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MAGENTA trial
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The '''MAGENTA trial''' (short for ''Managed Activity Graded Exercise in Teenagers and Pre-Adolescents'') was a trial investigating the effectiveness and value for money of [[graded exercise therapy]] (GET) in children compared to "activity management".<ref>{{Cite web|url=http://www.bristol.ac.uk/ccah/research/childdevelopmentdisability/chronic-fatigue/magenta-trial/ | title = MAGENTA: Managed Activity Graded Exercise in Teenagers and Pre-Adolescents |last = | first = | date = | website = bristol.ac.uk|publisher=University of Bristol|language=en-GB|archive-url=|archive-date=|url-status=|access-date=2018-10-21}}</ref> == Research team == * Dr. [[Esther Crawley]], Chief Investigator * [[Amberly Brigden]], Trial Manager * [[Lucy Beasant]], Research Associate<ref>{{Cite web|url=http://www.bristol.ac.uk/ccah/research/childdevelopmentdisability/chronic-fatigue/magenta-trial/people/ | title = Meet the team {{!}} Centre for Academic Child Health | website = |last = University of Bristol |language=en-GB|access-date=2018-10-21}}</ref> ==Protocol== The protocol of the trial was published in ''BMJ Open'' in July 2016.<ref name="magentaprotocol" /> == Feasibility study == MAGENTA feasibility study (an assessment of the feasibility and acceptability of a full trial)<ref name=":0" /> ran from September 2015 to August 2016 with a planned sample size of 100. The results were expected to be published in 2017.<ref name="magentaisrctn" /><ref name=":0" /> Dr. [[David Tuller]] wrote a [[Trial By Error]] piece ''So What’s Happening with the MAGENTA Trial?''<ref name=":0">{{Cite web|url=http://www.virology.ws/2018/09/17/trial-by-error-so-whats-happening-with-the-magenta-trial/ | title = Trial By Error: So What’s Happening with the MAGENTA Trial? | last = Tuller | first = David | date = Sep 17, 2018 | website = [[Virology blog]]|language=en-US|archive-url=|archive-date=|url-status=|access-date=2018-10-20}}</ref> Dr. Tuller noted the MAGENTA feasibility study was being folded into the larger sample.<blockquote>They were thus able to prioritize outcome measures based on actual data from the trial sample—an excellent way to bias the reported findings. In this case, the investigators designated physical function at six months as the primary outcome measure after almost half the full study sample had already provided data.<ref name=":0" /></blockquote>The trial is expected to finish some time in 2019.<ref name=":0" /> ==Funding== The trial was funded in full by the [[National Institute for Health Research]].<ref name="magentaisrctn" /> ==Criticism== The trial has been criticized on several points. *It makes no use of objective outcome measures, instead opting to interview children and parents "in order to judge how well the treatment is working". *It told potential participants that there were no risks in participating in the trial, although there is evidence that [[GET]] may cause harm to patients.<ref>[http://wames.org.uk/cms-english/2016/02/magenta-trial-pace-for-children/ WAMES - MAGENTA trial – PACE for children]</ref><ref>23 Sep 2016, [http://blogs.plos.org/mindthebrain/2016/09/23/before-you-enroll-your-child-in-the-magenta-chronic-fatigue-syndrome-study-issues-to-be-considered/ PLoS Blogs - "Before you enroll your child in the MAGENTA chronic fatigue syndrome study: Issues to be considered", James Coyne.]</ref> *The feasibility for the trial is based on the [[PACE trial]], the results of which are contested.<ref>{{Cite web|url=http://www.stopget.org/sign-now/background/what-is-magenta/ | title = STOP GET: What is MAGENTA?|last = StopGET|first = | date = 2016 | website = |archive-url=|archive-date=|url-status=|access-date=2016-11-01}}</ref> There have been petitions to stop MAGENTA and other trials of GET until a safety review has been undertaken and the evidence reassessed.<ref>{{Cite news | url=https://my.meaction.net/petitions/stop-graded-exercise-therapy-trials-for-me-cfs | title = STOP GRADED EXERCISE THERAPY TRIALS FOR ME/CFS|work=#MEAction|access-date=2018-10-20|language=en}}</ref><ref>{{Cite news | url=https://petition.parliament.uk/petitions/166601 | title = Archived Petition: Suspend all trials of graded exercise therapy in children and adults with ME/CFS|work=Petitions - UK Government and Parliament|access-date=2018-10-20|language=en-GB}}</ref> [[James Coyne]] has urged parents not to enroll their children in the trial. He has highlighted the lack of information given to patients about potential harm, the consent procedure and the lack of published data on previous studies.<ref>{{Cite news | url=http://blogs.plos.org/mindthebrain/2016/09/23/before-you-enroll-your-child-in-the-magenta-chronic-fatigue-syndrome-study-issues-to-be-considered/ | title = Concerns about the MAGENTA chronic fatigue syndrome study {{!}} Mind the Brain|last = Coyne | first = James | date = 2016-09-23|work=Mind the Brain|access-date=2018-10-20|archive-url=|archive-date=|url-status=|language=en-US | authorlink = James Coyne}} </ref> == Research publications == * Managed Activity Graded Exercise iN Teenagers and pre-Adolescents (MAGENTA) feasibility randomised controlled trial: study protocol<ref name="magentaprotocol" /> [[pubmed:27377634|(Full text)]] ==See also== * [[PACE trial]] * [[FITNET trial]] ==References== <references> <ref name="magentaprotocol">{{Cite journal | doi = 10.1136/bmjopen-2016-011255 | issn = 2044-6055 | volume = 6 | issue = 7 | pages = 011255 | last1 = Brigden | first1 = Amberly | authorlink = Amberly Brigden | last2 = Beasant | first2 = Lucy | author-link2 = Lucy Beasant | last3 = Hollingworth | first3 = William | authorlink3 = William Hollingworth | last4 = Metcalfe | first4 = Chris | authorlink4 = Chris Metcalfe | last5 = Gaunt | first5 = Daisy | authorlink5 = Daisy Gaunt | last6 = Mills | first6 = Nicola | authorlink6 = Nicola Mills | authorlink7 = Russ Jago | last7 = Jago | first7 = Russell | last8 = Crawley | first8 = Esther | authorlink8 = Esther Crawley | title = Managed Activity Graded Exercise iN Teenagers and pre-Adolescents (MAGENTA) feasibility randomised controlled trial: study protocol | journal = BMJ open | date = 2016-07-04 | pmid = 27377634 | pmc = 4947787 | url=https://bmjopen.bmj.com/content/6/7/e011255.info|via= }}</ref> <ref name="magentaisrctn">{{Cite web|url=http://www.isrctn.com/ISRCTN23962803 | title = The MAGENTA trial: can we investigate the effectiveness and cost effectiveness of managed activity compared to graded exercise in teenagers and pre-adolescents. | last = Crawley|first = Esther | authorlink = Esther Crawley | date = 2015-09-03 | website = isrctn.com|language=en|doi=10.1186/ISRCTN23962803|archive-url=|archive-date=|url-status=|access-date=2018-10-20}}</ref> </references> [[Category:Psychological paradigm]] [[Category:Notable studies]]
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