التفاصيل البيبلوغرافية
| العنوان: |
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. |
| المؤلفون: |
Allison, Annabel, Edlmann, Ellie, Kolias, Angelos G., Davis-Wilkie, Carol, Mee, Harry, Thelin, Eric P., Turner, Carole, Hutchinson, Peter J., Bond, Simon |
| المصدر: |
Trials; 12/10/2019, Vol. 20 Issue 1, p1-5, 5p |
| مصطلحات موضوعية: |
DEXAMETHASONE, STATISTICS, CLINICAL trials, HEMATOMA |
| مصطلحات جغرافية: |
UNITED Kingdom |
| مستخلص: |
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/ISRCTN80782810Test. EudraCT, 2014-004948-35. Registered on 20 March 2015. [ABSTRACT FROM AUTHOR] |
|
Copyright of Trials is the property of BioMed Central and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) |
| قاعدة البيانات: |
Complementary Index |
Full Text Finder