Evidence map›Paper›PMID 30971773›Full record

ArticleScientific reports2019

Dex-CSDH randomised, placebo-controlled trial of dexamethasone for chronic subdural haematoma: report of the internal pilot phase.

Ellie Edlmann, Eric P Thelin, Karen Caldwell, Carole Turner, Peter Whitfield, Diederik Bulters, Patrick Holton, Nigel Suttner, Kevin Owusu-Agyemang, Yahia Z Al-Tamimi and 24 more

Open access · goldAbstract read
In one paragraph

Article in Scientific reports, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 16% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Postoperative neutrophil-to-lymphocyte ratio variation is associated with chronic subdural hematoma recurrence.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2022
    Article
  5. Observational
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

34 authors at 20 institutions in 2 countries.

Ellie EdlmannDepartment of Clinical Neuroscience, University of Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK. ee291@cam.ac.uk.ORCID http://orcid.org/0000-0002-7253-9115
Eric P ThelinDepartment of Clinical Neuroscience, University of Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.ORCID http://orcid.org/0000-0002-2338-4364
Karen CaldwellDivision of Neurosurgery, Box 167, Addenbrooke's Hospital, Cambridge, CB2 0QQ, UK.
Carole TurnerDivision of Neurosurgery, Box 167, Addenbrooke's Hospital, Cambridge, CB2 0QQ, UK.
Peter WhitfieldSouthwest Neurosurgical Centre, Plymouth University Hospitals NHS trust, Plymouth, PL6 8DH, UK.
Diederik BultersWessex Neurological Centre, University Hospital Southampton NHS Foundation Trust, Tremona Rd, Southampton, Hampshire, SO16 6YD, UK.ORCID http://orcid.org/0000-0001-9884-9050
Patrick HoltonWessex Neurological Centre, University Hospital Southampton NHS Foundation Trust, Tremona Rd, Southampton, Hampshire, SO16 6YD, UK.
Nigel SuttnerInstitute of Neurosciences, Queen Elizabeth University Hospital, 1345 Govan Road, Glasgow, G51 4TF, UK.
Kevin Owusu-AgyemangInstitute of Neurosciences, Queen Elizabeth University Hospital, 1345 Govan Road, Glasgow, G51 4TF, UK.
Yahia Z Al-TamimiDepartment of Neurosurgery, Sheffield Teaching Hospitals NHS Trust, Royal Hallamshire Hospital, Glossop Road, Sheffield, S10 2JF, UK.
Daniel GattDepartment of Neurosurgery, Sheffield Teaching Hospitals NHS Trust, Royal Hallamshire Hospital, Glossop Road, Sheffield, S10 2JF, UK.
Simon ThomsonDepartment of Neurosurgery, Leeds General Infirmary, Great George Street, Leeds, LS1 3EX, UK.
Ian A AndersonDepartment of Neurosurgery, Leeds General Infirmary, Great George Street, Leeds, LS1 3EX, UK.
Oliver RichardsDepartment of Neurosurgery, Leeds General Infirmary, Great George Street, Leeds, LS1 3EX, UK.
Monica GherleSouthwest Neurosurgical Centre, Plymouth University Hospitals NHS trust, Plymouth, PL6 8DH, UK.
Emma TomanDepartment of Neurosurgery, University Hospital Birmingham NHS Foundation Trust, Edgbaston, Birmingham, B15 2WB, UK.
Dipankar NandiDepartment of Neurosurgery, Imperial College Healthcare NHS Trust, Fulham Palace Road, London, W6 8RF, UK.
Phillip KaneDepartment of Neurosurgery, The James Cook University Hospital, Marton Road, Middlesbrough, TS4 3BW, UK.
Beatrice PantaleoCambridge Clinical Trials Unit, Box 401, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.
Carol Davis-WilkieCambridge Clinical Trials Unit, Box 401, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.
Silvia TarantinoDivision of Neurosurgery, Box 167, Addenbrooke's Hospital, Cambridge, CB2 0QQ, UK.
Garry BartonNorwich Medical School, University of East Anglia, Norwich, NR4 7TJ, UK.
Hani J MarcusDepartment of Neurosurgery, Imperial College Healthcare NHS Trust, Fulham Palace Road, London, W6 8RF, UK.ORCID http://orcid.org/0000-0001-8000-392X
Aswin ChariDepartment of Neurosurgery, Barts Health NHS trust, Whitechapel Road, London, E1 1BB, UK.
Antonio BelliNIHR Surgical Reconstruction and Microbiology Research Centre & University Hospitals Birmingham NHS Foundation Trust, School of Clinical and Experimental Medicine, University of Birmingham, Institute of Biomedical Research (West), Room WX 2.61, Edgbaston, Birmingham, B15 2TT, UK.
Simon BondCambridge Clinical Trials Unit, Box 401, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.
Rafael GafoorCambridge Clinical Trials Unit, Box 401, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.
Sarah DawsonCambridge Clinical Trials Unit, Box 401, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.
Lynne WhiteheadClinical Trials Pharmacy, Addenbrooke's Hospital, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.
Paul BrennanDepartment of Clinical Neurosciences, Western General Hospitals NHS Trust, Crewe Road, Edinburgh, EH4 2XU, UK.
Ian WilkinsonCambridge Clinical Trials Unit, Box 401, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.
Angelos G KoliasDepartment of Clinical Neuroscience, University of Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.ORCID http://orcid.org/0000-0003-3992-0587
Peter J A HutchinsonDepartment of Clinical Neuroscience, University of Cambridge, Cambridge Biomedical Campus, Cambridge, CB2 0QQ, UK.
Dex-CSDH trial collaborative and BNTRC collaborative.
Leeds General Infirmary · GBRoyal Sussex County Hospital · GBRoyal Victoria Infirmary · GBSt George's Hospital · GBAddenbrooke's Hospital · GBUniversity Hospitals Birmingham NHS Foundation Trust · GBUniversity of Cambridge · GBWestern General Hospital · GBAberdeen Royal Infirmary · GBUniversity Hospital Southampton NHS Foundation Trust · GBBarts Health NHS Trust · GBImperial College Healthcare NHS Trust · GBJames Cook University Hospital · GBMRC Biostatistics Unit · GBNHS Tayside · GBQueen Elizabeth University Hospital · GBRoyal Hallamshire Hospital · GBRoyal Stoke University Hospital · GBUniversity Hospitals Plymouth NHS Trust · GBHull Royal Infirmary · GB

Funding

Department of Health HTA/13/15/02
6 · The paper itself

Abstract

The Dex-CSDH trial is a randomised, double-blind, placebo-controlled trial of dexamethasone for patients with a symptomatic chronic subdural haematoma. The trial commenced with an internal pilot, whose primary objective was to assess the feasibility of multi-centre recruitment. Primary outcome data collection and safety were also assessed, whilst maintaining blinding. We aimed to recruit 100 patients from United Kingdom Neurosurgical Units within 12 months. Trial participants were randomised to a 2-week course of dexamethasone or placebo in addition to receiving standard care (which could include surgery). The primary outcome measure of the trial is the modified Rankin Scale at 6 months. This pilot recruited ahead of target; 100 patients were recruited within nine months of commencement. 47% of screened patients consented to recruitment. The primary outcome measure was collected in 98% of patients. No safety concerns were raised by the independent data monitoring and ethics committee and only five patients were withdrawn from drug treatment. Pilot trial data can inform on the design and resource provision for substantive trials. This internal pilot was successful in determining recruitment feasibility. Excellent follow-up rates were achieved and exploratory outcome measures were added to increase the scientific value of the trial.

Indexed as

DexamethasoneDouble-Blind MethodDrug Administration ScheduleHematoma, Subdural, ChronicHumansPilot ProjectsPlacebo EffectRandomized Controlled Trials as TopicTreatment OutcomeDexamethasone

Identifiers

PMID30971773
PMCPMC6458174
OpenAlexW2921238186

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.