SMILE trial data to be released

[Skycloud]

If you go home after an hour does that still count as half a day?

If you go in for three half days, what does that count as?

In year 11 (when my daughter's problems began) we were told that if my daughter could only get in for a short bit of the morning including morning registration it would count as a morning session on the register. If she went home 5 minutes after afternoon registration having been there all morning for attendance record purposes it counted as the whole day. We were encouraged (not pressured) to play the system like this if possible.

My daughter's school keeps an electronic record of lesson attendance now and don't have form registration first thing in the morning after lunch. The same principle still applies for the attendance record though.

Similarly 6th form - e.g. if a pupil has one timetabled lesson in the morning for which they have to be in school but are not required to be in for the rest of the day, they are registered as being present for the morning session. (6th form presence required in school outside of lessons varies from school to school)

The 6th form signing in/out book is obv. supposed to fill the gap as to who is actually on the premises.

I think since Michael Gove and his zero tolerance of school absence schools have been incentivised to optimise their systems to show the best attendance they can.

edit - clarity

 

[Lucibee]

What was the percentage of data missing at 6 months?

Sorry - I mistyped. A quarter (26%) in the SMC group and just under a third (30%) in the SMC+LP group at 12 months. Still not great.

At 6 months, it was about 20% missing in both groups (22% and 18% respectively).

 

[Graham]

At the end of one term, when my son was only getting in for about a quarter of the time, was struggling to walk up stairs and certainly hadn't attended any physical education classes, the section in the report from the PE teacher noted that my son was showing pleasing progress but was quite quiet.

Back in the sixties a friend of mine had a minor op, and was excused PE for a term. At the end of that he received a reasonable report from the PE department as a lad who did his best. So he never went back: each time there was a PE lesson, he went to the library. His next PE report noted his pleasing improvement.

When you teach a subject like maths, where you see one class several times a week, it is much easier to keep track of things, but subjects that only have one or two lessons a week make it much more difficult for teachers to spot problems or chase things up. Mind you, we weren't computerized then: just an abacus on the wall of the cave to note how many pupils were there.

 

[Adrian]

In Scotland all hell broke loose over illegal data sharing between schools and third parties ( including health , social services) a few years ago. There has been a significant court judgement regarding this and some parents are pushing for and enquiry.

Personal data can only be shared for a predefined purpose so if a school hasn't declared data can be used for research then it can't be used for that purpose and where consent has been given for that purpose. GDPR is much stronger around consent and how explicit permission needs to be.

However some government data may be excluded.

 

[rvallee]

its not acceptable to just say, "we couldn't get the objective info so we used subjective information"

It worked for 3 decades. Can't see why they will ever change unless compelled by medical journals or funders somehow deciding to do their actual job of vetting research on substance rather than style, and I don't see that happening. I pretty much see the opposite, there is growing demand for this crap research because it gives public health agencies complete freedom to do whatever they want and call it "evidence-based".

We've seen it clearly from David Tovey's comments that subjective outcomes being less useful than objective ones is just an opinion, even though it only applies in exceptional cases where it allows psychosocial nonsense to work without restraints. It seems like the whole point is to remove the normal restraints of, you know, science, and allow pet theories to be propped up until one somehow manages to gain enough support to sustain itself despite all evidence showing it is utterly useless.

 

[Trish]

I hope someone is planning to do an analysis of the problems with this study and specifically the problems with this data (too many gaps and anomalies surely make the results unreliable) and write it up as a letter to the journal that published SMILE, or as a reanalysis paper that could be published elsewhere. Especially important given its likely inclusion for consideration by NICE.

 

[Esther12]

I hope someone is planning to do an analysis of the problems with this study and specifically the problems with this data (too many gaps and anomalies surely make the results unreliable) and write it up as a letter to the journal that published SMILE, or as a reanalysis paper that could be published elsewhere. Especially important given its likely inclusion for consideration by NICE.

The problems with SMILE are not so much to do with access to data imo (though I still suspect that there is something of interest in their unmentioned school record data tbh). Tuller's piece on this was a pretty thorough take-down: www.virology.ws/2017/12/13/trial-by-error-the-smile-trials-undisclosed-outcomes/

Maybe it would be worth turning those arguments into a paper?

 

[dreampop]

Quick note; study says mild/moderate me/cfs - I count 10 patients with sf-36-pfs of 25 or less - some were 15, one was 5 (wow!) and one was 10. Looks like given the data missing at 6 months, least some of them were included in the study.

Am I right that generall sub 30 is the severe me/cfs cut-off? Certainly 25 is getting pretty low.

Patients Aged 12–18 years with mild/moderate CFS/ME.

 

[Snow Leopard]

Quick note; study says mild/moderate me/cfs - I count 10 patients with sf-36-pfs of 25 or less - some were 15, one was 5 (wow!) and one was 10. Looks like given the data missing at 6 months, least some of them were included in the study.

Am I right that generall sub 30 is the severe me/cfs cut-off? Certainly 25 is getting pretty low.

There is no magic cutoff, because it is a self report questionnaire with limited scope.

In the real world, data like this is not clean. It's not just the potential for missing data but deliberate behaviour in answering the questionnaire in biased ways. It's quite possible to deliberately exaggerate (or under-rate) one's illness severity with a variety of motivations.

 

[Amw66]

There is no magic cutoff, because it is a self report questionnaire with limited scope.

In the real world, data like this is not clean. It's not just the potential for missing data but deliberate behaviour in answering the questionnaire in biased ways. It's quite possible to deliberately exaggerate (or under-rate) one's illness severity with a variety of motivations.

Yes. And children may be motivated in different ways, depending on their relationship with the authority figure.

 

[Mithriel]

I may have said it before on this thread but Dr Bell said that his teenage patients would downplay their symptoms to please their parents.

At 14 if I said I felt ill there were consequences

Sometimes I was not believed. Five minutes of weeding in a hot sun and wanting to go inside and lie down, imagine how that went down!

I would be pulled off to a doctor which meant a 20 minute walk each way and a wait in a room for ages on hard backed chairs. Then it would be minimized, or I would get a prescription - another 10 minute walk and wait. Then I was home feeling much worse and not helped at all.

My mother would either believe the doctor and I would be accused of complaining about nothing much or she would believe me but then she would get all angry and emotional and I would have to use energy coping with her. I just wanted it all to go away.

Other times, I would be believed but everyone would go into a huddle and worry about what to do. More than once I said I was feeling better just to stop it all.

They worried about me and were pleased if it was not too bad. I wanted to make them happy. When I was sent for tests I was frightened of what I did not know, some things were painful and some people were unpleasant.

If I had done the LP, especially if i knew it had cost a lot and my parents were optimistic I would have said it cured me.

 

[Amw66]

I may have said it before on this thread but Dr Bell said that his teenage patients would downplay their symptoms to please their parents.

At 14 if I said I felt ill there were consequences

Sometimes I was not believed. Five minutes of weeding in a hot sun and wanting to go inside and lie down, imagine how that went down!

I would be pulled off to a doctor which meant a 20 minute walk each way and a wait in a room for ages on hard backed chairs. Then it would be minimized, or I would get a prescription - another 10 minute walk and wait. Then I was home feeling much worse and not helped at all.

My mother would either believe the doctor and I would be accused of complaining about nothing much or she would believe me but then she would get all angry and emotional and I would have to use energy coping with her. I just wanted it all to go away.

Other times, I would be believed but everyone would go into a huddle and worry about what to do. More than once I said I was feeling better just to stop it all.

They worried about me and were pleased if it was not too bad. I wanted to make them happy. When I was sent for tests I was frightened of what I did not know, some things were painful and some people were unpleasant.

If I had done the LP, especially if i knew it had cost a lot and my parents were optimistic I would have said it cured me.

Again, this

 

[ladycatlover]

I may have said it before on this thread but Dr Bell said that his teenage patients would downplay their symptoms to please their parents.

At 14 if I said I felt ill there were consequences

Sometimes I was not believed. Five minutes of weeding in a hot sun and wanting to go inside and lie down, imagine how that went down!

<snip>

So sorry for your experiences with your family - just cruel.

 

[Mithriel]

So sorry for your experiences with your family - just cruel.

Thank you for your kind words. I wasn't really ill just not right with strange neurological symptoms like not being able to talk sometimes that I hid because I could not explain them. Lots of bits I recognize as ME now, PEM and fatiguability. They wanted to think I was well because they worried about me.

Actually, I had a better time than many people here. I was able to attend school though the PE department got me mixed up with a girl who was excused all classes and I didn't tell them for most of the year That helped.

The doctors did not dismiss me and I had lots of tests. Even neurology were kind at that time. I was told I had migraine with lots of funny symptoms but not so much of the headaches and I believed that for years.

There was none of the nonsense with FND even if they did think it was emotional was never made to feel to blame.

My heart aches for pour souls now who are forced into exercise when they need to rest and the constant nagging that they would be better if they tried harder. My parents were never turned against me by doctors which is an unforgivable thing to do. The conflict of thinking that your child would be well if they only did exercise while all your instincts are to keep do what makes them feel best must cause so much guilt.

 

[Barry]

Yes. And children may be motivated in different ways, depending on their relationship with the authority figure.

Yes, children are vulnerable in so many ways. They are still developing how to interact with the world, to interact with with people, and much of the mechanism is to take their cues from adults, authority figures. Highly impressionable basically.

 

[Amw66]

Thank you for your kind words. I wasn't really ill just not right with strange neurological symptoms like not being able to talk sometimes that I hid because I could not explain them. Lots of bits I recognize as ME now, PEM and fatiguability. They wanted to think I was well because they worried about me.

Actually, I had a better time than many people here. I was able to attend school though the PE department got me mixed up with a girl who was excused all classes and I didn't tell them for most of the year That helped.

The doctors did not dismiss me and I had lots of tests. Even neurology were kind at that time. I was told I had migraine with lots of funny symptoms but not so much of the headaches and I believed that for years.

There was none of the nonsense with FND even if they did think it was emotional was never made to feel to blame.

My heart aches for pour souls now who are forced into exercise when they need to rest and the constant nagging that they would be better if they tried harder. My parents were never turned against me by doctors which is an unforgivable thing to do. The conflict of thinking that your child would be well if they only did exercise while all your instincts are to keep do what makes them feel best must cause so much guilt.

I know of one child with quite acute OCD, which came to a head after his grandfather died.They were very close and in part he attached blame to himself for not being with his grandfather at the end ( he was on a school trip)

He had a referral to CAMHS, and started making progress over the first 3 weeks with a therapist. She left on maternity leave and the replacement was completely different and they didn't gel at all.

He managed to anticipate and supply " correct" responses to the designated therapy * no prizes which format* and was discharged. Boxes ticked. Everything resolved on paper.

He still has huge issues but will not go back.

Tell the people what they want to hear and they will go away.....