Cochrane Review: 'Exercise therapy for chronic fatigue syndrome' 2017, Larun et al. - Recent developments, 2018-19

OMG - I think I've seen it all and then this...

"what we're trying to do here as I've said to you is to break this association between activity and your symptoms because equally if you feel rotten I still want you to do that activity...even if you're absolutely exhausted I still want you to do your ten minute walk in the morning and the ten minute walk in the evening after work"​

Thanks @Adrian

 

Acknowledging the elephant may turn a spotlight on other members of its species which exist at least in other flavours of CBT research according to https://www.psychologytoday.com/gb/...havioral-therapy-evidence-base-is-exaggerated and some well referenced tweets by https://twitter.com/Keith_Laws. Cochrane probably thinks it can't afford to get noticed for that sort of thing, while the best course of action would be to step up and sweep out such cobwebs. Establish quality conforming to better standards, rather than trying to gloss over past mistakes.

 

Interesting post from Cochrane:

"Cochrane’s support of trial transparency
Cochrane has supported the AllTrials initiative since it started in 2013. AllTrials calls for all past and present clinical trials to be registered and their full methods and summary results reported.

In 2017, Cochrane co-published a report with Transparimed, Transparency International and the Collaboration for Research Integrity and Transparency, Clinical Trial Transparency – A Guide for Policy Makers, highlighting the dangers of inadequate reporting of clinical trials and making recommendations to improve the situation. These include ensuring that publicly-funded trials are transparent; effectively enforcing existing rules; and strengthening laws and regulation."

Wednesday, July 10, 2019

https://www.cochrane.org/news/cochr...e-clinical-trial-sponsors-share-their-results

ETA: Includes a comment from the new boss at Cochrane

 

Well it has been over one month with no change...

 

Does " Montgomery v north lanarkshire" ruling apply to physios ?
The physio we saw was completely uninformed re ME, conflated with chronic fatigue, no knowledge of use of hear monitors, oi issues, what PEM actually is.
When is lack of knowledge a defence when there is so much info outside their bubble ?

@PhysiosforME

https://www.themdu.com/guidance-and-advice/guides/montgomery-and-informed-consent



https://www.bmj.com/content/357/bmj.j2224

ETA additional link

 

The wording in the BMJ article is 'medical professional' and 'doctor' but I would be surprised if it did not apply to health care professionals generally. It would be interesting to know.

This will be an important part of my testimony to the NICE committee. I personally do not think CBT and GET for ME/CFS are ethical because they inevitably involve giving 'information' that is simply not true: i.e. telling the patient that there is reason to believe they will get better if they change attitude and do more activity, or, as Dr Gerada said, that we know the treatments are safe.

I think physios should be legally liable for misinformation just like doctors but the chain of responsibility may be quite complicated. Lack of knowledge in itself may be excusable. In the Montgomery case the issue was failing to provide information in the context of delivering a treatment because it was thought better the patient did not know. The problem at the moment is that physios are failing to provide patients with realistic information because they have been taught to think GET is beneficial.

Where I think physios themselves must be considered responsible is in a situation where it is widely known in their profession that the evidence for GET being effective and safe is unsound. That is where spreading the word amongst the profession would be very helpful.

 

I agree, and this is why David, and to a lesser extent myself, writes letters every other day to try to get these people to take their ethical responsibilities seriously.

It may be unrealistic to expect professionals to check everything. I think it may be more realistic to say that if serious doubts about validity are circulating such that they will be well aware of those doubts they have a duty to evaluate the evidence in a rigorous and unbiased fashion.

 

I've heard of similar cases in Australia. 1/1000 chance of cerebral palsy due to injuries during birth is far too high to be acceptable in my opinion.

 

New article in the Guardian makes it sound like they're preparing to celebrate the new Editor in Chief for bravely supporting PACE/Larun/etc in the face of vile activists:

https://web.archive.org/web/2019072...-encephalomyelitis-chronic-fatigue-pace-trial

Moderator note: To discuss this Guardian article please go to this thread:
New poor Guardian article "ME and the perils of internet activism" 28th July 2019

 

Yes the 2015 law on consent does indeed apply to all medical personnel:

" Doctors, and other healthcare professionals, are now under a clear duty to take reasonable care to ensure that patients are aware of all material risks. This judgment aligns the law with the guidance on consent set out by the General Medical Council."
UK Supreme Court Blog, Case Comment: Montgomery v Lanarkshire Health Board [2015]UKSC 11, Emily Dorotheou, 27th March 2015
http://ukscblog.com/case-comment-montgomery-v-lanarkshire-health-board-2015-uksc-11/

I've attached a file on information I've compiled on the issue of consent, which includes responses Lady Mar received from Professor Baker of NICE and Dr Mark Devlin of the Medical Defence Union who agreed that the 2015 law requires patients are fully informed of the risks of CBT/GET and all other material risks.

Lady Mar did use this information on consent for the Forward ME submission to NICE

I think the issue of consent is pivotal to protecting patients.

 

Grrh!! Another response would not be polite!

 

Thank you for tagging us in this. We are really hoping we can start to make a difference in some of these cases. We have a meeting lined up with our professional body to discuss how best to approach this.

 

This is what we are hoping to achieve through @PhysiosforME -- we have a meeting lined up with our professional body to discuss how to address the situation. We will keep you posted but this is a really useful thread for us - thank you

 

I was just thinking about their attempts to use low figures for MCID for questionnaire sores in nonblinded trials based on rsearch of seemingly questionnable relevance - is there any way to get someone to do a real study on this? eg: Explain to patients what MCID is and who it would be used, and explain the dangers of questionnaire results being biased in unblinded trials, then ask them what would they want an MCID to be for i) a double blind trial and ii) an open label trial where participants may have been encouraged to view the treatment being tested positively?

@Carolyn Wilshire @Brian Hughes @Jonathan Edwards (wasn't David Marks a member here? - I've forgotten who to tag)

 

What is MCID?

 

Sorry - minimum clinically important difference.

So if they have a low MCID it makes it easier for them to claim that their changes in questionnaire scores reflect an improvement in heath that is of real clinical importance that should be appreciated by patients and doctors and seen as more than worth any trouble associated with treatment.

 

Are there formal guidelines for arriving at MCIDs? Or it is down to fingers waving in the air according to researchers wanting to report favourable results?

 

It seems to really vary. Didn't PACE define MCID as half of a measures standard deviation at baseline? There can be research of really varying quality on this too, with some of it seeming to be designed to get a low MCID. I can't remember the specifics of the released Cochrane correspondence now but it sounded like Larun was trying to use research from other conditions to define MCID for CFS patients - I don't think they said specifically which research they were citing.