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
dc.contributor.author | Allison, A | |
dc.contributor.author | Edlmann, Ellie | |
dc.contributor.author | Kolias, AG | |
dc.contributor.author | Davis-Wilkie, C | |
dc.contributor.author | Mee, H | |
dc.contributor.author | Thelin, EP | |
dc.contributor.author | Turner, C | |
dc.contributor.author | Hutchinson, PJ | |
dc.contributor.author | Bond, S | |
dc.date.accessioned | 2021-09-28T09:36:14Z | |
dc.date.issued | 2019-12-10 | |
dc.identifier.issn | 1745-6215 | |
dc.identifier.issn | 1745-6215 | |
dc.identifier.other | 698 | |
dc.identifier.uri | http://hdl.handle.net/10026.1/17955 | |
dc.description.abstract |
Abstract Background 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. Methods and design 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). Conclusions This paper and the accompanying additional material describe the statistical analysis plan for the trial. Trial registration ISRCTN, ISRCTN80782810. Registered on 7 November 2014. http://www.isrctn.com/ISRCTN80782810. EudraCT, 2014-004948-35. Registered on 20 March 2015. | |
dc.format.extent | 698- | |
dc.format.medium | Electronic | |
dc.language | en | |
dc.language.iso | en | |
dc.publisher | BMC | |
dc.subject | Dexamethasone | |
dc.subject | Chronic subdural haematoma | |
dc.subject | Randomised trial | |
dc.subject | Steroid | |
dc.title | 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 | |
dc.type | journal-article | |
dc.type | Clinical Trial Protocol | |
dc.type | Letter | |
plymouth.author-url | https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000506885200001&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=11bb513d99f797142bcfeffcc58ea008 | |
plymouth.issue | 1 | |
plymouth.volume | 20 | |
plymouth.publication-status | Published | |
plymouth.journal | Trials | |
dc.identifier.doi | 10.1186/s13063-019-3866-6 | |
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/Research Groups/Plymouth Institute of Health and Care Research (PIHR) | |
plymouth.organisational-group | /Plymouth/Users by role | |
plymouth.organisational-group | /Plymouth/Users by role/Academics | |
plymouth.organisational-group | /Plymouth/Users by role/Researchers in ResearchFish submission | |
dc.publisher.place | England | |
dcterms.dateAccepted | 2019-10-29 | |
dc.rights.embargodate | 2021-9-29 | |
dc.identifier.eissn | 1745-6215 | |
dc.rights.embargoperiod | Not known | |
rioxxterms.versionofrecord | 10.1186/s13063-019-3866-6 | |
rioxxterms.licenseref.uri | http://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.licenseref.startdate | 2019-12-10 | |
rioxxterms.type | Journal Article/Review |