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".[1]

Research team[edit | edit source]

Protocol[edit | edit source]

The protocol of the trial was published in BMJ Open in July 2016.[3]

Feasibility study[edit | edit source]

MAGENTA feasibility study (an assessment of the feasibility and acceptability of a full trial)[4] ran from September 2015 to August 2016 with a planned sample size of 100. The results were expected to be published in 2017.[5][4] Dr. David Tuller wrote a Trial By Error piece So What’s Happening with the MAGENTA Trial?[4] Dr. Tuller noted the MAGENTA feasibility study was being folded into the larger sample.

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.[4]

The trial is expected to finish some time in 2019.[4]

Funding[edit | edit source]

The trial was funded in full by the National Institute for Health Research.[5]

Criticism[edit | edit source]

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.[6][7]
  • The feasibility for the trial is based on the PACE trial, the results of which are contested.[8]

There have been petitions to stop MAGENTA and other trials of GET until a safety review has been undertaken and the evidence reassessed.[9][10]

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.[11]

Research publications[edit | edit source]

  • Managed Activity Graded Exercise iN Teenagers and pre-Adolescents (MAGENTA) feasibility randomised controlled trial: study protocol[3] (Full text)

See also[edit | edit source]

References[edit | edit source]

  1. ↑ "MAGENTA: Managed Activity Graded Exercise in Teenagers and Pre-Adolescents". bristol.ac.uk. University of Bristol. Retrieved October 21, 2018.
  2. ↑ University of Bristol. "Meet the team | Centre for Academic Child Health". Retrieved October 21, 2018.
  3. ↑ 3.0 3.1 Brigden, Amberly; Beasant, Lucy; Hollingworth, William; Metcalfe, Chris; Gaunt, Daisy; Mills, Nicola; Jago, Russell; Crawley, Esther (July 4, 2016). "Managed Activity Graded Exercise iN Teenagers and pre-Adolescents (MAGENTA) feasibility randomised controlled trial: study protocol". BMJ open. 6 (7): 011255. doi:10.1136/bmjopen-2016-011255. ISSN 2044-6055. PMC 4947787. PMID 27377634.
  4. ↑ 4.0 4.1 4.2 4.3 4.4 Tuller, David (September 17, 2018). "Trial By Error: So What's Happening with the MAGENTA Trial?". Virology blog. Retrieved October 20, 2018.
  5. ↑ 5.0 5.1 Crawley, Esther (September 3, 2015). "The MAGENTA trial: can we investigate the effectiveness and cost effectiveness of managed activity compared to graded exercise in teenagers and pre-adolescents". isrctn.com. doi:10.1186/ISRCTN23962803. Retrieved October 20, 2018.
  6. ↑ WAMES - MAGENTA trial – PACE for children
  7. ↑ 23 Sep 2016, PLoS Blogs - "Before you enroll your child in the MAGENTA chronic fatigue syndrome study: Issues to be considered", James Coyne.
  8. ↑ StopGET (2016). "STOP GET: What is MAGENTA?". Retrieved November 1, 2016.
  9. ↑ "STOP GRADED EXERCISE THERAPY TRIALS FOR ME/CFS". #MEAction. Retrieved October 20, 2018.
  10. ↑ "Archived Petition: Suspend all trials of graded exercise therapy in children and adults with ME/CFS". Petitions - UK Government and Parliament. Retrieved October 20, 2018.
  11. ↑ Coyne, James (September 23, 2016). "Concerns about the MAGENTA chronic fatigue syndrome study | Mind the Brain". Mind the Brain. Retrieved October 20, 2018.

graded exercise therapy (GET) - A gradual increase in exercise or activity, according to a pre-defined plan. Focuses on overcoming the patient's alleged unhelpful illness beliefs that exertion can exacerbate symptoms, rather than on reversing physical deconditioning. Considered controversial, and possibly harmful, in the treatment or management of ME. One of the treatment arms of the controversial PACE trial.

See Graded exercise therapy.

The BMJ (previously the British Medical Journal) is a weekly peer-reviewed medical journal.

BMJ The BMJ (previously the British Medical Journal) is a weekly peer-reviewed medical journal.

Bias in research is "a systematic deviation of an observation from the true clinical state".[1] (Learn more: me-pedia.org)

bias Bias in research is "a systematic deviation of an observation from the true clinical state". (Learn more: me-pedia.org)

An outcome of a clinical trial that is independent of the judgement of opinion of the assessor/clinician, e.g. distance walked in 6 minutes. Patient-reported outcomes like questionnaires are not objectives.[2]

objective outcome An outcome of a clinical trial that is independent of the judgement of opinion of the assessor/clinician, e.g. distance walked in 6 minutes. Patient-reported outcomes like questionnaires are not objectives.

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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