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Leveraging a global, federated, real-world data network to optimize investigator-initiated pediatric clinical trials: the TriNetX Pediatric Collaboratory Network.利用全球联合的真实世界数据网络优化研究者发起的儿科临床试验:TriNetX儿科合作网络
JAMIA Open. 2024 Sep 2;7(3):ooae077. doi: 10.1093/jamiaopen/ooae077. eCollection 2024 Oct.
2
Retrospective Cohort Studies in Craniofacial Outcomes Research: An Epidemiologist's Approach to Mitigating Bias.颅面结果研究中的回顾性队列研究:流行病学家减轻偏倚的方法。
Cleft Palate Craniofac J. 2025 Jun;62(6):1061-1067. doi: 10.1177/10556656241233234. Epub 2024 Feb 22.
3
Exploring Breast Cancer Systemic Drug Therapy Patterns in Real-World Data.探索真实世界数据中乳腺癌系统药物治疗模式。
JCO Clin Cancer Inform. 2023 Sep;7:e2300061. doi: 10.1200/CCI.23.00061.
4
Comparison of EHR Data-Completeness in Patients with Different Types of Medical Insurance Coverage in the United States.美国不同类型医疗保险覆盖的患者电子健康记录数据完整性比较。
Clin Pharmacol Ther. 2023 Nov;114(5):1116-1125. doi: 10.1002/cpt.3027. Epub 2023 Sep 1.
5
The Detection of Date Shifting in Real-World Data.真实世界数据中的日期错位检测。
Appl Clin Inform. 2023 Aug;14(4):763-771. doi: 10.1055/a-2130-2197. Epub 2023 Jul 17.
6
Electronic health record data quality variability across a multistate clinical research network.多州临床研究网络中电子健康记录数据质量的变异性
J Clin Transl Sci. 2023 May 15;7(1):e130. doi: 10.1017/cts.2023.548. eCollection 2023.
7
An Overview of Current Methods for Real-world Applications to Generalize or Transport Clinical Trial Findings to Target Populations of Interest.当前用于将临床试验结果推广或转移到目标人群的真实世界应用的方法概述。
Epidemiology. 2023 Sep 1;34(5):627-636. doi: 10.1097/EDE.0000000000001633. Epub 2023 May 26.
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9
Automatic Outlier Detection in Laboratory Result Distributions Within a Real World Data Network.在真实世界数据网络中检测实验室结果分布中的自动异常值。
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TriNetX与真实世界证据:对其在临床研究中的优势、局限性及偏倚考量的批判性综述

TriNetX and Real-World Evidence: A Critical Review of Its Strengths, Limitations, and Bias Considerations in Clinical Research.

作者信息

Nassar Mahmoud, Abosheaishaa Hazem, Elfert Khaled, Beran Azizullah, Ismail Abdellatif, Mohamed Mouhand, Misra Anoop, Essibayi Muhammed Amir, Altschul David J, Azzam Ahmed Y

机构信息

Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, USA.

Internal Medicine Department, Icahn School of Medicine at Mount Sinai, NYC H+H Queens, New York, NY, USA.

出版信息

ASIDE Intern Med. 2025 Apr;1(2):24-33. doi: 10.71079/aside.im.03222516. Epub 2025 Mar 22.

DOI:10.71079/aside.im.03222516
PMID:40697879
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12282508/
Abstract

INTRODUCTION

The increasing utilization of real-world data platforms in medical research necessitates a comprehensive understanding of their methodological strengths and limitations. TriNetX has emerged as a significant platform for exploring large healthcare datasets. This review aims to critically evaluate the methodological framework and limitations of TriNetX, assess the impact of electronic health record coding accuracy on data reliability, and analyze the platform's capacity for generating generalizable real-world evidence in clinical research.

METHODS

We conducted a comprehensive review examining TriNetX's data architecture, quality metrics, and research applications, focusing on data integrity, platform architecture, and the external validity of research findings.

RESULTS

The analysis reveals significant methodological considerations. TriNetX's reliance on retrospective data introduces biases such as selection bias and confounding variables. The coding accuracy of electronic health records, which have not been independently validated, is a critical determinant of data reliability. The demographic representation is limited, affecting the generalizability of results.

DISCUSSION

Despite its extensive use, TriNetX's effective utilization requires careful consideration of its inherent limitations. The platform's data, predominantly from insured populations in academic and acute care settings, may not fully represent broader demographic groups. Addressing these methodological constraints is crucial for enhancing the reliability and applicability of research findings derived from TriNetX.

CONCLUSIONS

TriNetX is a valuable resource for healthcare research. However, its limitations must be acknowledged, and future research should focus on standardizing data collection and enhancing data validation processes to mitigate platform-specific biases and improve the quality and applicability of the findings.

摘要

引言

医学研究中对真实世界数据平台的使用日益增加,这就需要全面了解其方法学优势和局限性。TriNetX已成为探索大型医疗数据集的重要平台。本综述旨在批判性地评估TriNetX的方法学框架和局限性,评估电子健康记录编码准确性对数据可靠性的影响,并分析该平台在临床研究中生成可推广的真实世界证据的能力。

方法

我们进行了一项全面综述,研究TriNetX的数据架构、质量指标和研究应用,重点关注数据完整性、平台架构以及研究结果的外部有效性。

结果

分析揭示了重要的方法学考量。TriNetX对回顾性数据的依赖会引入选择偏倚和混杂变量等偏倚。未经独立验证的电子健康记录的编码准确性是数据可靠性的关键决定因素。人口统计学代表性有限,影响结果的可推广性。

讨论

尽管TriNetX被广泛使用,但其有效利用需要仔细考虑其固有局限性。该平台的数据主要来自学术和急性护理环境中的参保人群,可能无法充分代表更广泛的人口群体。解决这些方法学限制对于提高从TriNetX得出的研究结果的可靠性和适用性至关重要。

结论

TriNetX是医疗保健研究的宝贵资源。然而,必须承认其局限性,未来的研究应专注于规范数据收集和加强数据验证过程,以减轻特定于该平台的偏倚,并提高研究结果的质量和适用性。