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.
Clinical Trials, Phase III as Topic
Data Interpretation, Statistical
Dexamethasone
/ adverse effects
Disability Evaluation
Double-Blind Method
Glucocorticoids
/ adverse effects
Hematoma, Subdural, Chronic
/ diagnosis
Humans
Multicenter Studies as Topic
Pragmatic Clinical Trials as Topic
Recovery of Function
Recurrence
Time Factors
Treatment Outcome
United Kingdom
Chronic subdural haematoma
Dexamethasone
Randomised trial
Steroid
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
10 Dec 2019
10 Dec 2019
Historique:
received:
12
06
2019
accepted:
29
10
2019
entrez:
12
12
2019
pubmed:
12
12
2019
medline:
1
9
2020
Statut:
epublish
Résumé
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. 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). This paper and the accompanying additional material describe the statistical analysis plan for the trial. ISRCTN, ISRCTN80782810. Registered on 7 November 2014. http://www.isrctn.com/ISRCTN80782810. EudraCT, 2014-004948-35. Registered on 20 March 2015.
Sections du résumé
BACKGROUND
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
METHODS
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
CONCLUSIONS
This paper and the accompanying additional material describe the statistical analysis plan for the trial.
TRIAL REGISTRATION
BACKGROUND
ISRCTN, ISRCTN80782810. Registered on 7 November 2014. http://www.isrctn.com/ISRCTN80782810. EudraCT, 2014-004948-35. Registered on 20 March 2015.
Identifiants
pubmed: 31822298
doi: 10.1186/s13063-019-3866-6
pii: 10.1186/s13063-019-3866-6
pmc: PMC6905057
doi:
Substances chimiques
Glucocorticoids
0
Dexamethasone
7S5I7G3JQL
Types de publication
Clinical Trial Protocol
Letter
Langues
eng
Sous-ensembles de citation
IM
Pagination
698Références
Stroke. 2011 Aug;42(8):2276-9
pubmed: 21680905
Md State Med J. 1965 Feb;14:61-5
pubmed: 14258950
Neurocirugia (Astur). 2009 Aug;20(4):346-59
pubmed: 19688136
J Neurosurg. 2017 Oct;127(4):732-739
pubmed: 27834599
Qual Life Res. 2011 Dec;20(10):1727-36
pubmed: 21479777
Value Health. 2012 Jul-Aug;15(5):708-15
pubmed: 22867780
Inflamm Res. 2012 Aug;61(8):845-52
pubmed: 22527446
Lancet. 2009 Sep 26;374(9695):1067-73
pubmed: 19782872
J Neurosurg. 2004 Jan;100(1):24-32
pubmed: 14743908
Br J Neurosurg. 2005 Aug;19(4):327-33
pubmed: 16455539
Neurosurg Rev. 2006 Jul;29(3):242-5
pubmed: 16528574
J Neurotrauma. 2016 Jul 1;33(13):1212-9
pubmed: 26295586
Trials. 2018 Dec 4;19(1):670
pubmed: 30514400
Addiction. 2014 Dec;109(12):1986-93
pubmed: 25171441
Nat Rev Neurol. 2014 Oct;10(10):570-8
pubmed: 25224156
J Neurosurg. 2019 Mar 22;132(4):1147-1157
pubmed: 30901751
Crit Care. 2011;15(3):R127
pubmed: 21586148
Surg Neurol. 2009 Feb;71(2):161-5; discussion 165-6
pubmed: 18423527