Evidence map›Paper›PMID 24939648›Full record

Trial reportTrials2014

Statistical analysis plan for the Stroke Oxygen Study (SO₂S): a multi-center randomized controlled trial to assess whether routine oxygen supplementation in the first 72 hours after a stroke improves long-term outcome.

Julius Sim, Richard Gray, Tracy Nevatte, Andrew Howman, Natalie Ives, Christine Roffe

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.4field-weighted citation impact, top 32% 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

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. Trial
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

6 authors at 3 institutions in 1 country.

Julius SimHealth Services Research Unit, Keele University, Keele ST5 5BG, UK. j.sim@keele.ac.uk.
Richard Gray
Tracy Nevatte
Andrew Howman
Natalie Ives
Christine Roffe
Keele University · GBUniversity of Birmingham · GBUniversity of Oxford · GB

Funding

Department of Health 09/104/21Medical Research Council MC_U137686861
6 · The paper itself

Abstract

backgroundThe Stroke Oxygen Study (SO₂S) is a multi-center randomized controlled trial of oxygen supplementation in patients with acute stroke. The main hypothesis for the trial is that fixed-dose oxygen treatment during the first 3 days after an acute stroke improves outcome. The secondary hypothesis is that restricting oxygen supplementation to night time only is more effective than continuous supplementation. This paper describes the statistical analysis plan for the study. METHODS AND

designPatients (n = 8000) are randomized to three groups: (1) continuous oxygen supplementation for 72 hours; (2) nocturnal oxygen supplementation for three nights; and (3) no routine oxygen supplementation. Outcomes are recorded at 7 days, 90 days, 6 months, and 12 months. The primary outcome measure is the modified Rankin scale at 90 days. Data will be analyzed according to the intention-to-treat principle. Methods of statistical analysis are described, including the handling of missing data, the covariates used in adjusted analyses, planned subgroups analyses, and planned sensitivity analyses.

trial registrationThis trial is registered with the ISRCTN register, number ISRCTN52416964 (30 September 2005).

Indexed as

Data Interpretation, StatisticalFollow-Up StudiesHumansKaplan-Meier EstimateNight CareOutcome and Process Assessment, Health CareOxygen Inhalation TherapyProportional Hazards ModelsRecovery of FunctionResearch DesignStrokeTime

Identifiers

PMID24939648
PMCPMC4067072
OpenAlexW2158065874

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.