A general thread on the PACE trial!

[Snowdrop]

Yes, and I think that is the point. Trial participants are not themselves likely to be familiar with scientific methodologies. The primary objective that was drilled into them was to do well, and I strongly suspect that the focus for that was to do well within the context of the trial itself. A well run trial would have emphasised the need to capture overall activities, but I bet that did not happen for PACE. The treatment was in a sense self indulgent - the emphasis on participants being motivated by the therapy itself, to show how well the therapy was benefiting them. Some (maybe most) participants may never have realised the biasing effects of swapping out some of their normal daily activities in order to fulfil GET activities, and the PACE mindset might well have been to not enlighten them!

Yes, it's obvious after the fact with dissecting the trial into it's various bits. But when actually engaged in the trial with a focus on doing well and no extra energy or expertise to pay attention to other motivations or reasonings it is an easy possibility.

 

[Esther12]

Matthees had compiled comments from PACE trial participants for his tribunal case, so the comment could be in there (although many more have been posted since then): https://b1ad200d-a-62cb3a1a-s-sites...YogFcDJTYw0zS1k9uouL9S_OCFQSo=&attredirects=2

 

[Lucibee]

Matthees had compiled comments from PACE trial participants for his tribunal case, so the comment could be in there (although many more have been posted since then): https://b1ad200d-a-62cb3a1a-s-sites.googlegroups.com/site/pacefoir/pace-trial-participants-experiences.pdf?attachauth=ANoY7cqYhi2J64IX3DBlg9x5po2KjcOCA40hEeu5uG2_OWUBRW7RHLbESGHQbLS_q7BtMEhrrQiwNQowdlmQbSVkvMtPy4fVximd_RIzkgAb6PWJNpRZ1-bYIJ_2tIE_pmH6tkKdT6X9fqU7-5GUhTXDpxOV3suvtP_Nvnb-KDA_cV36xuow1cC23c9t5pBjwEzDMEdNTgKPfZ7gPkRtNoi3o6YogFcDJTYw0zS1k9uouL9S_OCFQSo=&attredirects=2

Yes, that's where the quote that @Barry and I quoted originally came from (posts #364 and #397).

 

[Mithriel]

We have to remember we are not typical patients, analysing everything said to us. If the specialist tells you that doing a walk every day is going to make you well, that is what you do. I know at one point I would have rested all morning to have the walk in the afternoon not understanding the thinking behind it was that I was not active enough.

It is the natural consequence of having a theory but not caring if it is accurate or not.

 

[Barry]

Matthees had compiled comments from PACE trial participants for his tribunal case, so the comment could be in there (although many more have been posted since then): https://b1ad200d-a-62cb3a1a-s-sites.googlegroups.com/site/pacefoir/pace-trial-participants-experiences.pdf?attachauth=ANoY7cqYhi2J64IX3DBlg9x5po2KjcOCA40hEeu5uG2_OWUBRW7RHLbESGHQbLS_q7BtMEhrrQiwNQowdlmQbSVkvMtPy4fVximd_RIzkgAb6PWJNpRZ1-bYIJ_2tIE_pmH6tkKdT6X9fqU7-5GUhTXDpxOV3suvtP_Nvnb-KDA_cV36xuow1cC23c9t5pBjwEzDMEdNTgKPfZ7gPkRtNoi3o6YogFcDJTYw0zS1k9uouL9S_OCFQSo=&attredirects=2

The whole document is very well worth a read (or re-read), but the following are some of the things that stand out for me. All bolding mine.

I took part in the trials and they didn't help me. What is very worrying is that the Pace trials were only ever meant for people with mild to moderate M.E. and not Severe M.E. and yet Severe M.E. sufferers are still too often being referred to clinics to take part in pacing under the Nice guidelines. Whilst pacing can help patients they are often pushed on to fast and running the risk of having a relapse.

At the start of the trial, I had to wear an accelerometor thing for a week, presumably to measure activity levels. But at the end of the trial, this wasn't repeated. The fitness tests measured the number of steps I could do in a set amount of time, but paid no attention to the fact that I usually couldn't walk for 2 days after these assessments.

I took part….I collapsed on week 3….Several of us had serious relapses. And when I was reduced to lying in bed every day, in pain, unable to do a thing for myself, these researchers did not want to know, believe me. I was on my own when it came to trying to undo the damage

My heart rate was showing higher readings as the trial progressed and I became more and more unwell as the exercise continued daily. I was reporting back to a physiotherapist and after several months with this trend increasing she did say that they had not expected this result from the heart rate monitor — and several times asked me to re-turn the monitor as she felt these results did not bring anything useful for the trial, so she suggested we stop keeping records of the heart rate readings. I refused as I felt they were important and did not under-stand how a medical trial could possibly be impartial if the criteria were changed to ensure only expected results were recorded? I'm not an expert, but I certainly felt that my results were not being viewed impartially.

Speaking as a patient on the trial I can tell you that there was no ‘specialist medical care group’ this was in fact a group that was offered nothing. I was in this group and I didn’t even have a review with my doctor – nothing, I didn’t see my doctor so to call it a specialist medical care group is a bit of a stretch of the imagination. If you were in this group you were left alone. Also I’ve never been followed up so when they pull out these new studies on the research and patient progress every 2 years or so they are being very selective about who they follow up therefore how can any conclusions be fully representative of the trial?

Being both a people pleaser & someone who liked to do well in tests (as well as a naive fool at the time) I pushed myself as far as I could each time then could barely get home before being so ill for the next few days after each assessment that I couldn't leave the house. No one asked about this post exertional fatigue and it wasn't recorded. I'm not sure I would call that good science, would you?

 

[JohnTheJack]

Ok, but there are still some things that don’t add up.

The patients in the trial were given very cautious instructions to increase their activity level. GET used a safe baseline, small increases with a mutual agreed planning, heart rate monitoring and 15 sessions of oversight by a trained supervisor. I suspect that in most illnesses this would help patients to get a little better or at least to increase their fitness.That didn’t happen in the patients in the PACE trial and they reported to be severely disabled at follow-up.

So what prevented them from increasing their fitness if they were merely chronically fatigued? I find it hard to believe that would have simply refused to follow the treatment plan. If you are part of such a big treatment trial, receive detailed instruction and meet 15 times with a therapist who checks up on you, I suspect the majority of participant would have honestly tried to increase their activity level.

To me, the failure to achieve increased activity is an indication that most of these patients had ME/CFS. Around 85% of them indicated they had post-exertional malaise at baseline.

Also: why isn't there an indication of a subgroup of patients doing worse (the 'real ME' patients) and a larger group making some small improvements (the chronically fatigued)? Wilshere indicated that the data did not show this to be the case. The argument that there were basically no 'real ME' patients in the trial seems a bit unlikely: all around the world ME patients report to be harmed by GET, but this large trial would have somehow excluded them all?

I'm not saying they refused to follow the treatment plan. I'm suggesting that they did try but were unable to. The therapists were hyper-vigilant to ensure the patients didn't harm themselves so didn't push them to follow the original plan. Instead the therapists modified the plan to fit the patients' capabilities. But if the plan is adapted to how the patient feels and how much the patient can do, it ceases to be GET. It is just another form of pacing.

For it properly to be GET, there has to be some element, some part of the plan, that the patient follows regardless of their symptoms. That is the defining essence of GET.

 

[Sean]

For it properly to be GET, there has to be some element, some part of the plan, that the patient follows regardless of their symptoms. That is the defining essence of GET.

Time based (scheduled, without regard to symptoms), or symptom based (without regard to time or schedules). Pick one, because it can't can't be both. They are incompatible. It is one or the other.

One of the BPS cult's more dishonest and cowardly tactics is morphing GET into pacing without changing the name, so they can claim they were right all along and it just needed some fine tuning.

 

[ME/CFS Skeptic]

Time based (scheduled, without regard to symptoms), or symptom based (without regard to time or schedules). Pick one, because it can't can't be both.

I personally think that gradually increasing exercise in the expectation of improved health or recovery should be called GET rather than pacing, even if it is symptom rather than time contingent. It's still an inappropriate and harmful advise, even though less risky than the time contingent version.

I suppose I take a minority position on this because people like Goudsmit and Vink have suggested the Wallman RCT is a form of pacing rather than GET.

 

[Unable]

My view is simple:

If the aim is increase, then it is GET.
If the aim is stabilisation, then it is pacing.

This distinction does not prevent natural fluctuations in activity levels.

So, the pacing folk could still have a fortuitous period of increase. However that increase would not be the aim of the pacing itself. Sure it might be an outcome of doing less damage along the way, by staying inside the energy envelope, but it is not a given that any increase will happen, nor is it a goal to work towards.

Pacing acknowledges the physical limits of the patient and does not aim to change those limits. No sneaking activity up, no matter how slowly, is advised. No patient blaming when “increase” doesn’t happen. No claiming a successful “treatment” or “cure” if/when fortuitous improvement actually occurs.

GET on the other hand is based on the aim of increasing. Set-backs are seen as temporary hiccups along a path towards “increase” and “improvement”. It is goal orientated.

Yet, GET has become more cautious I think. Now there is more careful emphasis on “establishing a baseline”, and then making the incremental increases tiny ones. These increases may at first look like success. In fact all that is happening is that the ME sufferer is creeping closer and closer to their absolute exertion threshold. When the relapse finally happens, the “Boom and Bust” scenario is envoked to blame the patient. (Obviously there will be some event where the patient can be told they “overdid” things leading to the relapse. They didn’t follow the plan closely enough, will be the explanation!)

The two are thus distinct in my view, no matter what the latest spin on GET becomes.

However, we do have a problem. NICE still recommend GET, so therapists delivering Pacing advice, may still call it GET, in order to demonstrate adherence to NICE. So there are many patients out there thinking they have done GET, when in fact they haven’t. These folk will say GET helped! This doesn’t help at all.

Edited to correct “autocorrect” errors!

 

[Barry]

My view is simple:

If the aim is increase, then it is GET.
If the aim is stabilisation, then it is pacing.

This distinction does not prevent natural fluctuations in activity levels.

So, the pacing folk could still have a fortuitous period of increase. However that increase would not be the aim of the pacing itself. Sure it might be an outcome of doing less damage along the way, by staying inside the energy envelope, but it is not a given that any increase will happen, nor is it a goal to work towards.

Pacing acknowledges the physical limits of the patient and does not aim to change those limits. No sneaking activity up, no matter how slowly, is advised. No patient blaming when “increase” doesn’t happen. No claiming a successful “treatment” or “cure” if/when fortuitous improvement actually occurs.

GET on the other hand is based on the aim of increasing. Set-backs are seen as temporary hiccups along a path towards “increase” and “improvement”. It is goal orientated.

Yet, GET has become more cautious I think. Now there is more careful emphasis on “establishing a baseline”, and then making the incremental increases tiny ones. These increases may at first look like success. In fact all that is happening is that the ME sufferer is creeping closer and closer to their absolute exertion threshold. When the relapse finally happens, the “Boom and Bust” scenario is envoked to blame the patient. (Obviously there will be some event where the patient can be told they “overdid” things leading to the relapse. They didn’t follow the plan closely enough, will be the explanation!)

The two are thus distinct in my view, no matter what the latest spin on GET becomes.

However, we do have a problem. NICE still recommend GET, so therapists delivering Pacing advice, may still call it GET, in order to demonstrate adherence to NICE. So there are many patients out there thinking they have done GET, when in fact they haven’t. These folk will say GET helped! This doesn’t help at all.

Edited to correct “autocorrect” errors!

Yes!

 

[ME/CFS Skeptic]

NICE still recommend GET, so therapists delivering Pacing advice, may still call it GET, in order to demonstrate adherence to NICE. So there are many patients out there thinking they have done GET, when in fact they haven’t. These folk will say GET helped! This doesn’t help at all

This is interesting. I think I remember Charles Shepherd saying something similar: that some cfs centres claim to use GET for the record, but actually apply something more akin to pacing.

 

[Unable]

This is interesting. I think I remember Charles Shepherd saying something similar: that some cfs centres claim to use GET for the record, but actually apply something more akin to pacing.

I spoke to a lady recently, who said she felt awkward talking on patient groups about how much GET had helped her, because she realised other patients disliked it so much.

She said GET helped her a lot! We talked some more, and it turned out the advice was really Pacing.

There were a couple of “goals” involved, but the solutions were all about re-prioritising other areas of her life to leave enough energy to achieve the “goals” that meant something to her. That included getting others to take on some of the household things she was doing. This is sensible pacing advice in my view.

 

[Barry]

I spoke to a lady recently, who said she felt awkward talking on patient groups about how much GET had helped her, because she realised other patients disliked it so much.

She said GET helped her a lot! We talked some more, and it turned out the advice was really Pacing.

There were a couple of “goals” involved, but the solutions were all about re-prioritising other areas of her life to leave enough energy to achieve the “goals” that meant something to her. That included getting others to take on some of the household things she was doing. This is sensible pacing advice in my view.

Sounds like there is a re-branding exercise underway so GET becomes acceptable? Or might it be that decent therapists realise the foolhardiness of GET, yet have to operate under its banner, so adapt it to something that is actually caring and effective. i.e. Pacing.

Probably both I suspect.

 

[chrisb]

That would be fine provided that there is an express acknowledgement of the alteration, and admission as to the reasons for the change.

 

[Esther12]

My view is simple:

If the aim is increase, then it is GET.
If the aim is stabilisation, then it is pacing.

So people who move towards a form of pacing with the aim of feeling better and being able to do more are really doing GET?

I think that the definitions are difficult here.

To me, an important distinction is between a therapist led approach, where it's assumed that someone paid to manage patients has valuable insights into how patients should respond to their illness, and a patient driven approach which recognises that almost no-one knows what they're talking about with 'ME/CFS' and that patients are often better off finding their own way to respond to their specific circumstances.

 

[rvallee]

The whole document is very well worth a read (or re-read), but the following are some of the things that stand out for me. All bolding mine.

We really need to be able to track down PACE participants and get a reliable picture of what truly happened. We get these bits and pieces that seem to confirm the overall picture but the PACE team's concerns with being able to identify participants from the data, ludicrous on its face but whatever, probably stems exactly from this concern, that so far the participants have kept silence about what happened but their testimony would ultimately be damning.

A full independent analysis from investigators who have access to all the data and all the participants is badly needed. There is so much dirt still to be uncovered and we've barely scratched the surface of how wrong this trial was. No doubt this is why they spend so much effort defending access, but it's just a matter of time.

 

[Unable]

I think there is a difference between what all patients would love to happen (and even aspire to), and the prescriptive intention to push for “increase”. Which I think is what you are saying in your last paragraph @Esther12

If a better balancing of exertion leads to fewer symptoms, and that in turn leads to some improvement in abilities, I see that as good fortune.

Pacing therapists are not pushing for “increase” as an outcome measure (are they?), nor is “increase” the goal. In my view ther should be an explicit acknowledgment that Pacing may not in fact alter the underlying disease process. However good pacing can (assuming no other uncontrollable factors) lead to stabilisation, or at very least a slowing of progressive symptoms.

 

[dave30th]

Pretty sure there was a comment on social media by a PACE participant (cannot remember where now though), which said they backed off from some of their normal daily life activities, in order to try and save their energy for the trial's activities.

One of the PACE participants I interviewed made this exact point--he increased his walking but did less of his other activities--he substituted or compensated one for the other. So he looked perhaps like a possible "success" but actually wasn't doing more overall.

 

[Trish]

We really need to be able to track down PACE participants and get a reliable picture of what truly happened.

I assume you mean there should be a proper follow up done by an independent team of researchers. Obviously 'we' shouldn't try to track people down!

 

[MEMarge]

This is interesting. I think I remember Charles Shepherd saying something similar: that some cfs centres claim to use GET for the record, but actually apply something more akin to pacing.

I think funding is an issue too. As NICE currently recommends CBT and GET, then that is what CCGs will pay for.
There was a very informed neurophysio at the NICE engagement workshop in Jan.

Their clinic provides home visits/letters and help with other coping strategies etc. They are not "doing PACE-style CBT and GET", but are able to provide a helpful service.

If GET and CBT are removed from Guidelines and not replaced with recommendations about Pacing or ?, then these services will no longer be funded. We will all just be left with IAPT!!

(I am not pro PACE-style GET/CBT, or any other BPS approach to ME)

It is such a shame that we ended up with a Bath physio and not the above one on the GDL Committee.