Action for M.E. - Placing Patient Views at the Heart of a New Research Strategy

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Action for M.E. - the UK's largest CFS/ME charity - launched a new research strategy in November based on the priorities identified by patients. We asked the Charity's Chief Executive, Sonya Chowdhury, about the new strategy and also about the commitment to greater patient involvement. By Russell Fleming and Simon McGrath.

Sonya Chowdhury, CEO, Action for M.E.

Charities have always connected with patients - many were founded by patients and are supported with patient help, but few have tried to give patients a voice when it comes to decision making.

Action for M.E. is working to do just that, a task made far more practical by the internet: consultation has never been so easy, so fast or so cheap.

At its Research Conference held at the beginning of November, Sonya Chowdhury the Chief Executive, announced a new research strategy, and what made it different, unique even, was that its' priorities had all been determined by patients.



The New Research Strategy

The new strategy is summarised in the graphic below and is perhaps worth taking some time to consider:

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Action for M.E.
Research Priority Survey Results - June 2013; click to view pdf

The priorities and themes were drawn from the top 5 patient priorities - determined by consulting the community through a survey in June, which attracted the views of 1,000 people (900 of whom had M.E.). Together, these 5 priorities won 85% of patient first-choice votes:

1. Disease Processes and causes (underlying pathology)
   
2. Better Treatments
   
3. Better Diagnosis
   
4. Clinical course of ME, outcomes and prognosis (Epidemiology)
   
5. Severely Affected patients

To which Action for M.E. has added Prevention, Genetics and Genomics, and Biomarkers, and I doubt many would quibble with those choices.

Two promises worth highlighting are, that:

“We will fund biomedical pilot studies to stimulate mainstream funding and will develop a programme of work with others to initiate and support social policy research to support our informing and influencing work”

and

“We will partner with patients and researchers to support patient participation and keep patient voice and the heart of research”

Committed to consultation

The patient survey served to also inform the Executive Board of the UK CFS/ME Research Collaborative which had initially sought patient feedback. However, this canvassing of opinion, is not to be seen as a one-off exercise, as Sonya was quick to explain:

“We will do the same again when we set any new strategy, but that’s not to say that we wouldn’t do something sooner if there was need or something changes significantly. There has to be a level of flexibility and agility in all of our strategies and policies.

We will, however, continue to pursue our commitment to patient engagement, to participation and to giving patient's a voice, and we will ensure that we listen on many different levels, for example through discussion threads, questions on Facebook and more surveys.

We have a list of ideas from various discussions we've already had such as establishing a patient reference group, focus groups (actual and virtual), and more regular consultations.”
​

We asked Sonya some more about the new strategy, the charity's approach to research and what consulting patients might actually mean in practice:

What do you see as the most important thing(s) in the new research strategy? And why?

“I strongly believe in the need for personalised medicine and anything that helps us get to that point has to be of importance. If I had to pick two promises, or core values that underpin the strategy, these would be collaboration and participation.

I have a background in children’s rights and ensuring meaningful engagement/participation and I fundamentally believe that you achieve the best possible outcomes by working with the people that you work on behalf of.

This isn’t an optional extra; meaningful engagement and consultation with our supporting members and others, such as other M.E. charities and patient groups, has to be inherent in our work.

I also believe that we have to work collaboratively if we are to achieve the level of transformation needed for people affected by ME/CFS. That includes people with whom we may have differing views as long as we can find some common ground that is in service of achieving positive change.”

Several of the patient-determined priorities have been talked about for a long time now, for example the need to focus on severe patients, epidemiology, and biomarkers. Why do you think it has it taken so long to act upon them? And how do you think highlighting them again in this way will make a difference?

“Action for M.E. has funded work in these areas and the UK ME/CFS Biobank that we’re co-funding is collating samples including from people who are more severely affected. However, there is still a significant gap and we must increase our focus on this.

It is not right that people with M.E. are so severely disadvantaged and that there is an imbalance in mainstream funding for research. It’s even worse that we have those who are more severely affected receiving less of a focus with limited or no services and a dearth of research.

You don’t really find that with other illnesses. A researcher once described people in this group as ‘severely affected, severely neglected’. It’s unjust and therefore we have to continue not only highlighting them, but work with others to turn this into action by securing more money and more research.”

Does this strategy represent a change in direction for Action for M.E. in terms of research funding and if so, in what way? For example, your website mentions 'biomedical', is this now the sole determinant for qualification, to the exclusion of, say, psychological research which came last in your survey as a first choice for patients?

“Our recent funding has been used for biomedical research and so this isn’t a change of direction. What we have sought to do is to be explicit about what we do and how we do it.

There is such a momentum at present within the research field and therefore it is right to review our position and work in this area. We are also continuing our commitment to being more transparent about our work.

Our assessment for which research projects we will fund, partner and/or support is focused on, “how might this benefit people with M.E.?” and you can read our assessment criteria for partnering requests.

We should never rule anything out if there is a strong case for supporting a project, but our focus currently is on biomedical research projects.”

Action for M.E. is currently funding the following CFS/ME research projects:​

• Epidemiology: The Disease Register
  
• Co-funding the UK's first Biobank
  
• A study into muscle dysfunction at Newcastle University
  
• Funding a case-controlled study exploring the qualitative experience of sleep at Northumbria University
  
• A study looking at cognitive impairment associated with fatigue at the University of Sheffield.

Action for M.E. 2013 Call for Research Proposals

Research Fortnight

Advertisement Nov. 28, 2013

“Action for M.E. offers research grants
Action for M.E. is calling for applications for its pilot research grants; £60,000 is available for up to three projects. Applications should focus on underlying chronic changes related to M.E./CFS, particularly focusing on post-exertional fatigue, autonomic dysfunction, immune dysregulation, phenotyping, epidemiology and severe M.E.”
Research Fortnight, p 10.​

How will you be actively seeking research projects and promoting CFS/ME as an exciting area of interest?

“We have circulated our 'Call for Proposals' as widely as possible across our network of researchers and universities as well as through social media and our Online M.E. Centre.

I have already had discussions with a number of researchers interested in submitting applications including some who are at present outside the CFS/ME field.

There are many things that make CFS/ME an exciting area of interest. Not only do you have the technological and social advances that are benefiting research more widely, but there is increasing collaboration in this field with many new discoveries yet to be made, and there is the opportunity to make a significant difference.

True, the same can be said for a number of other illness areas. However, when I talk to researchers who have recently started working in the CFS/ME field, the thing that many say is different is the higher level of patient engagement, and the commitment and passion to work in a meaningful way with researchers.”

Why do you think there remains a need for small, and potentially fragmented 'pilot' studies when the field is dominated by such research dating back 50 years? Isn't it time we looked to more significant, larger, and better defined research, that includes perhaps the replication of existing research?

“We would love to be in a position to fund larger projects but we’re not. We are not just a research charity and also need funds to deliver services which provide information and support to more than 300,000 people.

We also believe that CFS/ME research is a priority, given the injustice, ignorance and neglect that exists and therefore larger research projects should have mainstream funding.

Our role is to add to, or complement mainstream funding through investing in feasibility studies and so forth. It is essential, though, that there is better collaboration between researchers so that the potential benefit from pilot projects is realised.”

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Sonya on winning patients' trust

​

“It’s now 14 months since I came into post... and what a rollercoaster ride it’s been. At our Research Conference and AGM a couple of weeks ago, I reflected back on my first few months, and commented on how shell-shocked I think I was.

​

I hadn’t anticipated the level of fragmentation, frustration and anger that existed, much of it understandable given the ignorance, inequalities and actual discrimination that I also saw and heard about.

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BUT... I was, and still continue to be, incredibly touched by the passion, the sheer determination and commitment that many people were taking to create the level of change that is so desperately needed.

​

Over the past year, I have had to front up to criticism and significant challenges to what we have said or done, both past and present. I have also received tremendous praise for things we have done, are doing and plan to do.

​

It is absolutely right that as a patient charity, we, and me personally, are held to account by our supporting members.

​

We are working hard to ensure that we engage with people affected by M.E. in a meaningful way to inform our work and to help ensure we continue to do better.

​

This is set out, in the form of ‘our promises’, in our Statement of Strategic Intent that we launched in May.”

I couldn't help but notice that Professor Stephen Holgate is a member of your Research Panel. Was this a recent appointment and what role does he play?

“Stephen has been a member of our Research Panel since it was launched in January 2012. He plays a significant role in the Panel and has contributed to all of our meetings and discussions.

The Panel, which also features three supporting members chosen by their peers, reports to the Board and oversees our research work as well as helping set the strategy, identify which projects to fund and/or partner and helps to ensure accountability for the funding that we invest.

Personally, I find Stephen incredibly supportive as a sounding-board and in offering guidance. We have a strong Research Panel and Stephen is very much a part of this.”

Involving patients appears then to be a continuing focus for your work, so what's the next step for the strategy and for continuing patient participation?

“We want to discover what our supporting members and others think about where we’ve got to and develop our plan to put this strategy into action.

We are also keen to hear how we can further engage with our supporting members and people affected by M.E. to inform our research work.

So, if anyone reading this has any views, thoughts, ideas or questions, please do contact Action for M.E., or you contact me direct.

We can always do better but I hope we are making good progress on really listening, responding and acting on what our supporting members and others affected by M.E. have to say.”

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There are many ways you can help Phoenix Rising to continue its work. If you feel able to offer your time and talent, we could really use some more authors, proof-readers, fundraisers, technicians etc. and we'd love to expand our Board of Directors. So, if you think you can help then please contact Mark through the Forum.

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We referred above to the recent Action for ME Research Conference - where Professor Stephen Holgate (who is also a member of the AfME Research Panel) delivered the keynote address.

The You Tube video of his speech is now available. I'm listening now - rather good I must say!

We have a thread running about Stephen's speech specifically - and I have popped the video on it this morning - HERE.

No mention of PACE, or the role Action for ME has played in preventing patients gaining information about this vitally important trial?

Is Sonya now going to step up, and start fighting for patients to be provided with the results for the outcomes laid out in the trial's protocol? Or is she going to continue to turn away from the most important research matter facing patients today? Does she show any understanding of how the results from PACE were spun? Were these matters discussed?

Not to be rude to simon or Russ, but Sonya's responses just sound like worthless blather, and will do until she indicates a real willingness to take the side of patients against those who are happy to mislead them, and force them to make decisions from a position of ignorance.

The h'ghly controversial PACE trial was developed by psychiatrists 'with the help and support of the UK charity Action for ME.' AfME have been silent on the way that the data from the trial appear to have been shamelessly manipulated to make it seem as if the very exercise regimes that have been detrimental to numerous M.E. patients' health , are somehow beneficial. They have been silent on the researchers' refusal to release the deterioration rates from the trial.

AfME 'S only full members are the executive, with all the others deemed 'associate members' and refused voting rights. How is this giving them a voice?

AfME could surely fund far more biomedical research if its salary bill were not so huge. The CEO alone earns approximately £75,000 a year.This is a huge amount, and in contrast, the charity Invest in ME is run entirely by volunteers and is already funding a vital entrovirus research project, with a Rutiximab research project planned soon.Unlike AfME, Invest in ME refuse to work alongside the very psychiatrists (known to have links to the health
insurance industry) who have stifled research into myalgic encephalomyelitis since the
1960s and caused untold suffering by their insistence that the illness is a functional somatic syndrome treatable by exercise.

Yes, AfME, you could do better.

What is Personalised medicine?
The AfME research strategy puts personalised medicine as the overall goal and I have to admit I was a bit hazy about what this means. Fortunately Prof Stephen Holgate explained this in more detail in his highly-recommended talk at AfME's AGM. He used breast cancer as the example:

Personalised medicine in breast cancer
There are, apparently, 15 different types of breast cancer with each different type having a different molecular cause and, crucially, needing a different treatment. As an example Stephen Holgate said that some breast cancers are due to overexpression of the oestrogen receptor on the cancer-cell surface - and such cancer responds very well to treatment with Tamoxifen (which seemed to be some kind of wonder drug when it first appeared in the 80s). But if your breast cancer isn't down to overexpression of oestrogen receptors, Tamoxifen won't help.

However, another type of breast cancer is due to overexpression of another cell receptor, HER2, and there is a different drug - trastuzumab - that will treat HER2 cancers effectively (though not other types of cancer).

Video of this (Personalised Medicine section starts at 27:40"


Later in his talk he argues that complex, chronic illnesses - including ME/CFS - will turn out to be a collection of different rare diseases.

I will quibble with the organization's choices, especially "prevention", and say that with limited money, the best choices of how to spend it are those that patients overwhelmingly selected.

So much depends on specifics. A lot of this stuff is really vague and could be good, could be bad.

I agree with Sing that 'prevention' is a potentially dodgy one. We've seen how Chalder and White have spun their past work on 'prevention', and more money for them would be sickening: http://forums.phoenixrising.me/inde...o-educational-intervention-to-aid-reco.13326/

Really, it comes down to trust, and there are good reasons to not trust Action for ME to do anything other than suck up to those with power, even when they're actively misleading and mistreating patients.

Well said, Esther!

Hi - I hope the following responds to some of the points that have been raised in the posts and hope that it's ok to pull them all into one post rather than respond to each individual post:

Action for M.E. supported the PACE trial because we believed that it would provide the NHS and other medical professionals with scientific confirmation of what people with M.E. had been telling us and other M.E. charities for years - that pacing was an effective technique for managing the symptoms of M.E.
We understand that a number of Freedom of Information requests have been made to the PACE Trial research team and will consider our position in light of any new information that is released. We do not have any plans at this stage to take any further action.
We support high quality research to gain insight into M.E. We do this by a variety of means, including sponsoring pilot schemes on the basis that they are high quality and peer reviewed. Any funding that we provide is done so following a transparent decision-making process and there is more info via the links in the article.

We added prevention to the list of priorities because, as with any illness, prevention is important. We will publish information about all research projects we fund on our Online M.E. Centre and all will go through a rigorous process, including peer review, before a decision is made. Increased transparency will ensure that we are explicit about who we are funding and why. As stated, one of the most likely next steps is to set up a patient reference group to help inform our health and research work.

While I have received many positive responses about our work and current direction, I do appreciate that for some, there remains a scepticism and lack of trust about our work. I hope that our actions will challenge this as we move forward and until then, we will continue with our commitment to opening up the dialogue. I will respond personally and appreciate the emails that I have received from individuals alongside the posts here and on other fourms/social media. Sonya

That's not a terribly revealing response - sounds committee drafted and evasive to be honest. Do you understand why patients are concerned with the way in which results from PACE have been spun? Maybe you, as an individual, have decided to it's best to say nothing, but if so, why? If you do not understand these problems, I'm sure Simon would be happy to explain them to you. Maybe you do have a good understanding of these matter of patient concern, but believe that the criteria for recovery used by PACE was appropriate - in which case, I think that you should take the time to defend this view.

What could have made Action for ME think that the way in which the PACE trial was designed would lead to evidence that 'Adaptive Pacing Therapy' was preferable to CBT or GET? That even now you seem to conflate 'Adaptive Pacing Therapy' with 'pacing' as it is commonly understood and used by patients is pretty worrying to me. Who is advising you on this stuff?

You understand that FOI requests have been made, and will consider your position in light of any new information released? What is your position now?

1) A representative from Action for ME made a statement on behalf of the PACE trial researchers, arguing against the release of minutes related to changes in the trial's outcome measures. Do you think that patients should be allowed access to information on the outcome measures laid out in the PACE trial's published protocols? Are Action for ME pushing for the release of this information?
2) Are you concerned at the falsehoods used to justify deviations from this protocol (are you even aware of them)?
3) Do you think that those making misleading claims about the efficacy of treatments for CFS should be condemned for doing so? Would you like to prevent further research funding going to those researchers with a history of making misleading claims about the efficacy of their treatments?
4) Do you think that it is harmful for patients and doctors to be given misleading information about the efficacy of CBT/GET for CFS? If so, who should be held accountable for this harm, and how?

Excellent questions, @Esther12 . Any responses, @Sonya Chowdhury ?

Ta Val. It would be nice to be able to understand what Action for ME think they're doing, and why.

If AfME is changing direction that is a very welcome thing, but I think this charity has a lot to prove. Other UK charities have been consistent in their demands for biomedical research and their opposition to the NICE guidelines and the psychosocial research such as the PACE trial - I have never understood why AfME has not taken that position too.

Significant changes were made to the PACE trial with only a trivial explanation. Where we they were more specific and data was available to check then we have found the reasons wrong. Hence we need
1) To understand that a good governance process was applied by the trial steering committee, hence the need to publish minutes. This way we will know more detail of the reasons for the given changes and whether they were adequately checked by the trial steering committee. Additionally it appears from the statistical analysis plan that the normal range and hence recovery thresholds were not covered. Unfortunately it appears AfME supported queen mary's in suppressing this data.
2) All the data including histograms for the results distributions (as listed in the statistical analysis plan). Also the original measures from the original protocol along with 3mwt (and other measures) for those who they claim are improved and recovered. Probably quite a lot of other data as well.

Without this patients and doctors looking to make clinical decisions are presented with a high degree of uncertainty. This is unacceptable when the data to clear this up exists.

You say the aim was to provide scientific conformation but whilst data appears to be cherry picked and not fully released there can be no conformation of anything. Its not just AfMEs silence that is concerning but the active support of suppressing data that appears to have been given.

I also wonder why AfME aren't calling for further meetings of the trial steering committee to review post hoc changes and uncorrected errors.

Part of supporting high quality research is ensuring that those doing research know that they must follow strong methodologies because weaknesses will be exposed. I would argue a huge about of research money has been wasted on trials and research with poor methodology. This will only be improved by challenging those carrying it out.

Peer review within a small community does not work. It allows sloppy behavior from all those with in the community. It will only be improved by pulling in people from outside.

We are currently in a situation where one researcher tells patients that they have had CFS for too long for it to be ME and claims she has cured their ME and (with no significant symptom change) says they have a dissociative disease (hysteria) due to the stress of being ill. Whilst at the same time getting huge amounts for research funding from the government. How can we reconcile such behavior with trusting someone with research money. Until there is a high level of governance applied to doctors and researches things will not improve.

I would very much like to see Action for ME explaining the actual results of the PACE trial to its members.
I think that patients have a right to know that CBT and GET are not expected to lead to any clinically useful improvements in objective outcomes (e.g. disability, employment, and welfare claims); and that roughly only 13% of mildly-moderately affected fatigued patients should expect to experience any additional subjective improvements when CBT or GET are added to SMC.

However, if the PACE trial is simply an area that AfME feels unable to visit (for whatever reason: sheer embarrassment at its involvement?), I'd perhaps be willing to overlook this if I felt that AfME were serious about transforming itself, and intended to represent patients' interests properly, going forwards. (But it's difficult to see how this is possible unless the results of the PACE trial are actually acknowledged.)

I'm impressed with the contents of the above article, and have tried to consider AfME's stated future intentions with an open mind.

The changes that Sonya outlines seem, to me, to be very promising and positive developments.

If AfME are prioritising open dialogue with patients, and transparency, then I'd very much welcome this. A move towards openness and transparency seems to me to be the most important initial step that AfME could take if it is to undergo a meaningful transformation. (AfME's AGM was an open affair, and so was the research priorities survey.)

The research priorities survey was a good example of patient engagement, and has led to a useful new set of AfME's priorities, which I can't fault.

If AfME are setting up a 'patient reference group' (and focus groups), then I think this would also be an exceptionally positive and productive development, if it's set up properly and openly.

So, yes, there are legacy (and trust) issues that AfME has its work cut-out to overcome, and we shouldn't forget those issues, but perhaps we should also cautiously welcome any meaningful changes and positive developments going forwards, and assess any new developments on their merits.



If 'preventative' research funding were to go towards Esther Crawley's cognitive-behavioural preventative strategies*, then it would make a mockery of the patient survey which put 'psychological aspects' firmly at the bottom of the list of priorities.

* University of Bristol - Chronic Fatigue Syndrome (CFS/ME) in Children:

Hi - I do not have access to any of the data (and have never seen any of the data) from the PACE trial and therefore cannot share it. I do understand the concerns that people have raised and the reason for the scepticism and lack of trust of Action for M.E.

A key focus for us now is to turn our intent and aspiration for meaningful patient involvement and engagement into something real and tangible. I am absolutely passionate about achieving this and am determined that we will get there. I am also committed to working with Stephen Holgate and the Collaborative to embed patient involvement in its work.

We are also exploring and responding to other suggestions and ideas about patient involvement in addition to a patient reference group.

As I've mentioned, and as is outlined in the draft strategy summary/our recent call for applications, we are keen to fund more biomedical research projects. We are also inviting our supporting members and those who donate to our current research appeal to select their top research project to help us prioritise the allocation of funding. This information will be openly available so the process and results are transparent.

Best wishes, Sonya

Hi - you seem to have missed my questions.

Bob was talking about the data which is already publicly available. Presumably you have taken the time to look at this data.
Do you understand the ways in which it has been manipulated, and used to make unjustifiable claims about recovery?

Unless we stumble upon some miracle breakthrough, PACE is going to be the most important piece of research affecting how patients are treated in the UK. As the chief executive of Action for ME, you have a personal moral responsibility to fight against the spin which is being used to mislead patients, and for the release of results for the trial's protocol defined outcome measures. Nothing else you do will be able to make up for turning your back on this vital matter.

Hi Esther - I have read and digested the information that has been produced from the various PACE papers. I absolutely hear what you say about your expectations of me and the and of Action for M.E. As I stated earlier, we are not currently going to take any further actions. I accept that this is unacceptable to you and whatever I say will not make up for this. We will of course continue to ensure patient involvement in our future work.
Best wishes, Sonya

Hi Sonya,
Thank you for responding. These look like very positive developments that you are leading. I'm grateful for these changes that you seem to be implementing.

Re the PACE trial. When I questioned why AfME has not explained the actual results to its members, I was referring to the published results, rather than the misinformation that was widely disseminated post-publication.
Just to clarify what I meant, the following are the actual results published in the various published papers:

CBT and GET did not lead to clinically significant improvements in objective outcomes (e.g. disability, employment hours, and welfare claims) (disability was assessed in the six minute walking distance test); and only 11-15% of participants experienced any (additional) subjective improvements for the primary outcomes when CBT or GET were added to SMC.

These actual results from the published papers are in stark contrast to the heavily promoted misinformation that there was a 30% 'recovery' rate, etc. (Although the subsequent 'recovery' paper is another story.)

It is difficult to understand why AfME has not explained these basic and central results to its members, in a factual manner.
Unless AfME understands and acknowledges these results (and ideally explains them to its members), I can't see how it can fully represent the interests of patients, as the results of the PACE trial are central to current NICE & NHS policy, etc., meaning that the results of the PACE trial affect every NHS patient.