Tell our charities: QMUL must release PACE data

[energyoverload]

Can anyone propose methods by which anonymous data such as that from pedometers could be personally identifiable? I'm having difficulty thinking how someone could identify an individual by their step count. We need to clarify this point?

Fb: https://www.facebook.com/actionforme/?fref=ts

 

[Yogi]

Surprise Surprise...Typical meaningless waffle from AFME.

This could be just a big lie. I just don't believe that anyone told them this.

We have also received requests from people who were involved in the Trial as participants to support them to ensure that their data should not be released, anonymised or otherwise, as this is a breach of their consent.

Full Message:
Action for M.E. has been asked to clarify its position on the PACE Trial and the release of data. As a charity, it’s very important that we consider the wide range of views shared with us and use these to inform our work. We have received requests to write to QMUL and support the release of data. We have also received requests from people who were involved in the Trial as participants to support them to ensure that their data should not be released, anonymised or otherwise, as this is a breach of their consent. As the scientific debate about the PACE trial moves forward, we continue to listen to our supporting members, carers and advocates that contact us to share their concerns and feedback as well as the discussion that continues on social media. We take our role and position very seriously and for this reason the Trustees will carefully consider the issues and our position at the forthcoming Board meeting and action will be taken following this

 

[Cheshire]

Response from SC to people asking if the situation has been fully explained to the people who refuse to share data:

Sonya Chowdhury Yes, absolutely. We have explained fully that this is the case. However, people who have contacted us have still expressed their concern that they did not give consent at the beginning and therefore they do not wish it to be shared.

 

[Sasha]

Response from SC to people asking if the situation has been fully explained to the people who refuse to share data:

It sounds to me as though they don't realise that they can't be identified. AfME should be explaining that to them.

 

[Mrs Sowester]

Can others dive in to FB, don't want to blow it now we've got SC responding, my comeback was pants!

 

[Sasha]

Does anyone know when their next board meeting is?

 

[Yogi]

It is all a big lie from AFME. AFME has been put in a difficult situation with this where their allegiances to the PACE PI's and their vested interests (DWP) or ME patients would be clear for all to see.

Unsurprisingly they have used corporate waffle to explain " we continue to listen to our supporting members, carers and advocates that contact us to share their concerns and feedback as well as the discussion that continues on social media" while screwing us all over with this message.

It has been clear for along time that AFME and AYME are not patient charities in the usual sense but are are just a patient charity FRONT to rubber stamp and provide approval for all the BPS school and their vested interests and for AFME to get rich by collecting government grants on the way.

They have been BOUGHT!

 

[Valentijn]

So AfME thinks that trial data should never be shared, because a few patients don't understand that anonymous trial data gets shared? I think AfME should be explaining to those supposed patients the difference between the anonymous trial data which was requested, and "personal data".

If someone objects to their SF-36 and CFQ numerical answers being shared under a random patient ID number, they should not be enrolling in trials. And if they still don't understand the difference between such data and personal data, I'd have to wonder if they had the cognitive faculty to provide informed consent to be in the trial in the first place.

But I don't believe that anyone is that incapable of understanding a simple explanation. It's more likely that QMUL, White, and/or AfME themselves are providing immense spin to support the ridiculous stance which they have chosen.

 

[Cheshire]

These patients offer AfME a good excuse for not taking side...

 

[Sasha]

We should be contacting AfME direct about this, I think.

 

[Mrs Sowester]

When negotiating it's often best to assume there has been a misunderstanding rather than to assume polar positions - it provides more chance of an accord being reached.
With that in mind my suggestion would be to write a letter from PR to the trial subjects who are concerned at their data being shared explaining the anti PACE position of patient groups. We'd ask for this to be passed on to the trial subjects via AfME (and/or post an open letter on FB).
I'd suggest this letter explain:

• the worries we have we re. PACE trial esp. that it included people with depression and not just ME
• The effect it's having on treatment policy for children with ME
• The way it's impacting policy for funding of future research here and around the world
• That they will be safe from identification

 

[Mrs Sowester]

But PACE will fall whatever - it cannot withstand this amount of criticism.
If they do not release data then PACE isn't replicable.
They will have to release data or retract the paper.

 

[daisybell]

Do we know exactly what the consent form said? Surely, it cannot have stated that data would not in any circumstance be shared with other researchers in anonymised form..... The issue must be that a few people who participated did not fully understand what they were consenting to - if that is the case, those peoples' data should be removed entirely from the dataset, or they need to be informed that they have in fact signed their consent.

 

[BurnA]

Response from SC to people asking if the situation has been fully explained to the people who refuse to share data:

It makes no sense. It's anonymised data. How could any reasonably sane person not want their anonymised data released ? These people signed up for a trial so they knew their data would be analysed, why would they object to it being analysed again anonymously.

 

[Scarecrow]

@charles shepherd, are you able to say whether any MEA members who were PACE trial participants have contacted the association to express their concerns about the release of anonymised data?

 

[BurnA]

Do we know exactly what the consent form said? Surely, it cannot have stated that data would not in any circumstance be shared with other researchers in anonymised form..... The issue must be that a few people who participated did not fully understand what they were consenting to - if that is the case, those peoples' data should be removed entirely from the dataset, or they need to be informed that they have in fact signed their consent.

https://www.whatdotheyknow.com/request/203455/response/508208/attach/html/3/Consent forms.pdf.html


3. 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.

https://twitter.com/i/web/status/696720661293744129

 

[Scarecrow]

3. 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.

Nice find but that particular clause is about consenting to medical records (eg, G.P. or hospital records) to be accessed by those running the trial or regulating the trial.

I don't see any statements on the consent form that expressly give or forbid consent for trial data to be released or shared with other researchers.

Anyone here with a legal background?

 

[charles shepherd]

@charles shepherd, are you able to say whether any MEA members who were PACE trial participants have contacted the association to express their concerns about the release of anonymised data?

As The MEA is now being asked if any of our members who took part in the PACE trial, or anyone else who did and took part in our questionnaire that provided the information for our 2015 report on efficacy and safety of CBT, GET and Pacing, has contacted us to express concerns or objections to anonymised data from the PACE trial being released for independent analysis, it's probably simpler if I just make a short public satement:

The answer is no.

All the messages we have received via email, MEA Facebook etc, have been in full support of the letter that we have sent to QMUL..

I would add that the FOI department at QMUL has acknowledged receipt of our letter this afternoon.

And it's good to see the 25% Group endorsing the MEA letter!

CS

 

[Scarecrow]

@Bob I didn't see the tweet embedded in @BurnA's post (#57) when I commented. I think that there has been a misinterpretation of clause 3 on the consent form (see #58). Would be good if someone with a legal or medical background could check it out.

 

[BurnA]

Response from SC to people asking if the situation has been fully explained to the people who refuse to share data:

So AfME thinks that trial data should never be shared, because a few patients don't understand that anonymous trial data gets shared? I think AfME should be explaining to those supposed patients the difference between the anonymous trial data which was requested, and "personal data", preferably using small words.

If someone objects to their SF-36 and CFQ numerical answers being shared under a random patient ID number, they should not be enrolling in trials. And if they still don't understand the difference between such data and personal data, I'd have to wonder if they had the cognitive faculty to provide informed consent to be in the trial in the first place.

But I don't believe that anyone is that daft. It's more likely that QMUL, White, and/or AfME themselves are providing immense spin to support the ridiculous stance which they have chosen.

I wonder if these patients contacting AfME were anonymous patients ? Hmmmmm