With all rights reserved for Keith Geraghty and his publication in the Journal of Health Psychology  (open-access) I want to reproduce his abstract relevant to the PACE trial commenting on the ups-and-downs of this study looking at the use of CBT (cognitive behaviour therapy) and GET (graded exercise therapy) for chronic fatigue syndrome (CFS) (also known as myalgic encephalomyelitis, ME):
"Science is not always plain sailing and sometimes the voyage is across an angry sea. A recent clinical trial of treatments for chronic fatigue syndrome (the PACE trial) has whipped up a storm of controversy. Patients claim the lead authors overstated the effectiveness of cognitive behavioural therapy and graded exercise therapy by lowering the thresholds they used to determine improvement. In this extraordinary case, patients discovered that the treatments tested had much lower efficacy after an information tribunal ordered the release of data from the PACE trial to a patient who had requested access using a freedom of information request."
For those familiar with PACE  and the 'angry sea' saga following its publication (see here for some of that saga), this paper represents one of the the first 'peer-reviewed' discussions that makes reference to the reanalysis of 'trial improvers' vs. that included in the original PACE trial publication (see here). Indeed, combined with other (as yet unpublished in the peer-reviewed domain) re-analyses (see here), there seem to be some pretty stark differences noted between the different 'versions' in terms of the effectiveness of different arms of the intervention tested during the PACE trial. Even before these latest re-analyses, some agencies were already adjusting the strength of their recommendations when it came to CBT and/or GET for CFS/ME (see here). Does this mean other organisations might follow suit?
The other issue central to the Geraghty discussions is that of 'enforced data release' and data transparency. This has been a focal point when it comes to PACE (including that with reference to other papers on the trial) and perhaps something that has significantly added to the sometimes bitter discussions about the trial. As Geraghty notes: "The PACE-Trial stands out as a showcase example of why data transparency is needed in contemporary science. Patients suffering from health conditions like CFS, and independent scientists, should have the right to see the evidence behind the claims of any scientific study, especially if this evidence is used to direct health policy or promote certain treatments – as was the case for the PACE-Trial." In light of how PACE has been contributory to public policy, and indeed was part funded by agencies such as "the UK Department for Work and Pensions", I don't think many people would argue against suitable data transparency in this case.
I say nothing more at this point in time but will no doubt be returning to this topic as the peer-reviewed literature allows (which should be quite soon). If there are however, some lessons that can already be learned from PACE-gate (e.g. stick to your "original protocol thresholds", make your data 'open-access' and think about how to do this in the planning/recruitment stages of your trial, be mindful that short-term gains don't necessarily translate into long-term ones, work with the ME/CFS community rather than labelling elements of them 'vexatious' or worse) one would hope that they would be applied to future research projects related to CFS/ME (see here) as well as their anticipated long-term follow-up ...
Music: The King and what wise men (might) say (easily recognisable to any Black Cats fan).
 Geraghty KJ. 'PACE-Gate': When clinical trial evidence meets open data access. J Health Psychol. 2016 Nov 1. pii: 1359105316675213.
 White PD. et al. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet. 2011 Mar 5;377(9768):823-36.
 Nijhof SL. et al. Internet-based therapy for adolescents with chronic fatigue syndrome: long-term follow-up. Pediatrics. 2013 Jun;131(6):e1788-95.
Geraghty KJ (2016). 'PACE-Gate': When clinical trial evidence meets open data access. Journal of health psychology PMID: 27807258
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