FITNET-NHS Esther Crawley - 5th protocol out now

[daftasabrush]

How many protocols does this harmful GET trial need exactly? There's 5 on the website now.

Is Action for ME supporting this street merging with AYME? They have a clear statement against GET now.

Selected GPs are now sending out letters on behalf Crawley et al for any kids aged 11+. For 16 or 17 year olds "invitations" go straight to the kids rather than parents. Since the protocol involves including reasons for refusal, does that mean GPs pass on data directly? Surely that can't be allowed?

Will GPs be informed Crawley is under investigation for ethics violations at Bristol?

I haven't managed to figure out all the differences from earlier protocols.

Obviously still the Oxford criteria.
Also only looking for those "recently" diagnosed...no doubt to bump up recovery rates.

£900,000 to manipulate and harm hey more children. ;-(

https://www.journalslibrary.nihr.ac.uk/programmes/hta/14192109/

 

[Dolphin]

How many protocols does this harmful GET trial need exactly? There's 5 on the website now.

Is Action for ME supporting this street merging with AYME? They have a clear statement against GET now.

Selected GPs are now sending out letters on behalf Crawley et al for any kids aged 11+. For 16 or 17 year olds "invitations" go straight to the kids rather than parents. Since the protocol involves including reasons for refusal, does that mean GPs pass on data directly? Surely that can't be allowed?

Will GPs be informed Crawley is under investigation for ethics violations at Bristol?

I haven't managed to figure out all the differences from earlier protocols.

Obviously still the Oxford criteria.
Also only looking for those "recently" diagnosed...no doubt to bump up recovery rates.

£900,000 to manipulate and harm hey more children. ;-(

https://www.journalslibrary.nihr.ac.uk/programmes/hta/14192109/

At the end, there is a section:

11. SUMMARY OF CHANGES TO THE PROTOCOL

which goes through the various changes for the different protocols.

 

[ME/CFS Skeptic]

Obviously still the Oxford criteria.

Crawley uses the NICE-criteria. From the protocol:

The NICE guidance will be used and not the Centre Disease Control (CDC) criteria [31] based on the relevance of NICE criteria to the NHS. The specialist nurse will also identify children who fulfil the CDC diagnostic criteria (Table 1) at the eligibility assessment as this will enable us to compare our results with those of other trials.[/QUOTE*

 

[Suffolkres]

How many protocols does this harmful GET trial need exactly? There's 5 on the website now.

Is Action for ME supporting this street merging with AYME? They have a clear statement against GET now.

Selected GPs are now sending out letters on behalf Crawley et al for any kids aged 11+. For 16 or 17 year olds "invitations" go straight to the kids rather than parents. Since the protocol involves including reasons for refusal, does that mean GPs pass on data directly? Surely that can't be allowed?

Will GPs be informed Crawley is under investigation for ethics violations at Bristol?

I haven't managed to figure out all the differences from earlier protocols.

Obviously still the Oxford criteria.
Also only looking for those "recently" diagnosed...no doubt to bump up recovery rates.

£900,000 to manipulate and harm hey more children. ;-(

https://www.journalslibrary.nihr.ac.uk/programmes/hta/14192109/

There is another issue here. If the children and Young people being contacted "For 16 or 17 year olds "invitations" go straight to the kids", -if they have a diagnosis and are, or have been out of school, other agencies will be involved and they may come under the heading of 'vulnerable" or 'disabled' young people.

Then there is then the issue of Mental capacity and Deprivation of Liberty( DOLs) complication and potential.

 

[Sly Saint]

We will disseminate the findings to researchers by publishing results in open access high impact journals. We will ensure that the trial outcome is known to clinicians by presenting research findings at national and international conferences and meetings. We will cascade information through clinical and research networks including: the British Association for CFS/ME, the UK CFS/ME Research Collaborative (CMRC) and the NIHR National School of Primary Care Research (SPCR). We have a robust plan to raise awareness of CFS/ME and this trial in the first 18 months of this study. At the end of the trial, we will work to further disseminate the findings through blogs, emails, podcasts, Twitter etc. to clinicians and GPs.

We will disseminate results to patients through the regional and national paediatric charity (Association of Young people with ME) and adult patient support groups that we work with
as well as liaising with other charities to ensure dissemination throughout the UK. We will write “research in progress” articles for newsletters/websites, and speak at their meetings.

Apart from saying that MJW had quit, they don't appear to have amended their info re AYME.
Don't they have to inform anyone that they no longer have the backing of a patient charity?
Or maybe they do?

We will communicate with the public by giving a public engagement lecture, an open academic lecture, press releasing every publication and giving interviews.

We will disseminate results to politicians and policy makers using the All Party Parliamentary Group for CFS/ME and members of parliament who are part of the CMRC.
We will inform NICE of the trial results so that results can be included in updated guidance.

And the APPG no longer exists(?) and the MPs who are part of the CMRC(?)
But the last line is the most concerning.

 

[Adrian]

From the amendment list

9. Protocol amended to state that we record all recruitment consultations in the pilot phase, but can continue to
record throughout trial as needed). (protocol page 21 and 22)

Not quite sure what this means but I wonder if it is the trick of using pilot patients in a full trial?

 

[Trish]

Is it normal for a clinical trial protocol to discuss plans for dissemination of the results beyond scientific journal publication?

From what I remember of looking at FITNET, and I don't have the energy to go back and look at it and study the protocols, the trial is designed as a win-win, since it has no control group, but has two active treatment groups receiving different variations on internet supported GET/activity management/CBT. Whichever group comes out ahead in the results will be claimed as an effective treatment.

 

[Adrian]

Is it normal for a clinical trial protocol to discuss plans for dissemination of the results beyond scientific journal publication

I suspect so I know with other government funded research they like to have dissemination plans to communicate the main ideas with a variety of different stakeholders through many sources.

 

[rvallee]

£900,000

Nice haul for someone who had claimed to have left the field because of all the "harassment".

Seems instead she found a more easily abusable population, one that will comply and not complain, especially with threats of FII on parents.

Science without a moral compass is bad for society. Always has. Always will.

 

[rvallee]

Is it normal for a clinical trial protocol to discuss plans for dissemination of the results beyond scientific journal publication?

From what I remember of looking at FITNET, and I don't have the energy to go back and look at it and study the protocols, the trial is designed as a win-win, since it has no control group, but has two active treatment groups receiving different variations on internet supported GET/activity management/CBT. Whichever group comes out ahead in the results will be claimed as an effective treatment.

PACE team made plans for the media blitz in coordination with the (totally neutral and objective) SMC and the Lancet during the trial, showing the results were pre-determined and would have had no impact on their conclusions. So I guess it's normalized now.

This is carry-the-football "research", where success is defined merely by the act of successfully publishing something and the substance is irrelevant, only the conclusions, which can be anything they want to apparently, no matter what the data show.

 

[Lacey Diamond]

Is it normal for a clinical trial protocol to discuss plans for dissemination of the results beyond scientific journal publication?

From what I remember of looking at FITNET, and I don't have the energy to go back and look at it and study the protocols, the trial is designed as a win-win, since it has no control group, but has two active treatment groups receiving different variations on internet supported GET/activity management/CBT. Whichever group comes out ahead in the results will be claimed as an effective treatment.

It's important to note that their "activity management" is also an increasing regimen but not quite as rigid as GET. My daughter has had this and there is an expectation that she would try to increase 15 minutes of red activity every week if there is no set-back. Needless to say she reached a level of activity that she could no longer increase and that was the end of it. I have heard similar reports from other parents. They do not seem to be specifically stating what they mean by these interventions and then clouding the picture by renaming things.

 

[obeat]

It's important to note that their "activity management" is also an increasing regimen but not quite as rigid as GET. My daughter has had this and there is an expectation that she would try to increase 15 minutes of red activity every week if there is no set-back. Needless to say she reached a level of activity that she could no longer increase and that was the end of it. I have heard similar reports from other parents. They do not seem to be specifically stating what they mean by these interventions and then clouding the picture by renaming things.

Do you know if your daughter will be classified as " recovered" or improved ?

 

[Tilly]

Crawley uses the NICE-criteria. From the protocol:

NICE have said that they do not give a criteria for diagnosis so how can she use it?

 

[Tilly]

Nice haul for someone who had claimed to have left the field because of all the "harassment".

Seems instead she found a more easily abusable population, one that will comply and not complain, especially with threats of FII on parents.

Science without a moral compass is bad for society. Always has. Always will.

This is done more by the RCPCH and the police involvement and they only have to site possible emotional harm now as a reason. Withholding the chance of recovery is used as a possible emotional harm.

 

[Amw66]

This is done more by the RCPCH and the police involvement and they only have to site possible emotional harm now as a reason. Withholding the chance of recovery is used as a possible emotional harm.

So that was what the safeguarding seminar was really all about ?

 

[chrisb]

One has to wonder whether, in this matter, they show "equipoise". Removing a child from parents and home also causes emotional trauma. How are the contrasting traumas evaluated and compared?

 

[Sly Saint]

found this in a pdf relating to 9th World Congress of Behavioural and Cognitive therapies (Berlin July 17-20 2019).

https://wcbct2019.org/Downloads/abstract-book-1.pdf

How do the Cognitions and Behaviours of Adolescents with Chronic Fatigue Syndrome (CFS) with Co-Morbid Depression Compare to Those Who Are Not Depressed? Implications for CBT
Maria Loades, University of Bath, United Kingdom
Esther Crawley & David Kessler, University of Bristol, United Kingdom
Paul Stallard, University of Bath, United Kingdom

Introduction: Approximately one in three adolescents with CFS/ME also have depression. CBT is an evidence-based treatment for both CFS/ME and depression (NICE, 2007; NICE 2015).

However, there are differences in the CBT maintenance model of depression and the CBT maintenance model of fatigue, and consequently, there are differences in the cognitive and behavioural techniques utilised and in what order. CBT for depression (CBT-D) is based on the Beckian model of depression, which purports that global, stable and internal negative cognitions about the self, others/world, and the future, interact with behavioural patterns of withdrawal to fuel and maintain low mood (Beck,1979). Behavioural activation, combined with recognising and challenging negative thoughts, have been shown to be at least moderately effective in adolescents.

CBT for fatigue (CBT-F) assumes that fatigue, once triggered, is maintained by unhelpful behavioural responses, which tend to either be that of excessive rest, or more commonly, adopting a ‘boom-and-bust’ approach, doing lots on one day and then very little the next. It is also maintained by unhelpful cognitions, which are specifically about the physical illness and its sequelae, such as ‘My fatigue will get worse if I do more’. CBT-F aims to stabilise activity levels before gradually increasing them, and to use behavioural experiments to test out the specific thoughts about fatigue.

Whilst there are some commonalities between CBT-D and CBT-F, there are also a
number of important differences (Loades & Chalder, 2017). What we don’t know is how best to understand and help those young people who present with both CFS/ME and low mood.

Method: This cross-sectional study was nested within the baseline of the FITNET-NHS trial. Participants were recruited via primary care and paediatric settings.
Inclusion criteria: Adolescents age 11-17 with a diagnosis of CFS/ME made by a local paediatrician, with no access to a local specialist CFS/ME service.
Measures & Procedure: Participants completed measures of negative cognitive errors (CNCEQ-R), cognitive and behavioural responses to symptoms (CBRQ) and depressive symptoms (RCADS depression subscale).

Results: (Data collection is currently ongoing. anticipated N = 200 by July 2019). Preliminary data: N = 179, mean age 14.2 (S.D. 1.68).
RCADS depression subscale score was not significantly correlated with any of the CNCEQ-R subscales. RCADS depression score was also not significantly correlated with any of the CBRQ subscales. Using a raw score cut-off of >14 on the RCADS depression subscale, those
with probable depression did not differ significantly on CNCEQ scores from those who were not probably depressed, nor did they differ significantly on the CBRQ.
Discussion: These preliminary findings suggest that young people with CFS/ME who score highly on a depression questionnaire do not necessarily report the negative cognitive errors that are predicted by the cognitive model of depression. They also do not report a significantly different pattern of responses to their symptoms compared to those with CFS/ME who score within the normal range on the depression questionnaire. This means that cognitive factors may not necessarily be maintaining the low mood, which has implications for CBT.

anyone have a link to this paper? can't find a thread on it (only the recent one with Chalder, but this one is with Crawley).

 

[Andy]

anyone have a link to this paper? can't find a thread on it (only the recent one with Chalder, but this one is with Crawley).

I'd guess that as they say data collection is ongoing, it hasn't been published yet, but I don't know for certain.

 

[Esther12]

Results: (Data collection is currently ongoing. anticipated N = 200 by July 2019). Preliminary data: N = 179, mean age 14.2 (S.D. 1.68).

So they're looking at data as it comes in, rather than waiting til the trial is completed?

 

[Sly Saint]

So they're looking at data as it comes in, rather than waiting til the trial is completed?

@dave30th
Looks like it.

I'm sure they will come up with some explanation as always.

200 doesn't sound very many given how long it's been running and the cost (nearly £1M).(?)