A Few Notes on GETSET

The latest GET study by Prof Peter White et al is entitled Graded Exercise Therapy guided Self-help Treatment (GETSET) for patients with chronic fatigue Syndrome: a randomised controlled trial in secondary care. This trial apparently aimed to assess the efficacy and safety of Guided Exercise Self-help (GES). At the time of writing, an abstract only is available and this has been discussed on the Phoenix Rising forum. Russell Fleming summarised some of the discussion in a useful series of tweets and I asked his permission to share them here, not least because tweets are such ephemeral things and can be hard to access for future reference.

Russell frequently tweets extremely useful summaries of new research papers and notable ME-related events and is well worth following if you don’t already do so. Follow him @Firestormmer

Here are Russell’s notes on GETSET. (Whatever you think of the research, you have to admire the acronyms, though someone on Phoenix Rising suggested that GETSHT might be more appropriate.) Over to Russell:

From the discussion on Phoenix Rising and without anyone seeing the full paper, there already appears to be some issues with this trial. Quelle surprise you might think. Let me try to summarise the concerns:

1.The Chalder fatigue scale outcome was added after the trial started.

2. The NICE criteria were used to recruit but from selected secondary care centres – we don’t yet know which ones but can probably guess.

3. Only after the trial was an attempt made to allocate patients to other criteria and only Fukuda and Oxford – e.g. no mandatory PEM

4. The trial ran for only 12 weeks – which might be a fair representation of secondary care – but may not be long enough.

5. The improvements are ‘tiny’ e.g. A CFQ 6.3 point improvement means patients marked one question one step better than at baseline.

6. They also only list “adjusted” scores, so unadjusted scores probably show no improvement.

7. Serious adverse events were recorded in each arm (1% GET, 2% SMC) but we don’t know what their definition was from the abstract.

8. The pre-specified outcome measure (SF36) recorded only small effect size, so they switched to Chalder post-hoc for a better result.

9. The end-date for the trial was extended and more patients recruited while the trial was underway. This would affect outcome measures.

10. There’s mention in the Phoenix Rising discussion of a 1 year outcome measure (Chalder) but I can’t see the results in the abstract.

11. “It’s interesting how they extended the judgment period and used an additional primary outcome after the original end of the trial.”

12 There was no control group used in the trial. These authors do not appear to have learned anything from past endeavours.

Note: It amazes me that they have the cheek to conclude these measly effect sizes as ‘moderate’. What on earth would they be for recovery?!

– Russell Fleming

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Door to Freedom Revisited

Following my earlier post about the tenuous argument put forward for the recent PACE Trial Freedom of Information Act refusal, I’ve been digging a bit deeper and I think it is now absolutely clear that the ‘evidence’ cited in the refusal notice totally fails to support QMUL’s case. It also appears that it has been deliberately quoted out of context by QMUL to create a misleading impression.

Just to remind you, here is my summary of the argument used for refusing the request:

“The argument seems to go like this: in spite of the fact that this specific request is not onerous and in spite of the fact that the complainant has not previously made an FOI request, he has been adjudged to be part of a coordinated campaign to discredit PACE (because he has talked to other people about PACE on the internet). Therefore the issue has been judged not on this specific request but on the overall burden of PACE-related FOI requests on QMUL, which are accepted not to be overwhelming but have nevertheless caused ‘disproportionate irritation and stress’ to Prof White and his team and are therefore vexatious. Therefore the request for this important piece of information is refused.”

What got me looking at things more closely was this comment by Chrisb on the Phoenix Rising forum in response to my post:

“Mr Spoonseeker has referred to and dealt with the point about the sheer weight of requests but I think there is another point.

“The Guidance apparently states that “if a public authority has reason to believe that several different requesters are acting in concert as part of a campaign to disrupt the organisation by virtue of the sheer weight of FOIA requests being submitted……”

“This guidance appears to be primarily, and quite reasonably, directed at and applicable to an entirely different type of campaign where the object is to bring about the disruption of the organisation, rather than a bona fide attempt to obtain information. Has any evidence been presented with the purpose of demonstrating that the requesters intent was disruption of the organisation of QMUL rather than obtaining the information which we believe to be the real object of the request?

“Given the Commissioner’s acceptance that this particular request on its own would not impose a significant burden, the onus of proof to establish whether the person was acting in concert with others, whose intent was disruption, ought to be significantly higher.

“In order to show that the request constituted part of a campaign one might expect it to be necessary to adduce evidence of a campaign predating the request. It seems to me that the examples quoted by QMUL probably were made after the request and in response to the initial refusal. Alternatively one might attempt to show a link to subsequent requests, but as I recall it there was no such attempt.”

In actual fact I had attempted to deal with most of this issue in my earlier post as follows: Continue reading “Door to Freedom Revisited”

Closing the Door on Freedom

OK, here’s my take on the Freedom of Information Refusal Notice which came out a couple of days ago, not to be confused with the Tribunal outcome which (as I write) is expected imminently. Apologies for the fact that it’s about twice as long as it should be but I now have brain fog so I don’t have the intellect to edit it down! If you manage to read it, I hope you find it of interest. Me, I’m going to get some sleep….

The latest PACE Trial Freedom of Information Refusal Notice causes particular concern, not only for the PACE Trial and its implications for the future prospects of people with ME/CFS, but also for the Freedom of Information Act itself – and even for freedom of speech. The Notice incorporates twelve pages of repetitive arguments from QMUL (Queen Mary University of London, home of the PACE Trial) and three pages of what seem to me to be concise and clearly argued response from ‘the complainant’ (i.e. the guy who has made the request for information). Unfortunately, the Commissioner then goes on to reject the latter in favour of the former, apparently believing every word that QMUL have told him, i.e. that patients have launched a concerted campaign to discredit the PACE Trial by submitting a burdensome number of FOI requests in the desperate hope of finding something wrong with it and in the meantime bringing Lead PACE Investigator Prof Peter White and his staff to their knees under the resultant administrative load so that they aren’t able to do any more of their vital research. Or something like that. Their evidence is not so much a linear argument as a trip several times round the houses in the hope that if they say the same things often enough, some of them will eventually convince the Commissioner. Unfortunately, this strategy appears to have been successful.

The information the complainant requested relates to the data from the step test, an objective outcome measure which went unreported in the original PACE report but appeared in the form of a small scale graph in an appendix to one of the follow up studies. Continue reading “Closing the Door on Freedom”

Time to be Heard

Six weeks on from the infamously unhelpful article by Sarah Knapton in the Daily Telegraph, the online version of the newspaper has published an article on ME by Dr Charles Shepherd of the ME Association with a view to correcting some of the misinformation. This was part of a deal which was struck by way of redress for the Telegraph falling so short of the truth on this occasion, as part of which they also published a ‘clarification’ of their assertion that ME isn’t really a chronic illness. As the clarification stated that the study they had reported actually said no such thing, it might have been more appropriate to call it  a ‘correction’ but I suppose you can’t expect a leading national newspaper to have such a precise grasp of the English language.

As for Dr Shepherd’s article, it doesn’t appear in the print edition, this in marked contrast to Knapton’s article which was linked from the front page. We have elderly relatives who read the original article but will only receive Shepherd’s piece because we’ll print it out and send them it. Many other Telegraph readers will sadly remain in ignorance.

This sort of imbalance is pretty much standard, of course, in situations like this, and Dr Shepherd and the ME Association are to be congratulated for at least getting the deal they did. It is worth, too, saying a word or two extra in praise of Charles Shepherd, who has been performing duties like this on our behalf for the best part of three decades now, plodding time and again to the barricades to call out the truth into the no man’s land of ignorance, doubt and incomprehension, then plodding patiently back again in the knowledge that he will probably have to do the same thing all over again in an another week’s time. And another. And another. The man is a hero. We are very fortunate to have him.

We are also lucky to have ME patients such as Tom Kindlon who have been plugging away with well reasoned comments for years, slowly exposing the fracture lines in the PACE Trial and counteracting other misconceptions. Not all of us are capable of such exhaustive feats of analysis, and yet there is a growing understanding that we all have a part to play in getting the truth out there. Continue reading “Time to be Heard”