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Practical application of good participatory practices for trials of emerging pathogens: Developing materials for use in ACTIV-3, -3b, and ACTIV-associated COVID-19 trials.
IF 2.1
Journal of Clinical and Translational Science Pub Date : 2024-10-15 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.485
Paola Del Carmen Guerra-de-Blas, Rubria Marines-Price, Olga Milman, Danae Deal, Jonathan Marchand, Jessica Linton, Sue Meger, John Rule, Thomas L Holland, Jonathan Kitonsa, Yvette Delph
{"title":"Practical application of good participatory practices for trials of emerging pathogens: Developing materials for use in ACTIV-3, -3b, and ACTIV-associated COVID-19 trials.","authors":"Paola Del Carmen Guerra-de-Blas, Rubria Marines-Price, Olga Milman, Danae Deal, Jonathan Marchand, Jessica Linton, Sue Meger, John Rule, Thomas L Holland, Jonathan Kitonsa, Yvette Delph","doi":"10.1017/cts.2024.485","DOIUrl":"10.1017/cts.2024.485","url":null,"abstract":"<p><p>The emergence of the COVID-19 pandemic required an immediate global clinical research response. The ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines)-3 trials and the ACTIV-associated Outpatient Treatment with Anti-Coronavirus Immunoglobulin trial used Good Participatory Practices (GPP) to develop materials for study implementation from a global network perspective. GPP guidelines offer a framework for engaging stakeholders throughout the research process. This paper provides an overview of the materials developed and their applicability in various settings, reports results from a survey of study site personnel on the materials' usefulness, summarizes important lessons learned, and serves as a reference for networks eager to apply GPP. Survey results showed that flipbooks and overview videos were highly ranked. Stakeholder input was valuable in developing easily understandable participant-facing materials with culturally appropriate images. Materials should be available to submit with the initial protocol submissions to ethics committees, and in formats that accommodate a wide range of institutional resources, policies, and infection-control practices. This article emphasizes the importance of GPP, including stakeholder consultation, in developing materials that support clinical research and address language, cultural, and sociopolitical barriers during a pandemic. The findings will be used to optimize efforts and resource allocation for new and ongoing studies.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e157"},"PeriodicalIF":2.1,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11602519/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142750660","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
ACTIV trials: cross-trial lessons learned for master protocol implementation. ACTIV 试验:主协议实施的交叉试验经验教训。
IF 2.1
Journal of Clinical and Translational Science Pub Date : 2024-10-15 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.507
Maryam Keshtkar-Jahromi, Stacey J Adam, Indira Brar, Lucy K Chung, Judith S Currier, Eric S Daar, Victoria J Davey, Eileen T Denning, Annetine C Gelijns, Elizabeth S Higgs, Prasanna Jagannathan, Arzhang Cyrus Javan, Tomas O Jensen, Nikolaus Jilg, Ioannis Kalomenidis, Peter Kim, Seema U Nayak, Matthew Newell, Babafemi O Taiwo, Tammy Yokum, Yvette Delph
{"title":"ACTIV trials: cross-trial lessons learned for master protocol implementation.","authors":"Maryam Keshtkar-Jahromi, Stacey J Adam, Indira Brar, Lucy K Chung, Judith S Currier, Eric S Daar, Victoria J Davey, Eileen T Denning, Annetine C Gelijns, Elizabeth S Higgs, Prasanna Jagannathan, Arzhang Cyrus Javan, Tomas O Jensen, Nikolaus Jilg, Ioannis Kalomenidis, Peter Kim, Seema U Nayak, Matthew Newell, Babafemi O Taiwo, Tammy Yokum, Yvette Delph","doi":"10.1017/cts.2024.507","DOIUrl":"10.1017/cts.2024.507","url":null,"abstract":"<p><p>The United States Government (USG) public-private partnership \"Accelerating COVID-19 Treatment Interventions and Vaccines\" (ACTIV) was launched to identify safe, effective therapeutics to treat patients with Coronavirus Disease 2019 (COVID-19) and prevent hospitalization, progression of disease, and death. Eleven original master protocols were developed by ACTIV, and thirty-seven therapeutic agents entered evaluation for treatment benefit. Challenges encountered during trial implementation led to innovations enabling initiation and enrollment of over 26,000 participants in the trials. While only two ACTIV trials continue to enroll, the recommendations here reflect information from all the trials as of May 2023. We review clinical trial implementation challenges and corresponding lessons learned to inform future therapeutic clinical trials implemented in response to a public health emergency and the conduct of complex clinical trials during \"peacetime,\" as well.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e152"},"PeriodicalIF":2.1,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11557279/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142621435","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
Overview of ACTIV trial-specific lessons learned. ACTIV 试验的具体经验教训概述。
IF 2.1
Journal of Clinical and Translational Science Pub Date : 2024-10-15 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2023.698
Ruxandra Draghia-Akli, Sarah W Read, Eric A Hughes
{"title":"Overview of ACTIV trial-specific lessons learned.","authors":"Ruxandra Draghia-Akli, Sarah W Read, Eric A Hughes","doi":"10.1017/cts.2023.698","DOIUrl":"10.1017/cts.2023.698","url":null,"abstract":"<p><p>Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) was an extraordinary example of a public-private partnership (PPP) that brought together over thirty organizations and hundreds of individuals to address one of the most pressing global health needs in recent decades. In particular, ACTIV provided a key avenue for testing numerous therapeutics for their potential benefit in treating the SARS-CoV-2 virus or the resulting symptoms of acute COVID-19 infection. Given the speed and scale at which ACTIV designed and implemented master protocols across global networks that it was simultaneously working to create, the PPP can provide valuable lessons for best practices and avoiding pitfalls the next time the world is faced with a global pandemic of a novel pathogen. This report provides a general overview of the ACTIV partnership to set the stage and context for the subsequent articles in this issue that will relay these lessons learned.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e149"},"PeriodicalIF":2.1,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11523021/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545786","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
Optimizing external advisory committee meetings of Clinical and Translational Science Awards through focused pre-review. 通过集中预审,优化临床和转化科学奖外部咨询委员会会议。
IF 2.1
Journal of Clinical and Translational Science Pub Date : 2024-10-14 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.575
Shannon L Casey, Elizabeth S Burnside, Allan R Brasier
{"title":"Optimizing external advisory committee meetings of Clinical and Translational Science Awards through focused pre-review.","authors":"Shannon L Casey, Elizabeth S Burnside, Allan R Brasier","doi":"10.1017/cts.2024.575","DOIUrl":"10.1017/cts.2024.575","url":null,"abstract":"<p><p>External advisory committees (EACs) are critical peer-review meetings that drive improvement at Clinical and Translational Science Award Program Hubs. Despite their ubiquity, evaluations of EAC optimization and effective implementation remain scarce. We present a two-tiered approach to optimizing EAC meetings through (1) in-depth, topically focused \"pre-review\" meetings comprised of external topic experts and at least one standing \"full-board\" EAC member, followed by (2) a traditional \"full-board\" EAC meeting. This approach allowed pre-review discussion of program-focused topics and specific recommendations, later delivered to the full-board for review and direction. To evaluate this approach, we interviewed 18 people who planned, administered, or attended pre-review and/or full-board meetings, including internal Hub staff, external topic experts, and standing EAC members. Thematic analysis was used to explore planning, implementation, and value of our two-tiered approach <i>versus</i> the traditional single full-board approach. Interviewees preferred the two-tiered approach, noting benefits including additional time to reflect, shared identification of strengths and challenges, and discussion of solutions to share later with the full-board. Those who attended pre-review meetings described building \"<i>transformational</i>,\" rather than <i>\"transactional</i>,\" relationships with invitees through more discussion and inter-hub sharing. That increased sharing invited more exploration, discussion, and planning of next steps toward innovation.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e162"},"PeriodicalIF":2.1,"publicationDate":"2024-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11557274/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142621355","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
Implementation of MyChart for recruitment at an academic medical center. 在一家学术医疗中心实施 MyChart 招聘。
IF 2.1
Journal of Clinical and Translational Science Pub Date : 2024-10-14 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.605
Carrie Dykes, Cody Gardner, Jack Chang, David Pinto, Karen Wilson, Martin S Zand, Ann Dozier
{"title":"Implementation of <i>MyChart for recruitment</i> at an academic medical center.","authors":"Carrie Dykes, Cody Gardner, Jack Chang, David Pinto, Karen Wilson, Martin S Zand, Ann Dozier","doi":"10.1017/cts.2024.605","DOIUrl":"10.1017/cts.2024.605","url":null,"abstract":"<p><strong>Introduction: </strong>Recruitment of participants into research studies remains a major concern for investigators. Using clinical teams to identify potentially eligible patients can present a significant barrier. To overcome this, we implemented a process for using our patient portal, called MyChart, as a new institutional recruitment option utilizing our electronic health record's existing functionality.</p><p><strong>Methods: </strong>To streamline the institutional approval process, we established a working group comprised of representatives from human subject protection, information technology, and privacy and vetted our process with many stakeholder groups. Our specific process for study approval is described and started with a consultation with our recruitment and retention function funded through our Clinical and Translational Science Award.</p><p><strong>Results: </strong>The time from consultation to the first message(s) sent ranged from 84 to 442 days and declined slightly over time. The overall patient response rate to MyChart messages about available research studies was 23% with one third of those saying they were interested in learning more. The response rate for Black and Hispanic patients was about 50% that of White patients.</p><p><strong>Conclusions: </strong>Many different types of studies from any medical specialty successfully identified interested patients using this option. Study teams needed support in defining appropriate inclusion/exclusion criteria to identify the relevant population in the electronic health records and they needed assistance writing study descriptions in plain language. Using MyChart for recruitment addressed a critical barrier and opened up the opportunity to provide a full recruitment consultation to identify additional recruitment channels the study teams would not have considered otherwise.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e160"},"PeriodicalIF":2.1,"publicationDate":"2024-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11557278/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142621350","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
Development of the Dissemination and Implementation Science Collaborative (DISC): Opportunities to enhance implementation science capacity among researchers and practitioners in South Carolina. 传播与实施科学合作组织(DISC)的发展:提高南卡罗来纳州研究人员和从业人员实施科学能力的机会。
IF 2.1
Journal of Clinical and Translational Science Pub Date : 2024-10-14 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.579
Caitlin G Allen, Katherine Sterba, Stephanie Oppenheimer, Rochelle F Hanson, Emma Coen, Ron Gimbel, Dee Ford
{"title":"Development of the Dissemination and Implementation Science Collaborative (DISC): Opportunities to enhance implementation science capacity among researchers and practitioners in South Carolina.","authors":"Caitlin G Allen, Katherine Sterba, Stephanie Oppenheimer, Rochelle F Hanson, Emma Coen, Ron Gimbel, Dee Ford","doi":"10.1017/cts.2024.579","DOIUrl":"10.1017/cts.2024.579","url":null,"abstract":"<p><p>This paper explores the development of the Dissemination and Implementation Science Collaborative (DISC) at the Medical University of South Carolina, established through the Clinical and Translational Science Award program. DISC aims to accelerate clinical and translational science by providing training, mentorship, and collaboration opportunities in dissemination and implementation (D&I) science. Through DISC, investigators, trainees, and community partners are equipped with the knowledge and skills to conduct D&I research and translate findings into practice, particularly in South Carolina's public health and healthcare landscape. We describe efforts to achieve the major overarching aims of DISC, which include conducting scientific workforce training, providing mentorship and consultation, and advancing methods and processes for D&I research. By sharing DISC experiences, successes, and challenges, this paper aims to support the growth of D&I research and capacity-building programs, fostering collaboration and shared resources in the field.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e161"},"PeriodicalIF":2.1,"publicationDate":"2024-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11557275/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142621436","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
Assessments of working group effectiveness in the planning of the New Jersey Kids Study: An applied mixed-methods study on the science of team science.
IF 2.1
Journal of Clinical and Translational Science Pub Date : 2024-10-14 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.578
Ralph A Gigliotti, Melissa Weidner, Michelle Jansen, Patricia Greenberg, Gloria Bachmann, Maria Gloria Dominguez-Bello, Veenat Parmar, Reynold A Panettieri, Nancy Reilly, Charletta A Ayers, Barrie Cohen, Lisa K Denzin, Cecile A Feldman, Nancy Fiedler, Manuel E Jimenez, Robert J Laumbach, Steven K Malin, Natale Mazzaferro, Shilpa Pai, Todd Rosen, Lisa Rossman-Murphy, Jessica E Salvatore, Kristine H Schmitz, Sue A Shapses, Stephanie Shiau, Helmut Zarbl, Nancy E Reichman, Emily S Barrett, Martin J Blaser, Daniel B Horton
{"title":"Assessments of working group effectiveness in the planning of the New Jersey Kids Study: An applied mixed-methods study on the science of team science.","authors":"Ralph A Gigliotti, Melissa Weidner, Michelle Jansen, Patricia Greenberg, Gloria Bachmann, Maria Gloria Dominguez-Bello, Veenat Parmar, Reynold A Panettieri, Nancy Reilly, Charletta A Ayers, Barrie Cohen, Lisa K Denzin, Cecile A Feldman, Nancy Fiedler, Manuel E Jimenez, Robert J Laumbach, Steven K Malin, Natale Mazzaferro, Shilpa Pai, Todd Rosen, Lisa Rossman-Murphy, Jessica E Salvatore, Kristine H Schmitz, Sue A Shapses, Stephanie Shiau, Helmut Zarbl, Nancy E Reichman, Emily S Barrett, Martin J Blaser, Daniel B Horton","doi":"10.1017/cts.2024.578","DOIUrl":"https://doi.org/10.1017/cts.2024.578","url":null,"abstract":"<p><strong>Introduction: </strong>The New Jersey Kids Study (NJKS) is a transdisciplinary statewide initiative to understand influences on child health, development, and disease. We conducted a mixed-methods study of project planning teams to investigate team effectiveness and relationships between team dynamics and quality of deliverables.</p><p><strong>Methods: </strong>Ten theme-based working groups (WGs) (e.g., Neurodevelopment, Nutrition) informed protocol development and submitted final reports. WG members (<i>n</i> = 79, 75%) completed questionnaires including de-identified demographic and professional information and a modified TeamSTEPPS Team Assessment Questionnaire (TAQ). Reviewers independently evaluated final reports using a standardized tool. We analyzed questionnaire results and final report assessments using linear regression and performed constant comparative qualitative analysis to identify central themes.</p><p><strong>Results: </strong>WG-level factors associated with greater team effectiveness included proportion of full professors (<i>β</i> = 31.24, 95% CI 27.65-34.82), team size (<i>β</i> = 0.81, 95% CI 0.70-0.92), and percent dedicated research effort (<i>β</i> = 0.11, 95% CI 0.09-0.13); age distribution (<i>β</i> = -2.67, 95% CI -3.00 to -2.38) and diversity of school affiliations (<i>β</i> = -33.32, 95% CI -36.84 to -29.80) were inversely associated with team effectiveness. No factors were associated with final report assessments. Perceptions of overall initiative leadership were associated with expressed enthusiasm for future NJKS participation. Qualitative analyses of final reports yielded four themes related to team science practices: organization and process, collaboration, task delegation, and decision-making patterns.</p><p><strong>Conclusions: </strong>We identified several correlates of team effectiveness in a team science initiative's early planning phase. Extra effort may be needed to bridge differences in team members' backgrounds to enhance the effectiveness of diverse teams. This work also highlights leadership as an important component in future investigator engagement.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e163"},"PeriodicalIF":2.1,"publicationDate":"2024-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11604504/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142769470","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
Realizing the potential of social determinants data in EHR systems: A scoping review of approaches for screening, linkage, extraction, analysis, and interventions. 发挥电子病历系统中社会决定因素数据的潜力:对筛选、链接、提取、分析和干预方法的范围审查。
IF 2.1
Journal of Clinical and Translational Science Pub Date : 2024-10-10 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.571
Chenyu Li, Danielle L Mowery, Xiaomeng Ma, Rui Yang, Ugurcan Vurgun, Sy Hwang, Hayoung K Donnelly, Harsh Bandhey, Yalini Senathirajah, Shyam Visweswaran, Eugene M Sadhu, Zohaib Akhtar, Emily Getzen, Philip J Freda, Qi Long, Michael J Becich
{"title":"Realizing the potential of social determinants data in EHR systems: A scoping review of approaches for screening, linkage, extraction, analysis, and interventions.","authors":"Chenyu Li, Danielle L Mowery, Xiaomeng Ma, Rui Yang, Ugurcan Vurgun, Sy Hwang, Hayoung K Donnelly, Harsh Bandhey, Yalini Senathirajah, Shyam Visweswaran, Eugene M Sadhu, Zohaib Akhtar, Emily Getzen, Philip J Freda, Qi Long, Michael J Becich","doi":"10.1017/cts.2024.571","DOIUrl":"10.1017/cts.2024.571","url":null,"abstract":"<p><strong>Background: </strong>Social determinants of health (SDoH), such as socioeconomics and neighborhoods, strongly influence health outcomes. However, the current state of standardized SDoH data in electronic health records (EHRs) is lacking, a significant barrier to research and care quality.</p><p><strong>Methods: </strong>We conducted a PubMed search using \"SDOH\" and \"EHR\" Medical Subject Headings terms, analyzing included articles across five domains: 1) SDoH screening and assessment approaches, 2) SDoH data collection and documentation, 3) Use of natural language processing (NLP) for extracting SDoH, 4) SDoH data and health outcomes, and 5) SDoH-driven interventions.</p><p><strong>Results: </strong>Of 685 articles identified, 324 underwent full review. Key findings include implementation of tailored screening instruments, census and claims data linkage for contextual SDoH profiles, NLP systems extracting SDoH from notes, associations between SDoH and healthcare utilization and chronic disease control, and integrated care management programs. However, variability across data sources, tools, and outcomes underscores the need for standardization.</p><p><strong>Discussion: </strong>Despite progress in identifying patient social needs, further development of standards, predictive models, and coordinated interventions is critical for SDoH-EHR integration. Additional database searches could strengthen this scoping review. Ultimately, widespread capture, analysis, and translation of multidimensional SDoH data into clinical care is essential for promoting health equity.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e147"},"PeriodicalIF":2.1,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11523026/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545788","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
The transformative journey of community health workers in implementing a lifestyle intervention in Brazil: A qualitative study. 巴西社区卫生工作者在实施生活方式干预中的转变历程:定性研究。
IF 2.1
Journal of Clinical and Translational Science Pub Date : 2024-10-10 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.612
Andiara Schwingel, Ana Selzer, Deanivea Mendes Felix, Wojtek Chodzko-Zajko, Daniel Umpierre, Felipe Reichert, Pedro Hallal
{"title":"The transformative journey of community health workers in implementing a lifestyle intervention in Brazil: A qualitative study.","authors":"Andiara Schwingel, Ana Selzer, Deanivea Mendes Felix, Wojtek Chodzko-Zajko, Daniel Umpierre, Felipe Reichert, Pedro Hallal","doi":"10.1017/cts.2024.612","DOIUrl":"10.1017/cts.2024.612","url":null,"abstract":"<p><strong>Introduction: </strong>Community health workers (CHWs) stand as critical frontline agents within the Brazilian healthcare system. In this qualitative study, we examined the impact of a community-based behavioral change intervention spearheaded by CHWs.</p><p><strong>Methods: </strong>The intervention focused on promoting healthy behaviors - physical activity, nutrition, and emotional well-being - among individuals aged 50 and older living in a rural community in Brazil. The intervention was designed, implemented, and evaluated in close collaboration with CHWs and local administrators. The implementation of the intervention unfolded in two waves, each lasting 12 months. Interviews with CHWs, health administrators, and intervention participants conducted at post-intervention and 6-year follow-up centered on CHWs as delivery agents and examined the implementation of the intervention in primary care contexts around adoption, implementation, and long-term maintenance.</p><p><strong>Results: </strong>Inductive analysis revealed four themes that highlight CHWs' motivation to take active roles in health promotion and overcoming challenges such as unfamiliarity with new roles or limited training. In addition, enhanced community bonds, job satisfaction, and trust in CHWs gained through the intervention, empowered CHWs to realize their potential and importance. Another important area relates to the CHWs' ability to leverage their deep community ties and cultural insights to enhance the intervention's significance. CHWs' participation in the program also led to personal benefits and self-care practices, setting an example for the community they serve.</p><p><strong>Conclusions: </strong>This study underscores the positive impact of a community-based intervention led by CHWs. Such programs have the potential for nationwide dissemination, leveraging the CHWs' widespread presence and deep community integration.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e158"},"PeriodicalIF":2.1,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11557276/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142621359","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
The application of quality improvement concepts, strategies, and tools to enhance participation in clinical trials among Latino families. 应用质量改进概念、策略和工具,提高拉丁裔家庭对临床试验的参与度。
IF 2.1
Journal of Clinical and Translational Science Pub Date : 2024-10-10 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.557
Keanaan Malke, Jennifer R Hemler, Daniel Lima, Pablo Colon, Caroline Mendoza, Naomy Azcona, Katie A Devine, Thomas I Mackie, Usha Ramachandran, Darlene Forbes, Michael Lucas, Shawna V Hudson, Manuel E Jimenez
{"title":"The application of quality improvement concepts, strategies, and tools to enhance participation in clinical trials among Latino families.","authors":"Keanaan Malke, Jennifer R Hemler, Daniel Lima, Pablo Colon, Caroline Mendoza, Naomy Azcona, Katie A Devine, Thomas I Mackie, Usha Ramachandran, Darlene Forbes, Michael Lucas, Shawna V Hudson, Manuel E Jimenez","doi":"10.1017/cts.2024.557","DOIUrl":"10.1017/cts.2024.557","url":null,"abstract":"<p><p>Underrepresentation of people from racial and ethnic minoritized groups in clinical trials threatens external validity of clinical and translational science, diminishes uptake of innovations into practice, and restricts access to the potential benefits of participation. Despite efforts to increase diversity in clinical trials, children and adults from Latino backgrounds remain underrepresented. Quality improvement concepts, strategies, and tools demonstrate promise in enhancing recruitment and enrollment in clinical trials. To demonstrate this promise, we draw upon our team's experience conducting a randomized clinical trial that tests three behavioral interventions designed to promote equity in language and social-emotional skill acquisition among Latino parent-infant dyads from under-resourced communities. The recruitment activities took place during the COVID-19 pandemic, which intensified the need for responsive strategies and procedures. We used the Model for Improvement to achieve our recruitment goals. Across study stages, we engaged strategies such as (1) intentional team formation, (2) participatory approaches to setting goals, monitoring achievement, selecting change strategies, and (3) small iterative tests that informed additional efforts. These strategies helped our team overcome several barriers. These strategies may help other researchers apply quality improvement tools to increase participation in clinical and translational research among people from minoritized groups.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e146"},"PeriodicalIF":2.1,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11523012/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545789","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}
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