Evidence map›Paper›PMID 33077615›Full record

ReviewJournal of the American Society of Nephrology : JASN2020

Leveraging the Capabilities of the FDA's Sentinel System To Improve Kidney Care.

Sruthi Adimadhyam, Erin F Barreto, Noelle M Cocoros, Sengwee Toh, Jeffrey S Brown, Judith C Maro, Jacqueline Corrigan-Curay, Gerald J Dal Pan, Robert Ball, David Martin and 3 more

Abstract readReview
In one paragraph

Review in Journal of the American Society of Nephrology : JASN, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–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

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Collaborative privacy-preserving analysis of oncological data using multiparty homomorphic encryption.Proceedings of the National Academy of Sciences of the United States of America · 2023
    Article
  6. The US Food and Drug Administration Sentinel System: a national resource for a learning health system.Journal of the American Medical Informatics Association : JAMIA · 2022
    Article
  7. Article
  8. Review
  9. Article
  10. Big Data in Nephrology.Nature reviews. Nephrology · 2021
    Review
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

13 authors.

Sruthi AdimadhyamDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts Sruthi_Adimadhyam@harvardpilgrim.org.
Erin F BarretoDepartment of Pharmacy, Mayo Clinic, Rochester, Minnesota.
Noelle M CocorosDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.
Sengwee TohDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.
Jeffrey S BrownDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.
Judith C MaroDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.ORCID 0000-0001-9900-2142
Jacqueline Corrigan-CurayCenter for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
Gerald J Dal PanCenter for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
Robert BallCenter for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
David MartinCenter for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
Michael NguyenCenter for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
Richard PlattDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.
Xiaojuan LiDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.ORCID 0000-0002-1305-0846

Funding

Beta-lactam individualization for critically ill patientsK23AI143882 · NIAID · MAYO CLINIC ROCHESTER · PI BARRETO, ERIN FRAZEE · 2020 to 2024
$986k
FDA HHS HHSF223201400030INIAID NIH HHS K23 AI143882
6 · The paper itself

Abstract

The Sentinel System is a national electronic postmarketing resource established by the US Food and Drug Administration to support assessment of the safety and effectiveness of marketed medical products. It has built a large, multi-institutional, distributed data network that contains comprehensive electronic health data, covering about 700 million person-years of longitudinal observation time nationwide. With its sophisticated infrastructure and a large selection of flexible analytic tools, the Sentinel System permits rapid and secure analyses, while preserving patient privacy and health-system autonomy. The Sentinel System also offers enhanced capabilities, including accessing full-text medical records, supporting randomized clinical trials embedded in healthcare delivery systems, and facilitating effective collection of patient-reported data using mobile devices, among many other research programs. The nephrology research community can use the infrastructure, tools, and data that this national resource offers for evidence generation. This review summarizes the Sentinel System and its ability to rapidly generate high-quality, real-world evidence; discusses the program's experience in, and potential for, addressing gaps in kidney care; and outlines avenues for conducting research, leveraging this national resource in collaboration with Sentinel investigators.

Indexed as

Databases, PharmaceuticalProduct Surveillance, PostmarketingBiomedical ResearchHealth Information SystemsHumansRenal Insufficiency, ChronicUnited StatesUnited States Food and Drug Administrationelectronic health dataepidemiologyoutcomes researchreal-world evidenceSentinel InitiativeU.S. Food and Drug Administration

Identifiers

PMID33077615
PMCPMC7608970

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.