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

That is indeed shocking, to think a few questions could be a diagnosis. The lack of physiological knowledge in this disease has lowered the bar for evidence to be actionable and it's not the only disease like that. I'm not a clinician and I expect their job is very difficult, especially because they are used to treating, people with problems need treatment. I'm hopeful with younger clinicians this is changing, it's a complicated job and I do unfortunately think the quality of clinician varies widely.

What you're describing is bias that we would be looking to avoid in interpreting the data.

 

I myself have been assessed by HADS a couple times, it never led to a diagnosis of anything. I do find it troubling that others have found different experiences. From clinician I speak to a survey might be one small part of a diagnosis, maybe even just a screening tool to put someone through a much more rigorous diagnosis process.

Yeah HADS is very broad, anyone suffering a chronic disease would answer higher.

 

Yes it could have been done on adults but we felt there was little biological research on pediatrics, felt it was a section of the community being under served and wanted to improve that. That was the goal of the NHMRC grant we got.

 

Yes the participants and guardians are provided with the full information of what will be performed during the study prior to their consent.and they can withdraw whenever they want, they could withdraw their data now if they wanted and we would delete it all.

 

"Complex" term I'm using is intended to be short for complicated, multiple factors and heterogenous.

 

Are the scales calibrated or verified with regards to the unique characteristics of PEM? There’s a reason FUNCAP was created - PEM does not fit with most models of how disease and the body works.

This is not very encouraging. The research standards for both the neuro and psych fields are rather poor, and I can’t imagine that it gets any better if you combine them.

Are the scales «good enough» for proper research, or are they just «what people use». The latter does not guarantee the former. Neither does an ethics clearance. You have an independent responsibility to ensure that any measurement tool in your study is good enough, that can’t be outsourced.

Data can have bias that was introduced during the measuring phase. The tools that collect the data can also have bias. Data isn’t some infallible our neutral thing - it’s quite the opposite.

 

The bigger problem is that they can't be reliably identified, so we can never know what is actually happening. There are no tests or markers for either, they are at the very best a guess. When the standard description of anxiety is worrying about outcomes, but then it's been turned into having symptoms of sympathetic arousal resembling stress, or whatever, and people routinely get labeled with either or both after infectious diseases or other causes where the whole process isn't understood. They are generically valid concepts, but for individual cases they are far less accurate and valid than even a chronic fatigue description. The state of knowledge is comparable to medicine's knowledge of autoimmune diseases in the 17th century. At least I haven't seen anything better than this.

Definitely. None of this relates to my experience in any way, and the confusion I described above, along with the decades of miserable failure, means I want absolutely no research dealing with this stuff. Ever. It's simply not useful and never will be, because no one knows what these things are or can differentiate them.

Most likely most cases have a physical cause that can be identified with more advanced technology, but that's about as useful as sending a radio signal to someone who knows nothing about electromagnetic radiation, antennas or anything related to electrical circuits, and definitely doesn't have a radio or anything more complex than using a coconut as a cup. It will be decades before medicine does something useful here, and mostly likely it will be AI that does it. This stuff is just too complex to deal with for now, human nature just gets in the way and no good can come out of it for us.

It would be useful to understand this, but psychosocial questionnaires ain't the way. It just categorically isn't. Most of them are plain weird and reflect deeply disturbing beliefs held by people who clearly struggle to relate to lived experience different than their own.

 

I think we can safely use the example of peptic ulcers here to answer categorically that none of this will be relevant. In fact in all the years of being here every day on this forum, reading through hundreds of papers, most of which are about pushing a particular psychosomatic school of thought, peptic ulcers have simply not been mentioned once in all this time. There is simply zero consideration for any psychosocial factors in peptic ulcers anymore, even though it used to be a significant industry in its own right.

Which is all that's needed to know whether this stuff is useful. One day there will be a breakthrough pointing us to the right biological process/mechanism, and from this day literally everything psychosocial will become obsolete. All of it. And just the same for all the stuff that get mislabeled as 'anxiety' or 'depression', which are far more likely to be many causes leading to many different outcomes that simply happen to crossing in a few key places.

All this stuff is only considered relevant here because we haven't had this tipping point. But we know for a fact what happens once the scientific process finds a beachhead, and it doesn't bother with this stuff because it produces absolutely nothing of value or interest.

 

The deeper problem is that it's simply not possible to do this. There is no 'calibration' here in the typical sense that people understand, like the way weights or lengths are calibrated using reference units, which themselves are precisely measured.

Biased things are being compared to other biased things using some form of interpretation, this is simply a completely different approach to how, say, temperature scales were calibrated using physical experimentation involving very precise measurements.

IMO questionnaires asking non-objective (i.e. your height, your age) questions simply cannot be calibrated to a scientific level, not anymore than it's possible to create a mathematical formula to categorize types of poetry or whether a policy is fiscally liberal or conservative, they simply depend on value judgments whose internal metrics are unique to each subject.

The original sin was described in a comment above, this silly idea clinical psychologists (and psychiatrists) made up to think that turning subjective terms into relative numbers on non-linear scales makes them precise. This is simply not how science works.

 

It’s still possible to make a reasonable judgement on how well a questionaire and its results matches with how the patient group understands and experiences their illness.

I’m not talking about physics levels of calibration. Calibration means something completely different in qualitative medicine than in quantitative medicine. Even FUNCAP is only calibrated to severity level.

I’m not looking for perfect, just better and closer to good enough.

 

On that child's medical notes for life: potentially influencing every subsequent diagnosis and treatment (or lack of it), they ever receive. Without the knowledge of the parents or the child going into adulthood. I find this truly shocking, if I'm understanding that correctly.

 

What?!

They are planning on giving data from the study to the participant’s GP? What’s the purpose? Why and/or how would that benefit the study or the participants? Is this normal? Why is the GP involved at all? I’m very confused.

 

I said 'might', being hypothetical.

 

But none of that justifies their use in pure research, Chris. They are intrusive and involve phoney concepts like somatisation. Psychological intrusion can cause huge harm. It destroyed a whole branch of my family. Maybe in a care context sometimes it is helpful but unless a research project is offering something therapeutic I see no justification in involving such intrusion at all.

A similar situation arose in the context of a rituximab study that was designed to provide explanatory scientific information but would yield no useful information on the value of giving rituximab which we already knew could kill people. I made it clear that I thought the study was unethical. Scientific studies that just hope to provide some useful theories cannot justify things that we know can do clinical harm.

 

I have only now caught up with this thread, which raises a whole lot of issues. I guess that the psychobehavioural studies may just reflect the practice of the people looking after the children any way but I do see a very major danger in combining these with omics and ending up with papers that appear to validate concepts like somatisation.

Non-clinical researchers need to be aware just how dumb and interfering clinicians can be in this area. Maybe this will just be a lesson learned. But I would advise against trying to collaborate with anyone who believes in a concept of 'somatisation'. This is the incompetent psychology that has been so damaging for people with ME/CFS.