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

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2025: The 2019/24 Cochrane Larun review Exercise Therapy for CFS - including IAG, campaign, petition, comments and articles

I think you make a very good point there! To Cochrane, we probably look like 15,000 patients in straitjackets complaining about being forced to take their meds.

And abuse of a group of patients on this scale is so rare that when patients push back, we're going to look like the weird ones, not the perpetrators - especially since they've managed to paint us as having dodgy thinking.

@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?

This practice needs driving out of medicine. It should never have got in through the door. It's time for the doctors to start the revolution!

Are clinicians/researchers likely to be too trapped in the system to feel free to sign? If so, there's surely a ton of retired ones ready to be unleashed...

 

I think the target of the kind of letter/petition that I'm proposing needs thinking about very carefully.

If we want big numbers, and we do, it might be better to either target nobody specific, or to target the full range of major organisations that perpetuate this shoddy, dangerous research - so not just Cochrane but the major funding bodies, the major journals, the health services, government bodies that assess research (such as NICE), etc. etc.

I think a lot more potential signatories could get excited about driving this insanity out of the whole of medicine, rather than just Cochrane. This needs to be a movement, IMO.

 

The people I imagine signing this would be doctors/researchers who don't work in the behavioural fields. @Jonathan Edwards said:

So those are the kind of people who can see the issue clearly. @Jonathan Edwards, are they likely to feel afraid of signing a petition/open letter?

Students signing wouldn't carry much weight but getting students involved in circulating the petition/letter would be a great way to educate them.

 

I'm off on a bit of a rant now, but on another thread:

This is how we can get past the gatekeepers. We don't go through their gate.

 

I completely agree, but I was addressing your point that if you're in a behavioural field and speak out, your funding may be much more likely to be at risk if you sign such a letter/petition than someone from another field.

 

I think I must be missing your point! I wasn't arguing that we should only suggest that people from non-behavioural areas should sign, only that those in behavioural areas might feel under particular pressure not to.

Are we at cross-purposes?

 

I have come to think that physicians have always been witch-doctors at heart, over history. In the immediate post-war years of 1950-80 scientists became leaders within practical medicine, whereas a generation before the scientists with medical degrees mostly went into science.

The payoff came in the period 1980-2000, with huge advances in all sort of fields, but already by then the witch-doctors had taken back control. I was at the tail end of the scientific era. Now the Royal Colleges are run by compromisers and empire builders.

That doesn't stop the ME/CFS community bucking the system but I don't see any signatures on a petition any time soon.

 

But what about all your colleagues who unanimously thought PACE was rubbish and clearly saw the issue with open-label/subjective-measures trials? That suggests that the vast majority of doctors, at least outside the behavioural fields, aren't witch doctors.

Have doctors ever signed a petition or open letter en masse? If so, on what sort of topics?

 

Google gave me this:
https://www.bma.org.uk/bma-media-ce...rave-concern-over-use-of-physician-associates

 

That's very interesting!

But surprisingly few signatories (14,000), considering the topic.

 

I suspect that changing an entire paradigm across medicine as a whole though desirable is too ambitious at present. I think chipping away at specific issues is the realistic option.

Interestingly the Magenta study did not solely rely on the open label subjective outcomes. Was this the result of years of criticism of the earlier bad research? Is change being effective at least in some areas?

 

It might have been, but Crawley retired (possibly instead of trying to implement a change - pure speculation).

 

Chipping away at specific issues could very much narrower the amount of professional support that we could expect to get, though. It's a good question where the right balance lies but I think the 'Go big' option is worth seriously considering.

 

Most people are mostly concerned about their immediate surroundings - including us. There are plenty of non-ME/CFS topics to be outraged about as well - most people aren’t.

 

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.