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SMILE trial
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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.<ref>{{Cite journal | last = Crawley | first = Esther | authorlink = Esther Crawley | last2 = Mills | first2 = Nicola | author-link2 = Nicola Mills | last3 = Beasant | first3 = Lucy | author-link3 = Lucy Beasant | last4 = Johnson | first4 = Debbie | authorlink4 = | last5 = Collin | first5 = Simon M. | authorlink5 = | last6 = Deans | first6 = Zuzana | last7 = White | first7 = Kate | last8 = Montgomery | first8 = Alan | date = 2013-12-05 | title = 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)|url=https://doi.org/10.1186/1745-6215-14-415|journal=Trials|volume=14|issue=1 | pages = 415|doi=10.1186/1745-6215-14-415|issn=1745-6215|pmc=4235039|pmid=24304689|quote=|via=}}</ref> 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.<ref>[http://www.bristol.ac.uk/media-library/sites/ccah/migrated/documents/protocol1.pdf SMILE Trial Protocol - Bristol University 2013]</ref> 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 == 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 exercise therapy |graded activity]] with phone calls and family-based rehabilitation consultations lasting an hour at six weeks, three months & 4.5 months. ==Outcome swapping == The primary outcome was initially to be based on school attendance.<ref>[http://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-14-415 Final Study Protocol - Crawley et al (Dec 2013)]</ref> 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,<ref name="HADS">{{Cite journal | last = Stern | first = Anna F. | date = 2014-07-01 | title = The Hospital Anxiety and Depression Scale|url=https://academic.oup.com/occmed/article/64/5/393/1436876|journal=Occupational Medicine|language=en|volume=64|issue=5|pages=393–394|doi=10.1093/occmed/kqu024|issn=0962-7480}}</ref>, and the [[Euroqol 5D|Euroqol]] (EQ-5D)<ref name="PainSociety2019">{{Cite journal | last = Dworkin | first =RH | last2 = Turk | first2 = DC | first3 = JT | last3 =Farrar | last4 = Haythornthwaite | first4 = JA| last5 = Jensen | first5 = MP | last6 = Katz | first6 = NP | last7 = Kerns | first7 = RD | last8 = Stucki | first8 = G | last9 = Allen | first9 = RR | last10 = Bellamy | first10 = N | last11 = Carr | first11 = DB| title = Core outcome measures for chronic pain clinical trials: IMMPACT recommendations|journal =PAIN| date = Jan 1, 2005|volume=113|issue=1 | pages = 9–19|url=https://www.britishpainsociety.org/static/uploads/resources/files/Outcome_Measures_January_2019.pdf}}</ref> a five-item quality of life inventory, plus school attendance. ==Funding== The initial budget was £164,000 funded by the Linbury Trust and the Ashden Trust.<ref>[http://www.meassociation.org.uk/2010/03/p164000-grant-for-study-into-the-lightning-process-and-children-with-me/ £164,000 grant for study into the Lightning Process and children with ME - ME Association (March 2010)]</ref> == Research ethics == 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."<ref>{{Cite web|url=https://www.meassociation.org.uk/study-involving-children-and-the-lightning-process-is-unethical-says-joint-charity-statement/ | title = The Lightning Process and SMILE trial is an “unethical” study involving children {{!}} 20 September 2010|language=en-US|access-date=2019-07-16}}</ref> [[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."<ref>[http://www.investinme.org/Article-501%20Childrens%20Study.htm Letter to National Research Ethics Committee - Invest in ME]</ref> 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.<ref>{{Cite web|url=https://meagenda.wordpress.com/2010/10/14/children-should-not-be-used-as-guinea-pigs-prof-robin-gill-church-times-lp-pilot-study/ | title = Children should not be used as guinea pigs: Prof Robin Gill, Church Times (LP pilot study) | last = meagenda | date = 2010-10-14 | website = ME agenda|language=en|access-date=2019-07-16}}</ref> ==Results== 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.<ref name=":1">{{Cite journal | last = Brown | first = Nick | authorlink = Nick Brown | author-link2 = | date = Jul 2019 | title = Editor's Note on Correction to Crawley et al 2018|url=https://adc.bmj.com/content/early/2019/07/11/archdischild-2017-313375ednote.full|journal=Archives of Disease in Childhood|volume=|issue=|pages=|quote=|via=}}</ref> 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.<ref name=":0">{{Cite journal | last = Crawley | first = Esther M | authorlink = Esther Crawley | last2 = Gaunt | first2 = Daisy M | authorlink2 = Daisy Gaunt | last3 = Garfield | first3 = Kirsty | author-link3 = Kirsty Garfield | last4 = Hollingworth | first4 = William | author-link4 = William Hollingworth| last5 = Sterne | first5 = Jonathan A C | authorlink5 = Jonathan Sterne | last6 = Beasant | first6 = Lucy | authorlink6 = Lucy Beasant | last7 = Collin | first7 = Simon M | authorlink7 = Simon Collin | last8 = Mills | first8 = Nicola | authorlink8 = Nicola Mills | last9 = Montgomery | first9 = Alan A | authorlink9 = Alan Montgomery | date = Feb 2018 | title = Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial|url=https://www.researchgate.net/publication/319961840_Clinical_and_cost-effectiveness_of_the_Lightning_Process_in_addition_to_specialist_medical_care_for_paediatric_chronic_fatigue_syndrome_Randomised_controlled_trial/link/59c3c21c458515af30661891/download|journal=Archives of Disease in Childhood|language=en|volume=103|issue=2|pages=155–164|doi=10.1136/archdischild-2017-313375|issn=0003-9888|pmc=5865512|pmid=28931531|quote=|via=}}</ref> There are some selective quotes in a 2015 paper<ref>[http://adc.bmj.com/content/100/12/1141.abstract 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]</ref> 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."<ref>[http://blogs.plos.org/mindthebrain/2016/09/23/before-you-enroll-your-child-in-the-magenta-chronic-fatigue-syndrome-study-issues-to-be-considered/ Before you enroll your child in the MAGENTA chronic fatigue syndrome study: Issues to be considered - James Coyne (September 2015) Plos Blog]</ref> To document the results from these threads, see [http://forums.phoenixrising.me/index.php?threads/got-me-just-smile-media-coverage-of-the-smile-trial….54503/page-19#post-909875 here,] [http://forums.phoenixrising.me/index.php?threads/embargo-broken-bristol-university-professor-to-discuss-trial-of-quack-cfs-tx.54441/page-17#post-909853 here], and [http://forums.phoenixrising.me/index.php?threads/me-cfs-cfs-me-on-bbc-today-programme-now-can-anyone-tune-in.54509/page-7#post-909874 here]. ==Criticisms== [[James Coyne]] has criticized Crawley's work with regard to public availability of data & the involvement of Phil Parker in the SMILE study.<ref>[https://jcoynester.wordpress.com/2016/06/04/why-patients-should-not-enroll-in-a-clinical-trial-of-video-gaming-treatment-for-chronic-fatigue-syndrome/ James Coyne's criticisms of the work of Esther Crawley]</ref> [[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'."<ref>[http://skepdic.com/lightningprocess.html Daniel Clark<nowiki>''</nowiki>s criticism on Skepdic website]</ref> The study only received final [[Ethical issues|ethical]] approval after prolonged protests from patient groups in January 2011.<ref>[http://www.meassociation.org.uk/2011/01/ethics-committee-finally-approves-controversial-pilot-into-lightning-process-and-children-with-mecfs/ Ethics Committee finally approves SMILE (January 2011)]</ref> Patient advocate [[John Peters]] has criticized the study.<ref>{{Cite web|url=https://johnthejack.com/2017/07/02/the-smile-trial-part-1/ | title = THE SMILE TRIAL (part 1)| date = 2017-07-02 | website = johnthejack|language=en|access-date=2019-07-16}}</ref><ref>{{Cite web|url=https://johnthejack.com/2017/07/05/smile-trial-part-2/ | title = THE SMILE TRIAL (part 2)| date = 2017-07-05 | website = johnthejack|language=en|access-date=2019-07-16}}</ref><ref>{{Cite web|url=https://johnthejack.com/2017/07/09/the-smile-trial-part-3/ | title = THE SMILE TRIAL (part 3)| date = 2017-07-09 | website = johnthejack|language=en|access-date=2019-07-16}}</ref> Dr [[David Tuller]] has severely criticised the SMILE trial.<ref>{{Cite web|url=http://www.virology.ws/2017/12/13/trial-by-error-the-smile-trials-undisclosed-outcomes/ | title = Trial By Error: The SMILE Trial’s Undisclosed Outcome-Swapping | last = Tuller | first = David | authorlink = David Tuller | date = Dec 13, 2017 | website = [[Virology blog]]|archive-url=|archive-date=|url-status=|access-date=2019-07-16}}</ref> 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 == [[File:LP-EstherCrawleyCorrection.jpg|alt=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)|right|thumb|Extracts from the editorial correction of the SMILE trial for ME/CFS by Esther Crawley et al (2018).]] An [[:Category:List of open letters|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.<ref>{{Cite web|url=http://www.virology.ws/2018/01/30/trial-by-error-a-letter-to-archives-of-disease-in-childhood/ | title = Trial By Error: A Letter to Archives of Disease in Childhood | last = Tuller | first = David | authorlink = David Tuller | date = Jan 30, 2018 | website = [[Virology blog]]|archive-url=|archive-date=|url-status=|access-date=2019-07-16}}</ref> <br /> 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.<ref name=":1" /> 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.<ref name=":1" /> == Notable publications == 2017, Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial<ref name=":0" /> [https://www.researchgate.net/publication/319961840_Clinical_and_cost-effectiveness_of_the_Lightning_Process_in_addition_to_specialist_medical_care_for_paediatric_chronic_fatigue_syndrome_Randomised_controlled_trial (Full text)] 2019, Editor's Note on Correction to Crawley et al. 2018<ref name=":1" /> [https://adc.bmj.com/content/early/2019/07/11/archdischild-2017-313375ednote.full (Full text)] ==Investigators== [[Esther Crawley]], [[Daisy Gaunt]], [[Kirsty Garfield]], [[Nicola Mills]], [[William Hollingworth|William Hollingworth]], [[Zuzana Deans]], [[Jonathan Sterne|Jonathan A Sterne]], [[Jenny Donovan|Jenny L Donovan]], [[Lucy Beasant]], [[Alan Montgomery]] and [[Simon Collin]]. ==See also== *[[Chalder fatigue scale]] *[[Esther Crawley]] *[[Lightning Process]] *[[Cognitive behavioral model]] *[[FITNET trial]] *[[MAGENTA trial]] *[[PACE trial]] *[[SF-36]] *[[Ethical issues]] *[[Pediatric myalgic encephalomyelitis/chronic fatigue syndrome]] == References == {{Reflist}} [[Category:Notable studies]] [[Category:Psychological paradigm]]
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