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TP1-3 Final phase of recruitment and statistics analysis plan for Dex-CSDH trial

Journal of neurology, neurosurgery and psychiatry, 2019-03, Vol.90 (3), p.e10-e11 [Peer Reviewed Journal]

2019, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions ;2019 2019, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions ;ISSN: 0022-3050 ;EISSN: 1468-330X ;DOI: 10.1136/jnnp-2019-ABN.33

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  • Title:
    TP1-3 Final phase of recruitment and statistics analysis plan for Dex-CSDH trial
  • Author: Edlmann, E ; Kolias, A ; Thelin, E ; Gatt, D ; Al-Tamimi, Y ; Owusu-Agyemang, K ; Suttner, N ; Holton, P ; Bulters, D ; Allison, A ; Bond, S ; Tarantino, S ; Davis-Wilkie, C ; Pantaleo, B ; Turner, C ; Hutchinson, PJ
  • Subjects: Statistical analysis
  • Is Part Of: Journal of neurology, neurosurgery and psychiatry, 2019-03, Vol.90 (3), p.e10-e11
  • Description: 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.
  • Publisher: London: BMJ Publishing Group LTD
  • Language: English
  • Identifier: ISSN: 0022-3050
    EISSN: 1468-330X
    DOI: 10.1136/jnnp-2019-ABN.33
  • Source: ProQuest One Psychology
    ProQuest Central
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