The feasibility and acceptability of conducting a trial of specialist medical care and the Lightning Process in children with chronic fatigue syndrome: feasibility randomized controlled trial (SMILE study)
The feasibility and acceptability of conducting a trial of specialist medical care and the Lightning Process in children with chronic fatigue syndrome: feasibility randomized controlled trial (SMILE study)
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DOI：
10.1186/1745-6215-14-415
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发表时间：
2013-12-05
期刊：
影响因子：
2.5
通讯作者：
Montgomery, Alan
中科院分区：
文献类型：
--
作者：
Crawley, Esther;Mills, Nicola;Montgomery, Alan
背景：慢性疲劳综合征（CFS）或肌痛性脑脊髓炎（ME）在儿童中相对常见，治疗证据有限。菲尔帕克闪电过程（LP）是一种注册的干预措施，每年有超过250名儿童使用。有没有报道的研究调查的有效性或可能的副作用LP.Methods：试验人群来自巴斯和布里斯托NHS专科儿科CFS或ME服务。这项研究是一项针对儿童（12至18岁）的试点随机试验，比较了专科医疗护理和专科医疗护理加闪电过程。结果：2010年10月1日至2012年6月16日，从156名符合条件的儿童中，共招募到56名儿童。招募、随机化和两种干预措施均可行且可接受。参与者建议进行修改以提高可行性和可接受性，我们在试验方案中纳入了以下内容：停止收集6周结局;引入第二封提醒信;使用电话收集无应答者的主要结局;告知参与者每种干预的不同方法，并将我们对整个研究的主要结果的建议从入学率改为残疾结论：进行随机对照试验（RCTs），以调查一种替代治疗，如LP是可行的，可接受的CFS或ME.可行性研究，纳入定性方法，使试验方案的变化，以提高可接受的参与者。这有可能提高征聘率和保留审判人员的情况。
Background: Chronic fatigue syndrome (CFS) or myalgic encephalomyelitis (ME) is relatively common in children with limited evidence for treatment. The Phil Parker Lightning Process (LP) is a trademarked intervention, which > 250 children use annually. There are no reported studies investigating the effectiveness or possible side effects of LP.Methods: The trial population was drawn from the Bath and Bristol NHS specialist paediatric CFS or ME service. The study was designed as a pilot randomized trial with children (aged 12 to 18 years) comparing specialist medical care with specialist medical care plus the Lightning Process. Integrated qualitative methodology was used to explore the feasibility and acceptability of the recruitment, randomization and interventions.Results: A total of 56 children were recruited from 156 eligible children (1 October 2010 to 16 June 2012). Recruitment, randomization and both interventions were feasible and acceptable. Participants suggested changes to improve feasibility and acceptability and we incorporated the following in the trial protocol: stopped collecting 6-week outcomes; introduced a second reminder letter; used phone calls to collect primary outcomes from nonresponders; informed participants about different approaches of each intervention and changed our recommendation for the primary outcome for the full study from school attendance to disability (SF-36 physical function subscale) and fatigue (Chalder Fatigue Scale).Conclusions: Conducting randomized controlled trials (RCTs) to investigate an alternative treatment such as LP is feasible and acceptable for children with CFS or ME. Feasibility studies that incorporate qualitative methodology enable changes to be made to trial protocols to improve acceptability to participants. This is likely to improve recruitment rate and trial retention.