Graded exercise therapy for ME/CFS is not effective and unsafe. Re-analysis of a Cochrane review (2018) Health Psychology / Vink

If you have a look at their table 2, the baseline fatigues scores were around 35 so it must have been likert

 

The latest installment of this is Sharpe saying that they did it that way because they did it that way. With more typos, anyway. These are not the droids you are looking for.

Compelling scientific argument. Real intellectual giants fighting against barbarian hordes of fiercely militant activists making vexatious demands.

https://twitter.com/user/status/1055858228637110275

 

EC nonsense.

 

It didn't occur to him to do a better study?

 

Yes, the paper itself is not clear on this.

But it is not impossible to use both bimodal scoring and Likert scoring for the Chalder fatigue scale in the same paper. For example, initially with the PACE Trial protocol, the primary outcome measure used bimodal scoring, but then there was a secondary outcome measure that used Likert scoring. And similarly with the FINE Trial, also by Wearden et al, data on bimodal scoring and Likert scoring was published.

The Wearden et al. 1998 paper references Chalder et al 1993 which tested a threshold of 4+ fatigue caseness using bimodal scoring.

http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.828.4300&rep=rep1&type=pdf

I have seen the threshold of 4+ for caseness bimodal scoring been used in papers. I have never seen it for Likert scoring, which is not surprising because it really doesn't make any sense: as I said healthy person would score 14 on average.

 

Just thought I would take the opportunity to plug my two open access papers. They look at the issues in a lot of depth. The second one focuses on PACE Trial; it initially had "PACE Trial" in the title, but the editor said the draft title was too long:

 

https://twitter.com/user/status/1056358124750340096

 

I think this is a good point and here's where their COIs and the bias they create come in.

It seems to me they were not trying to find an effective treatment or cure for ME/CFS. If they were they would have done it differently. It is more that they were trying to prove if you push these patients you can get them back into work, education, whatever and get them off the benefit books. In hindsight, you could say they were trying to prove the case for IAPT.

To my mind, as a techie with no medical training at all, if I have a group of patients who seemingly can't exercise I would firstly listen to what they have to say and then design my trial around their experience, rather than what I think they should be able to do, based in what "normal" people can do.

Matched groups with one arm very, very slowly increasing frequency, but not intensity. Another arm where you increase intensity, but not frequency. Starting intensity and frequency well below levels that cause the patient any setback. Recording of harms, stopping and recording why as necessary, recording recovery period from PEM....

If they had started from the premise of listening to their patients and customising their trial to patients, a lot could have been learned.

Instead, they tried to force patients to conform to the totally unfounded BPS concept of the illness. They harmed them and many others with their misguided arrogance. Then they continued on, even when it became clear from their own data they were wrong.

When does COI of interest, arrogance and a refusal to see, or recognise the proof that you were wrong become discrimination?

 

My history may be wrong but I think in the early days exercise testing was only performed on day1, as no account was taken of postexertional malaise. The first 2 day study was 2007 which then showed abnormalities. Unfortunately some of the early 1990 studies concluded that our perception of fatigue was abnormal.

 

I fully agree with this. However, one must be careful not to equate evidence that has been reported in a controlled trial with anecdotal evidence or evidence from surveys. (NB I’m not saying that the latter should be ignored or dismissed – only that it is different.)

In response to Richard Gardner’s comment about harms (p.138 of Cochrane review of exercise therapy for CFS) Larun writes: “We decided to rely on data from randomised controlled trials (RCT), as RCTs provide much more robust data than for example anecdotal evidence.”

Are there any RCTs (or studies which claim to be RCTs) which include reports of serious deterioration from, or following, GET?

 

In his early writings Wessely stressed the importance of this very point, that legitimizing ME would send hundreds of thousands of undeserving patients onto medical services and disability benefits. A point that is further driven by the attempt to create the fiction of MUS that would bring in sufferers of several other marginalized conditions.

Wessely barged in on the field loudly saying everything that has been published about it is wrong and the patients are all wrong and only he knew better. Some of his early articles acknowledge the "common sense" knowledge of pacing and how it is critical to avoid pushing into exacerbation. He knew. He bullied his way through political influence.

This was absolutely the trial run for IAPT. It was never about helping anyone. It was always driven by politics and prejudice. Worst is their published writings make that perfectly clear, but no one holds them accountable for it.

 

There wouldn't be any such trials because the premise that there is harm is questioned by those tasked with recording it or reviewing the evidence. That's the essence of their framing it strictly as chronic fatigue. They only ever acknowledge fatigue, which a severe crash into being bed bound long-term would not account for. They can just frame it as "pervasive refusal" or whatever and just write it down as missing data, something we know they did.

Someone would have to conduct a trial specifically for this. Which there are, measuring biomedical anomalies. But the premise that there is significant harm is itself denied in the psychosocial model itself. The psychosocial researchers deliberately bury evidence of harm and would never report because they don't even believe it's real so it doesn't count in their mind.

They created a model where heads they win, tails they win. That's why they only use subjective trials. Any objective evidence will contradict them. As unscientific as it gets, but politics overrule the issue every time.

 

I don't think he sees it that way:
http://www.simonwessely.com/index.php/cfs-personal-story/

 

Well for a start they did not lookout any randomised controlled trials because none of the trials were adequately controlled. And data on harms will only be robust if the gathering is robust, as you know. In general data on harms is not specifically gathered from RCTs. In fact it is often gathered initially from open phase 1 studies and then from open phase 4 post marketing studies.

 

I know what you mean @obeat, but it looks to me that the very concept of the PACE trial was biased as it was designed to simply try to prove that you could push patients off the books in terms of benefits etc.

They missed so many opportunities to learn about PEM, because they had no interest in learning and studying the disease only in pushing the hypothesis that suited their own ends.

So, yes, it could and should have to Sharpe to do a much better study.

 

On looking at the history in the 1980's it rather looks as the whole object of the redefinition of ME or PVFS was tpo prevent patients from acquiring the status and legitimation of "the sick role", with which came the right to benefits. CFS is a sociological category rather than a medical one.

 

I think we may need to speak more in terms of deterioration than harm, because I suspect there may be ways to consider patients not being 'harmed', even if their condition deteriorates. Not sure, but I would not be surprised. I cannot help think that PACE might have done this.

 

The companion piece is even more interesting:

http://www.simonwessely.com/index.php/misunderstandings-misperceptions/

Virtually all of his myth busting comes from very early days when a few frustrated patients might possibly have been a tad careless in what they said and were more venting frustration then doing advocacy as 'activists'.

No where on either page does W make use of corroborating citations. The force of him saying so is authority enough.

 

There's always the "official" story and then there's the real story. He gave many tells in other writings. Of course he wants to claim he did it to help the patients.

Everyone's the hero in their life story. I doubt any of the physicians who published studies for the tobacco industry saw anything wrong with their work either. In their mind, they were just doing a job that needed to be done and providing for their family.