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

[Adrian]

Thanks! Not about any specific issue nor about criticism or criticizing the same thing persistently. However, the "is there a way we can increase the attention...?" does go straight to the question of effectiveness.

If people don't listen and act on valid criticism then things need repeating. Lets face it Cochrane ignored the issues with the current review for many years and patients had to keep campaigning. Lets face it when a bunch of people such as those involved in Cochrane have ingrained attitudes and are unwilling to change what else can be done - especially when they are in a position of power.

If Cochrane had stronger processes to ensure reviews didn't have bias then maybe that would be different but as far as I am concerned Cochrane seems to run like a club of friends rather than as a professional organization with a trusted brand.

 

[Adrian]

One point that might not have been made yet (I haven't been able to keep up with the discussion in this thread) is that this process isn't just about our patient group.

It is a pilot programme and if successful, should in principle be used to revise or guide the development new meta analyses covering other conditions where there are similar methodological problems and ideally, improve the quality of non-pharmacological clinical trials in the future.

That is a good point but the 'process' seems to be to appoint someone to appoint a group. Where is the analysis of the skills needed for the different roles and a strong process for recruitment to reduce the biases of one given individual that should be part of such a programme.

 

[Adrian]

For the IAG: I got to know George Faulkner in the discussions at Cochrane that led up to this process. For the methodologist positions on the IAG, I am going to rely on people I have known a long time, in whose expertise and integrity and listening/communication skills I have enormous confidence, who I know will be both diligent and have zero reluctance to tell me when I'm screwing up, and who I know will engender a lot of confidence in members of the Cochrane community.

So basically this process is about the Hilda club - people Hilda has met and worked with over a logner time. Its not about patient participation and partnership with patients.

 

[Trish]

Feel free not to read my diversion into history and metaphor. [Edit: I think it is highly relevant.]

Spoiler: a diversion

History shows us that over a lot more than the last century people with chronic disabling diseases without an established physical cause have been viewed as possessed by the devil or equivalent needing some version of exorcism, or as morally weak needing some sort of religious cleansing by a powerful priestly caste, or, right up to the present, as psychologically flawed (psychosomatic) and/or morally flawed (malingering) and in need of brainwashing to rid us of our wrong thinking and behaviour. Societies have been taught to see us as to be pitied or shamed and excluded. We are 'other'.

Modern medicine's approach to 'treatment' of people with chronic disease they don't understand is to continue to act out the role of the all knowing and powerful priestly caste, today in the form of psychiatrists and a range of their acolytes called 'therapists' whose task is to teach us to think and act according to their norms, to make us compliant so we don't bother society - to withhold financial support to force us to conform to the current work and exercise are good for you ethic, and if we refuse to / cannot conform, to hide us away with minimal support to keep us just alive. [Edit to add: And when their prescribed magical thinking and behaviour changes don't work and make us sicker, we are blamed and shunned - it is our failure and confirms our psychological and moral weakness].

I realise this may seem a ridiculous diversion and nothing to do with the present situation, but I think this puts the picture of the 'two sides' into a wider context. It is in the interests of the powerful to continue to place in authority of us the 'priestly and acoloyte' group of psychiatrists and therapists to keep is in order. And it is in the interests of the priests and acolytes to maintain their power and status by all means possible, including via the media, scientific organisations, medical review bodies and the wider population, and by hoodwinking reviewers into believing their scientifically illiterate research has validity.

So now we have several situations happening all at once as the priestly class feel threatened. We have this Cochrane review, the CDC taking a massive step backwards by uncritically including all the old Oxford studies in their current literature review in preparation for a new guideline, and the NICE committee faced with a massive backlash of more poor quality so-called evidence thrust at them by the priestly caste to try to get them to reverse their recommendations.

Is it no wonder some patients who spend time delving into the murky history, while at the same time feeling very ill, being significantly disabled, and lacking medical care, feel bruised and angered by the cumulative effect of the power of the priestly caste over us.

No this is not a polite debate between two equal sides who need to listen to each other's point of view and come to a compromise.

This is about the desperate need for good science and justice.

While the priestly caste continue to weaponise incompetent science, which better scientists say would not even pass as a simple undergraduate study, let alone should pass Cochrane review level scrutiny. And while Cochrane and other bodies continue to fail to recognise that they have reviews on their books that are completely incompetent and harmful, we find ourselves yet again in this situation of having to go through the same tortuous process of a review body taking seriously and 'reviewing' research so deliberately incompetent as to be both laughable and criminal.

I hope a review is done. If it is to pass the first most basic level of competence its protocol must include first and foremost that no subjective data from an unblinded trial will be included as valid data. There are studies with objective outcomes - PACE had several. Last time, if I recall correctly, the review specifically excluded these - the reviewers were doing the bidding of the BPS researchers. This time, if it is to have any credibility scientifically, it has to take that first step of rejecting subjective data, since blinding is impossible.

 

[Barry]

I hope a review is done. If it is to pass the first most basic level of competence its protocol must include first and foremost that no subjective data from an unblinded trial will be included as valid data. There are studies with objective outcomes - PACE had several. Last time, if I recall correctly, the review specifically excluded these - the reviewers were doing the bidding of the BPS researchers. This time, if it is to have any credibility scientifically, it has to take that first step of rejecting subjective data, since blinding is impossible.

I think in the past @Jonathan Edwards has said that subjective outcomes in unblinded trials can sometimes be OK, provided they are only secondary, and that primary outcomes are objective; the objective outcomes can then be used to assess the validity or not of the subjective ones. But I may have remembered this wrong.

 

[adambeyoncelowe]

Think this might be worth noting here especially in relation to what is going on within NICE? ?


'Awareness of the FOI response has got me looking at minutes of Guideline Committee [GC] meetings subsequent to the consultation on the draft.

It takes time to download and find the record of what went on at these. Which can be summed up in a single page - attached.

Key messages:
* the first meeting subsequent to the consultation period took place on March 1st.
at this meeting guideline lead Kate Kelley presented the GC with “an overview of stakeholder comments" - it is unclear whether or not the GC actually get to see the comments, or have to proceed solely on the basis of "an overview” produced by NICE
all other items begin “The committee reviewed and discussed stakeholder comments and recommendations on ….” with the following exception …
… at the meeting of 8th of March, having "reviewed and discussed stakeholder comments and recommendations on CBT”: “The committee amended recommendations on CBT”.

* the issue of “indirectness in GRADE ratings” was discussed on 5th March; there is no record of the decision to seek further papers etc., as revealed in the e-mails shared following FOI; this could mean that it wasn’t a GC decision, but taken by NICE - albeit recording that the GC were informed of this would have been appropriate (assuming that they were made aware).

The most recent meeting for which a minute has been posted on the website is 22nd March. Next meeting was scheduled for 19th April, two and a half weeks ago now.

Hope this is helpful.

PERMISSION TO SHARE

BW, H"

Just as a point of clarity:

Obviously, I can't comment on discussions or outcomes, but I can reassure you that we see everything. There are no secrets.

The summaries are presented because we're often dealing with, as you can see from the evidence reviews, hundreds to thousands of pages of evidence and material at a time.

The summaries are provided in addition to giving us access to the raw info those summaries are based on, not instead of.

 

[Sly Saint]

Gladwell and colleagues surveyed members of a patient organisation and concluded:
“The negative themes [which were reported] may help explain the negative outcomes from rehabilitation reported by previous patient surveys.

The negative themes indicate rehabilitation processes which contradict the NICE (National Institute for Health and Clinical Excellence) Guideline advice regarding GET, indicating that some clinical encounters were not implementing these.

These findings suggest areas for improving therapist training, and for developing quality criteria for
rehabilitation in CFS/ME.” [32]

https://www.s4me.info/threads/adver...ome-2021-white-etherington.20767/#post-347678

 

[Hilda Bastian]

So basically this process is about the Hilda club - people Hilda has met and worked with over a logner time. Its not about patient participation and partnership with patients.

I took it for granted that I didn't need to repeat that the 3 organizations of people with ME/CFS nominated their own representatives to the IAG and that it would be obvious I didn't know people with a clinical background in ME/CFS. I didn't know people from those organizations of people with ME/CFS and I had never met the people they nominated till they joined. I had never met either of the people appointed for clinical background either until I interviewed them.

I am increasingly comfortable with not having taken chances with methodologists, watching this unfold in the last few days. I didn't want to risk having people who would patronize, bull-doze, just not bother too much, etc. And these had to be people with an extremely deep familiarity with Cochrane's methods (which of course really increased the odds that we would know each other).

Yes, I agree, a lot was vested in me in this role. And no, that doesn't mean the editor-in-chief picked someone she'd have in her pocket, which I think is the implication of the comment. She explicitly picked someone she wouldn't have in her pocket, and she knew it. In fact, I was genuinely shocked that it was me that she asked - and I made very sure she understood the risks and implications of that choice before I accepted.

I don't think the setup was ideal either, but when I saw the tasks ahead that needed to be done to get there even by early 2022, that's the call I made. As I've said before, I had discussions with people with ME/CFS beginning when this was announced in October 2019, and came to decisions and negotiated arrangements that I believed were the best plan within the constraints. The IAG will make recommendations about all this at the end, when we've seen what seemed to work well and what didn't.

 

[Barry]

I think in the past @Jonathan Edwards has said that subjective outcomes in unblinded trials can sometimes be OK, provided they are only secondary, and that primary outcomes are objective; the objective outcomes can then be used to assess the validity or not of the subjective ones. But I may have remembered this wrong.

This is an example of what I was thinking of:
https://www.s4me.info/threads/uk-pa...ay-24th-january-2019.7826/page-16#post-138969

It is true that subjective endpoints for things like pain and fatigue are the most important, but if you cannot blind the trial you just cannot use them on their own. But that does NOT mean you have to use something else instead. We do not do that for rheumatoid arthritis. What we do is respect the subjective score, but we require that to be backed up as well by some objective sign that confirms that the subjective score is likely to be a true reflection of what you want to change. You still just have one measure of outcome, but it is a belt and braces measure.

But having reread that I think I may have been taking Jonathan's comment out of context a bit, because for ME/CFS there are better, objective, outcomes that can be used instead. But I still think it might be unwise to suggest removing mention of all unblinded/subjective outcome trials on that basis alone, but better to clarify that they should not be considered unless all the belt-and-braces safeguards are being employed; in the case of the trials we have concerns with, they never have any such safeguards, and the investigators never even seem to have any awareness of the need for them. This would avoid walking into a trap of our own making.

 

[MSEsperanza]

Apologies for self-quoting. Searching for references to Barry's posts I stumbled across a somewhat related post that seems still to be relevant:

About the Cochrane Work Group's reviews

At a quick glance I found only one review that used sick leaves as one of the outcome measures for health conditions usually classified as 'subjective':

Conservative interventions for treating work‐related complaints of the arm, neck or shoulder in adults (2013)

https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD008742.pub2/full

Other reviews on allegedly 'subjective' impairments that are listed on the Work Group's site under 'Our Systematic Reviews' → Cochrane reviews about occupational safety and health (mostly edited by other groups though) at a very quick glance either didn't apply any objective outcomes or didn't report them as important outcomes in the summaries:

(A proper search could bring some more encouraging results though-)

Cochrane Work Group

Workplace interventions for increasing standing or walking for decreasing musculoskeletal symptoms in sedentary workers (2019)

https://doi.org/10.1002/14651858.CD012487.pub2

Cochrane Back and Neck Group:

Exercises for mechanical neck disorders

Version published: 28 January 2015 see what's new

https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD004250.pub5/full



Cochrane Back and Neck Group

Behavioural treatment for chronic low‐back pain - Henschke, N - 2010 | Cochrane Library

https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD002014.pub3/full

Comment

https://www.cochranelibrary.com/cds....pub3/detailed-comment/en?messageId=244235352


Cochrane Musculoskeletal Group

Multidisciplinary rehabilitation for fibromyalgia and musculoskeletal pain in working age adults (1999, amended 2008: Converted to new review format. )

https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD001984/information#authors

Edited to add: Meanwhile I doubt any editor at Cochrane is interested in understanding the criticism discussed on S4ME. I think the best thing would be if members of the advisory group had a say in choosing the authors (and if there were S4ME members among the authors).

The addition about the review authors was made back then.

 

[petrichor]

The composition of the author team is far from perfect, but I think there are pretty strong limits to how perfect it can get. Other reviews, such as NICE and the Dutch health council both had a mix of people with different views and backgrounds on them, but they still both concluded that GET should not be recommended. There is an advantage to having a mix of people on a team, as that gives the final review more credibility, rather than a perception of being loaded with people that will lead to a foregone conclusion.

I think that people's points in this thread are all pretty much valid, and there are probably things that could have been done better and could still be done better in the process of this review. And it isn't easy to predict what the final conclusion will be. I've had a look at some previous reviews of people on the team, and in order to accept the criticisms of PACE, they would need to consider things which they don't seem to usually consider when reviewing evidence. But I'm not sure how possible it would be for there to be (mostly) people on the team who do usually consider the kinds of criticisms made against PACE.

None of the people on the author team seem to have outright conflicts of interest, and there doesn't seem to be anything to suggest they're ideologically opposed to criticisms of GET trials or to criticisms to the universal utility of exercise, so there doesn't seem to be much reason to believe they'll outright reject those criticisms.

The specific inclusion of a "non-activist" patient picked for differing experiences with exercise on the author team is unusual and a bit strange, and I assume that has something to do with cochrane wanting to maintain the pretty significant amount of credibility and respect it has among people who might assume the review is pandering to "activists". I agree with other people that that's weird and not a very good look for cochrane, and may indicate some questionable views in cochrane. But Kay does seem like a fairly good pick, regardless.

I think that people should still keep expressing their concerns about the composition of the team and other things in this thread though, because Hilda is the Lead on the IAG and the IAG was set up to ensure and facilitate responsiveness to stakeholder concerns.

 

[Trish]

This is an example of what I was thinking of:
https://www.s4me.info/threads/uk-pa...ay-24th-january-2019.7826/page-16#post-138969

But having reread that I think I may have been taking Jonathan's comment out of context a bit, because for ME/CFS there are better, objective, outcomes that can be used instead. But I still think it might be unwise to suggest removing mention of all unblinded/subjective outcome trials on that basis alone, but better to clarify that they should not be considered unless all the belt-and-braces safeguards are being employed; in the case of the trials we have concerns with, they never have any such safeguards, and the investigators never even seem to have any awareness of the need for them. This would avoid walking into a trap of our own making.

What safeguards? Even if an unblinded clinical trial is carried out very well with all possible safeguards, the placebo effect still happens - as demonstrated by the unblinded early stage Rituximab trials, and the asthma trial we keep dredging up to illustrate the point. I can't see any way around unblinded trials only being valid if they have objective primary outcomes.

I thought the point of still including subjective outcomes was as a secondary adjunct to objective measures, simply to help clarify the patient's reported experience.

For example, if an objective measure shows benefit, but the patients don't feel any better subjectively, then that is useful information - perhaps that the objective measure is not measuring something central to the disease - like improving a vitamin level in the blood, but that vitamin is not relevant to that disease.

Or if an objective measure fails to show any benefit from the treatment, then it may be useful to see that a subjective measure indicates patients reporting benefit. This is useful information, for example in an ME trial, it indicates that the reported improvement may be caused by placebo or therapist effect, and may give patients and therapists a false idea that exercise is beneficial, leading to patient harms. Or in the asthma trial, the sham treatment led to patients thinking their breathing was OK, and could lead to them not taking the medication they need to prevent possibly life threatening worsening.

 

[MSEsperanza]

Comment from 2000 on the review Behavioural treatment for chronic low‐back pain quoted above -- didn't check the revisions so no idea how the author team from 2010 (when Henschke joined them) responded to it, also don't know Henschke's current stance on that:

Comment on the Back Group behavioural review (The Cochrane Library 2000, issue 2)
Note: This comment may relate to a previous version of this Review.

The commentator thinks there is a discrepancy between the author's presentation and discussion on the studies, and their conclusions. The commentator states that the results indicate that behavioral therapy gives a moderate effect only with back patients that receive no other treatment, but that effect is not proved in comparison with other treatment modalities. The commentator goes on to suggest that the whole treatment effect of behavioral treatment in this patient group is a placebo effect and no real treatment effect. The commentator states, "Behavioral treatment should not be recommended outside the setting of clinical trials."

Reply
We indeed clearly state in the review that behavioral therapy only gives moderate effect in the comparison with no treatment or waiting list control and that there were no differences identified when behavioral therapy was compared to other treatments. Moreover, comments like this and ongoing discussion regarding the potential beneficial effect of behavioral treatment (among other in guideline committees) prompted us to disaggregate the analyses regarding the comparison of behavioural treatment versus waiting list control, no treatment or placebo for this up‐date. The main reason for this is that we wanted to assess what components or types of behavioural treatment were effective. This update shows that especially a combined cognitive‐respondent therapy or progressive relaxation are effective for short‐term pain reduction.

We disagree with the commentator when he states that, "Behavioural treatment should not be recommended outside the setting of clinical trials." In our opinion many treatment modalities are used for chronic low back pain and there is not one treatment option that has been proven beyond doubt to be more effective than other treatment modalities. It is unlikely that the effectiveness of behavioral treatment is merely a placebo effect. As we have stated in our recommendations, we do agree that more research is needed in order to improve the understanding what specific patient populations benefit most from what kind of behavioral treatment.

Contributors
Commentator ‐ Ottar Grimstad
Criticism Editor ‐ Dr. Alf Nachemson

Declarations of interest:
No conflict of interest declared.

Edited to clarify: didn't check the revisions so no idea how the author team from 2010 (when Henschke joined them) responded to that comment from 2000 also don't know Henschke's current stance on that.

Apologies for causing extra confusion.

 

[Adrian]

I took it for granted that I didn't need to repeat that the 3 organizations of people with ME/CFS nominated their own representatives to the IAG and that it would be obvious I didn't know people with a clinical background in ME/CFS. I didn't know people from those organizations of people with ME/CFS and I had never met the people they nominated till they joined. I had never met either of the people appointed for clinical background either until I interviewed them.

But you got to choose the organizations and that organizations would nominate people and why it was a good idea. There seems to be no systematic process behind choices or if there is nothing is being communicated. So by saying its the Hilda club I mean things like these choices which as far as I can tell from what is communicated are arbitary and at your whim rather than the result of any analysis of needs and process to look at how to best meet these needs. That really isn't the way professional organizations operate!

I am increasingly comfortable with not having taken chances with methodologists, watching this unfold in the last few days. I didn't want to risk having people who would patronize, bull-doze, just not bother too much, etc. And these had to be people with an extremely deep familiarity with Cochrane's methods (which of course really increased the odds that we would know each other).

Again you are describing yourself being comfortable with making your choices. And quite honestly the previous review demonstrated Cochranes methods are not upto the task - blindly taking results and combining with some vague 'oh I think that trial is good quality' such as has happened simply isn't sufficient. A detailed analysis of the interverions, how they are controlled and whether the measurement technqiues are likely to be sufficiently independent given the controls seems to me to be pretty basic. As well as an analysis of the actual properties of a measurement system and hence the statistical methods that can apply - I wouldn't trust an organization that signs off on using results on a 'scale' with two marking schemes allowing patients to both simulaniously improve and get worse - yet that is what Cochrane did.

Many more things than need to be in the analysis such as the equivalence of the interventions and whether they are comparable. Assess whether the protocol was carried out (I think there were for example serious issues in one site for PACE). How was treatment dose and compliance measured (it wasn't). All these types of questions are really key as they address the structural uncertainty of all the results.

But as far as I can tell Cochrane's methods do not dig and do detailed analysis of the protocols, measures, execution of the trials more a collective finger in the air about what was good or not.

Yes, I agree, a lot was vested in me in this role. And no, that doesn't mean the editor-in-chief picked someone she'd have in her pocket, which I think is the implication of the comment. She explicitly picked someone she wouldn't have in her pocket, and she knew it. In fact, I was genuinely shocked that it was me that she asked - and I made very sure she understood the risks and implications of that choice before I accepted.

You really don't get the point do you. Its not how professional organizations run (or perhaps the do in the medical world but not outside). There are always processes to reduce bias and arbitary (and potentailly bad choices) along with suitable checks and balances. Whether you make good or bad choices is not the point the point is that there is no control or mitigations in place to ensure good choices happen. And perhaps this is also why we have seen huge and massive delays since no one bar you has an eye on the actual process and hence no one (apart from patients) is raising a red flag that action isn't happening and looking for suitable resources.

This is why I label it as Hilda's club and why for Cochrane to run this way I think is completely amateur and hence likely to produce untrustworthy reviews.

I don't think the setup was ideal either, but when I saw the tasks ahead that needed to be done to get there even by early 2022, that's the call I made. As I've said before, I had discussions with people with ME/CFS beginning when this was announced in October 2019, and came to decisions and negotiated arrangements that I believed were the best plan within the constraints. The IAG will make recommendations about all this at the end, when we've seen what seemed to work well and what didn't.

I don't see it as a highly complex task really. Its just a review. Define what is needed skills wise with reviewers and advisers. Recruit, device protocol, publish, get reviews, revise, review the trials, combine results and publish.

 

[Barry]

I can't see any way around unblinded trials only being valid if they have objective primary outcomes.

Which is what I said in my preceding post (and subsequent post in no way meant to countermand) ...

I think in the past @Jonathan Edwards has said that subjective outcomes in unblinded trials can sometimes be OK, provided they are only secondary, and that primary outcomes are objective; the objective outcomes can then be used to assess the validity or not of the subjective ones.

The point being that subjective outcomes in unblinded trials alone can never pass muster.

I thought the point of still including subjective outcomes was as a secondary adjunct to objective measures, simply to help clarify the patient's reported experience.

You may well be right, and maybe I've not fully appreciated this.

Or if an objective measure fails to show any benefit from the treatment, then it may be useful to see that a subjective measure indicates patients reporting benefit. This is useful information, for example in an ME trial, it indicates that the reported improvement may be caused by placebo or therapist effect, and may give patients and therapists a false idea that exercise is beneficial, leading to patient harms. Or in the asthma trial, the sham treatment led to patients thinking their breathing was OK, and could lead to them not taking the medication they need to prevent possibly life threatening worsening.

Which is surely an argument to not unconditionally ignore trials with subjective outcomes in unblinded trials, but to assess whether those outcomes may have some value in the context you speak of, even if that value is to show they are not reliable. The "safeguards" I was speaking of are the ones you also mention - having the trial data necessary to make those assessments.

 

[Jonathan Edwards]

We disagree with the commentator when he states that, "Behavioural treatment should not be recommended outside the setting of clinical trials." In our opinion many treatment modalities are used for chronic low back pain and there is not one treatment option that has been proven beyond doubt to be more effective than other treatment modalities. It is unlikely that the effectiveness of behavioral treatment is merely a placebo effect.

This is worryingly muddled.
That many treatments are used for back pain is a fact, not something to have an opinion ion about.
That there is not one treatment proven to be more effective than another is a reasonable opinion - but in what way is it a rebuttal of the criticism? It isn't.
That it is unlikely that 'effectiveness' is merely a placebo effect makes no real sense and is not a fact but an opinion. It ought to be justified in some way.

 

[Caroline Struthers]

It's number 24.

Yes, I know it's on the list. That wasn't my question. I think I suggested at some point that Vink and Vink-Niese be invited to Cochranize their study to convert it into a Cochrane review. I think there are precendents for this. But of course Vink and Vink-Niese would have to agree which is by no means a given. Would that also be considered once you and the IAG and the author team have read and analysed the NICE review, the Vink Vink-Niese review and any other reviews of the evidence for exercise that already exist? The Cochrane process seems to be a process of re-inventing the wheel with many more hands on deck and potential spanners in the works (excuse shameless mixing of metaphors) than is necessary to make the simple point that the evidence that exercise is safe for people with ME/CFS and also has a useful positive effect (if objective outcomes measures are considered) is non-existent.

 

[Robert 1973]

Here are my thoughts:

Thanks for your excellent posts, Hutan. In expressing your views so clearly you’ve saved me a lot of energy.

For the methodologist positions on the IAG, I am going to rely on people I have known a long time, in whose expertise and integrity and listening/communication skills I have enormous confidence, who I know will be both diligent and have zero reluctance to tell me when I'm screwing up, and who I know will engender a lot of confidence in members of the Cochrane community.

I’m a bit puzzled by this. Why does it matter to engender confidence in members of the Cochrane community? Perhaps I am misunderstanding what you’re saying but are we not in agreement that the “Cochrane community” has completely failed people with ME/CFS by its inability and/or unwillingness to adequately address the issues raised by Robert Courtney, Tom Kindlon, George Faulkner and others for so long?

As I see it, if you and your team do a good job a lot of people in the Cochrane community are going to be exposed for having overseen multiple failures.

One point that might not have been made yet (I haven't been able to keep up with the discussion in this thread) is that this process isn't just about our patient group.

It is a pilot programme and if successful, should in principle be used to revise or guide the development new meta analyses covering other conditions where there are similar methodological problems and ideally, improve the quality of non-pharmacological clinical trials in the future.

Yes, I fear this may be the compromise/bodge some BPS activists and the Cochrane community might be looking to achieve: allowing GET to be dropped for well defined ME but keeping it for more general chronic fatigue and ignoring the methodological problems with the trials which could (and should) lead to the collapse of an entire house of cards – ie the withdrawal of multiple Cochrane reviews for unevidenced therapist-delivered interventions across the board. For me, such a bodge would be completely unacceptable.

Many of us are here because we’re fighting for our own lives, but in many cases our eyes have been opened to problems that go far beyond ME/CFS. My great hope is that the work that has been done by “ME activists” will eventually benefit a far wider patient population, and that those who have worked so hard to expose the methodological problems in studies of interventions which can’t be blinded will eventually receive due recognition from the establishment for their contributions to science and medicine.

 

[Trish]

Which is surely an argument to not unconditionally ignore trials with subjective outcomes in unblinded trials, but to assess whether those outcomes may have some value in the context you speak of, even if that value is to show they are not reliable. The "safeguards" I was speaking of are the ones you also mention - having the trial data necessary to make those assessments.

To clarify my point. I was not excluding, for example PACE, on the grounds of subjective outcomes being recorded. I included it on the proviso that it also had objective outcomes that could be used by the reviewers as their primary outcome measures. Then the subjective ones could possibly be helpful in the way I suggested. The trials I think need to be excluded are the ones with NO objective measures, so no possiblity of the reviewers assessing them on the basis of primary objective measures. I think that cuts out most CFS GET trials.

 

[Hoopoe]

Yes, I fear this may be the compromise/bodge some BPS activists and the Cochrane community might be looking to achieve: allowing GET to be dropped for well defined ME but keeping it for more general chronic fatigue and ignoring the methodological problems with the trials which could (and should) lead to the collapse of an entire house of cards – ie the withdrawal of multiple Cochrane reviews for unevidenced therapist-delivered interventions across the board. For me, such a bodge would be completely unacceptable.

Many of us are here because we’re fighting for our own lives, but in many cases our eyes have been opened to problems that go far beyond ME/CFS. My great hope is that the work that has been done by “ME activists” will eventually benefit a far wider patient population, and that those who have worked so hard to expose the methodological problems in studies of interventions which can’t be blinded will eventually receive due recognition from the establishment for their contributions to science and medicine.

A compromise wouldn't do justice to people with ME/CFS because as long as the core issue is not adressed, there will be a never ending stream of placebo therapies that cause harm in all the ways they cause harm. LP and ACT are already lined up to take the spot of CBT/GET, should they be discredited. The door for placebo therapies must be closed for good.

Edit: so a good question for this review is, how will it protect patients, policymakers and clinicians from placebo treatments being presented as effective?