SMILE trial

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The SMILE Trial was a feasibilty study which took place at the Royal National Hospital for Rheumatic Diseases in Bath and the University of Bristol in Britain.[1] The principle investigator was Esther Crawley. It was designed to the effects of standard medical treatment (SMC) against that of the Lightning Process & SMC. The Lightning process takes place over three consecutive days in a group format. Participants were children aged between 12 and 18 drawn from the Bristol and Bath areas.[2] Those who were housebound were excluded.

The co-applicant for the study was Fiona Finch, the Research Director at the Lightning Process company (Phil Parker Ltd).

Methodology[edit | edit source]

The trial compared patients receiving Standard Medical Care (SMC) against the Lightning Process (LP) in conjunction with SMC.

Outcome was initially to be based on school attendance.[3] This was changed to assessment based on the following scales: the Chalder fatigue scale, pain visual analogue scale,[4] physical function short form (SF-36), the Spence Children’s Anxiety Scale (SCAS),[5][6] the Hospital Anxiety and Depression Scale (HADS) for children aged 14 and over,[7][8] and the Euroqol (EQ-5D),[9] a five-item quality of life inventory.

Out of 156 children considered eligible, 56 participated, with the study beginning in September 2012. Anxious children were offered 3 sessions of CBT over a 6 week period.

SMC was graded activity with phone calls and family based rehabilitation consultations lasting an hour at 6 weeks, 3 months & 4.5 months.

Funding[edit | edit source]

The initial budget was £164,000 funded by the Linbury Trust and the Ashden Trust.[10]

Research ethics[edit | edit source]

In a joint statement in August 2010, the ME Association and the Young ME Sufferers Trust called the SMILE study "unethical" saying, "The ME Association and The Young ME Sufferers Trust do not believe that it is ethically right to use children in trialling an unproven and controversial process such as the Lightning Process."[11]

Invest in ME in a letter to the National Research Ethics Committee (NRES) described the process as "rather like CBT but with bullying and risks of harm."[12]

Professor Robin Gill, a member of the BMA medical ethics committee, wrote to the Church Times about the LP and the SMILE trial. He expressed concern about the issue of coercion of children in the trial.[13]

Results[edit | edit source]

The results have been not published in paper despite the trial being completed in 2013. There has been no further study following on from this feasibility one.

There are some selective quotes in a 2015 paper[14] as well the final study protocol, which was published after the trial ended. James Coyne said of the quotes "(they) cannot be independently evaluated. Readers are not told how representative these quotes, the outcomes for the children being quoted or the overall outcomes of the trial." [15]

To document the results from these threads:….54503/page-19#post-909875

Criticisms[edit | edit source]

James Coyne has criticised Crawley's work with regard to public availability of data & the involvement of Phil Parker in the SMILE study.[16]

Daniel Clark has noted that the primary outcome measure was changed from school attendance to scores on a self-report questionnaire. He stated, "Given that LP involves making claims to patients about their own ability to control symptoms in exactly the sort of way likely to lead to response bias, it seems very likely that this trial will now find LP to be 'effective'." [17]

The study only received final ethical approval after prolonged protests from patient groups in January 2011. [18]

John Peters has criticised the study.[19][20][21]

Dr David Tuller has severely criticised the SMILE trial [22].

An open letter was sent to the editor of Archives of Disease in Childhood in January 2018 by Dr David Tuller and over twenty other signatories for a correction to the serious issues and anomalies in the published paper [23].

Investigators[edit | edit source]

Esther Crawley, Nicola Mills, Will Hollingworth, Zuzana Deans, Jonathan A Sterne, Jenny L Donovan, Lucy Beasant and Alan Montgomery

See also[edit | edit source]

References[edit | edit source]

  1. Crawley, Esther; Mills, Nicola; Beasant, Lucy; Johnson, Debbie; Collin, Simon M; Deans, Zuzana; White, Kate; Montgomery, Alan (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)", Trials, 14 (415), doi:10.1186/1745-6215-14-415 
  2. SMILE Trial Protocol - Bristol University 2013
  3. Final Study Protocol - Crawley et al (Dec 2013)
  4. Viusal Analogue Scale - Physiopedia
  5. Self completed questionnaires were completed at the first clinical assessment and subsequently at 6 weeks, 3 months, 4.5 months Wikipedia - Spence Children's Anxiety Scale
  6. Example of Spence Children's Anxiety Scale - Psychology Tools
  7. Wikipedia - Hospital Anxiety and Depression Scale
  8. Example of HADS questionnaire - Scales and Measures
  9. Wikipedia - EQ-5D
  10. £164,000 grant for study into the Lightning Process and children with ME - ME Association (March 2010)
  11. Statement of ME Association and Young Sufferers Trust on SMILE (August 2010)
  12. Letter to National Research Ethics Committee - Invest in ME
  13. Children should not be used as Guinea Pigs - Church Times 8 October 2010
  14. What matters to children with CFS/ME? A conceptual model as the first stage in developing a PROM - Archives of Disease in Childhood, Crawley et al 2015
  15. Before you enroll your child in the MAGENTA chronic fatigue syndrome study: Issues to be considered - James Coyne (September 2015) Plos Blog
  16. James Coyne's criticisms of the work of Esther Crawley
  17. Daniel Clark''s criticism on Skepdic website
  18. Ethics Committee finally approves SMILE (January 2011)
  19. THE SMILE TRIAL (part 1)
  20. THE SMILE TRIAL (part 2)
  21. THE SMILE TRIAL (part 3)

The information provided at this site is not intended to diagnose or treat any illness.

From MEpedia, a crowd-sourced encyclopedia of ME and CFS science and history