With the analysis of the data as per the protocol, I thought I'd look again at Professor Sir Simon Wessely's article from last November in Mental Elf, where he defended the trial, using the analogy of HMS PACE.
It was embarrassing enough then, it's even more so now......
Here are some snippets from it in case of interest:
http://www.nationalelfservice.net/o...choppy-seas-but-a-prosperous-voyage/#comments
The PACE Trial for chronic fatigue syndrome: choppy seas but a prosperous voyage
Professor Sir Simon Wessely 4th November 2015
"In this blog I will argue that HMS PACE did make it successfully across the Atlantic. Small corrections to the route taken were made on the way, but these were of little significance. The fundamental mechanics of the ship remained water tight and at no time were the ship or its passengers in peril until it safely docked exactly where it was supposed to."
"..... I am well informed about clinical trials in general, and about the issues that surround chronic fatigue syndrome in particular. I have previously made it clear that I think that PACE was a good trial; I once described it as a thing of beauty. In this blog I will describe why I still think that and I will try and avoid very technical issues, which have been addressed by the investigators on many occasions."
"It (PACE) has already been used as an example of how to conduct a large complex intervention, and has been cited 219 times in Scopus. But of course it has also been subjected to what in my experience is an unprecedented campaign of criticism, which sometimes has merged into something approaching vilification that goes well beyond a reasoned scientific critique."
"e. Changes to original protocol
The researchers changed the way they scored and analysed the primary outcomes from the original protocol.
The actual outcome measures did not change, but it is true that the investigators changed the way that fatigue was scored from one method to another (both methods have been described before and both are regularly used by other researchers) in order to provide a better measure of change (one method gives a maximum score of 11, the other 33). How the two primary outcomes (fatigue and physical function) were analysed was also changed from using a more complex measure, which combined two ways to measure improvement, to a simple comparison of mean (average) scores. This is a better way to see which treatment works best, and made the main findings easier to understand and interpret. This was all done before the investigators were aware of outcomes and before the statisticians started the analysis of outcomes. The changes were approved by the two independent oversight committees. The very detailed analysis plan, including these changes, was published, and these changes and the reasons for them were also described in the main paper."
"Conclusion
No trial is perfect. Nothing as complex as a multi-centre trial (there were six centres involved), that recruited 641 people, delivered thousands of hours of treatment, and managed to track nearly all of them a year later, can ever be without some faults. But this trial was a landmark in behavioural complex intervention studies. That is why it survived all the independent scrutiny as it progressed, survived the rigorous review processes of one of the world’s top medical journals, which rejects nearly all the papers it receives, and this is why it has already been cited in over 200 medical publications. But even then, one trial does not a summer make, and one needs to see it as part of the totality of similar trials before and since."
..................................
And now, in Juile Rehmeyer's excellent article
https://www.statnews.com/2016/09/21/chronic-fatigue-syndrome-pace-trial/ when asked about the re-analysis and the lack of recovery with CBT/GET, Professor Sir Simon Wessely, President of the Royal College of Psychiatrists, said:
“OK folks, nothing to see here, move along please.”
He still doesn't have the grace/sense/ integrity to concede how seriously flawed the trial was.
Self preservation, loyalty to his peers and the BSP ideology would seem to take absolute precedence over any notion of scientific integrity and certainly patient safety.
