Simon
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Hats' off to Ben Goldacre and co for COMPare: Tracking switched outcomes in clinical trials
The COMPare Project
Centre for Evidence-Based Medicine Outcomes Monitoring Project:
Tracking Switched Outcomes in Clinical Trials
Retraction watch blog about it here: Did a clinical trial proceed as planned? New project finds out
Do hope they will be looking at PACE, which changed both the primary outcomes, and the recovery definition, after the protocol was published. Simply publishing the primary and secondaary outcomes as specified in the protocol would be a big step forward in transparency.
The COMPare Project
Centre for Evidence-Based Medicine Outcomes Monitoring Project:
Tracking Switched Outcomes in Clinical Trials
Retraction watch blog about it here: Did a clinical trial proceed as planned? New project finds out
Ben Goldacre said:However, pre-specified outcomes are often left unreported, while novel outcomes that were not pre-specified are reported. This is an extremely common problem that distorts the evidence we use to make real-world clinical decision
...My personal view is that if a trial has misreported its outcomes, then the journal should simply issue a correction where the prespecified primary and secondary outcomes are reported.
Do hope they will be looking at PACE, which changed both the primary outcomes, and the recovery definition, after the protocol was published. Simply publishing the primary and secondaary outcomes as specified in the protocol would be a big step forward in transparency.
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