Cognitive behavioural therapy versus standardised medical care for adults with dissociative non-epileptic seizures (CODES): statistical and economic analysis plan for a randomised controlled trial

TY - JOUR

T1 - Cognitive behavioural therapy versus standardised medical care for adults with dissociative non-epileptic seizures (CODES)

T2 - statistical and economic analysis plan for a randomised controlled trial

AU - Robinson, Emily J.

AU - Goldstein, Laura H.

AU - McCrone, Paul

AU - Perdue, Iain

AU - Chalder, Trudie

AU - Mellers, John DC

AU - Richardson, Mark P.

AU - Murray, Joanna

AU - Reuber, Markus

AU - Medford, Nick

AU - Stone, Jon

AU - Carson, Alan

AU - Landau, Sabine

PY - 2017/6/6

Y1 - 2017/6/6

N2 - Background: Dissociative seizures (DS), also called psychogenic ‘non-epileptic’ seizures, are a distressing and disabling problem for many patients in neurological settings with high and often unnecessary economic costs. The CODES Trial evaluates a specifically-tailored psychological intervention with the aim of reducing seizure frequency and severity, and improving psychological well-being in adults with DS. The aim of this paper is to report in detail the quantitative and economic analysis plan for the CODES Trial, as agreed by the Trial Steering Committee.Methods: The CODES Trial is a multicentre, pragmatic parallel group randomised controlled trial (RCT) to evaluate the clinical and cost-effectiveness of 13 sessions of cognitive behavioural therapy (CBT) plus standardised medical care (SMC) in comparison to SMC alone for adult outpatients with DS. Discussion: The objectives and design of the trial are summarised, and the aims and procedures of the planned analyses are illustrated. The proposed analysis plan addresses statistical considerations such as maintaining blinding, monitoring adherence with the protocol, describing aspects of treatment and dealing with missing data. The formal analysis approach for the primary and secondary outcomes is described, as well as the descriptive statistics that will be reported. This paper offers transparency to the planned inferential analyses for the CODES Trial, prior to the extraction of outcome data. It also provides an update to the previously published trial protocol and guidance to those conducting similar trials.Trial RegistrationISRCTN registry ISRCTN05681227 (registered 05 March 2014); ClinicalTrials.gov NCT02325544 (registered 15 December 2014). KeywordsStatistical Analysis Plan, CODES Trial, nonepileptic seizures, dissociative seizures, cognitive behavioural therapy, randomised controlled trial.

AB - Background: Dissociative seizures (DS), also called psychogenic ‘non-epileptic’ seizures, are a distressing and disabling problem for many patients in neurological settings with high and often unnecessary economic costs. The CODES Trial evaluates a specifically-tailored psychological intervention with the aim of reducing seizure frequency and severity, and improving psychological well-being in adults with DS. The aim of this paper is to report in detail the quantitative and economic analysis plan for the CODES Trial, as agreed by the Trial Steering Committee.Methods: The CODES Trial is a multicentre, pragmatic parallel group randomised controlled trial (RCT) to evaluate the clinical and cost-effectiveness of 13 sessions of cognitive behavioural therapy (CBT) plus standardised medical care (SMC) in comparison to SMC alone for adult outpatients with DS. Discussion: The objectives and design of the trial are summarised, and the aims and procedures of the planned analyses are illustrated. The proposed analysis plan addresses statistical considerations such as maintaining blinding, monitoring adherence with the protocol, describing aspects of treatment and dealing with missing data. The formal analysis approach for the primary and secondary outcomes is described, as well as the descriptive statistics that will be reported. This paper offers transparency to the planned inferential analyses for the CODES Trial, prior to the extraction of outcome data. It also provides an update to the previously published trial protocol and guidance to those conducting similar trials.Trial RegistrationISRCTN registry ISRCTN05681227 (registered 05 March 2014); ClinicalTrials.gov NCT02325544 (registered 15 December 2014). KeywordsStatistical Analysis Plan, CODES Trial, nonepileptic seizures, dissociative seizures, cognitive behavioural therapy, randomised controlled trial.

KW - Cognitive Behavioural Therapy

KW - Randomised Controlled Trial

KW - Statistical analysis plan

KW - CODES Trial

KW - Nonepileptic seizures

KW - Dissociative seizures

UR - http://www.scopus.com/inward/record.url?scp=85020259182&partnerID=8YFLogxK

U2 - 10.1186/s13063-017-2006-4

DO - 10.1186/s13063-017-2006-4

M3 - Article

SN - 1745-6215

VL - 18

JO - Trials

JF - Trials

IS - 1

ER -