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

Trials

Markus Reuber¹  Alan Carson²  Mark P. Richardson³  Sabine Landau⁴  Emily J. Robinson⁴  Jon Stone⁵  Joanna Murray⁶  Paul McCrone⁶  John D. C. Mellers⁷  Trudie Chalder⁸  Iain Perdue⁹  Laura H. Goldstein⁹  Nick Medford^1,10 

[1] Academic Neurology Unit, Royal Hallamshire Hospital, University of Sheffield;Centre for Clinical Brain Sciences, Western General Hospital, University of Edinburgh;Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King’s College London;Department of Biostatistics & Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King’s College London;Department of Clinical Neurosciences, Western General Hospital, University of Edinburgh;Department of Health Service and Population Research, Institute of Psychiatry, Psychology and Neuroscience, King’s College London;Department of Neuropsychiatry, Maudsley Hospital, South London and Maudsley NHS Foundation Trust;Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King’s College London;Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King’s College London;The Lishman Unit, South London and Maudsley NHS Foundation Trust;

关键词: Statistical analysis plan;    CODES trial;    Non-epileptic seizures;    Dissociative seizures;    Cognitive behavioural therapy;    Randomised controlled trial;   

DOI  :  10.1186/s13063-017-2006-4

来源: DOAJ

【 摘 要 】

Abstract Background Dissociative seizures (DSs), 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 COgnitive behavioural therapy versus standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES) trial is an evaluation of a specifically tailored psychological intervention with the aims 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 performed to evaluate the clinical effectiveness and cost-effectiveness of 13 sessions of cognitive behavioural therapy (CBT) plus standardised medical care (SMC) compared with 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 are the descriptive statistics that will be reported. This paper provides 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 registration ISRCTN registry ISRCTN05681227 (registered on 5 March 2014); ClinicalTrials.gov NCT02325544 (registered on 15 December 2014).

【 授权许可】

Unknown