Can we influence trial and review methodology, eg open-label trials with subjective primary outcomes?

Nightsong said:
I have also wondered if there are indirect things - not ME/CFS specific but that have a wider support base - we could lend our support to that would move things along in a beneficial direction for us. One example: if journals & funders insisted that anonymised raw data had to be uploaded to a publicly accessible data repository. There is already an open data movement but it would be unusually beneficial for us because of the low quality of trials & ideological capture in the ME/CFS field - psychobehavioural triallists would have to be much more honest in their analyses if they know their data would have to be made freely & openly available. Reanalyses would probably become more common, fraud would be harder to get away with; it'd be a boon for robustness in general.

On ethics, too - some of the things in the 2024 Helsinki declaration could make it more difficult to perform "patient-unfriendly" behavioural research - as long as ethics committees & triallists are actually held to those standards. Pretty much any effort aiming to increase methodological robustness, patient involvement in research & open data is something we should learn about & support as it will disproportionately benefit us.
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Very good points. Is there no international patients' research charter?
 
Nightsong said:
On ethics, too - some of the things in the 2024 Helsinki declaration could make it more difficult to perform "patient-unfriendly" behavioural research - as long as ethics committees & triallists are actually held to those standards. Pretty much any effort aiming to increase methodological robustness, patient involvement in research & open data is something we should learn about & support as it will disproportionately benefit us.
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Do we know what sort of teeth that declaration has? If PACE was proposed now, how could the new Helsinki declaration but used to stop it?
 
Jonathan Edwards said:
Human nature is complicated, Sasha.
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It sure is but I'm not grasping what factors are at play here. There seems to have been a field-wide dereliction of research standards in medicine that's clearly against the interests of patients, and against the interests of doctors who care about patients. It's beyond weird that no fightback is happening within the profession.

Is anyone even talking about this stuff apart from us?
 
Sasha said:
Is anyone even talking about this stuff apart from us?
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I feel like it’s not rare to see people talk about the low standards of evidence in psychiatry and psychology. But people often accuse these people of “stigmatising mental health” so they don’t get much attention. (Kind of like how criticisms of FND are often silenced because people see it as an attack on the label they have co-opted).
 
Sasha said:
It sure is but I'm not grasping what factors are at play here. There seems to have been a field-wide dereliction of research standards in medicine that's clearly against the interests of patients, and against the interests of doctors who care about patients. It's beyond weird that no fightback is happening within the profession.
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Maybe it's a bit like the puma eyes motif decorating the porticos in Catholic Churches in Cajamarca (the place where Atahualpa was executed) in Northern Peru. The Cajamarcas never liked the Incas anyway and were happy to chant Catholic prayers as long as they could go on decorating their temples the way they were used to.
 
Jonathan Edwards said:
Maybe it's a bit like the puma eyes motif decorating the porticos in Catholic Churches in Cajamarca (the place where Atahualpa was executed) in Northern Peru. The Cajamarcas never liked the Incas anyway and were happy to chant Catholic prayers as long as they could go on decorating their temples the way they were used to.
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I'll confess that you've lost me there!

I sometimes think it's a pity that doctors don't live their lives backwards so that they can first experience chronic illness as part of aging and be on the receiving end of bad research, before then getting younger and becoming doctors. Maybe then they'd take action to prevent and call out bad research. It just beggars belief that they don't.

If doctors are being weird about demanding good standards in medical research, what professional group or institutions wouldn't be? Who could lead the charge? Surely not every group is useless or corrupt?
 
Nightsong said:
I have also wondered if there are indirect things - not ME/CFS specific but that have a wider support base - we could lend our support to that would move things along in a beneficial direction for us. One example: if journals & funders insisted that anonymised raw data had to be uploaded to a publicly accessible data repository. There is already an open data movement but it would be unusually beneficial for us because of the low quality of trials & ideological capture in the ME/CFS field - psychobehavioural triallists would have to be much more honest in their analyses if they know their data would have to be made freely & openly available. Reanalyses would probably become more common, fraud would be harder to get away with; it'd be a boon for robustness in general.

On ethics, too - some of the things in the 2024 Helsinki declaration could make it more difficult to perform "patient-unfriendly" behavioural research - as long as ethics committees & triallists are actually held to those standards. Pretty much any effort aiming to increase methodological robustness, patient involvement in research & open data is something we should learn about & support as it will disproportionately benefit us.
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I sit on a research ethics committee. I was astonished that at a group training day, one of the presentations about a case of a complaint made against a REC decision to approve a vaccine trial on children. The complainants invoked the Declaration of Helsinki. I distinctly remember one of the presenters - a chair of an ethics committee i think - say that RECs should "distance themselves" from the Declaration of Helsinki...I was too dumbstruck to say anything...it was right at the end of a very long day. I did write to complain. Will follow that up. When I've mentioned the Declaration of Helsinki in meetings, my fellow committee members seem not to be aware of it, or not think it's relevant to our work.
 
Caroline Struthers said:
I sit on a research ethics committee. I was astonished that at a group training day, one of the presentations about a case of a complaint made against a REC decision to approve a vaccine trial on children. The complainants invoked the Declaration of Helsinki. I distinctly remember one of the presenters - a chair of an ethics committee i think - say that RECs should "distance themselves" from the Declaration of Helsinki...I was too dumbstruck to say anything...it was right at the end of a very long day. I did write to complain. Will follow that up. When I've mentioned the Declaration of Helsinki in meetings, my fellow committee members seem not to be aware of it, or not think it's relevant to our work.
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Are there any research standards guidelines in ethics committees?
 
Yann04 said:
I feel like it’s not rare to see people talk about the low standards of evidence in psychiatry and psychology. But people often accuse these people of “stigmatising mental health” so they don’t get much attention. (Kind of like how criticisms of FND are often silenced because people see it as an attack on the label they have co-opted).
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It’s a good retort isn’t it - even when it’s not, it’s trying to protect mental health and those who need support

it’s a shame they’ve worded it so you can’t reply ‘no just bad staff’ type thing because it needs a one-liner tgat everyone can use to finally start being unsilenced -

at the moment everyone is stumped because it’s like asking whether a security light can be installed somewhere due to ongoing crime issues and someone replying with ‘do you hate children/homeless people/puppies?!!’ Loudly in a crowded room.

You learn to back off.

it’s so illogical, clearly attention-drawing so you know that person is now intending to pantomime to bystanders who haven’t heard what you actually just brought up, and indicative of someone who is either not capable of taking in sense or won’t fight fair/is a sophist antagonist that anyone has to step back

except in this circumstance it’s also like the additional context of said protagonist publicly being known as running a shelter for abandoned puppies- that even if there are all sorts of dodgy policies for people either don’t have the position to query or are just happy to see that stray mutts out of their own hair..

at least having a one-liner so you can walk away having clarified their DARVO was untrue would remove this issue?
 
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Utsikt said:
@Valerie Eliot Smith tried to get the ME/CFS community to push in the same direction. Nobody wanted to listen.

I’m not saying we should give up. But I don’t see another clear path forward.

Btw, this might be a topic for another thread..

https://valerieeliotsmith.com/wp-co...e-end-further-explanatory-note-sep-2022-1.pdf
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This is exactly the issue. ‘Pushing in the same direction’ and ‘agreeing a specific message and sticking to it’ so we aren’t undermining each other (people can have variations on it that are coherent, but have to carefully be on board so it’s worded to make that clear and not contradict and give people excuses for thinking we all disagree and want different things)
 
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Sasha said:
I'll confess that you've lost me there!

I sometimes think it's a pity that doctors don't live their lives backwards so that they can first experience chronic illness as part of aging and be on the receiving end of bad research, before then getting younger and becoming doctors. Maybe then they'd take action to prevent and call out bad research. It just beggars belief that they don't.

If doctors are being weird about demanding good standards in medical research, what professional group or institutions wouldn't be? Who could lead the charge? Surely not every group is useless or corrupt?
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I think understanding the position they are in helps

it means we know what needs to be created for them to be at a point where they could back x and what that x would need to be.

ie how to go about things.
 
Caroline Struthers said:
I sit on a research ethics committee. I was astonished that at a group training day, one of the presentations about a case of a complaint made against a REC decision to approve a vaccine trial on children. The complainants invoked the Declaration of Helsinki. I distinctly remember one of the presenters - a chair of an ethics committee i think - say that RECs should "distance themselves" from the Declaration of Helsinki...I was too dumbstruck to say anything...it was right at the end of a very long day. I did write to complain. Will follow that up. When I've mentioned the Declaration of Helsinki in meetings, my fellow committee members seem not to be aware of it, or not think it's relevant to our work.
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The old precedent issue

‘Historically we’ve / it’s always’ as the exemption to close people down and convince others it’s a choice for them to change !
 
Sasha said:
@Jonathan Edwards @dave30th - What do you think about starting up a petition or very widely circulated open letter for only clinicians/researchers to sign, in their tens of thousands? Probably one not specifically about the Larun review but about the use of open-label trials with subjective primary measures, which would take Larun (and possibly Cochrane) down with it?
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That was the thinking behind this proposition I made: Ideas for a Declaration to raise standards in evidence-based medicine.

As long as those substandards are accepted as normal, there really is nothing we can do, because the substandards will always be used to justify themselves. What's most absurd is how circular the reasoning to use substandard evidence:
  1. Pragmatic trials of psychological therapies 'show promise' (literally for decades) in subjective reports of benefits
  2. Which means that chronic fatigue is a psychological condition
  3. Which makes it OK to use (otherwise invalid) garbage quality pragmatic trials not only as evidence, but to assert #2, even though by design this is not allowed (pragmatic trials do not allow to infer cause)
Even though #1 is fake. All of this is invalid, but since it has been decided based on the unreasoning above, it's considered OK. Basically it's OK because it's OK. Because they want it to be.

Until the bar is raised to minimal acceptable standards, the only thing that can unblock things is a research breakthrough, but then it will only apply to a narrow slice of issues. But moving away from substandards would mean almost all of clinical psychology evidence is worthless. Which is accurate, but the medical profession is unable to let go of this "get that patient out of my face" button that opens a trap out of which we seem to disappear. Even though we don't actually disappear, we're just out of their sight, and out of their mind.

Event though technically speaking, all of this evidence is invalid. It's just that it has been decided that pseudoevidence of pseudoscientific concepts is good enough for pseudoillnesses. Which is wrong. This is exactly why standards are important, because if they can be sidestepped arbitrarily, they will be. They have. They are. They will continue to be until minimal standards are actually put in place.
 
Midnattsol said:
If this is a problem in the whole field you are working in, you are setting yourself up to not receive funding or be taken seriously. And giving credence to anyone who say what you work with is all rubbish. I'm sure this will influence people in different ways, but as a dietitian we've been taught to reply to "difficult" patients that all we do is evidence-based. If you stop believing that, what have you really got?
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What have they got? Dealing with reality as it is, not as they want it to be. Which is how it's supposed to be. It's a very hard pill to swallow, but in technical terms they already know this, they simply exempt in exactly all the places where they are the most needed.

Basically it would be like criminal trials having an exemption where hearsay (witness heard someone say they saw something) is accepted as evidence, but only when there is no other evidence. Hearsay is always invalid. So is subjective evidence out of open label trials using extremely biased methodologies run by obviously biased people. Especially so, in fact. But otherwise, they have no evidence to convict a criminal they know, just know, is guilty. Which is exactly why it's never allowed, because otherwise it would simply be abused as a standard. And once established as a standard, there is no going back. Which is the situation we are in.

Dealing with reality the way it is would truly be a gift to them. This way they could start actually solving problems, instead of playing dolls with real humans. It's for their own good, and for everyone's.
 
Caroline Struthers said:
my fellow committee members seem not to be aware of it, or not think it's relevant to our work.
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This is exceedingly common in business as well. If an EU directive makes your life difficult, it’s easier to just not think about it or argue that it’s irrelevant. And if you didn’t have a good mentor, you might not even be aware of the directive or you don’t know how to pay attention to the regulations.

All of this is to say that this kind of behaviour seems to be a part of «human nature».

Finance tries to solve it through external and internal audits, but that has its own set of challenges.

In the end, it all comes down to the people involved and what kind of mindset they have. If you want to change something, swapping out the people might the most plausible solution. And that’s a difficult one.
 
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