SMILE trial

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

The SMILE Trial was a feasibilty study followed by a clinic trial of the controversial Lightning Process in children and adolescents with chronic fatigue syndrome. It 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 & Standard Medical Care (SMC) together. 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.

Self-assessment questionnaires were completed at the first clinical assessment and subsequently at 6 weeks, 3 months, 4.5 months.

Out of 156 children considered eligible, 56 participated, with the study beginning in September 2012. Anxious children were offered three sessions of cognitive behavioral therapy (CBT) over a six-week period.

Specialized Medical Care (SMC) consisted of graded activity with phone calls and family-based rehabilitation consultations lasting an hour at six weeks, three months & 4.5 months.

Outcome swapping[edit | edit source]

The primary outcome was initially to be based on school attendance.[3] This was changed to the physical function short form (SF-36) questionnaire, with most secondary outcomes also being self-assessed using the following scales: the Chalder fatigue scale, pain visual analogue scale, the Spence Children’s Anxiety Scale (SCAS), the Hospital Anxiety and Depression Scale (HADS) for children aged 14 and over,[4], and the Euroqol (EQ-5D)[5] a five-item quality of life inventory, plus school attendance.

Funding[edit | edit source]

The initial budget was £164,000 funded by the Linbury Trust and the Ashden Trust.[6]

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."[7]

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."[8]

Professor Robin Gill, a member of the British Medical Association's 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.[9]

Results[edit | edit source]

The results of the SMILE trial were not published until 2017, despite the trial being completed in 2013, with the print version published in 2018.[10] Complaints to the publishing journal, Archives of Disease in Childhood, were extensively investigated in 2018 and 2019, resulting in a significant editorial correction in July 2019.[11]

There are some selective quotes in a 2015 paper[12] 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."[13]

To document the results from these threads, see here, here, and here.

Criticisms[edit | edit source]

James Coyne has criticized Crawley's work with regard to public availability of data & the involvement of Phil Parker in the SMILE study.[14]

Daniel Clark has noted that the primary outcome measure was changed from school attendance to scores on a self-report questionnaire after the trial was registered, a process known as outcome swapping. Before the publication of trial, 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'."[15]

The study only received final ethical approval after prolonged protests from patient groups in January 2011.[16]

Patient advocate John Peters has criticized the study.[17][18][19]

Dr David Tuller has severely criticised the SMILE trial.[20]

Frown at Smile - This blog concerns what is widely believed to be an unethical pilot study (SMILE) of a non-medical training programme (The Lightning Process) on children with the neuro-immune disease myalgic encephalomyelitis, also referred to as chronic fatigue syndrome or ME/CFS. (https://frownatsmile.wordpress.com/)

Editorial correction[edit | edit source]

The final version includes acknowledgement from the authors that the study was not fully ICMJE compliant. The process has additionally involved seeking assurance from the authors that the change in primary outcome was not influenced by (positive) findings in the feasibility phase... BMJ policy requires prospective registration of randomised trials but we do not consider a failure to enforce that policy grounds for retraction. - Nick Brown, Editor of Archives of Disease in Childhood (2019)
Extracts from the editorial correction of the SMILE trial for ME/CFS by Esther Crawley et al (2018).

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.[21]
In July 2019, after an investigation by the Archives of Disease in Childhood, and significant correspondence between the study's authors, journal editor Nick Brown, and Dr David Tuller, a lengthy and detailed editorial correction to the SMILE trial was published.[10] In the correction, Archives of Disease in Childhood published a justification for the journal's refusal to retract the SMILE publication, and a list of many of the issues with the original publication.[10]

Notable publications[edit | edit source]

2017, Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial[11] (Full text)

2019, Editor's Note on Correction to Crawley et al. 2018[10] (Full text)

Investigators[edit | edit source]

Esther Crawley, Daisy Gaunt, Kirsty Garfield, Nicola Mills, William Hollingworth, Zuzana Deans, Jonathan A Sterne, Jenny L Donovan, Lucy Beasant, Alan Montgomery and Simon Collin.

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 (December 5, 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 (1): 415. doi:10.1186/1745-6215-14-415. ISSN 1745-6215. PMC 4235039. PMID 24304689.
  2. ↑ SMILE Trial Protocol - Bristol University 2013
  3. ↑ Final Study Protocol - Crawley et al (Dec 2013)
  4. ↑ Stern, Anna F. (July 1, 2014). "The Hospital Anxiety and Depression Scale". Occupational Medicine. 64 (5): 393–394. doi:10.1093/occmed/kqu024. ISSN 0962-7480.
  5. ↑ Dworkin, RH; Turk, DC; Farrar, JT; Haythornthwaite, JA; Jensen, MP; Katz, NP; Kerns, RD; Stucki, G; Allen, RR; Bellamy, N; Carr, DB (January 1, 2005). "Core outcome measures for chronic pain clinical trials: IMMPACT recommendations" (PDF). PAIN. 113 (1): 9–19.
  6. ↑ £164,000 grant for study into the Lightning Process and children with ME - ME Association (March 2010)
  7. ↑ "The Lightning Process and SMILE trial is an "unethical" study involving children | 20 September 2010". Retrieved July 16, 2019.
  8. ↑ Letter to National Research Ethics Committee - Invest in ME
  9. ↑ meagenda (October 14, 2010). "Children should not be used as guinea pigs: Prof Robin Gill, Church Times (LP pilot study)". ME agenda. Retrieved July 16, 2019.
  10. ↑ 10.0 10.1 10.2 10.3 Brown, Nick (July 2019). "Editor's Note on Correction to Crawley et al 2018". Archives of Disease in Childhood.
  11. ↑ 11.0 11.1 Crawley, Esther M; Gaunt, Daisy M; Garfield, Kirsty; Hollingworth, William; Sterne, Jonathan A C; Beasant, Lucy; Collin, Simon M; Mills, Nicola; Montgomery, Alan A (February 2018). "Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial". Archives of Disease in Childhood. 103 (2): 155–164. doi:10.1136/archdischild-2017-313375. ISSN 0003-9888. PMC 5865512. PMID 28931531.
  12. ↑ 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
  13. ↑ Before you enroll your child in the MAGENTA chronic fatigue syndrome study: Issues to be considered - James Coyne (September 2015) Plos Blog
  14. ↑ James Coyne's criticisms of the work of Esther Crawley
  15. ↑ Daniel Clark''s criticism on Skepdic website
  16. ↑ Ethics Committee finally approves SMILE (January 2011)
  17. ↑ "THE SMILE TRIAL (part 1)". johnthejack. July 2, 2017. Retrieved July 16, 2019.
  18. ↑ "THE SMILE TRIAL (part 2)". johnthejack. July 5, 2017. Retrieved July 16, 2019.
  19. ↑ "THE SMILE TRIAL (part 3)". johnthejack. July 9, 2017. Retrieved July 16, 2019.
  20. ↑ Tuller, David (December 13, 2017). "Trial By Error: The SMILE Trial's Undisclosed Outcome-Swapping". Virology blog. Retrieved July 16, 2019.
  21. ↑ Tuller, David (January 30, 2018). "Trial By Error: A Letter to Archives of Disease in Childhood". Virology blog. Retrieved July 16, 2019.

cognitive behavioral therapy (CBT) - A type of psychotherapy geared toward modifying alleged unhealthy thinking, behaviors or illness beliefs. One of the treatment arms used in the controversial PACE trial.

See cognitive behavioral therapy.

randomized controlled trial (RCT) - A trial in which participants are randomly assigned to two groups, with one group receiving the treatment being studied and a control or comparison group receiving a sham treatment, placebo, or comparison treatment.

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