With advances in computing and information technology, large health care research databases are becoming increasingly accessible to investigators across the world. These rich, population-level data sources can serve many purposes, such as to generate “real-world evidence,” to enhance disease phenotyping, or to identify unmet clinical needs, among others. This is of particular relevance to the study of patients with end-stage liver disease (ESLD), a socioeconomically and clinically heterogeneous population that is frequently under-represented in clinical trials. This review describes the recommended “best practices” in the execution, reporting, and interpretation of large database clinical epidemiology research in hepatology. The advantages and limitations of selected data sources are reviewed, as well as important concepts on data linkages. The appropriate classification of exposures and outcomes is addressed, and the strategies needed to overcome limitations of the data and minimize bias are explained as they pertain to patients with ESLD and/or liver transplantation (LT) recipients. Lastly, selected statistical concepts are reviewed, from model building to analytic decision making and hypothesis testing. The purpose of this review is to provide the practical insights and knowledge needed to ensure successful and impactful research using large clinical databases in the modern era and advance the study of ESLD and LT.

中文翻译：

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大型数据库肝病临床流行病学研究的最佳实践：障碍与机遇

随着计算和信息技术的进步，世界各地的研究人员越来越多地可以访问大型医疗保健研究数据库。这些丰富的人口水平数据源可以用于多种目的，例如生成“真实世界的证据”，以加强疾病表型分析，或识别未满足的临床需求等。这与终末期肝病 (ESLD) 患者的研究特别相关，ESLD 是一种社会经济和临床异质性人群，在临床试验中经常代表性不足。本综述描述了在肝病学大型数据库临床流行病学研究的执行、报告和解释方面推荐的“最佳实践”。审查了选定数据源的优点和局限性，以及有关数据链接的重要概念。解决了暴露和结果的适当分类，并解释了克服数据限制和最小化偏倚所需的策略，因为它们与 ESLD 患者和/或肝移植 (LT) 接受者有关。最后，回顾选定的统计概念，从模型构建到分析决策制定和假设检验。这篇综述的目的是提供确保在现代使用大型临床数据库进行成功和有影响力的研究并推进 ESLD 和 LT 研究所需的实用见解和知识。选定的统计概念被审查，从模型构建到分析决策和假设检验。这篇综述的目的是提供确保在现代使用大型临床数据库进行成功和有影响力的研究并推进 ESLD 和 LT 研究所需的实用见解和知识。选定的统计概念被审查，从模型构建到分析决策和假设检验。这篇综述的目的是提供确保在现代使用大型临床数据库进行成功和有影响力的研究并推进 ESLD 和 LT 研究所需的实用见解和知识。