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

[Hutan]

I don't mind if there are people from outside the community that opposes GET, as long as they do not have conflicts of interest. They should be easy to convince with the information that is available and their presence makes the review more credible.

The aim in recruiting the consumer reps was to have someone actively supporting GET for ME/CFS, to balance someone who does not support it. I think there's a high chance that anyone in the ME/CFS community who actively supports GET and has a profile high enough to come to the attention of Cochrane will not be swayed by science. Surely they would have had to step around good science to come to their conclusion?

I do agree that there may not have been any politically acceptable alternative. But, I think a better approach to achieving credibility would be to bring in neutral people with a very good level of analytical skills. We don't really need people who understand ME/CFS - we need people who understand what good trials look like. The truth from the studies can stand alone if given a chance.

 

[Hilda Bastian]

I think the key thing is the people involved:
So there's a group of authors:

For the consumer reps, the aim was to have 'Different experiences/beliefs about exercise' represented. It's nice to see @Medfeb on the team, but having consumers with different beliefs about exercise for ME/CFS writing an exercise review makes as much sense as ensuring that you have a believer in climate change and a disbeliever in climate change writing a climate change review.

It will be interesting to see if there are any dyed-in-the-wool BPS proponents in the the other roles.



And there's the Independent Advisory Group



I don't know all the people in the IAG, but I have some reservations. @Hilda Bastian, what made you choose ME/CFS Australia as one of the international consumer representative organisations? This is a very very small organisation and, despite its name, it is not a national organisation. That said, I think the ME/CFS Australia people involved are not fans of GET.

Aside from those points, it looks ok I think. There is an aim to get a protocol out for a short public consultation later in the year and produce the review next year.

Many thanks! I very much take your point about what different views of exercise might mean - I can assure you it didn't mean opposite ends of the spectrum. But you can see the views of the people who were chosen for those roles from their public statements, as I did when I was looking into their backgrounds. (There were interviews as well.)

Why I chose ME/CFS Australia: I had multiple national organizations on my list - I spent a long time researching ME/CFS groups. They were also one of the groups that expressed interest. At that point, Europe and the US were already represented, and although #MEAction is also clearly an international group, not just the US, I was considering options in the southern hemisphere.

 

[Andy]

Very disappointed that I don't see any patient rep who clearly represents the patient population arguably most impacted by exercise, UK pwME. From comments made above, I assume that the representative from the European ME Alliance is meant to fulfil that role, but I don't see myself represented at the moment.

 

[Lucibee]

Thanks for subscribing.

I've not received anything. I don't think I was ever included in the list.

I suspect, as usual, I have completely misunderstood what the process was.

meh

 

[Trish]

Why I chose ME/CFS Australia: I had multiple national organizations on my list - I spent a long time researching ME/CFS groups. They were also one of the groups that expressed interest.

Edit: I've deleted a section about ME/CFS Australia from this post, since it seems I mistook it for a different organisation. Sorry.

I also concur with @Andy's point about no representative from the UK where arguably GET has had the most dire impact on patients, being both the product largely of UK funded and run studies like PACE, and the mainstay of the only treatment offered to pwME in the UK at least up until the new NICE guideline is implemented, and arguably even after that, given the loopholes in the draft guideline. I also think it's not enough for a patient/carer rep to understand ME/CFS, they need to understand clinical research and have an in depth understanding of the flaws in the GET studies and the harms experienced, and how a protocol works.

 

[JemPD]

• Two people from a clinical background with active interest in ME/CFS:
  

  • Lily Chu (USA) (medical practitioner);
  • Peter Gladwell (UK) (physiotherapist);

Would that be this Peter Gladwell? I'd think so

'Pacing for people with M.E.' Action for ME booklet - revised and updated January 2020. | Science for ME (s4me.info)

 

[Sly Saint]

I would far prefer to see @PhysiosforME involved rather than Peter Gladwell (BACME, physiotherapist).

eta: I would think that any key member of BACME would be considered to have a definite COI
see BACME board:
https://www.s4me.info/threads/bacme...led-to-11th-may-2021.13349/page-4#post-345838

 

[Hilda Bastian]

We probably offered too many criticisms....

Very disappointed that I don't see any patient rep who clearly represents the patient population arguably most impacted by exercise, UK pwME. From comments made above, I assume that the representative from the European ME Alliance is meant to fulfil that role, but I don't see myself represented at the moment.

Perhaps you could look a bit more into George Faulkner's background? (Several invitations/proposals were declined - UK among them. The pandemic complicated things in very many ways for many people.) And as I pointed out, there's still one position to fill.

 

[MSEsperanza]

Only able to skim the report so without having read the report or the first replies on the forum:

Thanks for posting here @Hilda Bastian, and thanks to all forum members who have been appointed to the IAG or review team and also to those who engaged and are engaging in the discussion in any way.

And for now, as it seems that S4ME weren't invited in any way, and since I don't know when or if I will be able to reply properly, just two questions:

1) There seem to be 3 systematic reviewers appointed, right?

So how about providing a space where people invited and elected by S4ME forum members could have a discussion with the systematic reviewers?

Forum members could discuss this on a private forum first, and if we found some topics and people wanting to discuss these with the reviewers, Cochrane could provide an adequate online space for an exchange with the systematic reviewers.

What do you think?


2) From the report:

Step 3: Content analysis

[...] These three resources – the spreadsheet of critiques, the list of literature, and the first rough distillation and mapping of discussion points – are being considered by the review authors and the IAG.

It's great that the spreadsheets are public, @Hilda Bastian. Will your 'first rough distillation' also be public?

If not and if you want to keep it confidential, is it possible to make it available, in confidentiality, to interested forum members who could discuss this in a private conversation group or on a private subforum on S4ME?

(edited to fix quotation)

 

[Trish]

Would that be this Peter Gladwell? I'd think so

'Pacing for people with M.E.' Action for ME booklet - revised and updated January 2020. | Science for ME (s4me.info)

Heaven help us. Why on earth was he chosen.

And Julia Newton, although she has done some interesting biological studies of ME/CFS, has put her name to some awful exercise studies for 'fatigue', and has been medical advisor to AfME during it's time of producing some dreadful materials for patients, some of which have been since improved to some extent.
https://www.s4me.info/threads/predi...-syndrome-patients-kujawski-et-al-2020.17471/
https://www.s4me.info/threads/conce...hods-clinical-evaluation-strassheim-19.10379/
The latter done with Vincent Deary, a BPS CBT therapist who I think she refers ME/CFS patients to.

 

[Andy]

Perhaps you could look a bit more into George Faulkner's background? (Several invitations/proposals were declined - UK among them. The pandemic complicated things in very many ways for many people.) And as I pointed out, there's still one position to fill.

I consider myself reasonably well connected and plugged in to the UK, and less so internationally, ME advocacy community. I mean no disrespect to George Faulkner, but I didn't recognise his name and it has now taken a Google search to be reminded that he has written about the review and issues with GET. I predict that the vast majority of UK pwME will be in exactly the same boat.

I note that he is listed under "Individuals who had been involved in discussions with Cochrane preceding the IAG" and as an "independent researcher" - therefore, even though I thank him for writing about these issues, I still do not see myself represented.

 

[Hilda Bastian]

The aim in recruiting the consumer reps was to have someone actively supporting GET for ME/CFS, to balance someone who does not support it. I think there's a high chance that anyone in the ME/CFS community who actively supports GET and has a profile high enough to come to the attention of Cochrane will not be swayed by science. Surely they would have had to step around good science to come to their conclusion?

I do agree that there may not have been any politically acceptable alternative. But, I think a better approach to achieving credibility would be to bring in neutral people with a very good level of analytical skills. We don't really need people who understand ME/CFS - we need people who understand what good trials look like. The truth from the studies can stand alone if given a chance.

Sorry if it looks like that, although I can't see how that certainty about something so specific is derived from the report. Either way, I can assure you "to have someone actively supporting GET for ME/CFS, to balance someone who does not support it" was definitely not the aim, and nor was that done.
[Typo fixed]

 

[Hilda Bastian]

I've not received anything. I don't think I was ever included in the list.

I suspect, as usual, I have completely misunderstood what the process was.

meh

Ah - the email was definitely sent (I got mine). Here's the original from March about to sign up:

Where can we get updates and answers to other questions?

• You can sign up for updates to this webpage by emailing: exerciseforme-cfsupdates@cochrane.org

 

[Hilda Bastian]

Edit: I've deleted a section about ME/CFS Australia from this post, since it seems I mistook it for a different organisation. Sorry.

I also concur with @Andy's point about no representative from the UK where arguably GET has had the most dire impact on patients, being both the product largely of UK funded and run studies like PACE, and the mainstay of the only treatment offered to pwME in the UK at least up until the new NICE guideline is implemented, and arguably even after that, given the loopholes in the draft guideline. I also think it's not enough for a patient/carer rep to understand ME/CFS, they need to understand clinical research and have an in depth understanding of the flaws in the GET studies and the harms experienced, and how a protocol works.

Thanks - already added Andy's UK comment to the list for the IAG.

 

[Hilda Bastian]

Only able to skim the report so without having read the report or the first replies on the forum:

Thanks for posting here @Hilda Bastian, and thanks to all forum members who have been appointed to the IAG or review team and also to those who engaged and are engaging in the discussion in any way.

And for now, as it seems that S4ME weren't invited in any way, and since I don't know when or if I will be able to reply properly, just two questions:

1) There seem to be 3 systematic reviewers appointed, right?

So how about providing a space where people invited and elected by S4ME forum members could have a discussion with the systematic reviewers?

Forum members could discuss this on a private forum first, and if we found some topics and people wanting to discuss these with the reviewers, Cochrane could provide an adequate online space for an exchange with the systematic reviewers.

What do you think?


2) From the report:




It's great that the spreadsheets are public, @Hilda Bastian. Will your 'first rough distillation' also be public?

If not and if you want to keep it confidential, is it possible to make it available, in confidentiality, to interested forum members who could discuss this in a private conversation group or on a private subforum on S4ME?

(edited to fix quotation)

Thank you!

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.

2) The rough distillation - no, the rough distillation is too messy for that, and there is already feedback from the IAG members pointing out things that need work. The only reason it was even shared internally as it is currently is, was as a shortcut for time. One of the purposes of going public with the next version is to get just that kind of feedback you're talking about. There'll be more on this in the June monthly report.

There'll be several opportunities in the coming months to participate.

 

[Hutan]

So, of the two consumer reps on the 8 person writing team, one is @Medfeb who is great but is not a person with ME/CFS. Therefore, the only person who can speak first hand about the impact of exercise is the person who was specifically chosen to balance Mary's view, Kay Hallsworth. Her views are therefore very important.

Kay Hallsworth biography
Kay was in the Royal Navy for 28 years. Compassionate and inclusive, Kay is a highly experienced specialist with a history of delivering medical operational capabilities in the military industry. Kay has a broad portfolio of skills including operational planning and support; emergency planning and management; healthcare governance and assurance; people management including work in diversity and inclusivity; coaching and mentoring; communication and social media lead for internal employee support networks. Kay is an ambassador and volunteer for the Association of Royal Navy Officers and RN Officer’s Charity. She co-owns a company called Explorer Coffees with her husband. Kay also has 2 children under 18, and has had a diagnosis of ME for 24 years.

She describes her experience in this 2019 article:

https://civilservice.blog.gov.uk/2019/05/03/personal-disability-stories-10-kays-story/

Civil Service blog - Personal Disability Stories - Kays story (ME sufferer)
Her experience has been complicated by anxiety and depression for which she has had rehabilitation and the 2019 story suggests her condition has fluctuated and perhaps become worse. It sounds as though a helpful husband who has 'stayed home to look after the children and do domestic tasks' may have allowed her to have enough energy for some exercise.

She says in the article:

Some types of exercise can be detrimental if not done the right way – I am, by necessity, more yoga than parkrun!

Actually there is no evidence telling us that a run is necessarily worse than yoga - what seems to matter is if a person exceeds a threshold of energy use over time where PEM is triggered. Kay mentions liking the energy envelope theory which might be good, although we have discussed here that the energy envelope theory is sometimes presented to include the unhelpful idea of 'pacing up'.

Either way, I can assure you "to have someone actively supporting GET for ME/CFS, to balance someone who does not support it" was definitely not the aim, and nor was that done.

That's good to hear. It's of course not fair to expect the one person with ME/CFS on the writing team to have personally experienced what we all have, but I don't hear a lot of my experience in Kay's story. Hopefully she will join us here to hear about more experiences, if she has not already.

 

[Andy]

My summary of ‘Cochrane Exercise and ME/CFS Review Update: May 2021’. All I've tried to do is distil the original document into the important 'highlights' without adding any extra commentary - I hope this helps.


What has happened?

Collection and analysis of critiques

Critiques of the existing review were gathered from a variety of sources, including S4ME, by Hilda. She has refined these into a format that will then feed into the review process.


The review has been moved out of Cochrane’s Common Mental Disorders Group to Cochrane's MOSS Network.

Acronyms for the groups involved in these editorial arrangements are

• MOSS: The Cochrane Musculoskeletal, Oral, Skin, and Sensory Network;
  
  
• PaPaS: The Cochrane Pain, Palliative and Supportive Care Group;
  
  
• EMD: The Cochrane Editorial and Methods Department.
  

An author team was established.

This consists of

• Consumers: Mary Dimmock (USA, carer, with ME/CFS activist background), Kay Hallsworth (UK, person with ME/CFS, non-ME/CFS-activist background);
  
  
• Clinicians: Todd Davenport (USA, physiotherapy), Julia Newton (UK, medical);
  
  
• Systematic reviewers with relevant methodological expertise: David Nunan (UK, experience with systematic reviews of exercise as an intervention); Argie-Angeliki Veroniki (Greece, statistician);
  
  
• Systematic reviewers from Cochrane response: Hanna Bergman (Israel), Nicholas Henschke (Germany, lead author).

The Independent Advisory Group (IAG) was established.

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.
  

Current IAG membership (eight appointed, two vacancies of which one will be filled shortly):

• Nominees of three organisations representing people with ME/CFS:
  
  
  • Penelope McMillan (with Penelope Del Fante, and proxy, Geoffrey Hallmann) (Australia) - ME/CFS Australia;
    
    
  • Jaime Seltzer (USA) - #MEAction;
    
    
  • Samuli Tani (Finland) - European ME Alliance;
    

• Two people from a clinical background with active interest in ME/CFS:
  
  
  • Lily Chu (USA) (medical practitioner);
    
    
  • Peter Gladwell (UK) (physiotherapist);
    

• Individuals who had been involved in discussions with Cochrane preceding the IAG:
  
  
  • Hilda Bastian (Australia, Lead);
    
    
  • Mike Clarke (Ireland/UK, systematic review methodologist); and
    
    
  • George Faulkner (UK, independent researcher).
    

 

[Ariel]

Sorry if this is covered already, but I was prompted to wonder after reading that patient experience whether the experiences of severe ME/CFS patients will be part of this?

 

[Adrian]

Many thanks! I very much take your point about what different views of exercise might mean - I can assure you it didn't mean opposite ends of the spectrum. But you can see the views of the people who were chosen for those roles from their public statements, as I did when I was looking into their backgrounds. (There were interviews as well.)

Why I chose ME/CFS Australia: I had multiple national organizations on my list - I spent a long time researching ME/CFS groups. They were also one of the groups that expressed interest. At that point, Europe and the US were already represented, and although #MEAction is also clearly an international group, not just the US, I was considering options in the southern hemisphere.

Why does it matter what peoples views on a given intervention are. Surely the issue is the quality (or lack of quality) of the evidence base.

What is needed is people who will ask deeper questions of the methodology and go past the basic apply this method to this thing questions. For example, the current review relies heavily on the CFQ which is a work of complete incompetance (there are no nice words possible for it) so applying a stats method on top is clearly bad, but too many who follow a formula won't dig and say well what are the properties of this as a scale, what evidence is there for those properties and therefore can you apply these techniques to it. We have learned as a patient group to really dig into the detail because there is so much that is wrong there that could be glossed over if a handle turning approach is taken.

 

[Hoopoe]

Something I wanted to say: I don't think that exercise has any special role to play in treating ME/CFS. Looking beyond my n=1 experience, there doesn't seem to be any data unambiguously showing improvement with exercise. Most of the work in this area has been done by people who were looking for any effect, no matter how small, that could support their preconceived idea that ME/CFS patients just had to exercise more and that this would somehow cure patients. This idea is a hypothesis that has failed but there is a refusal to acknowledge this. Its failure needs to acknowledged so that we can finally move on and focus on other hypotheses. Unfortunately some people's jobs now depend on ME/CFS being viewed as something that needs to be treated with exercise and psychotherapy so there is resistance to acknowledge that these approaches don't work.

I'm able to do 20-30 minute walks on most days. I could do much longer ones if I wanted to but this increasingly causes next-day deterioration which builds up. I've never had the impression that exercise is viable treatment for ME/CFS. When I became ill, I was in good physical shape so deconditioning cannot possibly be the cause of the illness. Too much physical activity however is a reliable way to get worse in the short term. I thnk there is often confusion about what patients are actually saying when they mean that GET is not appropriate. They aren't saying that any amount of exercise is bad. They're saying that encouragement to do more or the involvement of a therapist is bad (because there is the implicit assumption that the patient is mismanaging their activity levels and needs external help). In practice there never seems to be too little pressure on patients to do more, and they never want to do less. Most patients do what they can and find their own activity levels. Adding some therapist that believes they need to get patients do more will add very little at best, and at worst sets patients up for a cycle of crashing and self-blame.

If poor fitness had any important causal role in the illness, it should be easy to objectively demonstrate large and lasting improvements.

I hope that there will be a discussion of whether this historical focus on exercise is justified. If it's not justified, then the review should highlight this.

Another aspect that needs attention is whether harms of GET are being reported honestly in clinical trials and by proponents of CBT/GET. I don't have a link at the moment but very recently Trudy Chalder was describing an exertion induced crash in a long covid patient as abnormal behaviour, rather than as actual worsening. When harms are redefined as abnormal psychological reaction then of course there are no harms. How do we know that they haven't redefined harms out of their studies in the same manner? The assumption that studies tell us anything reliable about harms seems unwise.