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Time Series AI Model for Acute Kidney Injury Detection Based on a Multicenter Distributed Research Network: Development and Verification Study 基于多中心分布式研究网络的急性肾损伤检测时间序列人工智能模型:开发与验证研究
IF 3.2 3区 医学 Q2 MEDICAL INFORMATICS Pub Date : 2024-07-05 DOI: 10.2196/47693
Suncheol Heo, Eun-Ae Kang, Jae Yong Yu, Hae Reong Kim, Suehyun Lee, Kwangsoo Kim, Yul Hwangbo, Rae Woong Park, Hyunah Shin, Kyeongmin Ryu, Chungsoo Kim, Hyojung Jung, Yebin Chegal, Jae-Hyun Lee, Yu Rang Park
Background: Acute kidney injury (AKI) is a marker of clinical deterioration and renal toxicity. While there are many studies offering prediction models for the early detection of AKI, those predicting AKI occurrence using distributed research network (DRN)-based time series data are rare. Objective: In this study, we aimed to detect the early occurrence of AKI by applying the interpretable LSTM-based model on a hospital EHR-based time series in patients who took nephrotoxic drugs using a DRN Methods: We conducted a multi-institutional retrospective cohort study of data from six hospitals using a DRN. For each institution, a patient-based dataset was constructed using five drugs for AKI, and the interpretable multi-variable long short-term memory (IMV-LSTM) model was used for training. This study employed propensity score matching to mitigate differences in demographics and clinical characteristics. Additionally, the temporal attention values of the AKI prediction model's contribution variables were demonstrated for each institution and drug, with differences in highly important feature distributions between the case and control data confirmed using one-way analysis of variance. Results: This study analyzed 8,643 and 31,012 patients with and without AKI, respectively, across six hospitals. When analyzing the distribution of AKI onset, vancomycin showed an earlier onset (median: 12 days), and acyclovir was the slowest compared to the other drugs (median: 23 days). Our temporal deep learning model for AKI prediction performed well for most drugs. Acyclovir had the highest average area under the receiver operating characteristic curve score per drug (0.94), followed by acetaminophen (0.93), vancomycin (0.92), naproxen (0.90), and celecoxib (0.89). Based on the temporal attention values of the variables in the AKI prediction model, verified lymphocytes and calcium had the highest attention, whereas lymphocytes, albumin, and hemoglobin tended to decrease over time, and urine pH and prothrombin time tended to increase. Conclusions: Early surveillance of AKI outbreaks can be achieved by applying the IMV-LSTM based on time series data through hospital electronic health records (EHR)-based DRNs. This approach can help identify risk factors and enable early detection of adverse drug reactions when prescribing drugs that cause renal toxicity before AKI occurs.
背景:急性肾损伤(AKI)是临床恶化和肾毒性的标志。虽然有许多研究提供了早期检测 AKI 的预测模型,但利用基于分布式研究网络(DRN)的时间序列数据预测 AKI 发生率的研究却很少见。研究目的在本研究中,我们的目的是通过在使用 DRN 的服用肾毒性药物患者的医院电子病历时间序列中应用基于 LSTM 的可解释模型来检测 AKI 的早期发生:我们对六家使用 DRN 的医院的数据进行了多机构回顾性队列研究。我们为每家医院构建了一个基于患者的数据集,其中使用了五种治疗 AKI 的药物,并使用可解释多变量长短期记忆(IMV-LSTM)模型进行训练。本研究采用倾向得分匹配来减少人口统计学和临床特征的差异。此外,AKI 预测模型的贡献变量的时间注意力值在每个机构和药物中都得到了证明,病例数据和对照数据之间的高重要性特征分布差异也通过单因素方差分析得到了证实。研究结果本研究分析了六家医院的 8643 名 AKI 患者和 31012 名无 AKI 患者。在分析 AKI 发病时间分布时,万古霉素的发病时间较早(中位数:12 天),而阿昔洛韦的发病时间与其他药物相比最慢(中位数:23 天)。我们用于预测 AKI 的时空深度学习模型对大多数药物都表现良好。阿昔洛韦的每种药物接收者操作特征曲线下的平均面积得分最高(0.94),其次是对乙酰氨基酚(0.93)、万古霉素(0.92)、萘普生(0.90)和塞来昔布(0.89)。根据 AKI 预测模型中各变量的时间关注值,经核实的淋巴细胞和钙的关注度最高,而淋巴细胞、白蛋白和血红蛋白随着时间的推移呈下降趋势,尿 pH 值和凝血酶原时间呈上升趋势。结论:通过基于医院电子病历 (EHR) 的 DRN,基于时间序列数据应用 IMV-LSTM 可实现对 AKI 爆发的早期监控。这种方法有助于识别风险因素,并在发生 AKI 之前,在处方会引起肾毒性的药物时,及早发现药物不良反应。
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引用次数: 0
Privacy-Preserving Prediction of Postoperative Mortality in Multi-Institutional Data: Development and Usability Study. 多机构数据中术后死亡率的隐私保护预测:开发和可用性研究。
IF 3.1 3区 医学 Q2 MEDICAL INFORMATICS Pub Date : 2024-07-05 DOI: 10.2196/56893
Jungyo Suh, Garam Lee, Jung Woo Kim, Junbum Shin, Yi-Jun Kim, Sang-Wook Lee, Sulgi Kim

Background: To circumvent regulatory barriers that limit medical data exchange due to personal information security concerns, we use homomorphic encryption (HE) technology, enabling computation on encrypted data and enhancing privacy.

Objective: This study explores whether using HE to integrate encrypted multi-institutional data enhances predictive power in research, focusing on the integration feasibility across institutions and determining the optimal size of hospital data sets for improved prediction models.

Methods: We used data from 341,007 individuals aged 18 years and older who underwent noncardiac surgeries across 3 medical institutions. The study focused on predicting in-hospital mortality within 30 days postoperatively, using secure logistic regression based on HE as the prediction model. We compared the predictive performance of this model using plaintext data from a single institution against a model using encrypted data from multiple institutions.

Results: The predictive model using encrypted data from all 3 institutions exhibited the best performance based on area under the receiver operating characteristic curve (0.941); the model combining Asan Medical Center (AMC) and Seoul National University Hospital (SNUH) data exhibited the best predictive performance based on area under the precision-recall curve (0.132). Both Ewha Womans University Medical Center and SNUH demonstrated improvement in predictive power for their own institutions upon their respective data's addition to the AMC data.

Conclusions: Prediction models using multi-institutional data sets processed with HE outperformed those using single-institution data sets, especially when our model adaptation approach was applied, which was further validated on a smaller host hospital with a limited data set.

背景:为了规避因个人信息安全问题而限制医疗数据交换的监管障碍,我们使用了同态加密(HE)技术,从而能够对加密数据进行计算并提高隐私保护:本研究探讨了使用 HE 整合加密的多机构数据是否能提高研究预测能力,重点关注跨机构整合的可行性,并确定医院数据集的最佳规模,以改进预测模型:我们使用了 341 007 名年龄在 18 岁及以上、在 3 家医疗机构接受过非心脏手术的患者的数据。研究的重点是预测术后 30 天内的院内死亡率,使用基于 HE 的安全逻辑回归作为预测模型。我们比较了该模型使用来自单一机构的明文数据和使用来自多个机构的加密数据的预测性能:结果:根据接收者操作特征曲线下面积(0.941),使用所有 3 家机构加密数据的预测模型表现最佳;根据精确度-调用曲线下面积(0.132),结合牙山医疗中心(AMC)和首尔国立大学医院(SNUH)数据的模型表现最佳。梨花女子大学医学中心和首尔国立大学医院在将各自的数据添加到AMC数据后,对各自机构的预测能力都有所提高:结论:使用 HE 处理的多机构数据集建立的预测模型优于使用单机构数据集建立的预测模型,尤其是在采用我们的模型适应方法时。
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引用次数: 0
Is Boundary Annotation Necessary? Evaluating Boundary-Free Approaches to Improve Clinical Named Entity Annotation Efficiency: Case Study. 边界注释有必要吗?评估无边界方法以提高临床命名实体注释效率:案例研究。
IF 3.1 3区 医学 Q2 MEDICAL INFORMATICS Pub Date : 2024-07-02 DOI: 10.2196/59680
Gabriel Herman Bernardim Andrade, Shuntaro Yada, Eiji Aramaki

Background: Named entity recognition (NER) is a fundamental task in natural language processing. However, it is typically preceded by named entity annotation, which poses several challenges, especially in the clinical domain. For instance, determining entity boundaries is one of the most common sources of disagreements between annotators due to questions such as whether modifiers or peripheral words should be annotated. If unresolved, these can induce inconsistency in the produced corpora, yet, on the other hand, strict guidelines or adjudication sessions can further prolong an already slow and convoluted process.

Objective: The aim of this study is to address these challenges by evaluating 2 novel annotation methodologies, lenient span and point annotation, aiming to mitigate the difficulty of precisely determining entity boundaries.

Methods: We evaluate their effects through an annotation case study on a Japanese medical case report data set. We compare annotation time, annotator agreement, and the quality of the produced labeling and assess the impact on the performance of an NER system trained on the annotated corpus.

Results: We saw significant improvements in the labeling process efficiency, with up to a 25% reduction in overall annotation time and even a 10% improvement in annotator agreement compared to the traditional boundary-strict approach. However, even the best-achieved NER model presented some drop in performance compared to the traditional annotation methodology.

Conclusions: Our findings demonstrate a balance between annotation speed and model performance. Although disregarding boundary information affects model performance to some extent, this is counterbalanced by significant reductions in the annotator's workload and notable improvements in the speed of the annotation process. These benefits may prove valuable in various applications, offering an attractive compromise for developers and researchers.

背景命名实体识别(NER)是自然语言处理中的一项基本任务。然而,在进行命名实体识别之前通常需要进行命名实体注释,这就带来了一些挑战,尤其是在临床领域。例如,确定实体边界是注释者之间产生分歧的最常见原因之一,原因在于修饰词或外围词是否应该注释等问题。如果这些问题得不到解决,就会导致生成的语料库不一致,而另一方面,严格的指导原则或裁定会议又会进一步延长本已缓慢而复杂的过程:本研究旨在通过评估两种新型注释方法--宽松跨度注释法和点注释法来应对这些挑战,从而减轻精确确定实体边界的难度:我们通过对日本医学病例报告数据集的注释案例研究来评估这两种方法的效果。我们比较了标注时间、标注者的一致意见和生成的标注质量,并评估了对在标注语料库上训练的 NER 系统性能的影响:我们发现标注过程的效率有了明显提高,与传统的边界严格方法相比,整体标注时间最多缩短了 25%,标注者的一致性甚至提高了 10%。不过,与传统标注方法相比,即使是效果最好的 NER 模型,其性能也会有所下降:我们的研究结果表明了注释速度和模型性能之间的平衡。虽然忽略边界信息会在一定程度上影响模型性能,但注释者工作量的显著减少和注释过程速度的明显提高抵消了这一影响。这些优势可能会在各种应用中证明是有价值的,为开发人员和研究人员提供了一个有吸引力的折中方案。
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引用次数: 0
Considerations for Quality Control Monitoring of Machine Learning Models in Clinical Practice. 临床实践中机器学习模型质量控制监测的注意事项。
IF 3.1 3区 医学 Q2 MEDICAL INFORMATICS Pub Date : 2024-06-28 DOI: 10.2196/50437
Louis Faust, Patrick Wilson, Shusaku Asai, Sunyang Fu, Hongfang Liu, Xiaoyang Ruan, Curt Storlie

Integrating machine learning (ML) models into clinical practice presents a challenge of maintaining their efficacy over time. While existing literature offers valuable strategies for detecting declining model performance, there is a need to document the broader challenges and solutions associated with the real-world development and integration of model monitoring solutions. This work details the development and use of a platform for monitoring the performance of a production-level ML model operating in Mayo Clinic. In this paper, we aimed to provide a series of considerations and guidelines necessary for integrating such a platform into a team's technical infrastructure and workflow. We have documented our experiences with this integration process, discussed the broader challenges encountered with real-world implementation and maintenance, and included the source code for the platform. Our monitoring platform was built as an R shiny application, developed and implemented over the course of 6 months. The platform has been used and maintained for 2 years and is still in use as of July 2023. The considerations necessary for the implementation of the monitoring platform center around 4 pillars: feasibility (what resources can be used for platform development?); design (through what statistics or models will the model be monitored, and how will these results be efficiently displayed to the end user?); implementation (how will this platform be built, and where will it exist within the IT ecosystem?); and policy (based on monitoring feedback, when and what actions will be taken to fix problems, and how will these problems be translated to clinical staff?). While much of the literature surrounding ML performance monitoring emphasizes methodological approaches for capturing changes in performance, there remains a battery of other challenges and considerations that must be addressed for successful real-world implementation.

将机器学习(ML)模型集成到临床实践中,面临着长期保持其有效性的挑战。虽然现有文献为检测模型性能下降提供了有价值的策略,但仍有必要记录与模型监控解决方案的实际开发和集成相关的更广泛挑战和解决方案。本文详细介绍了梅奥诊所开发和使用生产级 ML 模型性能监控平台的情况。在本文中,我们旨在提供将此类平台集成到团队技术基础设施和工作流程中所需的一系列注意事项和指导原则。我们记录了我们在集成过程中的经验,讨论了在实际实施和维护过程中遇到的更广泛的挑战,并包含了该平台的源代码。我们的监控平台是以 R shiny 应用程序的形式构建的,开发和实施过程历时 6 个月。该平台已使用和维护了 2 年,截至 2023 年 7 月仍在使用。实施监控平台所需的考虑因素主要围绕 4 个支柱:可行性(可用于平台开发的资源有哪些?);设计(将通过哪些统计数据或模型对模型进行监控,以及如何将这些结果有效地显示给最终用户?尽管有关流式传输性能监控的许多文献都强调了捕捉性能变化的方法,但要在现实世界中成功实施,还必须应对一系列其他挑战和考虑因素。
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引用次数: 0
AI: Bridging Ancient Wisdom and Modern Innovation in Traditional Chinese Medicine. 人工智能:连接传统中医的古老智慧与现代创新。
IF 3.1 3区 医学 Q2 MEDICAL INFORMATICS Pub Date : 2024-06-28 DOI: 10.2196/58491
Linken Lu, Tangsheng Lu, Chunyu Tian, Xiujun Zhang

The pursuit of groundbreaking health care innovations has led to the convergence of artificial intelligence (AI) and traditional Chinese medicine (TCM), thus marking a new frontier that demonstrates the promise of combining the advantages of ancient healing practices with cutting-edge advancements in modern technology. TCM, which is a holistic medical system with >2000 years of empirical support, uses unique diagnostic methods such as inspection, auscultation and olfaction, inquiry, and palpation. AI is the simulation of human intelligence processes by machines, especially via computer systems. TCM is experience oriented, holistic, and subjective, and its combination with AI has beneficial effects, which presumably arises from the perspectives of diagnostic accuracy, treatment efficacy, and prognostic veracity. The role of AI in TCM is highlighted by its use in diagnostics, with machine learning enhancing the precision of treatment through complex pattern recognition. This is exemplified by the greater accuracy of TCM syndrome differentiation via tongue images that are analyzed by AI. However, integrating AI into TCM also presents multifaceted challenges, such as data quality and ethical issues; thus, a unified strategy, such as the use of standardized data sets, is required to improve AI understanding and application of TCM principles. The evolution of TCM through the integration of AI is a key factor for elucidating new horizons in health care. As research continues to evolve, it is imperative that technologists and TCM practitioners collaborate to drive innovative solutions that push the boundaries of medical science and honor the profound legacy of TCM. We can chart a future course wherein AI-augmented TCM practices contribute to more systematic, effective, and accessible health care systems for all individuals.

对突破性医疗创新的追求促使人工智能(AI)与传统中医药(TCM)的融合,从而标志着一个新的前沿领域,展示了将古老治疗方法的优势与现代技术的尖端进步相结合的前景。中医是一个拥有超过 2000 年经验支持的整体医疗体系,使用独特的诊断方法,如检查、听诊和嗅觉、询问和触诊。人工智能是机器对人类智能过程的模拟,特别是通过计算机系统。中医以经验为导向,具有整体性和主观性,它与人工智能的结合会产生有益的效果,这可能来自于诊断准确性、治疗效果和预后真实性等方面。人工智能在中医中的作用突出表现在其在诊断中的应用,机器学习通过复杂的模式识别提高了治疗的精确性。例如,通过人工智能分析舌象,中医辨证分型的准确性更高。然而,将人工智能融入中医药也面临着多方面的挑战,如数据质量和伦理问题;因此,需要采取统一的策略,如使用标准化的数据集,以提高人工智能对中医原理的理解和应用。通过整合人工智能实现中医药的发展是阐明医疗保健新视野的关键因素。随着研究的不断发展,技术专家和中医从业者必须通力合作,推动创新解决方案,突破医学科学的界限,传承博大精深的中医药。我们可以规划出一条未来之路,让人工智能增强的中医实践为更系统、更有效、更便于所有人使用的医疗保健系统做出贡献。
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引用次数: 0
Data Set and Benchmark (MedGPTEval) to Evaluate Responses From Large Language Models in Medicine: Evaluation Development and Validation. 数据集和基准(MedGPTEval),用于评估大型医学语言模型的响应:评估开发与验证。
IF 3.1 3区 医学 Q2 MEDICAL INFORMATICS Pub Date : 2024-06-28 DOI: 10.2196/57674
Jie Xu, Lu Lu, Xinwei Peng, Jiali Pang, Jinru Ding, Lingrui Yang, Huan Song, Kang Li, Xin Sun, Shaoting Zhang

Background: Large language models (LLMs) have achieved great progress in natural language processing tasks and demonstrated the potential for use in clinical applications. Despite their capabilities, LLMs in the medical domain are prone to generating hallucinations (not fully reliable responses). Hallucinations in LLMs' responses create substantial risks, potentially threatening patients' physical safety. Thus, to perceive and prevent this safety risk, it is essential to evaluate LLMs in the medical domain and build a systematic evaluation.

Objective: We developed a comprehensive evaluation system, MedGPTEval, composed of criteria, medical data sets in Chinese, and publicly available benchmarks.

Methods: First, a set of evaluation criteria was designed based on a comprehensive literature review. Second, existing candidate criteria were optimized by using a Delphi method with 5 experts in medicine and engineering. Third, 3 clinical experts designed medical data sets to interact with LLMs. Finally, benchmarking experiments were conducted on the data sets. The responses generated by chatbots based on LLMs were recorded for blind evaluations by 5 licensed medical experts. The evaluation criteria that were obtained covered medical professional capabilities, social comprehensive capabilities, contextual capabilities, and computational robustness, with 16 detailed indicators. The medical data sets include 27 medical dialogues and 7 case reports in Chinese. Three chatbots were evaluated: ChatGPT by OpenAI; ERNIE Bot by Baidu, Inc; and Doctor PuJiang (Dr PJ) by Shanghai Artificial Intelligence Laboratory.

Results: Dr PJ outperformed ChatGPT and ERNIE Bot in the multiple-turn medical dialogues and case report scenarios. Dr PJ also outperformed ChatGPT in the semantic consistency rate and complete error rate category, indicating better robustness. However, Dr PJ had slightly lower scores in medical professional capabilities compared with ChatGPT in the multiple-turn dialogue scenario.

Conclusions: MedGPTEval provides comprehensive criteria to evaluate chatbots by LLMs in the medical domain, open-source data sets, and benchmarks assessing 3 LLMs. Experimental results demonstrate that Dr PJ outperforms ChatGPT and ERNIE Bot in social and professional contexts. Therefore, such an assessment system can be easily adopted by researchers in this community to augment an open-source data set.

背景:大语言模型(LLMs)在自然语言处理任务中取得了巨大进步,并展示了在临床应用中的使用潜力。尽管大型语言模型具有强大的功能,但在医疗领域却容易产生幻觉(不完全可靠的反应)。LLMs 响应中的幻觉会带来巨大风险,可能会威胁到患者的人身安全。因此,要感知并预防这种安全风险,就必须对医疗领域的 LLM 进行评估,并建立系统的评估体系:我们开发了一个由标准、中文医疗数据集和公开基准组成的综合评估系统--MedGPTEval:方法:首先,根据全面的文献综述设计了一套评价标准。方法:首先,根据全面的文献综述设计了一套评价标准;其次,与 5 位医学和工程学专家采用德尔菲法对现有的候选标准进行了优化。第三,3 位临床专家设计了与 LLM 交互的医学数据集。最后,对数据集进行了基准测试。基于 LLMs 的聊天机器人生成的回复被记录下来,由 5 位持证医学专家进行盲评。获得的评价标准涵盖医疗专业能力、社交综合能力、语境能力和计算鲁棒性,共有 16 个详细指标。医疗数据集包括 27 个医疗对话和 7 个中文病例报告。对三个聊天机器人进行了评估:三个聊天机器人分别是:OpenAI 的 ChatGPT、百度公司的 ERNIE Bot 和上海人工智能实验室的浦江医生(Dr PJ):结果:在多轮医疗对话和病例报告场景中,浦江医生的表现优于 ChatGPT 和 ERNIE Bot。在语义一致率和完全错误率方面,PJ 博士的表现也优于 ChatGPT,这表明它具有更好的鲁棒性。不过,在多轮对话场景中,Dr PJ 的医疗专业能力得分略低于 ChatGPT:MedGPTEval提供了医疗领域LLM评估聊天机器人的综合标准、开源数据集和评估3个LLM的基准。实验结果表明,PJ 博士在社交和专业场合的表现优于 ChatGPT 和 ERNIE Bot。因此,该社区的研究人员可以轻松采用这种评估系统来增强开源数据集。
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引用次数: 0
Data Flow Construction and Quality Evaluation of Electronic Source Data in Clinical Trials: Pilot Study Based on Hospital Electronic Medical Records in China 临床试验电子源数据的数据流构建与质量评价:基于中国医院电子病历的试点研究
IF 3.2 3区 医学 Q2 MEDICAL INFORMATICS Pub Date : 2024-06-27 DOI: 10.2196/52934
Yannan Yuan, Yun Mei, Shuhua Zhao, Shenglong Dai, Xiaohong Liu, Xiaojing Sun, Zhiying Fu, Liheng Zhou, Jie Ai, Liheng Ma, Min Jiang
Background: The traditional clinical trial data collection process requires a Clinical Research Coordinator (CRC) who is authorized by the investigators to read from the hospital electronic medical record. Using electronic source data opens a new path to extract subjects' data from EHR and transfer directly to EDC (often the method is referred to as eSource ).The eSource technology in clinical trial data flow can improve data quality without compromising timeliness. At the same time, improved data collection efficiency reduces clinical trial costs. Objective: Explore how to extract clinical trial-related data from hospital electronic health record system (EHR), transform the data into an electronic data capture system (EDC) required format, and transfer it into sponsor's environment. Evaluate the transferred datasets to validate the availability, completeness, and accuracy of building eSource dataflow. Methods: A prospective clinical trial study registered on the "Drug Clinical Trial Registration and Information Disclosure Platform (http://www.chinadrugtrials.org.cn/) " was selected, and the production data environment of EHR relied on to extract the structured data of four Case Report Form(CRF) data modules: demographics, vital signs, local laboratory, and concomitant medications from EHR. Extracted data was mapped & transformed, de-identified, and transferred to the sponsor’s environments. Data validation was performed based on availability, completeness and accuracy. Results: In a secure and controlled data environment, clinical trial data was successfully transferred from a hospital EHR to sponsor's environment with 100% transcriptional accuracy, but availability and completeness could be improved. Conclusions: Data availability is low due to some fields required in EDC not being available directly in the EHR. Concurrently, some data is still in unstructured data format and paper-based medical record data, therefore data completeness in the EHR is low. The top-level design of eSource and the construction of hospital electronic data standards should help lay a foundation for full electronic data flow from EHR to EDC in future.
背景:传统的临床试验数据采集过程需要临床研究协调员(CRC)经研究者授权从医院电子病历中读取数据。在临床试验数据流中使用电子源数据开辟了一条从电子病历中提取受试者数据并直接传输到 EDC 的新途径(通常这种方法被称为 eSource)。同时,数据收集效率的提高还能降低临床试验成本。目标探索如何从医院电子病历系统(EHR)中提取临床试验相关数据,将数据转换为电子数据采集系统(EDC)要求的格式,并将其传输到申办者的环境中。评估传输的数据集,以验证构建 eSource 数据流的可用性、完整性和准确性。方法选择一项在 "药物临床试验注册与信息公开平台(http://www.chinadrugtrials.org.cn/)"上注册的前瞻性临床试验研究,依托电子病历的生产数据环境,从电子病历中提取病例报告表(CRF)四个数据模块的结构化数据:人口统计学、生命体征、当地实验室和伴随药物。提取的数据经过映射和转换、去标识化后传输到赞助商的环境中。根据可用性、完整性和准确性进行数据验证。结果在安全可控的数据环境中,临床试验数据成功地从医院电子病历传输到赞助商的环境中,转录准确率达到 100%,但可用性和完整性有待提高。结论:由于 EDC 所需的某些字段无法直接在 EHR 中使用,因此数据可用性较低。同时,一些数据仍是非结构化数据格式和纸质病历数据,因此电子病历中的数据完整性较低。eSource 的顶层设计和医院电子数据标准的建设,应有助于为今后从电子健康记 录到电子病历数据库的全面电子数据流奠定基础。
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引用次数: 0
An Ontology-Based Decision Support System for Tailored Clinical Nutrition Recommendations for Patients With Chronic Obstructive Pulmonary Disease: Development and Acceptability Study. 基于本体论的决策支持系统,为慢性阻塞性肺病患者量身定制临床营养建议:开发与可接受性研究。
IF 3.1 3区 医学 Q2 MEDICAL INFORMATICS Pub Date : 2024-06-26 DOI: 10.2196/50980
Daniele Spoladore, Vera Colombo, Alessia Fumagalli, Martina Tosi, Erna Cecilia Lorenzini, Marco Sacco
<p><strong>Background: </strong>Chronic obstructive pulmonary disease (COPD) is a chronic condition among the main causes of morbidity and mortality worldwide, representing a burden on health care systems. Scientific literature highlights that nutrition is pivotal in respiratory inflammatory processes connected to COPD, including exacerbations. Patients with COPD have an increased risk of developing nutrition-related comorbidities, such as diabetes, cardiovascular diseases, and malnutrition. Moreover, these patients often manifest sarcopenia and cachexia. Therefore, an adequate nutritional assessment and therapy are essential to help individuals with COPD in managing the progress of the disease. However, the role of nutrition in pulmonary rehabilitation (PR) programs is often underestimated due to a lack of resources and dedicated services, mostly because pneumologists may lack the specialized training for such a discipline.</p><p><strong>Objective: </strong>This work proposes a novel knowledge-based decision support system to support pneumologists in considering nutritional aspects in PR. The system provides clinicians with patient-tailored dietary recommendations leveraging expert knowledge.</p><p><strong>Methods: </strong>The expert knowledge-acquired from experts and clinical literature-was formalized in domain ontologies and rules, which were developed leveraging the support of Italian clinicians with expertise in the rehabilitation of patients with COPD. Thus, by following an agile ontology engineering methodology, the relevant formal ontologies were developed to act as a backbone for an application targeted at pneumologists. The recommendations provided by the decision support system were validated by a group of nutrition experts, whereas the acceptability of such an application in the context of PR was evaluated by pneumologists.</p><p><strong>Results: </strong>A total of 7 dieticians (mean age 46.60, SD 13.35 years) were interviewed to assess their level of agreement with the decision support system's recommendations by evaluating 5 patients' health conditions. The preliminary results indicate that the system performed more than adequately (with an overall average score of 4.23, SD 0.52 out of 5 points), providing meaningful and safe recommendations in compliance with clinical practice. With regard to the acceptability of the system by lung specialists (mean age 44.71, SD 11.94 years), the usefulness and relevance of the proposed solution were extremely positive-the scores on each of the perceived usefulness subscales of the technology acceptance model 3 were 4.86 (SD 0.38) out of 5 points, whereas the score on the intention to use subscale was 4.14 (SD 0.38) out of 5 points.</p><p><strong>Conclusions: </strong>Although designed for the Italian clinical context, the proposed system can be adapted for any other national clinical context by modifying the domain ontologies, thus providing a multidisciplinary approach to the management of pa
背景:慢性阻塞性肺病(COPD)是一种慢性疾病,是全球发病率和死亡率的主要原因之一,给医疗保健系统造成了沉重负担。科学文献强调,营养在与慢性阻塞性肺病有关的呼吸道炎症过程(包括病情加重)中起着关键作用。慢性阻塞性肺病患者罹患糖尿病、心血管疾病和营养不良等营养相关并发症的风险增加。此外,这些患者还经常表现出肌肉疏松症和恶病质。因此,充分的营养评估和治疗对于帮助慢性阻塞性肺病患者控制病情发展至关重要。然而,由于缺乏资源和专门服务,营养在肺康复(PR)项目中的作用往往被低估,这主要是因为肺科医生可能缺乏这方面的专业培训:本研究提出了一种基于知识的新型决策支持系统,以支持肺科医生考虑肺康复中的营养问题。该系统利用专家知识为临床医生提供适合患者的饮食建议:方法:从专家和临床文献中获取的专家知识在领域本体和规则中得到了正式化,这些本体和规则是在意大利慢性阻塞性肺病患者康复方面具有专长的临床医生的支持下开发的。因此,通过采用敏捷本体工程方法,开发出了相关的正式本体,作为针对肺科医生的应用程序的骨干。决策支持系统提供的建议由一组营养专家进行了验证,而肺科专家则对此类应用程序在PR背景下的可接受性进行了评估:共有 7 名营养学家(平均年龄 46.60 岁,平均年龄偏差 13.35 岁)接受了访谈,通过评估 5 名患者的健康状况来评估他们对决策支持系统建议的认同程度。初步结果显示,该系统的表现非常出色(总平均分为 4.23 分,标准差为 0.52 分(满分为 5 分)),提供的建议既有意义又安全,符合临床实践。关于肺科专家(平均年龄 44.71 岁,中位数 11.94 岁)对该系统的可接受性,他们对该解决方案的实用性和相关性给予了极高的评价--在技术接受模型 3 的每个感知实用性分量表上的得分均为 4.86(中位数 0.38)(满分 5 分),而在使用意向分量表上的得分则为 4.14(中位数 0.38)(满分 5 分):尽管该系统是针对意大利临床环境设计的,但通过修改领域本体论,也可适用于其他国家的临床环境,从而为慢性阻塞性肺病患者的管理提供一种多学科方法。
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引用次数: 0
User Preferences and Needs for Health Data Collection Using Research Electronic Data Capture: Survey Study. 使用研究电子数据采集技术收集健康数据的用户偏好和需求:调查研究。
IF 3.1 3区 医学 Q2 MEDICAL INFORMATICS Pub Date : 2024-06-25 DOI: 10.2196/49785
Hiral Soni, Julia Ivanova, Hattie Wilczewski, Triton Ong, J Nalubega Ross, Alexandra Bailey, Mollie Cummins, Janelle Barrera, Brian Bunnell, Brandon Welch

Background: Self-administered web-based questionnaires are widely used to collect health data from patients and clinical research participants. REDCap (Research Electronic Data Capture; Vanderbilt University) is a global, secure web application for building and managing electronic data capture. Unfortunately, stakeholder needs and preferences of electronic data collection via REDCap have rarely been studied.

Objective: This study aims to survey REDCap researchers and administrators to assess their experience with REDCap, especially their perspectives on the advantages, challenges, and suggestions for the enhancement of REDCap as a data collection tool.

Methods: We conducted a web-based survey with representatives of REDCap member organizations in the United States. The survey captured information on respondent demographics, quality of patient-reported data collected via REDCap, patient experience of data collection with REDCap, and open-ended questions focusing on the advantages, challenges, and suggestions to enhance REDCap's data collection experience. Descriptive and inferential analysis measures were used to analyze quantitative data. Thematic analysis was used to analyze open-ended responses focusing on the advantages, disadvantages, and enhancements in data collection experience.

Results: A total of 207 respondents completed the survey. Respondents strongly agreed or agreed that the data collected via REDCap are accurate (188/207, 90.8%), reliable (182/207, 87.9%), and complete (166/207, 80.2%). More than half of respondents strongly agreed or agreed that patients find REDCap easy to use (165/207, 79.7%), could successfully complete tasks without help (151/207, 72.9%), and could do so in a timely manner (163/207, 78.7%). Thematic analysis of open-ended responses yielded 8 major themes: survey development, user experience, survey distribution, survey results, training and support, technology, security, and platform features. The user experience category included more than half of the advantage codes (307/594, 51.7% of codes); meanwhile, respondents reported higher challenges in survey development (169/516, 32.8% of codes), also suggesting the highest enhancement suggestions for the category (162/439, 36.9% of codes).

Conclusions: Respondents indicated that REDCap is a valued, low-cost, secure resource for clinical research data collection. REDCap's data collection experience was generally positive among clinical research and care staff members and patients. However, with the advancements in data collection technologies and the availability of modern, intuitive, and mobile-friendly data collection interfaces, there is a critical opportunity to enhance the REDCap experience to meet the needs of researchers and patients.

背景:自填式网络问卷被广泛用于收集患者和临床研究参与者的健康数据。REDCap(研究电子数据采集;范德堡大学)是一个全球性的安全网络应用程序,用于建立和管理电子数据采集。遗憾的是,很少有人研究过利益相关者对通过 REDCap 收集电子数据的需求和偏好:本研究旨在对 REDCap 研究人员和管理人员进行调查,评估他们使用 REDCap 的经验,尤其是他们对 REDCap 作为数据采集工具的优势、挑战和改进建议的看法:我们对美国 REDCap 成员组织的代表进行了网络调查。调查收集了受访者的人口统计学信息、通过 REDCap 收集的患者报告数据的质量、患者使用 REDCap 收集数据的体验,以及关于增强 REDCap 数据收集体验的优势、挑战和建议的开放式问题。描述性和推论性分析方法用于分析定量数据。专题分析用于分析开放式回答,重点关注数据收集体验的优势、劣势和改进:共有 207 位受访者完成了调查。受访者非常同意或同意通过 REDCap 收集的数据是准确的(188/207,90.8%)、可靠的(182/207,87.9%)和完整的(166/207,80.2%)。超过半数的受访者非常同意或同意患者认为 REDCap 易于使用(165/207,79.7%),可以在没有帮助的情况下成功完成任务(151/207,72.9%),并且可以及时完成任务(163/207,78.7%)。对开放式回答的专题分析得出了 8 个主要专题:调查开发、用户体验、调查分发、调 查结果、培训和支持、技术、安全和平台功能。用户体验类别包含了超过半数的优势代码(307/594,占代码总数的 51.7%);同时,受访者表示在调查开发方面遇到了更多挑战(169/516,占代码总数的 32.8%),也提出了最多的改进建议(162/439,占代码总数的 36.9%):受访者表示,REDCap 是一种有价值、低成本、安全的临床研究数据收集资源。临床研究和护理人员以及患者对 REDCap 的数据收集体验普遍持肯定态度。然而,随着数据收集技术的进步,以及现代、直观、移动友好的数据收集界面的出现,我们有机会提升 REDCap 的体验,以满足研究人员和患者的需求。
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引用次数: 0
Implementing a Biomedical Data Warehouse From Blueprint to Bedside in a Regional French University Hospital Setting: Unveiling Processes, Overcoming Challenges, and Extracting Clinical Insight. 在法国一所地区性大学医院实施 "从蓝图到床边 "的生物医学数据仓库:揭示流程、克服挑战并提取临床洞察力。
IF 3.1 3区 医学 Q2 MEDICAL INFORMATICS Pub Date : 2024-06-24 DOI: 10.2196/50194
Matilde Karakachoff, Thomas Goronflot, Sandrine Coudol, Delphine Toublant, Adrien Bazoge, Pacôme Constant Dit Beaufils, Emilie Varey, Christophe Leux, Nicolas Mauduit, Matthieu Wargny, Pierre-Antoine Gourraud

Background: Biomedical data warehouses (BDWs) have become an essential tool to facilitate the reuse of health data for both research and decisional applications. Beyond technical issues, the implementation of BDWs requires strong institutional data governance and operational knowledge of the European and national legal framework for the management of research data access and use.

Objective: In this paper, we describe the compound process of implementation and the contents of a regional university hospital BDW.

Methods: We present the actions and challenges regarding organizational changes, technical architecture, and shared governance that took place to develop the Nantes BDW. We describe the process to access clinical contents, give details about patient data protection, and use examples to illustrate merging clinical insights.

Unlabelled: More than 68 million textual documents and 543 million pieces of coded information concerning approximately 1.5 million patients admitted to CHUN between 2002 and 2022 can be queried and transformed to be made available to investigators. Since its creation in 2018, 269 projects have benefited from the Nantes BDW. Access to data is organized according to data use and regulatory requirements.

Conclusions: Data use is entirely determined by the scientific question posed. It is the vector of legitimacy of data access for secondary use. Enabling access to a BDW is a game changer for research and all operational situations in need of data. Finally, data governance must prevail over technical issues in institution data strategy vis-à-vis care professionals and patients alike.

背景:生物医学数据仓库(BDW)已成为促进研究和决策应用中健康数据再利用的重要工具。除技术问题外,生物医学数据仓库的实施还需要强有力的机构数据管理以及对欧洲和国家研究数据访问和使用管理法律框架的业务知识:在本文中,我们将介绍一家地区性大学医院 BDW 的复合实施过程和内容:我们介绍了为开发南特 BDW 而在组织变革、技术架构和共享管理方面采取的行动和面临的挑战。我们描述了访问临床内容的过程,介绍了患者数据保护的细节,并用实例说明了合并临床见解的过程:超过6800万份文本文档和5.43亿条编码信息涉及2002年至2022年间CHUN收治的约150万名患者,可通过查询和转换提供给研究人员。自2018年创建以来,已有269个项目受益于南特BDW。数据访问根据数据使用和监管要求进行组织:数据使用完全由提出的科学问题决定。它是二次使用数据访问合法性的载体。对研究和所有需要数据的业务情况来说,启用访问边界数据集的功能将改变游戏规则。最后,在医疗专业人员和患者面前,机构数据战略中的数据管理必须优先于技术问题。
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引用次数: 0
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