Independent advisory group for the full update of the Cochrane review on exercise therapy and ME/CFS (2020), led by Hilda Bastian

[Hoopoe]

Another way to think about this is that essentially the money that was meant to help patients has been diverted into subsidies for researchers and therapists with treatments that haven't been shown to be better than a placebo. It's a form of exploitation and we must finally break free of this and ensure that the money goes towards sensible research and interventions that actually work.

 

[MSEsperanza]

Apologies for again just popping in for one reply:

There will be a communication channel with groups that aren't on the IAG - and how that will work will be discussed with them: including S4ME.

Your question 1) If you mean authors for the systematic review, there are 8: https://community.cochrane.org/orga...gement-high-profile-reviews-pilot/author-team

I'll add your suggestion to the list of ideas for consideration, thanks. I'm assuming you mean the authors of the systematic review, but let me know if not.

Thanks.

I meant the people assessing the evidence. Maybe even better if the complete authors team could participate in the discussion. Anyhow, my suggestion was prompted by the wording of what the IAG's goals are:

The stated goals of this newly formed group are to:

• Ensure and facilitate responsiveness to stakeholders' concerns; and
  
  
• Improve the relevance, accessibility, and credibility of the revised and updated review

If I understand properly, that means the IAG won't have a say in the applied methods to assess evidence, e.g. won't be able to discuss prerequesites/ corrections / amendments if the standard Cochrane processes to assess evidence are applied?

(Which probably would imply an essential criticism of much of Cochrane's work, not only the work directly related to ME/CFS).

That's a point I thought would be worthwhile to discuss with people chosen by S4ME before starting the phase of writing the protocol and assessing the evidence.

(But I'm afraid would need some time for S4ME to prepare.)

 

[Lucibee]

It seems a shame that your blog on the CFQ isn't listed in the set of documents reviewed (maybe I missed it). But it would be very very bad if a protocol used the CFQ in any form of review!

The blog I posted is simply a repeat of the submission I made. I've only just found it on the list - I'm at no. 42.

 

[Hutan]

Reposting this link to the Cochrane announcement for people's convenience, and I'll add it to the first post of the thread.
https://community.cochrane.org/orga...h-profile-reviews-pilot/cochrane-exercise-and

 

[Adrian]

The blog I posted is simply a repeat of the submission I made. I've only just found it on the list - I'm at no. 42.

I hadn't realised that was you. It would be good to update the link to your blog as currently it doesn't point to the content.

 

[Hutan]

I note Kay's declaration of interest

Kay Hallsworth declaration of interest
Non-financial: Civil Service Blog post in 2018.

Non-financial: Previous role as Nurse and Medical Services Officer in Royal Navy (28 years) - no direct link to topic. Royal Navy.

It goes a good deal deeper than 'Royal Navy'. Please read this thread - Etherington, who co-wrote a defence of GET with White is a Defence specialist in rehabilitation.
Adverse outcomes in trials of graded exercise therapy for adult patients with chronic fatigue syndrome, 2021, White & Etherington
In 2019, Kay wrote glowingly about the help she had received from a defence rehabilitation team. Her ongoing employment depends on the goodwill of an organisation with a vested interest in suggesting that ME/CFS and GWI can be fixed with GET.

As long as the process is rigorous I don't think it will matter. When it fails it's because no one is there to actually enforce it and people just push their position freely without regard for evidence or reality. This can't happen here and there are several people involved with genuine experience. Really pleased to see Davenport, he is a tireless (heh) advocate for physical therapy and truly understands the issue.

rvallee, that is an uncharacteristically optimistic attitude you are taking there. Yes, there might be some good people on the IAG, but I think they will have limited power. It is the people on the writing team that matter. And it looks to me that Kay, with no track record in analysing GET trials and a substantial conflict of interest, is not going to be able to explain the issues that we want examined.

I really think we need a person with ME/CFS who understands the issues we have been banging on about and who is clearly conflict-free to be on that writing team. The Cochrane process is not credible as it stands.

 

[Hilda Bastian]

@Hilda Bastian I am sorry my comments today have been rather grumpy. I can see that you have put a lot of thought and effort into this process so far, and according to your brief have acted fairly. I thank you for doing your best and hope that now the process has started to become more open, and a structure of engagement is starting to become clearer, we will be able to have more meaningful input.

I think the dragging out of the whole process by Cochrane, first of not withdrawing the current Cochrane Exercise for CFS review when the changeover of chief editor happened just as Tovey had almost achieved getting it withdrawn, and the implications of that review continuing to stand for YEARS after the problems with it have been pointed out comprehensively. Then promises of patient involvement taking so long to even begin to come to fruition... Alongside seeing distressingly awful crap about GET continuing to be published, including just yesterday, one of the PACE authors publishing a paper saying GET does no harm...

So the sum total of Cochrane's involvement in ME/CFS has been decades of harm to probably hundreds of thousands, if not millions, of patients... And still we wait for crumbs.

Well, I think you can see it reaches the stage where despair sets in.

As someone with 31 years ME, and carer for a daughter with 23 years ME, both severe for many years, and with the only medical 'help' a GP who said on the phone with me the other day in my first very brief contact in over a year, 'Oh, do you have pain, how long have you had that'. And she is our only medical 'help'. The only 'medical advice' we have had over the years is 'try to get more exercise'.

And this same story and worse are being played out all over the world every day. National guidelines are being written with this and the equally awful CBT for CFS review as 'evidence'. Every day's delay causes more harm.

Cochrane, along with NICE and the authors of the studies used to support them have, metaphorically speaking, blood on their hands.

Although there are some good people on the Advisory group and the list of Review Authors, I am not confident there is sufficient expertise there to dig into the flaws of the clinical trials and write a review that does more than yet another 'statistical analysis' of data so flawed as to be worthless. I hope I am proved wrong.

Thank you! And yes, I would despair in that situation, too. I am confident we have enough expertise to do an excellent job, plus the commitment to do it, too, and the commitment of enough people to point out mistakes and suggest improvements as we go along.

 

[Hilda Bastian]

@Hilda Bastian I echo every word of Trish's comment here

Looking for the fundamental flaws in the evidence is not best done by those who have proved themselves already obtuse to them, so I too hope & pray that we are proved wrong.
I thank you for all your hard work Hilda & wish you all the best with the process, i recognise it wont be the easiest project you've worked on!

Thanks!

 

[Hilda Bastian]

I hadn't realised that was you. It would be good to update the link to your blog as currently it doesn't point to the content.

Thanks - I added the link just now.

 

[JemPD]

It goes a good deal deeper than 'Royal Navy'. Please read this thread - Etherington, who co-wrote a defence of GET with White is a Defence specialist in rehabilitation.
Adverse outcomes in trials of graded exercise therapy for adult patients with chronic fatigue syndrome, 2021, White & Etherington
In 2019, Kay wrote glowingly about the help she had received from a defence rehabilitation team. Her ongoing employment depends on the goodwill of an organisation with a vested interest in suggesting that ME/CFS and GWI can be fixed with GET.

Oh for _ sake!...



<insert scottish accent> "we're doomed!"

apols to those who dont get the doomed quote, am trying to lighten my own mood about all this

 

[Adrian]

Thank you! And yes, I would despair in that situation, too. I am confident we have enough expertise to do an excellent job, plus the commitment to do it, too, and the commitment of enough people to point out mistakes and suggest improvements as we go along.

I'm wondering what an excellent job would be. However good experts are you can't take studies that are simply not up to any sort of standard and make conclusions from them. Hence I assume an excellent job would be to have a protocol that no studies would meet?

As I've said before I think any protocol that uses the CFQ would be a work of incompetance. And great care needs to be taken with something like the sf36-pf scale as it isn't suitable for measuring improvements (certainly not mean improvements). I guess a protocol could rely on a mix of secondary outcomes that are more objective but not many trials and we know from PACE they didn't do the 6mwt properly.

 

[Hilda Bastian]

Another massive disappointment. Where are the people who have been fighting for a proper review? I am not convinced that there is anyone on this panel who understands the issues and the science.

I am a great admirer of Lily Chu, but find the experts from the US do not understand the depths of the problem with the rubbish research that pours out of the UK BPS clique.

George Faulkner definitely fits the description of people who have been fighting for a proper review: he's been doing so intensively with Cochrane since 2013 (see his bio for the IAG): for context, that's a couple of years before Tom Kindlon and then Robert Courtney submitted their comments on the review to Cochrane. I'm not intending to dust off people's disappointment here, but at the same time, I'd like to make sure that people's disappointment with my decisions doesn't translate into dismissing the contributions of people who have worked very hard behind the scenes for years.

I agree Lily Chu is wonderful! But I don't agree that people from the US don't understand the perspective on the issues and science expressed in this Forum - for example, see the MEpedia entry about Mary Dimmock and Thirty Years of Disdain, which she co-authored with Matthew Lazell-Faiman (her severely ill son).

I also wouldn't underestimate how useful the extensive articulation of the issues and concerns is: all that effort to explain to explain concerns and points of view has created a body of writing that can inform others very well. That's why the starting point has been deeply engaging with that material, so that the issues and concerns people have put so much time into articulating are listened to. And consulting about how we distilled will provide the opportunity for people to point out what we miss, or misunderstand.

If they were not able to make a formal announcement asking for nominations for patient representatives that was clear enough for S4ME to understand what hope is there for a decent review?

But they did nominate S4ME for participation in the IAG, and they were notified the group was under consideration: I answered all the questions they asked, and I accepted their invitation for me to join this Forum as a guest.

I'll expand on what the report explains on this point: for those 3 positions, the member of the IAG is the group. Once a group accepted the invitation to join the IAG, they didn't nominate patient representatives for consideration: they were asked to name a representative with ME/CFS. It wasn't a case of providing nominations that I chose from: it was their choice, and the same would have applied to S4ME had the group been chosen. (In the case of ME/CFS Australia, because of illness, their representation is shared by two people, with a named proxy in case both cannot participate at some point because of illness.)

It is vital that severe ME is taken into account. The 25% group (not represented) found that many of their members had not been severe until they had been forced to exercise, does the whole panel understand this?

Is someone who also has issues with depression which can be improved by exercise going to understand that exercise has no positive effect on ME, none, nothing at all. We continually do more than we know we ought to so if our ME was getting better we would have no need to build up a level of activity.

I share the experience of many that I thought I was improving, did more and more then crashed to the point I have not walked for 23 years.

I feel betrayed again but would welcome being proved wrong.

Thanks for stressing and articulating this important point. I think you can count on the people with severe illness on the advisory group to keep bringing that point home - and I'm sure it will be in the consultations too. And I am confident that Mary Dimmock will ensure that severe illness remains a clear priority for the author group.

 

[Hilda Bastian]

I note Kay's declaration of interest


It goes a good deal deeper than 'Royal Navy'. Please read this thread - Etherington, who co-wrote a defence of GET with White is a Defence specialist in rehabilitation.
Adverse outcomes in trials of graded exercise therapy for adult patients with chronic fatigue syndrome, 2021, White & Etherington
In 2019, Kay wrote glowingly about the help she had received from a defence rehabilitation team. Her ongoing employment depends on the goodwill of an organisation with a vested interest in suggesting that ME/CFS and GWI can be fixed with GET.


rvallee, that is an uncharacteristically optimistic attitude you are taking there. Yes, there might be some good people on the IAG, but I think they will have limited power. It is the people on the writing team that matter. And it looks to me that Kay, with no track record in analysing GET trials and a substantial conflict of interest, is not going to be able to explain the issues that we want examined.

I really think we need a person with ME/CFS who understands the issues we have been banging on about and who is clearly conflict-free to be on that writing team. The Cochrane process is not credible as it stands.

In fairness, Kay's bio also makes it clear she is no longer employed by the Navy. I wouldn't have proposed her if I didn't have confidence in her knowledge, abilities with research, integrity, and skills in communication and persuasion.

Power is always limited, but the IAG has a lot of it. I am very committed to this group and have a huge amount of respect for them.

 

[Hilda Bastian]

Today?

Public and individual notifications were all done within a few hours, on the same day.

 

[Hilda Bastian]

From Hilda's article:

I don't know whether it's too late to add more to this. I added Jonathan Edwards expert testimony to NICE this morning, as I couldn't see it anywhere on the lists. I suggest anyone go ahead and add any other documents even if it is past a deadline.

Thanks! Not too late. As the report says, this is an ongoing process: we're listening.

 

[Hutan]

But I don't agree that people from the US don't understand the perspective on the issues and science expressed in this Forum

I'm not suggesting people from the US don't understand the perspective on the issues expressed in this forum, but even Medfeb, as good as she is, has a different outlook about the fundamental importance of the issue of subjective outcomes in unblinded trials than most who are active on this forum. See, for example the discussion earlier in this thread following on from this post:
Independent advisory group for the full update of the Cochrane review on exercise therapy and ME/CFS (2020), led by Hilda Bastian

Given that Kay, as far as I know has no track record in evaluating GET trials, and given her links with people who have expressed support for GET in the most emphatic of terms, I am not seeing anyone on the writing team who does completely reflect the views of the majority of people active on this forum. Are you confident Hilda that, for example, Kay can clearly articulate the deep concerns that informed people with ME/CFS have about the CFQ?

George sounds great, and I'm very glad that he is on the IAG. But how will he be able to influence what the writing team produce? How can we, making a noise from the sidelines, make sure that the main issue of the unreliability of subjective outcomes in unblinded trials is front and centre in the exercise review? At present, the composition of the writing team suggests that it will be an issue that is sidestepped.

 

[Hilda Bastian]

Great that you are happy to discuss the delay and how it came to be. Perhaps you can say what the original plan was, what had to be re-negotiated, why and with whom, and why there was a desire to still reach the same goal? From what I gather, the desired goal is to write a new exercise review come what may, and that is not negotiable.

Remember when you were criticizing the plans for the review to be authored by staff? That's where I came in: the composition of the review team is clearly very different.

On Cochrane's side, the new editorial group had to be negotiated. That took time. Then the respective roles and responsibilities of the different arms of this were negotiated - it's a completely new arrangement, and it was important to enter into this with enough clarity to enable everyone to concentrate on the critical tasks and avoid conflicts, duplication, and things being overlooked because someone assumed someone else would be doing it.

That process included negotiating the role of the IAG in the review: usually, there's just rounds with editors and peer reviewers. It included things like my proposal for a public discussion of the protocol post-peer review and before a final editorial round for publication.

The pandemic affected everything - even down to making recruitment harder. And the task of analyzing the history of critiques took longer than anticipated.

What will a new Cochrane review add to what NICE have just done in their review for the new ME/CFS guideline? A strength of the NICE process is that it looks at all the evidence for interventions for one (hopefully) clearly defined patient group rather than one intervention at a time for a less clearly defined patient group, a patient group which may well be defined differently by different review teams looking at one intervention on its own. With NICE, there is also a clear distinction between the people who do the technical review and quality assessment of the evidence within a strict scope set (with the input of patients), and the committee (also including patients) who write the guideline. The reviewers have no vested interests in, opinions about, or experience of any of the interventions, as this is not necessary to identify the outcomes measured, or evaluate the quality of the research methods used.

It's a different process.

Lf course I'm very familiar with the view that reviewers who know nothing about a topic are the ones best placed to review it, I don't share that view, and I've always opposed it. You complained about Cochrane's original plan to do just that, if you remember. Consider, too, the current opinions being expressed on this Forum about a review done by the CDC on that basis.

I don't believe anyone could come to this review with no opinion about exercise, even if they had never before heard of ME/CFS, and I think people's beliefs about exercise have been a key part of the problem with this issue from the beginning. And even when you start on a review process with no prior strong opinions, you develop opinions very quickly.

 

[Hutan]

Possibly the definition of 'activist' is part of the problem? It seems to me that any person appointed to the writing team to represent people with ME/CFS should have a strong background and demonstrated skills in evaluating ME/CFS trials, really good links with some ME/CFS communities and an ability to explain issues related to ME/CFS clearly. If that is an activist, then surely all of the appointed patient representatives need to be activists?

Kay has popped up, apparently selected because she is 'not an activist'. We don't know what her capability to evaluate ME/CFS trials is, we don't know her views. But we do know that she has had involvement with a defence rehabilitation service that is overseen by a person who has just authored a paper suggesting that GET is great. (Sorry for my mistake in assuming Kay was still hoping to return to service with the Navy, as she was in 2019.)

 

[Hilda Bastian]

Most noteworthy is that no Cochrane group wanted it. That's puzzling, that there should be no group dealing with chronic health problems. Seems like a massive blindsight, but it certainly spells plainly the important chronic illness has in medicine: out of bounds.

On this point - there are many Cochrane groups dealing with chronic health problems, but they focus on parts of the body - like the gut, or hepato-biliary system, or airways - or on particular conditions that are large parts of the health and care systems and medical research, like cancers. ME/CFS may one day fit more unquestionably into one are than another, but not yet. And I don't think it's puzzling. Pounding at a group of people constantly has negative consequences. It's a situation people typically prefer to avoid, and defend against. I'm very hopeful that we can chart a more fruitful course for the future.

 

[Hilda Bastian]

Possibly the definition of 'activist' is part of the problem? It seems to me that any person appointed to the writing team to represent people with ME/CFS should have a strong background and demonstrated skills in evaluating ME/CFS trials, really good links with some ME/CFS communities and an ability to explain issues related to ME/CFS clearly. If that is an activist, then surely all of the appointed patient representatives need to be activists?

Kay has popped up, apparently selected because she is 'not an activist'. We don't know what her capability to evaluate ME/CFS trials is, we don't know her views. But we do know that she has had involvement with a defence rehabilitation service that is overseen by a person who has just authored a paper suggesting that GET is great. (Sorry for my mistake in assuming Kay was still hoping to return to service with the Navy, as she was in 2019.)

No problem - she was in the Navy in 2019. Her bio makes it clear that's past tense, though.
Yes, I know you don't know her views or her capabilities, and I realize you're not going to take my word for it. I wouldn't expect anything different.

I don't believe every patient who ever depended on a health care service is compromised by the views of the people who ran it.