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首页> 外文期刊>Trials >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

机译：认知行为疗法与标准化医疗相结合对成人非分离性非癫痫性癫痫发作（CODES）的影响：一项随机对照试验的统计和经济分析计划

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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).
机译：背景分离性癫痫发作（DSs），也称为精神性非癫痫性癫痫发作，对于神经系统环境中的许多患者来说，是令人痛苦和致残的问题，其经济损失通常很高且不必要。认知行为疗法与标准医学护理相结合的针对非离解性非癫痫性癫痫发作（CODES）的成年人进行的一项临床评估，旨在降低DS成年人的癫痫发作频率和严重程度，并改善其心理健康。本文的目的是详细报告由试验指导委员会同意的CODES试验的定量和经济分析计划。方法CODES试验是一项多中心，务实，平行组的随机对照试验，旨在评估13次认知行为疗法（CBT）加标准化医疗（SMC）与成人SMC相比的临床有效性和成本效益。 DS的门诊病人。讨论总结了试验的目的和设计，并说明了计划分析的目的和程序。拟议的分析计划解决了统计方面的考虑，例如保持盲目性，监测对方案的依从性，描述治疗方面以及处理丢失的数据。描述了主要和次要结果的正式分析方法，以及将要报告的描述性统计数据。本文在提取结果数据之前为CODES试验的计划推论分析提供了透明度。它还提供了以前发布的试验方案的更新，并为进行类似试验的人员提供了指南。试用注册ISRCTN注册中心ISRCTN05681227（于2014年3月5日注册）; ClinicalTrials.gov NCT02325544（于2014年12月15日注册）。

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