Reports from participants in GET and CBT trials

lunarainbows said:
There must be a way of getting this recorded - why is it so hard though? I’m genuinely asking because if we can record adverse effects for vaccines and medications, why not for this?
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Of course there is a way. Design the d*** trials properly!

An awful lot of lip service is going on about patient involvement and this is definitely somewhere we need to be involved.

Keeping an eye on research proposals and trying to make sure they are properly designed and are ethical.

Where there's an issue publicise it.

This is where David Tuller & Keith Geraghty come in and by shining a light on all.sorts of murky corners hopefully wake people up to these things.
 
lunarainbows said:
There must be a way of getting this recorded - why is it so hard though? I’m genuinely asking because if we can record adverse effects for vaccines and medications, why not for this?
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Invisible Woman said:
Of course there is a way. Design the d*** trials properly!
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Absolutely.

The very first thing is to not have harmful expectation bias built into the trial design, which PACE did by presuming to some degree that the hypothesis under test was already proven to be right. How else could PACE have presumed that for people whose condition declined, it could only have been due to their not adhering to the treatments, rather than the treatments themselves causing their decline. Only very severe symptoms were acknowledged as indications of potential harms; significant declines in outcome measures were never considered as potentially harmful side effects of the treatments, but more likely that people were not adhering to the treatments properly.

The presumption was that the underlying physical condition was being deconditioned, and so they presumed that CBT and GET would not cause harms based on this; from that point on - i.e. before the trial even started - they were blind to the possibility. It is probably true, that for people whose condition really is deconditioning, CBT and GET likely would help them improve, and not harm. The huge PACE blunder being of course, that deconditioning was not the fundamental problem.
 
@Barry from my experience, as I just went back through my emails at the time - I had said that I was very unwell and described my symptoms when I had to drop out of the trial I was on. They said that it’s important I keep practising the techniques, take a rest period and then come back when I’m feeling better. So I think that their expectation is that people will feel worse - “setbacks” - but that’s totally normal and actually an opportunity to practice techniques. It’s not considered a harm. In a similar way as how the “pacing up” kind of CBT expects you to push at your envelope and rest afterwards. And if you overdo it beyond that - well - not much to be done. They wanted me to come back later and I agreed to it. Then I seem to have emailed them some time later, saying I could not talk, had to eat lying down and cannot eat unless someone helps me. They said they were sorry to hear that and hoped that my health improve soon. Nothing about this being recorded as a harm.
 
lunarainbows said:
So I think that their expectation is that people will feel worse - “setbacks” - but that’s totally normal and actually an opportunity to practice techniques. It’s not considered a harm. In a similar way as how the “pacing up” kind of CBT expects you to push at your envelope and rest afterwards. And if you overdo it beyond that - well - not much to be done. They wanted me to come back later and I agreed to it. Then I seem to have emailed them some time later, saying I could not talk, had to eat lying down and cannot eat unless someone helps me. They said they were sorry to hear that and hoped that my health improve soon. Nothing about this being recorded as a harm.
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To me this is very significant, being told during a trial that feeling worse is normal ... but normal for what! That very advice presumes the problem to be deconditioning, a presumption, nothing more. Being told to presume a symptom is normal, and you should persevere with a treatment that may in fact be harming you, is way beyond incompetence, it is more like medical negligence.

The PACE manuals actually make statements that confirm this expectation bias inbuilt into the trial (Participants GET manual in this example):
The evidence we have is in fact the opposite: there is no evidence to suggest that an increase in symptoms is causing you harm. It is certainly uncomfortable and unpleasant, but not harmful. In fact, there is much evidence to support the alternate view: if you rest too much, it is the resting that can cause negative changes in the body. Resting and withdrawing from activity can also make us feel fed up or worried, and this can also make it harder to continue being active.
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How could they possibly have said this, in writing, when the trial itself is supposed to be trialling the veracity of their claims! Especially when considering harms. It's utterly shameful, yet the investigators seem to have no capacity for shame.

It is akin to someone on antibiotics reporting a skin rash, and the doctor telling them this is normal and to persevere with taking the antibiotics.

It this stuff wasn't so serious it would be utterly hilarious ... it's certainly farcical. Medical school Christmas pantomime stuff, if they do such things.

And because I think it is so important to not be overlooked, I'm going to repeat myself:

Being told that feeling worse is normal with GET and CBT-a-la-PACE, shows that expectation bias was inbuilt into the PACE trial design right from its inception, because how else could you otherwise presume that worsening symptoms were normal!​
 
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@Barry there are similar statements in the manual I have too. I agree I think it is medical negligence as well. I remember there were times even before I had to drop out where I said to the person that I wasn’t feeling well after increasing exercise / increasing activity, she just said to rest more directly after it, and then continue again. It was a totally normal thing, to have setbacks. But I should never rest too much - or think about it too much - because that itself would cause fatigue, stress, and start the thought patterns which lead to me avoiding activity.

“People can sometimes find that increasing an activity or doing more may lead to an increase in symptoms. This can make people think that they are making their condition worse. Let us reassure you that while it is common for symptoms to get worse to start with, as you repeat the activity, or even gradually increase it, before long any worsening of symptoms will fade. The important thing to remember is that you are not causing damage if you have a balanced weekly schedule of activities.”
 
Barry said:
It is akin to someone on antibiotics reporting a skin rash, and the doctor telling them this is normal and to persevere with taking the antibiotics.
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That sort of thing does happen, though. All the time. On multiple occasions in my life I have had relatively minor adverse reactions to medication, including it making the symptom I was prescribed it for worse, only to be blithely told that it's extremely unlikely and to carry on.

I know from conversations with other forum members & friends and family I am not the only one this has happened to. This isn't that rare.


lunarainbows said:
I agree I think it is medical negligence as well. I remember there were times even before I had to drop out where I said to the person that I wasn’t feeling well after increasing exercise / increasing activity, she just said to rest more directly after it, and then continue again. It was a totally normal thing, to have setbacks.
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The snag here is the assumption that the pwME's body will respond to exercise in the same way a healthy body would.

If you are training up for a seasonal sport, or you have had several months out for injury or whatever, getting fit can hurt. It can also build in levels so it's painful for a bit and your fitness levels come up and you push to the next stage and so on.

The thing they fail to take into account is that it feels completely different to a deconditioned body getting fit again. I have done both - they are not the same thing at all.

If they had listened to patients they woukd have quickly realised this. This is possibly the drawback of some physios. Patients who need physio after certain injuries and surgeries often have to exercise through some level of pain. I have friends who have cheerfully cursed their physio while acknowledging if they hadn't pushed them they might not have regained full function. However, injury or surgery aside their bodies reaction was normal, ours is not.
 
Invisible Woman said:
That sort of thing does happen, though. All the time. On multiple occasions in my life I have had relatively minor adverse reactions to medication, including it making the symptom I was prescribed it for worse, only to be blithely told that it's extremely unlikely and to carry on.
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I chose the example of antibiotics because that is invariably taken very seriously. When I was on an antibiotic drip once I had a rash start up, and they disconnected me there and then, no messing.
 
Barry said:
How could they possibly have said this, in writing, when the trial itself is supposed to be trialling the veracity of their claims! Especially when considering harms. It's utterly shameful, yet the investigators seem to have no capacity for shame.
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It helps when whatever passes for oversight in medicine is of the opinion that it's not their job to do oversight or pass judgment about research.

Remember that Richard Horton described PACE as neutral researchers taking a step back to evaluate this treatment model with neutral neutrality (it really was that neutral) and objectivity. A treatment model they invented, had been promoting for decades by then, were openly promising to their participants is 100% safe and effective, and had sold to the government as saving BILLIONS in health care spending.

The idea in science is that peer review provides the quality assurance, along with a bit of oversight process. So much for that, and fast-tracked based on a lie no less, for having pre-registered the protocol, which they did not even respect, negating the excuse. Enforcement truly is 9.9/10th of the law. When they are not enforced, rules, laws, requirements and obligations are just words.
 
DokaGirl said:
Their response is shocking. Is there no follow up requirement written into these studies? Apparently not! Where are the ethics committees on this?
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I told them I was dropping out at that point, but yeah their first response before was to persuade me that I could be ok to continue after resting and my symptoms reducing. But when they didn’t get better, they don’t have anything else to say. I did get an email from another person, a year later, she later says it’s part of the trial but also part of her doctoral research:

“I'm just getting in touch with you now as I am inviting everyone who has taken part in the trial to do a one-off qualitative interview with me (face to face or over the phone) discussing your experiences in accessing healthcare - both through your GP and the hospital, your experience of living with your symptoms and any personal/ cultural beliefs that you may have relating to symptoms.”

DokaGirl said:
How far does this definition of normal go? How dire do symptoms have to be? Many pwME have tachycardia with exertion, or feeling faint. Were they urged to just keep going?
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Actually on the trial I was on, they invited people who specifically had PoTS and non cardiac chest pain as well (not just ME/CFS). So yeah there would have been lots of people with tachycardia. Who also got sheets telling them their symptoms were only a “software” problem. How many of them would have been harmed too? I simply don’t understand how they got ethical approval for it.

One thing which I just remembered which may be of interest was before the trial, they sent me a sheet asking me whether I would like to be in the treatment arm or the placebo (standard medical care) arm.

And they said that my responses would be read by a separate person, (not the person who would be allocating me to the treatment/standard medical care), but I ticked that yes I’d like treatment (at the time I didn’t know anything about all this, and was wanting desperately to get better - I only really joined ME groups after becoming ill from it all), and then afterwards I got a call like 2 days after I’d sent it in, saying I’d get treatment.
 
lunarainbows said:
One thing which I just remembered which may be of interest was before the trial, they sent me a sheet asking me whether I would like to be in the treatment arm or the placebo (standard medical care) arm.

And they said that my responses would be read by a separate person, (not the person who would be allocating me to the treatment/standard medical care), but I ticked that yes I’d like treatment (at the time I didn’t know anything about all this, and was wanting desperately to get better - I only really joined ME groups after becoming ill from it all), and then afterwards I got a call like 2 days after I’d sent it in, saying I’d get treatment.
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How bizarre!
 
lunarainbows said:
I told them I was dropping out at that point, but yeah their first response before was to persuade me that I could be ok to continue after resting and my symptoms reducing. But when they didn’t get better, they don’t have anything else to say. I did get an email from another person, a year later, she later says it’s part of the trial but also part of her doctoral research:

“I'm just getting in touch with you now as I am inviting everyone who has taken part in the trial to do a one-off qualitative interview with me (face to face or over the phone) discussing your experiences in accessing healthcare - both through your GP and the hospital, your experience of living with your symptoms and any personal/ cultural beliefs that you may have relating to symptoms.”



Actually on the trial I was on, they invited people who specifically had PoTS and non cardiac chest pain as well (not just ME/CFS). So yeah there would have been lots of people with tachycardia. Who also got sheets telling them their symptoms were only a “software” problem. How many of them would have been harmed too? I simply don’t understand how they got ethical approval for it.

One thing which I just remembered which may be of interest was before the trial, they sent me a sheet asking me whether I would like to be in the treatment arm or the placebo (standard medical care) arm.

And they said that my responses would be read by a separate person, (not the person who would be allocating me to the treatment/standard medical care), but I ticked that yes I’d like treatment (at the time I didn’t know anything about all this, and was wanting desperately to get better - I only really joined ME groups after becoming ill from it all), and then afterwards I got a call like 2 days after I’d sent it in, saying I’d get treatment.
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@lunarainbows

I shouldn't really be shocked by the treatment you received. I've read lots about PACEGate. But the additional details such as no follow up, except a year later, and really the follow up was only for the caller's benefit, not yours, just fits with the whole mess. No caring whatsoever for the participants.

If I estimate how much of my own experience being a study subject, was negative, I would say 75%. Even as a prospective study subject, those wanting my participation were pushy, presumptious, and invasive.
 
My bolding in the quotes below.

lunarainbows said:
Actually on the trial I was on, they invited people who specifically had PoTS and non cardiac chest pain as well (not just ME/CFS). So yeah there would have been lots of people with tachycardia.
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Non-cardiac chest pain (in my experience) is treated as a mental condition in the UK once heart attack has been ruled out. I am guessing that if someone was diagnosed with non-cardiac chest pain and had tachycardia too, the tachycardia would probably be assumed to be part of a mental problem as well - probably anxiety. But, in reality if it gets severe enough, iron deficiency anaemia can cause all sorts of heart problems including severe chest pain and heart failure.

If you look up the NHS page about iron deficiency anaemia you can see the following things being mentioned :

Link : https://www.nhs.uk/conditions/iron-deficiency-anaemia/

Symptoms can include:

  • tiredness and lack of energy
  • shortness of breath
  • noticeable heartbeats (heart palpitations)
  • pale skin
...

Untreated iron deficiency anaemia:

may increase your risk of developing complications that affect the heart or lungs – such as an abnormally fast heartbeat (tachycardia) or heart failure
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But compare the NHS information to what is published in the US on drugs.com

Link : https://www.drugs.com/mcd/iron-deficiency-anemia

Iron deficiency anemia signs and symptoms may include:

  • Extreme fatigue
  • Weakness
  • Pale skin
  • Chest pain, fast heartbeat or shortness of breath
  • Headache, dizziness or lightheadedness
  • Cold hands and feet
  • Inflammation or soreness of your tongue
  • Brittle nails
  • Unusual cravings for non-nutritive substances, such as ice, dirt or starch
  • Poor appetite, especially in infants and children with iron deficiency anemia
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So, in the UK, severe anaemia doesn't (allegedly) cause chest pain although it may cause tachycardia. But in the US severe anaemia can cause both chest pain and tachycardia. If you have chest pain and tachycardia in the UK, but the standard heart attack checks find nothing, it doesn't prompt an iron panel to be done it causes you to be diagnosed with anxiety - or it did in my case, when in reality it was severe anaemia that was the cause of my problem.

Lunarainbows, I wonder how many of the people who took part in the study that you were in were actually tested for anaemia with a check on both iron and ferritin? I think I might guess at approximately zero.
 
Arnie Pye said:
it doesn't prompt an iron panel to be done it causes you to be diagnosed with anxiety - or it did in my case, when in reality it was severe anaemia that was the cause of my problem.
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I don't quite follow that. Severe anaemia does not require an iron panel - just a blood count. For anaemia to cause cardiac symptoms the simple blood count would need to be grossly abnormal.
 
Crawley and probably others get ethical approval because they have to state the risks of harms to participants. She wrote that they were the effort required to fill in the questionnaires. No wonder she got approval.

This is blatant lying. If she does not know of patient's concerns and the mass survey's done by the 25% group, AfME, the ME association and others then it is negligent of her not to have read the full literature on a disease for which she runs clinics and researches.

If she knows about these patients claims of very high numbers harmed, especially the 25% group which found many patients were not severe until they did the exercise programmes, and did not mention them in the statement of harms that is a very serious violation for a doctor.

Even if becoming worse is a rare concern, think blood clots in 7 people from millions of vaccinations, it must be considered by any ethics committee.
 
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