Patient and Public Involvement opportunities in ME/CFS and other research

I was ranting on another thread about how crazy it is to involve local patients in trying to develop local ME/CFS services, when most patients don't have the necessary knowledge, or understanding of NHS systems, to do that. I think it's clearly a national issue that should have a national framework, with patients who have demonstrated expertise helping draw it up.

I think the same applies to PPI involvement in ME/CFS research, to a large extent. Why should knackered, inexpert patients have to reinvent a wheel with every research project? Why can't expert patients, working with researchers and charities, come up with a set of (inter)national guidelines about what they want to see in studies, or at least with a list of issues that they would want to see addressed, with some guidance? Such as outcome measures, harms reporting, involvement (or not) of severely ill patients, and so on?
 
I am quite sceptical about the PPI project as a whole - which I suspect is largely another of these these things that achieves the opposite of what is wanted. It gives the impression that patient interests are being served when in fact it has not means of ensuring that and may well screw things up in the process.

The extra bureaucracy of needing to have PPI documentation worries me - it makes life difficult for researchers. The extra paperwork of this sort is now so horrendous that I now refuse to referee grant applications because of all the waste of my time, except where I am particularly motivated by what looks like an exceptionally good idea.

All that researchers need is evidence that they are consulting. Nothing about whether they consult anyone with expertise nor whether they take any notice. And if you start off with an idea for a project you are going to tick boxes for that project, not change to some other project. So patients having priorities doesn't actually impact on what grants get written.

Researchers should try to make sure that they are looking at something relevant and not making major methodological mistakes through lack of knowledge of the illness but as @Sasha says those questions are likely to be outside the expertise of local patients. There wouldn't have been much point in my asking patients whether they thought rituximab was a good thing to try for RA.
 
Jonathan Edwards said:
I am quite sceptical about the PPI project as a whole
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Same here, and the burden of it on researchers and reviewers that you describe is in no-one's interests if it's not actually adding anything.

In ME/CFS, it's so easy to pull the wool over the eyes of gaslit patients. And no amount of PPI would have stopped PACE, no matter how expert the patients - the imbalance of power is too extreme.

Overall, I fear that PPI in the hands of bad researchers does more harm than good, giving a meaningless badge of quality to research that doesn't deserve it.
 
Sasha said:
I think the same applies to PPI involvement in ME/CFS research, to a large extent. Why should knackered, inexpert patients have to reinvent a wheel with every research project? Why can't expert patients, working with researchers and charities, come up with a set of (inter)national guidelines about what they want to see in studies, or at least with a list of issues that they would want to see addressed, with some guidance? Such as outcome measures, harms reporting, involvement (or not) of severely ill patients, and so on?
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This seems to be a muddled view over what PPI is in research studies.

First, a list of desired research priorities has already been produced, see UK: Priority Setting Partnership for ME/CFS. This is not an example of the PPI that is the focus of this thread.

Second, we have this thread, Making a 'Charter for Ethical ME/CFS Research', which discusses what roughly would be the equivalent of the guidelines you talk about. Again, this is not an example of the PPI that is the focus of this thread.

Third, I would suggest that without patients and carers being actually involved in research studies then there is nobody to hold the researchers to a higher standard than the minimum necessary. Additionally, guidelines can not possibly account for every situation; having members of the community being researched involved provides an immediate source of expertise that it is unlikely that the researchers would have themselves.

Is it 'fair' that patients and carers have to use their precious energy and time in this way? No, but we are where we are, and I know for absolutely certain that PPI has made DecodeME a far better study than it would be otherwise.
 
I agree, @Andy, that the issue is not a need for guidelines but for intelligent well informed individuals contributing to fine-tuning of study design in ways that are often unique to a given study.

I have no doubt that DecodeME has benefitted hugely from patient involvement!!

I am not sure that patients and carers are necessarily going to provide the gold standard for 'holding researchers to higher standards' though. Years ago almost all PIs for medical research were medically qualified and had their own patients to get feedback from - I certainly did. Things are different now and patient input must be a good thing. But when I was setting up rituximab trials both in RA and for ME/CFS (which we withdrew from) I had very heavy pressure from patients and carers to not just cut corners but to set up studies worse even than PACE in terms of reliable design. I even had a billionaire who pestered me to cure one of his house staff of RA, with no not being an acceptable answer.

Patients might be helpful in trying to discourage researchers from setting up unethical and useless animal models of ME/CFS but even there I suspect there will be pressure from patients and carers to go ahead.

I am hugely impressed by the way Chris P has interacted with and opened up opportunities for the ME/CFS community. When people do things well it is obvious. What I am less sure about is trying to formalise that in any systematic way. But if that is what is needed to play the grant game, then we have the right person in charge.
 
Sasha said:
Overall, I fear that PPI in the hands of bad researchers does more harm than good, giving a meaningless badge of quality to research that doesn't deserve it.
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Jonathan Edwards said:
What I am less sure about is trying to formalise that in any systematic way.
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This gets to the heart of it. It would be easy to design a manipulative questionnaire that gives no opportunity to comment on the real questions and concerns, and to fulfil a PPI quota by finding enough unwary patients willing to fill it in.
 
I also have mixed feelings about PPI.

It is potentially a good thing, and has proved to be in some cases. But the required level of knowledge and understanding of broader science, and trial methodology in particular, plus understanding how the politics of it all works, is high. If the trained and experienced pros are struggling with it, and they are, then it is a very big ask of patients to master it as well to help keep the pros in line.

There is also a real danger of becoming too cosy with the establishment, that patient reps, even with the best will and effort on their part, get co-opted and institutionalised, and hence de-fanged. There still needs to be some patients (and pros) who stay outside the official tent and throw well aimed bombs in every so often.
 
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With the caveats in my previous comment in mind:

I do agree that PPI is something we have to engage with as robustly as possible. In principle it is worth a serious go. Done right it can deliver real benefits.

At the very least it needs to give us a much better pathway for raising concerns about harms, which has been a long standing and very serious barrier to progress for us thus far. This feature should be one of the core non-negotiable demands of our participation.
 
Sean said:
At the very least it needs to give us a much better pathway for raising concerns about harms, which has been a long standing and very serious barrier to progress for us thus far. This feature should be one of the core non-negotiable demands of our participation.
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Very much agree, but I also wonder about the issue of timing.

Ideally the PPI group should be involved before a grant application is even drafted. If it isn't, it could be more difficult to change some of the elements that are most important from the patients' point of view—outcome measures being one.

If a treatment's expected to help rather than cure, there's a lot of potential for PIs to design outcomes that are most likely to make their study look good. The participants will want outcomes that show whether or not their quality of life is better. A statistic showing participants were able to pedal a static bike for a few minutes longer after treatment is only a real gain to those whose hobby is pedalling a static bike.
 
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