Evidence map›Paper›PMID 31822298›Full record

ArticleTrials2019

Statistical analysis plan for the Dex-CSDH trial: a randomised, double-blind, placebo-controlled trial of a 2-week course of dexamethasone for adult patients with a symptomatic chronic subdural haematoma.

Annabel Allison, Ellie Edlmann, Angelos G Kolias, Carol Davis-Wilkie, Harry Mee, Eric P Thelin, Carole Turner, Peter J Hutchinson, Simon Bond

Open access · goldAbstract readClinical Trial ProtocolLetter
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.3field-weighted citation impact, top 20% 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

6 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Observational
  3. Article
  4. Article
  5. Article
  6. 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

9 authors at 3 institutions in 2 countries.

Annabel AllisonCambridge Clinical Trials Unit, Coton House Level 6, Cambridge University Hospitals NHS Foundation Trust, Hills Road, Cambridge, CB2 0QQ, UK. ara41@medschl.cam.ac.uk.ORCID http://orcid.org/0000-0002-9122-6341
Ellie EdlmannUniversity of Cambridge & Cambridge University Hospitals NHS Foundation Trust, Division of Neurosurgery, Box 167, University of Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.
Angelos G KoliasUniversity of Cambridge & Cambridge University Hospitals NHS Foundation Trust, Division of Neurosurgery, Box 167, University of Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.
Carol Davis-WilkieCambridge Clinical Trials Unit, Coton House Level 6, Cambridge University Hospitals NHS Foundation Trust, Hills Road, Cambridge, CB2 0QQ, UK.
Harry MeeUniversity of Cambridge & Cambridge University Hospitals NHS Foundation Trust, Division of Neurosurgery, Box 167, University of Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.
Eric P ThelinUniversity of Cambridge & Cambridge University Hospitals NHS Foundation Trust, Division of Neurosurgery, Box 167, University of Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.
Carole TurnerUniversity of Cambridge & Cambridge University Hospitals NHS Foundation Trust, Division of Neurosurgery, Box 167, University of Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.
Peter J HutchinsonUniversity of Cambridge & Cambridge University Hospitals NHS Foundation Trust, Division of Neurosurgery, Box 167, University of Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.
Simon BondCambridge Clinical Trials Unit, Coton House Level 6, Cambridge University Hospitals NHS Foundation Trust, Hills Road, Cambridge, CB2 0QQ, UK.
University of Cambridge · GBCambridge University Hospitals NHS Foundation Trust · GBKarolinska University Hospital · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe incidence of chronic subdural haematoma (CSDH) is increasing. Although surgery remains the mainstay of management for symptomatic patients, uncertainty remains regarding the role of steroids. Hence, the Dex-CSDH trial was launched in the UK in 2015 aiming to determine whether, compared to placebo, dexamethasone can improve the 6-month functional outcome of patients with symptomatic CSDH by reducing the rate of surgical intervention and recurrence rate. METHODS AND

designDex-CSDH is a multi-centre, pragmatic, parallel group, double-blind, randomised trial assessing the clinical utility of a 2-week course of dexamethasone following a CSDH. Seven hundred fifty patients were randomised to either dexamethasone or placebo. The primary outcome is the modified Rankin Scale at 6 months which is dichotomised to favourable (a score of 0-3) versus unfavourable (a score of 4-6).

conclusionsThis paper and the accompanying additional material describe the statistical analysis plan for the trial.

trial registrationISRCTN, ISRCTN80782810. Registered on 7 November 2014. http://www.isrctn.com/ISRCTN80782810. EudraCT, 2014-004948-35. Registered on 20 March 2015.

Indexed as

Clinical Trials, Phase III as TopicData Interpretation, StatisticalDexamethasoneDisability EvaluationDouble-Blind MethodGlucocorticoidsHematoma, Subdural, ChronicHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicRecovery of FunctionRecurrenceTime FactorsTreatment OutcomeUnited KingdomDexamethasoneGlucocorticoidsChronic subdural haematomaDexamethasoneRandomised trialSteroid

Identifiers

PMID31822298
PMCPMC6905057
OpenAlexW2995632785

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.