1. TP1-3 Final phase of recruitment and statistics analysis plan for Dex-CSDH trial
- Author
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Simon Bond, Ellie Edlmann, Diederik Bulters, Kevin Owusu-Agyemang, Silvia Tarantino, Patrick Holton, Peter J. Hutchinson, Carole L. Turner, Annabel Allison, Bntrc, Angelos G. Kolias, Beatrice Pantaleo, Nigel Suttner, Daniel Gatt, Eric Peter Thelin, Yahia Z. Al-Tamimi, and Carol Davis-Wilkie
- Subjects
medicine.medical_specialty ,business.industry ,Placebo ,Logistic regression ,Psychiatry and Mental health ,Statistical Analysis Plan ,Standard care ,Modified Rankin Scale ,Secondary analysis ,Clinical endpoint ,Physical therapy ,medicine ,Surgery ,Neurology (clinical) ,business ,Proportional odds - Abstract
ObjectivesReview recruitment progression and statistical analysis plan for Dex-CSDH trial.DesignA UK multi-centre, randomised, double-blind, placebo-controlled trial of dexamethasone versus placebo for CSDH.SubjectsSymptomatic, adult CSDH patients admitted to a participating neurosurgical unit.MethodsTrial participants receive a 2 week course of dexamethasone in addition to standard care, including surgery. The primary outcome measure is the modified Rankin Scale (mRS) at 6 months. An mRS of 0–3 requires the patient to be independently mobile and we have considered this a favourable outcome, with scores 4–6 (non-mobile) as unfavourable. The primary analysis will be performed on an intention-to-treat basis, estimating the absolute difference between the two treatment arms in the proportions achieving a favourable outcome. Secondary analysis will be done with an ordinal analysis of mRS scores and proportional odds logistic regression of the original mRS score adjusting for baseline covariates (age, GCS).Results629/750 patients (84%) have been recruited to the Dex-CSDH trial which is on-going as of 20-06-2018. Recruitment progress and follow-up at time of presentation will be reviewed alongside full statistical analysis plan.ConclusionsThe Dex-CSDH trial is drawing close to target following excellent recruitment across 22 UK centres. Transparent communication of the statistical analysis plan is essential prior to unblinding of the data. Up-to-date recruitment and primary endpoint completion rates will also be reviewed.
- Published
- 2019
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