Follow-up results of GETSET never published?

ME/CFS Skeptic

ME/CFS Skeptic

Senior Member (Voting Rights)
Does anyone know if the follow-up results of the GETSET trial were ever published? Apologies in advance if I'm overlooking something.

The 2017 paper in the Lancet writes:
Participants were also followed up at 12 months after randomisation, and these results will be published in a separate paper
Click to expand...
But was there ever a separate paper with the follow-up results of GETSET?
 
Michiel Tack said:
Does anyone know if the follow-up results of the GETSET trial were ever published? Apologies in advance if I'm overlooking something.

The 2017 paper in the Lancet writes:

But was there ever a separate paper with the follow-up results of GETSET?
Click to expand...
One possible set of reasons for the follow-up study not being published would be Peter White's health problems, plus his retirement from his professorship and from clinical practice (though not from his insurance work, from what I understand).

Some data from the PACE Trial that was promised, such as on the predictors and moderators, has never been published.
 
Dolphin said:
One possible set of reasons for the follow-up study not being published would be Peter White's health problems, plus his retirement from his professorship and from clinical practice (though not from his insurance work, from what I understand).
Click to expand...
Thanks for pointing this out. On the other hand, Peter White did manage to publish a 2018 paper on patient experiences and perceptions from the GETSET trial. I also remember him writing an angry response to one of Twisks letters not too long ago.

He was the principal investigator, but there were a handful of other researchers involved. It should be possible for them the publish the follow-up results. I don't think that would be that much work and normally researchers are happy to have an extra publication. I think it's weird that the follow-up results weren't published.

Is it worth sending emails about this? Perhaps we could ask for the anonymized raw data?

@JohnTheJack @Esther12
 
Michiel Tack said:
Thanks for pointing this out. On the other hand, Peter White did manage to publish a 2018 paper on patient experiences and perceptions from the GETSET trial. I also remember him writing an angry response to one of Twisks letters not too long ago.

He was the principal investigator, but there were a handful of other researchers involved. It should be possible for them the publish the follow-up results. I don't think that would be that much work and normally researchers are happy to have an extra publication. I think it's weird that the follow-up results weren't published.

Is it worth sending emails about this? Perhaps we could ask for the anonymized raw data?

@JohnTheJack @Esther12
Click to expand...

It is strange that the follow-up results have not been published.

Yes, I'll ask for the data when I'm up and running again. Or walking at least. Hehe.
 
I had the following letter published in The Lancet re GETSET in 2018:

Graded exercise self help
for chronic fatigue
syndrome in GETSET
The mean score for physical
functioning (measured by the Short
Form-36 [SF-36] subscale)1 for people
aged 35–44 years is 93·3 (SD 13·4).2
Participants in the GETSET trial by
Lucy Clark and colleagues3 (July 22,
p 363) had a mean age of 38·1 years in
the active treatment arm (guided
graded exercise self-help [GES] group)
and 38·7 years in the control group.
After the short 12-week intervention,
participants’ mean self-reported
physical functioning score using the
SF-36 scale was 55·7 (23·3) in the GES
group, an increase from 47·3 (22·2)
before the intervention, compared
with a slight increase in physical
functioning in the control group from
50·1 (22·6) to 50·8 (25·3).3 Clark and
colleagues state that “GES significantly
improved fatigue and physical
functioning compared with SMC
[specialist medical care] alone”.
However, this modest change in a self reported
outcome measure in a nonblinded
trial, in which bias is highly
likely without use of objective
measures of activity, is extremely
unlikely to translate to a clinically
meaningful improvement for
patients. Nor does this change return
them anywhere close to healthy and
robust good physical functioning
compared with controls, which
patients heartily desire. Overall, these
observations suggest such modest
improvements are unlikely to be due
to countering deconditioning and
exercise avoidance as proposed by the
authors, but are much more likely to
be accounted for by nothing more
than the placebo effect, in other words
a desire by patients to please their
therapists. Moreover, there was no
attempt during this trial to obtain
measurable objective activity levels to
ascertain if patients increased exercise
and activity or complied with the
intervention at all.

I declare no competing interests.

Joan S Crawford
joan.crawford1@outlook.com

1 McHorney CA, Ware JE Jr, Raczek AE. The MOS
36-item Short-Form Health Survey (SF-36): II.
Psychometric and clinical tests of validity in
measuring physical and mental health
constructs. Med Care 1993; 31: 247–53.

2 Bowling A, Bond M, Jenkinson C, Lamping DL.
Short Form 36 (SF-36) Health Survey
questionnaire: which normative data should
be used? Comparisons between the norms
provided by the Omnibus Survey in Britain,
the Health Survey for England and the Oxford
Healthy Life Survey. J Public Health Med 1999;
21: 255–70.

3 Clark LV, Pesola F, Thomas JM, Vergara-
Williamson M, Beynon M, White PD. Guided
graded exercise self-help plus specialist
medical care versus specialist medical care
alone for chronic fatigue syndrome (GETSET):
a pragmatic randomised controlled trial.
Lancet 2017; 390: 363–73.

Others published critical responses too. I suspect they/PDW got a bit too woo hoo about publishing further. I think they do need to publish follow up results. PDW is one of many in the team - there are plenty others in the group who can write and publish. It was public money after all. To be fair it can take a while to get published once the data is collected. A polite email to one of the GETSET team might be illuminating :-)

Joan Crawford
Counselling Psychologist
UK
 
Thank you @Joan Crawford for sharing.

Below is the main text of the letter reformatted for those who like me might struggle to read it:

Graded exercise self help for chronic fatigue syndrome in GETSET

The mean score for physical functioning (measured by the Short Form-36 [SF-36] subscale) for people aged 35–44 years is 93·3 (SD 13·4)

Participants in the GETSET trial by Lucy Clark and colleagues (July 22, p 363) had a mean age of 38·1 years in the active treatment arm (guided graded exercise self-help [GES] group) and 38·7 years in the control group.

After the short 12-week intervention, participants’ mean self-reported physical functioning score using the SF-36 scale was 55·7 (23·3) in the GES group, an increase from 47·3 (22·2) before the intervention, compared with a slight increase in physical functioning in the control group from 50·1 (22·6) to 50·8 (25·3). Clark and colleagues state that “GES significantly improved fatigue and physical functioning compared with SMC [specialist medical care] alone”.

However, this modest change in a self reported outcome measure in a nonblinded trial, in which bias is highly likely without use of objective measures of activity, is extremely unlikely to translate to a clinically meaningful improvement for patients. Nor does this change return them anywhere close to healthy and robust good physical functioning compared with controls, which patients heartily desire. Overall, these observations suggest such modest improvements are unlikely to be due to countering deconditioning and exercise avoidance as proposed by the authors, but are much more likely to be accounted for by nothing more than the placebo effect, in other words a desire by patients to please their therapists. Moreover, there was no attempt during this trial to obtain measurable objective activity levels to ascertain if patients increased exercise and activity or complied with the intervention at all.
 
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