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

Affiliations

¹ Department of Biostatistics & Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, Denmark Hill Campus, London, SE5 8AF, UK. emily.robinson@kcl.ac.uk.
² Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, Denmark Hill Campus, London, SE5 8AF, UK.
³ Department of Health Service and Population Research, Institute of Psychiatry, Psychology and Neuroscience, King's College London, Denmark Hill Campus, London, SE5 8AF, UK.
⁴ Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, Denmark Hill Campus, London, SE5 8AF, UK.
⁵ Department of Neuropsychiatry, Maudsley Hospital, South London and Maudsley NHS Foundation Trust, Denmark Hill Campus, London, SE5 8AZ, UK.
⁶ Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, Denmark Hill Campus, London, SE5 8AF, UK.
⁷ Academic Neurology Unit, Royal Hallamshire Hospital, University of Sheffield, Glossop Road, Sheffield, S10 2JF, UK.
⁸ The Lishman Unit, South London and Maudsley NHS Foundation Trust, Denmark Hill, London, SE5 8AZ, UK.
⁹ Department of Clinical Neurosciences, Western General Hospital, University of Edinburgh, Edinburgh, EX4 2XU, UK.
¹⁰ Centre for Clinical Brain Sciences, Western General Hospital, University of Edinburgh, Edinburgh, EX4 2XU, UK.
¹¹ Department of Biostatistics & Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, Denmark Hill Campus, London, SE5 8AF, UK.

PMID: 28587649
PMCID: PMC5461767
DOI: 10.1186/s13063-017-2006-4

Randomized Controlled Trial

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

Emily J Robinson et al. Trials. 2017.

. 2017 Jun 6;18(1):258.

doi: 10.1186/s13063-017-2006-4.

Authors

Affiliations

¹ Department of Biostatistics & Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, Denmark Hill Campus, London, SE5 8AF, UK. emily.robinson@kcl.ac.uk.
² Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, Denmark Hill Campus, London, SE5 8AF, UK.
³ Department of Health Service and Population Research, Institute of Psychiatry, Psychology and Neuroscience, King's College London, Denmark Hill Campus, London, SE5 8AF, UK.
⁴ Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, Denmark Hill Campus, London, SE5 8AF, UK.
⁵ Department of Neuropsychiatry, Maudsley Hospital, South London and Maudsley NHS Foundation Trust, Denmark Hill Campus, London, SE5 8AZ, UK.
⁶ Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, Denmark Hill Campus, London, SE5 8AF, UK.
⁷ Academic Neurology Unit, Royal Hallamshire Hospital, University of Sheffield, Glossop Road, Sheffield, S10 2JF, UK.
⁸ The Lishman Unit, South London and Maudsley NHS Foundation Trust, Denmark Hill, London, SE5 8AZ, UK.
⁹ Department of Clinical Neurosciences, Western General Hospital, University of Edinburgh, Edinburgh, EX4 2XU, UK.
¹⁰ Centre for Clinical Brain Sciences, Western General Hospital, University of Edinburgh, Edinburgh, EX4 2XU, UK.
¹¹ Department of Biostatistics & Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, Denmark Hill Campus, London, SE5 8AF, UK.

PMID: 28587649
PMCID: PMC5461767
DOI: 10.1186/s13063-017-2006-4

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).

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

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Figures

**Fig. 1**
COgnitive behavioural therapy versus standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES) trial Consolidated Standards of Reporting Trials (CONSORT) diagram. *RCT* Randomised controlled trial, *CBT* Cognitive behavioural therapy, *SMC* Standardised medical care

See this image and copyright information in PMC

References

1. Goldstein LH, Mellers JD, Landau S, Stone J, Carson A, Medford N, et al. COgnitive behavioural therapy vs standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES): a multicentre randomised controlled trial protocol. BMC Neurol. 2015;15:98. doi: 10.1186/s12883-015-0350-0. - DOI - PMC - PubMed
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1. Brown RJ, Reuber M. Psychological and psychiatric aspects of psychogenic non-epileptic seizures (PNES): a systematic review. Clin Psychol Rev. 2016;45:157–82. doi: 10.1016/j.cpr.2016.01.003. - DOI - PubMed
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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

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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

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