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Multifaceted Intervention to Improve Graft Outcome Disparities in African American Kidney Transplants (MITIGAAT Study): Protocol for a Randomized Controlled Trial. 改善非裔美国人肾移植移植结果差异的多方面干预（MITIGAAT 研究）：随机对照试验协议》。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2024-10-10 DOI: 10.2196/57784
Morgan Overstreet, Hannah Culpepper, Deanna DeHoff, Mulugeta Gebregziabher, Maria Aurora Posadas Salas, Zemin Su, Jessica Chandler, Felicia Bartlett, Paige Dunton, Taylor Carcella, David Taber
<p><strong>Background: </strong>The outcome disparities for African American recipients of kidney transplant is a public health issue that has plagued the field of transplant since its inception. Based on national data, African American recipients have nearly twice the risk of graft loss at 5 years after transplant, when compared with White recipients. Evidence demonstrates that medication nonadherence and high tacrolimus variability substantially impact graft outcomes and racial disparities, most notably late (>2 years) after the transplant. Nonadherence is a leading cause of graft loss. Prospective multicenter data demonstrate that one-third of all graft loss are directly attributed to nonadherence. We have spent 10 years of focused research to develop a comprehensive model explaining the predominant risk factors leading to disparities in African American kidney recipients. However, there are still gaps in patient-level data that hinder the deeper understanding of the disparities. Lack of data from the patient often lead to provider biases, which will be addressed with this intervention. Culturally competent, pharmacist-led interventions in medication therapy management will also address therapeutic inertia. Pharmacist interventions will mitigate medication access barriers as well (cost and insurance denials). Thus, this multidimensional intervention addresses patient, provider, and structural factors that drive racial disparities in African American kidney recipients.</p><p><strong>Objective: </strong>This prospective, randomized controlled trial aimed to determine the impact of multimodal health services intervention on health outcomes disparities in African American recipients of kidney transplant. The aims of this study are to improve adherence and control of late clinical issues, which are predominant factors for racial disparities in kidney recipients, through a technology-enabled, telehealth-delivered, 4-level intervention.</p><p><strong>Methods: </strong>The Multifaceted Intervention to Improve Graft Outcome Disparities in African American Kidney Transplants (MITIGAAT) study is a 24-month, 2-arm, single-center (Medical University of South Carolina), 1:1 randomized controlled trial involving 190 participants (95 in each arm), measuring the impact on adherence and control of late clinical issues for racial disparities in kidney recipients, through a technology-enabled, telehealth-delivered, 4-level intervention. The key clinical issues for this study include tacrolimus variability, blood pressure, and glucose control (in those with diabetes mellitus). We will also assess the impact of the intervention on health care use (hospitalizations and emergency department visits) and conduct a cost-benefit analysis. Finally, we will assess the impact of the intervention on acute rejection and graft survival rates as compared with a large contemporary national cohort.</p><p><strong>Results: </strong>This study was funded in July 2023. Enrolled began
背景：非裔美国人肾移植受者的结果差异是一个公共卫生问题，自移植领域成立以来一直困扰着该领域。根据国家数据，与白人受者相比，非裔美国人受者在移植后 5 年的移植物损失风险几乎是白人受者的两倍。有证据表明，不坚持用药和他克莫司的高变异性会严重影响移植结果和种族差异，尤其是在移植后晚期（>2 年）。不坚持用药是造成移植物损失的主要原因。前瞻性多中心数据显示，三分之一的移植物损失直接归因于不依从性。我们花了 10 年时间进行重点研究，建立了一个全面的模型来解释导致非裔美国人肾脏受者差异的主要风险因素。然而，患者层面的数据仍然存在缺口，这阻碍了我们对差异的深入理解。缺乏来自患者的数据往往会导致提供者的偏见，而这项干预措施将解决这一问题。在药物治疗管理方面，由药剂师主导的文化胜任型干预措施也将解决治疗惰性问题。药剂师的干预还将减少药物获取障碍（费用和保险拒绝）。因此，这一多维干预措施可解决导致非裔美国肾脏接受者种族差异的患者、提供者和结构性因素：这项前瞻性随机对照试验旨在确定多模式医疗服务干预对非裔美国人肾移植受者健康结果差异的影响。这项研究的目的是通过技术驱动、远程医疗提供的四级干预措施，改善肾移植受者对后期临床问题的依从性和控制，这些问题是造成种族差异的主要因素：MITIGAAT 是一项为期 24 个月的双臂、单中心（南卡罗来纳医科大学）、1:1 随机对照试验，共有 190 名参与者（每臂 95 人）参加，目的是通过技术辅助、远程医疗、4 级干预，衡量对肾脏受者的依从性和后期临床问题控制的影响，这些问题是造成肾脏受者种族差异的主要因素。这项研究的关键临床问题包括他克莫司的变异性、血压和血糖控制（糖尿病患者）。我们还将评估干预措施对医疗服务使用（住院和急诊就诊）的影响，并进行成本效益分析。最后，我们还将评估干预措施对急性排斥反应和移植物存活率的影响，并将其与当代大型国家队列进行比较：本研究于 2023 年 7 月获得资助。2024 年 4 月开始入组，预计 2026 年完成。所有患者将于 2028 年底完成研究：在本协议中，我们描述了正在进行的 MITIGAAT 临床试验中将使用的研究设计、方法、目的和结果测量：试验注册：ClinicalTrials.gov NCT06023615；https://www.clinicaltrials.gov/study/NCT06023615.International 注册报告标识符（irrid）：PRR1-10.2196/57784。
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引用次数: 0
A Novel Cognitive Behavioral Therapy-Based Generative AI Tool (Socrates 2.0) to Facilitate Socratic Dialogue: Protocol for a Mixed Methods Feasibility Study. 基于认知行为疗法的新型生成式人工智能工具（苏格拉底 2.0）促进苏格拉底式对话：混合方法可行性研究协议》。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2024-10-10 DOI: 10.2196/58195
Philip Held, Sarah A Pridgen, Yaozhong Chen, Zuhaib Akhtar, Darpan Amin, Sean Pohorence
<p><strong>Background: </strong>Digital mental health tools, designed to augment traditional mental health treatments, are becoming increasingly important due to a wide range of barriers to accessing mental health care, including a growing shortage of clinicians. Most existing tools use rule-based algorithms, often leading to interactions that feel unnatural compared with human therapists. Large language models (LLMs) offer a solution for the development of more natural, engaging digital tools. In this paper, we detail the development of Socrates 2.0, which was designed to engage users in Socratic dialogue surrounding unrealistic or unhelpful beliefs, a core technique in cognitive behavioral therapies. The multiagent LLM-based tool features an artificial intelligence (AI) therapist, Socrates, which receives automated feedback from an AI supervisor and an AI rater. The combination of multiple agents appeared to help address common LLM issues such as looping, and it improved the overall dialogue experience. Initial user feedback from individuals with lived experiences of mental health problems as well as cognitive behavioral therapists has been positive. Moreover, tests in approximately 500 scenarios showed that Socrates 2.0 engaged in harmful responses in under 1% of cases, with the AI supervisor promptly correcting the dialogue each time. However, formal feasibility studies with potential end users are needed.</p><p><strong>Objective: </strong>This mixed methods study examines the feasibility of Socrates 2.0.</p><p><strong>Methods: </strong>On the basis of the initial data, we devised a formal feasibility study of Socrates 2.0 to gather qualitative and quantitative data about users' and clinicians' experience of interacting with the tool. Using a mixed method approach, the goal is to gather feasibility and acceptability data from 100 users and 50 clinicians to inform the eventual implementation of generative AI tools, such as Socrates 2.0, in mental health treatment. We designed this study to better understand how users and clinicians interact with the tool, including the frequency, length, and time of interactions, users' satisfaction with the tool overall, quality of each dialogue and individual responses, as well as ways in which the tool should be improved before it is used in efficacy trials. Descriptive and inferential analyses will be performed on data from validated usability measures. Thematic analysis will be performed on the qualitative data.</p><p><strong>Results: </strong>Recruitment will begin in February 2024 and is expected to conclude by February 2025. As of September 25, 2024, overall, 55 participants have been recruited.</p><p><strong>Conclusions: </strong>The development of Socrates 2.0 and the outlined feasibility study are important first steps in applying generative AI to mental health treatment delivery and lay the foundation for formal feasibility studies.</p><p><strong>International registered report identifier (irrid):
背景介绍数字心理健康工具旨在增强传统的心理健康治疗，由于获得心理健康护理的各种障碍，包括临床医生的日益短缺，数字心理健康工具正变得越来越重要。现有的大多数工具都使用基于规则的算法，与人类治疗师相比，往往导致交互感觉不自然。大型语言模型（LLM）为开发更自然、更吸引人的数字工具提供了解决方案。在本文中，我们详细介绍了苏格拉底 2.0 的开发过程，它旨在让用户围绕不现实或无益的信念进行苏格拉底式对话，这是认知行为疗法的核心技术。这款基于多代理 LLM 的工具以人工智能（AI）治疗师苏格拉底（Socrates）为特色，苏格拉底（Socrates）会接收来自 AI 监督员和 AI 评分员的自动反馈。多代理的组合似乎有助于解决常见的 LLM 问题，如循环问题，并改善了整体对话体验。有心理健康问题亲身经历的个人以及认知行为治疗师的初步用户反馈都很积极。此外，在大约 500 个场景中进行的测试表明，苏格拉底 2.0 在不到 1% 的情况下做出了有害的反应，而人工智能主管每次都会及时纠正对话。不过，还需要对潜在的最终用户进行正式的可行性研究：本混合方法研究探讨了苏格拉底 2.0 的可行性：在初步数据的基础上，我们设计了苏格拉底 2.0 的正式可行性研究，以收集有关用户和临床医生与该工具交互体验的定性和定量数据。采用混合方法，我们的目标是从 100 名用户和 50 名临床医生那里收集可行性和可接受性数据，为最终在心理健康治疗中使用苏格拉底 2.0 等生成式人工智能工具提供参考。我们设计这项研究的目的是为了更好地了解用户和临床医生如何与该工具互动，包括互动的频率、长度和时间，用户对工具的总体满意度，每次对话的质量和个人反应，以及该工具在用于疗效试验之前应如何改进。将对经过验证的可用性测量数据进行描述性和推论性分析。将对定性数据进行主题分析：招募工作将于 2024 年 2 月开始，预计于 2025 年 2 月结束。截至 2024 年 9 月 25 日，共招募了 55 名参与者：苏格拉底 2.0 的开发和概述的可行性研究是将生成式人工智能应用于心理健康治疗的重要第一步，并为正式的可行性研究奠定了基础：DERR1-10.2196/58195。
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引用次数: 0
Assessing a Couples-Based, Digital HIV Serostatus-Neutral Intervention (Para Ti, Para Mí, Para Nosotros) for Adult Cisgender Sexual Minority Male Couples in Lima, Peru: Protocol for a 6-Month Pilot Randomized Controlled Trial. 为秘鲁利马的成年同性性行为少数群体男性夫妇评估基于夫妇的数字 HIV 血清学中立干预（Para Ti、Para Mí、Para Nosotros）：为期 6 个月的试点随机对照试验方案》（Protocol for a 6-Month Pilot Randomized Controlled Trial）。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2024-10-10 DOI: 10.2196/63106
Jason W Mitchell, Zoran Bursac, David Diaz, Edward Michael Reyes Diaz, Alfonso Silva-Santisteban, Kelika A Konda
<p><strong>Background: </strong>HIV disproportionately affects sexual minority men (SMM; eg, gay, bisexual, and other men who have sex with men) in Lima, Peru; epidemiological data estimate that 32% to 39% of new HIV infections occur among adult cisgender SMM within primary partnerships (ie, male couples). Most HIV prevention-care research in Lima, Peru, has focused on SMM as individuals and not couples. To help address this critical gap in prevention care, we developed Para Ti, Para Mí, Para Nosotros (P3): a couples-based, digital HIV serostatus-neutral intervention (DHI) for adult cisgender SMM couples in Lima, Peru. The P3 DHI is designed to facilitate couples with skill-building, communication, decision-making, and working together to form and adhere to a detailed prevention care plan that aligns with their explicit sexual agreement. The P3 DHI is theoretically informed, self-guided, directed, sequential, and fully automated.</p><p><strong>Objective: </strong>This pilot randomized controlled trial (RCT) aims to examine the preliminary effects of P3 on couples' formation and adherence to a detailed prevention care plan containing evidence-based strategies that also aligns with their explicit sexual agreement over time. In addition, the feasibility of enrollment and retention and couples' acceptability of P3 will be assessed.</p><p><strong>Methods: </strong>The research implements a prospective, 6-month pilot RCT with a 3-month delayed control condition. After baseline, 60 enrolled SMM couples will be randomized to 1 of 2 conditions. Couples randomized to the unmatched, delayed control condition will receive access to the P3 DHI to use during the last 3 months of the trial after the 3-month assessment. Couples randomized to the immediate intervention condition will immediately receive access to the P3 DHI for 6 months. Study assessments will occur at baseline and months 3 and 6. Descriptive, comparative, qualitative, and longitudinal analyses using generalized linear mixed-effect, multilevel, and actor-partner interdependence models will be conducted to address the specific aims.</p><p><strong>Results: </strong>The 6-month pilot RCT is ongoing. Recruitment, enrollment, and data collection began in January 2023 and ended in April 2024. A total of 74 adult cisgender SMM couples met all inclusion criteria, provided consent, and were enrolled in the pilot RCT. Retention was 92% (68/74) at month 6. Data are currently being analyzed to address the 3 specific aims regarding feasibility, acceptability, and preliminary efficacy.</p><p><strong>Conclusions: </strong>Findings from this research will reveal whether couples deemed the P3 DHI to be acceptable. Findings will also highlight the preliminary efficacy of the P3 DHI on couples managing their vulnerability to HIV and other sexually transmitted infections (STIs) over time via alignment of their prevention-care plan and sexual agreement. Trial findings will help shape the future direction of the P3 DH
背景：在秘鲁利马，艾滋病毒对性少数男性（SMM，即男同性恋、双性恋和其他男男性行为者）的影响尤为严重；流行病学数据估计，32% 至 39% 的艾滋病毒新感染病例发生在主要伴侣关系（即男性伴侣）中的成年顺性别 SMM 身上。秘鲁利马的大多数艾滋病预防护理研究都集中在作为个体的 SMM 上，而不是夫妻。为了帮助解决预防保健中的这一关键缺口，我们开发了 "Para Ti, Para Mí, Para Nosotros"（P3）：一种以夫妻为基础的、数字化 HIV 血清状态中立干预措施（DHI），针对秘鲁利马的成年同性 SMM 夫妻。P3 DHI 的设计目的是促进夫妻双方的技能建设、沟通、决策，并共同制定和遵守符合其明确性协议的详细预防护理计划。P3 DHI 具有理论依据、自我指导、定向、顺序和全自动等特点：这项试点随机对照试验（RCT）旨在研究 P3 对夫妻形成和坚持详细的预防保健计划的初步效果，该计划包含循证策略，并随着时间的推移与他们明确的性协议保持一致。此外，还将评估注册和保留的可行性以及夫妇对 P3 的接受程度：研究实施了一项为期 6 个月的前瞻性试点 RCT，其中有 3 个月的延迟对照条件。基线结束后，60 对注册的 SMM 夫妇将被随机分配到两种条件中的一种。随机进入非匹配延迟对照条件的夫妇将在 3 个月评估后的试验最后 3 个月中获得 P3 DHI。被随机选入即时干预条件的夫妇将立即获得 P3 DHI，使用期为 6 个月。研究评估将在基线、第 3 个月和第 6 个月进行。为实现具体目标，将使用广义线性混合效应模型、多层次模型和行为主体-伴侣相互依赖模型进行描述性分析、比较分析、定性分析和纵向分析：为期 6 个月的试点 RCT 正在进行中。招募、注册和数据收集工作于 2023 年 1 月开始，2024 年 4 月结束。共有 74 对成年顺性别 SMM 夫妇符合所有纳入标准，提供了同意书，并被纳入试点 RCT。第 6 个月的保留率为 92%（68/74）。目前正在对数据进行分析，以实现可行性、可接受性和初步疗效这三个具体目标：这项研究的结果将揭示夫妇们是否认为 P3 DHI 可以接受。研究结果还将突显 P3 DHI 通过调整预防保健计划和性协议，对夫妻双方长期控制艾滋病和其他性传播感染 (STI) 易感性的初步效果。试验结果将有助于确定 P3 DHI 的未来发展方向，同时解决当地夫妻预防和护理服务的现有差距：试验注册：ClinicalTrials.gov NCT05873855；https://clinicaltrials.gov/study/NCT05873855.International 注册报告标识符 (irrid)：DERR1-10.2196/63106。
{"title":"Assessing a Couples-Based, Digital HIV Serostatus-Neutral Intervention (Para Ti, Para Mí, Para Nosotros) for Adult Cisgender Sexual Minority Male Couples in Lima, Peru: Protocol for a 6-Month Pilot Randomized Controlled Trial.","authors":"Jason W Mitchell, Zoran Bursac, David Diaz, Edward Michael Reyes Diaz, Alfonso Silva-Santisteban, Kelika A Konda","doi":"10.2196/63106","DOIUrl":"10.2196/63106","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;HIV disproportionately affects sexual minority men (SMM; eg, gay, bisexual, and other men who have sex with men) in Lima, Peru; epidemiological data estimate that 32% to 39% of new HIV infections occur among adult cisgender SMM within primary partnerships (ie, male couples). Most HIV prevention-care research in Lima, Peru, has focused on SMM as individuals and not couples. To help address this critical gap in prevention care, we developed Para Ti, Para Mí, Para Nosotros (P3): a couples-based, digital HIV serostatus-neutral intervention (DHI) for adult cisgender SMM couples in Lima, Peru. The P3 DHI is designed to facilitate couples with skill-building, communication, decision-making, and working together to form and adhere to a detailed prevention care plan that aligns with their explicit sexual agreement. The P3 DHI is theoretically informed, self-guided, directed, sequential, and fully automated.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This pilot randomized controlled trial (RCT) aims to examine the preliminary effects of P3 on couples' formation and adherence to a detailed prevention care plan containing evidence-based strategies that also aligns with their explicit sexual agreement over time. In addition, the feasibility of enrollment and retention and couples' acceptability of P3 will be assessed.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The research implements a prospective, 6-month pilot RCT with a 3-month delayed control condition. After baseline, 60 enrolled SMM couples will be randomized to 1 of 2 conditions. Couples randomized to the unmatched, delayed control condition will receive access to the P3 DHI to use during the last 3 months of the trial after the 3-month assessment. Couples randomized to the immediate intervention condition will immediately receive access to the P3 DHI for 6 months. Study assessments will occur at baseline and months 3 and 6. Descriptive, comparative, qualitative, and longitudinal analyses using generalized linear mixed-effect, multilevel, and actor-partner interdependence models will be conducted to address the specific aims.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The 6-month pilot RCT is ongoing. Recruitment, enrollment, and data collection began in January 2023 and ended in April 2024. A total of 74 adult cisgender SMM couples met all inclusion criteria, provided consent, and were enrolled in the pilot RCT. Retention was 92% (68/74) at month 6. Data are currently being analyzed to address the 3 specific aims regarding feasibility, acceptability, and preliminary efficacy.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Findings from this research will reveal whether couples deemed the P3 DHI to be acceptable. Findings will also highlight the preliminary efficacy of the P3 DHI on couples managing their vulnerability to HIV and other sexually transmitted infections (STIs) over time via alignment of their prevention-care plan and sexual agreement. Trial findings will help shape the future direction of the P3 DH","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11502978/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142400305","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
Clinical Data Flow in Botswana Clinics: Protocol for a Mixed-Methods Assessment. 博茨瓦纳诊所的临床数据流：混合方法评估协议》。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2024-10-09 DOI: 10.2196/52411
Grey Faulkenberry, Audrey Masizana, Badisa Mosesane, Kagiso Ndlovu
<p><strong>Background: </strong>Botswana has made significant investments in its health care information infrastructure, including vertical programs for child health and nutrition, HIV care, and tuberculosis. However, effectively integrating the more than 18 systems in place for data collection and reporting has proved to be challenging. The Botswana Health Data Collaborative Roadmap Strategy (2020-24) states that "there exists parallel reporting systems and data is not integrated into the mainstream reports at the national level," seconded by the Botswana National eLearning strategy (2020), which states that "there is inadequate information flow at all levels, proliferation of systems, reporting tools are not synthesized; hence too many systems are not communicating."</p><p><strong>Objective: </strong>The objectives of this study are to (1) create a visual representation of how data are processed and the inputs and outputs through each health care system level; (2) understand how frontline workers perceive health care data sharing across existing platforms and the impact of data on health care service delivery.</p><p><strong>Methods: </strong>The setting included a varied range of 30 health care facilities across Botswana, aiming to capture insights from multiple perspectives into data flow and system integration challenges. The study design combined qualitative and quantitative methodologies, informed by the rapid assessment process and the technology assessment model for resource limited settings. The study used a participatory research approach to ensure comprehensive stakeholder engagement from its inception. Survey instruments were designed to capture the intricacies of data processing, sharing, and integration among health care workers. A purposive sampling strategy was used to ensure a wide representation of participants across different health care roles and settings. Data collection used both digital surveys and in-depth interviews. Preliminary themes for analysis include perceptions of the value of health care data and experiences in data collection and sharing. Ethical approvals were comprehensively obtained, reflecting the commitment to uphold research integrity and participant welfare throughout the study.</p><p><strong>Results: </strong>The study recruited almost 44 health care facilities, spanning a variety of health care facilities. Of the 44 recruited facilities, 27 responded to the surveys and participated in the interviews. A total of 75% (112/150) of health care professionals participating came from clinics, 20% (30/150) from hospitals, and 5% (8/150) from health posts and mobile clinics. As of October 10, 2023, the study had collected over 200 quantitative surveys and conducted 90 semistructured interviews.</p><p><strong>Conclusions: </strong>This study has so far shown enthusiastic engagement from the health care community, underscoring the relevance and necessity of this study's objectives. We believe the methodology, cent
背景：博茨瓦纳对其医疗保健信息基础设施进行了大量投资，包括儿童健康与营养、艾滋病护理和结核病等垂直项目。然而，有效整合现有的 18 个以上的数据收集和报告系统已被证明是一项挑战。博茨瓦纳健康数据合作路线图战略（2020-24 年）》指出："存在并行的报告系统，数据未被纳入国家层面的主流报告。"《博茨瓦纳国家电子学习战略（2020 年）》也指出："各个层面的信息流不足，系统激增，报告工具不综合；因此，太多系统无法沟通：本研究的目标是：(1) 创建一个可视化的表述方式，说明数据是如何通过医疗保健系统的各个层级进行处理和输入输出的；(2) 了解一线工作者如何看待现有平台上的医疗保健数据共享，以及数据对医疗保健服务提供的影响：研究环境包括博茨瓦纳各地的 30 家医疗机构，旨在从多个角度了解数据流和系统整合方面的挑战。研究设计结合了定性和定量方法，并借鉴了快速评估流程和资源有限环境下的技术评估模型。研究采用参与式研究方法，确保利益相关者从一开始就全面参与。调查工具的设计旨在捕捉医护人员之间数据处理、共享和整合的复杂性。研究采用了有目的的抽样策略，以确保不同医护角色和环境的参与者具有广泛的代表性。数据收集采用了数字调查和深度访谈两种方式。初步的分析主题包括对医疗数据价值的看法以及在数据收集和共享方面的经验。研究获得了全面的伦理批准，体现了在整个研究过程中维护研究完整性和参与者福利的承诺：研究招募了近 44 家医疗机构，涵盖了各种医疗机构。在招募的 44 家医疗机构中，有 27 家回应了调查并参与了访谈。参与访谈的医护人员中，75%（112/150）来自诊所，20%（30/150）来自医院，5%（8/150）来自卫生站和流动诊所。截至 2023 年 10 月 10 日，该研究共收集了 200 多份定量调查问卷，并进行了 90 次半结构式访谈：到目前为止，这项研究得到了卫生保健界的热情参与，突出了这项研究目标的相关性和必要性。我们相信，以广泛的社区参与为核心的研究方法对于深入了解医疗数据生态系统至关重要。现在，重点将转移到研究的分析阶段，目的是为改善博茨瓦纳医疗保健系统内的数据流提出全面建议：DERR1-10.2196/52411。
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引用次数: 0
Acupuncture as Adjuvant Therapy for Glaucoma: Protocol for a Randomized Controlled Trial. 针灸作为青光眼的辅助疗法：随机对照试验方案》。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2024-10-08 DOI: 10.2196/57888
Yi-Fang Liao, Yu-Chen Lee, Hui-Ju Lin, Yi-Ching Shao

Background: Glaucoma is a chronic progressive optic neuropathy that necessitates lifelong treatment to reduce the decline of the optic nerve. Due to the extended and continuous treatments required for patients, complementary therapies are often considered alongside conventional treatments to enhance the effectiveness of the treatment. Acupuncture has demonstrated the potential to lower intraocular pressure in previous clinical trials, making it a promising glaucoma intervention.

Objective: The primary objective of this study is to conduct a single-center randomized control trial involving patients with glaucoma. Acupuncture will be evaluated as an adjunctive therapy. The trial aims to explore its effectiveness for glaucoma.

Methods: In this single-center randomized controlled trial, participants (N=50) with primary open-angle glaucoma will be randomly assigned to the treatment group, receiving ophthalmic acupuncture with "De Qi" sensation, or the control group, receiving minimum acupuncture stimulation on nonophthalmic acupoints. The intervention will consist of weekly acupuncture treatments for a total of 6 sessions. Participants will be assessed at 8 time points, which are baseline, during the intervention (6 times), and at a 3-month follow-up. The primary outcome measure is a change in the intraocular pressure before and after each acupuncture treatment. Secondary outcomes will include measurements of heart rate and blood pressure before and after acupuncture, best-corrected visual acuity, visual field, optical coherence tomography, optical coherence tomography angiography, the Glaucoma Symptom Scale, and the Glaucoma Quality of Life-15 questionnaire.

Results: Recruitment of participants for the trial commenced on June 28, 2023. A total of 10 participants have been enrolled to test the feasibility of the experiment. We anticipate that the preliminary data from this trial will be completed by December 2025.

Conclusions: This trial uses rigorous methodology and comprehensive outcome measurements to assess the clinical efficacy of acupuncture as an adjunctive therapy for glaucoma, providing valuable insights for future clinical treatment guidelines.

Trial registration: ClinicalTrials.gov NCT05753137; https://clinicaltrials.gov/study/NCT05753137.

International registered report identifier (irrid): DERR1-10.2196/57888.

背景：青光眼是一种慢性进行性视神经病变，需要终生治疗以减少视神经的衰退。由于患者需要长期持续接受治疗，辅助疗法往往与传统疗法并用，以提高治疗效果。在以往的临床试验中，针灸已被证明具有降低眼压的潜力，是一种很有前景的青光眼干预方法：本研究的主要目的是对青光眼患者进行单中心随机对照试验。针灸将作为一种辅助疗法进行评估。试验旨在探讨针灸对青光眼的疗效：在这项单中心随机对照试验中，患有原发性开角型青光眼的参与者（N=50）将被随机分配到治疗组（接受具有 "得气 "感觉的眼部针灸）或对照组（接受非眼部穴位的最低针灸刺激）。干预措施包括每周一次的针灸治疗，共 6 次。参与者将在 8 个时间点接受评估，分别是基线、干预期间（6 次）和 3 个月的随访。主要结果是每次针灸治疗前后眼压的变化。次要结果包括针灸前后的心率和血压测量、最佳矫正视力、视野、光学相干断层扫描、光学相干断层血管造影、青光眼症状量表和青光眼生活质量-15问卷：试验于 2023 年 6 月 28 日开始招募参与者。共招募了 10 名参与者，以测试试验的可行性。我们预计该试验的初步数据将于 2025 年 12 月完成：本试验采用严格的方法和全面的结果测量来评估针灸作为青光眼辅助疗法的临床疗效，为未来的临床治疗指南提供有价值的见解：试验注册：ClinicalTrials.gov NCT05753137；https://clinicaltrials.gov/study/NCT05753137.International 注册报告标识符 (irrid)：DERR1-10.2196/57888。
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引用次数: 0
Investigating Exposure and Hazards of Micro- and Nanoplastics During Pregnancy and Early Life (AURORA Project): Protocol for an Interdisciplinary Study. 调查孕期和生命早期接触微塑料和纳米塑料的情况及其危害（AURORA 项目）：跨学科研究协议。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2024-10-08 DOI: 10.2196/63176
Amanda M Durkin, Runyu Zou, Justin M Boucher, Matthew Sp Boyles, Jeske van Boxel, Mariona Bustamante, Emily A Christopher, Payam Dadvand, Hanna M Dusza, Majorie van Duursen, Markus M Forsberg, Karen S Galea, Juliette Legler, Laurens Db Mandemaker, Florian Meirer, Jane Muncke, Tim S Nawrot, Petra Přibylová, Anna R Robuck, Nelly D Saenen, Barbara M Scholz-Böttcher, Kuanliang Shao, Martine Vrijheid, Douglas I Walker, Lisa Zimmermann, Laura M Zoutendijk, Virissa Lenters, Roel Vermeulen

Background: Micro- and nanoplastics (MNPs) are emerging pollutants of concern with ubiquitous presence in global ecosystems. MNPs pose potential implications for human health; however, the health impacts of MNP exposures are not yet understood. Recent evidence suggests that MNPs can cross the placental barrier, underlying the urgent need to understand their impact on reproductive health and development.

Objective: The Actionable eUropean ROadmap for early-life health Risk Assessment of micro- and nanoplastics (AURORA) project will investigate MNP exposures and their biological and health effects during pregnancy and early life, which are critical periods due to heightened vulnerability to environmental stressors. The AURORA project will enhance exposure assessment capabilities for measuring MNPs, MNP-associated chemicals, and plastic additives in human tissues, including placenta and blood.

Methods: In this interdisciplinary project, we will advance methods for in-depth characterization and scalable chemical analytical strategies, enabling high-resolution and large-scale toxicological, exposure assessment, and epidemiological studies. The AURORA project performs observational studies to investigate determinants and health impacts of MNPs by including 800 mother-child pairs from 2 existing birth cohorts and 110 women of reproductive age from a newly established cohort. This will be complemented by toxicological studies using a tiered-testing approach and epidemiological investigations to evaluate associations between maternal and prenatal MNP exposures and health perturbations, such as placental function, immune-inflammatory responses, oxidative stress, accelerated aging, endocrine disruption, and child growth and development. The ultimate goal of the AURORA project is to create an MNP risk assessment framework and identify the remaining knowledge gaps and priorities needed to comprehensively assess the impact of MNPs on early-life health.

Results: In the first 3 years of this 5-year project (2021-2026), progress was made toward all objectives. This includes completion of recruitment and data collection for new and existing cohorts, development of analytical methodological protocols, and initiation of the toxicological tiered assessments. As of September 2024, data analysis is ongoing and results are expected to be published starting in 2025.

Conclusions: As plastic pollution increases globally, it is imperative to understand the impact of MNPs on human health, particularly during vulnerable developmental stages such as early life. The contributions of the AURORA project will inform future risk assessment.

International registered report identifier (irrid): DERR1-10.2196/63176.

背景：微塑料和纳米塑料（MNPs）是新出现的令人担忧的污染物，在全球生态系统中无处不在。MNPs 对人类健康具有潜在影响；然而，人们尚未了解接触 MNP 对健康的影响。最近的证据表明，MNPs 可穿过胎盘屏障，因此迫切需要了解其对生殖健康和发育的影响：微塑料和纳米塑料早期生命健康风险评估可操作欧洲路线图（AURORA）项目将调查怀孕和早期生命期间的 MNP 暴露及其对生物和健康的影响。AURORA 项目将提高暴露评估能力，测量人体组织（包括胎盘和血液）中的 MNP、MNP 相关化学品和塑料添加剂：在这一跨学科项目中，我们将推进深入表征的方法和可扩展的化学分析策略，从而实现高分辨率和大规模的毒理学、暴露评估和流行病学研究。AURORA 项目将开展观察性研究，调查 MNPs 的决定因素和对健康的影响，研究对象包括现有 2 个出生队列中的 800 对母子和新建立队列中的 110 名育龄妇女。此外，还将采用分层测试方法进行毒理学研究，并开展流行病学调查，以评估母体和产前暴露于 MNP 与健康干扰（如胎盘功能、免疫炎症反应、氧化应激、加速衰老、内分泌紊乱以及儿童生长发育）之间的关联。AURORA 项目的最终目标是建立一个 MNP 风险评估框架，并确定全面评估 MNP 对生命早期健康影响所需的其余知识差距和优先事项：在该 5 年期项目的前 3 年（2021-2026 年），所有目标都取得了进展。这包括完成新队列和现有队列的招募和数据收集、制定分析方法协议以及启动毒理学分层评估。截至 2024 年 9 月，数据分析正在进行中，预计将于 2025 年开始公布结果：随着全球塑料污染的加剧，当务之急是了解 MNPs 对人类健康的影响，尤其是在生命早期等脆弱的发育阶段。AURORA 项目的贡献将为未来的风险评估提供参考：DERR1-10.2196/63176。
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引用次数: 0
Development and Evaluation of the Telehealth in Motor Neuron Disease System: The TIME Study Protocol. 运动神经元疾病远程保健系统的开发与评估：TIME 研究协议》。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2024-10-08 DOI: 10.2196/57685
Liam Knox, Elizabeth Coates, Alys Griffiths, Yasmin Ali, Esther Hobson, Christopher McDermott
<p><strong>Background: </strong>For more responsive care provision for motor neuron disease and caregivers, a digital system called Telehealth in MND-Care (TiM-C) was created. TiM-C sends regular symptom questionnaires to users; their responses are sent to health care professionals (HCPs). To enable people with motor neuron disease to participate in research studies more easily, a parallel platform was developed from TiM-C, called Telehealth in MND-Research (TiM-R). TiM-R can advertise studies, collect data, and make them available to MND researchers.</p><p><strong>Objective: </strong>This study has 4 work packages (WPs) to facilitate service approval, codevelop the TiM systems, and evaluate the service. Each WP aims to understand (1) what helps and hinders the approval of the TiM-C system as a National Health Service; (2) what aspects of MND care and research are currently unmet and can be addressed through the TiM-C and TiM-R systems; (3) how TiM-C influences MND care, from the perspective of people with motor neuron disease, their caregivers, and HCPs; and (4) the costs and benefits associated with TiM-C.</p><p><strong>Methods: </strong>WP1 will use semistructured interviews with 10-15 people involved in the approval of TiM-C to understand the barriers and facilitators to governance processes. WP2 will use individual and group interviews with 25-35 users (people with motor neuron disease, caregivers, HCPs, MND researchers, and industry) of TiM-C and TiM-R to understand the current unmet needs of these user groups and how TiM services can be developed to meet these needs. WP3 will use a process evaluation involving 5 elements; local context, engagement, user experiences, service impact, and mechanisms of action. A range of methods, including audits, analysis of routine data, questionnaires, interviews, and observations will be used with people with motor neuron disease, caregivers, and HCPs, both those using the system and those who declined the service when invited. WP4 will use data collected through the process evaluation and known costs to conduct a cost-consequence and budget impact analysis to explore the cost-benefit of the TiM-C service. Most data collected will be qualitative, with thematic and framework analysis used to develop themes from transcripts and observations. Descriptive statistics or t tests and chi-square tests will be used to describe and analyze quantitative data.</p><p><strong>Results: </strong>This study has received ethical approval and has begun recruitment in 1 site. Further, 13 specialist MND centers will adopt TiM-C and the TIME study, beginning in July 2024. The study will conclude in November 2026 and a final report will be produced 3 months after the completion date.</p><p><strong>Conclusions: </strong>This study will facilitate the implementation and development of TiM-C and TiM-R and fully evaluate the TiM-C service, enabling informed decision-making among health care providers regarding continued involvement
背景：为了给运动神经元疾病患者和护理人员提供更有针对性的护理，我们创建了一个名为 "MND 护理中的远程保健"（Telehealth in MND-Care，TiM-C）的数字系统。TiM-C 会定期向用户发送症状调查问卷，并将用户的回复发送给医疗保健专业人员 (HCP)。为了让运动神经元病患者更方便地参与研究，在 TiM-C 的基础上开发了一个并行平台，名为 Telehealth in MND-Research (TiM-R)。TiM-R 可以发布研究广告、收集数据并提供给 MND 研究人员：本研究有 4 个工作包（WPs），以促进服务审批、TiM 系统的编码开发和服务评估。每个工作包旨在了解：（1）TiM-C 系统作为国家医疗服务获得批准的帮助和阻碍因素；（2）MND 护理和研究的哪些方面目前尚未得到满足，可通过 TiM-C 和 TiM-R 系统加以解决；（3）从运动神经元病患者、其护理者和 HCPs 的角度看，TiM-C 如何影响 MND 护理；以及（4）与 TiM-C 相关的成本和效益：WP1将对参与TiM-C审批的10-15人进行半结构化访谈，以了解治理过程中的障碍和促进因素。WP2将对TiM-C和TiM-R的25-35名用户（运动神经元疾病患者、护理人员、HCPs、MND研究人员和行业）进行个人和小组访谈，以了解这些用户群体当前未满足的需求，以及如何开发TiM服务以满足这些需求。WP3 将采用过程评估，包括 5 个要素：当地环境、参与、用户体验、服务影响和行动机制。将对运动神经元病患者、护理人员和保健医生（包括使用该系统的人员和应邀拒绝接受服务的人员）采用一系列方法，包括审计、常规数据分析、问卷调查、访谈和观察。WP4 将使用通过过程评估收集的数据和已知成本进行成本后果和预算影响分析，以探讨 TiM-C 服务的成本效益。收集到的大部分数据将是定性的，使用主题分析和框架分析来从记录和观察中确定主题。描述性统计或 t 检验和卡方检验将用于描述和分析定量数据：本研究已获得伦理批准，并已开始在 1 个地点进行招募。此外，从 2024 年 7 月开始，13 个专业 MND 中心将采用 TiM-C 和 TIME 研究。该研究将于 2026 年 11 月结束，并在结束日期后 3 个月编写最终报告：这项研究将促进 TiM-C 和 TiM-R 的实施和发展，并对 TiM-C 服务进行全面评估，使医疗服务提供者能够在知情的情况下决定是否继续参与，并为更广泛的有关技术辅助护理服务如何影响临床护理的文献做出贡献：DERR1-10.2196/57685。
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引用次数: 0
Investigating Data Diversity and Model Robustness of AI Applications in Palliative Care and Hospice: Protocol for Scoping Review. 调查姑息治疗和安宁疗护中人工智能应用的数据多样性和模型稳健性：范围审查协议》。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2024-10-08 DOI: 10.2196/56353
Selen Bozkurt, Soraya Fereydooni, Irem Kar, Catherine Diop Chalmers, Sharon L Leslie, Ravi Pathak, Anne Walling, Charlotta Lindvall, Karl Lorenz, Tammie Quest, Karleen Giannitrapani, Dio Kavalieratos

Background: Artificial intelligence (AI) has become a pivotal element in health care, leading to significant advancements across various medical domains, including palliative care and hospice services. These services focus on improving the quality of life for patients with life-limiting illnesses, and AI's ability to process complex datasets can enhance decision-making and personalize care in these sensitive settings. However, incorporating AI into palliative and hospice care requires careful examination to ensure it reflects the multifaceted nature of these settings.

Objective: This scoping review aims to systematically map the landscape of AI in palliative care and hospice settings, focusing on the data diversity and model robustness. The goal is to understand AI's role, its clinical integration, and the transparency of its development, ultimately providing a foundation for developing AI applications that adhere to established ethical guidelines and principles.

Methods: Our scoping review involves six stages: (1) identifying the research question; (2) identifying relevant studies; (3) study selection; (4) charting the data; (5) collating, summarizing, and reporting the results; and (6) consulting with stakeholders. Searches were conducted across databases including MEDLINE through PubMed, Embase.com, IEEE Xplore, ClinicalTrials.gov, and Web of Science Core Collection, covering studies from the inception of each database up to November 1, 2023. We used a comprehensive set of search terms to capture relevant studies, and non-English records were excluded if their abstracts were not in English. Data extraction will follow a systematic approach, and stakeholder consultations will refine the findings.

Results: The electronic database searches conducted in November 2023 resulted in 4614 studies. After removing duplicates, 330 studies were selected for full-text review to determine their eligibility based on predefined criteria. The extracted data will be organized into a table to aid in crafting a narrative summary. The review is expected to be completed by May 2025.

Conclusions: This scoping review will advance the understanding of AI in palliative care and hospice, focusing on data diversity and model robustness. It will identify gaps and guide future research, contributing to the development of ethically responsible and effective AI applications in these settings.

International registered report identifier (irrid): DERR1-10.2196/56353.

背景：人工智能（AI）已成为医疗保健领域的关键要素，在包括姑息治疗和临终关怀服务在内的各个医疗领域都取得了重大进展。这些服务的重点是改善患有局限生命疾病的病人的生活质量，而人工智能处理复杂数据集的能力可以在这些敏感环境中加强决策和个性化护理。然而，将人工智能纳入姑息治疗和临终关怀需要仔细研究，以确保其反映这些环境的多面性：本范围综述旨在系统地描绘姑息关怀和安宁疗护环境中的人工智能前景，重点关注数据的多样性和模型的稳健性。目的是了解人工智能的作用、临床整合及其开发的透明度，最终为开发符合既定伦理准则和原则的人工智能应用奠定基础：我们的范围界定审查包括六个阶段：(1) 确定研究问题；(2) 确定相关研究；(3) 选择研究；(4) 绘制数据图表；(5) 整理、总结和报告结果；(6) 咨询利益相关者。我们在多个数据库中进行了检索，包括 MEDLINE、PubMed、Embase.com、IEEE Xplore、ClinicalTrials.gov 和 Web of Science Core Collection，涵盖了从每个数据库建立之初到 2023 年 11 月 1 日的研究。我们使用了一套全面的检索词来获取相关研究，如果非英文记录的摘要不是英文的，则将其排除在外。数据提取将遵循系统性方法，利益相关者咨询将完善研究结果：2023 年 11 月进行的电子数据库搜索共收集到 4614 项研究。在去除重复内容后，根据预先设定的标准筛选出 330 项研究进行全文审阅，以确定其是否符合条件。提取的数据将整理成表格，以帮助撰写叙述性摘要。综述预计将于 2025 年 5 月完成：本次范围界定综述将促进对姑息关怀和安宁疗护中人工智能的了解，重点关注数据多样性和模型的稳健性。国际注册报告标识符（irrid）：DERR1-10.2196/56353。
{"title":"Investigating Data Diversity and Model Robustness of AI Applications in Palliative Care and Hospice: Protocol for Scoping Review.","authors":"Selen Bozkurt, Soraya Fereydooni, Irem Kar, Catherine Diop Chalmers, Sharon L Leslie, Ravi Pathak, Anne Walling, Charlotta Lindvall, Karl Lorenz, Tammie Quest, Karleen Giannitrapani, Dio Kavalieratos","doi":"10.2196/56353","DOIUrl":"10.2196/56353","url":null,"abstract":"<p><strong>Background: </strong>Artificial intelligence (AI) has become a pivotal element in health care, leading to significant advancements across various medical domains, including palliative care and hospice services. These services focus on improving the quality of life for patients with life-limiting illnesses, and AI's ability to process complex datasets can enhance decision-making and personalize care in these sensitive settings. However, incorporating AI into palliative and hospice care requires careful examination to ensure it reflects the multifaceted nature of these settings.</p><p><strong>Objective: </strong>This scoping review aims to systematically map the landscape of AI in palliative care and hospice settings, focusing on the data diversity and model robustness. The goal is to understand AI's role, its clinical integration, and the transparency of its development, ultimately providing a foundation for developing AI applications that adhere to established ethical guidelines and principles.</p><p><strong>Methods: </strong>Our scoping review involves six stages: (1) identifying the research question; (2) identifying relevant studies; (3) study selection; (4) charting the data; (5) collating, summarizing, and reporting the results; and (6) consulting with stakeholders. Searches were conducted across databases including MEDLINE through PubMed, Embase.com, IEEE Xplore, ClinicalTrials.gov, and Web of Science Core Collection, covering studies from the inception of each database up to November 1, 2023. We used a comprehensive set of search terms to capture relevant studies, and non-English records were excluded if their abstracts were not in English. Data extraction will follow a systematic approach, and stakeholder consultations will refine the findings.</p><p><strong>Results: </strong>The electronic database searches conducted in November 2023 resulted in 4614 studies. After removing duplicates, 330 studies were selected for full-text review to determine their eligibility based on predefined criteria. The extracted data will be organized into a table to aid in crafting a narrative summary. The review is expected to be completed by May 2025.</p><p><strong>Conclusions: </strong>This scoping review will advance the understanding of AI in palliative care and hospice, focusing on data diversity and model robustness. It will identify gaps and guide future research, contributing to the development of ethically responsible and effective AI applications in these settings.</p><p><strong>International registered report identifier (irrid): </strong>DERR1-10.2196/56353.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11496913/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142390639","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
Family-Centered Treatment Program for Problematic Gaming and Excessive Screen Use in a Clinical Child and Youth Population (FAME): Protocol for a Feasibility Pilot Mixed Method Study. 以家庭为中心的临床儿童和青少年问题性游戏和屏幕过度使用治疗计划（FAME）：可行性试点混合方法研究协议》。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2024-10-08 DOI: 10.2196/56387
Marie Werner, Sabina Kapetanovic, Emma Claesdotter-Knutsson
<p><strong>Background: </strong>Screen time among children and adolescents has increased dramatically, raising concerns about its impact on development and mental health. While research highlights both potential benefits and risks, excessive use has been linked to issues like anxiety, depression, and gaming addiction. Despite growing concern, effective interventions are scarce. Recognizing the importance of family dynamics in child development, we propose a family-centered program to address problematic gaming and excessive screen use in a clinical population. By involving both children and parents, we aim to create a more comprehensive approach to prevention and treatment.</p><p><strong>Objective: </strong>This study aims to determine the possibility of distributing and evaluating a family-centered group program for problematic gaming and excessive screen use (FAME) in a clinical child and adolescent psychiatry (CAP) population. We will monitor the recruitment rate; track the retention and attendance rates of both parents and children; and assess whether each session's objectives are met, the content is delivered within the allotted time, and the necessary resources (eg, facilitators and materials) are available. Additionally, we will gather qualitative and quantitative feedback from participants through postprogram surveys and individual interviews with both children and parents.</p><p><strong>Methods: </strong>A total of 10 families with ongoing contact with CAP in Skåne, Sweden, will be recruited and offered participation in a family-centered group program targeting children aged 10-18 years with reported difficulties regarding screen gaming or screen use. The intervention to be tested is a newly developed, family-centered, psychoeducational, cognitive behavioral therapy-based intervention addressing both positive and negative aspects of screen use; setting boundaries; the connection between thoughts, feelings, and behaviors; conflict triggers; and sleep hygiene. The primary goal of the pilot study is to test the feasibility of the program, as well as recruitment and the analysis of participants' experiences with the program.</p><p><strong>Results: </strong>A total of 11 children and their parents were enrolled during first quarter of 2024. A 4-session pilot was delivered in first quarter of 2024, and the first results are expected in the third quarter of 2024.</p><p><strong>Conclusions: </strong>The overarching goal of this pilot study is to determine the possibility of distributing and evaluating a family-centered group program for problematic gaming and excessive screen use (FAME) in a clinical CAP population. The insights gained from this study will guide our future research, which will focus on conducting a larger-scale evaluation of the intervention's impact on family screen time conflicts and inform future strategies for the implementation of family-centered interventions in child and youth clinics.</p><p><strong>Trial registration: </
背景：儿童和青少年使用屏幕的时间急剧增加，引发了人们对其对发育和心理健康影响的担忧。虽然研究强调了潜在的益处和风险，但过度使用屏幕与焦虑、抑郁和游戏成瘾等问题有关。尽管人们越来越关注这一问题，但有效的干预措施却很少。认识到家庭动态对儿童发展的重要性，我们提出了一项以家庭为中心的计划，以解决临床人群中存在的游戏和过度使用屏幕的问题。通过让儿童和家长共同参与，我们旨在创建一种更全面的预防和治疗方法：本研究旨在确定是否有可能在临床儿童和青少年精神病学（CAP）人群中推广和评估一项针对问题游戏和过度使用屏幕（FAME）的以家庭为中心的小组计划。我们将监测招募率；跟踪家长和孩子的保留率和出席率；评估是否达到了每节课的目标，是否在规定时间内完成了内容，以及是否提供了必要的资源（如主持人和材料）。此外，我们还将通过计划后调查以及对儿童和家长的个别访谈，收集参与者的定性和定量反馈意见：方法：我们将在瑞典斯科纳招募 10 个与 CAP 有持续接触的家庭，让他们参加一项以家庭为中心的小组项目，该项目针对 10-18 岁在屏幕游戏或屏幕使用方面有困难的儿童。要测试的干预措施是一种新开发的、以家庭为中心的心理教育认知行为疗法干预措施，涉及屏幕使用的积极和消极方面；设定界限；思想、情感和行为之间的联系；冲突触发因素；以及睡眠卫生。试点研究的主要目的是测试该计划的可行性，以及招募和分析参与者对该计划的体验：结果：在 2024 年第一季度，共有 11 名儿童及其父母报名参加。在 2024 年第一季度进行了为期 4 节课的试点，预计在 2024 年第三季度取得初步成果：本试点研究的总体目标是确定在临床 CAP 群体中推广和评估以家庭为中心的游戏和屏幕过度使用（FAME）问题小组计划的可能性。从这项研究中获得的见解将指导我们今后的研究，重点是对干预措施对家庭屏幕时间冲突的影响进行更大规模的评估，并为今后在儿童和青少年诊所实施以家庭为中心的干预措施提供参考：试验注册：ClinicalTrials.gov NCT06098807；https://clinicaltrials.gov/study/NCT06098807.International 注册报告标识符 (irrid)：DERR1-10.2196/56387。
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引用次数: 0
Outcomes of Patients With Early and Locally Advanced Lung Cancer: Protocol for the Italian Lung Cancer Observational Study (LUCENT). 早期和局部晚期肺癌患者的预后：意大利肺癌观察性研究（LUCENT）方案》。
IF 1.4 Q3 HEALTH CARE SCIENCES & SERVICES
JMIR Research Protocols
Pub Date : 2024-10-08 DOI: 10.2196/57183
Luca Bertolaccini, Oriana Ciani, Marco Lucchi, Francesco Zaraca, Alessandro Bertani, Roberto Crisci, Lorenzo Spaggiari
<p><strong>Background: </strong>Lung cancer, predominantly non-small cell lung cancer (NSCLC), remains a formidable challenge, necessitating an in-depth understanding of evolving treatment paradigms. The Italian Lung Cancer Observational Study (LUCENT) addresses this need by investigating the outcomes of patients with early and locally advanced lung cancer in Italy.</p><p><strong>Objective: </strong>With a focus on real-world data and patient registries, this study aims to provide comprehensive insights into clinical, psychosocial, and economic impacts, contributing to informed decision-making in health care.</p><p><strong>Methods: </strong>LUCENT is a prospective observational multicenter cohort study enrolling patients eligible for minimally invasive manual, robot-assisted, or traditional open surgery. The study will develop a web-based registry to collect longitudinal surgical, oncological, and socioeconomic outcome data. The primary objectives include performance assessment through the establishment of national benchmarks based on risk-adjusted outcomes and processes of care indicators. The secondary objectives encompass economic and psychosocial impact assessments of innovative technologies and treatment pathways. The multicenter design ensures a diverse and representative study population.</p><p><strong>Results: </strong>The evolving landscape of NSCLC treatment necessitates a nuanced approach with consideration of the dynamic shifts in therapeutic strategies. LUCENT strives to fill existing knowledge gaps by providing a platform for collecting and analyzing real-world data, emphasizing the importance of patient-reported outcomes in enhancing the understanding of the disease. By developing a web-based registry, the study not only facilitates efficient data collection but also addresses the limitations of traditional methods, such as suboptimal response rates and costs associated with paper-and-pencil questionnaires. Recruitment will be conducted from January 01, 2024, to December 31, 2026. Follow-up will be performed for a minimum of 2 years. The study will be completed in the year 2028.</p><p><strong>Conclusions: </strong>LUCENT's potential implications are substantial. Establishing national benchmarks will enable a thorough evaluation of outcomes and care processes, guiding clinicians and policymakers in optimizing patient management. Furthermore, the study's secondary objectives, focusing on economic and psychosocial impacts, align with the contemporary emphasis on holistic cancer care. Insights gained from this study may influence treatment strategies, resource utilization, and patient well-being, thereby contributing to the ongoing refinement of lung cancer management.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05851755; https://clinicaltrials.gov/study/NCT05851755. ISRCTN 67197140; https://www.isrctn.com/ISRCTN67197140.</p><p><strong>International registered report identifier (irrid): </strong>PRR1-10.2196/57183.
背景：肺癌，主要是非小细胞肺癌（NSCLC），仍然是一项艰巨的挑战，需要深入了解不断发展的治疗模式。意大利肺癌观察研究（LUCENT）通过调查意大利早期和局部晚期肺癌患者的治疗效果来满足这一需求：本研究以真实世界数据和患者登记为重点，旨在全面了解临床、社会心理和经济影响，为医疗保健领域的知情决策做出贡献：LUCENT是一项前瞻性多中心队列观察研究，招募符合微创人工、机器人辅助或传统开放手术条件的患者。该研究将开发一个基于网络的登记系统，以收集纵向的手术、肿瘤和社会经济结果数据。主要目标包括根据风险调整后的结果和护理流程指标建立国家基准，从而进行绩效评估。次要目标包括创新技术和治疗路径的经济和社会心理影响评估。多中心设计确保了研究对象的多样性和代表性：NSCLC治疗领域不断发展，因此有必要采用细致入微的方法，考虑治疗策略的动态变化。LUCENT 致力于填补现有的知识空白，提供了一个收集和分析真实世界数据的平台，强调了患者报告的结果对加深对疾病的了解的重要性。通过开发基于网络的登记系统，该研究不仅提高了数据收集的效率，还解决了传统方法的局限性，如回复率不理想和与纸笔问卷相关的成本问题。招募时间为 2024 年 1 月 1 日至 2026 年 12 月 31 日。随访时间至少为 2 年。研究将于 2028 年完成：LUCENT 的潜在影响是巨大的。建立国家基准将有助于对结果和护理流程进行全面评估，从而指导临床医生和决策者优化患者管理。此外，该研究的次要目标是关注经济和社会心理影响，这与当代对癌症综合治疗的重视不谋而合。从这项研究中获得的启示可能会影响治疗策略、资源利用和患者福祉，从而促进肺癌管理的不断完善：试验注册：ClinicalTrials.gov NCT05851755；https://clinicaltrials.gov/study/NCT05851755。ISRCTN 67197140; https://www.isrctn.com/ISRCTN67197140.International registered report identifier (irrid)：PRR1-10.2196/57183。
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