TY - JOUR T1 - Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial JF - Archives of Disease in Childhood JO - Arch Dis Child SP - 155 LP - 164 DO - 10.1136/archdischild-2017-313375 VL - 103 IS - 2 AU - Esther M Crawley AU - Daisy M Gaunt AU - Kirsty Garfield AU - William Hollingworth AU - Jonathan A C Sterne AU - Lucy Beasant AU - Simon M Collin AU - Nicola Mills AU - Alan A Montgomery Y1 - 2018/02/01 UR - http://adc.bmj.com/content/103/2/155.abstract N2 - Objective Investigate the effectiveness and cost-effectiveness of the Lightning Process (LP) in addition to specialist medical care (SMC) compared with SMC alone, for children with chronic fatigue syndrome/myalgic encephalitis (CFS/ME).Design Pragmatic randomised controlled open trial. Participants were randomly assigned to SMC, or SMC plus the LP (SMC+LP). Randomisation was minimised by age and gender.Setting Specialist paediatric CFS/ME service.Patients Aged 12–18 years with mild/moderate CFS/ME.Main outcome measures The primary outcome was the SF-36 physical function subscale (PFS) at 6 months. Secondary outcomes included the SF-36-PFS at 3 and 12 months, and pain, anxiety, depression, school attendance and cost-effectiveness from a health service perspective at 3, 6 and 12 months.Results We recruited 100 participants between September 2010 and September 2013. We tested the feasibility of running the trial with a feasibility phase (29 September 2010 to 18 September 2012). The full trial was registered in June 2012 when we had determined it was a feasible study. Of the 100 participants, 51 were randomised to SMC+LP. Data from 81 participants were analysed at 6 months. Physical function (SF-36-PFS) was better in those allocated SMC+LP (adjusted difference in means 12.5 [95% CI 4.5 to 20.5], p=0.003) and this improved further at 12 months (15.1 [95% CI 5.8 to 24.4], p=0.002). At 6 months, fatigue and anxiety were reduced and at 12 months, fatigue, anxiety, depression and school attendance had improved in the SMC+LP arm. Results were similar following multiple imputation. SMC+LP was more cost-effective in the multiple imputation data set (difference in means in net monetary benefit at 12 months £1474 [95% CI £111 to £2836], p=0.03) but not for complete cases.Conclusion The LP is effective and is probably cost-effective when provided in addition to SMC for mild/moderately affected adolescents with CFS/ME.Trial registration number ISRCTN81456207. ER -