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Research bias in ME/CFS
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== Emphasis on randomized controlled trials and systematic reviews == Following an Evidence-Based Medicine (EBM) model gives greater weight to systematic reviews and randomized controlled trials.<ref name="Davenport2018">{{Cite journal | last = Davenport | first=Todd E | authorlink = Todd Davenport | last2 = Stevens | first2 = Staci R | authorlink2 = Staci Stevens | last3 = VanNess | first3 = J Mark | authorlink3 = Mark VanNess | last4 = Stevens | first4 = Jared | authorlink4 = Jared Stevens | last5 = Snell | first5 = Christopher R | authorlink5 = Christopher Snell| date = Jul 17, 2018| title = Checking our blind spots: current status of research evidence summaries in ME/CFS|url=http://bjsm.bmj.com/lookup/doi/10.1136/bjsports-2018-099553|journal=British Journal of Sports Medicine|language=en|volume=|issue=|pages=1-2|doi=10.1136/bjsports-2018-099553|issn=0306-3674|quote=|via=}}</ref> However, some systematic reviews and a number of randomized controlled trials have been shown to have significant flaws, including a failure to follow pre-defined procedures or standards, and [[outcome swapping|altering the primary outcome(s)]] part way through ''unblinded trials'' either without adequate justification or without a referring to the change, and failure to comply with prespecified trial plans, serious failings in [[Ethical issues|ethics]] including [[Esther_Crawley#Ethics_investigation|false ethical approval statements]] in the publication of more than a dozen research outputs about children with CFS, and research incompatible with child protection and safeguarding, e.g. in the [[SMILE trial]]. The most influential examples of these are the [[Cochrane]] review of exercise therapy for CFS, which Cochrane initially planned to withdraw after admitting it did not meet the set standards, and the [[PACE trial]], which is the largest treatment trial for CFS, and resulting in a lengthy legal battle for the release of the original primary outcome data including the results of the six-minute walk test. === PACE trial === Davenport et al. (2018) state the lack of [[randomized controlled trial]]s in [[ME/CFS]] research mean that an evidence-based model can be unduly influenced by a very small number of studies, for example the [[PACE trial]] found that treating ME/CFS with [[graded exercise therapy]] or [[cognitive behavioral therapy]] did not result in clinically significant improvements - but this trial heavily influenced the clinical use of those treatments.<ref name="Davenport2018" /> The PACE trial was so problematic that it was used an the example for Prof. [[Bruce Levin|Bruce Levin's]] presentation ''How Not To Conduct A Randomized Clinical Trial'', and [[The Lancet]] received [[Open letter to the Lancet|open letters]] signed by over 100 people, including researchers and academics, calling for the trial to be retracted. === Cochrane systematic review === The highly influential [[Cochrane|Cochrane review]] of [[Graded exercise therapy|exercise therapy]] for [[chronic fatigue syndrome]] was also found to have significant flaws. Cochrane announced it would be withdrawn, but when the authors refused to agree Cochrane then changed its position and published repeated amendments and editorial notes instead. Cochrane allocated to reviews about [[chronic fatigue syndrome]] to its ''Common Mental Disorders'' group, despite the long standing classification of CFS as a neurological disease by the [[World_Health_Organization#ICD10|World Health Organization]], and the absence of any psychological symptoms in any of the differing [[:Category:Definitions|diagnostic criteria]].<ref>{{Cite book | title = ICD-10 | last = World Health Organization | date = 2016}}</ref> Cochrane have withdrawn the individual patient data used in the exercise review.{{citation needed| date = Sep 2020}}
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