Evidence map›Paper›PMID 41398062›Full record

ArticleNPJ digital medicine2025

Strengthening inferential studies in the FDA Sentinel initiative: results from a methodological demonstration project.

Rishi J Desai, Janick Weberpals, Haritha Pillai, Adebola Ajao, Mukund Desibhatla, Rebecca Hawrusik, José J Hernández-Muñoz, Chanelle Jones, Jamal T Jones, Joyce Lii and 7 more

Abstract read
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In one paragraph

Article in NPJ digital medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Rishi J DesaiDivision of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. rdesai@bwh.harvard.edu.
Janick WeberpalsDivision of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Haritha PillaiDivision of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Adebola AjaoOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Mukund DesibhatlaDepartment of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Rebecca HawrusikDepartment of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, MA, USA.
José J Hernández-MuñozOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Chanelle JonesOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Jamal T JonesOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Joyce LiiDivision of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Jie LiOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Jennifer G LyonsDepartment of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA, USA.
Ryan SchoepleinDepartment of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Fatma M SheblOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Sengwee TohDepartment of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA, USA.
Elisabetta PatornoDivision of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Sebastian SchneeweissDivision of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.

Funding

Randomized Cardiovascular Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT DUPLICATE)R01HL141505 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI SCHNEEWEISS, SEBASTIAN G., WANG, SHIRLEY · 2019 to 2023
$3.6M
NHLBI NIH HHS R01 HL141505
6 · The paper itself

Abstract

The FDA Sentinel Real-World Evidence Data Enterprise (RWE-DE) contains linked electronic health records with claims data for over 25 million patients. To demonstrate the applicability of the RWE-DE to a study previously considered infeasible in claims-based Sentinel network, we emulated a target trial using a case study comparing acute pancreatitis among new users of sodium-glucose cotransporter-2 inhibitors (SGLT-2i) with new users of dipeptidyl peptidase-4 inhibitors (DPP-4i) among 97,119 patients with type 2 diabetes mellitus from HealthVerity [2018-2020] and TriNetX [2013-2024] databases. We applied a previously validated computable phenotyping algorithm using EHRs to identify acute pancreatitis as the primary outcome. After confounding adjustment for >135 variables using propensity score fine stratification weighting, the hazard ratio (95% confidence interval) for acute pancreatitis following SGLT-2i initiation compared to DPP-4i initiation was 0.85 (0.67-1.07) for intent-to-treat and 0.84 (0.58-1.22) for per-protocol analysis. This study serves as a proof-of-concept for future safety assessments in Sentinel.

Identifiers

PMID41398062
PMCPMC12816695

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Registered trials

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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.