Clinical and cost-effectiveness of the Lightning Process ... for paediatric chronic fatigue syndrome, 2018, Crawley et al (Smile Trial)

Short and sweet.

 

This is old but couldn't find it posted on the forum yet. Some interesting quotes in it.

Hawkes, N. (2017). Training for children with chronic fatigue works better than medical care alone, finds study. BMJ, j4372. doi:10.1136/bmj.j4372

sci-hub link: sci-hub.se/10.1136/bmj.j4372

Rapid response by Anton Mayer: https://www.bmj.com/content/358/bmj.j4372/rapid-responses

More about Hawkes:

https://www.s4me.info/threads/uk-he...uestion-february-2019.8045/page-5#post-142373

https://www.s4me.info/threads/trial-by-error-letters-to-fiona-godlee-and-nigel-hawkes.8233/

 

Could anyone check if the following paragraph is correct?

I would like to use it for a comment on the IQWiG report plan -- comment is due by Wednesday and there's a lot of work until then, so any help much appreciated.

That's my draft (translated from German) :

Edit -- go to:

Explicitly mentioning the verifiability of self-reported 'objective' end-points here seems important, as one large study of the benefits of an alternative medical therapy in children and adolescents (SMILE), for example, used school attendance as an objective end point, but school attendance was self-reported by study participants alone and was not verified, even in random samples.

@dave30th @Lucibee @JohnTheJack @Jonathan Edwards @Sean @Snow Leopard @strategist @Esther12
@Robert 1973

Edited to add: I'm aware that there were many other issues with this trial, so that's only to check if the point about checking whether seemingly 'objective' outcomes are actually objective is one that can be made with respect to the SMILE trial.

 

@cassava7 @Dolphin -- see above post.

 

Just checking back. The intention in the SMILE protocol was that they would check against school records - but the trial paper doesn't state that they did - and the measure was downgraded to a secondary outcome measure anyway.
@Adrian will remember better than me probably...

 

I remember that bit and also some other issues.

Would this work:

"Explicitly mentioning the verifiability of seemingly objective end-points here seems important, as one large study of the benefits of an alternative medical therapy in children and adolescents (SMILE), for example, included school attendance as an endpoint. According to the study protocol, it was planned to verify the self-reported data by checking against school records in random samples, so that these could count as objective outcomes.

In the original trial paper, however, school attendance was self-reported by study participants alone, but this (among other) deviations from the study protocol where only added in a corrected version following repeated criticism."

Could the school absence study also be referenced? Sorry, I don't remember details about that one.

Edited to add amendments in bold.

Edited again -- now completely re-phrased.

 

Had a look now at the corrected version -- Will have to reword the paragraph as the corrected paper now acknowledges:

"We did not have capacity to check school attendance using school records, but this could have provided an objective outcome."

And then they go on: "Further unpublished work suggests this is highly correlated with the self report measure we used."

What a bad correction to a bad paper that is -- and even the editorial note on the corrections seems again to be misleading.

Anyway, thanks @Lucibee that was already very helpful.

Any further help also appreciated (e.g. which measures did the school absence study use?)

Edit: Now edited the paragraph in the post above -- amendments in bold.

 

Is this the correct one? https://bmjopen.bmj.com/content/1/2/e000252
(Thread: https://www.s4me.info/threads/unide...school-based-clinics-2011-crawley-et-al.12187)

If this is the correct study, then "School attendance was recorded at the time of assessment using a single-item inventory." So, same - self-report.

Also from Methods: "The attendance officer in each school identified all children in years 7–11 (ages 11–16 years) who had missed ≥20% of school over a 6-week term."

"We used school attendance at 6 months, ascertained through follow-up questionnaires and by review of medical notes, as our primary outcome."

 

I now found one of @dave30th's very helpful replies that answers also my questions about the SMILE trial:

 

Excellent -- yes that's it. Many thanks!

 

Would this not have been at the transition of GDPR?
Which may have made accessing school records a bit more difficult?

 

In the protocols for both the feasibility and full trials (they wrote one for each), they promised to vet self-reported school attendance against official records. They didn't mention these official records one way or the other in the feasibility trial report and in the full trial report. The original primary outcome in the feasibility trial was school attendance at six months, measured both ways--self-report and school records. Physical function was a secondary outcome. So more than half the participants in the full trial were recruited when that was the primary outcome.

In the full trial, school attendance at six months had been relegated to being a secondary outcome. Of course, they still should have mentioned the school records, but they failed to. School attendance at six months had null results, but no one noticed. They had positive findings on another secondary outcome--school attendance at 12 months--so they did promote that as a benefit.

In the 3,000-word correction/clarification, it was stated that they didn't get the school records--I forget why exactly.

 

Sharing info on kids is more strictly controlled via GDPR legislation (2018 in Scotland)
Interests have to be legitimate and for general, non life threatening areas like this parental / childs' consent would be required .

In Scotland there was a legal challenge to GIRFEC ( get it right for every child which underpins education and social care provision ) re information sharing without consent as it conflicted with GDPR.

So it may boil down to how they handled the initial interaction ( given it involved attendance officers my guess is not well) - telling that letters / written info to parents etc were not provided despite being requested?

The school may also have had a part to play which they may not wish highlighted. They were facilitators.

My guess is that they did not have the legal consent required to obtain records.
It may not have been a necessity at feasibility when law was different and perhaps a bit more elastic in its definition and was therefore not considered at full trial stage.

Privilege tends to promote assumption.

Eta GIRFEC paragraph.

 

Thanks for replying again @dave30th -- I realize we had discussed this repeatedly before the correction was added (see e.g. post above )

"We did not have capacity to check school attendance using school records"

I wonder what people who aren't aware of the criticism and now read the editor's note and the corrected paper will make of the evidence.

I'll post other questions related to this and how to best refer to it in the comment for evidence reviews here.

 

Given how schools work re: progrsss monitoring there should be predicted grades or attainment almost for each person who gets NE/CFS because they use this to measure ‘value added’ for schools by seeing whether a pupil who was eg really clever at start of year attained what they’d be reasonably expected to with good teaching, and do fir middle and lower down etc to total up a score.

no reason why - given my big bear if watching as the focus seems to be attendance at the expense of future recovery sbd health and ergo future grades bring worse than if say home learning or fewer subjects or years out had been possible - all of these different management possibilities couldn’t be compared based on actual ‘what grades should they have got vs what did they get in the end’ measure. Which would be more accurate as per how the system measures it.