Robinson Emily J, Goldstein Laura H, McCrone Paul, Perdue Iain, Chalder Trudie, Mellers John D C, Richardson Mark P, Murray Joanna, Reuber Markus, Medford Nick, Stone Jon, Carson Alan, Landau Sabine
Department of Biostatistics & Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, Denmark Hill Campus, London, SE5 8AF, UK.
Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, Denmark Hill Campus, London, SE5 8AF, UK.
Trials. 2017 Jun 6;18(1):258. doi: 10.1186/s13063-017-2006-4.
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.
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.
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.
ISRCTN registry ISRCTN05681227 (registered on 5 March 2014); ClinicalTrials.gov NCT02325544 (registered on 15 December 2014).
分离性癫痫发作（DSs），也称为精神性非癫痫性发作，对于许多神经科患者来说是一个令人痛苦且致残的问题，会产生高昂且往往不必要的经济成本。成人分离性非癫痫性发作认知行为疗法与标准化医疗护理对照试验（CODES）旨在评估一种专门定制的心理干预措施，目的是减少成人DS患者的癫痫发作频率和严重程度，并改善其心理健康状况。本文旨在详细报告经试验指导委员会商定的CODES试验的定量和经济分析计划。
CODES试验是一项多中心、实用、平行组随机对照试验，旨在评估13节认知行为疗法（CBT）加标准化医疗护理（SMC）与单纯SMC相比，对成年门诊DS患者的临床有效性和成本效益。
总结了试验的目标和设计，并说明了计划分析的目的和程序。拟议的分析计划涉及统计方面的考虑，如保持盲法、监测方案依从性、描述治疗情况以及处理缺失数据。描述了主要和次要结局的正式分析方法以及将要报告的描述性统计数据。本文在提取结局数据之前，为CODES试验的计划推断分析提供了透明度。它还更新了之前发表的试验方案，并为进行类似试验的人员提供了指导。
国际标准随机对照试验编号注册库ISRCTN05681227（于2014年3月5日注册）；美国国立医学图书馆临床试验注册库NCT02325544（于2014年12月15日注册）。
