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PACE-gate ……. More wrongdoings? – PARTICIPANT NUMBERS seemingly just DON’T ADD UP

Discussion in 'General ME/CFS News' started by lilpink, Jul 27, 2017.

  1. lilpink

    lilpink Senior Member

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    So where DID the PACE investigators find all 641 patients willing to take part in the PACE trial? Key to this is - How many came from each participating clinic/centre?


    The PACE Trial paper in the Lancet http://www.thelancet.com/action/showFullTextImages?pii=S0140-6736(11)60096-2 shows in Figure 1 (explanatory notes beneath) that the maximum number of patients that took part from any Trial centre was 135, the minimum 63. (You have to ask yourself though- why didn’t they reveal how many from each centre?)

    From online sources – The Edinburgh cohort was about 100 – http://www.meassociation.org.uk/201...he-body-edinburgh-evening-news-15-april-2011/

    The Frenchay cohort was around 70 patients - https://www.nbt.nhs.uk/news-media/l...gest-research-trial-treatment-chronic-fatigue


    Neither of these were 135 or 63. So now we know the numbers from 4 centres. Assuming that the online reports are reasonably accurate, let’s add up these 4 centres – 135 + 63 + 70 + 100 = 368. That leaves 273 patients from the remaining 2 centres. But 273 divided by 2 is 136.5 - this exceeds the maximum number from any centre – an impossibility.

    A little suspicious don’t you think? ….. but not absolute proof. So the next logical step is to make a FOI request to QMUL for the numbers from each centre. Their response, as I understand it, was refusal on the grounds that releasing the figures could breach the first data protection rule by increasing the chances that a patient could be identified. Well they’re certainly playing true to form! Next step was to ask for a review of their decision, the outcome of which was no response at all. Is that the best they can do? This case is now with the ICO……. so we’ll have to wait to see what they decide.

    Naturally, I’m sure that if fictitious or unconsented existing patient data was to be added to a Trial of this sort then it’s very unlikely that many people would be told about it, the least possible I would imagine, so one might ponder that the staff in the individual participating centres very likely wouldn’t be aware that this was going on. To this end, FOI requests have been made by different parties to each of the participating centres (i.e. the Trusts involved) for their participant numbers and these responses also strongly suggest that the figures do not add up. These figures will be released in due course when the numbers from all of the participating centres have been obtained. Notably, obtaining some of these numbers was not that easy but all centres apart from King’s (quelle surprise) have now returned numbers. (Strange that - surely these other centres must all therefore have breached the first rule of data protection…..duh?) The King’s centre participant number is still outstanding with some quite bizarre responses along the route; this may well necessitate a separate complaint to the ICO. NB The total doesn’t come anywhere close to 641 when the ‘maximum’ number of 135 is added to the numbers that have been returned from the five centres. Not looking good….. :eek:


    Sometimes the simplest things…..
     
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  2. dangermouse

    dangermouse Senior Member

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    Watch this space....interesting.
     
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  3. Jo Best

    Jo Best Senior Member

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    My first thought was, but didn't they expand the pool of potential participants by asking GPs to refer any patients with complaints of fatigue, and then I thought, even so, that would have been referral to one of the participating centres?
     
  4. lilpink

    lilpink Senior Member

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    The information required by FOI was the number who "actually took part in the PACE Trial which reported in the Lancet in March 2011, i.e those patients who were randomly allocated to treatment groups for the Trial and were therefore part of the published PACE Trial research data" for each centre.
    Thus it was that final number, whose data was reported in the various published papers that mattered, & subsequent to the shenanigans wrt how the cohorts were recruited. Of course if this data illustrates a shortfall that can't be accounted for, then questions about recruitment might well ensue.
     
  5. Stewart

    Stewart Senior Member

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    @lilpink

    Not sure if it's you or someone else who has put on their deerstalker and taken up their magnifying glass to get to the bottom of this - but it would be worth paying particular attention to the figures obtained from St Barts.

    I seem to remember that for the first 14 or 15 months that PACE was recruiting patients there were two trial centres based at St Bartholomew's, but they merged in mid-2006. It might be worth getting confirmation that the figure you - or whoever it is - has been given by St Bartholomew's includes all the patients seen by both clinics between March 2005 and June 2006.
     
  6. lilpink

    lilpink Senior Member

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    Yes that's a very good point (redacted)

    EDIT: Some information from this post has been deleted.
     
    Last edited: Jul 28, 2017
  7. JoanDublin

    JoanDublin Senior Member

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    @lilpink A very interesting thread. Your sleuthing definitely raised some interesting questions which I believe should be addressed. As I understand from your post it seems pretty clear already that with all numbers now in, with one notable exception, even adding the 'max' number of 135 to that sub-total doesn't make 641? Is that correct?

    If so, questions need to be asked now. I would say there is no need to wait for the final return of numbers based on what information is already out there in the public domain. Have you brought this to the attention of David Tuller?
     
  8. lilpink

    lilpink Senior Member

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    That does seem to be the case. David Tuller is aware of this.
     
  9. snowathlete

    snowathlete

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    I imagine the numbers will add up, somehow. But you never know and it ought to be very straightforward to verify already, this is simple data which should already be available for anyone to simply add up and understand the breakdown of the clinics involved in the trial. I think the fact it is so difficult to verify such a basic issue shows there is a problem with a lack of transparency in this trial, and you have to question why the attitude is to hide as much data as you possibly can even when it's totally reasonable and presumably innocuous information the public want to see.
     
  10. MEMum

    MEMum Senior Member

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    Excellent!

    I would now like to have a picture of a James Bond baddie stroking a large furry cat. Maybe @slysaint could oblige...
     
  11. RogerBlack

    RogerBlack Senior Member

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    As the furry cat, or as the villain?
     
  12. lilpink

    lilpink Senior Member

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    Mmmmmm ..maybe..in a world where 2 + 2 = 5 :thumbdown: It is possible the Trusts have made grave errors or lied about the numbers given in response to a FOIA request, which would be concerning in itself.
     
  13. Barry53

    Barry53 Senior Member

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    I thought they did somewhere, but cannot check until this evening.
     
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  14. lilpink

    lilpink Senior Member

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    I'd be curious for your input.
     
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  15. Barry53

    Barry53 Senior Member

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    I thought I saw a table or something in one of the papers that showed the participant numbers from each centre, but I may be remembering wrong. Will try and check when I get home this evening.
     
  16. snowathlete

    snowathlete

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    The way I look at it, it's far more likely that the trusts have got it wrong; they're being asked to provide figures from years ago about a study that is not that important to then. The people retrieving that data may have not even been around when the trial occurred, or there may just be human error. Errors are very plausible, and if there are errors questions will need to be asked to get that cleared up so we get the correct figures.

    It is much more unlikely that the PACE investigators made up trial participants - such an action in any trial would very plainly be research misconduct and if you were to commit research misconduct like that it would logically follow that you would have no qualms about inventing results for such made up participants that are more impressive than the ones they actually published. I mean, the figures showed a null result it was so unimpressive. The trial results showed the treatments were a massive fail, and it was so bad that had they not massively deviated from their published criteria for improvers and recoverers the study would have reported the treatments didn't work, or perhaps wouldn't have even made it a journal at all.

    So the figures don't suggest fictitious trial participants, leading to my conclusion that it is far more likely the FOI figures are incorrect, or something else is wrong in that area. But as I said, important and valid to check these things.
     
  17. slysaint

    slysaint Senior Member

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    take your pick:
    upload_2017-7-27_13-26-14.png
    upload_2017-7-27_13-27-3.png
    upload_2017-7-27_13-30-30.jpeg
    :devil::cat:
     
  18. kirstenthomson2000

    kirstenthomson2000 K

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    Hi, might have found the table you are meaning with the number of trial participants to centres. If you click the link ( http://www.sciencedirect.com/science/article/pii/S0022399914001883 ) then go to the top of Table B. It's from the adverse events paper. If you add up the participants experiencing less than 4 and more than 4 adverse events then that should give you how many participants were at each centre. Kx
     

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  19. Malcx

    Malcx

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    From the Frenchay news link
    >> Around 70 patients

    This could have been 74 rounded to the nearest 10 for the sake of reporting.

    This gives us:
    135 + 63 + 74 + 100 = 372
    => 269/2 = 134.5 i.e. less than the stated max of 135.

    Similar rounding errors could be in the Edinburgh report, so although a little suspicious I don't think this a smoking gun per se. It's more likely just ascribing actual numbers to fuzzy "around" numbers.
     
  20. lilpink

    lilpink Senior Member

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    Kind of the object of the exercise ;)
     
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