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From patient voices to policy: Data analytics reveals patterns in Ontario's hospital feedback. 从病人的声音到政策:数据分析揭示了安大略省医院反馈的模式。
IF 7.7 Pub Date : 2026-02-05 eCollection Date: 2026-02-01 DOI: 10.1371/journal.pdig.0000739
Pourya Momtaz, Mohammad Noaeen, Konrad Samsel, Neil Seeman, Robert Cribb, Syed Ishtiaque Ahmed, Amol Verma, Dionne M Aleman, Zahra Shakeri

Patient satisfaction is a central measure of high-performing healthcare systems, yet real-world evaluations at scale remain challenging. In this study, we analyzed 122,194 de-identified patient reviews from 45 Ontario general hospitals between January 2015 and July 2022. We applied a natural language processing (NLP) pipeline using a clinical named entity recognition (NER) model fine-tuned on biomedical literature to extract references to diseases, symptoms, and medical procedures from patient reviews. Geospatial analysis was conducted to examine sentiment patterns based on regional census data related to low-income status and visible-minority composition. Our primary objective was to investigate how the COVID-19 pandemic influenced patient satisfaction trends, with a specific focus on clinical units and hospitals serving marginalized populations. We assessed changes in the proportion of positive comments across time periods and socioeconomic groups using multivariate logistic regression. Our findings show that over 80% of the hospitals studied had fewer than 50% positive reviews, highlighting possible systemic gaps in patient needs. Interestingly, the proportion of negative reviews decreased during the COVID-19 pandemic, suggesting possible changes in patient expectations or increased appreciation for healthcare workers. However, certain units, such as dentistry and radiology, experienced more negative ratings as a proportion of their total reviews. 'Anxiety' emerged as a recurrent concern in negative reviews, especially during the start of the pandemic, pointing to the growing awareness of mental health needs. Based on our geospatial analysis, hospitals located in regions with higher percentages of visible minority and low-income populations initially saw higher positive review proportions before COVID-19, but this trend reversed after 2020. Our statistical models confirmed that these shifts were significant, particularly for low-income-serving hospitals. Collectively, these results demonstrate how large-scale unstructured data can identify fundamental drivers of patient satisfaction, while underscoring the urgent need for adaptive strategies to address anxiety and combat systemic inequities.

患者满意度是衡量高绩效医疗保健系统的核心指标,但现实世界的大规模评估仍然具有挑战性。在这项研究中,我们分析了2015年1月至2022年7月期间来自安大略省45家综合医院的122194名未识别患者的评论。我们应用自然语言处理(NLP)管道,使用临床命名实体识别(NER)模型对生物医学文献进行微调,从患者评论中提取有关疾病、症状和医疗程序的参考资料。通过地理空间分析,研究了与低收入地位和少数族裔构成相关的区域人口普查数据的情感模式。我们的主要目标是调查COVID-19大流行如何影响患者满意度趋势,并特别关注为边缘人群服务的临床单位和医院。我们使用多元逻辑回归评估了不同时期和社会经济群体的积极评论比例的变化。我们的研究结果显示,超过80%的医院的积极评价低于50%,突出了患者需求方面可能存在的系统性差距。有趣的是,在2019冠状病毒病大流行期间,负面评价的比例有所下降,这表明患者的期望可能发生了变化,或者对医护人员的赞赏有所增加。然而,某些单位,如牙科和放射学,经历了更多的负面评价,作为他们的总评价的比例。“焦虑”在负面评论中反复出现,特别是在大流行开始期间,这表明人们对心理健康需求的认识日益增强。根据我们的地理空间分析,在2019冠状病毒病之前,位于少数族裔和低收入人口比例较高地区的医院最初的积极评价比例较高,但这一趋势在2020年之后发生逆转。我们的统计模型证实,这些变化是显著的,特别是对低收入医院。总的来说,这些结果证明了大规模非结构化数据如何识别患者满意度的基本驱动因素,同时强调了迫切需要适应性策略来解决焦虑和对抗系统性不平等。
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引用次数: 0
Optimizing vedolizumab therapy in ulcerative colitis: A critical synthesis of trial evidence and the emerging role of artificial intelligence. 优化vedolizumab治疗溃疡性结肠炎:试验证据的关键综合和人工智能的新兴作用。
IF 7.7 Pub Date : 2026-02-05 eCollection Date: 2026-02-01 DOI: 10.1371/journal.pdig.0001208
Alfadl Abdulfattah

Background: Vedolizumab, a monoclonal antibody targeting the α4β7 integrin, offers gut-selective immunosuppression and represents a cornerstone biologic therapy for moderate-to-severe ulcerative colitis (UC). While pivotal randomized controlled trials (RCTs) have established its efficacy, a substantial subset of patients experience primary non-response. This variability presents significant clinical challenges, including patient morbidity and healthcare costs associated with cycling through ineffective therapies, underscoring an urgent need for personalized treatment strategies.

Objectives: This review aims to critically reappraise the foundational RCT evidence supporting vedolizumab use in UC, examining both strengths and limitations, and providing a comprehensive analysis of how artificial intelligence (AI), particularly machine learning (ML), can be leveraged to optimize vedolizumab treatment selection, predict outcomes, and personalize management.

Methods: A systematic literature search was performed across PubMed, Scopus, and Web of Science databases. The review synthesized data from key Phase III trials (GEMINI 1, VARSITY), long-term extension safety studies, relevant meta-analyses summarizing efficacy and safety, and pertinent studies investigating the application of AI and ML techniques within inflammatory bowel disease management. The search included terms such as vedolizumab, UC, AI, and predictive modeling.

Findings: Landmark trials confirmed vedolizumab's superiority over placebo for inducing and maintaining remission, with week 52 clinical remission rates reaching 41.8% in the GEMINI 1 trial. Concurrently, emerging AI/ML models, integrating complex patient data, show considerable promise in predicting biologic response with high accuracy, with some models achieving an area under the curve (AUC) of 0.82 (95% CI 0.78-0.86). Neural networks have demonstrated an accuracy of approximately 79% in specific predictive contexts.

Conclusions: The strategic integration of AI-driven predictive analytics with vedolizumab's clinical and pharmacodynamic data represents a pivotal next step towards achieving true precision medicine in UC.

背景:Vedolizumab是一种靶向α4β7整合素的单克隆抗体,具有肠道选择性免疫抑制作用,是中重度溃疡性结肠炎(UC)的基础生物治疗方法。虽然关键随机对照试验(rct)已经确定了其疗效,但仍有相当一部分患者出现原发性无反应。这种可变性带来了重大的临床挑战,包括患者发病率和与无效治疗循环相关的医疗费用,强调了对个性化治疗策略的迫切需要。目的:本综述旨在批判性地重新评估支持vedolizumab在UC中使用的基础RCT证据,检查其优势和局限性,并提供如何利用人工智能(AI),特别是机器学习(ML)优化vedolizumab治疗选择,预测结果和个性化管理的综合分析。方法:通过PubMed、Scopus和Web of Science数据库进行系统的文献检索。该综述综合了关键的III期试验(GEMINI 1、VARSITY)、长期扩展安全性研究、总结疗效和安全性的相关荟萃分析,以及调查AI和ML技术在炎症性肠病管理中的应用的相关研究的数据。搜索包括vedolizumab、UC、AI和预测建模等术语。研究结果:具有里程碑意义的试验证实了vedolizumab在诱导和维持缓解方面优于安慰剂,在GEMINI 1试验中,52周临床缓解率达到41.8%。与此同时,新兴的AI/ML模型,整合了复杂的患者数据,在预测生物反应方面显示出相当大的希望,准确度很高,一些模型的曲线下面积(AUC)达到0.82 (95% CI 0.78-0.86)。在特定的预测环境中,神经网络的准确率约为79%。结论:人工智能驱动的预测分析与vedolizumab的临床和药效学数据的战略整合代表了UC实现真正精准医学的关键下一步。
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引用次数: 0
Hierarchy and hope: Exploring AI's role in medicine through a thematic analysis of online discourse. 层级与希望:通过在线话语的主题分析探索人工智能在医学中的作用。
IF 7.7 Pub Date : 2026-01-30 eCollection Date: 2026-01-01 DOI: 10.1371/journal.pdig.0001212
Johan Pushani, Sherwin Rajkumar, Alishya Burrell, Erin Peebles, Amrit Kirpalani

The healthcare community remains divided on the benefits of artificial intelligence (AI) in medicine. In this qualitative study, we sought to better understand the perceived opportunities and threats of AI among premedical students, medical students, and physicians. We conducted a thematic analysis on Reddit, a social platform where candid opinions are often shared. Posts from the r/premed, r/medicalschool, and r/medicine subreddits were searched using the terms "AI", "chatGPT", "openAI", and "artificial intelligence". We analyzed 2403 comments across 47 threads from December 2022 to August 2023. A coding scheme was developed manually following Braun and Clarke's (2006) framework, and common themes were extracted. The main themes identified centered on AI enhancement versus replacement. Careers perceived to be lower in the medical social hierarchy were considered most at risk of replacement. AI was thought to first replace non-medical jobs, followed by mid-levels, and then primary care and diagnostic specialties, with specialists and surgeons affected last. Some contributors emphasized that AI could never replace a physician's compassion and nuanced clinical judgment. Others viewed AI as a tool to enhance efficiency, particularly in tasks such as studying, note writing, screening, and triage. Although verifying the credentials of commenters on online forums poses a challenge, platforms like Reddit offer a valuable opportunity to understand nuanced attitudes and perceptions regarding AI in medicine. Online forums allow for a unique understanding of the impressions of AI in medicine. While AI was generally well-received, we identified a key finding: a socially hierarchical, biased form of thinking among healthcare professionals. The perpetuation of this biased mindset may contribute to role devaluation, mistrust, and collaboration challenges within healthcare teams-ultimately impacting patient care. To fully leverage AI's potential in medicine, it is critical to acknowledge and address potentially biased perceptions within the healthcare community.

对于人工智能(AI)在医学上的好处,医疗界仍存在分歧。在这项定性研究中,我们试图更好地了解医学预科学生、医学生和医生对人工智能的机会和威胁的感知。我们在Reddit这个经常分享坦率观点的社交平台上进行了主题分析。来自r/premed, r/medicalschool和r/medicine子版块的帖子使用“AI”,“chatGPT”,“openAI”和“人工智能”进行搜索。从2022年12月到2023年8月,我们分析了47个线程中的2403条评论。编码方案是按照Braun和Clarke(2006)的框架手工开发的,并提取了共同的主题。确定的主要主题集中在人工智能增强与替代。在医疗社会等级中被认为较低的职业被认为最有可能被取代。人工智能被认为首先会取代非医疗工作,其次是中级工作,然后是初级保健和诊断专业,最后受影响的是专家和外科医生。一些撰稿人强调,人工智能永远无法取代医生的同情心和细致入微的临床判断。其他人则将人工智能视为提高效率的工具,尤其是在学习、写笔记、筛查和分诊等任务中。尽管验证在线论坛上评论者的身份是一项挑战,但Reddit等平台提供了一个宝贵的机会,可以了解人们对医学中人工智能的细微态度和看法。在线论坛让人们对人工智能在医学上的印象有了独特的理解。虽然人工智能普遍受到欢迎,但我们发现了一个关键发现:医疗保健专业人员的社会等级和偏见思维形式。这种偏见心态的延续可能会导致医疗团队中的角色贬值、不信任和协作挑战,最终影响患者护理。为了充分利用人工智能在医学领域的潜力,必须承认并解决医疗保健界可能存在的偏见。
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引用次数: 0
Development and evaluation of machine learning algorithms for the prediction of opioid-related deaths among UK patients with non-cancer pain. 开发和评估用于预测英国非癌症疼痛患者阿片类药物相关死亡的机器学习算法。
IF 7.7 Pub Date : 2026-01-27 eCollection Date: 2026-01-01 DOI: 10.1371/journal.pdig.0001190
Jose Benitez-Aurioles, Carlos Raul Ramirez Medina, David Jenkins, Niels Peek, Meghna Jani

The global rise in prescription opioid use has contributed to an opioid epidemic, associated harms, and unintentional deaths in several western countries. Opioids however continue to be regularly prescribed for acute pain and in the chronic pain context due to limited treatment options. Currently there are no accurate tools that help predict which patients prescribed opioids may be at risk of death, which depends on the cultural context and varies across countries. Existing models do not account for statistical considerations such as censoring and competing risks. Using nationally representative data from the United Kingdom from 1,026,139 patients newly prescribed an opioid, we developed three competing risk time-to-event models: a regression model, a random forest, and a deep neural network to predict opioid-related deaths using UK primary care records. The models were externally validated in an external cohort of 337,015 patients. The models exhibited good discrimination and positive predictive value during internal validation (C-statistic for the regression model, random forest, and neural network: 84.3%, 84.4% and 82.1% respectively), and external validation (C-statistic for the regression model, random forest, and neural network: 81.8%, 81.5% and 81.5% respectively). Prior substance abuse, lung and liver comorbidities, morphine, fentanyl, or oxycodone at initiation and co-prescription of gabapentinoids were some of candidate predictors associated with a higher risk of opioid-related mortality within the models. These results demonstrate how routinely collected data from a nationally representative dataset may be used to develop and validate opioids risk algorithms to better help clinicians and patients predict risk to this serious adverse outcome.

处方阿片类药物使用的全球增加导致阿片类药物流行、相关危害和一些西方国家的意外死亡。然而,由于治疗选择有限,阿片类药物继续定期用于急性疼痛和慢性疼痛。目前还没有准确的工具来帮助预测哪些处方阿片类药物的患者可能有死亡风险,这取决于文化背景,并因国家而异。现有的模型没有考虑到诸如审查和竞争风险等统计因素。利用来自英国1026139名新开阿片类药物患者的全国代表性数据,我们开发了三种相互竞争的风险时间-事件模型:回归模型、随机森林和深度神经网络,利用英国初级保健记录预测阿片类药物相关死亡。这些模型在337,015例患者的外部队列中进行了外部验证。模型在内部验证(回归模型、随机森林和神经网络的c统计量分别为84.3%、84.4%和82.1%)和外部验证(回归模型、随机森林和神经网络的c统计量分别为81.8%、81.5%和81.5%)中具有良好的判别性和正预测值。先前的药物滥用、肺和肝脏合并症、吗啡、芬太尼或羟考酮以及加巴喷丁类药物的联合处方是模型中与阿片类药物相关死亡率较高风险相关的一些候选预测因素。这些结果表明,如何从具有全国代表性的数据集中常规收集数据,以开发和验证阿片类药物风险算法,以更好地帮助临床医生和患者预测这种严重不良后果的风险。
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引用次数: 0
Awareness, trust, and expectations of AI for glaucoma care among Bulgarian ophthalmologists: Role of demographic factors. 保加利亚眼科医生对人工智能青光眼护理的认识、信任和期望:人口统计学因素的作用。
IF 7.7 Pub Date : 2026-01-22 eCollection Date: 2026-01-01 DOI: 10.1371/journal.pdig.0001199
Mladena Nikolaeva Radeva, Elitsa Hristova, Rosen Tsvetanov Georgiev, Zornitsa Ivanova Zlatarova

Artificial intelligence (AI) holds promise for enhancing glaucoma screening and management, yet its adoption depends on clinician perceptions, particularly in resource-limited regions like Eastern Europe. This study explores awareness, trust, and expectations of AI in glaucoma care among Bulgarian ophthalmologists, examining the influence of demographic factors such as age, gender, and professional experience. A cross-sectional survey was conducted from March to May 2024 among 156 ophthalmologists and residents recruited via Bulgarian professional societies. The 25-question survey, informed by the Technology Acceptance Model and validated (content validity index = 0.85; Cronbach's α = 0.78), assessed awareness, trust (5- point Likert scale), and expectations. Data were analyzed using non-parametric tests (chi-square, Spearman correlation) and thematic analysis for qualitative responses. The study was approved by the Ethics Committee of Medical University of Varna (No141/14.03.2024), with informed consent obtained and adherence to the Declaration of Helsinki. Participants (73.1% female; median age 35 years, IQR 10) showed varying awareness, with less experienced clinicians (<5 years) more informed (χ2 = 17.89, p < 0.001). Trust was low (7.5% fully trusted AI diagnosis; 5.7% for treatment), with gender differences (males more distrustful in diagnosis, p = 0.009). Younger respondents were more optimistic about AI's impact (ρ = 0.268, p < 0.001). Qualitative themes highlighted diagnostic utility (95% mentions) and concerns like training deficiencies (45%). Bulgarian ophthalmologists exhibit cautious optimism toward AI in glaucoma care, shaped by demographics, underscoring the need for targeted training to build trust. These findings inform regional AI implementation strategies, aligning with ethical priorities for equitable digital health adoption.

人工智能(AI)有望加强青光眼的筛查和管理,但它的采用取决于临床医生的看法,特别是在东欧等资源有限的地区。本研究探讨了保加利亚眼科医生对青光眼护理中人工智能的认识、信任和期望,研究了年龄、性别和专业经验等人口因素的影响。2024年3月至5月,通过保加利亚专业协会对156名眼科医生和住院医生进行了横断面调查。25个问题的调查,由技术接受模型告知并验证(内容效度指数= 0.85;Cronbach's α = 0.78),评估意识,信任(5点李克特量表)和期望。数据分析采用非参数检验(卡方检验、Spearman相关检验)和专题分析进行定性分析。该研究得到了瓦尔纳医科大学伦理委员会的批准(No141/14.03.2024),获得了知情同意并遵守了赫尔辛基宣言。参与者(73.1%女性,中位年龄35岁,IQR 10)表现出不同的意识,缺乏经验的临床医生(
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引用次数: 0
Dharma: A novel, clinically grounded machine learning framework for pediatric appendicitis-Diagnosis, severity assessment and evidence-based clinical decision support. Dharma:一种新颖的、临床基础的儿童阑尾炎机器学习框架——诊断、严重程度评估和基于证据的临床决策支持。
IF 7.7 Pub Date : 2026-01-21 eCollection Date: 2026-01-01 DOI: 10.1371/journal.pdig.0000908
Anup Thapa Kshetri, Subash Pahari, Shashank Timilsina, Binay Chapagain

Acute appendicitis is a common but diagnostically challenging surgical emergency in children. Existing linear scoring systems lack sufficient accuracy for standalone use, while advanced imaging is constrained by risks of sedation, contrast, and radiation. Furthermore, no available tools provide prognostic guidance. We introduce Dharma, a machine learning framework consisting of a clinically grounded imputer and two random forest classifiers for diagnosis and severity assessment. Designed for real-world bedside use, Dharma is open-sourced and accessible through a web application. Dharma achieved excellent diagnostic performance, with an AUC-ROC of 0.98 [0.97-0.99] and accuracy of 93% [91-95]. For prognostic classification, it identified complicated appendicitis with high sensitivity (96% [93-99]) and negative predictive value (97% [94-99]). Even in cases without appendix visualization-a frequent limitation in resource-constrained settings-Dharma maintained strong performance (AUC-ROC 0.96 [0.93-0.99]), with specificity of 97% [93-100] and PPV of 93% [84-100] at a 44% threshold, and sensitivity of 92% [84-98] with NPV of 95% [91-99] at a 25% threshold. These threshold-dependent trade-offs enable Dharma to support both ruling in and ruling out appendicitis within diverse clinical workflows. Beyond pediatric appendicitis, Dharma's open-source framework and clinically grounded design also provide a generalizable foundation for developing equitable and practical decision-support systems in healthcare.

急性阑尾炎是儿童常见但诊断困难的外科急症。现有的线性评分系统在单独使用时缺乏足够的准确性,而先进的成像则受到镇静、对比和辐射风险的限制。此外,没有可用的工具提供预后指导。我们介绍了Dharma,这是一个机器学习框架,由一个临床接地的灌输器和两个用于诊断和严重程度评估的随机森林分类器组成。Dharma是为现实世界的床边使用而设计的,它是开源的,可以通过web应用程序访问。Dharma的诊断效果非常好,AUC-ROC为0.98[0.97-0.99],准确率为93%[91-95]。对于预后分类,该方法对复杂阑尾炎的诊断敏感性高(96%[93-99]),阴性预测值高(97%[94-99])。即使在没有阑尾显像的病例中(在资源受限的情况下,这是一种常见的限制),dharma也保持了良好的表现(AUC-ROC 0.96[0.93-0.99]),在44%的阈值下,特异性为97% [93-100],PPV为93%[84-100],在25%的阈值下,敏感性为92% [84-98],NPV为95%[91-99]。这些依赖阈值的权衡使达摩能够在不同的临床工作流程中支持阑尾炎的诊断和排除。除了小儿阑尾炎,Dharma的开源框架和基于临床的设计也为开发公平实用的医疗保健决策支持系统提供了可推广的基础。
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引用次数: 0
Mobile phone infrastructure provides evidence of improved HIV viral load monitoring in Malawi. 移动电话基础设施提供了马拉维改善艾滋病毒载量监测的证据。
IF 7.7 Pub Date : 2026-01-21 eCollection Date: 2026-01-01 DOI: 10.1371/journal.pdig.0001094
Rachel Haggard, Christopher Mwase, Brandon Klyn, Lynn Metz, Tyler Smith, Hannah Cooper, Brown Chiwandira, Dylan Green, Linley Chewere

Malawi has 991,600 people living with HIV and has expanded access to annual HIV viral load testing to enhance care quality for clients. However, significant delays persist in returning viral load (VL) results back to facilities and to clients. To address this, we implemented a digital VL results return (VLRR) application, using existing mobile phone platforms to expedite results return to clients and healthcare providers (HCPs).VLRR is a digital SMS/USSD platform leveraging mobile phones to reduce turnaround time (TAT) and improve access to VL results. To evaluate the VLRR intervention, we: (1) estimated the TAT for digital results return, (2) calculated open rates of digital results, (3) conducted a mixed methods evaluation with VLRR users, and (4) estimated the potential cost savings from avoiding unnecessary sample redraws. From April 2022 to June 2024, HCPs registered 4,067 clients. For each client, TAT was calculated separately for the periods before and after enrollment in the VLRR system. On average during this period, clients received results in 128 days before VLRR enrollment and 48.5 days after enrollment, reflecting a 62.4% improvement. By July 2023, VLRR clients and HCPs received results in an average of 30 and 38 days. The overall open rate for digital results (opened by either a client or HCP) was 60% and nearly 100% of clients and HCPs indicated they wanted to the application to continue. Lastly, if VLRR were scaled nationally, it has the potential cost savings of $1.8-6.7 million USD.VLRR is effective in reducing TAT and improving access to VL results. To enhance uptake and achieve national scale, VLRR can be integrated into Malawi's existing EMR systems, further reducing TAT and enabling HCPs to deliver higher quality care and improve clinical outcomes.

马拉维有991,600名艾滋病毒感染者,并扩大了每年进行艾滋病毒载量检测的机会,以提高对客户的护理质量。然而,在将病毒载量(VL)结果返回给设施和客户时,仍然存在明显的延迟。为了解决这个问题,我们实施了一个数字VL结果返回(VLRR)应用程序,使用现有的移动电话平台来加快结果返回给客户和医疗保健提供者(HCPs)。VLRR是一个数字短信/USSD平台,利用移动电话减少周转时间(TAT)并改善对VL结果的访问。为了评估VLRR干预,我们:(1)估计了数字结果返回的TAT,(2)计算了数字结果的打开率,(3)与VLRR用户进行了混合方法评估,(4)估计了避免不必要的样本重画所节省的潜在成本。从2022年4月到2024年6月,hcp注册了4067名客户。对于每个客户,分别计算在VLRR系统登记之前和之后的TAT。在此期间,患者平均在VLRR入组前128天和入组后48.5天收到结果,改善了62.4%。到2023年7月,VLRR患者和HCPs平均在30天和38天内获得结果。数字结果的总体打开率(由客户或HCP打开)为60%,几乎100%的客户和HCP表示他们希望继续应用程序。最后,如果VLRR在全国范围内推广,它可以节省180万至670万美元的潜在成本。VLRR有效地减少了TAT并改善了VL结果的获取。为了加强吸收和实现全国规模,可以将VLRR整合到马拉维现有的电子病历系统中,进一步减少TAT并使卫生保健提供者能够提供更高质量的护理并改善临床结果。
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引用次数: 0
A pilot feasibility study of human-centered design for cirrhosis care: Development and pilot testing of SMARTLiver prototype, a FHIR-based clinical decision support system for hepatology. 肝硬化以人为中心设计的中试可行性研究:基于fhr的肝病临床决策支持系统SMARTLiver原型的开发和中试测试
IF 7.7 Pub Date : 2026-01-20 eCollection Date: 2026-01-01 DOI: 10.1371/journal.pdig.0000969
Keerthika Sunchu, Archita P Desai, Raj Vuppalanchi, Saptarshi Purkayastha

Management of cirrhosis suffers from poor guideline adherence due to fragmented electronic health record (EHR) systems that scatter critical patient data across multiple modules, creating cognitive burden for clinicians and impeding evidence-based care delivery. We developed SMARTLiver, a Substitutable Medical Applications and Reusable Technologies on Fast Healthcare Interoperability Resources (SMART-on-FHIR) clinical decision support application employing human-centered design principles to consolidate patient data, incorporate evidence-based guidelines, and enhance cirrhosis care workflows. Following literature reviews of cirrhosis management guidelines and clinical workflow analysis within our health system, we created a FHIR-based application integrating automated task management, prognostic scoring, patient-reported outcomes, and real-time clinical decision support features. Usability evaluation with five clinical staff members using Think-Aloud protocols and the validated Health-ITUES survey revealed high satisfaction scores for Clinical Utility (4.4-4.6/5.0) and User Interface design (4.2/5.0), with moderate scores for workflow integration (4.0/5.0) and decision support (3.8-4.0/5.0). Qualitative feedback aligned with quantitative results, identifying enhancement opportunities in customization controls and notification management. The SMARTLiver prototype demonstrated technical feasibility in aggregating fragmented clinical data into a unified interface, automating evidence-based task generation, and maintaining interoperability across healthcare systems. This pilot study provides initial evidence for the potential of SMART-on-FHIR technology to address EHR fragmentation in cirrhosis care, though clinical effectiveness remains to be demonstrated.

由于分散的电子健康记录(EHR)系统将关键患者数据分散在多个模块中,给临床医生带来认知负担,阻碍了循证护理的提供,肝硬化管理的指南依从性较差。我们开发了SMARTLiver,这是一款基于快速医疗互操作性资源(SMART-on-FHIR)的替代医疗应用和可重用技术临床决策支持应用程序,采用以人为本的设计原则来整合患者数据,纳入循证指南,并增强肝硬化护理工作流程。根据对肝硬化管理指南的文献回顾和我们卫生系统内的临床工作流程分析,我们创建了一个基于fhir的应用程序,集成了自动任务管理、预后评分、患者报告的结果和实时临床决策支持功能。对5名临床工作人员使用Think-Aloud方案和经过验证的Health-ITUES调查进行的可用性评估显示,临床效用(4.4-4.6/5.0)和用户界面设计(4.2/5.0)得分较高,工作流程集成(4.0/5.0)和决策支持(3.8-4.0/5.0)得分中等。定性反馈与定量结果一致,确定了自定义控制和通知管理方面的增强机会。SMARTLiver原型展示了将分散的临床数据聚合到统一界面、自动化循证任务生成以及保持医疗系统互操作性的技术可行性。这项初步研究为SMART-on-FHIR技术在肝硬化治疗中解决电子病历碎片化问题的潜力提供了初步证据,尽管临床有效性仍有待证实。
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引用次数: 0
Decentralized clinical trials: A comprehensive analysis of trends, technologies, and global challenges. 分散临床试验:趋势、技术和全球挑战的综合分析。
IF 7.7 Pub Date : 2026-01-16 eCollection Date: 2026-01-01 DOI: 10.1371/journal.pdig.0001191
Sara Kijewski, Claire McBride, Eric Owens, Elsa Bernheim, Effy Vayena

Decentralized clinical trials (DCTs), particularly in the U.S., gained substantial attention during the COVID-19 pandemic, enabling trial activities to be conducted from participants' homes or local healthcare facilities despite restrictions and lockdowns. Regardless of the growth in interest, many facets of the DCT landscape remain unexplored or nascent in their development. This study aims to explore the key characteristics and development of the U.S.-registered DCT landscape, adoption patterns across various clinical contexts, and the role of digital technologies. We analyzed 1370 decentralized trials from ClinicalTrials.gov, collected using a broad DCT-keyword search. The data were screened and coded manually, and analyzed descriptively for temporal trends, purpose of decentralization, intervention type, geographic representation, and digitalization. Our findings align with previous reports of a growing, heterogeneous landscape of DCTs, with behavioral interventions appearing more suitable for decentralization than other types of interventions. Notably, most DCTs still focus on evaluating decentralized methods rather than merely implementing them in their investigations. Often, studies integrate digital tools either as the interventions themselves or to enable the digital delivery of study activities. Although the trial registry used is U.S.-based, and a U.S. partner is part of more than 50% of the studies identified, many trials are done in multiple countries or countries outside of the U.S. (42%). Among these trials, the data revealed considerable differences, with digitalized DCTs in this sample concentrated in high-income countries. Despite rapid growth in DCTs, our findings suggest the presence of a field in development, very much focused on establishing a methodological foundation. To unlock the potential of DCTs locally and globally, four critical areas demand further attention: digital equity, regulatory frameworks for diverse technologies, establishment of methodological validation processes, and further research on barriers to implementation.

分散临床试验(dct),特别是在美国,在2019冠状病毒病大流行期间获得了大量关注,使试验活动能够在参与者家中或当地医疗机构进行,尽管有限制和封锁。尽管人们的兴趣在增长,但DCT领域的许多方面仍未被探索或处于发展初期。本研究旨在探讨美国注册DCT的主要特征和发展,不同临床背景下的采用模式,以及数字技术的作用。我们分析了ClinicalTrials.gov网站上1370个分散的试验,这些试验是通过广泛的dct关键字搜索收集的。对数据进行手动筛选和编码,并对时间趋势、分权目的、干预类型、地理代表性和数字化进行描述性分析。我们的研究结果与之前的报告一致,即dct的异质性日益增加,行为干预似乎比其他类型的干预更适合分散。值得注意的是,大多数dct仍然专注于评估分散的方法,而不仅仅是在调查中实施这些方法。通常,研究将数字工具作为干预措施本身或使研究活动的数字化交付成为可能。尽管所使用的试验注册是在美国,并且超过50%的研究是由美国合作伙伴参与的,但许多试验是在多个国家或美国以外的国家进行的(42%)。在这些试验中,数据显示出相当大的差异,该样本中的数字化dct集中在高收入国家。尽管dct快速增长,但我们的研究结果表明,在发展中存在一个领域,非常注重建立方法学基础。为了释放dct在本地和全球的潜力,需要进一步关注四个关键领域:数字公平、不同技术的监管框架、方法验证流程的建立以及对实施障碍的进一步研究。
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引用次数: 0
Impact of virtual ICU implementation on clinical outcomes across multiple critical care units: A before-and-after study. 虚拟ICU实施对多个重症监护病房临床结果的影响:一项前后研究。
IF 7.7 Pub Date : 2026-01-16 eCollection Date: 2026-01-01 DOI: 10.1371/journal.pdig.0001186
Annemarie Nguyen, Sprague W Hazard, Anthony S Bonavia

Virtual intensive care units (vICUs) provide continuous remote monitoring and support for critically ill patients. Increasing patient complexity and staffing shortages have driven interest in vICUs, but evidence of their impact on clinical outcomes is limited. This study evaluated the effect of vICU implementation across critical care units in a large academic medical center. We conducted a before-and-after study comparing outcomes during the initial vICU implementation period (October 2022-April 2023) and the established program period (October 2023-April 2024), with a 6-month washout interval. Adult patients from a multispecialty surgical intensive care unit (ICU), neurocritical care unit, and ICU step-down unit were included if they had ICU stays longer than 6 h, hospital stays under 30 days, and mechanical ventilation for at least 12 h. The primary outcome was ICU length of stay, with secondary outcomes including hospital stay, ventilation time, vasopressor use, readmissions, and mortality. Among 530 patients (266 implementation, 264 established), ICU length of stay decreased from 232 to 198 h (p=0.011), ventilation time from 110 to 90 h (p=0.044), and vasopressor use for more than 12 h from 55% to 43% (p=0.007). Hospital stay, mortality, and readmission rates were unchanged. Subgroup analysis showed the greatest improvements in the surgical ICU, with reductions in ICU stay, ventilation time, and vasopressor use. These improvements may reflect earlier recognition of deterioration, better care coordination, and timely withdrawal of intensive therapies. Variation across units highlights the need to tailor vICU integration strategies to specific clinical workflows. These findings suggest that vICU implementation is feasible and may enhance critical care efficiency, though further multi-center studies are needed to determine generalizability and to assess patient-centered and economic outcomes.

虚拟重症监护病房(vicu)为危重患者提供持续的远程监测和支持。日益增加的患者复杂性和人员短缺促使人们对vicu产生了兴趣,但有关其对临床结果影响的证据有限。本研究评估了在一家大型学术医疗中心的重症监护病房实施vICU的效果。我们进行了一项前后研究,比较了初始vICU实施期间(2022年10月至2023年4月)和既定计划期间(2010月至2024年4月)的结果,并进行了6个月的洗脱期。来自多专科外科重症监护病房(ICU)、神经危重监护病房和ICU降压病房的成年患者,如果其ICU住院时间超过6小时、住院时间小于30天、机械通气至少12小时,则纳入研究。主要结局是ICU住院时间,次要结局包括住院时间、通气时间、血管加压剂使用、再入院和死亡率。在530例患者中(266例实施,264例已建立),ICU住院时间从232小时减少到198小时(p=0.011),通气时间从110小时减少到90小时(p=0.044),血管加压药使用超过12小时从55%减少到43% (p=0.007)。住院时间、死亡率和再入院率没有变化。亚组分析显示,外科ICU的改善最大,ICU住院时间、通气时间和血管加压药的使用都减少了。这些改善可能反映了对恶化的早期认识、更好的护理协调以及及时退出强化治疗。各单位之间的差异突出了为特定临床工作流程量身定制vICU集成策略的必要性。这些发现表明,vICU的实施是可行的,并可能提高重症监护效率,但需要进一步的多中心研究来确定其普遍性,并评估以患者为中心的经济结果。
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引用次数: 0
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