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.
- chronic fatigue syndrome
- adolescent health
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Correction notice This is a republished, corrected version. For full details please see the correction note, 10.1136/archdischild-2017-313375corr1.
Contributors EMC obtained the funding, and designed and supervised the trial. DMG conducted the statistical analysis and compiled the results tables. KG conducted the health economic analyses and compiled the health economic tables. WH contributed to the study design and supervised the health economic analyses. JACS and AAM contributed to the study design and cosupervised the statistical analyses. LB contributed to the study design and running the trial. SMC managed the data and contributed to the statistical analyses. NM contributed to the study design. All authors contributed to the data interpretation and writing the paper. EMC is the guarantor. The authors had access to all the data. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.
Funding This trial was funded by the Linbury Trust (grant number LIN2038) and the Ashden Trust (grant numbers ASH1062, 1063, 1064). EMC was funded by an NIHR Clinician Scientist Fellowship followed by an NIHR Senior Research Fellowship (SRF-2013-06-013) during the trial. SMC was funded by an NIHR Postdoctoral Fellowship during the analyses of the trial.
Disclaimer No member of the LP team had any involvement in the analyses or in writing the paper. No member of the Linbury Trust or the Ashden Trust had any involvement in the design, analyses or in writing the paper. This report is an independent research and the views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health. The funders and the sponsor of the study had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; and decision to submit the manuscript for publication. All researchers involved in this study were independent from both the funders and the sponsor.
Competing interests Financial support for the submitted work was received from the Linbury Trust and the Ashden Trust. EMC and SMC have received fellowship grants from the NIHR. JACS has received grants from the NIHR. EMC runs the specialist CFS/ME service at Royal United Hospital NHS Foundation Trust, has received one grant from MRC, one grant from the NIHR and is a medical advisor to the Sussex and Kent ME/CFS Society. The authors declare they did not receive any funding from the Lightning Process.
Ethics approval A favourable ethical opinion was given on 8 September 2010 (reference 10/H0206/32) by South West 2 Local Research Ethics Committee. Two favourable opinions were provided for amendments to study documents and protocol on 31 May 2011 and 6 September 2012.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Given the nature of this data set, access is controlled. Requests are referred to the University of Bristol Data Access Committee (DAC) for approval before data can be released under an appropriate data access agreement. For details on how to access data please see the repository record at http://dx.doi.org/10.5523/bris.1myzti8qnv48g2sxtx6h5nice7.
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