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

E Edlmann; A Kolias; E Thelin; D Gatt; Y Al-Tamimi; K Owusu-Agyemang; N Suttner; P Holton; D Bulters; A Allison; S Bond; S Tarantino; C Davis-Wilkie; B Pantaleo; C Turner; PJ Hutchinson

doi:10.1136/jnnp-2019-abn.33

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

E Edlmann, A Kolias, E Thelin, D Gatt, Y Al-Tamimi, K Owusu-Agyemang, N Suttner, P Holton, D Bulters, A Allison, S Bond, S Tarantino, C Davis-Wilkie, B Pantaleo, C Turner, PJ Hutchinson

Peninsula Medical School

Research output: Contribution to journal › Conference proceedings published in a journal › peer-review

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.

Original language	English
Pages (from-to)	e10.4-e11
Number of pages	0
Journal	Journal of Neurology, Neurosurgery & Psychiatry
Volume	90
Issue number	3
Early online date	14 Feb 2019
DOIs	https://doi.org/10.1136/jnnp-2019-abn.33
Publication status	Published - Mar 2019

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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. (2019). TP1-3 Final phase of recruitment and statistics analysis plan for Dex-CSDH trial. Journal of Neurology, Neurosurgery & Psychiatry, 90(3), e10.4-e11. https://doi.org/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",

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.",

author = "E Edlmann and A Kolias and E Thelin and D Gatt and Y Al-Tamimi and K Owusu-Agyemang and N Suttner and P Holton and D Bulters and A Allison and S Bond and S Tarantino and C Davis-Wilkie and B Pantaleo and C Turner and PJ Hutchinson",

year = "2019",

month = mar,

doi = "10.1136/jnnp-2019-abn.33",

language = "English",

volume = "90",

pages = "e10.4--e11",

journal = "Journal of Neurology, Neurosurgery & Psychiatry",

issn = "0022-3050",

number = "3",

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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 2019, 'TP1-3 Final phase of recruitment and statistics analysis plan for Dex-CSDH trial', Journal of Neurology, Neurosurgery & Psychiatry, vol. 90, no. 3, pp. e10.4-e11. https://doi.org/10.1136/jnnp-2019-abn.33

TY - JOUR

T1 - TP1-3 Final phase of recruitment and statistics analysis plan for Dex-CSDH trial

AU - Edlmann, E

AU - Kolias, A

AU - Thelin, E

AU - Gatt, D

AU - Al-Tamimi, Y

AU - Owusu-Agyemang, K

AU - Suttner, N

AU - Holton, P

AU - Bulters, D

AU - Allison, A

AU - Bond, S

AU - Tarantino, S

AU - Davis-Wilkie, C

AU - Pantaleo, B

AU - Turner, C

AU - Hutchinson, PJ

PY - 2019/3

Y1 - 2019/3

N2 - 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.

AB - 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.

U2 - 10.1136/jnnp-2019-abn.33

DO - 10.1136/jnnp-2019-abn.33

M3 - Conference proceedings published in a journal

SN - 0022-3050

VL - 90

SP - e10.4-e11

JO - Journal of Neurology, Neurosurgery & Psychiatry

JF - Journal of Neurology, Neurosurgery & Psychiatry

IS - 3

ER -

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

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