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When and how can endpoints be changed after initiation of a RCT?

Discussion in 'Other Health News and Research' started by Dolphin, Jun 5, 2011.

  1. Dolphin

    Dolphin Senior Member

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    "Endpoints" doesn't simply mean timing but also (and more usually) the outcome measures that are used.

    This is probably going to be of minority appeal - if you're interested in, for example, the fact that the PACE Trial authors changed how they said they'd analyse the data, you may find this of interest.

     
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  2. Dolphin

    Dolphin Senior Member

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    Just bits I underlined for myself in case anyone is interested:

     
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  3. Dolphin

    Dolphin Senior Member

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    I have copied a lot of the sections/paragraphs from the original article but not all.

     
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  4. Dolphin

    Dolphin Senior Member

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    Relevance to PACE Trial protocol changes

    It doesn't look to me like there were particular changes in knowledge about ME/CFS that would generally have justified the changes the authors made between the (published) PACE Trial protocol and the final paper.
     
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  5. Sean

    Sean Senior Member

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    Thanks for this.
     
  6. CBS

    CBS Senior Member

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    I concur. Thank you.
     
  7. oceanblue

    oceanblue Senior Member

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    I haven't read the paper, only what was posted here but I have a few questions and comments based on this:

    Do the change in endpoints in the paper refer to changing the outcomes measured, or the way that outcome is reported? PACE continued to use SF36 and CFQ as primary outcomes but changed from categorical to continous reporting.

    The changes were approved by the Trial Steering committee who would not have had seen any interim data and are independent of the trial investigators (that's the point of it) so would meet the criteria for appropriate people to approve the change, which they did. But:
    Agreed, so I don't know why the trial committee did agree to the changes. I'd love to see the documentation for the meeting where these changes were agreed.

    The authors seemed to have done all of this apart from point 3. Point 1 is flaky - they cited a paper on assesssing trial stats that was published after their protocol, but I'm not sure this paper actually said anything that hadn't been in the literature available when they wrote the protocol. They didn't address the issues very well but they did address them in the paper. I think they have, as usual, been very slippery here - they haven't done everything right but they've done enough right to get away with it (while completely breaching the spirit of such guidelines).
     
  8. Dolphin

    Dolphin Senior Member

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    No, as I recall, it doesn't make any point on such an issue. To me, that's still a change and I don't recall reading anything that said otherwise.
    The piece is only 3 pages and there are no numbers so other people could read the full piece if they preferred.

    Two specific points: they also went from bimodal scoring to Likert scoring with one of the primary measures so not quite simply a change from categorical to continuous scoring.

    Also, one of the secondary outcome measures was:
    so it could be called substituting a primary outcome measure with a secondary outcome measure. Put another way, the data that was presented as a primary outcome measure for fatigue could still have been presented if they stuck to published protocol.[/QUOTE]

    If you mean by "independent of the trial investigators" that it did not include the trial investigators, that is not correct, although it is easy to miss it on the PACE Protocol website:
    Trial Steering Committee (TSC)

    I also have minutes from meetings where the three investigators were at them (and not listed as observers).

    Indeed at the end, the one I'm looking at has at the end
    so the PIs look like they were writing up the minutes.

    No, the authors didn't do all of them apart from (3).

    One of the aims of the trial was to assess safety. They didn't report the outcome measures they said they would there or mention they had changed them.

    There was at least one other change I can recall (apart from outcome measures they didn't give):
    They didn't give us Likert scores for the total symptoms or the two symptoms they listed; they just gave presence/absence.

    Also, with regard to the primary outcome measures, as well as giving continuous scoring, they could still have given the score for improvement (see third section):
    We are instead given figures for improvement which is defined in a different way

    which when reported in the results sounds like improvement scores (I'm not saying people would think it was the same as the protocol, but the wording is similar)
     
  9. Esther12

    Esther12 Senior Member

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    I've only just read this, but think it's worth bumping with a 'thanks'.
     

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