1. Patients launch $1.27 million crowdfunding campaign for ME/CFS gut microbiome study.
    Check out the website, Facebook and Twitter. Join in donate and spread the word!
9th Invest in ME International ME Conference, 2014 - Part 2: Pathogens and the Gut
Mark Berry continues his series of articles on the 9th Invest in ME International ME Conference in London, with the emphasis shifting from autoimmunity to pathogens and the gut ...
Discuss the article on the Forums.

SMILE Trial protocol: Comparing Specialist Medical Care (SMC) with SMC plus Lightning Process (LP)

Discussion in 'Latest ME/CFS Research' started by Dolphin, Dec 30, 2013.

  1. Dolphin

    Dolphin Senior Member

    Messages:
    6,870
    Likes:
    6,161
    Fulltext available free at: http://www.trialsjournal.com/content/14/1/444/abstract

    *I gave each sentence its own paragraph
     
    Bob and Esther12 like this.
  2. Dolphin

    Dolphin Senior Member

    Messages:
    6,870
    Likes:
    6,161
    A lot of the points I'd make have been made in previous threads on this trial e.g.
    Here are two comments from reading the protocol:

    The abstract says:

    The full text says:

    ISRCTN Register says:
    So conflicting information there on the most important reason for releasing/publishing a trial protocol!
     
    Last edited: Dec 30, 2013
    Valentijn, Simon, Bob and 1 other person like this.
  3. Dolphin

    Dolphin Senior Member

    Messages:
    6,870
    Likes:
    6,161
    This is the only reference I saw talking about "possible side effects":

    http://www.trialsjournal.com/content/pdf/1745-6215-14-444.pdf

    A 30+ point deterioration is a huge deterioration.
    Requiring 20 participants have it is a high threshold. For example, with 50 patients, there will on average only have been 25 patients who had done LP.

    And in total they
    "aim to recruit 80 to 112 participants to the study."
    i.e. 40 to 56 participants, on average, for LP.

    By contrast, this is what they are using for improvements:
     
    Last edited: Dec 30, 2013
    Valentijn, biophile, Simon and 2 others like this.
  4. Esther12

    Esther12 Senior Member

    Messages:
    5,385
    Likes:
    5,893
    Thanks D.

    Anyone know who 'each panel' are?
     
  5. Dolphin

    Dolphin Senior Member

    Messages:
    6,870
    Likes:
    6,161
    I'm guessing it was panels for chronic lung disease, asthma, and heart disease
    I've now added in reference 23 to the extract above.
     
    Esther12 likes this.
  6. Dolphin

    Dolphin Senior Member

    Messages:
    6,870
    Likes:
    6,161
    (Minority interest)

    One of the reviewers, Per Fink, makes this suggestion:

    The authors replied:
     
  7. Dolphin

    Dolphin Senior Member

    Messages:
    6,870
    Likes:
    6,161
    Possibly of interest the authors don't think patients should have a diagnostic interview

    One of the reviewers, Per Fink (psychiatrist), makes this suggestion:

    The authors replied:

     
    Valentijn and Simon like this.
  8. Bob

    Bob

    Messages:
    8,866
    Likes:
    12,461
    South of England
    That's slightly more stringent than the PACE trial which required an SF-36 PF improvement of 8 points for a clinically useful improvement to be recorded.

    Edit: I've changed this post. I had misinterpreted their text earlier.
     
    Last edited: Dec 31, 2013
  9. Esther12

    Esther12 Senior Member

    Messages:
    5,385
    Likes:
    5,893
    Thanks D.

    I was just reading a commentary on that, which seemed relevant to a lot of discussion on PR, and perhaps particularly to @Simon

    eg:

    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1361157/

    The full paper for the study cited and being commented upon is here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1361158/

    I've not read that yet though.
     
    Snow Leopard, Simon and Dolphin like this.
  10. Esther12

    Esther12 Senior Member

    Messages:
    5,385
    Likes:
    5,893
    I just had a quick look at that paper, and thought: isn't this MID based on the assumption that response bias, etc has all been properly accounted for? In that case, it would mean it was inappropriate to use those panels as a justification for setting the MID in a non-blinded trial for a treatment intended to lead to patient thinking differently about their symptoms.
     
    Dolphin likes this.
  11. Simon

    Simon

    Messages:
    1,530
    Likes:
    4,901
    Monmouth, UK
    Yes, 30+ points is a huge deterioration, 3.5x what PACE called a clinically useful difference. We are talking relapses here, so effectively the authors are saying that:
    "Primary outcome data at six months will be examined once data are available from 50 patients, to ensure that neither arm is having a detrimental effect on the majority of patients" means that if less than half of patients relapse then there is nothing major to worry about. I wonder if that would be acceptable in a drug trials?

    My hear always sinks when someone flags a up a paper that looks both relevant and important: lot of reading needed. But thanks.
     
    Valentijn, Esther12 and Dolphin like this.
  12. Esther12

    Esther12 Senior Member

    Messages:
    5,385
    Likes:
    5,893
    Sorry Simon. The commentary which I thought would be of most interest to you was pretty short, and seems to just back up all the things you've been saying.

    Although there is stuff like this from the cited paper:

    re the LP paper and this claim:

    Actually, two of the three (COPD and asthma panels) panels decided 10 was a small clinically important difference, while the heart disease panel decided that 15 was a small CID. And none of them said that a change of just 10 would be important in a trial like SMILE, where there's such potential for bias to distort results - I think that this is important, as a smaller change could be assumed to be important if there was clear evidence that the change was a result of a real improvement in health rather than bias.

    Also, the cited paper could (if taken seriously) be seen as evidence that different conditions have different CIDs, and therefore that SMILE should not just use the asthma and COPD panel's consensus for CID for CFS patients.

    Really though, I thought the commentary did a good job of criticising this paper, and found it hard to take it that seriously.

    (I need to leave SMILE alone until I get some other things done!!)
     
    Last edited: Dec 30, 2013
    Simon, biophile and Dolphin like this.
  13. biophile

    biophile Places I'd rather be.

    Messages:
    1,407
    Likes:
    4,916
    Minor correction in red below:

    I would not trust these researchers with my child.
     
    Valentijn, Purple and alex3619 like this.
  14. Simon

    Simon

    Messages:
    1,530
    Likes:
    4,901
    Monmouth, UK
    I think this is important. I hadn't realised that NICE didn't require a psychiatric diagnostic interview (required by all research case definitions) and it's worrying that such interviews are not standard practice, particularly as the authors admit some psychiatric cases may be misdiagnosed as CFS as a result.

    As far as this trial of the Lightning Process goes it is worrying that the study may well include non-CFS psychiatric cases as they may respond well to such a technique, and so lead to misleading results for the trial.
     
    Last edited: Dec 31, 2013
    Valentijn and Dolphin like this.
  15. Snow Leopard

    Snow Leopard Senior Member

    Messages:
    2,417
    Likes:
    2,074
    Australia
    I'm not impressed with their protocol on the issues mentioned above...

    Several UK studies found that misdiagnosis was common in adults:

    http://www.ncbi.nlm.nih.gov/pubmed/22299071
    http://www.ncbi.nlm.nih.gov/pubmed/21132135

    Do you guys thing that psychological screening should be implemented into the NICE guidelines? Keeping in mind that some/many patients may dislike psychiatric screening if conducted by a psychiatrist.

    Regardless, it should be a part of this trial.
     
    Valentijn and Esther12 like this.
  16. Dolphin

    Dolphin Senior Member

    Messages:
    6,870
    Likes:
    6,161
    Yes, there are two questions: the research scenario and general clinical practice.

    It could be quite easy for plenty of people to be misdiagnosed and given one or more psychiatric diagnoses they don't have if it was the norm so I have some doubts although am undecided. In the Belgian clinics, which used Fukuda, there were huge variations in the rates of somatisation disorder diagnosed, with some clinics having rates in the low single figures while at least one had a rate around 90%! It is difficult to believe the patients were that different which suggests bias in terms of diagnosis.

    James C. Coyne has written about the problems of screening for distress with Cancer patients.

    Another problem with having default psychiatric diagnostic screening in ME/CFS clinics is that it means a psychiatrist will be involved in every clinic who might then have influence about the overall philosophy.

    So as I say, I'm undecided for general clinical practice. However, in the research scenario, precision is more important.
     
    Valentijn and Esther12 like this.
  17. Tom Kindlon

    Tom Kindlon Senior Member

    Messages:
    257
    Likes:
    797
    Valentijn likes this.
  18. Dolphin

    Dolphin Senior Member

    Messages:
    6,870
    Likes:
    6,161
    Includes 3 people with "CFS/ME" who got worse after LP

     
    Sean and Valentijn like this.

See more popular forum discussions.

Share This Page