Protocol: Persistent physical symptoms reduction intervention: a system change and evaluation (PRINCE), 2015 onwards, Chalder, Moss-Morris, et al

Michiel Tack said:
I was confused by that as well, and don't quite get why they call it a feasibility study when it seems like a full intervention study to test efficacy.
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one of the other reviewers also picked up on that
They are going to include a large number of practices (8-12) and
patients (240) for a feasibility study: is that really necessary? If you
want to study for example the willingness to be randomised, both
among GPs and patients, surely you could draw valid conclusions
based on a much smaller number of patients.
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Why include an extensive cost-effectiveness analysis in a feasibility study?-
On page 24, rule 53, the authors say that this is the first trial to
establish efficacy and feasibility of.... So now it would seem that
this is an efficacy trial, which is not the same as a feasibility trial.
They got me quite confused now
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Why include an extensive cost-effectiveness analysis in a feasibility study?-
On page 24, rule 53, the authors say that this is the first trial to
establish efficacy and feasibility of.... So now it would seem that
this is an efficacy trial, which is not the same as a feasibility trial.
They got me quite confused now
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Well that's a lie. Several trials, including by Chalder herself, tried GP-delivered CBT. The differences here are inconsequential, about as significant about whether or not the therapist has a funny mustache.

Pretty sure it's not OK to just lie like that. I remember something about that... from kindergarten.
 
I was enrolled on this PRINCE secondary trial. I still have all my documents from that time. When I started the trial, I was in a wheelchair but could walk for up to 5 minutes, was going to sewing classes during weekends and sitting up for 4-5 hours.

At the end of the trial, I was no longer able to eat solid food, bedbound, and couldn’t speak more than a few words. I emailed the trial coordinator saying I can’t carry on with this anymore, not even on the telephone anymore, and she said something like “make sure you use all the things we taught you and keep going with it”.

When do these results come out because I want to make sure my case was represented in this. I wonder if they just put me as a “dropped out” case but didn’t record the harm they caused.
 
lunarainbows said:
When do these results come out because I want to make sure my case was represented in this. I wonder if they just put me as a “dropped out” case but didn’t record the harm they caused
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Judging by the response you've had, they will probably consider it a normal setback. In their narrative, this kind of thing is normal and not harm. You're supposed to keep going and overcome your erroneous belief that you have an illness that causes exertion intolerance and then you get better (or so the narrative goes). They will probably consider you as having dropped out for some inexplicable reason.
 
Just looked through my emails. I tried to drop out but instead they were telling me I should pause and get back to them in one months time when my “flare” had got better. Unfortunately, my “flare” has lasted nearly 3 years and counting.
 
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strategist said:
Judging by the response you've had, they will probably consider it a normal setback. In their narrative, this kind of thing is normal and not harm. You're supposed to keep going and overcome your erroneous belief that you have an illness that causes exertion intolerance and then you get better (or so the narrative goes). They will probably consider you as having dropped out for some inexplicable reason.
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Ok but how can you keep going when you literally cannot speak on the telephone anymore.
 
lunarainbows said:
I was enrolled on this PRINCE secondary trial. I still have all my documents from that time. When I started the trial, I was in a wheelchair but could walk for up to 5 minutes, was going to sewing classes during weekends and sitting up for 4-5 hours.

At the end of the trial, I was no longer able to eat solid food, bedbound, and couldn’t speak more than a few words. I emailed the trial coordinator saying I can’t carry on with this anymore, not even on the telephone anymore, and she said something like “make sure you use all the things we taught you and keep going with it”.

When do these results come out because I want to make sure my case was represented in this. I wonder if they just put me as a “dropped out” case but didn’t record the harm they caused.
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How awful... I'm so sorry.
Their answer is so telling in that it shows how unwilling they are to change their mind about their theories when confronted with facts. They'll twist reality to make it fit their view. They can't consider they're wrong, and no proof of them being so will be taken into account.
 
I’m also really worried about how they recorded my data. I had to fill out a sheet every day and the main “record” was I had to focus on something that I did that day that made me really happy - and rate how good/well that made me feel. And that was like a measure of how well I was doing or something. So (because I’m actually a very positive person) I would put 10 (out of 10) every day even though all I was doing was reading a few pages of a book or walking for a few minutes or writing in my gratitude journal. Even when I was deteriorating I was putting 10 every day as I was trying to find something to make me happy as that’s what I do.

And the other measures were questionnaires once in a while, which again only asked me things like “how good do you feel” like subjective measures and because I felt I had to answer very positively as I was told that’s what will make me better (was given a booklet saying there’s basically nothing wrong with my “hardware” and it’s my “software” that’s faulty so not to focus on things) and trying to look for silver linings etc I was putting like 70,80 out of 100, even when I was essentially bedbound.

I don’t remember any objective measures at all.
 
Snowdrop said:
Are case reports of harm like this being considered in the NICE guidance review?
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I was trying to speak to someone who would submit my case report to someone at NICE. I think at some point someone asked me to send it to NICE with a covering letter but I was so unwell at the time I couldn’t do it myself. I contacted David Tuller about it on Facebook - he didn’t get back to me at the time. I would be happy to give someone a copy of the booklet I received if they would be willing to submit it as evidence, as the booklet was so terrible, pseudo-scientific and really brainwashed me a lot.
 
lunarainbows said:
I was trying to speak to someone who would submit my case report to someone at NICE. I think at some point someone asked me to send it to NICE with a covering letter but I was so unwell at the time I couldn’t do it myself. I contacted David Tuller about it on Facebook - he didn’t get back to me at the time. I would be happy to give someone a copy of the booklet I received if they would be willing to submit it as evidence, as the booklet was so terrible, pseudo-scientific and really brainwashed me a lot.
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@dave30th,. @Jonathan Edwards, @Keela Too, @adambeyoncelowe, can any of you help with this?
 
lunarainbows said:
So (because I’m actually a very positive person) I would put 10 (out of 10) every day even though all I was doing was reading a few pages of a book or walking for a few minutes or writing in my gratitude journal. Even when I was deteriorating I was putting 10 every day as I was trying to find something to make me happy as that’s what I do.

And the other measures were questionnaires once in a while, which again only asked me things like “how good do you feel” like subjective measures and because I felt I had to answer very positively as I was told that’s what will make me better
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Compelling concrete evidence that unblinded trials with subjective outcomes where people are told to think positively are not measuring anything about people's functioning.
Thanks @lunarainbows for your testimony, it's very interesting and revealing and also saddening indeed.
 
lunarainbows said:
I’m also really worried about how they recorded my data. I had to fill out a sheet every day and the main “record” was I had to focus on something that I did that day that made me really happy - and rate how good/well that made me feel. And that was like a measure of how well I was doing or something. So (because I’m actually a very positive person) I would put 10 (out of 10) every day even though all I was doing was reading a few pages of a book or walking for a few minutes or writing in my gratitude journal. Even when I was deteriorating I was putting 10 every day as I was trying to find something to make me happy as that’s what I do.

And the other measures were questionnaires once in a while, which again only asked me things like “how good do you feel” like subjective measures and because I felt I had to answer very positively as I was told that’s what will make me better (was given a booklet saying there’s basically nothing wrong with my “hardware” and it’s my “software” that’s faulty so not to focus on things) and trying to look for silver linings etc I was putting like 70,80 out of 100, even when I was essentially bedbound.

I don’t remember any objective measures at all.
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I find their advice to be utterly patronising. I wouldn't treat children to this kind of fluffy nonsense.
 
Quote from the booklet - “The best advice would be to try out this practical approach because nothing will be lost by trying but much may be gained“.

Nothing will be lost?
I’m in a very bad mood now

Another thing is this trial absolutely was graded exercise by the back door. It said CBT only. But I was advised and coached on increasing exercise.
 
lunarainbows said:
Just looked through my emails. I tried to drop out but instead they were telling me I should pause and get back to them in one months time when my “flare” had got better. Unfortunately, my “flare” has lasted nearly 3 years and counting.
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That's awful, it boggles the mind why people running trials like this seem to lack empathy for their patients...
 
Amw66 said:
Illustrates perhaps why there is so little follow up .
A follow up study of participants may be illuminating.
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There was a follow up of sorts, a few months after I dropped out.

“I don't know if you remember me, but I'm the Research Worker on the PRINCE trial - we spoke briefly at the start of the PRINCE trial. I hope all is well with you anyway.

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. I've attached an information sheet with more information on this study.

I've also attached the Consent form, just in case you would like to take part (please note that I would require a wet signature on it in order for it to be valid). Just so you're aware, this study is still related to the PRINCE trial, but it's also part of my own doctorate research.

If it sounds like something you may be interested in taking part in, please do let me know and we can take things from there. Also - let me know if you would need to have your consent form posted out instead - I can do that if it's easier!

Take care and best wishes,”

I didn’t get anything after that. And I also didn’t reply I think.
 
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