Questionnaires - design, validation and use in ME/CFS research - discussion thread

@rvallee posted this in another thread but this BMJ opinion piece is also relevant here.

Using condition specific patient reported outcome measures for long covid
https://www.bmj.com/content/376/bmj.o257

 

This blog was linked elsewhere but the quoted bit is relevant here. It's unclear to me if the part I bolded below means they're only going to analyse existing questionnaires or develop new ones. Either way, are any of the Canadians here involved in this? If not, can they muscle in?

https://www.eleanorsteinmd.ca/blog/ICanCME

 

Apologies, not able to read through the thread, but stumbled across this study on fatigue in Lupus. Not sure if it aimed to be a validation study, but they used actimetry/ accelerometers to examine the correlation between subjective and objective measures and also tested the internal consistency of the subjective measures (patient reported outcomes).

Fatigue, patient reported outcomes, and objective measurement of physical activity in systemic lupus erythematosus. Lupus. 2016 Oct ;25(11):1190-9. https://pubmed.ncbi.nlm.nih.gov/26869353/

Forum thread here.

Haven't read beyond the the abstract so don't know how the idea that physical activation could decrease fatigue impacts the authors' overall reasoning.



I think both the conclusion and how they present the results doesn't suggest the study showed more than a strong correlation between fatigue and physical activity?

That means the subjective measures were consistent with the objective measures.

Don't know however if this is what they wanted to find out.

What interests me in this regard is:

Is the risk of bias in a validation study comparable to the risk of bias in a clinical trial?

If a validation study shows a strong consistency between subjective and objective measures, does that mean there would be a similar consistency when using the same measures in a clinical trial?

Edit:
I don't think there is a comparable risk of bias in both sorts of studies so don't think that in an unblinded trial even the best validated subjective measure could make an additional objective measure redundant.

 

I've just found this thread.

If there is anyone in Toronto who might know about this it would be @ScottTriGuy.

But His name is not coming up as available so I don't know if he reads anything here.

 

I wonder if there is a link to something other than an unreadable photograph? That looks very useful.

Also, whats with the cucumber hanging over that woman's head?

 

I've just completed round 2 of a Delphi Consensus for long COVID evaluation. See https://www.pc-cos.org. I only just came across this on Twitter last night and hadn't seen it discussed previously. I rushed and just managed to register in as a "health professional with Long Covid" before close today and the process took a couple of hours.

Many of the questionnaires discussed here were being assessed. I hope to have rated appropriately as discussed above and elsewhere. Apart from the ridiculous overload of anxiety/depression/psych instruments, they only offered Fukuda for ME type evaluation. I zero-rated and suggested ICC.

Cognitive instruments also focused on dementia/AD or depression. Physical symptoms seemed overly focused on "lung damage" rather than eg dysautonomia/metabolic failure. I made some suggestions there too, but mucked up at the end when I intended to add the NASA lean test. There was no ability to return and review from the penultimate page, grrr.

 

It's a shame I didn't catch this for the initial intake — and others here could have been involved too, or perhaps S4ME as an organisation. Suggests it can't have been placed on the radars of the large ME groups?

Highly surprising (and also not) that Fukuda was the only one on offer. I presume CCC/ICC weren't offered up by those initially involved. If that is so, I am doubly glad I came across it. There will be two more surveys that I have to complete.

I'll see and report back how things progress, but yes it might require further direct correspondence.

 

Are they including patient experts in this round, or is this a case of the blind leading the blind? (so to speak, no offence to blind people) There are no "long-COVID experts" for a Delphi Consensus process to be valid...

 

As I recall, the options I could choose definitely included "patient with Long Covid" or words to that effect; as well as healthcare professionals who are or are not involved in caring for pwLC, or who themselves have LC; and researchers into LC. I think there were other categories also (eg perhaps patient support group rep). I had to hustle to make the deadline, so I didn't spend too much time looking at these preliminaries.

Hopefully, I'll get a sense of the contributors from the responses when they come through, but I guess there will be varying degrees of relative expertise (and the inevitable self-assumed expertise). As you point out, no-one can be an expert in a condition that has yet to be explained. Let's hope the process can make something reasonable, although I expect it will inevitably be well short of ideal.

 

Relating to POTS, I didn't see this German article already, so posted at [Anxiety in patients with postural tachycardia syndrome (POTS)]. Haven't accessed or translated yet but abstract indicates normal anxiety results for POTS patients when questionnaires do not include autonomic symptoms.

 

I've just completed round 2 of the Delphi process. This is the part where you can change your responses depending on your review of the spread of others' responses. They divided into: patients with LC, medics/researchers with LC, and medics/researchers without LC. Groups 2 and 3 seemed broadly similar as I was going through.

Perhaps unsurprisingly, I was at significant variance with the majority of my responses. Those I was happy with tended to also be favoured by others, but where I disliked the instrument, most favoured. Eg various* fatigue scales were included, which I had independently rated at 2, or occasionally 1. Many respondees were clustered at 7-9. Now that I review commentary here and in other threads, I think I probably managed to represent our thoughts, but suspect it'll end up as a minority opinion.

* You know.

 

Just to expand on that. The medics/researchers with or without LC looked to have a similar mode +/- mean, but the deviation was more in those with LC. As I was going through I wondered if this meant that only some of those with lived experience were overcoming their professional biases and seeing the deficiencies of the existing instruments (and paradigm). I may be trying to read too much into it.

 

Maybe all our doctors are so overworked and burnt out they don't bother to read the New Zealand Medical Journal? Or maybe they quickly worked out that this sort of nonsense is not worth wasting reading time on? It's not like this article provides any actionable information when faced with an individual patient. Even if the data was rock solid - which almost certainly it is not (though I've only read the abstract) - it's hardly relevant if men as a group on average have "less pain acceptance an willingness" or whether as a group on group average "Middle Eastern/Latin/African patients showed highest levels of kinesiophobia".

Doesn't explain though why anyone thought this was a good way to study pain experiences, why anyone thought it was a good study to fund, or why anyone thought it was worth publishing. Sigh

 

Just in case any questionnaire developer has stumbled across this thread, and for a glimmer of hope that things can be done better, linking this thread

https://www.s4me.info/threads/norwa...ctioning-in-pwme-cfs-open-for-feedback.24995/

 

It reads like a variant of patient-blaming, only with racist overtones.

Even if "catastrophising" actually exists (which is not a given, despite the researchers' peculiar lack of curiosity about it), so what? The patients would still be in pain even if they stopped.

I wonder if some respondents haven't gained insight into some of the issues yet? For patients at least, it can take a long time to develop an appreciation of the differences between fatigue, fatiguability, and weakness, and even then it can be hard to make clear distinctions. But an awareness of the differences does at least highlight the problems with some fatigue scales, which don't offer opportunities to rate them separately or even acknowledge they exist.