ArticleClinical pharmacology and therapeutics2016
Successful Comparison of US Food and Drug Administration Sentinel Analysis Tools to Traditional Approaches in Quantifying a Known Drug-Adverse Event Association.
Article in Clinical pharmacology and therapeutics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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
16 citing papers in PubMed, 35 citations in OpenAlex.
- Application of the U.S. Food and Drug Administration's Sentinel Routine Querying Tools to the Taiwan Sentinel Data Model-formatted National Health Insurance Research Database.Journal of food and drug analysis · 2023Article
- Revealing Unknown Benefits of Existing Medications to Aid the Discovery of New Treatments for Post-Traumatic Stress Disorder.Psychiatric research and clinical practice · 2022Article
- Conducting Real-world Evidence Studies on the Clinical Outcomes of Diabetes Treatments.Endocrine reviews · 2021Article
- Risk of Nonmelanoma Skin Cancer in Association With Use of Hydrochlorothiazide-Containing Products in the United States.JNCI cancer spectrum · 2021Article
- Leveraging the Capabilities of the FDA's Sentinel System To Improve Kidney Care.Journal of the American Society of Nephrology : JASN · 2020Review
- Evaluation of the US Food and Drug Administration Sentinel Analysis Tools Using a Comparator with a Different Indication: Comparing the Rates of Gastrointestinal Bleeding in Warfarin and Statin Users.Pharmaceutical medicine · 2019Article
- Aiding the discovery of new treatments for dementia by uncovering unknown benefits of existing medications.Alzheimer's & dementia (New York, N. Y.) · 2019Article
- Evaluation of Switching Patterns in FDA's Sentinel System: A New Tool to Assess Generic Drugs.Drug safety · 2018Article
- First Conference on Big Data for Pharmacovigilance.Drug safety · 2018Review
- Association of Risk for Venous Thromboembolism With Use of Low-Dose Extended- and Continuous-Cycle Combined Oral Contraceptives: A Safety Study Using the Sentinel Distributed Database.JAMA internal medicine · 2018Article
- Data Mining for Adverse Drug Events With a Propensity Score-matched Tree-based Scan Statistic.Epidemiology (Cambridge, Mass.) · 2018Article
- A Query Workflow Design to Perform Automatable Distributed Regression Analysis in Large Distributed Data Networks.EGEMS (Washington, DC) · 2018Article
- Automated data-adaptive analytics for electronic healthcare data to study causal treatment effects.Clinical epidemiology · 2018Review
- Development and application of two semi-automated tools for targeted medical product surveillance in a distributed data network.Current epidemiology reports · 2017Article
- Pharmacoepidemiology in the era of real-world evidence.Current epidemiology reports · 2017Article
- Sentinel Modular Program for Propensity Score-Matched Cohort Analyses: Application to Glyburide, Glipizide, and Serious Hypoglycemia.Epidemiology (Cambridge, Mass.) · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 6 institutions in 1 country.
Funding
Abstract
The US Food and Drug Administration's Sentinel system has developed the capability to conduct active safety surveillance of marketed medical products in a large network of electronic healthcare databases. We assessed the extent to which the newly developed, semiautomated Sentinel Propensity Score Matching (PSM) tool could produce the same results as a customized protocol-driven assessment, which found an adjusted hazard ratio (HR) of 3.04 (95% confidence interval [CI], 2.81-3.27) comparing angioedema in patients initiating angiotensin-converting enzyme (ACE) inhibitors vs. beta-blockers. Using data from 13 Data Partners between 1 January 2008, and 30 September 2013, the PSM tool identified 2,211,215 eligible ACE inhibitor and 1,673,682 eligible beta-blocker initiators. The tool produced an HR of 3.14 (95% CI, 2.86-3.44). This comparison provides initial evidence that Sentinel analytic tools can produce findings similar to those produced by a highly customized protocol-driven assessment.
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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.