Professor Crawley BPSU study - Chronic fatigue syndrome (CFS) Severe children Feb 2019 - 2020

I just came across this this morning and it fills me with what I can only describe as the collywobbles.

Firstly how many children with severe ME will go to the GP or hospital? Almost never.

What condition will the Dr/Paediatric know what to look out for?

I now need a bucket of coffee and to get my head around this.

https://www.rcpch.ac.uk/bpsu-study-chronic-fatigue-syndrome-cfs#funding

Anyone else want to comment?

 

"The fatigue is made worse by activity and is not relived by rest."

Don't know about anyone else, but I relive my fatigue every day, regardless of rest. If fatigue is not "relived" by rest, doesn't that mean that it goes away with rest, and therefore by definition the patient would not have ME/CFS? I'm confused.

 

Not had a chance to look at this properly but yes worrying.
Protocol:
https://www.rcpch.ac.uk/sites/default/files/2019-02/protocolcard_cfs_04022019.pdf

eta:

HRA Sub-committee meeting (Sept 2018) (do a search on the REC number 18/SW/0051)
https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=7&cad=rja&uact=8&ved=2ahUKEwjO4_CY0-DgAhWOERQKHZX0CFQQFjAGegQIARAC&url=https://www.hra.nhs.uk/documents/1630/Sub-Committee_Minutes_-_September_2018.pdf&usg=AOvVaw26ZceBeLlgghSj5bEiTopm

will come back to this later.

 

@dave30th

doesn't look like the investigation has stopped her getting get ethics approval for this one (although from the date looks like this was before).

She really is trying to get as much stuff in before 2020(?) can't think why.

 

That made me giggle. Look who is funding it the MRC which will let them off the hook when they talk about funding and the minister can talk about figures and no one will talk about PEM or tube feeding and travelling to GP or hospital is too much. convenient all round.

How do I add to the title. Sorry crap at finding out how to do things on here

 

From the sub committee meeting

note - abuse data not being requested or included in database ( had this originally been part of the protocol?)
school records also not being linked due to D of Education timescale ( or perhaps 3rd party data sharing without consent)
from document
The following point was appended to the CAG’s advice on the guidance of the decision- maker:
1. The applicants should consider ways to strengthen the patient and public involvement and engagement as the project progressed, due to the potential wider interest in children with Chronic Fatigue Syndrome or Myalgic Encephalitis. It was noted that this was a recommendation only and not a formal condition of support; however, feedback should be provided at the time of annual review around any action which has been undertaken in this area.

The applicant advised that the communication plan detailed ways in which the study team planned to work with and disseminate information to patients and the public. It was advised that a CFS/ME young person’s advisory group was held approximately every six months. This Group will be kept informed about the progress of the study, and their advice would be sought around how information about the study can be disseminated to other young people with CFS/ME.
The Sub-Committee received the response and issues were raised in this area. - my bold - what issues

Confidentiality Advisory Group advice conclusion
The CAG agreed that the minimum criteria under the Regulations appeared to have been met and that there was a public interest in projects of this nature being conducted, and therefore advised recommending support to the Health Research Authority, subject to compliance with the specific and standard conditions of support as set out below.
Specific conditions of support (Final)

1. Favourable opinion from a Research Ethics Committee. (Confirmed – issued 20/03/2018)
2. Confirmation from the IGT Team at NHS Digital of suitable security arrangements via Information Governance Toolkit (IGT) submission. (Confirmed – University of Bristol, Bristol Medical School, Sever Paediatric CFS/ME Surveillance Study, shows a reviewed satisfactory grade of Version 14.1, 2017/18). - does anyone know what this is/ how it works

 

Just managed to edit the title so that date and EC appears. Amazing what you can do with more coffee and staring at a screen willing yourself to understand the obvious

 

Whilst collecting data on severe ME in kids is good, this type of research could have been done years ago, obviously EC connection is a concern and what type of “treatment “ does she think exists? I see no support group involvement

 

From the Abstract:
"This is different to children with mild or moderate CFS/ME who will be able to do carry out most normal childhood activities and are attending at least some school."

sorry to keep bleating on about this but no, this is not accurate about 'moderate' patients even under the current NICE guidelines

"People with 'moderate' CFS/ME can't move around easily and have problems continuing normal levels of daily activities. They have usually had to give up their work or education, may need to sleep in the afternoon and rest frequently between activities, and have problems sleeping at night."
https://www.nice.org.uk/guidance/cg53/ifp/chapter/What-is-CFSME

But then given that not that long ago Crawley denied the existance of severe ME (she seemed to think that if kids could only attend school 2-3 days a week that was severe ; see 2016 CMRC presentation)...

and as for the real severely affected well that was Pervasive Refusal syndrome............
https://adc.bmj.com/content/99/Suppl_1/A70.2

 

I agree, @Tilly. A child with severe ME/CFS would not be attending a GP's surgery, and gone are the days of doctors making house calls unless in an emergency.

The definition for school attendance is pure nonsense. For example, as long as the child attends hospital school for more than one hour a week, they would not qualify to be included in the study. I remember hospital school. The teachers come to the ward and if you are bedridden, you are seen to be "attending", regardless of whether you are capable of actually participating. So, I would have been ineligible for this study, despite being so severely affected by ME/CFS that I was . . . in hospital!

The follow up one year later to see how many children have "recovered" and are back to school is insufficient. Many of us make it back to school, only to relapse a few years later. Such is the nature of this illness.

Another pointless, self-serving, money-wasting piece of work from the Crawley stable.

 

From the section on Privacy Information

Well if they have your NHS number surely they can find your name and address easily enough? Talk about living in an age of surveillance.

 

Shows the value of doing everything you can to opt out of providing data that people like Crawley can then be given special access to:

https://medconfidential.org/how-to-opt-out/

 

She clearly has no idea what severe/moderate means.

"Case definition
Children aged 5 to 16 years who has been given a clinical diagnosis of CFS/ME with fatigue that is so severe that they are unable to attend school for more than one hour a week during the last 6 weeks of the school term. "


My daughter is moderately affected, but was only able to attend a handful of lessons over the 3 years of sixth form.
These were during periods when her cognition and stamina improved on antibiotic regimes.

 

What happened to doctor / patient confidentiality?

I am totally alarmed by this

Can anyone find the REC approval? Nothing comes up under the number when I looked, not even under the old name of Somerset REC.

It seems pretty obvious that to prevent being in one of EC's "research" studies / service evaluations you must avoid the NHS.

[It also appears - unrelated to this - that on some research there are questionnaires planned in advance designed for possible future research being passed off as normal feedback / progress assessment then sometime later a "service evaluation" is conducted which only differs from research in terms of not allowing patients to withdraw consent!]

If this is all being done under service evaluations then HRA & other policies must change - no way should one researcher be able to access everyone's medical data without their consent.

 

From abstract above;

"This is different to children with mild or moderate CFS/ME who will be able to do carry out most normal childhood activities and are attending at least some school."

Does anyone know of moderately affected children who can carry out "most normal childhood activities"?

 

They seem to have a random twaddle generator. And these people get hailed as experts .

 

I have read and reread this and still I think it is bonkers, I have added my questions in BOLD


The literature that is available suggests that once children become housebound and stop going to school for more than 6 weeks, recovery and return to school is slow. Unpublished data (is that allowed? if this is from her centre then this could be children made worse and take off her list) from our cohort suggest that approximately 18% will recover eventually and a further 18% will attend some school (what?? this is just not right!). These figures are based on follow up that occurred between 8 and 35 months after assessment (well that explains it forced to go to school until they drop out). This suggests that once children have been at home housebound for weeks, they are unlikely to fluctuate between attending school and being housebound within a short period of time (that makes no sense at all. It sounds as if fluctuating between going to school and being housebound is a good thing?). Because these children are unable to attend school, they need home tuition to fulfil their statutory right to education. We have chosen the BPSU as all children with medical symptoms who are unable to attend school will be seen by a paediatrician. This is because these children need a paediatric assessment prior to home tuition being provided by the local authority. Most of these children will not be seen by a child psychiatrist (why should any child with ME be seen by a psychiatrist?) and therefore this study is not possible with CAPSS (Child and Adolescent Psychiatry Surveillance System). Principal Investigator Professor Esther Crawley Centre of Child and Adolescent Health, University of Bristol, 1-5 Whiteladies Road, Bristol BS8 1NU

The rest of it is embarrassing and shameful. I do not want my child to be used in this way allowing her to say what she wants without him being able to put his reality forward is outrageous.

 

Use the data opt out if you don't want your kids data involved - https://your-data-matters.service.nhs.uk/privacynotice#How-to-view-and-change-your-choice - but they can't do it unless you have an email address or phone number registered with your GP - since bizarrely opting out needs you to do an electric verification.
Otherwise you need to phone the GP's practice manager / admin staff.

Given that NHS number, date of birth and other identifiers are left in it out would seem to me that advocates could well be identified by researchers and have their medical data seen by those same researchers. I find this alarming.

 

I can't imagine that she has ever met a child with severe ME. A child in this category may not be able to sit up at all, walk at all, raise her/his arms, bear light or noise , may find light touch very painful and host of other difficult symptoms. I have never come across any indication that this woman has insight, understanding or compassion for people with ME. It fills me with dread that she would venture in here. I hope that she will not choose a cohort that are not severe and make her deductions from those. Even that school is mentioned with this category shows real lack of knowledge or understanding. Fools rush in where angels fear to tread. I hope that muddying the waters is not her motivation here.