PACE trial TSC and TMG minutes released

It was felt sensible in the long term to have cross cover because if one treatment is shown to have a greater efficacy than the others then it will avoid the issue of one clinical discipline ‘owning’ the best therapy.

I can see that would put the cat among the pigeons. You might not even need a multidisciplinary team after all. Worse still the doctor might be able to do it and so would be stuck with the patients and the girls would all be out of work.

Fortunately we now know from SMILE that any barmy therapy gives the same results. So plenty of room for six colours of cardigans.

 

Primary and complementary colours- i had not truly appreciated the variety available!

 

I only started to become aware of PACE, and what an appalling state things were in for PwME, in August 2016, so seeing that the MEA was saying this in 2004 really warms my heart to them.

 

Action: PW to write to all members outlining potential conflicts of interest, and invite replies.

Is it possible to ask for these letters under another FOI request?

 

"a) Professor Butler expressed concern that the APT manual appeared to be considerably smaller than those for CBT and GET. Recommendations including copying the format of the GET manual for information on engaging the patient, the initial assessment and troubleshooting such as `what to do if your therapist is on holiday'. it was stated that APT should have equal face validity to the other therapies, and that because this was a new treatment and one advocated by the patient groups, it was important to make this treatment of equal quality. Chris Clark was asked to comment on whether there were items for pacing that could be included that reflect users views. Chris stated that the surveys carried out by AfME produced a wealth of complex answers and that these could not be easily included."

Confirmation from within that there was concern about the way APT was being perceived. As the manual was approved though there was obviously nothing done to address it.

 

I could be wrong, and I think these are them (so much info is coming out recently I can tell I'm getting a bit lost in it):

https://www.s4me.info/threads/statements-on-conflict-of-interest-of-pace-trial-tsc.3189/

This stuff also helps explain why APT is this weird version of pacing that includes a lot of the problematic therapist led stuff from CBT/GET.

I can see why they did this, considering concern about biasing their primary outcomes, but that they were aware their primary outcomes were prone to problems with bias in this way should have led to them fundamentally reassessing their whole approach, not just trying to botch it together.

 

Hello, Clare here. Action for M.E.'s Chief Executive Sonya Chowdhury has been on annual leave (and is still out of the office) but has asked me to post the following on her behalf, given the keen interest in this topic, and the fact that she received one or two emails over the weekend. She says:

“The QMUL’s FAQ about the PACE trial says: Actigraphy was the obvious measure to reject because of its burden in time and effort required by participants. The patient charity advising us agreed that this would be sensible.

“However, as you can see from the minutes of meetings that have been released, there is no detailed record of any discussion about this, and Action for M.E. holds no further notes from these meetings. So I cannot tell you why the charity’s representative at these meetings agreed it would be sensible not to use actigraphs, because I don’t know, have no way of finding out, and I think it’s futile to speculate about decisions that were made by people I don’t know in meetings I didn’t attend.

“If I or any other representative of the charity was asked to offer our view on the use of objective outcome measures such as actigraphs now, I can assure you that we would be unequivocal in our support.

"Speaking as a parent of a 15-year-old who has had M.E. now for nearly four and a half years, recovery for my son means returning to school full-time and being able to engage in all the normal activities his peers are enjoying. Anything short of this is not recovery and we must ensure that we do not sell our children and others with M.E. short. It is my personal view, as well as that of the charity’s, that greater investment in high quality biomedical research is required to achieve this hope of recovery.

"With the exception of involvement with the big data study (MEGA) application, the charity no longer involves itself on trial management or steering groups, and now focuses our research-related activity solely on the promises set out in our 2016-2021 strategy.

"While I understand that trust in the charity remains an issue for some, I strongly refute the statements I have seen about individual researchers having any role, including a decision-making one, in the charity. As CEO, I hold responsibility for what the charity does and doesn’t do, and I work closely with the Board of Trustees who hold overall accountability for setting this strategic direction. I report to them and am accountable to them, to our Supporting Members, donors and recipients of our services.

"There is so much to do to achieve my hope to see treatments and recovery for my son, and for the many other millions of people suffering as a result of this horrid illness. While I am CEO, we will continue to work with as many people as possible to achieve this including the UK CFS/M.E. Research Collaborative (CMRC). I know the CMRC’s recent announcement about its new purpose, objectives and values has been a hot topic and I am also very excited to see the progress of its proposals to instigate a top-level report, work with the James Lind Alliance and establish a CFS/ME Platform.”

Thanks

Clare Ogden
Head of Communications and Engagement
Action for M.E.

 

Thank you Clare (@Action for M.E.) and Sonya. That seems very helpful.

 

Thanks Clare.

I think the question that follows would be, which Doctors/Researchers held AFME advisory positions at the time and would agreement from any singular person in such a position have been construed (Or quite possibly, misconstrued) as 'support from the charity'?

 

@Action for M.E. Hi Clare can you ask Sonia why she doesn't enrol her son on an LP course? Esther Crawley has published evidence that it cures children. Alternatively she could speak out publicly and denounce Crawley as many other people have. She is the head of an ME charity afteral.

 

So Action for ME has no record of who was representing it during the biggest most expensive study into ME?

Are charities not obliged to keep records?

 

Possibly not, not in the way that you mean it. A quick Google confirmed that financial records, typically, need to be kept for 6 years but there didn't seem to be anything on 'operational' records (or however you might term them). And we are also talking now of events around 10 years old, so it wouldn't surprise me in any way if records haven't been kept.

 

Speculatively, if an AFME advisor acted outside of their remit/authority to speak on behalf of the charity, that could be enough to justify the PACE author's claims of charity support. AFME can of course retroactively remove that support as improperly given (in the event that was the case) it's hard to know if there is recourse beyond that, especially if such an advisor has already moved on.

You could of course ask the question, whether support should of been confirmed by the PACE authors with official correspondence and board agreement. But that would require a technical knowledge of legal/ethical responsibilities.

In the future, ME charities should consider updating their protocols to make it impossible for unintentional consent to be given without full board agreement and inform their members of those protocols to ensure confidence. Patients should feel justified in questioning charities and expecting transparency, given what might have transpired with PACE.

I think AFME should be commended for engaging with the patient community, my attitude towards the charity is receptive to change, but vigilant, based on past associations.

 

I don't think it matters who the researchers blame. They are the researchers, and are responsible for their research.

(With regard to AfME I'm far more interested in what they do now and going forward)

 

Any chance we could lose the cardigan jokes?

I wore a cardigan in work, a red one (speech & language therapist). I worked with people who wore green cardigans (occupational therapists) and navy cardigans (physiotherapists and nurses) and all kinds of cardigan-free clothing (doctors, medical social workers etc). There did not seem to be any correlation between whether people wore cardigans or not and the ability to critically review the science/be a decent clinician/assess whether treatment was effective/ listen to patients/treat patients with respect/think independently.

Male and female health professionals and non-professionals in a wide variety of clothing deliver ineffective care to people with ME/CFS every day. In the future, effective care will be delivered by male and female health professionals in a wide variety of clothing.

 

Thank you, Clare and Sonya (@Action for M.E.) Whatever the details about who made the decision and what discussions took place, it seems clear that AfME made a serious error of judgement in agreeing to drop actigraphy as an outcome measure. Had actigraphy been kept it seems highly probable that it would have returned a null result, which may not have been "useful" to White et al but it would have been of significant benefit to ME patients. Clearly Sonya is not responsible for this or any other mistakes that were made before she joined AfME. However, my strong feeling is that it would be helpful if AfME was able to acknowledge and apologise for this and other mistakes that it has made in the past.

Thank you again to Sonya and Clare for taking the time to listen and respond.