comparing emergency department versus high school-based recruitment for a hypertension research study with adult-youth dyads. 比较急诊科和高中为成人-青少年二元组高血压研究进行的招募。
IF 2.1
Journal of Clinical and Translational Science Pub Date : 2024-09-16 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.586
Sara W Heinert, Ryan Salvatore, Kelsey M Thompson, Divya Krishna, Kayla Pena, Pamela Ohman-Strickland, Kathryn Greene, Carolyn J Heckman, Benjamin F Crabtree, Phillip Levy, Shawna V Hudson
{"title":"Comparing emergency department versus high school-based recruitment for a hypertension research study with adult-youth dyads.","authors":"Sara W Heinert, Ryan Salvatore, Kelsey M Thompson, Divya Krishna, Kayla Pena, Pamela Ohman-Strickland, Kathryn Greene, Carolyn J Heckman, Benjamin F Crabtree, Phillip Levy, Shawna V Hudson","doi":"10.1017/cts.2024.586","DOIUrl":"10.1017/cts.2024.586","url":null,"abstract":"<p><p>Dyads can be challenging to recruit for research studies, but detailed reporting on strategies employed to recruit adult-adolescent dyads is rare. We describe experiences recruiting adult-youth dyads for a hypertension education intervention comparing recruitment in an emergency department (ED) setting with a school-based community setting. We found more success in recruiting dyads through a school-based model that started with adolescent youth (19 dyads in 7 weeks with < 1 hour recruitment) compared to an ED-based model that started with adults (2 dyads in 17 weeks with 350 hours of recruitment). These findings can benefit future adult-youth dyad recruitment for research studies.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e122"},"PeriodicalIF":2.1,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11440580/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142347670","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}
引用次数: 0
Unveiling readability challenges: An extensive analysis of consent document accessibility in clinical trials. 揭开可读性难题的面纱:广泛分析临床试验中同意书的可读性。
IF 2.1
Journal of Clinical and Translational Science Pub Date : 2024-09-16 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.595
Adrian H Zai, Jamie M Faro, Jeroan Allison
{"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}
引用次数: 0
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