A general thread on the PACE trial!

Not sure if this was better as a separate thread or in here (where it's a bit buried), but due to a Twitter thread by @Adam pwme I came across, I decided on a whim to combine the video, blog and MRC screenshots in the thread with things from my own collection regarding Wessely's denial about involvement in the PACE trial in a document. As it's outside my regular research field, I though I'd post the result here. Maybe it's been done already (difficult to search), but it wouldn't hurt to have it in one place again.



“I’m not connected with this trial, I recruited some patients for it, but I was not part of it, I wish I had been.”
Simon Wessely, 4 May 2011.

https://twitter.com/user/status/1464211820621803520

Events - FST (foundation.org.uk)

​

“I was not on the ship, neither as passenger or crew. I helped recruit some patients to the study from our clinic, as did many doctors, but that was as far as it went.”
Simon Wessely, 15 November 2015

The PACE Trial for chronic fatigue syndrome (nationalelfservice.net) (blog by SW)



However:

• Wessely was an author of the PACE trial manual for CBT, dated 19 June 2002

• MRC grant application documents for the PACE trial, printed 3-7-2002(proposed starting date 1-4-2003) , page 10, mention Simon Wessely as a collaborator.

• The Trial identifier, part of the MRC Grant application documents printed on 3-7-2002, page 7/8, under the header "4.1 What are the arrangements for day to day management of the trial?" states: "[The trial co-ordinator] will liaise regularly with staff at the Clinical Trials Unit (CTU) who themselves will be primarily responsible for randomisation and database design and management (overseen by the centre statistician Dr Tony Johnson), directed by Professor Simon Wessely, in collaboration with Professor Janet Darbyshire at the MRC CTU."

• The Trial identifier, part of the MRC Grant application documents, printed on 3-7-2002 states on page 8, under the header "4.4 What will be the responsibilities of the named collaborators?": “Prof. Simon Wessely will oversee the CTU [=Clinical Trials Unit], with the support of Dr Tony Johnson and Prof. Janet Darbyshire."

• An advertisement for recruiting a Trial Manager for PACE, running 20-3-2004 (applications in by 6-4-2004) stated: "Other members of the team include Professor Simon Wessely. The Clinical Trials Unit at the Institute of Psychiatry will be leading on database management and analysis”. (Williams, 2004)

• The authors of the "Protocol of the PACE trial", published 8-3-2007, “thank Simon Wessely for advice about design and execution” and his name is also under “All center leaders and co-leaders”

• The PACE trial, published 18-2-2011, names Simon Wessely as a centre leader, and "We thank the participants who took part in the PACE trial, staff from all the centres .... specialist medical care doctors:.....Simon Wessely." And: "Simon Wessely commented on an early draft of the report."

There's probably more, I'm not specifically collecting on this, but now these are at least in one place for further use.




Edited to add some info from the PACE trial MRC grant application.
Edited to remove a double entry

 

Some exchanges on Twitter with SW from 2018 about his involvement in PACE for what they are worth…

If you click on the tweets you can go back to the start of the discussion and find other comments. Twitter jumbles up thread and replies so it’s not always easy to find all the comments but SW didn’t reply to my last tweet above.

 

Did this ever get satisfactorily responded to?

And what would be the reason why, by the time of publication, Sir Simon wouldn't have wanted to have been an author?

 

If it did, I’ve not seen it.

Good questions. In fact, I’m fairly sure SW asked this question himself somewhere in his defence – ie words to the effect of “I’m not publication shy. If I was an author why would I not have wanted my name on it?”

[Edit: I’ve deleted my wild speculations that I originally posted here as I don’t think they are helpful or accurate. Lucibee’s and Jonathan’s comments below are much more useful and informative.]

 

I'm sure I've commented on this somewhere before, but in case I haven't...

There are restrictions to being listed as an author in The Lancet. First, you have to have actually written part of the paper, or at least been involved in writing it (eg, review, editing). Writing the manual doesn't count. Second, whatever intentions were listed in the protocol, things can change. It's possible that he did step back from involvement at a later stage.
However, it is annoying that those things we identified (see @Robert 1973 's post) haven't been corrected, but not exactly surprising.

I don't think this means anything, other than they really don't give a stuff.

 

Thanks, Lucibee. I had intended to tag you because I remembered you commenting on this before.

 

There are lots of political reasons for not being an author. I have been in that position. If one has been involved in getting a project set up in some other capacity or is expecting to act as referee or things like that. It suggests some potential conflict of interest.

I have made decisions not to have my name on some ME research that I might have done because I was instrumental in an advisory capacity in getting the work set up.

 

Good morning!

Without clues I think it's useless to speculate .

What I find of main concern is that SW's claim of "not being part of it" and regularly posing as an independent party justified to give "outsider" comment on the PACE trial is utter baloney. He's been closely involved, so the whole wide-eyed "Gee whiz, I'll have to ask Mike" attitude on Twitter when confronted with his lie does not fly.
I just wanted to create a(nother) post putting this information together for easy rebuttal if he again pops up claiming independence.

I'm not much at home in this, but it looks like at some point some chairs were shuffeled, and Rebecca Walwyn took over as CTU head & author (but that's not something to forget if that was initially supposed to be your prominent position), but then he was still actively involved with the setup & design of the trial and part of it as center leader.


(I also edited the post yesterday to add another mention in the PACE trial MRC grant application)

 

James C.Coyne to Daniël Lakens on Twitter : "I volunteer to cover a topic that you won’t how the failure of the #PACE investigators to share the data for reanalysis hertz science and patients."

("hertz" = hurts I guess.)

 

I think Wessely tried to distance himself from the PACE trial when he understood that the data was showing CBT/GET did not work.

 

Can he be said to be meaningfully distancing himself from a project that he still endorses as high quality science and that he has cited as a good evidence base for service planning?

I suspect he did not seek authorship for pragmatic reasons, either because of potential conflicts in roles such as reviewing articles or in academic, grant awarding or NHS bodies. Perhaps it was part of his moving on up to positions above the nitty gritty of research, an éminence guise. I don’t know the normal pathways for medical researchers and clinicians to become life peers, but imagine being seen to rise above more mundane activities and conflicts may help.

However this speculation is without any evidence, and may in part say as much about us as about Wessely. All we can conclude is that his current narrative around his own role in PACE does not correspond with the historic record.

 

Haven’t watched myself but Julie is bright so imagine could be good:

PTOT4MECFS Jan 2021 Rethinking the PACE Trial with Julie Rehmeyer

45 views 8 Oct 2022
Science writer, Julie Rehmeyer discusses issues around infamous PACE Trial in relation to article, "Rethinking the treatment of chronic fatigue syndrome - a reanalysis of findings from a recent major trial of graded exercise and CBT" (Wilshire, Kindlon, Courtney, Matthees, Tuller, Geraghty & Levin, 2018). PT and OT implications discussed.

https://www.youtube.com/watch?v=RgatxMfqomM

 

A recent reference to the PACE trial in a study protocol (*) by one of the project teams of the large SOMA.CROSS research group at the UKE Hamburg:

"Integrated biopsychosocial research in patients with multiple sclerosis (MS) and poststroke found a fatigue-enhancing cycle of avoidance behaviour towards physical activity and depression,22 23 whereas cognitive behavioural therapy reduced fatigue in patients with MS,22 and graded exercise therapy moderately improved outcomes for patients with CFS.24

"The effectiveness of a home-based exercise programme to reduce refractory fatigue in patients with PBC is currently being studied.25 A recent systematic review on fatigue in RA stated that multivariate and longitudinal associations were too seldom assessed to draw firm conclusions on biopsychosocial pathways.26 The same appears true for fatigue in PBC."

(Bolding mine)

24 = The PACE trial

23 = Model of Understanding Fatigue After Stroke (2015), by Trudie Chalder, Malcolm Macleod et al


(*) Toussaint A, Buck L, Hartl J, et al, 2022,
Factors associated with severity and persistence of fatigue in patients with primary biliary cholangitis: study protocol of a prospective cohort study with a mixed-methods approach (SOMA.LIV)
BMJ Open 2022;12:e061419. doi: 10.1136/bmjopen-2022-061419
https://bmjopen.bmj.com/content/12/12/e061419


SOMA.LIV is part of the SOMACROSS research group -- thread here.

Also:

 

Should Authors Declare a Conflict of Interest If They Suffer From the Illness They Are Writing About?
Recalling the interference from the PACE trial investigators in the editorial decisions of the Journal of Health Psychology concerning the #PACEgate Special Issue
https://jimcoyneakacoyneoftherealm.substack.com/p/should-authors-declare-a-conflict

 

Oh, I hadn’t read it.

 

What a spiteful load of tittle-tattle. Stopped reading before I got half way.

 

This time I have read the blog post before posting here. It’s mainly a re blogging of an earlier (2017) blog that is no longer available at the original site and includes the comments underneath, many of which were from members of the ME community.​

https://jimcoyneakacoyneoftherealm.substack.com/p/should-the-bmj-have-silenced-authors

Should The BMJ Have Silenced Authors Who Were Abused by a Reviewer?
Recalling how The BMJ told patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and their allies not to share unfair and abusive reviews of their paper

 

you might want to do some screen shots etc of these.