Do graded activity therapies cause harm in chronic fatigue syndrome?

[user9876]

It's an ethical issue because people are so pro and against GET. Proponents will design a trial so that only very serious harm is recorded (not necessarily cynically but they don't expect problems).

Most trials were small trials without any harms reporting. Pace was intended to cover this but they did not do it properly. They changed their definition of serious adverse events (without mentioning it) and they did not check compliance with treatment. I think there could also be issues due to the review process where events are discarded as not relevant to treatments. If the reviewers don't thing GET can harm they will not allocate it as such.

 

[Tom Kindlon]

https://twitter.com/i/web/status/844601419223195649

 

[Jenny TipsforME]

Congratulations on being in the 97th percentile @Tom Kindlon!

 

[Karen Kirke]

Congrats @Tom Kindlon. So many good points that I've sent you an email!

 

[Jenny TipsforME]

@Karen Kirke hi how are things going with you? You've started posting here, is this a good sign?

 

[kaffiend]

Thank you for your hard work.

 

[Karen Kirke]

@Karen Kirke hi how are things going with you? You've started posting here, is this a good sign?

Hi Jenny! Hope you’re doing as well as possible. No improvement here (pesky illness beliefs /pyruvate dehydrogenase function). But I do have a commentary coming out in the Journal of Health Psychology in a few weeks’ time, on patient surveys.

 

[Jenny TipsforME]

Oh looking forward to your paper @Karen Kirke ! Will you start a new thread with it when it's published?

I'm actually just starting on a research project (very part time from home) and guess what we will be writing patient surveys! So it could be useful.

 

[Yogi]

our new best friend

https://twitter.com/i/web/status/845229752898273282

 

[mango]

I, too, am immensely grateful for all your courageous & heroic efforts and all your sterling work, @Tom Kindlon! There are no words...

 

[Karen Kirke]

Oh looking forward to your paper @Karen Kirke ! Will you start a new thread with it when it's published?

I'm actually just starting on a research project (very part time from home) and guess what we will be writing patient surveys! So it could be useful.

Yes, I'll start a new thread with bells on! Your research project sounds interesting - let's keep in touch. Will they be ME/CFS patient surveys?

 

[Tom Kindlon]

https://twitter.com/i/web/status/846725236770902017

 

[Tom Kindlon]

https://twitter.com/i/web/status/847836548137615360

http://journals.sagepub.com/doi/full/10.1177/1359105317697323

 

[Tom Kindlon]

https://twitter.com/i/web/status/847916500530933761

 

[Sea]

"In the PACE trial, which used the broad Oxford criteria, post-exertional malaise at baseline was reported by 84 per cent in the APT group, 85 per cent in the CBT group, 82 per cent in the GET group and 87 per cent in the control (SMC-only) group (White et al., 2011)."
@Tom Kindlon do we have any way of correlating those classified as improvers with their baseline symptoms? ie do we know whether any of the improvers had PEM as a baseline symptom?

I know this is a pipe dream, but what would be enlightening would be a qualitative study of the original PACE participants asking them about their experiences and perceptions of the study.

I know you understand it isn't possible but any move made to identify/contact PACE participants would be jumped on by PACE authors and used against the patient community. It was their biggest argument in not releasing the data that we would try to identify participants. Pretty sure it was for the sake of their reputation rather than patient confidentiality though. Any of the patients that have come forward and said anything that I've read has been damning towards the trial. Of course the PACE authors could say those people were not part of the trial and we would have no way of verifying that.

 

[Tom Kindlon]

"In the PACE trial, which used the broad Oxford criteria, post-exertional malaise at baseline was reported by 84 per cent in the APT group, 85 per cent in the CBT group, 82 per cent in the GET group and 87 per cent in the control (SMC-only) group (White et al., 2011)."
@Tom Kindlon do we have any way of correlating those classified as improvers with their baseline symptoms? ie do we know whether any of the improvers had PEM as a baseline symptom?

Not at the moment. A paper looking at predictors from the PACE trial authors has been promised which may or may not have some interesting information.

 

[Tom Kindlon]

https://twitter.com/i/web/status/847921335384854528

 

[Jenny TipsforME]

Any of the patients that have come forward and said anything that I've read has been damning towards the trial. Of course the PACE authors could say those people were not part of the trial and we would have no way of verifying that.

In theory (I know this won't happen!) the qualitative follow up could be done by PACE researchers themselves. If they're confident about participants having a neutral/positive experience they could evidence this with more detailed feedback.

 

[RogerBlack]

Is there any general protocol for contacting patients to do a followup trial if you are not the original researchers?

 

[trishrhymes]

Is there any general protocol for contacting patients to do a followup trial if you are not the original researchers?

I suspect the answer is, you can't. And I have to admit, much as I'd like this to be done, it's surely a non starter. Patient confidentiality must be preserved in terms of personal details.