David Tuller: Trial By Error: My Letter to Red Whale/GP Update

[Kalliope]

My letter to Red Whale/GP Update

Earlier today I sent the following letter to the e-mail address I found at the website of Red Whale/GP Update, which recently disseminated a recruitment ad for FITNET-NHS. I blogged about it on Monday. I cc’d officials at the Health Research Authority, the agency that regulate research ethics.

 

[Daisymay]

Excellent, thank you yet again Dave, specially like the fact you've written to the UK Health Research Authority too.

That this recruitment ad was ever sent out, when the whole fiasco with the PACE biased newsletters has been exposed beggars belief. Unbelievable, the gall of these people.......

 

[Kalliope]

Is this correct?

 

[Trish]

wessley is head of gp's now after taking over from his wife after he retired from head of psych post. he is behind this bs

Not correct. Wessely's wife, Clare Gerada, was head of the Royal College of GP's. Wessely moved from being at the head of the RC Psychiatrists to the RC Medicine.

 

[Hutan]

Excellent to make Red Whale think about what they are doing.

I think the attacking of the Dutch study could be stronger although I understand there's a limit on how long letters can be.

This is the main paragraph in the letter addressing the results:

Moreover, it is inaccurate to call the results from the Dutch study “impressive.” The “recovery” data were based on a post-hoc definition of “recovery.” That is, the Dutch investigators made up the definition after they had seen their results. It was likely not a challenging task to construct a definition that yielded the desired rate of “recovery”—which is why post-hoc findings are accorded relatively little weight as scientific evidence.

Changing the definition of recovery isn't good of course, but a reader of this is likely to think, well, no matter where the recovery level was set, there must have been some improvement.

I think I'd want to draw some attention to:
1. the length of the study was only 6 months
(My son saw a psychologist who encouraged him to go back to school. He rested over the summer, enthusiastically went to school and then had a great first couple of months. But just after 6 months after finishing the sessions with the psychologist, he fell in a heap and slept for 20 hours a day for a month. It can take time for the effects of over-exertion to accumulate.)

2. the measures were self-reported (even the school attendance - and there's that recent paper that found that self-reported school attendance is not reliable). Objective actometer measurements were made but not published.

3. The selection criteria were lax - maybe many of the participants didn't even have CFS.

4. I think there was no real control treatment. I expect the recovery rate of a group of young people suffering from vaguely defined fatigue is pretty good over 6 months.

I've only read abstracts on this and then I forget what I've read, I may have things wrong. There was the paper by Gatinah and Vink on the Dutch Fitnet study.

 

[Lucibee]

I was quite shocked as to how this appears on the Red Whale update site.

This is what GPs will see:


When you click on More, you get this text:

The authors concluded that this study demonstrated a viable treatment option for adolescents with CFS/ME, and supported wider implementation – this is now happening within the context of a clinical trial in the UK.

FITNET–NHS is a randomised trial based at the Royal United Hospital in Bath, in association with Bristol University. It is aiming to recruit more than 700 adolescents. Subjects will be randomised to receive either FITNET (19 online psychoeducation modules) or Activity Management (the NICE recommended treatment strategy) – there is no placebo arm.

These interventions can be delivered at home – no visits to Bath are required, and GPs across the UK can refer to this service (although the diagnosis does have to have been confirmed by a paediatrician). We think this is a good opportunity for teenagers with this difficult diagnosis.

Click below to see our summary of the Lancet 2012 article, details of the eligibility criteria and how to refer your patients to the FITNET-NHS trial, which is recruiting until May 2020.

The only link to the Bath website, which is a little more toned down, is at the end of the pdf - https://www.gp-update.co.uk/SM4/Mutable/Uploads/pdf_file/CFS-ME_-treatment-for-teenagers.pdf - and is non-clickable!

 

[Peter T]

Thank you @dave30th for following up this misleading and inappropriate advertising with your letter to Red Whale.

I understand you wanted to focus on the unambiguously indefensible methodological problems of which here the pre-recruitment promotion of the treatment as effective and the misleading use of the word 'recovery' are the most relevant, but personally I would have wanted also to point out the problems of the BPS researchers' definitions of ME/CFS meaning these studies may include people without PEM and that this therapy approach is potentially contra indicated for people with classical ME given it promotes increased activity/exercise. Such promotion of activity/exercise is even more worrying when the intervention is provided on line reducing the ability to monitor adverse reactions.

All that Red Whale have on their website relating to ME/CFS is information about this trial. Obviously it takes time to build up resources on all topics, but that they have chosen to present an advert for participants in this trial ( https://www.gp-update.co.uk/SM4/Mutable/Uploads/pdf_file/CFS-ME_-treatment-for-teenagers.pdf ) as an up date on ME/CFS is worrying given it completely ignores the serious controversies around this treatment approach, ignores the thousands of studies indicating a biomedical basis for the condition and ignores the potentially harmful consequences of this intervention.

It may be useful to be ready to encourage a fuller more balanced understanding of ME on the part of Red Whale, and I would be interested in participating in a complaint to the Advertising Standards Agency if they do not give an adequate response to David's letter. Obviously it is important to know if they were specifically commissioned to promote this trial or if they themselves made the decision to pursue this line in their 'update' on ME/CFS; if the latter is it relevant to ask if they are positioning themselves to develop marketable training packages in relation to FITNET and/or the emerging MUS bandwagon?

 

[Sly Saint]

https://www.gp-update.co.uk/SM4/Mutable/Uploads/pdf_file/CFS-ME_-treatment-for-teenagers.pdf

in tiny weeny print
"
We make every effort to ensure the information in these articles is accurate and correct at the date of publication, but it is of necessity of a brief and general nature, and
this should not replace your own good clinical judgement, or be regarded as a substitute for taking professional advice in appropriate circumstances. In particular check
drug doses, side-effects and interactions with the British National Formulary. Save insofar as any such liability cannot be excluded at law, we do not accept any liability
for loss of any type caused by reliance on the information in these articles."

"
There is also a more comprehensive article on CFS/ME including the 2007 NICE Guideline in the
online handbook."

which online handbook?

"
The Medically Unexplained Symptoms Course
London Thur 18 Oct 2018"

sigh.

eta:

if the latter is it relevant to ask if they are positioning themselves to develop marketable training packages in relation to FITNET and/or the emerging MUS bandwagon?

 

[Peter T]

Thank you @Sly Saint for pointing out that Red Whale are already providing training in relation to MUS. So they are already invested in the BPS approach, and depressingly their October MUS course is already fully booked (see https://www.gp-update.co.uk/course/Medically-Unexplained-Symptoms-Course ).

Added later: the course information is limited

A significant proportion of patients who present to us will turn out to have symptoms that are medically inexplicable. We all know that there is no magic solution with these patients and sometimes they leave us feeling defeated and not sure what to do. However, there is evidence which can help address the issue. We work through a toolkit of techniques that have been shown to enhance the confidence and skill of doctors and clinicians.

so it would also be interesting to see the 'Medically Unexplained Symptoms Handbook' they promise to include.

 

[Arnie Pye]

I'm probably being dim here, but if the FITNET trial was so fabulous a success why would researchers want to do the trial again? I know FITNET wasn't actually good, but I'm wondering why doctors or anyone else might think that getting patients into another trial of the same thing was worth doing.

 

[Jonathan Edwards]

I'm probably being dim here, but if the FITNET trial was so fabulous a success why would researchers want to do the trial again? I know FITNET wasn't actually good, but I'm wondering why doctors or anyone else might think that getting patients into another trial of the same thing was worth doing.

The GPs will think it useful to offload patients whether it is called a trial or a service.

The Health Research Authority should already be up in arms about this. It is about time that it was appreciated that people selling duff therapies have exactly the same conflicts of interest as people selling duff drugs.

 

[Adrian]

"
We make every effort to ensure the information in these articles is accurate and correct at the date of publication, but it is of necessity of a brief and general nature, and
this should not replace your own good clinical judgement, or be regarded as a substitute for taking professional advice in appropriate circumstances. In particular check
drug doses, side-effects and interactions with the British National Formulary. Save insofar as any such liability cannot be excluded at law, we do not accept any liability
for loss of any type caused by reliance on the information in these articles."

"

I wonder about the legality of that disclaimer.

 

[Adrian]

I'm assuming that Crawley has had to get someone like Red Whale involved because she is having problems recruiting to Fitnet.

 

[Sean]

I wonder about the legality of that disclaimer.

Yeah, I was wondering that too.

 

[Moosie]

I was quite shocked as to how this appears on the Red Whale update site.

This is what GPs will see:
View attachment 3973

When you click on More, you get this text:



The only link to the Bath website, which is a little more toned down, is at the end of the pdf - https://www.gp-update.co.uk/SM4/Mutable/Uploads/pdf_file/CFS-ME_-treatment-for-teenagers.pdf - and is non-clickable!

Can't read much at the moment but is this the first time anyone involved in any of this hocus pocus has stated what 'recovery' means? (Bottom of clip above.) I thought it was some undefinable, vague state that nobody understands. Sorry if this is already discussed.

 

[Lucibee]

Can't read much at the moment but is this the first time anyone involved in any of this hocus pocus has stated what 'recovery' means? (Bottom of clip above.) I thought it was some undefinable, vague state that nobody understands. Sorry if this is already discussed.

FITNET-UK site FAQs says this about the Dutch definition of recovery:

'Recovery' meant that participants' fatigue, physical function and
school attendance had to cross certain thresholds, and participants also
had to rate themselves as being completely recovered or feeling much better.

Maybe they should modify the definition below the table accordingly: *Recovery = full school attendence, moderate fatigue, 'normal' physical functioning (where 'normal' means normal for those with congestive heart failure [my mistake - that's another paper]).

 

[Lucibee]

Just checked. It wasn't really full school attendence at all, although that's how they described it. This is from the paper:

Fatigue was measured using the subscale fatigue severity of the CIS (Checklist Individual Strength)-20 (range 8–56).
Physical functioning was measured using the subscale physical functioning of the CHQ (Child Health Questionnaire)-CF87 (0–100%).
No objective measures.

 

[adambeyoncelowe]

Just checked. It wasn't really full school attendence at all, although that's how they described it. This is from the paper:
View attachment 3975
Fatigue was measured using the subscale fatigue severity of the CIS (Checklist Individual Strength)-20 (range 8–56).
Physical functioning was measured using the subscale physical functioning of the CHQ (Child Health Questionnaire)-CF87 (0–100%).
No objective measures.

So all they had to do was tell patients to go to school 9 days out of 10 in the preceding two weeks, and then they fulfilled that criteria.

 

[dave30th]

Just checked. It wasn't really full school attendence at all, although that's how they described it. This is from the paper:

Also, self-reported school attendance is still self-reported--to measure school attendance as an objective measure you'd have to get the school records.

 

[Invisible Woman]

....and just because your behind is on the seat doesn't mean that you are capable of participating fully and taking on board the information being imparted.

Edited - spelling