研究FITNET-NHS（英国国家医疗服务体系中青少年网络疲劳项目）与活动管理相比，治疗儿童慢性疲劳综合征（CFS）/肌痛性脑脊髓炎（ME）的有效性和成本效益：一项随机对照试验方案
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.
作者信息
Baos Sarah, Brigden Amberly, Anderson Emma, Hollingworth William, Price Simon, Mills Nicola, Beasant Lucy, Gaunt Daisy, Garfield Kirsty, Metcalfe Chris, Parslow Roxanne, Downing Harriet, Kessler David, Macleod John, Stallard Paul, Knoop Hans, Van de Putte Elise, Nijhof Sanne, Bleijenberg Gijs, Crawley Esther
机构信息
Centre for Child and Adolescent Health, Bristol Medical School: Population Health Sciences, University of Bristol, Oakfield House, Oakfield, Grove, Bristol, BS8 2BN, UK.
Bristol Medical School: Population Health Sciences, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.
出版信息
Trials. 2018 Feb 22;19(1):136. doi: 10.1186/s13063-018-2500-3.
BACKGROUND
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.
METHODS
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.
DISCUSSION
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.
TRIAL REGISTRATION
ISRCTN registry, registration number: ISRCTN18020851 . Registered on 4 August 2016.
背景
儿童慢性疲劳综合征或肌痛性脑脊髓炎（CFS/ME）是一种相对常见且使人衰弱的病症。英国国家卫生与临床优化研究所（NICE）推荐认知行为疗法（CBT）作为儿童CFS/ME的一种治疗选择，因为有充分证据表明其有效。尽管如此，英国大多数年轻人无法获得针对CFS/ME的当地专科CBT治疗。一项随机对照试验（RCT）表明FITNET在荷兰有效，但我们不知道它在国民医疗服务体系（NHS）中是否有效，也不知道它是否具有成本效益。本试验将调查FITNET-NHS在NHS中是否具有临床疗效和成本效益。
方法
734名患有CFS/ME的儿童患者（年龄在11至17岁之间）将被随机分组（1:1），分别接受FITNET-NHS（在线CBT）或活动管理（通过视频通话提供）。内部试点研究将使用综合定性方法来检验招募的可行性和治疗的可接受性。完整试验将评估FITNET-NHS是否具有临床疗效和成本效益。主要结局是6个月时的残疾情况，使用SF-36-PFS（身体功能量表）问卷进行测量。成本效益从NHS的角度通过成本效用分析来衡量。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。
讨论
如果发现FITNET-NHS可行且可接受（内部试点）、有效且具有成本效益（完整试验），那么NHS提供该疗法有可能为大量患有CFS/ME但因当地没有专科服务而无法获得治疗的年轻人带来显著的健康益处。本试验将提供进一步的证据，以评估为患有慢性病的年轻人提供在线CBT的效果。
试验注册
ISRCTN注册库，注册号：ISRCTN18020851。于2016年8月4日注册。
Zotero 插件