PACE Trial and PACE Trial Protocol

[urbantravels]

Doesn't seem to fit the first requirement though:

"1. The study presents the results of primary scientific research."

Or a systematic review. But that definition appears to apply to a review of multiple papers in an area, not a critique of one paper:

Systematic reviews are considered for publication in PLoS ONE but are limited to areas where appropriate standards for conduct and reporting apply and where the methods ensure the utmost rigor in the comprehensive and unbiased sampling of existing literature. A systematic review differs substantially from a narrative-based review or synthesis article and has its roots in the medical sciences (but is beginning to be applied to other disciplines such as environmental sciences). As defined by the Cochrane Centre, it is a review of a clearly formulated question that uses systematic and explicit methods to identify, select, and critically appraise relevant research, and to collect and analyze data from the studies that are included in the review. Statistical methods (meta-analysis) may or may not be used to analyze and summarize the results of the included studies. Please also see our reporting guidelines for such articles.

The other type of thing they publish:

Commissioned reviews, synthesis and commentary articles are considered but only where they form part of an agreed collection.

seems to be editorially driven - but that doesn't mean someone couldn't propose that they do such a collection on the subject of ME/CFS research.

All easy for me to say - all I ever do is sit around and tweet and blog once in a great while - but I do think that multiple avenues of publication should be considered, and PLoS One has the stated editorial goals of providing open access in an accelerated matter, and letting the "marketplace" of ideas decide which articles and papers are significant. I'd bet they're pretty happy with the response that the Fluge/Mella paper has generated.

 

[biophile]

I think someone mentioned earlier on this thread that the timing of publication suggests the PACE paper could have first been rejected by another journal before being submitted for fast tracked publication in the Lancet. Any further information on that? As we saw, fast track publication can lead to sloppy errors, regardless of Horton's claim about the paper having gone through "endless rounds of peer review". The hypothetical rejection could also suggest PACE weren't willing to compromise in order to make it acceptable.

 

[Dolphin]

I think someone mentioned earlier on this thread that the timing of publication suggests the PACE paper could have first been rejected by another journal before being submitted for fast tracked publication in the Lancet. Any further information on that? As we saw, fast track publication can lead to sloppy errors, regardless of Horton's claim about the paper having gone through "endless rounds of peer review". The hypothetical rejection could also suggest PACE weren't willing to compromise in order to make it acceptable.

Yes, it seems quite possible given the various talks on the PACE Trial Peter White had lined up from (from memory) October 2010 that never happened because paper wasn't published. Indeed I think it wasn't submitted till Dec 2010 or Jan 2011.

I remember reading once it being suggested that authors should declare if they have submitted a paper elsewhere and it wasn't published. Indeed, it may have said something about showing the reviews to the new journal. However, I don't recall often seeing this being suggested. Maybe other people know more?

 

[Dolphin]

Doesn't it cost a bit of money to publish in PLoS One? e.g. for some reason $1500 is in my head (or at least the figure of 1500 in some currency) but I've little confidence in the figure - and perhaps it depends on the length?

 

[Snow Leopard]

http://www.plos.org/publish/pricing-policy/publication-fees/
They've fixed the price at $1350US since 2009.

 

[oceanblue]

I think someone mentioned earlier on this thread that the timing of publication suggests the PACE paper could have first been rejected by another journal before being submitted for fast tracked publication in the Lancet. Any further information on that? As we saw, fast track publication can lead to sloppy errors, regardless of Horton's claim about the paper having gone through "endless rounds of peer review". The hypothetical rejection could also suggest PACE weren't willing to compromise in order to make it acceptable.

It could also be that PACE withdrew the paper, rather than it being formally rejected. But it's nice to think that some reviewer may have pulled them up on some of the dodgy methodology. Post-hoc analysis, in particular, is generally viewed with huge suspicion by scientists and that could well have been a red line for reviewers, especially as it effectively replaced the protocol recovery measure (which was never dropped from the protocol).

As for timing, Peter White took around 6 months off from clinical practice to work on PACE, roughly March-Sep. I think the data was formally 'unblinded' in Spring (possibly early summer). And I'm pretty sure that at some stage in 2010 at least someon in the PACE gang said they would be submitting by the autumn. All of which makes it rather unlikely the paper wasn't ready for submission til late December 2010/early Jan 2011.

I guess the BMJ would have been another strong candidate journal for them - maybe they tried there first?

I would so love to get to the bottom of this.

 

[Esther12]

I guess the BMJ would have been another strong candidate journal for them - maybe they tried there first?

The BMJ said:

Patients with chronic fatigue syndrome have nothing to fear from CBT or graded exercise, say the authors. Both work as a bolt on to specialist care, although their overall effects looked modest. Less than a third of patients were cured by either treatment (30% (44/148) after CBT and 28% (43/154) after graded exercise therapy).

Maybe they wanted to spin the results even more than White was willing to do!!

 

[Sean]

Less than a third of patients were cured...

There is no possible way a competent honest medical author/reporter who did proper due diligence could justify using the very specific term "cured" to thus describe the PACE results.

It needs to be explicitly retracted.

 

[oceanblue]

The BMJ said:...
Maybe they wanted to spin the results even more than White was willing to do!!

Maybe!

But seriously, that was from a news in brief piece - no reviewers involved. In fact, the BMJ published the negative FINE trial. Now - he says warming to his theme - if PACE submitted to the BMJ there's a pretty good chance they'd have used at least one of the FINE reviewers who would, of course, then be very familiar with SF36 & CFQ thresholds for properly normal: FINE thresholds were very similar to those in the original PACE protocol. Such a reviewer would probably immediately spot the PACE sleights of hand and might have asked for PACE to be judged by the same standards as FINE. Or at least not play silly post-hoc games to make the results look good.

So there you have it: PACE was originally submitted to the BMJ who gave it to FINE-experienced reviewers - they saw through the PACE tricks and were having none of it. Well that's my theory and I'm sticking to it.

 

[oceanblue]

There is no possible way a competent honest medical author/reporter who did proper due diligence could justify using the very specific term "cured" to thus describe the PACE results.

It needs to be explicitly retracted.

Yup, it's bollocks*. I submitted a rapid response comment to correct this but got nowhere, probably because it was only a news in brief, not a BMJ article (or maybe my comment wasn't good enough).

*I refer M'lud to the case of The Sex Pistols vs the Crown in the late 70s where said word, featuring in the title of that classic album, was deemed not to be offensive on account of it's sometime use as the term for English vicars (er, in the 18th century, I think).

 

[Esther12]

There is no possible way a competent honest medical author/reporter who did proper due diligence could justify using the very specific term "cured" to thus describe the PACE results.

It needs to be explicitly retracted.

Instead they did those articles suggesting that patient anger about PACE was part of a rejection of science that challenged their preconceptions, and an unjustified distrust of psychiatrists (I think - that's from memory, so could have conflated the BMJ's coverage with Horton's comments).

No interest in pointing to the fact that this own coverage of PACE was deeply misleading, and should not have been trusted by anyone.

 

[oceanblue]

The BMJ said:
Maybe they wanted to spin the results even more than White was willing to do!!

I sense a lack of enthusiasm for my BMJ suggestion. Can anyone suggest other journals PACE might have tried? With such a big and 'important' study they would probably have a lot of choice and I guess they'd want something widely read and with a high impact factor. To fit the bill, the journal would also need to be smart enough to spot PACE's failings and demand changes/reject it.

The New England Journal of Medicine would fit, I guess. Any other ideas?

Or maybe the PACE gang just took a long time to submit.

 

[biophile]

Assuming it was submitted elsewhere first before publication in the Lancet, I agree the BMJ is a good candidate. As oceanblue says, another possibility is that PACE just took longer to submit, afterall the gyroscopic spin in the paper may have taken a while to work in with the cherry picked outcome measures and post-hoc analyses. But going from memory and what Dolphin said recently, White was apparently anticipating publication several months before it was "fast tracked" by the Lancet, then we heard nothing about it until February 2011. Do we know when the authors were unblinded to the data???

 

[Esther12]

It could be that the BMJ accidentally sent it to a decent reviewer who noticed the dodgy statistics, and White et al decided to go elsewhere rather than address their concerns... that could have happened anywhere, regardless of the journal.

Unless we get some information from elsewhere, I don't think we'll be able to make much of a guess.

 

[oceanblue]

It could be that the BMJ accidentally sent it to a decent reviewer who noticed the dodgy statistics, and White et al decided to go elsewhere rather than address their concerns... that could have happened anywhere, regardless of the journal.

Unless we get some information from elsewhere, I don't think we'll be able to make much of a guess.

Sure, it's a bit of a game. But I don't actually think there are many other credible candidate journals. I think they'd probably have avoided the psych journals as too niche, too obviously biased and also they almost certainly wouldn't have rejected the dodgy stats. So apart from the BMJ (which has previously published other stuff from PDW, as well as FINE, and New Eng JM, I can't think of any other likely journals - though I don't exactly have an encyclopedic knowledge of them.

 

[Esther12]

Sure, it's a bit of a game. But I don't actually think there are many other credible candidate journals. I think they'd probably have avoided the psych journals as too niche, too obviously biased and also they almost certainly wouldn't have rejected the dodgy stats. So apart from the BMJ (which has previously published other stuff from PDW, as well as FINE, and New Eng JM, I can't think of any other likely journals - though I don't exactly have an encyclopedic knowledge of them.

I see what you're saying. It would be nice to know, and see any comments from other reviewers.

 

[Mark]

I see what you're saying. It would be nice to know, and see any comments from other reviewers.

Wouldn't it just? Sounds like you're suggesting some kind of open scientific process there, where the scrutiny applied to scientific papers, and the nature and identity of the "peers", became information that was in the public domain. A process where contentious scientific papers are not discussed and approved behind closed doors by a peer group of the authors' choosing, and then presented as if they were uncontroversially reliable to a public that is supposed to blindly accept the word of the priesthood. Open science might make it possible for dissenters to assess, comment on, and maybe even trust the publication process...and we could all weigh up the arguments and form opinions on a rational basis rather than on the basis of appeals to authority. Maybe one day...

 

[Bob]

I don't think this would make much difference to our situation:

Results of publicly funded research will be open access science minister
http://www.guardian.co.uk/science/2011/dec/08/publicly-funded-research-open-access

The government say they want all publicly-funded research published in open access journals.
But I thought this was already supposed to be the case.
We need the data to be open-source, not just the results!

 

[Dolphin]

I sense a lack of enthusiasm for my BMJ suggestion.

I agree it's the most likely if they did go elsewhere. The BMJ have sent out press releases in the past too for such studies as well as having lots of nice editorials.

I would be very interested to know what happened.

As has been suggested, working on the stats is another possibility. If that took a few months longer than expected, it suggests the possibility the analysis plan might have been altered. I'm pretty sure they said they'd release this (the analysis plan). It will be interesting to see (potentially - if nothing else, I'm not sure I've seen one before).

 

[Dolphin]

Somebody has just got in touch and showed me the E-mail Peter White sent to them where he said it hadn't been submitted to another journal.