Evidence map›Paper›PMID 24588789›Full record

Trial reportInternational journal of stroke : official journal of the International Stroke Society2014

Statistical analysis plan for the 'Efficacy of Nitric Oxide in Stroke' (ENOS) trial.

Philip M W Bath, Aimee Houlton, Lisa Woodhouse, Nikola Sprigg, Joanna Wardlaw, Stuart Pocock, ENOS Trialists

Open access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of stroke : official journal of the International Stroke Society, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
3.0field-weighted citation impact, top 9% 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

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Antihypertensive withdrawal for the prevention of cognitive decline.The Cochrane database of systematic reviews · 2016
    Pooled it
  3. Trial
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  9. Statistical analysis plan for the 'Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke' (TARDIS) trial.International journal of stroke : official journal of the International Stroke Society · 2015
    Trial
  10. Trial
  11. Article
  12. Review
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  14. Review
  15. Article
  16. Article
  17. Review
  18. 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

7 authors at 3 institutions in 1 country.

Philip M W BathStroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.
Aimee Houlton
Lisa Woodhouse
Nikola Sprigg
Joanna Wardlaw
Stuart Pocock
ENOS Trialists
University of Nottingham · GBLondon School of Hygiene & Tropical Medicine · GBUniversity of Edinburgh · GB

Funding

Medical Research Council G0501797
6 · The paper itself

Abstract

High blood pressure is common during the acute phase of stroke and is associated with a poor outcome. However, the management of high blood pressure remains unclear. The 'Efficacy of Nitric Oxide in Stroke' trial tested whether transdermal glyceryl trinitrate, a nitric oxide donor that lowers blood pressure, is safe and effective in improving outcome after acute stroke. Efficacy of Nitric Oxide in Stroke is an international multicenter, prospective, randomized, single-blind, blinded endpoint trial, with funding from the U.K. Medical Research Council. Patients with acute ischemic stroke or intracerebral hemorrhage and systolic blood pressure 140-220 mmHg were randomized to glyceryl trinitrate or no glyceryl trinitrate and, where relevant, to continue or stop prestroke antihypertensive therapy. The primary outcome is shift in modified Rankin Scale at three-months. Patients or relatives gave written informed (proxy) consent, and all sites had research ethics approval. Analyses will be done by intention to treat. This paper and attachment describe the trial's statistical analysis plan, developed prior to unblinding of date. The statistical analysis plan contains design and methods for analyses, and unpopulated tables and figures for the two primary publications and some secondary publications. The database will be locked in late February 2014 in preparation for presentation of the results in May 2014. The data from the trial will improve the precision of the estimates of the overall treatment effects (efficacy and safety) of results from completed trials of blood pressure management in acute stroke, and provide the first large-scale randomized evidence on transdermal glyceryl trinitrate, and of continuing (vs. stopping) prestroke antihypertensive medications, in acute stroke.

Indexed as

Data Interpretation, StatisticalAdministration, CutaneousHumansHypertensionNitric OxideNitroglycerinStrokeVasodilator AgentsNitric OxideNitroglycerinVasodilator Agentsacute stroke trialblood pressureglyceryl trinitrateintracerebral hemorrhageischemic strokestatistical analysis plan

Identifiers

PMID24588789
PMCPMC4235425
OpenAlexW1571469955

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.