ArticlePharmacoepidemiology and drug safety2025
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.
Article in Pharmacoepidemiology and drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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Who cites it
5 citing papers in PubMed.
- Switching Patterns of Oral Retinoids to Alternative Medications: An Interrupted Time-Series Analysis of Four European Countries.Drug safety · 2026Article
- Identifying Pregnancies in Population-Based Data Sources: Development and Application of the ConcePTION Pregnancy Algorithm.Pharmacoepidemiology and drug safety · 2026Article
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- A comprehensive study on factors influencing online impulse buying behavior: Evidence from Shopee video platform.Heliyon · 2024Article
Corrections and comments
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Authors and funding
7 authors.
Funding
Abstract
purposeTo describe the development of INSIGHT, a real-world data quality tool to assess completeness, consistency, and fitness-for-purpose of observational health data sources.
methodsWe 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.
resultsINSIGHT 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.
conclusionINSIGHT 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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.