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Harms of outcome switching in reports of randomised trials: CONSORT perspective

Discussion in 'Other Health News and Research' started by Dolphin, Feb 15, 2017.

  1. Dolphin

    Dolphin Senior Member

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    Continues at: http://www.bmj.com/content/356/bmj.j396.short
     
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  2. Simon

    Simon

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    Monmouth, UK
    Doug Altman is a huge figure in the world of statistics, and one of the key players to raise doubts over the medical trials are reported.

    That's particularly true of PACE's recovery outcomes. Note they failed to report the predeclared recovery outcomes - let alone explaing differences - and they have now admitted their published findings were 'exploratory' ie after access to the data rather than the prespecified ones declared in the protocol.
    Can patients with chronic fatigue syndrome really recover after graded exercise or cognitive behavioural therapy? A critical commentary and preliminary re-analysis of the PACE trial
     
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  3. trishrhymes

    trishrhymes Senior Member

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    Do you know whether he has looked specifically at PACE - or is aware of it?
     
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  4. user9876

    user9876 Senior Member

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    Of course it wasn't just the recovery outcomes they switched it was their primary outcomes as well and the definition of harm. With PACE it was open label so even without seeing the data they would have a feel.
     
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  5. Barry53

    Barry53 Senior Member

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    Exactly. Huge concerns. The authors might claim it was done before any analysis, but I would love to see them in a court of law, and state under oath it was done without any prior knowledge of the data, nor strong inkling of where the results were headed. Given all the evidence of how dishonestly they try to defend their claims ... what chance is there, (I mean - really!) that the PACE authors' switched outcomes for any other reason than knowing the originals would prove their prejudices to be unfounded.
     
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  6. Sean

    Sean Senior Member

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    Yes, we have seen just how well their claims hold up in such a setting, which is not at all.

    Not that it stops them from subsequently repeating the same claims.
     
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