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Investigating the effectiveness ... of FITNET-NHS compared to Activity Management to treat paediatric CFS/ME, 2018, Crawley et al. Protocol

Discussion in 'Psychosomatic research - ME/CFS and Long Covid' started by hixxy, Feb 24, 2018.

  1. obeat

    obeat Senior Member (Voting Rights)

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    It's still totally misleading information.
     
  2. MSEsperanza

    MSEsperanza Senior Member (Voting Rights)

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    I saw this only now.

    In addition to all already pointed to in the previous comments I found the part about "possible benefits and risks of participating" very strange.

    What are possible benefits and risks of participating?
    (And if FITNET-NHS is not effective?)

    Also the supposed risks seem to tell more about the study design, underlying hypotheses and diagnostic criteria than about risks for the particpants...
    (Edited to add first quote.)
     
    Last edited: Sep 3, 2019
    rvallee, Annamaria, MEMarge and 5 others like this.
  3. Sly Saint

    Sly Saint Senior Member (Voting Rights)

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  4. Barry

    Barry Senior Member (Voting Rights)

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    Really!
     
    Joh, Annamaria, NelliePledge and 2 others like this.
  5. Amw66

    Amw66 Senior Member (Voting Rights)

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    Yes - remember with paediatric CFS being able to go to school for an hour a day counts as being severely affected...... not a clue.....
     
    Joh, Annamaria, ladycatlover and 5 others like this.
  6. MSEsperanza

    MSEsperanza Senior Member (Voting Rights)

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    ...and still updating...

    Editorial Notes
    http://www.isrctn.com/ISRCTN18020851
     
    Last edited: Sep 3, 2019
  7. Trish

    Trish Moderator Staff Member

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    Interesting, so they have cut the number of participants to less than half, and extended by six months. They must be having a lot of trouble recruiting and/or retaining participants. I wonder if they have given back half the funding.
     
    Joh, Annamaria, Cheshire and 8 others like this.
  8. Amw66

    Amw66 Senior Member (Voting Rights)

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    The interventions have changed - to what end?
     
  9. Amw66

    Amw66 Senior Member (Voting Rights)

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    pilot rolled into full trial again?
    not enough coffee so could have picked this up wrongly.
     
    MSEsperanza likes this.
  10. MSEsperanza

    MSEsperanza Senior Member (Voting Rights)

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    Stop criteria
    published protocol, 22 Feb 2018, Trials volume 19, Article number: 136 (2018),
    https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2500-3
     
    Last edited: Sep 3, 2019
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  11. Amw66

    Amw66 Senior Member (Voting Rights)

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    In an asymmetric power relationship define " acceptable"
     
  12. Amw66

    Amw66 Senior Member (Voting Rights)

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    Given that recruitment seems to have fallen off a cliff compared to original protocol do we know when " pilot" became study and if the only way participant numbers stack up is via a rollover mechanism ?
     
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  13. Esther12

    Esther12 Senior Member (Voting Rights)

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    So they halved their target recruitment and gave themselves extra time in order to not be below target? [I've not checked those facts, just posting quickly off what was reported in this thread re recruitment]
     
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  14. MSEsperanza

    MSEsperanza Senior Member (Voting Rights)

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    It took me quite a while to find the location where all versions of the protocol are collected:

    https://www.journalslibrary.nihr.ac.uk/programmes/hta/14192109#/

    Edit: A summary of all changes to the protocol can be found here, pp. 36-42
    https://njl-admin.nihr.ac.uk/document/download/2029706


    Protocol version 06/2019
    https://njl-admin.nihr.ac.uk/document/download/2029706
    p. 19 f:

    4.8 RECRUITMENT RECOVERY PLAN – revised sample size (added May, 2019)
     
    Last edited: Sep 3, 2019
  15. MSEsperanza

    MSEsperanza Senior Member (Voting Rights)

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    Last edited: Sep 3, 2019
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  16. MSEsperanza

    MSEsperanza Senior Member (Voting Rights)

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    How about doing a trial on the effectiveness and cost-effectiveness of trials on the effectiveness and cost-effectiveness of interventions in ME?
     
  17. "This was higher than our original estimates as the rate of co-morbid mood disorders was 40%"

    It is perhaps worth considering that some of the questionnaires used to quantify mood disorders in both adult and paediatric populations might cause their prevalence to be overestimated in ME patient cohorts. For example, the paediatric RCADS scale includes at least five questions that will likely be scored highly by ME patients regardless of the status of their mood: q11 ("I have trouble sleeping"); q19 ("I have no energy for things"); q21 ("I am tired a lot"); q25 ("I cannot think clearly"), and, for those with orthostatic tachycardia, q24 ("When I have a problem, my heart beats really fast").

    Similar questions exist on the adult BDI-II: q15 (loss of energy); q16 (changes in sleeping pattern); q19 (concentration difficulty); q20 (tiredness or fatigue).
     
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  18. Amw66

    Amw66 Senior Member (Voting Rights)

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    So similar issues to HADS ?
    How is the RCADS scale scored ?
     
  19. Adrian

    Adrian Administrator Staff Member

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    I would have thought this was very dodgy. They should have done power calculations for the initial ethics approval to size the trial so cutting in half suggests that they either got these wrong or they are running a trial which may risk not having sufficient participants to give a meaningful result.
     
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  20. Sly Saint

    Sly Saint Senior Member (Voting Rights)

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    would love to see a break down of the costs to see how the money was spent.
     
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