An open letter to Psychological Medicine, again! by D Tuller et al

[slysaint]

A rumour tells me he applied for the presidency there first, but they wouldn't have him.

He should have tried for the Guild of Cobblers.

 

[Esther12]

Doesn't the RSM have influence over training? I thought that could be what appealed to Wessely. The conferences they put on, and their videos online, are presented as being significant but I've really got no idea if anyone pays any attention to them.

I'd like to be President of the Royal Society of Medicine!

 

[jodie100]

I was wondering if the investigators are correct here as I cannot see any issue with their argument or am I missing something?

From the New York Times article: "The investigators had weakened their outcome measures from their trial protocol so much that participants could actually deteriorate on physical function and still qualify as “recovered.” Thirteen percent entered the trial already having met the definition of “recovered” on that measure. The investigators have argued that this didn’t matter since participants also had to meet additional recovery criteria."

As far as I understand trial participants had to have a physical function score of 65 or less to qualify for entry to the trial, and were only considered recovered if they met several criteria simultaneously- fatigue and physical function in the normal range (physical function>or=60), plus rating themselves as much or very much better, plus no longer meeting the Oxford CFS criteria which included having a physical function score of 70 or more, so there was no overlap between entry and recovery criteria for physical function.(although there was an overlap between what was considered physical function in the normal range and what was necessary for trial entry).

 

[Snow Leopard]

They don't want to retract because of the political fallout - the "blow" to the perception of the evidence by the public and secondly, they'd have to admit that the peer review in Psych Med is rubbish.

 

[alex3619]

He should have tried for the Guild of Cobblers.

So he can join a load of old cobblers? (For anyone unfamiliar with the slang, a load of cobblers translates to "nonsense".)

 

[slysaint]

"nonsense"

thats the polite version. The other rhymes with rollocks.

 

[Wolfiness]

Is any doctor welcome to add a signature to Tuller's letter?

 

[Wolfiness]

I was wondering if the investigators are correct here as I cannot see any issue with their argument or am I missing something?

From the New York Times article: "The investigators had weakened their outcome measures from their trial protocol so much that participants could actually deteriorate on physical function and still qualify as “recovered.” Thirteen percent entered the trial already having met the definition of “recovered” on that measure. The investigators have argued that this didn’t matter since participants also had to meet additional recovery criteria."

As far as I understand trial participants had to have a physical function score of 65 or less to qualify for entry to the trial, and were only considered recovered if they met several criteria simultaneously- fatigue and physical function in the normal range (physical function>or=60), plus rating themselves as much or very much better, plus no longer meeting the Oxford CFS criteria which included having a physical function score of 70 or more, so there was no overlap between entry and recovery criteria for physical function.(although there was an overlap between what was considered physical function in the normal range and what was necessary for trial entry).

Yup, do we have a *concise* Refutation Of PACE Defences FAQ anywhere? Would help with PR.

 

[Jonathan Edwards]

Doesn't the RSM have influence over training? I thought that could be what appealed to Wessely. The conferences they put on, and their videos online, are presented as being significant but I've really got no idea if anyone pays any attention to them.

I'd like to be President of the Royal Society of Medicine!

The RSM has no influence on anything. It is a club or society, not a college. They do put on some good conferences. Charles put on an excellent one on ME a couple of years ago. I have done one on RA there. It can be good value for trainees because it can attract big names who can then have dinner with their chums afterwards. But in general nobody in medicine knows who the president is. I cannot recall ever knowing who a previous president was, except maybe John Scadding, because he is a friend and asked me to do a meeting.

 

[Aurator]

He should have tried for the Guild of Cobblers.

I suspect they might have regarded him as overqualified.

 

[me/cfs 27931]

Is any doctor welcome add a signature to Tuller's letter?

I've asked my doctor if he or another doctor from Kaiser Permanente would be willing to sign. He passed.

But he appreciates what is going on, and that it has been signed by a doctor from where he went to medical school, University of California, San Francisco.

My doctor even told me he thought of me when he ran across the NY Times article last weekend.

 

[Jonathan Edwards]

As far as I understand trial participants had to have a physical function score of 65 or less to qualify for entry to the trial, and were only considered recovered if they met several criteria simultaneously- fatigue and physical function in the normal range (physical function>or=60), plus rating themselves as much or very much better, plus no longer meeting the Oxford CFS criteria which included having a physical function score of 70 or more, so there was no overlap between entry and recovery criteria for physical function.(although there was an overlap between what was considered physical function in the normal range and what was necessary for trial entry).

You may be technically correct there jodie100, which is why my own critique of PACE focuses on wider problems. However, nobody who is genuinely trying to get to the truth of the matter fiddles about with criteria midstream like this. Moreover, if you are right then the revised criteria appear to be nonsensical - with two different numerical requirements for the same measure within one set of criteria. It looks very much as if the researchers did not really stop to think what they were doing.

 

[Esther12]

I was wondering if the investigators are correct here as I cannot see any issue with their argument or am I missing something?

From the New York Times article: "The investigators had weakened their outcome measures from their trial protocol so much that participants could actually deteriorate on physical function and still qualify as “recovered.” Thirteen percent entered the trial already having met the definition of “recovered” on that measure. The investigators have argued that this didn’t matter since participants also had to meet additional recovery criteria."

As far as I understand trial participants had to have a physical function score of 65 or less to qualify for entry to the trial, and were only considered recovered if they met several criteria simultaneously- fatigue and physical function in the normal range (physical function>or=60), plus rating themselves as much or very much better, plus no longer meeting the Oxford CFS criteria which included having a physical function score of 70 or more, so there was no overlap between entry and recovery criteria for physical function.(although there was an overlap between what was considered physical function in the normal range and what was necessary for trial entry).

That's not quite right, as patients were not required to not fulfil any aspect of the trial entry criteria (which was: assessed as having Oxford, and SF36-PF of 65 or under, and Chalder Fatigue bimodal score of 6 or under), but they were required to not fulfil all of them. So a patient could still report a decline in SF36-PF score from baseline and be classed as recovered, but they could not fulfil all aspects of the trial entry criteria and be classed as recovered.

Simple!

 

[A.B.]

It looks very much as if the researchers did not really stop to think what they were doing.

Entering numbers and pushing buttons on their stats analysis software until it looked good?

 

[Esther12]

Yup, do we have a *concise* Refutation Of PACE Defences FAQ anywhere? Would help with PR.

It would be good to have that... but a nightmare to do it! If anyone wants to have a go I'd be happy to try to help with editing it.

 

[Countrygirl]

It may not be entirely irrelevant that Professor Carmine M Pariante, Institute of Psychiatry, London, is an associate editor of Psychological Medicine while a certain Sir Professor Simon Wessely and Professor Michael Sharpe are on the board.

Asking Psychological Medicine to retract the paper in the presence of these people is perhaps like expecting turkeys to vote for Christmas.

 

[Tom Kindlon]

https://twitter.com/i/web/status/845364241871855616

 

[Jonathan Edwards]

But can my dad sign it? He is a retired UK consultant.

I am pretty sure that David Tuller would be happy to add him on.

 

[Wolfiness]

@Jonathan Edwards Thanks

@jodie100 Does this help?

www.senseaboutscienceusa.org/pace-research-sparked-patient-rebellion-challenged-medicine/#_ftn4

The ME/CFS criteria for recovery. The change in the fourth criterion for recovery is the strangest of all, and points to confusion about the qualification for entry. This requirement sounds extremely impressive—the patients no longer have CFS!—but in fact, patients who met the first three criteria may have automatically met this one as well.
In the changes to the protocol in 2013, the authors added a requirement to all the definitions of ME/CFS (Oxford, London ME, and CDC) that patients also had to meet the trial entry requirements for the fatigue and physical function scores. In other words, the 2013 Oxford “case” definition of CFS had three criteria:
meeting the Oxford criteria for CFS AND
having a physical function sore of 65 or lower/worse AND
having a bimodal fatigue score of 6 or more/worse
To meet the fourth 2013 criterion for recovery, one must only fail to meet one of the three conditions above, as one needs to satisfy all three to have CFS by the new definition. In this revised version, one could meet the CFS recovery criterion with an improved fatigue or physical function score alone.
In particular, if someone were to have a bimodal fatigue score of 5 or less on the fatigue scale (where less is better), then regardless of any other assessment, that person would no longer be said to have CFS, irrespective of other symptoms.

(My italics)

 

[Barry53]

I was wondering if the investigators are correct here as I cannot see any issue with their argument or am I missing something?

From the New York Times article: "The investigators had weakened their outcome measures from their trial protocol so much that participants could actually deteriorate on physical function and still qualify as “recovered.” Thirteen percent entered the trial already having met the definition of “recovered” on that measure. The investigators have argued that this didn’t matter since participants also had to meet additional recovery criteria."

As far as I understand trial participants had to have a physical function score of 65 or less to qualify for entry to the trial, and were only considered recovered if they met several criteria simultaneously- fatigue and physical function in the normal range (physical function>or=60), plus rating themselves as much or very much better, plus no longer meeting the Oxford CFS criteria which included having a physical function score of 70 or more, so there was no overlap between entry and recovery criteria for physical function.(although there was an overlap between what was considered physical function in the normal range and what was necessary for trial entry).

I think of it as a bit akin to taking a very poorly car in for much needed repairs. The engine is running incredibly badly with not much power, the brakes are binding and holding the car back all the time; the tyres are ancient and almost flat so they really drag; the clutch is slipping so what little power the engine does develop is not all getting to gearbox anyway.

So you take it into the garage and they tell you up front that you will know when they have recovered your car to its working state, because: The engine will be repaired and working properly again; the brakes will be freed up and no longer slowing the car down; the tyres will be sorted and pumped up so they only have their designed rolling resistance; the clutch will be replaced so all the power from the engine gets into the gearbox. Which is a pretty good up front definition of recovery for your car - albeit promising to be a bit expensive.

So you happily leave your car at your garage, and return a few days later to pick it up. The garage assures you your car is now recovered to its former glory and you pay your money and drive off. But very quickly you realise your car is far from fixed. It is different, but still very wrong. The tyres seem better, and the clutch does not seem to be slipping like it did, but the engine still seems pretty useless, and if you dip the clutch the car stops pretty rapidly, so the brakes are still binding somewhat. Overall your car goes a bit better than it did, but it is still way short of what a fixed car is supposed to be!

So you go back to the garage, and they tell you that your car is fully recovered, because they redefined what is meant by recovery. They decided it would be OK for the engine to be a bit worse than before (handy, because it is), and the brakes are still about the same, but they accounted for that in their redefinition of recovery also. True, the fixed tyres and clutch help things a bit, but your poor car is still woefully unwell - no way fixed in any normal sense of the word. But the garage insists that their revised definition of recovery is valid, and just because the engine is worse that does not matter, because overall your car now meets their revised recovery criteria.

And in any case, when your car went into the garage, it did not meet all their revised recovery criteria, just some of it - the tyres and clutch did need to be fixed even by their revised definition.

So they keep your money and insist there is nothing more they are obliged to do.

And this analogy is using pretty objective criteria, not subjective self-reporting!