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G73(P) The MAGENTA protocol: The feasibility and acceptability of conducting a trial investigating t

Discussion in 'Latest ME/CFS Research' started by JaimeS, May 31, 2016.

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  1. JaimeS

    JaimeS Senior Member

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    Full title:
    G73(P) The MAGENTA protocol: The feasibility and acceptability of conducting a trial investigating the effectiveness and cost effectiveness of graded exercise therapy compared to activity management for paediatric CFS/ME – a feasibility randomised controlled trial

    By -- you guessed it:
    1. AB Brigden1,
    2. LB Beasant1,
    3. WH Hollingworth1,
    4. CM Metcalfe1,
    5. DG Gaunt1,
    6. NM Mills1,
    7. RJ Jago2,
    8. EC Crawley1
    Abstract:



    Introduction Paediatric chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) is a relatively common and disabling yet there is a limited evidence base for treatment. There is good evidence that Graded Exercise Therapy (GET) is moderately effective in adults with CFS/ME but there is no evidence for the effectiveness, cost effectiveness, acceptability or best method of delivery for paediatric CFS/ME.

    This study aims to investigate the acceptability and feasibility of a carrying out a multi-centre randomised control trial (RCT) investigating the effectiveness of GET compared with activity management for mildly and moderately affected children.

    Methods and analysis 100 paediatric patients (8–17 years) with CFS/ ME will be recruited from three UK specialist NHS CFS/ME services (Bath, Cambridge and Newcastle). Patients will be randomised (1:1) to receive either Graded exercise Therapy (GET) or Activity Management (AM). Feasibility analysis will include: the number of young person’s eligible, approached and consented to the trial; attrition rate and treatment compliance; questionnaire and accelerometer completion rates. Integrated qualitative methods will ascertain perceptions of feasibility and acceptability of recruitment, randomisation and the intervention. All Adverse events (SAE/AEs) will be monitored to assess the safety of the trial.

    Ethics and dissemination The trial has received ethical approval from the National Research Ethics Service Committee NRES Committee South West – Frenchay (15/SW/0124).

    ________________________________________________

    "Patients will be randomised (1:1) to receive either Graded exercise Therapy (GET) or Activity Management (AM)."

    Activity, or else activity. Is the latter self-paced activity?

    It's hard for me to believe someone else hasn't pounced on this article, so if this is cross-posted let me know and I will delete the thread.


    -J
     
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  2. Denise

    Denise Senior Member

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  3. A.B.

    A.B. Senior Member

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    Hopefully that won't be dropped halfway through the trial like in PACE.

    They probably mean the activity management described here:

    http://www.ayme.org.uk/activity-mgt

    Which involves keeping a diary of activities and making small increases. It's a form of self management.

    It does sound like a lot of effort though. I do very poorly on tasks that require so much consistency.
     
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  4. JaimeS

    JaimeS Senior Member

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    I'll link to it there. I think it discusses the "first arm" of that trial:

    "we will move on to a full study and find out whether GET is effective and cost effective."

    Now we're here.
     
  5. Denise

    Denise Senior Member

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    @JaimeS - Can you add the link where you found this?

    Edit to clarify - It looks as though this may be the link .
    The trial registration # for the abstract is the same as
    ISRCTN23962803


    The MAGENTA trial: can we investigate the effectiveness and cost effectiveness of managed activity compared to graded exercise in teenagers and pre-adolescents.
     
    Last edited: May 31, 2016
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  6. Denise

    Denise Senior Member

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    The peer-review history for this trial.
     
  7. Cheshire

    Cheshire Senior Member

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    From the peer-review paper:
    upload_2016-7-6_19-8-27.png

    Crawley has to be taught what aerobic exercise is by her reviewer.
    That woman is writing a protocol for an exercise therapy trial.
    Everything is just perfectly normal and FINE.
     
    Last edited: Jul 6, 2016
  8. A.B.

    A.B. Senior Member

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    @Cheshire strangely the protocol seemed to be most vague when it came to GET.
     
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  9. A.B.

    A.B. Senior Member

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    I also find it funny that they originally tried to portrait reliance on self reported outcomes as strength. A reviewer took issue with this... but now self reported outcomes are listed in the "Strengths and limitations" box in an ambiguous way so that it is not clear whether this is a stregnth or a limitation. They sure love vagueness.
     
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  10. Scarecrow

    Scarecrow Revolting Peasant

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    ......well that's what the other reviewer thought!!
    Lucy Clark, QMUL, one of the GETSET investigators. NICE.
     
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  11. Yogi

    Yogi Senior Member

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    The faces behind the names and both are exercise physios rather than medical doctors- UNETHICAL
    [​IMG]

    Exercise physiologist
    http://www.wolfson.qmul.ac.uk/a-z-staff-profiles/lucy-clark

    Suzanne Broadbent
    https://works.bepress.com/suzanne_broadbent/
    http://www.jacobspublishers.com/index.php/journal-of-sports-medicine-editorial-board
    Journal of *** SPORTS*** Medicine Editorial Board
    [​IMG]
     
    Last edited: Jul 6, 2016
  12. JaimeS

    JaimeS Senior Member

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    I like that the reviewer strongly advises them to use the NICE guidelines rather than PACE's data, and the authors defensively reply that PACE data is the biggest trial ever and awesome and very sound and they WILL use its findings thank you much. ;)

    Where on earth did you GET this?
     
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  13. Denise

    Denise Senior Member

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    Not referring to G(raded) E(xercise) T(herapy) ;)
    PEER REVIEW HISTORY
    On the article page,
    under the tab (to the right of the text) labeled This Article,
    option Review History
     
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  14. Dolphin

    Dolphin Senior Member

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    Background information on the reviewer Lucy Clark:


    Lucy Clark was previously Lucy Darbishire. Some people might recognise that name from earlier studies.


    Http://www.wolfson.qmul.ac.uk/a-z-staff-profiles/lucy-clark#publications



     
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  15. Denise

    Denise Senior Member

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    Thanks @Dolphin.
    I had not made the connection that Lucy Clark was previously Lucy Darbishire. This is good to know.
     
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  16. Kina

    Kina

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