Protocol Serial Paediatrics Omics Tracking in [ME] (SPOT-ME): protocol paper for a multidisciplinary, observational study..., 2024, Armstrong+

It is a concern that such questionnaires have not been evaluated in relation to ill or disabled populations, and that their design means they do not reliably distinguish between psycho pathological responses in the physically well and rational or even positively adaptive responses in the ill or physically disabled. Certainly in relation to their use in relation to ME/CFS it is even more concerning that so many researchers seem unaware of their limitations when used with this population.

Historically their use with ME/CFS reflects an unevidenced belief that the condition results from or is sustained by false cognitions, and reflects researchers failing to recognise confirmation bias. So not only have they been of dubious scientific value in this context, but they have been misused to justify ineffective and potentially harmful interventions.

I don’t know the rationale for their use in this context, but any researchers wanting to use them needs a clear justification and to demonstrate how they plan to overcome their problematic nature when used with the ME/CFS population. Historically as others have said there have been problems with the issue of informed consent in this context.

Increasingly I feel at our current level of understanding whether any researchers wanting to involving children with ME/CFS is appropriate and certainly that we should not be engaging with pyschobehavioural investigations involving children with ME/CFS, until we can guarantee that the historical harms inflicted on this population will be avoided.

 

I'm sure there are physicians still clinging to their preferred version of reality, but I meant in the research. I haven't seen a single mention of peptic ulcers in the hundreds of papers and studies posted on the forum. Everything has instead moved towards 'functional' GI problems, which peptic ulcers 100% would be included in if it hadn't been for the work of a small team.

Although of course there is the whole 'functional overlay' nonsense where anything can be included, but that's just because they made the set of their things so large that literally everything fits in them by default, and only remains in there until 'innocence can be proven'.

 

HADS isn't appropriate for chronic illness full stop .

 

@MelbME

Have you read all of the questions in BASC-3 as a part of the preparations for this study?

 

I don’t view the questions as details - they are at the core of that part of the research.

Not wanting to over rule the «experts» sounds like an excuse to not check on the work or to not speak up. I know it comes at a personal cost to intervene, but we can’t just accept bad research practices because they are common. And we’re dealing with children - which ups the responsibilities.

I have no doubt in the sincere intention to help push ME/CFS research forward, and I’m gratefull for that. But it’s still a very unfortunate situation.

 

I don’t follow the logic of ethics here. Standard does not automatically equal safe, appropriate or ethical. The ethics should be assessed on a case-by-case basis.

I can understand that one would argue that non-standard is not ethical because it hasn’t been tested, but that does not make the standard ethical. IMHO, the only ethical thing in this case is to disallow any questionaire due to the issues outlined in this thread.

We should not allow bad neuropsych research just because they don’t have better alternatives. The best bad option is still bad.

 

And if there is a gate keeping issue going on

 

For the most part, yes. But its unfortunate if his(?) project enables harmfull research from others.

 

This might vary from country to country? I'm not aware in the U.S. that "complex" in this context often means "psychological factors" or something parallel to "biopsychosocial" (in UK--biopsychosocial is used differently by clinicians I know in US and not in the limited UK BPS manner).
Who is using "complex" to mean psychological factors?

 

Yes that's about right.

The plan is that omics work will be published independently. There is potential to combine for a later paper if someone has the interest/time. The project recruitment itself was delayed considerably by COVID lockdowns, timeline is blown out.

 

FUNCAP was not published at the time we began recruiting for this study unfortunately. Would have liked that to be part of this, it's in all our more recently started projects.

We typically look for best available scales. At the time the best for ME specifically was the DSQ.

 

Thank you for taking the time!

Great to see that FUNCAP is becoming more if a standard. Can’t expect you to use it before it came out.

This is where I end up asking if the DSQ is actually good enough, despite being the best option? The question is probably more like: did you need a scale or could you have done the study without it?

Very good!

 

We as a team are responsible for overseeing the project that it's sticks to the ethically approved protocol, the neuropsychs are responsible for the patients they speak to as part of the study.

I'm not sure if we can share the documents without ethical clearance but can look into it. I will bring up with the team about reminding people they are free to withdraw from trial or specifically withdraw their data from a specific section.

The section I think you had concerns with was filled by the parents and guardians. The children only do cognitive tasks. The report is given to the parent/guardian.

 

Well the ME/CFS cohort is wildly variable. Different triggers, different symptoms, different severities, different co- morbidities, different order of symptom severities. It's defined by broad symptoms and by exclusion of other diseases that explain those symptoms.

I have heard from clinicians about a lot of patients that were diagnosed by ME/CFS but ended up being later diagnosed with a genetic disorder or MS or some other condition. These patients are in our cohorts we study because the diagnosis that defines the disease let's them in. So that's a big part why it's complex.

It could be a simple mechanism but it's unlikely to be because of how it's defined, it's far more likely that it's a complex multi-factor mechanism or multiple different mechanisms with a shared phenotype.

I'm not used to using complex as it pertains to psychology, I'll tone down my use of the word.

 

No I I think I misrepresented that. A report is made from neurocognitive testing that includes the BASC, the report goes to the parent. The parent then has the option to provide this to their GP.

So it's not a direct transfer to the GP, I realize I miswrote that in a reply to @Hutan who was concerned regarding which clinicians would have access, I was meaning to say that it wouldn't be refereed on to a different clinician.

We won't be validating that concept of somatization but I understand the concerns of simply asking the questions. We will be careful with how we present this work.

 

Yes we work with Sarah Knight and they are experienced with using these surveys. They publish on MRI work and not on these surveys, my impression is that they don't think the disease is somatization, they think it's to do with neural structures, at least that's their main interest.

The somatisation questions go to the parent/guardian. The patients fill cognitive questionnaires. I don't know if the data go to the GP or if that includes the somatisation questions, the report does have results of the cognitive questions. The parent is the one that gets report and decides if they want to pass it to their GP. That's all I know for sure. But I can clarify.

 

Yes, at least a version of it. It seemed like a typical broad set of questions you see on scales looking to assess mood and behavior. I think the interpretation for any of these answers to mean something serious is a problem though.

It's a tool that can do damage in the wrong hands but can be useful in the right hands. Haven't seen anything of our collaborators to suggest they are the wrong hands.

They are answered by the parent/guardian, not the child.