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Correction: Smartphone App-Based Eating Behavior Monitoring and Feedback Intervention for Glucocorticoid-Induced Appetite Increase in Patients With Systemic Lupus Erythematosus: Protocol for a Pilot Randomized Controlled Trial. 更正:基于智能手机应用程序的饮食行为监测和反馈干预糖皮质激素诱导的系统性红斑狼疮患者食欲增加:一项试点随机对照试验方案。
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-01-21 DOI: 10.2196/90010
Takashi Yamaguchi, Nobuyuki Takahashi, Ryohei Inanaga, Ryuhei So, Hiroe Kikuchi, Hisashi Noma, Hiroyuki Sasai, Kazuro Kamada, Tomohiro Sugimoto, Hiroshi Tsushima, Takanori Ichikawa, Hirofumi Miyake, Shunichi Fujita, Keisuke Ono, Yusuke Miwa, Anna Hasegawa, Naoki Suzuki, Akira Onishi, Toshihiro Matsui, Ryu Watanabe, Yasuhiro Hasegawa, Rei Ono, Takeo Isozaki, Yuichi Ishikawa, Nobuyuki Yajima, Noriaki Kurita
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引用次数: 0
International Case Studies to Identify Success Factors and Contextual Conditions in the Digital Transformation of Health Care Systems and Derive Lessons for Germany: Study Protocol for a Mixed Methods Study. 确定医疗保健系统数字化转型的成功因素和背景条件的国际案例研究,并为德国提供经验教训:混合方法研究的研究方案。
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-01-21 DOI: 10.2196/80301
Lena Kraft, Anna-Lena Brecher, Sophia Sgraja, Reinhard Busse, Volker Eric Amelung
<p><strong>Background: </strong>Germany's health care system continues to face significant challenges in its digital transformation due to outdated structures, interoperability issues, strict data protection regulations, and low user acceptance, despite numerous legislative initiatives, such as the Digital Care Act in 2019, which was intended to promote practical use and innovation. In contrast, several international health care systems have successfully advanced their digital transformation, offering valuable insights and potential lessons for the German health care system.</p><p><strong>Objective: </strong>This study, as part of the research project "NADI: Benefits and Acceptance of Digital Health," analyzes international health care systems to identify key success factors and develop pragmatic recommendations for German policymakers to enhance the country's digital health implementation.</p><p><strong>Methods: </strong>This study uses a mixed methods triangulation approach, combining case study selection, qualitative expert interviews, and a quantitative online survey to develop actionable policy recommendations for the digital transformation of health care in Germany. The study applies the conceptual framework of tipping points and success factors to identify critical factors in the digital transformation of health care systems, where certain actions or conditions fundamentally influence adoption and success. A total of more than 100 interviews were conducted with experts representing 8 stakeholder groups from 9 different health care systems. The qualitative data are evaluated using qualitative content analysis according to Kuckartz and Rädiker. In an online survey, a minimum of 305 participants from the German health care system will be surveyed regarding the relevance and feasibility of the key success factors identified in the international case studies. The dataset will be analyzed statistically using SPSS, both descriptively and inferentially (eg, subgroup analyses).</p><p><strong>Results: </strong>Between November 2024 and September 2025, interviews with international health care experts were conducted. As of October 2025, the qualitative content analysis is still ongoing. The recruitment phase for the online survey is planned from October 15 to December 15, 2025. Initial results are expected to be available in 2026. The study protocol was submitted during the qualitative data collection phase before the commencement of the quantitative survey. Analysis had not yet begun at the time of submission.</p><p><strong>Conclusions: </strong>The use of a case study methodology has been demonstrated to facilitate the acquisition of invaluable insights into international best practices, while concurrently offering the opportunity to identify specific success and failure factors. The integration of qualitative expert interviews serves to contextualize international findings on tipping points and success factors in the implementation and use of digi
背景:尽管有许多立法举措,如2019年的《数字医疗法案》,旨在促进实际使用和创新,但由于过时的结构、互操作性问题、严格的数据保护法规和低用户接受度,德国的医疗保健系统在数字化转型中继续面临重大挑战。相比之下,一些国际医疗保健系统已经成功地推进了他们的数字化转型,为德国医疗保健系统提供了宝贵的见解和潜在的经验教训。目的:作为研究项目“NADI:数字健康的好处和接受”的一部分,本研究分析了国际医疗保健系统,以确定关键的成功因素,并为德国决策者制定实用的建议,以加强该国的数字健康实施。方法:本研究采用混合方法三角测量方法,结合案例研究选择、定性专家访谈和定量在线调查,为德国医疗保健数字化转型制定可操作的政策建议。该研究应用了临界点和成功因素的概念框架,以确定医疗保健系统数字化转型中的关键因素,其中某些行动或条件从根本上影响采用和成功。与来自9个不同卫生保健系统的8个利益攸关方团体的专家共进行了100多次访谈。根据库卡兹和Rädiker的定性内容分析对定性数据进行评价。在一项在线调查中,将对来自德国卫生保健系统的至少305名参与者进行调查,以了解国际案例研究中确定的关键成功因素的相关性和可行性。数据集将使用SPSS进行统计分析,包括描述性和推理性(例如,子组分析)。结果:在2024年11月至2025年9月期间,对国际卫生保健专家进行了访谈。截至2025年10月,定性内容分析仍在进行中。在线调查的招募阶段计划于2025年10月15日至12月15日进行。初步结果预计将于2026年公布。研究方案在定量调查开始前的定性数据收集阶段提交。在提交报告时,分析尚未开始。结论:案例研究方法的使用已被证明有助于获得对国际最佳实践的宝贵见解,同时提供确定具体成功和失败因素的机会。定性专家访谈的整合有助于将关于实施和使用数字卫生工具的引爆点和成功因素的国际调查结果置于背景下。将国际结果转移到德国环境是研究项目的核心组成部分,旨在调查实际实施情况。这些方法的结合形成了为德国卫生保健系统提供具体行动建议的综合基础。
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引用次数: 0
Shared Decision-Making With a Surrogate for Life-Sustaining Treatment of Critically Ill Patients: Protocol for a Scoping Review. 危重病人维持生命治疗的替代方案共同决策:范围审查方案。
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-01-21 DOI: 10.2196/83284
Yoshiyasu Ito, Mika Moriyama, Akemi Nasu, Keiko Kamitani, Shimpei Hayashi, Satoko Ono, Yasuko Sumida, Keiko Matsumoto, Misae Ito

Background: Shared decision-making (SDM) is a collaborative process that integrates patients' values and preferences into health care decisions. In intensive care units, patients who are critically ill often lack the capacity to make decisions, necessitating surrogates to make complex choices regarding life-sustaining treatments (LSTs).

Objective: This scoping review aims to assess the range of research conducted on surrogate SDM for LSTs among patients who are critically ill over the past decade and highlight areas where current research remains limited.

Methods: This scoping review will follow the Joanna Briggs Institute methodology and adhere to the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) reporting guidelines. Studies will be included if they examine SDM involving surrogates of adult patients who are critically ill in relation to LST decisions within intensive care unit settings. SDM is defined using 4 criteria: participation of both health care professionals and surrogates, mutual information sharing, consensus building, and agreement on treatment based on the patient's values and preferences. A comprehensive search will be performed across PubMed, CINAHL, PsycInfo, CENTRAL, and Ichushi-Web for English- and Japanese-language studies published between 2016 and 2025. Eligible study designs will include quantitative, qualitative, and mixed methods research. Title and abstract screening, as well as full-text selection, will be conducted independently by 2 reviewers using Rayyan. Data will be extracted on study characteristics, SDM definitions, participant roles, and key findings. Results will be synthesized descriptively and presented in tables and narrative summaries to identify research gaps and inform future investigations.

Results: As of June 13, 2025, the literature search has been completed. A total of 2899 citations were identified through the specified database searches, and 527 (18.2%) duplicates were removed. Title and abstract screening are currently in progress, and full-text review is expected to be completed by September 2025.

Conclusions: This scoping review will systematically map recent evidence on surrogate SDM in the context of LST decisions for patients who are critically ill. By synthesizing diverse studies, it will identify challenges faced by surrogates and summarize existing interventions that aim to improve SDM processes. The findings are expected to inform future interventions and policies and advance patient- and family-centered care in critical care settings.

背景:共享决策(SDM)是一个将患者的价值观和偏好整合到医疗保健决策中的协作过程。在重症监护室,危重病人往往缺乏做决定的能力,这就需要代理人就维持生命治疗(LSTs)做出复杂的选择。目的:本综述旨在评估过去十年来在危重患者中对lst的替代SDM进行的研究范围,并突出当前研究仍然有限的领域。方法:本次范围评价将遵循Joanna Briggs研究所的方法,并遵循PRISMA-ScR(系统评价和范围评价扩展元分析的首选报告项目)报告指南。如果研究涉及重症成人患者的代理人的SDM与重症监护病房设置中的LST决定有关,则将纳入研究。SDM使用4个标准来定义:卫生保健专业人员和代理人的参与、相互信息共享、共识的建立以及基于患者价值观和偏好的治疗协议。将在PubMed, CINAHL, PsycInfo, CENTRAL和Ichushi-Web上进行全面搜索,以检索2016年至2025年间发表的英语和日语研究。合格的研究设计将包括定量、定性和混合方法研究。题目和摘要筛选以及全文选择将由2名审稿人使用Rayyan独立进行。将提取有关研究特征、SDM定义、参与者角色和主要发现的数据。将对结果进行描述性综合,并以表格和叙述性摘要的形式呈现,以确定研究差距,并为未来的调查提供信息。结果:截至2025年6月13日,文献检索已完成。通过指定的数据库检索,共鉴定出2899条引文,其中527条(18.2%)重复被删除。目前正在进行标题和摘要筛选,预计2025年9月完成全文审稿。结论:这一范围综述将系统地绘制关于替代SDM在危重患者LST决策背景下的最新证据。通过综合各种研究,它将确定替代品面临的挑战,并总结旨在改善SDM过程的现有干预措施。研究结果有望为未来的干预措施和政策提供信息,并在重症监护环境中推进以患者和家庭为中心的护理。
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引用次数: 0
Virtual Reality-Based Program for Pediatric Patients With Amblyopia: Protocol for a Multicenter, Randomized, Open-Label, Two-Arm Study. 基于虚拟现实的弱视儿童项目:一项多中心、随机、开放标签、两组研究方案。
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-01-21 DOI: 10.2196/85194
Ken Nagino, Yuichi Okumura, Masakazu Hirota, Saiko Matsumura, Tadashi Matsumoto, Takashi Negishi, Akie Midorikawa-Inomata, Makiko Ui, Takao Hayashi, Yuichi Hori, Shintaro Nakao, Takenori Inomata

Background: Conventional amblyopia treatment involves the occlusion of the fellow eye using an eye patch. However, this approach imposes a substantial psychological and physical burden on pediatric patients with amblyopia, resulting in low adherence and suboptimal visual outcomes. As responsiveness to therapy declines beyond early childhood, treatments that can enhance adherence and improve efficacy are needed. We developed a virtual reality dichoptic training app (VR app) that integrates gamification and hand-eye coordination training in pediatric patients with amblyopia.

Objective: This study investigated the effect of a VR app on visual acuity improvement in pediatric patients with amblyopia compared with conventional occlusion therapy using an eye patch.

Methods: This is a multicenter, open-label, prospective, randomized controlled trial that will be conducted at 3 centers in Tokyo, Japan. Pediatric patients aged 3-10 years with anisometropic, strabismic, or refractive amblyopia will be enrolled. Participants will be assigned 1:1 to a VR app group or a control group. The VR app group will use the VR app at home for 1 hour per day for 6 months. The control group will undergo conventional occlusion therapy with an eye patch for 6 months. Each group will comprise 15 participants (30 participants in total). Ophthalmologic examinations will be performed at baseline and at weeks 4, 8, 12, 16, 20, and 24. The primary endpoint will be the change in the best-corrected visual acuity in the amblyopic eye from baseline to week 12. Secondary endpoints will include changes in best-corrected visual acuity, stereopsis, and ocular deviation through week 24. We will also assess treatment adherence, defined as the ratio of the cumulative actual treatment time to the cumulative prescribed time; record adverse events, and evaluate usability in the VR app group. Longitudinal changes in outcome measures will be analyzed using a mixed-effects model.

Results: Participant enrollment will start from January 1, 2026, to September 30, 2026. The data analysis will begin on October 1, 2026, and the results will be reported by March 31, 2027.

Conclusions: This study will clarify the effectiveness of the newly developed VR app in improving treatment outcomes and adherence among pediatric patients with amblyopia. By addressing the limitations of conventional occlusion therapy and providing a potentially more efficacious and acceptable treatment option, the VR app may enhance clinical outcomes and represent a paradigm shift in the treatment of pediatric amblyopia.

背景:传统的弱视治疗包括用眼罩遮挡另一只眼睛。然而,这种方法给弱视儿童患者带来了巨大的心理和身体负担,导致低依从性和次优视力结果。由于儿童早期以后对治疗的反应性下降,因此需要能够增强依从性和提高疗效的治疗方法。我们开发了一款虚拟现实弱视训练应用程序(VR应用程序),将游戏化和手眼协调训练结合起来,用于弱视儿童患者。目的:本研究探讨了VR应用程序对儿童弱视患者视力改善的影响,并与传统的使用眼罩遮挡治疗进行了比较。方法:这是一项多中心、开放标签、前瞻性、随机对照试验,将在日本东京的3个中心进行。3-10岁的儿童参差、斜视或屈光性弱视患者将被纳入研究对象。参与者将以1:1的比例被分配到VR应用组或对照组。VR应用组将在6个月内每天在家使用VR应用1小时。对照组患者采用常规的眼罩遮挡治疗,疗程6个月。每组15人(共30人)。在基线和第4、8、12、16、20和24周进行眼科检查。主要终点是弱视眼的最佳矫正视力从基线到第12周的变化。次要终点包括24周最佳矫正视力、立体视和眼偏差的变化。我们还将评估治疗依从性,定义为累计实际治疗时间与累计规定时间之比;记录不良事件,评估VR应用组的可用性。结果测量的纵向变化将使用混合效应模型进行分析。结果:参与者报名将于2026年1月1日至2026年9月30日开始。数据分析将于2026年10月1日开始,结果将于2027年3月31日报告。结论:本研究将阐明新开发的VR应用程序在改善弱视儿童患者治疗结果和依从性方面的有效性。通过解决传统遮挡治疗的局限性,并提供一种潜在的更有效和可接受的治疗选择,VR应用程序可能会提高临床结果,并代表儿童弱视治疗的范式转变。
{"title":"Virtual Reality-Based Program for Pediatric Patients With Amblyopia: Protocol for a Multicenter, Randomized, Open-Label, Two-Arm Study.","authors":"Ken Nagino, Yuichi Okumura, Masakazu Hirota, Saiko Matsumura, Tadashi Matsumoto, Takashi Negishi, Akie Midorikawa-Inomata, Makiko Ui, Takao Hayashi, Yuichi Hori, Shintaro Nakao, Takenori Inomata","doi":"10.2196/85194","DOIUrl":"10.2196/85194","url":null,"abstract":"<p><strong>Background: </strong>Conventional amblyopia treatment involves the occlusion of the fellow eye using an eye patch. However, this approach imposes a substantial psychological and physical burden on pediatric patients with amblyopia, resulting in low adherence and suboptimal visual outcomes. As responsiveness to therapy declines beyond early childhood, treatments that can enhance adherence and improve efficacy are needed. We developed a virtual reality dichoptic training app (VR app) that integrates gamification and hand-eye coordination training in pediatric patients with amblyopia.</p><p><strong>Objective: </strong>This study investigated the effect of a VR app on visual acuity improvement in pediatric patients with amblyopia compared with conventional occlusion therapy using an eye patch.</p><p><strong>Methods: </strong>This is a multicenter, open-label, prospective, randomized controlled trial that will be conducted at 3 centers in Tokyo, Japan. Pediatric patients aged 3-10 years with anisometropic, strabismic, or refractive amblyopia will be enrolled. Participants will be assigned 1:1 to a VR app group or a control group. The VR app group will use the VR app at home for 1 hour per day for 6 months. The control group will undergo conventional occlusion therapy with an eye patch for 6 months. Each group will comprise 15 participants (30 participants in total). Ophthalmologic examinations will be performed at baseline and at weeks 4, 8, 12, 16, 20, and 24. The primary endpoint will be the change in the best-corrected visual acuity in the amblyopic eye from baseline to week 12. Secondary endpoints will include changes in best-corrected visual acuity, stereopsis, and ocular deviation through week 24. We will also assess treatment adherence, defined as the ratio of the cumulative actual treatment time to the cumulative prescribed time; record adverse events, and evaluate usability in the VR app group. Longitudinal changes in outcome measures will be analyzed using a mixed-effects model.</p><p><strong>Results: </strong>Participant enrollment will start from January 1, 2026, to September 30, 2026. The data analysis will begin on October 1, 2026, and the results will be reported by March 31, 2027.</p><p><strong>Conclusions: </strong>This study will clarify the effectiveness of the newly developed VR app in improving treatment outcomes and adherence among pediatric patients with amblyopia. By addressing the limitations of conventional occlusion therapy and providing a potentially more efficacious and acceptable treatment option, the VR app may enhance clinical outcomes and represent a paradigm shift in the treatment of pediatric amblyopia.</p>","PeriodicalId":14755,"journal":{"name":"JMIR Research Protocols","volume":"15 ","pages":"e85194"},"PeriodicalIF":1.5,"publicationDate":"2026-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12822861/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146018404","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
Using Alcohol and Sleep Sensors to Understand Blackout Risk in Young Adults' Natural Settings (The Lights Out Study): Protocol for an Intensive Longitudinal Pilot Study. 使用酒精和睡眠传感器了解年轻人自然环境中的停电风险(熄灯研究):一项密集纵向试点研究的协议。
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-01-21 DOI: 10.2196/83980
Veronica L Richards, Ashlea Braun, Michael R Sladek, Junru Zhao, Thad Leffingwell, Sydney Newell Chesebro, Julie M Croff

Background: Alcohol-induced blackouts (AIBs) are a serious consequence of alcohol use that are strongly associated with experiencing excess alcohol-related harms. AIBs are common and recurrent among young adults who drink. The risk factors for AIBs include dynamics of alcohol use (quantity, speed, duration), alcohol-related behaviors (eg, playing drinking games, not using protective behavioral strategies), and factors related to the subjective experience of alcohol intoxication (eg, expectancies, motivations).

Objective: This study seeks to examine 2 modifiable behaviors that have been shown to impact both alcohol consumption and subjective experiences of intoxication and may therefore be associated with AIB risk: (1) other substance use and (2) sleep.

Methods: Approximately 50 participants will be recruited to participate in this study. Interested individuals will complete an online screening assessment, and those who are eligible (young adults who report recent heavy episodic drinking and AIBs) will be invited to an in-person baseline visit. At the baseline visit, participants will complete a baseline assessment, be fitted with a wrist-worn alcohol sensor (BACtrack Skyn) and a sleep or activity ring sensor (Oura ring), and receive training on the study protocol. Participants will complete a 14-day intensive data collection period consisting of twice daily scheduled mobile surveys and participant-initiated drinking surveys with hourly follow-ups. Participants will also wear the alcohol and sleep or activity sensors continuously during this 14-day period. After the intensive data collection period ends, participants will complete an in-person return visit to return their sensors, complete a follow-up survey, and receive compensation. The data will be processed and cleaned, and analyses will include multi-level structural equation models.

Results: This study was funded in July 2025. Data collection is projected to span January 2026 through June 2026.

Conclusions: This study seeks to understand 2 key modifiable behaviors that may be associated with increased AIB risk by leveraging multiple forms of innovative measurement. The integration of ecological momentary assessments with 2 sensors to capture alcohol use and sleep also supports potential applications in future digital interventions. This study will further enhance our preliminary data on the feasibility and acceptability of these methods, providing opportunities for conducting future research on a larger scale.

背景:酒精引起的昏厥(AIBs)是酒精使用的严重后果,与经历过量的酒精相关伤害密切相关。AIBs在饮酒的年轻成年人中是常见和反复发作的。AIBs的危险因素包括酒精使用的动态(数量、速度、持续时间)、酒精相关行为(例如,玩饮酒游戏,不使用保护性行为策略)以及与酒精中毒的主观体验相关的因素(例如,预期、动机)。目的:本研究旨在研究两种可改变的行为,这两种行为已被证明会影响酒精消费和主观醉酒体验,因此可能与AIB风险相关:(1)其他物质使用和(2)睡眠。方法:将招募约50名参与者参加本研究。感兴趣的个人将完成在线筛选评估,那些符合条件的人(报告最近大量间歇性饮酒和AIBs的年轻人)将被邀请进行亲自基线访问。在基线访问时,参与者将完成基线评估,佩戴手腕佩戴的酒精传感器(BACtrack Skyn)和睡眠或活动环传感器(Oura环),并接受研究方案培训。参与者将完成为期14天的密集数据收集期,包括每日两次预定的移动调查和参与者发起的每小时随访的饮酒调查。在这14天的时间里,参与者还将连续佩戴酒精和睡眠或活动传感器。在密集的数据收集期结束后,参与者将完成亲自回访,归还传感器,完成随访调查,并获得补偿。数据将被处理和清理,分析将包括多层次结构方程模型。结果:本研究于2025年7月获得资助。数据收集预计将从2026年1月持续到2026年6月。结论:本研究旨在通过利用多种形式的创新测量来了解可能与AIB风险增加相关的两个关键可修改行为。将生态瞬时评估与2个传感器相结合,以捕捉酒精使用和睡眠情况,也支持在未来数字干预措施中的潜在应用。本研究将进一步加强我们对这些方法的可行性和可接受性的初步数据,为今后进行更大规模的研究提供机会。
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引用次数: 0
Sickle Cell Disease at a Tertiary Care Center in the Vidarbha Region of India: Protocol for a Clinical and Observational Study. 镰状细胞病在印度维达巴地区三级保健中心:临床和观察研究方案。
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-01-21 DOI: 10.2196/80483
Tanushree Budhbaware, Jaishriram Rathored

Background: More than 20 million individuals worldwide, especially in the Vidarbha region of India, are affected by sickle cell anemia (SCA), a hereditary condition that results in aberrant hemoglobin S and red blood cell distortion. The condition leads to anemia, organ complications, and recurrent pain crises, making region-specific data necessary for efficient therapy and public health initiatives.

Objective: The goal of the study is to examine the clinical characteristics and unusual manifestations of SCA in the Vidarbha region, with an emphasis on dietary practices, clinical presentations, demographic distribution, and lifestyle factors such as alcohol consumption and smoking.

Methods: This observational cross-sectional study with random sampling will be conducted at Acharya Vinoba Bhave Rural Hospital in Wardha for 3 months. We will recruit 131 individuals aged 18 to 50 years with dominant hemoglobin S and a positive sickling test. A standardized questionnaire addressing clinical symptoms, nutrition, substance use, inheritance patterns, and demographic information will be used to gather data. SPSS (version 17; IBM Corp) will be used for statistical analysis. Data will be summarized using descriptive statistics. Group differences will be evaluated using inferential tests such as 1-way ANOVA, independent 2-tailed t tests, and chi-square tests. Associations between symptoms and lifestyle variables will be investigated by correlation analysis. Statistical significance is defined as a 2-tailed P value <.05.

Results: The anticipated findings may support the need for targeted regional public health initiatives and underscore the importance of comprehensive screening, detailed patient history, and tailored care strategies for individuals with SCA. As of January 2026, this observational study has not received external funding. Participant recruitment and data collection commenced in January 2026 and are currently ongoing. Data analysis will be undertaken following completion of data collection, and the final results are expected to be submitted for publication in April 2026.

Conclusions: The findings will support the need for focused regional public health initiatives and emphasize the need for thorough screening, patient history, and customized care techniques for SCA.

背景:全世界有超过2000万人患有镰状细胞性贫血(SCA),特别是在印度的Vidarbha地区,这是一种导致血红蛋白S异常和红细胞畸变的遗传性疾病。这种疾病会导致贫血、器官并发症和复发性疼痛危机,因此需要针对特定区域的数据来进行有效治疗和采取公共卫生行动。目的:本研究的目的是检查维达巴地区SCA的临床特征和异常表现,重点是饮食习惯、临床表现、人口分布和生活方式因素,如饮酒和吸烟。方法:本观察性横断面随机抽样研究将在瓦尔达Acharya Vinoba Bhave农村医院进行为期3个月的研究。我们将招募年龄在18至50岁之间的131名显性血红蛋白S和镰状细胞试验阳性的个体。收集数据将使用一份涉及临床症状、营养、物质使用、遗传模式和人口统计信息的标准化问卷。将使用SPSS (version 17; IBM Corp)进行统计分析。数据将使用描述性统计进行汇总。采用单因素方差分析、独立双尾t检验和卡方检验等推理检验评估组间差异。将通过相关分析调查症状与生活方式变量之间的关系。结果:预期的研究结果可能支持有针对性的区域公共卫生倡议的必要性,并强调了对SCA患者进行全面筛查、详细病史和量身定制护理策略的重要性。截至2026年1月,该观察性研究尚未获得外部资助。参与者招募和数据收集于2026年1月开始,目前正在进行中。数据收集完成后将进行数据分析,预计最终结果将于2026年4月提交发表。结论:研究结果将支持有重点的区域公共卫生倡议的必要性,并强调对SCA进行彻底筛查、患者病史和定制护理技术的必要性。
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引用次数: 0
Mapping Algorithmic Bias in AI-Powered Electrocardiogram Interpretation Across the AI Life Cycle: Protocol for a Scoping Review. 在人工智能生命周期中,人工智能供电心电图解释中的映射算法偏差:范围审查方案。
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-01-20 DOI: 10.2196/82486
Luqman Lawal, Christopher Paton, Mike English, Bruno Holthof, Tabitha Preston
<p><strong>Background: </strong>Artificial intelligence (AI)-powered analysis of electrocardiograms (ECGs) is reshaping cardiac diagnostics, offering faster and often more accurate detection of conditions such as arrhythmias and heart failure. However, growing evidence suggests that algorithmic bias, defined as performance disparities across patient subgroups, may undermine diagnostic equity. These biases can emerge at any stage of the AI life cycle, including data collection, model development, evaluation, deployment, and clinical use. If unaddressed, they risk exacerbating health disparities, particularly in underrepresented populations and low-resource settings. Early identification and mitigation of such bias are essential to ensuring diagnostic equity.</p><p><strong>Objective: </strong>This scoping review protocol outlines a structured approach to mapping the evidence on algorithmic bias in AI-enabled ECG interpretation. Following the population-concept-context framework and PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidance, the planned review will systematically identify and categorize reported sources and types of bias, examine their effects on diagnostic performance across demographic and geographic subgroups, and document mitigation strategies applied throughout the AI life cycle. By synthesizing how bias and fairness considerations are handled in this field, this review aims to clarify existing evidence, highlight key gaps, and inform future efforts toward equitable and clinically trustworthy application of AI in cardiology.</p><p><strong>Methods: </strong>We will conduct a comprehensive literature search across 5 electronic databases (PubMed, Embase, Cochrane CENTRAL, CINAHL, and IEEE Xplore) and gray literature sources. Eligible studies will include original research (2015-2025) evaluating the performance of AI-based ECG models across different subgroups or reporting on bias mitigation strategies. Two reviewers will independently screen studies, extract data using a standardized form, and resolve disagreements through consensus. This review will follow the PRISMA-ScR reporting framework.</p><p><strong>Results: </strong>At the time of submission, study identification and screening has been completed. Database searches conducted in August and September 2025 yielded 430 records, with an additional 18 records identified through other sources. After duplicates removal, 398 unique records remained. Title and abstract screening led to the exclusion of 250 records, and 148 articles proceeded to full-text review. Following full-text assessment, 110 articles were evaluated for eligibility, of which 38 studies met the inclusion criteria and were included in the qualitative synthesis. The study selection process is summarized in a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flow diagram. Data extraction was conducted between November and December
背景:人工智能(AI)驱动的心电图(ecg)分析正在重塑心脏诊断,为心律失常和心力衰竭等疾病提供更快、更准确的检测。然而,越来越多的证据表明,算法偏差(定义为患者亚组之间的表现差异)可能会破坏诊断公平性。这些偏差可能出现在人工智能生命周期的任何阶段,包括数据收集、模型开发、评估、部署和临床使用。如果不加以解决,这些问题就有可能加剧健康差距,特别是在代表性不足的人口和资源匮乏的环境中。及早发现和减轻这种偏见对确保诊断公平至关重要。目的:本范围审查方案概述了一种结构化的方法来绘制人工智能心电图解释中算法偏差的证据。按照人口-概念-背景框架和PRISMA-ScR(系统评价和扩大范围的荟萃分析首选报告项目)指南,计划中的审查将系统地确定报告的偏倚来源和类型并对其进行分类,检查其对人口和地理亚组的诊断绩效的影响,并记录整个人工智能生命周期中应用的缓解战略。通过综合如何处理该领域的偏倚和公平性考虑,本综述旨在澄清现有证据,突出关键差距,并为未来在心脏病学中公平和临床可信的人工智能应用提供信息。方法:我们将在5个电子数据库(PubMed、Embase、Cochrane CENTRAL、CINAHL和IEEE explore)和灰色文献来源中进行全面的文献检索。符合条件的研究将包括原始研究(2015-2025),评估基于人工智能的ECG模型在不同亚组中的表现或报告偏倚缓解策略。两名审稿人将独立筛选研究,使用标准化表格提取数据,并通过共识解决分歧。本次审查将遵循PRISMA-ScR报告框架。结果:在提交时,研究识别和筛选已经完成。在2025年8月和9月进行的数据库搜索产生了430条记录,另外通过其他来源确定了18条记录。删除重复项后,保留了398条唯一记录。标题和摘要筛选排除了250条记录,148篇文章进行了全文审查。在全文评估之后,110篇文章被评估为合格,其中38篇研究符合纳入标准,被纳入定性综合。研究选择过程总结在PRISMA(系统评价和荟萃分析的首选报告项目)流程图中。数据提取于2025年11月至12月进行。结论:这篇综述将是第一个全面描绘人工智能心电解释中算法偏差图景的综述。通过识别不公平的模式并评估拟议的解决方案,它将为旨在促进人工智能心脏护理公平性的开发人员、临床医生和政策制定者提供可操作的见解。国际注册报告标识符(irrid): PRR1-10.2196/82486。
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引用次数: 0
Flopropione, a cysteine-conjugate-β-lyase 1 inhibitor, for prevention of cisplatin-induced nephrotoxicity: protocol for a randomized, open-label, proof-of-concept phase I/IIa trial. 氟丙酮,一种半胱氨酸偶联β裂解酶1抑制剂,用于预防顺铂引起的肾毒性:一项随机、开放标签、概念验证的I/IIa期试验方案
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-01-20 DOI: 10.2196/87907
Takenao Koseki, Masashi Kondo, Hidetsugu Fujigaki, Kayoko Kikuchi, Yuko Oya, Hiroshi Kato, Tomohiro Mizuno, Naotake Tsuboi, Kenji Kawada, Yasuhiro Goto, Naozumi Hashimoto, Kazuyoshi Imaizumi, Akiko Kada, Hikaru Yabuuchi, Kuniaki Saito, Hideyuki Saya

Background: Cisplatin-induced nephrotoxicity (CIN) is a major dose-limiting adverse event that can lead to both acute and chronic kidney injury. The formation of thiol-cisplatin conjugates within renal tubular cells has been implicated as a key mechanism underlying CIN. Flopropione is an inhibitor of cysteine conjugate β-lyase 1, an enzyme that catalyzes the formation of the thiol-cisplatin conjugate, which might prevent CIN.

Objective: We designed a clinical trial to evaluate the safety of flopropione in patients receiving cisplatin-based chemotherapy and explore its efficacy in preventing CIN.

Methods: This is a phase I/IIa, single-center, randomized, open-label trial conducted in patients undergoing cisplatin therapy. Participants are randomized at a 5:2 ratio per cohort to receive either flopropione or no treatment. On the day of cisplatin administration, the flopropione group receives oral flopropione twice daily (80 mg in Cohort 1, 160 mg in Cohort 2, and 240 mg in Cohort 3). On the following day, all cohorts receive three doses of 80 mg of oral flopropione. A step-up dose escalation design is adopted, progressing from Cohort 1 to 3 after confirming safety at each level. The primary endpoint is the safety of flopropione use in combination with cisplatin; the secondary endpoints include changes in the levels of urinary biomarkers of nephrotoxicity, such as neutrophil gelatinase-associated lipocalin, liver-type fatty acid-binding protein, and kidney injury molecule-1. Blood and urine samples are collected within 48 h before cisplatin administration and at 24 h, 48 h, and 1 week after its initiation for safety and efficacy assessments.

Results: The first participant was registered in July 2024. As of the date of manuscript submission in November 2025, participant registration is ongoing. The final participant will complete the study by March 2026. Publication of results is expected by March 2027.

Conclusions: This study is expected to contribute to advances in preventive strategies for CIN by providing evidence that inhibition of cysteine conjugate β-lyase 1 by flopropione may attenuate CIN.

Clinicaltrial: Japan Registry of Clinical Trials jRCTs041220021; https://jrct.mhlw.go.jp/en-latest-detail/jRCTs041220021.

背景:顺铂引起的肾毒性(CIN)是一种主要的剂量限制性不良事件,可导致急性和慢性肾损伤。肾小管细胞内巯基顺铂偶联物的形成被认为是CIN的一个关键机制。氟丙酮是半胱氨酸偶联β-裂解酶1的抑制剂,该酶催化巯基顺铂偶联物的形成,可能预防CIN。目的:设计一项临床试验,评价氟丙酮在以顺铂为主的化疗患者中的安全性,探讨其预防CIN的疗效。方法:这是一项I/IIa期、单中心、随机、开放标签试验,在接受顺铂治疗的患者中进行。受试者按5:2的比例随机接受氟丙酮治疗或不接受治疗。顺铂给药当日,氟丙酮组每日口服氟丙酮2次(队列1 80 mg,队列2 160 mg,队列3 240 mg)。第二天,所有队列接受三剂口服氟丙酮80mg。采用剂量递增设计,在确认每个级别的安全性后,从队列1推进到队列3。主要终点是氟丙酮与顺铂联合使用的安全性;次要终点包括尿肾毒性生物标志物水平的变化,如中性粒细胞明胶酶相关脂钙蛋白、肝型脂肪酸结合蛋白和肾损伤分子-1。在顺铂给药前48小时、开始给药后24小时、48小时和1周采集血液和尿液样本进行安全性和有效性评估。结果:第一位受试者于2024年7月注册。截至2025年11月稿件提交之日,参与者注册正在进行中。最终参与者将在2026年3月前完成研究。预计结果将于2027年3月公布。结论:本研究提供了氟丙酮抑制半胱氨酸偶联β-裂解酶1可能减轻CIN的证据,有望促进CIN预防策略的进展。临床试验:日本临床试验登记处jRCTs041220021;https://jrct.mhlw.go.jp/en-latest-detail/jRCTs041220021。
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引用次数: 0
Exploring Medical Students' Representations of Future Specialties and Parenthood: Protocol for a Scoping Review. 探索医学生对未来专业和亲子关系的代表:范围审查方案。
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-01-20 DOI: 10.2196/78133
Sylvie Arnoux, Mia Gisselbaek, Georges Louis Savoldelli, Nadia Masood Bajwa

Background: Several factors come into consideration when medical students choose their future specialty. Among these factors, the desire to start a family and planning the best timing for pregnancy may interfere with career advancement in certain specialties.

Objective: To the best of our knowledge, this is the first scoping review aimed at understanding medical students' career choice and parental expectations without restriction of the specialty chosen. This protocol describes a scoping review aiming to understand how representations regarding specialties and parenthood influence medical students' career choice., This protocol describes a scoping review aiming to understand how representations regarding specialties and parenthood influence medical students' career choice.

Methods: We will search PubMed, Embase, Web of Science, ERIC, and PsycInfo for literature. Additionally, the reference lists of included articles will be screened for further inclusion. Rayyan and Endnote will be used to organize data screening and extraction. The database selection will allow us to extract and analyze data from various disciplines. This diversity will increase our understanding of medical students' career and personal life decisions. This protocol and the upcoming scoping review have been designed following the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines to ensure the quality of the searching process, the data screening, and the data extraction.

Results: This study will conduct a thematic synthesis of how the concepts of representations and perceptions of parenthood are used by medical students in the selected literature, comparing them to theoretical frameworks to clarify their meanings. We also plan to identify key themes related to parenthood and medical specialty choice when planning a career. As of December 2025, we proceeded to data screening. We anticipate publishing our results in the second quarter of 2026.

Conclusions: This scoping review aims to better understand medical students' representations of medical specialties and parenthood, and how these perceptions influence their specialty preferences and career choices. By mapping existing evidence across various disciplines, the review will identify research gaps and provide a foundation for future studies. The findings will offer valuable insights into the challenges of balancing career aspirations and family life, particularly in the context of physician shortages and the growing feminization of the medical profession.

背景:医学生在选择未来专业时要考虑几个因素。在这些因素中,想要建立家庭和计划最佳怀孕时间的愿望可能会影响某些专业的职业发展。目的:据我们所知,这是第一次旨在了解医学生的职业选择和父母的期望,而不受所选专业的限制。本协议描述了一项范围审查,旨在了解关于专业和父母身份的陈述如何影响医学生的职业选择。本协议描述了一项范围审查,旨在了解关于专业和父母身份的陈述如何影响医学生的职业选择。方法:检索PubMed、Embase、Web of Science、ERIC、PsycInfo等文献。此外,将筛选纳入文章的参考文献列表以进一步纳入。Rayyan和Endnote将用于组织数据筛选和提取。数据库选择将允许我们提取和分析来自不同学科的数据。这种多样性将增加我们对医学生的职业和个人生活决定的理解。本方案和即将进行的范围审查是按照PRISMA-ScR(范围审查的系统审查和元分析扩展首选报告项目)指南设计的,以确保搜索过程、数据筛选和数据提取的质量。结果:本研究将对医学生在选定的文献中如何使用父母身份的表征和感知概念进行专题综合,并将其与理论框架进行比较,以澄清其含义。我们还计划在规划职业生涯时确定与父母和医学专业选择相关的关键主题。从2025年12月起,我们开始进行数据筛选。我们预计在2026年第二季度公布我们的业绩。结论:本综述旨在更好地了解医学生对医学专业和为人父母的看法,以及这些看法如何影响他们的专业偏好和职业选择。通过绘制不同学科的现有证据,该综述将确定研究差距,并为未来的研究提供基础。这些发现将为平衡职业抱负和家庭生活的挑战提供有价值的见解,特别是在医生短缺和医疗行业女性化日益增加的背景下。
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引用次数: 0
Effectiveness and Safety of a Supplement Containing a Pharmacologically Active Basidiomycete Mushroom for Chronic Fatigue and Post-COVID-19 Fatigue Syndrome: Protocol for a Randomized Controlled Trial. 含有药理活性担子菌蘑菇的补充剂治疗慢性疲劳和covid -19后疲劳综合征的有效性和安全性:一项随机对照试验方案
IF 1.5 Q3 HEALTH CARE SCIENCES & SERVICES Pub Date : 2026-01-20 DOI: 10.2196/82633
Yunqing Xun, Tung Leong Fong, Guang Chen, Yibin Feng, Linda Chan, Ning Wang
<p><strong>Background: </strong>Chronic fatigue syndrome, or myalgic encephalomyelitis, is characterized by persistent, unexplained exhaustion unalleviated by rest, with a pathophysiology distinct from underlying medical conditions. It is diagnostically complex due to symptoms that overlap with other disorders and the absence of definitive biomarkers, contributing to limited therapeutic options in current medicine. Lingzhi, a pharmacologically active basidiomycete mushroom, has been empirically used in traditional Chinese medicine for two millennia. This study has a dual focus: (1) systematically evaluating the efficacy and safety of lingzhi in managing chronic fatigue and post-COVID-19 fatigue syndrome and (2) elucidating its clinical associations with inflammatory, immune, and oxidative stress biomarkers to uncover potential therapeutic mechanisms.</p><p><strong>Objective: </strong>The primary objective is to investigate whether a 6-week intake of CP003, a lingzhi-containing supplement, can reduce physical and mental fatigue in patients with chronic fatigue syndrome (ie, myalgic encephalomyelitis) or post-COVID-19 fatigue. Secondary objectives include assessing its effects on sleep quality, anxiety, depression, and general health status and exploring associations with inflammatory, immune, and oxidative stress biomarkers.</p><p><strong>Methods: </strong>This randomized, waitlist-controlled trial will enroll 130 participants in Hong Kong, equally allocated (1:1) to either the CP003 intervention group or a waitlist control group. The intervention period spans 6 weeks, followed by a 6-week follow-up phase to assess the sustained effects. The trial data will be managed using REDCap (Research Electronic Data Capture) and analyzed via an intention-to-treat approach with inverse probability weighting for missing data, assessed through generalized linear regression (adjusted for covariates and interaction terms) at 6 and 12 weeks and supplemented by subgroup and sensitivity analyses in R, with results reported as mean differences (with 95% CIs) and P<.05 considered significant.</p><p><strong>Results: </strong>This study was funded in March 2024 (ITF/PRP/029/24FX). As of December 2025, all participants had been enrolled, but data entry had not yet commenced. Data analysis will commence after the completion of the 12-week follow-up for all participants. Results are expected to be submitted for publication in mid-2026. Safety outcomes will also be assessed and reported.</p><p><strong>Conclusions: </strong>This trial will evaluate the efficacy and safety of CP003 for chronic fatigue and post-COVID-19 fatigue syndrome and explore potential underlying mechanisms of action. The findings will provide experimental data to inform future clinical applications and research on traditional Chinese medicine-based interventions for fatigue-related disorders.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06739720; https://clinicaltrials.gov/study/NCT
背景:慢性疲劳综合征,或肌痛性脑脊髓炎,其特征是持续的、无法解释的疲劳,不能通过休息来缓解,其病理生理学与潜在的医学条件不同。由于症状与其他疾病重叠,并且缺乏明确的生物标志物,因此在诊断上很复杂,导致当前医学的治疗选择有限。灵芝是一种具有药理活性的担子菌,在中药中已有两千年的历史。本研究有两个重点:(1)系统评估灵芝治疗慢性疲劳和covid -19后疲劳综合征的有效性和安全性;(2)阐明其与炎症、免疫和氧化应激生物标志物的临床关联,揭示潜在的治疗机制。目的:主要目的是探讨6周服用含灵栀补充剂CP003是否能减轻慢性疲劳综合征(即肌痛性脑脊髓炎)或covid -19后疲劳患者的身心疲劳。次要目标包括评估其对睡眠质量、焦虑、抑郁和一般健康状况的影响,并探索其与炎症、免疫和氧化应激生物标志物的关联。方法:这项随机、候补对照试验将在香港招募130名参与者,平均分配(1:1)到CP003干预组或候补对照组。干预期为6周,随后进行为期6周的随访,以评估持续效果。试验数据将使用REDCap (Research Electronic data Capture)进行管理,并通过对缺失数据进行逆概率加权的意图治疗方法进行分析,在第6周和第12周通过广义线性回归(调整协变量和相互作用项)进行评估,并通过R中的亚组和敏感性分析进行补充,结果报告为平均差异(95% ci)。截至2025年12月,所有参与者都已登记,但数据输入尚未开始。数据分析将在所有参与者完成为期12周的随访后开始。预计结果将于2026年年中提交公布。安全结果也将被评估和报告。结论:本试验将评估CP003治疗慢性疲劳和covid -19后疲劳综合征的有效性和安全性,并探讨其潜在的作用机制。研究结果将为今后中医干预疲劳相关疾病的临床应用和研究提供实验数据。试验注册:ClinicalTrials.gov NCT06739720;https://clinicaltrials.gov/study/NCT06739720.International注册报告标识符(irrid): PRR1-10.2196/82633。
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