David Tuller: Trial By Error: Cochrane Withdraws Flawed Exercise Review

Cochrane Withdraws Flawed Exercise Review

Cochrane has decided to withdraw, at least for now, its fatally flawed review of exercise treatments for ME/CFS—or CFS, as the review calls the illness. This review, which reported that graded exercise therapy was an effective treatment, was first published in 2014 and republished last year. The more recent version included extensive exchanges between two very smart patient-advocates—Tom Kindlon and the late Robert Courtney—and Lillebeth Larun, the lead author. The Kindlon and Courtney arguments were cogent, persuasive and unassailable. Larun’s responses were not.

 

Re PACE:
"Larun’s position is unsustainable. Clinical trial investigators write protocols so that everyone understands what the goal-posts are.

No matter what Larun and the PACE authors might argue, “pre-specified” does not mean “specified post-data-collection-but-pre-data-viewing”—and that’s per Cochrane’s own risk-of-bias guidelines, which Larun apparently decided she could ignore.

Moreover, PACE was an open-label trial relying on subjective outcomes. In such cases, investigators are likely to know the outcome trends long before they look at any actual data. In this context, to define the reported PACE outcome measures as “pre-specified” is ridiculous."

Unpublished second review:

"The Common Mental Disorders group has written a second exercise systematic review, using individual participant data from the various trials rather than just the published results.

This IPD review was reportedly supposed to have been published last year, but it remains unpublished. It was known that Cochrane—to its credit—sent it out for peer review to people beyond the usual orbit. These further peer reviews were said to have been scathing. This would not be a surprise to anyone outside the biopsychosocial bubble-think."

Cochrane challenge:

"In other words, international support for the CBT/GET paradigm is crumbling. Yet members of the Common Mental Disorders group still champion these treatments, basing their arguments on deficient research.

This presents a challenge for Cochrane. The challenge involves not just what to do with the unpublished IPD review but how to handle the published reviews as well. These reviews, and in particular the exercise review, continue to exert a harmful impact on patient treatment options, as I noted in a recent post about the Mayo Clinic. That will continue as long as CBT/GET promoters can hide behind Cochrane’s skirts."

 

Thank you, @dave30th - clear summary of a sorry situation.