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一种用于精准医学的数据管理系统。

A data management system for precision medicine.

作者信息

Jacobs John J L, Beekers Inés, Verkouter Inge, Richards Levi B, Vegelien Alexandra, Bloemsma Lizan D, Bongaerts Vera A M C, Cloos Jacqueline, Erkens Frederik, Gradowska Patrycja, Hort Simon, Hudecek Michael, Juan Manel, Maitland-van der Zee Anke H, Navarro-Velázquez Sergio, Ngai Lok Lam, Rafiq Qasim A, Sanges Carmen, Tettero Jesse, van Os Hendrikus J A, Vos Rimke C, de Wit Yolanda, van Dijk Steven

机构信息

Clinical Care & Research, ORTEC B.V., Zoetermeer, The Netherlands.

Faculty of Mathematics, VU, Amsterdam, The Netherlands.

出版信息

PLOS Digit Health. 2025 Jan 9;4(1):e0000464. doi: 10.1371/journal.pdig.0000464. eCollection 2025 Jan.

Abstract

Precision, or personalised medicine has advanced requirements for medical data management systems (MedDMSs). MedDMS for precision medicine should be able to process hundreds of parameters from multiple sites, be adaptable while remaining in sync at multiple locations, real-time syncing to analytics and be compliant with international privacy legislation. This paper describes the LogiqSuite software solution, aimed to support a precision medicine solution at the patient care (LogiqCare), research (LogiqScience) and data science (LogiqAnalytics) level. LogiqSuite is certified and compliant with international medical data and privacy legislations. This paper evaluates a MedDMS in five types of use cases for precision medicine, ranging from data collection to algorithm development and from implementation to integration with real-world data. The MedDMS is evaluated in seven precision medicine data science projects in prehospital triage, cardiovascular disease, pulmonology, and oncology. The P4O2 consortium uses the MedDMS as an electronic case report form (eCRF) that allows real-time data management and analytics in long covid and pulmonary diseases. In an acute myeloid leukaemia, study data from different sources were integrated to facilitate easy descriptive analytics for various research questions. In the AIDPATH project, LogiqCare is used to process patient data, while LogiqScience is used for pseudonymous CAR-T cell production for cancer treatment. In both these oncological projects the data in LogiqAnalytics is also used to facilitate machine learning to develop new prediction models for clinical-decision support (CDS). The MedDMS is also evaluated for real-time recording of CDS data from U-Prevent for cardiovascular risk management and from the Stroke Triage App for prehospital triage. The MedDMS is discussed in relation to other solutions for privacy-by-design, integrated data stewardship and real-time data analytics in precision medicine. LogiqSuite is used for multi-centre research study data registrations and monitoring, data analytics in interdisciplinary consortia, design of new machine learning / artificial intelligence (AI) algorithms, development of new or updated prediction models, integration of care with advanced therapy production, and real-world data monitoring in using CDS tools. The integrated MedDMS application supports data management for care and research in precision medicine.

摘要

精准医学,即个性化医疗,对医学数据管理系统(MedDMSs)提出了更高的要求。用于精准医学的MedDMS应能够处理来自多个地点的数百个参数,具备适应性并能在多个地点保持同步,实时同步至分析系统,且符合国际隐私法规。本文介绍了LogiqSuite软件解决方案,旨在为患者护理(LogiqCare)、研究(LogiqScience)和数据科学(LogiqAnalytics)层面的精准医学解决方案提供支持。LogiqSuite已通过认证并符合国际医学数据和隐私法规。本文在精准医学的五种用例中对一个MedDMS进行了评估,范围从数据收集到算法开发,以及从实施到与真实世界数据的整合。该MedDMS在七个精准医学数据科学项目中进行了评估,涉及院前分诊、心血管疾病、肺病学和肿瘤学。P4O2联盟将该MedDMS用作电子病例报告表(eCRF),可在长期新冠和肺部疾病中进行实时数据管理和分析。在一项急性髓系白血病研究中,整合了来自不同来源的数据,以便于针对各种研究问题进行简单的描述性分析。在AIDPATH项目中,LogiqCare用于处理患者数据,而LogiqScience用于为癌症治疗生产假名化的嵌合抗原受体T细胞(CAR-T)。在这两个肿瘤学项目中,LogiqAnalytics中的数据也用于促进机器学习,以开发用于临床决策支持(CDS)的新预测模型。该MedDMS还针对来自U-Prevent用于心血管风险管理的CDS数据以及来自中风分诊应用程序用于院前分诊的CDS数据进行了实时记录评估。本文还讨论了该MedDMS与精准医学中其他隐私设计、集成数据管理和实时数据分析解决方案的关系。LogiqSuite用于多中心研究数据注册和监测、跨学科联盟中的数据分析、新机器学习/人工智能(AI)算法的设计、新预测模型或更新预测模型的开发、将护理与先进治疗生产整合,以及使用CDS工具进行真实世界数据监测。集成的MedDMS应用程序支持精准医学中护理和研究的数据管理。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3b9a/11717228/5c93862c17c1/pdig.0000464.g001.jpg

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