Evidence map›Paper›PMID 37524153›Full record

ArticleJournal of vascular surgery2023

Consensus minimum core data elements adapted to peripheral vascular intervention in the drug-eluting era: Consensus report from the Registry Assessment of Peripheral Interventional Devices (RAPID) Pathways "LEAN" working group.

James H Black, Donna Buckley, Martha Velezis, Jens Eldrup-Jorgensen, Nina D Serratore, Jorge A Gutierrez, Eleni Whatley, Rebecca A Marmor, Daniel J Bertges, James E Tcheng and 10 more

Open access · bronzeAbstract readConsensus Statement
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of vascular surgery, 2023. 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
0.3field-weighted citation impact, top 39% of its field
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, 1 citations in OpenAlex.

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

20 authors at 10 institutions in 1 country.

James H BlackJohns Hopkins University School of Medicine, Baltimore, MD. Electronic address: jhblack@jhmi.edu.
Donna BuckleyOffice of Cardiovascular Devices, Food and Drug Administration, Silver Spring, MD.
Martha VelezisOffice of Cardiovascular Devices, Food and Drug Administration, Silver Spring, MD.
Jens Eldrup-JorgensenSociety of Vascular Surgery Patient Safety Organization, Chicago, IL.
Nina D SerratoreCook Research, Inc, West Lafayette, IN.
Jorge A GutierrezDuke University Medical Center/Duke Clinical Research Institute, Durham, NC.
Eleni WhatleyOffice of Cardiovascular Devices, Food and Drug Administration, Silver Spring, MD.
Rebecca A MarmorJohns Hopkins University School of Medicine, Baltimore, MD.
Daniel J BertgesUniversity of Vermont Medical Center, Burlington, VT.
James E TchengDuke University Medical Center/Duke Clinical Research Institute, Durham, NC.
Sara RoyceOffice of Cardiovascular Devices, Food and Drug Administration, Silver Spring, MD.
Misti MaloneOffice of Cardiovascular Devices, Food and Drug Administration, Silver Spring, MD.
Andrew FarbOffice of Cardiovascular Devices, Food and Drug Administration, Silver Spring, MD.
Eric A SecemskySmith Center for Outcomes Research, Beth Israel Deaconess Medical Center, Boston, MA.
Sahil A ParikhColumbia University Irving Medical Center, New York, NY.
Joshua SmaleBecton, Dickinson and Company, Franklin Lakes, NJ.
Michael R JaffBoston Scientific, Corporation, Inc, Marlborough, MA.
Roseann WhiteSyntactx, New York, NY.
Rebecca W WilgusDuke University Medical Center/Duke Clinical Research Institute, Durham, NC.
Mitchell W KrucoffDuke University Medical Center/Duke Clinical Research Institute, Durham, NC.
Center for Devices and Radiological Health · USClinical Research Institute · USJohns Hopkins University · USBecton Dickinson (United States) · USBeth Israel Deaconess Medical Center · USBoston Scientific (United States) · USColumbia University Irving Medical Center · USCook Research (United States) · USSociety for Vascular Surgery · USUniversity of Vermont Medical Center · US

Funding

Shared Decision-Making to Improve the Health Status of Patients with Claudication: Developing and Implementing Strategies to Individualize Treatment DecisionsK23HL150290 · NHLBI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI SECEMSKY, ERIC ALEXANDER · 2020 to 2024
$851k
NHLBI NIH HHS K23 HL150290
6 · The paper itself

Abstract

Registry Assessment of Peripheral Interventional Devices (RAPID) initiated the Pathways Program to provide a transparent, collaborative forum in which to pursue insights into multiple unresolved questions on benefit-risk of paclitaxel-coated devices, including understanding the basis of the mortality signal, without a demonstrable potential biological mechanism, and whether the late mortality signal could be artifact intrinsic to multiple independent prospective randomized data sources that did not prespecify death as a long-term end point. In response to the directive, the LEAN-Case Report Form working group focused on enhancements to the RAPID Phase I Minimum Core Data set through the addition of key clinical modifiers that would be more strongly linked to longer-term mortality outcomes after peripheral arterial disease intervention in the drug-eluting device era, with the goal to have future mortality signals more accurately examined.

Indexed as

Drug-Eluting StentsEndovascular ProceduresPeripheral Arterial DiseaseRegistriesCardiovascular AgentsHumansPaclitaxelRisk AssessmentRisk FactorsTime FactorsTreatment OutcomeCardiovascular AgentsPaclitaxelPaclitaxelPADRAPID

Identifiers

PMID37524153
PMCPMC11268369
OpenAlexW4385383353

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.