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

[Caroline Struthers]

https://www.nice.org.uk/guidance/ng206/evidence

-> H Management of ME/CFS

https://www.nice.org.uk/guidance/ng206/evidence/h-management-of-mecfs-pdf-9265183029

-> Appendices Non-Pharmacological interventions.....p.5

-> Appendix J Excluded studies.....p. 545

That's great. Thank you. I didn't click on that link because it has the title "Management of ME/CS" in the index page, but the title "[H] Appendices for the management of ME/CFS" on the document. Not making it very easy for people.

 

[Caroline Struthers]

Possibly along the same lines --- is there anything to stop us reviewing publicly funded studies, re ME/CFS/Lyme/---, and highlighting that they're a waste of money and communicating that to the APPGs etc?
There may be some overlap with @Caroline Struthers blog ----

It's kind of related to the project I'm hoping to get funding for. Originally I wanted to include systematically alerting funders of when they have wasted their money. But the main thrust of the project is to develop a way to involve patients in rectifying the mistakes of the past by taking the lead in the design of future studies which funders can then put out for tender. The former (naming and shaming) element has been less popular with my colleagues (!!), so it won't form part of my funding bid

 

[FMMM1]

The former (naming and shaming) element has been less popular with my colleagues (!!), so it won't form part of my funding bid

Yes, the real benefit would be avoiding replicating mistakes --- rather than complaining after they've been funded.

 

[CRG]

Yes, have realised that the CC have sort of explained this point to me in the letter. But I didn't understand. They have left (and are leaving) the decision about whether Cochrane have harmed beneficiaries or not to Cochrane. Maybe they will find it harder to say that they haven't caused harm with my latest more focused complaint. But I see the CC isn't going to do anything until Cochrane investigate that.

In case it helps other readers follow this thread: The Charity Commission (CC) is concerned with process - it issues guidance about how Charities should adopt and institute processes but the CC doesn't specify what every Charity should do - only that there is Charity Law that must be followed and that there is a body of 'good practice', but it is still up to individual Charities to interpret how the Law, good practice and CC Guidance as it applies to them.

In this case while it's obvious that Cochrane has been failing in its response to Caroline's very reasonable enquiries, as Cochrane's management is now saying it will set up an appropriate 'process' to look at Caroline's complaint(s), then from the CC perspective everything is right with the world. This does not mean that Cochrane is obliged to find that the arguments that Caroline has put to them are well founded, from the CC perspective it is only necessary that a reasonable complaint is handled in an appropriate manner and a proportionate response given. Only at that point would there be a potential for a further complaint to the CC depending upon what the outcome of the first complaint was.

If the current process doesn't lead to a) the permanent withdrawal of Cochrane's Exercise as treatment for adults with chronic fatigue syndrome or b) the timely 'start and completion' of the report of the promised independent advisory group then there would likely be grounds for a formal complaint to the CC - the failure to deliver that report in timely manner is an unequivocal failing of reasonableness, because Cochrane have recognised a need, have promised to meet that need and (will) have demonstrably failed to meet it i.e the organisation promised a 'process' but didn't deliver it - the CC should be able to recognise that.

 

[NelliePledge]

Should doesn’t automatically mean will be able to recognise. Especially in unequivocal non weasel word terms. But it is still definitely worth chipping away.

 

[CRG]

Should doesn’t automatically mean will be able to recognise. Especially in unequivocal non weasel word terms. But it is still definitely worth chipping away.

It's a question of identifying where the Commission should reasonably take an interest. Process and failures of process are clearly areas where the CC is required by its own terms to have an understanding in both principle and practice, from there it becomes possible to build further arguments.

So if it comes to the point where Cochrane are offering no means of resolution for patients concerned about what Cochrane publishes about treatments for ME/CFS, then the CC can be ask to decide whether or not the level of 'risk' (to the Charity's reputation, and/or the reputation of the Charity sector as a whole and/or the health of an identifiable group) for it (the CC) to intervene.

If the CC decides that the risk is not sufficient for its involvement, then that becomes the focus for potential action against the CC - firstly by pursuing the internal complaints procedure and then if necessary going to the Parliamentary Ombudsman - the latter is a free service but it does require a supporting MP. If going as far the Ombudsman and the decision there is that the CC has failed in its responsibilities, then the Ombudsman can make direction to the CC to put things right.

Obviously this is a lot of potential work and no one should be obliged to take it to its conclusion - however if someone/s is/are taking the process forward I think it would be valuable to get specialist legal advice before embarking on the 2nd stage so that a formal complaint to the CC is set clearly within Charity Law and the responsibilities of the CC as set out by Parliament.

 

[FMMM1]

If the CC decides that the risk is not sufficient for its involvement, then that becomes the focus for potential action against the CC - firstly by pursuing the internal complaints procedure and then if necessary going to the Parliamentary Ombudsman - the latter is a free service but it does require a supporting MP. If going as far the Ombudsman and the decision there is that the CC has failed in its responsibilities, then the Ombudsman can make direction to the CC to put things right.

If the process is free, i.e. appealing to the [Charity Commission] Parliamentary Ombudsman, then why not ask a supportive MP? Even if it doesn't go to conclusion it may e.g. "encourage" the Charity Commission --- or Cochrane --- to do something. It might damage Cochrane's "reputation" ----

I don't know much about this issue but if I were in the Charity Commission I'd be reluctant to:

• bluntly state we [Charity Commission] are free to decide when to act in the public interest;
• say that Cochrane is conducting an inquiry ---- given how long they've been "reviewing" this.

OK possibly something about --- we [Charity Commission] will continue to review/monitor --- [other weasel words] ----

So maybe rattle the cage --- get an MP on board and ask the Parliamentary Ombudsman --- given the NICE review --- Cochrane clearly in conflict --- concern re potential for harm ----
Public bodies do often have considerable autonomy -- but if those in power start showing an interest then "values" can change!

 

[Sean]

Public bodies do often have considerable autonomy -- but if those in power start showing an interest then "values" can change!

A bit of 'nudging', one might even say.

 

[FMMM1]

A bit of 'nudging', one might even say.

get an MP on board and ask the Parliamentary Ombudsman

Do we wish to draft something - I could ask my MP (Northern Ireland) to "sponsor" - rather a Conservative/Government party - or ask the APPGs! Prefer APPGs as they're cross party ---
EDIT --- we could ask the APPGs to ask the Charity Commission to write to Cochrane expressing concern re conflict NICE Guideline & Cochrane review --- Cochrane review needs to be progressed as a matter of urgency ---
@Caroline Struthers @CRG --- others?

 

[CRG]

If the process is free, i.e. appealing to the [Charity Commission] Parliamentary Ombudsman, then why not ask a supportive MP? Even if it doesn't go to conclusion it may e.g. "encourage" the Charity Commission --- or Cochrane --- to do something. It might damage Cochrane's "reputation" ----

I don't know much about this issue but if I were in the Charity Commission I'd be reluctant to:

• bluntly state we [Charity Commission] are free to decide when to act in the public interest;
• say that Cochrane is conducting an inquiry ---- given how long they've been "reviewing" this.

OK possibly something about --- we [Charity Commission] will continue to review/monitor --- [other weasel words] ----

So maybe rattle the cage --- get an MP on board and ask the Parliamentary Ombudsman --- given the NICE review --- Cochrane clearly in conflict --- concern re potential for harm ----
Public bodies do often have considerable autonomy -- but if those in power start showing an interest then "values" can change!

I've never been directly involved in an Ombudsman complaint, and I'm long out of touch with anything Parliamentary but - my impression is that MPs take the Ombudsman process pretty seriously and don't like being involved in low chance of success cases and/or cases that are other than unequivocally evident of injustice (Knight on white horse syndrome). Free doesn't mean there is no test of validity - indeed the first hurdle is whether the complaints procedure of the contentious organisation has been exhausted: follow the "can we look into your complaint" arrows here: https://www.ombudsman.org.uk/

I'm dubious about cage rattling in my (limited) experience, rather than promoting positive action it produces retreat to the bunker responses and an unwillingness to engage positively. In this case we do not know that Cochrane has acted outside the Law or acted contrary Charity Commission guidance, and there's no substantive evidence of maladministration by the CC. We can see why both organisations are 'in the wrong' but that doesn't mean that they are wrong in Law or in regulation - that is a case to be made, and as far as I can see that needs significant work and expert advice. Part of that work is following the processes and building evidence along the way.

Cross posted but I think the above still stands

Do we wish to draft something - I could ask my MP (Northern Ireland) to "sponsor" - rather a Conservative/Government party - or ask the APPGs! Prefer APPGs as they're cross party ---
@Caroline Struthers @CRG --- others?

I really think this needs a clear view of the process. Although a complaint to the Ombudsman is not contingent on Caroline's engagement with the CC, in practical terms any complaint to the Ombudsman must have exhausted the complaints procedure of the contended organisation - here the CC, so if Caroline's complaint is not referenced a whole new complaint process with the CC will have to be started in another name, at which point the CC will reference a) it's already position (as put to Caroline) b) the need for any complaint to be put first to Cochrane - the new named complainant is then drawn back to Cochrane who will than refer to a) the Bastian review b) the principles that it is following in Caroline's complaint.

And if Caroline's complaint to the CC is referenced then the Ombudsman will merely test the CC's position which would lead back to Cochrane which is currently (seemingly) taking Caroline's complaint seriously and so 'no case'.

As I said above it's all about process - the CC has processes and it requires processes to be developed and followed by Charities, the CC will only involve itself where processes in a Charity are demonstrably failing (fraud, reputational damage etc) AND the Ombudsman will only find against the CC where its processes have demonstrably failed (maladministration). Circles of Hell etc.

So my conclusion is that a stepped approach, frustrating as it is, is the only way forward which is: Cochrane complaint process >success| or failure then> CC complaint process >success| or failure then> Parliamentary Ombudsman.

 

[FMMM1]

I've never been directly involved in an Ombudsman complaint, and I'm long out of touch with anything Parliamentary but - my impression is that MPs take the Ombudsman process pretty seriously and don't like being involved in low chance of success cases and/or cases that are other than unequivocally evident of injustice (Knight on white horse syndrome). Free doesn't mean there is no test of validity - indeed the first hurdle is whether the complaints procedure of the contentious organisation has been exhausted: follow the "can we look into your complaint" arrows here: https://www.ombudsman.org.uk/

I'm dubious about cage rattling in my (limited) experience, rather than promoting positive action it produces retreat to the bunker responses and an unwillingness to engage positively. In this case we do not know that Cochrane has acted outside the Law or acted contrary Charity Commission guidance, and there's no substantive evidence of maladministration by the CC. We can see why it both organisations are 'in the wrong' but that doesn't mean that they are wrong in Law or in regulation - that is a case to be made, and as far as I can see that needs significant work and expert advice. Part of that work is following the processes and building evidence along the way.

Cross posted but I think the above still stands



I really think this needs a clear view of the process. Although a complaint to the Ombudsman is not contingent on Caroline's engagement with the CC, in practical terms any complaint to the Ombudsman must have exhausted the complaints procedure of the contended organisation - here the CC, so if Caroline's complaint is not referenced a whole new complaint process with the CC will have to be started in another name, at which point the CC will reference a) it's already position (as put to Caroline) b) the need for any complaint to be put first to Cochrane - the new named complainant is then drawn back to Cochrane who will than refer to a) the Bastian review b) the principles that it is following in Caroline's complaint.

And if Caroline's complaint to the CC is referenced then the Ombudsman will merely test the CC's position which would lead back to Cochrane which is currently (seemingly) taking Caroline's complaint seriously and so 'no case'.

As I said above it's all about process - the CC has processes and it requires processes to be developed and followed by Charities, the CC will only involve itself where processes in a Charity are demonstrably failing (fraud, reputational damage etc) AND the Ombudsman will only find against the CC where its processes have demonstrably failed (maladministration). Circles of Hell etc.

So my conclusion is that a stepped approach, frustrating as it is, is the only way forward which is: Cochrane complaint process >success| or failure then> CC complaint process >success| or failure then> Parliamentary Ombudsman.

Thanks for your coherent and detailed response.

I haven't followed this, nor do I have your depth of knowledge of the procedures/system ---
13th February 2020 - 3 years ago:
"[Bastian] Honored to be leading an independent advisory group for the full update of the Cochrane review on exercise therapy and ME/CFS. I'm so happy to see community concerns taken this seriously! Details & contact address in @cochranecollab announcement:"
[https://www.s4me.info/threads/indep...y-and-me-cfs-2020-led-by-hilda-bastian.13645/]
So could we suggest frustration & concern and ask the ombudsman to look into it --- there hasn't even been an update from Cochrane. The Cochrane review is plainly at odds with the NICE Guideline. Evidently [3 years] the Cochrane integral review system isn't working ----
EDIT - I agree re not pushing the Ombudsman/system into the bunker --- but the APPGs are cross-party.

 

[Sean]

we could ask the APPGs to ask the Charity Commission to write to Cochrane expressing concern re conflict NICE Guideline & Cochrane review

This could work.

 

[Trish]

This could work.

I suspect the response will be that the Charity Commission doesn't adjudicate on medical issues when there is professional disagreement and where the Charity has followed its own rules.

And Cochrane is likely to say the matter is in hand with the appointment of the current team tasked with writing a new review, and even boast about having a PAG as well.
I think at present all we can expect from communication with Charity Commissioners is getting it on record that they have been informed of the problem.

I'm not in favour of asking MP's who have very limited time to work on any issue, to tackle something where we are aware already that there is little or no chance of achieving anything. Better I think to get their support on the broader issues the APPG and working groups are already tackling like getting NICE implemented, getting better access to disability benefits for pwME and increasing research funding.

 

[FMMM1]

Cochrane is likely to say the matter is in hand with the appointment of the current team tasked with writing a new review

Apologies, I really haven't followed this closely, so we have a Hilda review [commenced 3 years ago] and (separately) a new Cochrane review of exercise therapy and ME/CFS?

NICE implemented, getting better access to disability benefits for pwME and increasing research funding

Yes, but we've seen research funding misdirected (poor research). Also, it depends how big a risk Cochrane is --- it contributes to the culture of useless research i.e. by defending same. On the + side, Cochrane's failure to align with NICE Guideline assessment, of the evidence base, possibly helps to undermine Cochrane.

 

[Trish]

Apologies, I really haven't followed this closely, so we have a Hilda review [commenced 3 years ago] and (separately) a new Cochrane review of exercise therapy and ME/CFS?

No. One review. Hilda leads the Patient Advisory Group (PAG) that is supposed to advise the review writing team. It's the same one this very long thread is about and hasn't yet even published its protocol.

Yes, but we've seen research funding misdirected (poor research). Also, it depends how big a risk Cochrane is --- it contributes to the culture of useless research i.e. by defending same. On the + side, Cochrane's failure to align with NICE Guideline assessment, of the evidence base, possibly helps to undermine Cochrane.

I agree the continuing existence of the old Cochrane review is a problem, as is Cochrane's wider support in many reviews for shoddy useless research. My point was that trying to get MP's to focus their energy on the specific point of whether such shoddy work by Cochrane is something the Charity Commission can tackle seems to me like misdirected effort. Better, I think, to focus on the wider issue of the quality of research funded by the government - which is already part of what the APPG is working on.
If others disagree with me, that's fine.

 

[CRG]

Thanks for your coherent and detailed response.

I haven't followed this, nor do I have your depth of knowledge of the procedures/system ---
13th February 2020 - 3 years ago:
"[Bastian] Honored to be leading an independent advisory group for the full update of the Cochrane review on exercise therapy and ME/CFS. I'm so happy to see community concerns taken this seriously! Details & contact address in @cochranecollab announcement:"
[https://www.s4me.info/threads/indep...y-and-me-cfs-2020-led-by-hilda-bastian.13645/]
So could we suggest frustration & concern and ask the ombudsman to look into it --- there hasn't even been an update from Cochrane. The Cochrane review is plainly at odds with the NICE Guideline. Evidently [3 years] the Cochrane integral review system isn't working ----
EDIT - I agree re not pushing the Ombudsman/system into the bunker --- but the APPGs are cross-party.

We have to start by parsing the respective responsibilities of the Charity (in this case Cochrane), of the Charity Commission and of the Ombudsman – in effect these are a daisy chain.

The Ombudsman service (PHSO) will only deal with a formalised complaint about a public body – so in this case the complaint has to be about the CC, to be successful the complainant will have to show that the CC has acted wrongly or failed to act in accordance with Law. The first test the PHSO will place on the complaint is whether the complainant has exhausted all avenues of complaint to the CC. The PHSO does not have general duty to investigate wrongs in the public sector – it is there as a (non Court) last line of remedy for those who believe a public body has failed in a specific way:

https://commonslibrary.parliament.uk/parliamentary-ombudsman/#heading-2

“The PHSO examines complaints of ‘maladministration’. Maladministration can be broadly defined as the public body not having acted properly or fairly or having given a poor service and not put things right.”

-----------------------------------

At this point in the daisy chain, (using Caroline’s complaint as the reference) the ‘exhausted all avenues’ test means a complaint to the PHSO will fall because the CC will say that it has no basis to be involved because the Charity (even if belatedly) is seeking to address the complaint.

As I said above this is all about process and even if the pace is glacial there’s clearly a process is being instituted by the Charity, which in turn vindicates the CC – so no maladministration, and therefore no case to take to the PHSO.

Re: the slowness of the Charity – even if this was put to the CC as a basis for it to become directly involved, Cochrane would have multiple justifications, not least the pandemic, it might also pointedly say its administration was affected by recent withdrawal of UK Government funding, as well as changes of personnel, and of course family bereavement.

Re: the NICE guideline update – this may not have the power of argument that seems obvious to us. In practical terms it is perverse that Cochrane doesn’t simply reference the guideline and remove Larun et al, but from the CC perspective things may be somewhat different and I would suggest proceeding cautiously in raising this with the CC. For example Cochrane might argue that their Charity Objects* require the freedom to publish all relevant reviews regardless of different academic perspectives. If the CC were to accept that, then the opportunity for successful complaint would be reduced. We are here into the technicalities of charity law and IMO that needs professional advice.

Re: the APPG while it might be appropriate for the APPG (secretariat is ME and AfME) to be made aware of Caroline’s correspondence with Cochrane and the CC, I’m not clear that the APPG has relevance to the Ombudsman or CC at this point – though it might be reasonable for the APPG and/or ForwardME to write to Cochrane expressing concern about the delay in the Bastion PAG informed report reaching a timely conclusion.

My concern re: bunker mentality was about Cochrane and the CC. Organisations questioned on their decisions by higher authorities often find it easier to defend their adopted positions rather than become open to reconsideration. My view is that there’s still a possibility of a more open response from both depending on where things get to on the daisy chain.

*Cochrane charitable objects:

https://register-of-charities.chari.../-/charity-details/1045921/governing-document

“The protection and preservation of public health through the preparation, maintenance and promotion of the accessibility of systematic reviews of the effects of health care or any other charitable activities, for the public benefit.”

My bold.

 

[CRG]

I suspect the response will be that the Charity Commission doesn't adjudicate on medical issues when there is professional disagreement and where the Charity has followed its own rules.

Yes, I'm sure that is right. There is though perhaps a different argument about patient safety, where the NICE guideline does have relevance, but identifying where Cochrane's responsibility relative to that might be is contingent on Cochrane's response to Caroline's complaint, and completion of the PAG process. Only then will we know what value Cochrane is placing on NICE.

 

[CRG]

Apologies, I really haven't followed this closely, so we have a Hilda review [commenced 3 years ago] and (separately) a new Cochrane review of exercise therapy and ME/CFS?

Sorry I misleadingly used the term 'Bastian review' above - as Trish has explained Hilda is slated to lead a PAG which is intended to feed into the subsequent 'new review'.

Yes, but we've seen research funding misdirected (poor research). Also, it depends how big a risk Cochrane is --- it contributes to the culture of useless research i.e. by defending same. On the + side, Cochrane's failure to align with NICE Guideline assessment, of the evidence base, possibly helps to undermine Cochrane.

Yes, but IMO if used in argument/complaint needs to be done so with caution and guided by expert knowledge of Charity Law.

 

[NelliePledge]

Charity law knowledge is definitely required the more I ponder this.

The parliamentary ombudsman focus is primarily on individual cases of maladministration so that an individual would need to show they had been negatively affected by the work of a public body and complain about that through their constituency mp,having exhausted the internal complaints process. Classic examples would be excessive delays in resolving a benefits claim or a tax issue.

The ombudsman lists when they will not investigate and that includes where the issue could be pursued through the courts.

 

[Caroline Struthers]

Confident "get stuffed" message from Cochrane, just received. [I also complained about the Exercise review update process, so there is a third complaint for them to respond to...maybe they're saving that for tomorrow?]

Dear Caroline,

We have considered the following complaints.
a) Complaint regarding the Editor-in-Chief dated 23.3.2023.
b) Complaint regarding information on the appointment of a consumer advocate to the Cochrane Library Oversight Committee dated 23.3.2023

Your complaints, along with your comments have been noted. With regard to our policies and procedures, the Terms of Reference for the Cochrane Library Oversight Committee and Complaints Resolution process will be revisited as part of a scheduled piece of work that the Head of Governance will take forward.

We now consider the matter closed. We do not believe further correspondence will be helpful. Thus, no further correspondence on these subjects will be considered.

Kind regards

Catherine