Evidence map›Paper›PMID 23291425›Full record

Trial reportJournal of neurointerventional surgery2013

Importance of proper patient selection and endpoint selection in evaluation of new therapies in acute stroke: further analysis of the SENTIS trial.

Ashfaq Shuaib, Stefan Schwab, J Neal Rutledge, Sidney Starkman, David S Liebeskind, Gary L Bernardini, Alan Boulos, Alex Abou-Chebl, David Y Huang, Geert Vanhooren and 4 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of neurointerventional surgery, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing 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

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

  1. Guideline
  2. Article
  3. Article
  4. Article
  5. Article
  6. Therapeutic Induction of Collateral Flow.Translational stroke research · 2023
    Review
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Augmenting collateral blood flow during ischemic stroke via transient aortic occlusion.Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism · 2014
    Article
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

14 authors.

Ashfaq ShuaibDepartment of Neurology, University of Alberta, Edmonton, Alberta Canada. hfaq.shuaib@ualberta.ca
Stefan Schwab
J Neal Rutledge
Sidney Starkman
David S Liebeskind
Gary L Bernardini
Alan Boulos
Alex Abou-Chebl
David Y Huang
Geert Vanhooren
Salvador Cruz-Flores
Richard Paul Klucznik
Jeffrey L Saver
SENTIS trial investigators

Funding

Modeling of Collateral Perfusion in the Ischemic BrainK24NS072272 · NINDS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI LIEBESKIND, DAVID SIGMUND · 2011 to 2015
$939k
NINDS NIH HHS K24 NS072272
6 · The paper itself

Abstract

backgroundThe magnitude of treatment effect in acute stroke depends on several factors, including time from symptom onset (TFSO) to treatment and severity of the initial insult.

objectiveTo report further evaluation of NeuroFlo therapy, focusing on the effect of time and stroke severity.

methodsSENTIS was a prospective randomized trial (N=515) comparing standard medical therapy with/without NeuroFlo therapy. For this analysis, we evaluated outcomes in groups of patients based on TFSO and stroke severity: patients randomized <6 h, 6-10 h, and >10 h with mild (NIHSS<8), moderate (8-14), and severe (>14) symptoms at randomization. 90-Day mRS (modified Rankin Scale) scores and stroke-related death rates were compared between treatment groups.

resultsFor patients randomized <6 h TFSO (n=128), the OR for mRS 0-2 was 3.11 (CI 1.30 to 7.46, p=0.011) for treated versus non-treated patients. In patients with disease of moderate severity (NIHSS 8-14, n=214), NeuroFlo-treated patients were more likely to have a good outcome (mRS 0-2; OR=1.84, CI 1.02 to 3.33, p=0.043). The stroke-related death rate was better in the treated group with TFSO >10 h and NIHSS >14 (n=42) (OR=7.10, CI 1.13 to 44.55, p=0.036).

conclusionsThe results of our analysis support the importance of careful selection of outcome measures and the impact that rapid treatment and initial stroke severity have on outcome.

Indexed as

Endpoint DeterminationPatient SelectionCohort StudiesFollow-Up StudiesHumansProspective StudiesRetrospective StudiesStrokeTreatment Outcome

Identifiers

PMID23291425
PMCPMC4156599

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.