Investigating the effectiveness and cost-effectiveness of FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) compared to Activity Management to treat paediatric chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME): protocol for a randomised controlled trial.
Investigating the effectiveness and cost-effectiveness of FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) compared to Activity Management to treat paediatric chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME): protocol for a randomised controlled trial.
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DOI：
10.1186/s13063-018-2500-3
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发表时间：
2018-02-22
期刊：
影响因子：
2.5
通讯作者：
Crawley E
中科院分区：
文献类型：
--
作者：
Baos S;Brigden A;Anderson E;Hollingworth W;Price S;Mills N;Beasant L;Gaunt D;Garfield K;Metcalfe C;Parslow R;Downing H;Kessler D;Macleod J;Stallard P;Knoop H;Van de Putte E;Nijhof S;Bleijenberg G;Crawley E
儿科慢性疲劳综合征或肌痛性脑脊髓炎（CFS/ME）是一种相对常见的致残性疾病。国家健康与临床卓越研究所（NICE）建议将认知行为疗法（CBT）作为儿科CFS/ME的治疗选择，因为有很好的证据表明它是有效的。尽管如此，大多数年轻人在英国是无法访问本地专家CBT CFS/ME.A随机对照试验（RCT）显示，FITNET是有效的在荷兰，但我们不知道它是否是有效的在国民保健服务（NHS）或如果它是具有成本效益。这项试验将调查FITNET-NHS在NHS中是否具有临床有效性和成本效益。734例CFS/ ME儿科患者（年龄11-17岁）将随机（1：1）接受FITNET-NHS（在线CBT）或活动管理（通过视频通话提供）。内部试点研究将采用综合定性方法，审查招募的可行性和治疗的可接受性。完整的试验将评估FITNET-NHS是否具有临床有效性和成本效益。主要结局是6个月时的残疾，使用SF-36-PFS（身体功能量表）问卷进行测量。成本效益是衡量通过成本效用分析从国民保健服务的角度。次要亚组分析将调查FITNET-NHS在患有共病情绪障碍的患者中的有效性。如果FITNET-NHS被认为是可行和可接受的（内部试点），有效和具有成本效益的（全面试验），由NHS提供的服务有可能为大量患有CFS/ME但由于没有当地专家服务而无法获得治疗的年轻人带来实质性的健康收益。这项试验将提供进一步的证据，评估向患有慢性病的年轻人提供在线CBT。ISRCTN注册中心，注册号：ISRCTN 18020851。于2016年8月4日注册。本文的在线版本（10.1186/s13063-018-2500-3）包含补充材料，可供授权用户使用。
Paediatric chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) is a relatively common and disabling condition. The National Institute for Health and Clinical Excellence (NICE) recommends Cognitive Behavioural Therapy (CBT) as a treatment option for paediatric CFS/ME because there is good evidence that it is effective. Despite this, most young people in the UK are unable to access local specialist CBT for CFS/ME. A randomised controlled trial (RCT) showed FITNET was effective in the Netherlands but we do not know if it is effective in the National Health Service (NHS) or if it is cost-effective. This trial will investigate whether FITNET-NHS is clinically effective and cost-effective in the NHS. Seven hundred and thirty-four paediatric patients (aged 11–17 years) with CFS/ ME will be randomised (1:1) to receive either FITNET-NHS (online CBT) or Activity Management (delivered via video call). The internal pilot study will use integrated qualitative methods to examine the feasibility of recruitment and the acceptability of treatment. The full trial will assess whether FITNET-NHS is clinically effective and cost-effective. The primary outcome is disability at 6 months, measured using the SF-36-PFS (Physical Function Scale) questionnaire. Cost-effectiveness is measured via cost-utility analysis from an NHS perspective. Secondary subgroup analysis will investigate the effectiveness of FITNET-NHS in those with co-morbid mood disorders. If FITNET-NHS is found to be feasible and acceptable (internal pilot) and effective and cost-effective (full trial), its provision by the NHS has the potential to deliver substantial health gains for the large number of young people suffering from CFS/ME but unable to access treatment because there is no local specialist service. This trial will provide further evidence evaluating the delivery of online CBT to young people with chronic conditions. ISRCTN registry, registration number: ISRCTN18020851. Registered on 4 August 2016. The online version of this article (10.1186/s13063-018-2500-3) contains supplementary material, which is available to authorized users.
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影响因子：
6.6
作者：
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通讯作者：
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