Alem Matthees analyses on released PACE data blast "recovery" claims - huge damage to PACE

[user9876]

There is a new article on virology covering the re-analysis of PACE data

http://www.virology.ws/2016/09/21/no-recovery-in-pace-trial-new-analysis-finds/

Summary

The PACE trial tested interventions for chronic fatigue syndrome, but the published ‘recovery’ rates were based on thresholds that deviated substantially from the published trial protocol. Individual participant data on a selection of measures has recently been released under the Freedom of Information Act, enabling the re-analysis of recovery rates in accordance with the thresholds specified in the published trial protocol. The recovery rate using these thresholds is 3.1% for specialist medical care alone; for the adjunctive therapies it is 6.8% for cognitive behavioural therapy, 4.4% for graded exercise therapy, and 1.9% for adaptive pacing therapy. This re-analysis demonstrates that the previously reported recovery rates were inflated by an average of four-fold. Furthermore, in contrast with the published paper by the trial investigators, the recovery rates in the cognitive behavioural therapy and graded exercise therapy groups are not significantly higher than with specialist medical care alone. The implications of these findings are discussed.

 

[Simon]

https://twitter.com/i/web/status/778521796559667201

https://twitter.com/i/web/status/778522308164087812

 

[Simon]

Julie Rehmeyer's piece at Stat

https://twitter.com/i/web/status/778521391083638784

Furthermore, the researchers weren’t recommending ordinary psychotherapy — they were recommending a form of cognitive behavior therapy that challenges patients’ beliefs that they have a physiological illness limiting their ability to exercise. Instead, the therapist advises, patients need only to become more active and ignore their symptoms to fully recover.

...I knew that the right forms of psychotherapy and careful exercise could help patients cope, and I would have been thrilled if they could have cured me. The problem was that, so far as I could tell, it just wasn’t true.

...Many people, including many very sick people, had to invest immense effort and withstand vitriol to use science to correct these mistakes. And even that might not have been enough without Tuller’s rather heroic investigation.

The PACE researchers, the editor of the Lancet, and the editors of Psychological Medicine (which published the follow-up study on recovery) all declined to comment for this article.

...Wessely declined to comment on the lack of recovery. He summarized his overall reaction to the new analysis this way: “OK folks, nothing to see here, move along please.”

 

[user9876]

As well as Alem and other patients this analysis is co-authored by 2 statistics professors

Philip Stark - Associate Dean, Mathematical and Physical Sciences; Professor, Department of Statistics; University of California, Berkeley, California, USA.
Bruce Levin - Professor of Biostatistics and Past Chair, Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, USA

 

[Valentijn]

Wessely declined to comment on the lack of recovery. He summarized his overall reaction to the new analysis this way: "OK folks, nothing to see here, move along please."

 

[sarah darwins]

"MOVE ALONG, FOLKS. NOTHING TO SEE HERE"​

 

[Sidereal]

Looks like the talking point by the Wessely school is going to be "the primary outcome of improvement was still statistically significant", neglecting to mention that the improvement rate plummeted from 60% in the Lancet to now 20%, only a 10% difference between SMC vs CBT/GET. Nothing to see here, indeed.

 

[user9876]

Looks like the talking point by the Wessely school is going to be "the primary outcome of improvement was still statistically significant", neglecting to mention that the improvement rate plummeted from 60% in the Lancet to now 20%, only a 10% difference between SMC vs CBT/GET. Nothing to see here, indeed.

But it was small and not backed up by objective measures. It would be shocking if it wasn't in a trial where you ask people how they feel, tell them they will recover if the feel different and ask them how they feel.

 

[A.B.]

The "medical care" may have been as little as 3 sessions of 30 minutes each over the course of a year.

All participants received what was described as standardised “specialist” medical care (SSMC), but those receiving SSMC alone may have seen the Fatigue clinic doctor only three times for 30 minutes each time during their participation in the trial, a total of 90 minutes throughout the trial.

Source http://www.margaretwilliams.me/2016/proof-positive-revisited.pdf

I also recall a comment on social media from a person claiming to be a PACE trial participant, sayin that she was in the "medical care" arm and never received any care at all.

 

[worldbackwards]

View attachment 17386

"MOVE ALONG, FOLKS. NOTHING TO SEE HERE"​

A personal favourite

 

[AndyPR]

Awesome work @Tom Kindlon , thank you so much, you and all the authors.

 

[ClarkEllis]

https://twitter.com/i/web/status/778528673645363200

 

[Sidereal]

The "medical care" may have been as little as 3 sessions of 30 minutes each over the course of a year.



Source http://www.margaretwilliams.me/2016/proof-positive-revisited.pdf

I also recall a comment on social media from a person claiming to be a PACE trial participant, sayin that she was in the "medical care" arm and never received any care at all.

Are there any data in their published papers on what SMC actually involved? In the real world, I mean, not in theory.

 

[Sam Carter]

Huge thank you to everyone involved in this. No wonder PDW retired ....

For anyone trying to replicate the analysis I thought I'd point out that the hash value for the excel file given in the accompanying notes is actually a SHA-1 checksum and not a SHA-256 value as stated.

 

[A.B.]

PACE authors will still try to spin these pathetic results as success, failing to acknowledge the problems of lack of blinding and the Oxford criteria.

 

[worldbackwards]

PACE authors will still try to spin these pathetic results as success, failing to acknowledge the problems of lack of blinding and the Oxford criteria.

Can really 6% vs 3% be spun in any language? It's nothing.

 

[adreno]

The analysis has to come from someone with authority, or it won't matter. Sadly.

 

[Simon]

As reported in a recent BMJ editorial by chief editor Fiona Godlee (3 March 2016), when there is enough doubt to warrant independent re-analysis [23]: “Such independent reanalysis and public access to anonymised data should anyway be the rule, not the exception, whoever funds the trial.”

The PACE trial provides a good example of the problems that can occur when investigators are allowed to substantially deviate from the trial protocol without adequate justification or scrutiny. We therefore propose that a thorough, transparent, and independent re-analysis be conducted to provide greater clarity about the PACE trial results.

 

[AndyPR]

The analysis has to come from someone with authority, or it won't matter. Sadly.

Did you not spot who all of the authors where?

Alem Matthees (1), Tom Kindlon (2), Carly Maryhew (3), Philip Stark (4), Bruce Levin (5).

1. Perth, Australia. alem.matthees@gmail.com
2. Information Officer, Irish ME/CFS Association, Dublin, Ireland.
3. Amersfoort, Netherlands.
4. Associate Dean, Mathematical and Physical Sciences; Professor, Department of Statistics; University of California, Berkeley, California, USA.
5. Professor of Biostatistics and Past Chair, Department of Biostatistics, Mailman School of Public Health, Columbia University, New York, USA.

At the very least those last two look reasonably authoritative to me, with no insult meant to the other authors.

 

[Amused]

I was on the Trial CBT. I asked for the SMC several times cos I wanted to discuss things like symptoms I had and how to deal with them like pain. Never got it. Ended up thinking the signoff to the Trial session was the SMC, it wasn't. The person running that session was the SMC person so tried to help but it was a bit of a muddle. Bascially he said 'try to take fewer pain killers' in response to my 'why aren't the pain killers working? is the pain real? are they the wrong ones? (basic paracetamol).

Oh I also got given a book before I went on the Trial that the Centre Director said SMC people were given.

So as far as I can see SMC was pretty much 'real world' in that no-one bloody listened or had any useful input! Not sure what was supposed to happen though.