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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 Q3 MEDICINE, RESEARCH & EXPERIMENTAL 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

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.

让不同的合作伙伴参与研究过程的每个阶段,是社区参与式研究的黄金标准,也为实施科学的影响力增添了价值。然而,合作伙伴参与传播,特别是有意义地参与撰写同行评审稿件的情况却很缺乏。癌症控制领域的实施科学中心正在使用转化科学效益模型来展示我们的工作在传统指标之外的影响,包括能力建设和促进社区参与。本文介绍了一个中心的案例,该中心制定了将社区合作伙伴列为共同作者的政策。中心采用标准做法来促进清晰的沟通和双向合作。在已发表的以中心基础设施和实施研究试点为重点的论文中,92% 的论文有社区合作伙伴作为共同作者。这其中包括 21 名个人,他们的角色从医生助理到医疗总监再到质量经理不等。通过这种有意识的共同创作经历,社区合作伙伴加强了实施科学的专业知识。社区共同作者还确保了数据解释和传播能够反映真实世界的实践环境,并为快速转化为实践改进提供了可持续的策略。资助者、学术期刊和研究人员都可以发挥重要作用,支持社区共同作者成为重要的思想伙伴,帮助缩小研究与实践之间的差距。
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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 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-09-20 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.596
Imani Nwokeji, Chisom Madu, Jin Ming Lin
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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 Q3 MEDICINE, RESEARCH & EXPERIMENTAL 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

Introduction: 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.

Methods: A mixed-methods design identified adolescent preferences for MBS lifestyle support. Data were collected from a racially and ethnically diverse sample of adolescents (N = 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 (N = 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.

Results: 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.

Conclusions: 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.

导言:代谢与减肥手术(MBS)对患有严重肥胖症的青少年是安全有效的。将代谢减重手术与行为生活方式干预措施相结合,可有效优化治疗效果。然而,目前还没有标准化的方案。青少年的视角对于了解如何设计干预措施以提高参与度、维持动机并满足MBS前后自我管理行为的信息需求至关重要。本研究的目的是根据青少年及其家庭的意见,在循证内容的基础上,开发一种MBS生活方式支持干预措施:方法:采用混合方法设计,确定青少年对 MBS 生活方式支持的偏好。数据收集自一个种族和民族多元化的青少年样本(样本数=17,76%为女性,24%为男性,41.2%为非西班牙裔黑人,41.2%为西班牙裔/拉丁美洲人,11.8%为非西班牙裔白人,5.8%为其他族裔)及其母亲(样本数=13,38.4%为西班牙裔)。定量调查和定性访谈评估了母亲健康教育计划内容、方式、频率和实施平台的首选类型,为干预措施的设计提供了参考。对混合方法数据进行三角测量,以全面了解青少年/家长的偏好:结果:青少年将饮食健康、管理压力和保持动力作为所需的支持策略。家长将家长支持小组和营养指导列为优先事项。同伴支持和社交媒体平台被认为是提高积极性和参与度的关键方法:患者的声音是了解如何以及是否可以优化结合了 MBS 的体重管理行为生活方式计划的重要第一步。青少年的偏好可增强计划的适宜性,并确定维持行为改变所需的健康行为支持。
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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 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-09-19 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.577
Kate Marusina, Olga Kishchenko, Angela Griffiths

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.

加州大学戴维斯分校临床与转化科学中心建立了 "加入团队 "模式,这是一种利用社区方法培养临床研究协调员的工作渠道。该模式已在加州大学戴维斯分校进行了广泛测试,证明能为临床研究领域的合格候选人提供一条可行的就业途径。该模式结合了以下要素:社区外联;由临床研究专业人员协会编写并根据当地环境进行调整的专业培训材料;为受训人员提供财政支持,以鼓励种族和社会经济多样性;以及实习/见习机会。考虑到学术医学中心(AMC)特有的管理障碍,该计划是为学术医学中心量身定制的。加州大学戴维斯分校的模式可以利用本文提供的信息,如项目的主要特点、面临和克服的障碍等,在其他地方复制。我们还讨论了未来项目迭代的创新理论。
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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 Q3 MEDICINE, RESEARCH & EXPERIMENTAL 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
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 > 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.
背景/目的:向参与者披露个人研究结果并非标准做法。将个人研究结果返还给参与者可能会提高研究的招募、保留和参与度。本研究旨在探讨研究参与者在接收个人研究结果时的偏好、期望和体验。研究方法采用混合方法,包括半结构式访谈和健康素养评估,对参加一项队列研究的参与者进行访谈。通过对访谈进行分析,了解参与者目前的经历。通过描述性分析,对参与者的回答进行比较,以确定参与者之间的一致性和差异性。结果43 名英语参与者和 16 名西班牙语参与者参加了访谈。98% 的参与者希望收到自己的个人研究成果。75%的参与者称他们与医疗保健提供者分享了研究结果。与 65 岁的参与者(20%)相比,更多 18-65 岁的参与者表示需要与医疗服务提供者进行后续沟通(70%)。三分之二的参与者表示在收到研究结果后有积极的体验,但也有 22% 表示焦虑和担心。大多数参与者(69%)称电子病历(EMR)是他们接收结果的首选方法。然而,只有 50% 讲西班牙语的人喜欢通过 EMR 接收研究结果,而讲英语的人则有 77%。健康知识水平较低的参与者更愿意亲自或通过电话接收研究结果。结论研究参与者重视接收个人的研究结果,这可能会增加研究机构的招募和留用。虽然还需要进行更多的研究,但从本研究中吸取的经验教训为制定有关个人研究成果返还的最佳实践和政策奠定了基础。
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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 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-09-16 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.589
Jonathan Orsini, So Hee Hyun, Fatima Sancheznieto

Introduction: The purpose of this study was to evaluate data from different implementations of the Mentoring Up 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.

Methods: The data set included 401 respondents who consented to participate after 59 Mentoring Up 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.

Results: 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 Mentoring Up curriculum when discussing their behavior change plans post-training.

Conclusion: Participants improved their mentoring competence by participating in the Mentoring Up curriculum, and this change was significantly and practically associated with an intent to modify their behavior in their mentoring relationships.

导言:本研究的目的是评估由研究指导经验改进中心设计的 "指导向上 "课程的不同实施情况的数据。研究调查了参与者自我报告的指导能力变化与他们培训后打算实施的行为之间的关系:数据集包括 401 名受访者,他们在 2015 年至 2022 年间由 34 个机构主办的 59 次 "指导向上 "培训活动后同意参加。对指导能力评估(MCA)的答复进行了分析,以确定哪些因素与参与者自我报告的培训后指导能力变化有关:定量分析显示,改变意愿、对培训价值的感知、培训模式和之前的指导者培训都与培训前和培训后测试之间的 MCA 分数变化幅度显著相关。此外,参加面对面培训的学员认为培训的价值明显高于参加在线培训的学员。对开放式问题的分析表明,MCA 分数变化较大的参与者在讨论培训后的行为改变计划时,更有可能涉及 "向上指导 "课程的核心原则:学员通过参加 "向上指导 "课程提高了他们的指导能力,这种变化与他们在指导关系中改变行为的意愿有显著的实际联系。
{"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":null,"pages":null},"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
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 Q3 MEDICINE, RESEARCH & EXPERIMENTAL 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

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 Just Research 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 (n = 70), and a follow-up survey administered 9-12 months following the workshop (n = 21). Participants demonstrate significant increases in knowledge and self-efficacy regarding implementing inclusive practices post-intervention (p < .001). 85.7% of participants who completed the follow-up survey reported implementing inclusive practices.

为研究人员和工作人员提供促进包容性研究实践的教育机会,是提高研究参与多样性和促进健康公平的重要一环。然而,迄今为止,很少有培训能通过经验证明会带来行为上的改变。我们介绍了 2022 年 10 月至 2023 年 8 月期间在威斯康星大学麦迪逊分校举办的 "公正研究 "研讨会的初步评估结果。这些课程包括 80 名参与者,他们组成了 4 个小组。数据是通过研讨会结束后 0-7 天内进行的回顾性前/后测试调查(n = 70)和研讨会结束后 9-12 个月内进行的跟踪调查(n = 21)收集的。参加者在干预后对实施全纳实践的了解和自我效能感都有了明显提高(p < .001)。在完成后续调查的学员中,85.7% 的人表示已实施了全纳实践。
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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 Q3 MEDICINE, RESEARCH & EXPERIMENTAL 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

Introduction: 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.

Methods: 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.

Results: A total of 394 CHW/Ps, mean age 41.6 ± 13.8 years, completed the training and survey (n = 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.

Discussion: 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.

导言:社区保健工作者和宣传员(CHW/Ps)越来越多地支持在社区开展的研究工作,但他们接受的培训却不尽相同,甚至根本没有接受过培训。我们为社区健康工作者和宣传员开发了一套符合其文化和语言特点的研究最佳实践课程,该课程既可独立进行,也可在小组协助下进行。本研究的目的是对协助式培训进行评估:方法:从密歇根州、佛罗里达州和加利福尼亚州的研究机构所属的社区和合作伙伴中招募社区保健工作者。他们参加了由同伴用英语或西班牙语主持的虚拟或现场培训,然后填写了一份关于其能力(即参与研究相关工作的知识和技能)和对培训的看法的调查问卷。我们使用线性回归分析法来研究不同因素对培训体验的影响:共有 394 名 CHW/Ps(平均年龄为 41.6 ± 13.8 岁)完成了培训和调查(n = 275 英语;119 西班牙语)。大多数社区保健工作者/护士为女性(80%),50%的社区保健工作者/护士被认定为西班牙裔、拉丁裔或西班牙人。超过 95% 的社区保健工作者/护工在培训后认为自己的能力得到了提高;98% 的社区保健工作者/护工认为课程与他们的工作相关,并认为培训很有用。不同培训地点之间的差异很小:讨论:大多数社区保健工作者/项目管理人员对培训给予了积极评价,并指出参与研究相关工作的知识和技能得到了提高。尽管培训地点略有不同,但培训仍受到好评,社区保健工作者/护理人员对有一位具有社区工作经验的主持人表示感谢。该课程为培训社区保健工作者/护士队伍提供了一种标准的、可扩展的方法。未来的研究可以考察其接受程度和对研究质量的影响。
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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 Q3 MEDICINE, RESEARCH & EXPERIMENTAL 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

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.

为研究项目招募二人组可能具有挑战性,但有关招募成人-青少年二人组策略的详细报告却很少见。我们介绍了为一项高血压教育干预活动招募成人-青少年二人组的经验,并比较了在急诊科(ED)和以学校为基础的社区环境中的招募情况。我们发现,与以成人为起点的急诊科模式相比,以青少年为起点的学校模式(7 周内招募了 19 个组合,招募时间小于 1 小时)招募组合的成功率更高(17 周内招募了 2 个组合,招募时间为 350 小时)。这些研究结果将有助于今后在研究项目中招募成人-青少年陪护。
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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 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-09-16 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.595
Adrian H Zai, Jamie M Faro, Jeroan Allison

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

背景:临床研究试验依赖知情同意书(ICF)向潜在参与者解释研究的方方面面。尽管我们努力确保 ICF 的可读性,但对其复杂性和参与者理解能力的担忧依然存在。机构审查委员会(IRB)的标准与 ICF 的实际可读性水平之间存在明显差距,ICF 的可读性往往超过了建议的八年级阅读水平。本研究评估了来自美国 ClinicalTrials.gov 的五千多份 ICF 的可读性,以评估其识字水平:我们使用可读性指标,如 Flesch 阅读轻松度、Flesch-Kincaid 等级、Gunning Fog 指数和难词百分比,对 ClinicalTrials.gov 中的 5,239 份美国 ICF 进行了分析。我们研究了 2005 年至 2024 年期间启动的各项研究的可读性水平趋势:结果:大多数 ICF 超过了建议的八年级阅读水平,平均 Flesch-Kincaid 等级为 10.99。虽然 91% 的国际功能、残疾和健康分类的写作水平高于 8 年级水平,但可读性明显提高,近年来超过 10 年级阅读水平的研究较少:结论:本研究揭示了建议的可读性水平与实际 ICF 之间的差异,凸显了简化的必要性。尽管近年来有改进的趋势,但仍有必要继续努力,确保不同教育背景的参与者都能理解 ICF,加强同意过程的道德完整性。
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引用次数: 0
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