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Why the PACE trial authors should publish the planned recovery analyses

The criteria for recovery used in the PACE trial are absurd, and this is why patients and others have requested from the study authors the trial’s recovery results according to the analyses specified in the study protocol, or data that would allow them to do the analyses themselves.

From the PACE data that have been published, such as the average physical function and fatigue scores in the CBT and GET groups, it appears likely that the percentage of patients who would be classed as recovered according to the original analyses would be in the low single figures — far less impressive than the reported analyses.

The study authors, represented by Professor Peter White, and supported by Queen Mary University of London, which is his administrative base, have failed to publish these results themselves. They have also rejected all requests for either the analysis results or for the raw data that would allow their calculation.

We believe that this is indefensible in a £5 million clinical trial funded by UK taxpayers’ money and is against the interests of patients, researchers and clinicians.

The real results of the trial should not be kept hidden.

We call upon the study authors to publish the recovery outcomes according to the analyses specified in the trial’s protocol and to publish the anonymised raw data to allow others to do so.

 

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