From BMC Trials, 5 December 2013.
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)
Esther Crawley(1,*), Nicola Mills(2), Lucy Beasant(3), Debbie Johnson(1), Simon M Collin(1), Zuzana Deans(2), Kate White(1) and Alan Montgomery(2,3)
1) Centre for Child & Adolescent Health, School of Social and Community Medicine, University of Bristol, Oakfield House, Oakfield Road, BS8 2BN Bristol, UK
2) School of Social and Community Medicine, University of Bristol, Canynge Hall, Bristol BS8 2PS, UK
3) Nottingham Clinical Trials Unit, Queen’s Medical Centre, Nottingham NG7 2UH, UK
Chronic fatigue syndrome (CFS) or myalgic encephalomyelitis (ME) isrelatively 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.
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.
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).
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.
Trial registration: Feasibility study first randomization: 29 September 2010.
Trial registration: Current Controlled Trials ISRCTN81456207 (31 July 2012).
Full trial first randomization: 19 September 2012.
The complete article is available as a provisional PDF. The fully
formatted PDF and HTML versions are in production.