Investigating the factors associated with meaningful improvement on the SF-36-PFS ... young people, 2023, Crawley et al

Investigating the factors associated with meaningful improvement on the SF-36-PFS and exploring the appropriateness of this measure for young people with ME/CFS accessing an NHS specialist service: a prospective cohort study
Daisy Gaunt; Amberly Brigden; Chris Metcalfe; Maria Loades; Esther Crawley

Objectives
Paediatric myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is relatively common and disabling, but little is known about the factors associated with outcome. We aimed to describe the number and characteristics of young people reaching the 10-point minimal clinically important difference (MCID) of SF-36-Physical Function Subscale (SF-36-PFS) and to investigate factors associated with reaching the MCID.

Design
Prospective observational cohort study.

Setting
A specialist UK National Health Service ME/CFS service, Southwest England; recruitment between March 2014 and August 2015.

Participants
193 eligible patients with ME/CFS aged 8–17 years reported baseline data. 124 (65%) and 121 (63%) with outcome data at 6 and 12 months, respectively.

Outcome measures
SF-36-PFS (primary outcome). Chalder Fatigue Questionnaire, school attendance, visual analogue pain scale, Hospital Anxiety and Depression Scale, Spence Young People Anxiety Scale, Clinical Global Impression scale and EQ-5D-Y (secondary).

Results
At 6 months 48/120 (40%) had reached the MCID for SF-36-PFS. This had increased to 63/117 (54%) at 12 months. On the Clinical Global Impressions, 77% and 79% reported feeling either a little better, much better or very much better. Those with worse SF-36-PFS at baseline assessment were more likely to achieve the MCID for SF-36-PFS at 6 months (odds ratio 0.97, 95% confidence interval 0.96 to 0.99, p value 0.003), but there was weaker evidence of effect at 12 months (OR 0.98, 95% CI 0.97 to 1.00, p value 0.038). No other factors at baseline were associated with the odds of reaching the MCID at 6 months. However, at 12 months, there was strong evidence of an effect of pain on MCID (OR 0.97, 95% CI 0.95 to 0.99, p value 0.001) and SF-36-PFS on MCID (OR 0.96, 95% CI 0.94 to 0.98, p value 0.001).

Conclusions
40% and 54% of young people reached the MCID at 6 and 12 months, respectively. No factors at assessment (other than SF-36-PFS at 6 months, and pain and SF-36-PFS at 12 months) are associated with MCID of SF-36-PFS at either 6 or 12 months. Further work is needed to explore the most appropriate outcome measure for capturing clinical meaningful improvement for young people with ME/CFS. No data are available, due to lack of consent from participants to share data.

Link | PDF (BMJ Open)

 

This analysis deviates from the intention to treat principle. They ignore the huge % of dropouts/missing data and use denominators of just those who completed the follow ups.

 

Although it's arguable to open the introduction of a paper submitted on "12 October 2022" referencing guidelines that are a year out of date.

They do say in the discussion —

I couldn't see NICE 2021 formally referenced, though.

 

they created this MCID
https://www.s4me.info/threads/defin...ale-for-paediatric-cfs-me-crawley-et-al.6286/

 

The CBT/GET program I followed used this scale and the accompanying questions I think or at least something very similar. They did so at intake, then again when I started the procedure. Then we'd have a workweek of treatment, a week off and that was repeated for 4 or 5 weeks of program. Then a follow-up week about a half year later. Then they sent the list again a year after that. But even at the start I couldn't remember what I jotted down in the week previous. I think you had to rate things on a severity scale among other things but most of it is completely arbitrary. I'm now reading through the questionnaire again.

Straight from the outset this first question on the physical health part poses enormous problems. Back when I started the program I was doing some sort of paper route, it was about the only work I could find and wanted to be a good little worker. When I wasn't feeling well, the time I'd spent on the route would actually increase. So a route that would normally take about 2 hours would now take 4, biking very slowly. So did I cut down the amount of time, no. Is that a sign of getting better, the opposite.

On top of that, we all have to cope with brainfog. I couldn't tell you right now how well the previous week went and how the current week stacks up against that. Impossible for me to do right now. It would be way handier if there were devices that could measure activity for us or something. Technology might not quite be there yet though.

 

Aside from being a superficial and mediocre study, published 8 years after it ended, this would then dispute all their claims about behavioral stuff, or whatever. But of course their conclusion is always the same: give us more money so we can waste it doing the same useless nonsense we've been doing for decades. Always money for them, never delivering anything for patients other than wasted lives and amplified suffering.

There is clearly a natural process of recovery, when it happens, we are seeing this plainly in Long Covid, which also disputes literally everything that has ever been claimed about recovery and treatment, since all meagre improvements they can boast about are far better explained by this being a natural process where time is the most important factor. Aside from using an invalid definition anyway, which makes this inapplicable to ME/CFS, merely to a generic idea of "fatigue".

It's also a fact that the recovery process is not final. I see so many long haulers who recovered, resumed their normal lives, and relapsed. Sometimes more than onces, and often worse and for longer. The same happened to me, although my initial recovery was not really complete, I was never back to my former healthy self. Single points in time are useless here, this is a long-term condition and it needs longitudinal studies with far more subjects.

There are no factors that are known yet, and of course doing yet another superficial study that looks at a few generic things won't accomplish that. It's been done plenty before, including by Crawley and her close colleagues. There is a biological process happening and knowledge of it has been completely impeded by mediocre research from lazy ideologues doing zero-effort copy-paste jobs like this.

But they keep getting funded anyway. They keep getting approved to do the exact same nonsense over and over again. Somehow. A giant con where we are the mark and the public pays for this blatant corruption.

 

Further evidence clinics don't help
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Taking a step back, it looks to me as if these findings show that the clinic made little meaningful difference to the people they were treating. In fact, the results look similar to those for the Pace trial control group (standardised medical care) at 12 months.

At 63% follow up is better than previous ME clinic observational studies, but still produces suspect data because it excludes dropouts, many of whom are likely to have deteriorated (given the nature of the treatments).

Let’s park that for the moment.

53% of those followed (with 12 months data) improved by 10 points on a 0-100 point scale after 12 months. Critically, there is no control group. Typically, you would expect to see a control group improve modestly over the same period.

UPDATE: As a comparison, the Pace trial control group (“standardised medical care“) SF36 PF score improved by 11.6 points over 12 months (baseline 39.2, 12 mo 50.8), which is similar to the 53% improving by 10 points M (presumably 10 points or more) found in the current study.

So the data doesn’t exactly inspire confidence in the methods or efficacy of the clinic.

[Deleted an erroneous point about odd ratios for SF 36 as a predictor for outcomes.]

Surely, the clinicians would worry that they were achieving so little for their patients? I haven’t read beyond the abstract, maybe the discussion section has the handwringing.


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No control group, huge amount of dropouts not counted as nonresponders, subjective outcome measure, no blinding... the usual BPS shit sandwich.

 

Were the participants asked ?

 

From memory this teams' definition of PEM is not wonderfully accurate.

There is never any acknowledgement of key issues in paediatrics.

the huge power imbalance which can manifest in therapist pleasing or telling people what you think they want to hear

having school attendance as a measure - there is huge pressure to attend ( FII is commonly kicked off by lack of attendance ) and being in school means nothing if you can't function in school or afterwards .

Brain fog - makes comparisons dodgy if you can't really remember what you did / how you felt yesterday let alone weeks ago . Even doing daily charts are not necessarily accurate.

Anxiety and mental health scales being used - given OI issues are not understood / fully acknowledged in paediatrics, common symptoms of known comorbiditues are are attributed to anxiety and MH issues . There needs to be a meaningful ME appropriate scale.

Where are the objective measures .

 

Oeeh, may I answer this one?!?