INSIGHT: A Tool for Fit-for-Purpose Evaluation and Quality Assessment of Standardized Observational Data Sources for Real World Evidence on Medicine and Vaccine Safety.

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY

Pharmacoepidemiology and Drug Safety Pub Date : 2025-01-01 DOI:10.1002/pds.70089

Vjola Hoxhaj, Constanza L Andaur Navarro, Judit Riera-Arnau, Roel J H J Elbers, Ema Alsina, Caitlin Dodd, Miriam C J M Sturkenboom

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引用次数: 0

Abstract

Purpose: To describe the development of INSIGHT, a real-world data quality tool to assess completeness, consistency, and fitness-for-purpose of observational health data sources.

Methods: We designed a three-level pipeline with data quality assessments (DQAs) to be performed in ConcePTION Common Data Model (CDM) instances. The pipeline has been coded using R.

Results: INSIGHT is an open-source tool that identifies potential data quality issues in CDM-standardized instances through the systematic execution and summary of over 588 configurable DQAs. Level 1 focuses on conformance to the ConcePTION CDM specifications. Level 2 evaluates the temporal plausibility of events and uniqueness of records. Level 3 provides an overview of distributions, outliers, and trends over time to facilitate fit-for-purpose evaluation. Therefore, level 1 and 2 assure a proper data standardization, while level 3 provides information regarding the study population, and potential sub-populations. The DQAs are run locally and assessed centrally by a data quality revisor together with the data access provider's representatives.

Discussion: Data quality is the sum of several internal and external features of the data. While DQAs can provide reassurance about fitness-for-purpose for secondary-use data sources, improvements in data collection are essential to reduce errors and enhance overall data quality for Real World Evidence.

Conclusion: INSIGHT aims to support clinical and regulatory decision-making for medicines and vaccines by evaluating the quality of observational health data sources to support fit for purpose assessment. Assessing and improving data quality will enhance the reliability and quality of the generated evidence.

Study registration: This research was registered in EU PAS registration with number EU50142.

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INSIGHT：用于医学和疫苗安全真实世界证据的标准化观测数据源的适合目的评估和质量评估的工具。

目的：描述INSIGHT的发展，INSIGHT是一种真实世界的数据质量工具，用于评估观察性健康数据源的完整性、一致性和适用性。方法：我们设计了一个具有数据质量评估（dqa）的三层管道，以在概念公共数据模型（CDM）实例中执行。该管道已经使用R.Results: INSIGHT是一个开源工具，它通过对588多个可配置dqa的系统执行和总结来识别cdm标准化实例中潜在的数据质量问题。第1级关注的是与concept CDM规范的一致性。级别2评估事件的时间合理性和记录的唯一性。级别3提供了随时间变化的分布、异常值和趋势的概述，以方便进行适合目的的评估。因此，第1级和第2级确保了适当的数据标准化，而第3级提供了有关研究人群和潜在亚人群的信息。dqa在本地运行，并由数据质量审查员和数据访问提供者的代表进行集中评估。讨论：数据质量是数据的几个内部和外部特征的总和。虽然dqa可以保证二次使用数据源的适用性，但改进数据收集对于减少错误和提高真实世界证据的整体数据质量至关重要。结论：INSIGHT旨在通过评估观察性健康数据源的质量来支持目的评估，从而支持药物和疫苗的临床和监管决策。评估和改进数据质量将提高所生成证据的可靠性和质量。研究注册：本研究已在EU PAS注册，注册号为EU50142。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmacoepidemiology and Drug Safety 医学-药学

CiteScore

4.80

自引率

7.70%

发文量

173

审稿时长

3 months

期刊介绍： The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.