ReviewNPJ digital medicine2021
Broadening the reach of the FDA Sentinel system: A roadmap for integrating electronic health record data in a causal analysis framework.
Review in NPJ digital medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
34 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Common data models and data standards for tabular health data: a systematic review.BMC medical informatics and decision making · 2025Pooled it
- Characterization and comparison of structured and unstructured electronic health record data mapped to MedDRA for post-marketing surveillance.JAMIA open · 2026Article
- Advancing real-world evidence in Brazil: regulatory gaps and global lessons.Lancet regional health. Americas · 2026Review
- Methodological and regulatory considerations for causal AI in drug development.NPJ digital medicine · 2026Review
- Scaling medical device regulatory science using large language models.NPJ digital medicine · 2026Article
- High-dimensional multiple imputation for partially observed confounders including natural language processing-derived auxiliary covariates.American journal of epidemiology · 2026Article
- Validation of the Medicare-Enhanced Laboratory and Demographics (MELD™) Dataset: A Comprehensive Psychometric, Epidemiologic, and Predictive-Utility Assessment of a 60-Million-Patient Real-World Evidence Resource.Journal of health economics and outcomes research · 2026Article
- Quantitative Bias Analysis for Single-Arm Trials With External Control Arms.JAMA network open · 2025Article
- A future of data-rich pharmacoepidemiology studies: transitioning to large-scale linked electronic health record + claims data.American journal of epidemiology · 2025Article
- Step-by-step causal analysis of EHRs to ground decision-making.PLOS digital health · 2025Article
- How life-cycle real-world evidence can bridge evidentiary gaps in precision oncology.Frontiers in medicine · 2025Article
- Capacity assessment for EHR-based medical device post-market surveillance for synthetic mid-urethral slings among women with stress urinary incontinence: a NEST consortium study.BMJ surgery, interventions, & health technologies · 2025Article
- Assessing and improving research readiness in PCORnet®.Journal of clinical and translational science · 2025Article
- Analyzing missingness patterns in real-world data using the SMDI toolkit: application to a linked EHR-claims pharmacoepidemiology study.BMC medical research methodology · 2024Article
- Scalable incident detection via natural language processing and probabilistic language models.Scientific reports · 2024Article
- Assessing Real-World Data From Electronic Health Records for Health Technology Assessment: The SUITABILITY Checklist: A Good Practices Report of an ISPOR Task Force.Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research · 2024Article
- smdi: an R package to perform structural missing data investigations on partially observed confounders in real-world evidence studies.JAMIA open · 2024Article
- Data-driven automated classification algorithms for acute health conditions: applying PheNorm to COVID-19 disease.Journal of the American Medical Informatics Association : JAMIA · 2024Article
- Natural language processing of multi-hospital electronic health records for public health surveillance of suicidality.Npj mental health research · 2024Article
- A Principled Approach to Characterize and Analyze Partially Observed Confounder Data from Electronic Health Records.Clinical epidemiology · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
Abstract
The Sentinel System is a major component of the United States Food and Drug Administration's (FDA) approach to active medical product safety surveillance. While Sentinel has historically relied on large quantities of health insurance claims data, leveraging longitudinal electronic health records (EHRs) that contain more detailed clinical information, as structured and unstructured features, may address some of the current gaps in capabilities. We identify key challenges when using EHR data to investigate medical product safety in a scalable and accelerated way, outline potential solutions, and describe the Sentinel Innovation Center's initiatives to put solutions into practice by expanding and strengthening the existing system with a query-ready, large-scale data infrastructure of linked EHR and claims data. We describe our initiatives in four strategic priority areas: (1) data infrastructure, (2) feature engineering, (3) causal inference, and (4) detection analytics, with the goal of incorporating emerging data science innovations to maximize the utility of EHR data for medical product safety surveillance.
Identifiers
What OpenQuestion holds
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.