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dc.contributor.authorAllison, Aen
dc.contributor.authorEdlmann, Een
dc.contributor.authorKolias, AGen
dc.contributor.authorDavis-Wilkie, Cen
dc.contributor.authorMee, Hen
dc.contributor.authorThelin, EPen
dc.contributor.authorTurner, Cen
dc.contributor.authorHutchinson, PJen
dc.contributor.authorBond, Sen
dc.date.accessioned2021-09-28T09:36:14Z
dc.date.issued2019-12-10en
dc.identifier.issn1745-6215en
dc.identifier.other698en
dc.identifier.urihttp://hdl.handle.net/10026.1/17955
dc.description.abstract

<jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>The 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.</jats:p> </jats:sec><jats:sec> <jats:title>Methods and design</jats:title> <jats:p>Dex-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).</jats:p> </jats:sec><jats:sec> <jats:title>Conclusions</jats:title> <jats:p>This paper and the accompanying additional material describe the statistical analysis plan for the trial.</jats:p> </jats:sec><jats:sec> <jats:title>Trial registration</jats:title> <jats:p>ISRCTN, ISRCTN80782810. Registered on 7 November 2014. <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.isrctn.com/ISRCTN80782810">http://www.isrctn.com/ISRCTN80782810</jats:ext-link>. EudraCT, 2014-004948-35. Registered on 20 March 2015.</jats:p> </jats:sec>

en
dc.languageenen
dc.language.isoenen
dc.publisherBMCen
dc.titleStatistical 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 haematomaen
dc.typeJournal Article
plymouth.issue1en
plymouth.volume20en
plymouth.journalTrialsen
dc.identifier.doi10.1186/s13063-019-3866-6en
plymouth.organisational-group/Plymouth
plymouth.organisational-group/Plymouth/Faculty of Health
plymouth.organisational-group/Plymouth/Faculty of Health/Peninsula Medical School
plymouth.organisational-group/Plymouth/REF 2021 Researchers by UoA
plymouth.organisational-group/Plymouth/REF 2021 Researchers by UoA/UoA01 Clinical Medicine
plymouth.organisational-group/Plymouth/Research Groups
plymouth.organisational-group/Plymouth/Research Groups/FoH - Applied Parkinson's Research
plymouth.organisational-group/Plymouth/Users by role
plymouth.organisational-group/Plymouth/Users by role/Academics
dcterms.dateAccepted2019-10-29en
dc.rights.embargodate2021-09-29en
dc.identifier.eissn1745-6215en
dc.rights.embargoperiodNot knownen
rioxxterms.versionofrecord10.1186/s13063-019-3866-6en
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserveden
rioxxterms.licenseref.startdate2019-12-10en
rioxxterms.typeJournal Article/Reviewen


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