Science Media Centre with Holgate/Crawley/McCrone - more anti-patient prejudice? (FITNET)

[Molly98]

Horrified, sickened and gutted.
I had been feeling so positive after the IACFSME conference reporting.

 

[user9876]

The protocol is available here
http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0007/170962/PRO-14-192-109.pdf

There are no objective tests included in the protocol

The primary outcome it the sf36-pf scale. Given White's tweaking of the protocols in GETSET I expect the CFQ to be added at a later date as in the past they haven't got the results they wanted with the Sf36 scale. Also note that they are choosing 6 months as the optimal time from the FITNET trial. PACE used 12 months for example and FITNET had a poor long term follow up.

4.11.3 Primary outcome
Our primary outcome will be disability measured using the Physical Function Scale ( SF-36-PFS) measured 6 months after randomisation. Disability is an important outcome [41] for children with CFS/ME and we have shown it is sufficiently sensitive in this patient group. We want to allow children with CFS/ME the longest possible window to return outcome data and therefore the permissible measurement window will be between 5 and 9 months after randomisation.

Secondary outcomes are

4.11.4
Secondary outcomes
All secondary outcomes are measured at 3, 6 and 12 mon
ths unless otherwise specified.
Our secondary outcomes include
:
1. SF36 - PFS [42] measured at 3 and 12 months after randomisation
.
2. Fatigue (Chalder scale [43]and
Checklist Individual Strength (CIS) fatigue severity subscale [44])
3. School attendance (self -report school or home tuition)
4. Mood (Revised Children’s Anxiety and Depression Scale (RCADS)[45])
5. Pain visual analogue scale [46]
6. Clinical Global Impression Scale [16]
7. Quality of Life (EQ-5D-Y) [47]
8. Parental completed: Healthcare Resource Use questionnaire

 

[BurnA]

So long as some of the UK leading charities are colluding with these people, there won't be a strong response. As usual we can most likely expect a response from IiME, Tymes Trust and the 25% group but the others are bought into MEGA with EC, Holgate et al leading them by the nose.

Indeed. This would be the perfect opportunity for the MEA to make a statement and withdraw support for MEGA as it currently stands. If there was any doubt about MEGA it should be well and truly gone now.

 

[AndyPR]

I believe this is the Dutch long term follow up
https://www.ncbi.nlm.nih.gov/pubmed/23669515

RESULTS:
After a mean follow-up of 2.7 years, 66 (58.9%) adolescents had recovered from CFS. Most adolescents who recovered directly after treatment with FITNET were still recovered at LTFU. At LTFU there was no difference between the recovery rates for the different treatment strategies (original randomization: FITNET [64%] versus any form of usual care [52.8%]). Per additional month of "pretreatment disease duration," the odds for recovery were 4% lower (odds ratio: 0.96; 95% confidence interval: 0.93-0.99; P = .016), and per added point on "focus on bodily symptoms" (Body Consciousness Scale) of the mother (0-20 points) the odds for recovery were 11% lower (odds ratio: 0.89; 95% confidence interval: 0.80-0.99; P = .029).

 

[trishrhymes]

Doesn't all this publicity invalidate the trial before it starts? Flooding the media with stories saying the treatment 'cures' two thirds of children means any parent or child who is asked to participate will already have preconceptions about the outcome.

 

[worldbackwards]

'Landmark'

A turd can be a landmark if there's little enough else there.

 

[Chrisb]

is Prof Holgate of the CMRC actually travelling from southampton to London to speak about the Crawley Trial and so nice that the independent trial steering committee is led by PACE trial author Prof. McCrone who did analysis of the cost effectiveness of PACE. - very independent indeed

Is it any longer possible to find independence within the UK research community? Presumably most or all interested in the subject are signed up to the CMRC. We know the rules akin to Cabinet collective responsibility which attach to all their members. Perhaps complaints should be made against any "scientist" subject to the CMRC rules who offers to the media an "independent" opinion on a colleagues work without an appropriate COI statement.

At least an understanding of these rules lets us avoid having to research Stockholm Syndrome sensu lato

 

[Cheshire]

I believe this is the Dutch long term follow up

At LTFU there was no difference between the recovery rates for the different treatment strategies (original randomization: FITNET [64%] versus any form of usual care [52.8%]).

https://www.ncbi.nlm.nih.gov/pubmed/23669515

Which Esther Crawley magically transforms into this:

Her second sentence is clearly a lie. Those without access to specialist treatment had the same outcome at long term. How is this possible?
How can the CMRC tolerate that?
What's driving EC, seriously?

 

[eafw]

So long as some of the UK leading charities are colluding with these people, there won't be a strong response.

I didn't mean directly from the charities, I meant from the patient community.

 

[Wildcat]

.
@trishrhymes wrote:
.
"Doesn't all this publicity invalidate the trial before it starts? Flooding the media with stories saying the treatment 'cures' two thirds of children means any parent or child who is asked to participate will already have preconceptions about the outcome."
.
Excellent point! Even worse than circulating a 'positive' newsletter to trial participants as was done part way through PACE.
.

 

[Chrisb]

It gets worse. A Landmark trial. Does this mean that Live is involved as well?

 

[AndyPR]

What's driving EC, seriously?

ETA: Allegedly of course, I have absolutely no comprehension what drives her, it's beyond my ability to understand.

 

[user9876]

I believe this is the Dutch long term follow up
https://www.ncbi.nlm.nih.gov/pubmed/23669515

Its not mentioned in the protocol which probably means those approving it are unaware the long term results are poor. There is a comment

Improvement was maintained at 12 months.

Which is somewhat misleading because the differences between the two groups narrowed.

If they are so sure of the solidity of the techniques they are seeking to try they should lay out all the evidence and arguments systematically. They have failed to do this.

 

[Stewart]

I can appreciate why so many people here are so upset about this latest batch of headlines - but really there's very little new here to get despondent about. The SMC pushes its propaganda and the British media unquestionably laps it up. Plus ça change, plus c'est la même chose. If anyone seriously thought that the FOI case would receive mainstream UK media coverage and that the SMC would have no choice but to shut up shop and admit defeat - well I don't mean to be rude, but you can't have understood how the British media works.

I don't mean this to sound as negative as it does. The scientific consensus behind PACE and CBT has certainly cracked as a consequence of the Matthees FOI request, even if media reporting often doesn't give that impression. Today's media coverage of FITNET will unquestionably appall some of those people in the scientific community who are now aware of the problems of PACE, and will hopefully encourage a few to be more public with their concerns. The more authority figures who openly condemn PACE, FITNET and CBT, the greater the likelihood the media will take those criticisms seriously in their future coverage.

The only 'new' thing here, as far as I can see, is that Holgate has very publicly associated himself with Crawley and her research, and that he's done this knowing there is widespread unhappiness in the patient community at her involvement with MEGA. I don't think he would have done that if he had any intention of removing her from the MEGA team.

 

[Cheesus]

Here is the coverage from BBC Breakfast

https://www.facebook.com/bbcbreakfast/videos/1471876832826450/

As it is on Facebook you are able to comment.

 

[Cheshire]

The only 'new' thing here, as far as I can see, is that Holgate has very publicly associated himself with Crawley and her research, and that he's done this knowing there is widespread unhappiness in the patient community at her involvement with MEGA. I don't think he would have done that if he had any intention of removing her from the MEGA team.

I think that's the point.

 

[Valentijn]

Her second sentence is clearly a lie. Those without access to specialist treatment had the same outcome at long term. How is this possible?
How can the CMRC tolerate that?
What's driving EC, seriously?

Crawley likes to compare scores from different assessment methods (questionnaires) to reach her desired conclusions. She has done this with mental health data in her CFS patients, ie using an inappropriate questionnaire (HADS) for CFS patients with an unusually low threshold, and comparing it to DSM structured interviews used for getting rates in the general population.

Essentially, she likes to compare apples to oranges to support her conclusions. I suppose to a BPS practitioner, everyone's a fruit and no further detail is desired

 

[snowathlete]

Doesn't all this publicity invalidate the trial before it starts? Flooding the media with stories saying the treatment 'cures' two thirds of children means any parent or child who is asked to participate will already have preconceptions about the outcome.

I think that's a very good point. Participants are going to see this, their parents are going to see this, it's like in the PACE trial when they gave them information praising the treatments mid trial. This is the same. It's telling them it is a success, that these treatments work, before they've even done the trial, which influences the self-reported questionnaires they fill in. In a trial without objective measures, this completely invalidates any result.

 

[Sidereal]

All the more reason to strongly oppose the CMRC and MEGA.

 

[Valentijn]

I noticed one comment in the process of it being deleted on the Facebook page:

Crawl back under your rock Crawley you are damaging children!! My child was put through hell following protocols and regimes to rid her of ME, pacing, GET, CBT, we stupidly thought we can cure this! Who the hell can cure a neurological disease with exercise and therapy, 5 years on end any amount of exertion will put her back to bed with a body fit for nothing, a childhood lost a future Unknown.
This money could be used for proper research, research to find a virus, research to find a bacteria, research for inflammatory markers not research for running and counselling.......
M.E. is a neurological disease(1) and stands for Myalgic Encephalomyelitis. My = muscle. Algic = pain. Encephalo = brain. Mye = spinal cord. Itis = inflammation. It is an injury to the Central nervous system usually triggered by an infectious disease process, e.g. a virus, or by chemicals over stimulating the immune system(3).