Evidence map›Paper›PMID 25563662›Full record

ArticleCirculation. Cardiovascular quality and outcomes2015

Medical device postapproval safety monitoring: where does the United States stand?

Prashant V Rajan, Daniel B Kramer, Aaron S Kesselheim

Abstract read
In one paragraph

Article in Circulation. Cardiovascular quality and outcomes, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing 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

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

  1. Landscape of Cardiovascular Device Registries in the United States.Journal of the American Heart Association · 2019
    Pooled it
  2. Article
  3. Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. Efficacy and Safety of Combined Ultrasonic and Bipolar Energy Source in Laparoscopic Surgery.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2016
    Article
  12. Getting approval for new therapeutic medical devices versus drugs: are the differences justified?European respiratory review : an official journal of the European Respiratory Society · 2016
    Article
  13. 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

3 authors.

Prashant V RajanFrom the Harvard Medical School, Boston, MA (P.V.R., D.B.K., A.S.K.); Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA (P.V.R., D.B.K., A.S.K.); and the Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (D.B.K.).
Daniel B KramerFrom the Harvard Medical School, Boston, MA (P.V.R., D.B.K., A.S.K.); Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA (P.V.R., D.B.K., A.S.K.); and the Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (D.B.K.).
Aaron S KesselheimFrom the Harvard Medical School, Boston, MA (P.V.R., D.B.K., A.S.K.); Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA (P.V.R., D.B.K., A.S.K.); and the Cardiovascular Institute, Beth Israel Deaconess Medical Center, Boston, MA (D.B.K.). akesselheim@partners.org.

Funding

Patient-Centered Outcomes of Implantable Defibrillator Therapy in Older PatientsK23AG045963 · NIA · HEBREW REHABILITATION CENTER FOR AGED · PI KRAMER, DANIEL BRUCE · 2013 to 2016
$714k
NIA NIH HHS K23 AG045963NIA NIH HHS K23AG045963
6 · The paper itself

Abstract

PubMed holds no abstract for this paper.

Indexed as

Device ApprovalProduct Surveillance, PostmarketingUnited States Food and Drug AdministrationHumansPatient SafetyProgram EvaluationRegistriesRisk AssessmentRisk FactorsUnited Statesequipment and suppliesproduct surveillance, postmarketingregistriesUnited States Food and Drug Administration

Identifiers

PMID25563662
PMCPMC4385582

What OpenQuestion holds

Textmetadata
LicenceTDM
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.