"Another request for data from the PACE trial" 36 more scientists join request for PACE data

[user9876]

Last night I remembered I know of one pwME who found GET useful (I know, please don't shoot me).
This lady was severe for years, needed spoon feeding and, at her worse, couldn't speak. She used the doing 10% extra every few weeks but always stopping at symptom onset GET (so maybe not true GET, more APT/GET).
She is now moderate/severe, wheelchair around the house and gets outside occasionally.

I think in GET they say to push through symptoms. As I understand Jason's envelope theory he suggests doing as much as you can within your energy envelope and saying this can help and lead to improvements over time but importantly not to go over the edge.

I also have a theory that as people are feeling a bit better they try new things and then its unclear as to whether it is the thing they are trying that helps further or if the improvements that allowed them to think about trying something new just continued. Which is why trials are important.

 

[Skippa]

Last night I remembered I know of one pwME who found GET useful (I know, please don't shoot me).
This lady was severe for years, needed spoon feeding and, at her worse, couldn't speak. She used the doing 10% extra every few weeks but always stopping at symptom onset GET (so maybe not true GET, more APT/GET).
She is now moderate/severe, wheelchair around the house and gets outside occasionally.

That's great news, except these quacks now log her as "recovered".

 

[Mrs Sowester]

I think in GET they say to push through symptoms. As I understand Jason's envelope theory he suggests doing as much as you can within your energy envelope and saying this can help and lead to improvements over time but importantly not to go over the edge.

I also have a theory that as people are feeling a bit better they try new things and then its unclear as to whether it is the thing they are trying that helps further or if the improvements that allowed them to think about trying something new just continued. Which is why trials are important.

I agree. Just throwing it out there as an example of a pwME who would support GET although maybe not GET as we understand it conventionally.
This lady was helped by an OT who believes ME is an autoimmune disease. The OT helped her increase her activity without boom and bust.

 

[Mrs Sowester]

That's great news, except these quacks now log her as "recovered".

Fortunately she wasn't part of the PACE trial!
I've been trying to imagine why a trial participant may support the PACE team by requesting their data be withheld since reading the AfME statement. But, in fact I think we may be putting to much importance on it (the small group of TPs not wanting data released) there are two groups saying NO to data release and a whole raft of groups and voices saying YES.

 

[ryan31337]

I think in GET they say to push through symptoms. As I understand Jason's envelope theory he suggests doing as much as you can within your energy envelope and saying this can help and lead to improvements over time but importantly not to go over the edge.

Having recently argued with an NHS CFS/ME clinic OT over this I can confirm that 'pushing through' on bad days is very much the 'official' line on GET

Before this when I first joined the forums I misunderstood the definition of GET and why it enraged people so. The OT I saw 20 years ago made it very clear that whilst you should aim for ever increasing activity, it is important to adapt your exertion on a daily basis according to symptoms - a common sense extension of pacing that worked wonders for me. Was 'GET' something the babblers have co-opted and manipulated or has it always been their definition?

 

[A.B.]

GET is also described as a form of exposure therapy meant to treat fear of exertion. Ignoring symptoms is part of that.

 

[MeSci]

I think the problem is that neither the patient information sheet nor the consent form explained the distinction between personal data and anonymised data, leaving participants with the distinct impression that *no* data of any kind would be shared.

The Patient Information Sheet stated:

"Will you keep my details confidential?
Yes. All your details and all recordings will be kept strictly confidential and held in a locked filing cabinet or on a secure computer. People on our research team will only see your records if they need to for the research.

Your GP and any other doctors you are consulting will be told you are joining our study. And occasionally, other researchers will need to see your notes so they can audit the quality of our work. An audit might be run by one of the universities helping with our study or hospital regulatory authorities, or by one of the organisations funding our study.

The data and recordings we collect will be securely stored for 20 years after the end of the trial, for your protection and to follow good clinical practice (GCP). The same applies to other records gathered for our study, including your medical notes and the database holding the collected data for this trial. ​

Your name, address, and telephone number will be on only one database. This will be held securely at St Bartholomew’s Hospital, in London, and it will be used only to monitor recruitment. You will not be named in any published results from our study." ​

The consent form stated:

"I understand that any of my medical notes may be looked at by responsible individuals from either the trial or regulatory authorities where it is relevant to my taking part in research. I give permission for these individuals to have access to my records."​

The PACE team seem to be taking the line that they can't release any data - even anonymised - because the participants only gave permission for it to be accessed by individuals involved directly with the trial.

(The reason that the participants gave only this limited permission is of course because that's all the trial investigators asked them for - it's almost as if they didn't want anyone else to be able to access the data, regardless of what the MRC guidance on data sharing might say...)

(And of course Kings College has publicly claimed that they *have* released data to independent investigators, so obviously this is less of a stumbling block than they claim it is when they're refusing FOI requests)

My understanding (which may be wrong) was that you don't need patient consent to release anonymised data, as it can't be considered personal data any longer (as participants aren't identifiable).

I think the problem is that neither the patient information sheet nor the consent form explained the distinction between personal data and anonymised data, leaving participants with the distinct impression that *no* data of any kind would be shared.

The Patient Information Sheet stated:

"Will you keep my details confidential?
Yes. All your details and all recordings will be kept strictly confidential and held in a locked filing cabinet or on a secure computer. People on our research team will only see your records if they need to for the research.

Your GP and any other doctors you are consulting will be told you are joining our study. And occasionally, other researchers will need to see your notes so they can audit the quality of our work. An audit might be run by one of the universities helping with our study or hospital regulatory authorities, or by one of the organisations funding our study.

The data and recordings we collect will be securely stored for 20 years after the end of the trial, for your protection and to follow good clinical practice (GCP). The same applies to other records gathered for our study, including your medical notes and the database holding the collected data for this trial. ​

Your name, address, and telephone number will be on only one database. This will be held securely at St Bartholomew’s Hospital, in London, and it will be used only to monitor recruitment. You will not be named in any published results from our study." ​

The consent form stated:

"I understand that any of my medical notes may be looked at by responsible individuals from either the trial or regulatory authorities where it is relevant to my taking part in research. I give permission for these individuals to have access to my records."​

The PACE team seem to be taking the line that they can't release any data - even anonymised - because the participants only gave permission for it to be accessed by individuals involved directly with the trial.

(The reason that the participants gave only this limited permission is of course because that's all the trial investigators asked them for - it's almost as if they didn't want anyone else to be able to access the data, regardless of what the MRC guidance on data sharing might say...)

(And of course Kings College has publicly claimed that they *have* released data to independent investigators, so obviously this is less of a stumbling block than they claim it is when they're refusing FOI requests)

My understanding (which may be wrong) was that you don't need patient consent to release anonymised data, as it can't be considered personal data any longer (as participants aren't identifiable).

Just a reminder of info raised in another thread, from Sasha's comment on Coyne's blog:

On 31st March 2006 Peter White wrote to the West Midlands Multi‐centre Research Ethics Committee to inform them of the theft of a digital audio recording (DAR) of GET sessions from Centre 03 (which is King’s College, ie. Trudie Chalder’s Centre). This confidential information was stolen from an unlocked drawer in the therapists’ office. Peter White informed West Midland MREC that: “There are no lockable cabinets in any of the therapists’ rooms so the drawer was not locked” (cf SSMC Participant Information Sheet). His letter continued:

“The burglary was reported to Southwark police on the day that it happened, which was Wednesday 22nd March 2006. The crime number is 3010018‐06. The therapist was away on leave 22nd‐24th March and therefore the DAR was not found to be missing until Monday 27th March 2006”. It was only after the theft that Professor Trudie Chalder sought advice on how to secure the data properly.

 

[Sean]

GET is also described as a form of exposure therapy meant to treat fear of exertion.

Exposure therapy is standard treatment for most phobias, I gather.

Makes it clear how they see our condition. Just an irrational phobia.

 

[Aurator]

The PACE doctors targeted some of the local London groups. At least one of them visited these groups. One particular group has / had a leader who was treated at Barts and is fully supportive of their methods and PACE.

We can't deny that there is a split in support and condemnation for Barts.

All these people at AFME and local groups haven't gone away or stopped working behind the scenes

There will be patients who encouraged others in their support group to listen to the Barts doctor and join PACE / get treatment there

I've been at meetings where a particular group leader speaks highly of BARTS. This person was closely allied to AFME when they were at their worst and supported PACE opening.

I can accept that some participants felt they improved or actually did improve as a result of the methods employed, and that they are ready to defend PACE as a result. What I can't accept is that any patient who has been adequately informed about PACE's undeniably very significant flaws and the highly unimpartial way in which the whole trial was carried out could still be opposed to release of the data merely on the grounds that the trial actually helped them. That would send a message to both the PACE investigators and the world at large that you don't give a fig about scientific and professional integrity as long as you get better. Who would want to give that kind of impression about themselves?

The claim that the patients who benefited from PACE are opposed to the data release on the grounds that they fear their anonymity may be jeopardized can again be dealt with by questioning how well informed they are of the actual risk of any participant's identity being discoverable from the data that will be released. If they have been properly informed about the nature of the data that is going to be released - namely that it is completely anonymized - there is no plausible reason for them to be opposed to the data's release.

My suspicion is that if there are in fact any trial participants opposed to the release of the data it is only because they have not been made aware of, or not grasped, firstly how serious PACE's flaws are and secondly how impossible it will be for anyone to discover their identity from the data.

Until an authentic trial participant posts a reasoned argument somewhere in opposition to the release of the data, in which he or she demonstrates a good grasp of PACE's flaws and the vanishingly small risk of any trial participant being identifiable from the data, I'm afraid I will remain deeply sceptical whether there is in fact anyone among the trial participants who is properly informed and yet still opposes the release of the data.

 

[Sasha]

Some great comments on there. My favourites:

To all the signatories - if only you knew how stirring it is just to read all your names and credentials, knowing what you stand for and what you are committed to achieving. For thousands of people you have never met, that simple alphabetical roll call of names has an aura and a significance you cannot imagine.

Back in 2011 I wrote to Richard Horton on behalf of a small group of patients who had similar concerns about the PACE trial. I got no reply, so I wrote to the assistant editor, simply asking for confirmation that they had received my message. I got no reply. The Countess of Mar was supportive, so she wrote to Richard Horton and, guess what, got no reply. Chasing it up with The Lancet's ombudsman, she didn't get anywhere either, and when she followed that up was told that the ombudsman was on holiday. I'm guessing he still is, and that Richard Horton has joined him.

It must be nice there.

 

[eafw]

Chasing it up with The Lancet's ombudsman, she didn't get anywhere either, and when she followed that up was told that the ombudsman was on holiday. I'm guessing he still is, and that Richard Horton has joined him. It must be nice there.

They seem to think that ethics and accountability is something beneath their superior selves.

 

[barbc56]

All very interesting about the patient confidentiality and as I suspected it's almost impossible to make a connection.

 

[Skippa]

Exposure therapy is standard treatment for most phobias, I gather.

Makes it clear how they see our condition. Just an irrational phobia.

That perfectly sums up just what we are facing.

 

[Sean]

Graded Exposure Therapy ?

 

[Skippa]

Graded Exposure Therapy ?

Fckrs, I want to believe!

 

[Dr Speedy]

If exercise made you better you either did not have ME in the first place or you had a spontaneous remission ... PACE trial NULL effect;

Published, independent review of the #PACEtrial http://niceguidelines.blogspot.com/2016/04/published-independent-review-of-pace.html