ArticleJournal of the American Medical Informatics Association : JAMIA2020
Using and improving distributed data networks to generate actionable evidence: the case of real-world outcomes in the Food and Drug Administration's Sentinel system.
Article in Journal of the American Medical Informatics Association : JAMIA, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 2 of them syntheses 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
29 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Common data models and data standards for tabular health data: a systematic review.BMC medical informatics and decision making · 2025Pooled it
- Application of Spatial Analysis on Electronic Health Records to Characterize Patient Phenotypes: Systematic Review.JMIR medical informatics · 2024Pooled it
- Identifying anaphylaxis using weakly-supervised prediction models and natural language processing.medRxiv : the preprint server for health sciences · 2026Article
- Serious Infection in Crohn's Disease Patients Treated With Ustekinumab: US Food and Drug Administration Active Postmarket Risk Identification and Analysis in the Sentinel Initiative.Clinical pharmacology and therapeutics · 2026Article
- Trust in Observational Research.Journal of the American College of Cardiology · 2026Article
- Article
- Assessing the harmonization of structured electronic health record data to reference terminologies and data completeness through data provenance.Learning health systems · 2025Article
- A future of data-rich pharmacoepidemiology studies: transitioning to large-scale linked electronic health record + claims data.American journal of epidemiology · 2025Article
- Exploring beyond diagnoses in electronic health records to improve discovery: a review of the phenome-wide association study.JAMIA open · 2025Review
- Collaborative pharmacy research across integrated health systems: A purpose and promise for opportunities to study the complete medication-use process.American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists · 2025Article
- Assessing and improving research readiness in PCORnet®.Journal of clinical and translational science · 2025Article
- Tree-based scan statistics to generate drug repurposing hypotheses: a test case using sodium-glucose cotransporter-2 inhibitors.American journal of epidemiology · 2024Article
- A general framework for developing computable clinical phenotype algorithms.Journal of the American Medical Informatics Association : JAMIA · 2024Article
- Centralized and Federated Models for the Analysis of Clinical Data.Annual review of biomedical data science · 2024Review
- Standards and frameworks.Journal of the American Medical Informatics Association : JAMIA · 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
- Trends and opportunities in computable clinical phenotyping: A scoping review.Journal of biomedical informatics · 2023Article
- Improving Methods of Identifying Anaphylaxis for Medical Product Safety Surveillance Using Natural Language Processing and Machine Learning.American journal of epidemiology · 2023Article
- An application of the Causal Roadmap in two safety monitoring case studies: Causal inference and outcome prediction using electronic health record data.Journal of clinical and translational science · 2023Article
- The US Food and Drug Administration Sentinel System: a national resource for a learning health system.Journal of the American Medical Informatics Association : JAMIA · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
Abstract
The US Food and Drug Administration (FDA) Sentinel System uses a distributed data network, a common data model, curated real-world data, and distributed analytic tools to generate evidence for FDA decision-making. Sentinel system needs include analytic flexibility, transparency, and reproducibility while protecting patient privacy. Based on over a decade of experience, a critical system limitation is the inability to identify enough medical conditions of interest in observational data to a satisfactory level of accuracy. Improving the system's ability to use computable phenotypes will require an "all of the above" approach that improves use of electronic health data while incorporating the growing array of complementary electronic health record data sources. FDA recently funded a Sentinel System Innovation Center and a Community Building and Outreach Center that will provide a platform for collaboration across disciplines to promote better use of real-world data for decision-making.
Indexed as
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.