GETSET letters in The Lancet

In their response to the points I raised about severe and very severe ME, Clark and colleagues suggest that the "use of teletherapy for patients too unwell to attend clinic is an innovative approach that merits further research.6, 7"

6 is Clauw's commentary which accompanied the original GETSET publication. 7 is the FITNET trial.


People with severe ME have voiced their opinions on both teletherapy and graded exercise.


298 respondents to Action for ME’s 2014 survey identified as severe. “Action for M.E.’s survey asked people with severe M.E. what would make a real different [sic] to their healthcare:

• 68% said a better informed GP

• 66% said more effective medication

• 63% said home visits

• 53% said joined-up health and social care

• 36% said having more of a say in their treatment

• 21% said telehealth”



See p.11 of https://www.actionforme.org.uk/uploads/pdfs/my-life-stopped-severe-ME-report.pdf


which quotes from p.27 of https://www.actionforme.org.uk/uploads/pdfs/me-time-to-deliver-survey-report.pdf


In 2004 the 25% ME Group (who represent those who are bedbound, housebound and use wheelchairs) surveyed a randomly selected 437 of their members. Their report summarises the findings of that survey regarding graded exercise as follows:


“By far the most unhelpful form of treatment was considered to be Graded Exercise Therapy (GET). [Bold in original.] This is a finding that may surprise some readers, given the current medical popularity of this approach. However, these patients’ perceptions are supported by data from previous experience: of the 39% of our members who had actually used Graded Exercise Therapy, a shocking 82% reported that their condition was made worse by this treatment. On the basis of our members’ experiences we question whether GET is an appropriate approach for patients with ME. It is worth noting that some patients were not severely affected before trying GET. [Bold in original.] Thus, it is not only people with severe ME who may be adversely affected by this form of treatment.”

The full report can be downloaded here (it’s the March 2005 Severe ME Analysis Report): http://www.25megroup.org/info_group_publications.html
 
I've asked on their FB page as well.

[Update: No - they didn't submit anything]
 
Last edited:
  • March 31, 2018
  • The Lancet 391, 10126 (2018)
  • Author: Robert H Saunders
I was surprised to read that the GETSET trial by Lucy Clark and colleagues1 excluded participants who had physical contraindications to exercise, as such a criterion would appear to exclude anyone suffering from post-exertional malaise (PEM). In its 2015 report,2 the US Institute of Medicine concluded: “There is sufficient evidence that PEM is a primary feature that helps distinguish ME/CFS [myalgic encephalomyelitis/chronic fatigue syndrome] from other conditions”. Indeed, post-exertional neuroimmune exhaustion is a compulsory requirement for a diagnosis of myalgic encephalomyelitis under the International Consensus Criteria.

From https://www.doctorportal.com.au/cor...elp-for-chronic-fatigue-syndrome-in-getset-3/
 
Kalliope said:
The letters

Karen D. Kirke
Graded exercise self-help for chronic fatigue syndrome in GETSET

Joan S Crawford
Graded exercise self-help for chronic fatigue syndrome in GETSET

Robert H Saunders
Graded exercise self-help for chronic fatigue syndrome in GETSET

Frank Twisk
Graded exercise self-help for chronic fatigue syndrome in GETSET

Anne Wood
Graded exercise self-help for chronic fatigue syndrome in GETSET

Lucy V Clark, Francesca Pesola, Janice M Thomas, Mario Vergara-Williamson, Michelle Beynond, Peter D White
Graded exercise self-help for chronic fatigue syndrome in GETSET
Click to expand...
Anna Wood is concerned about adherence to GES and missing data; both were reported in the paper and neither significantly altered our findings or conclusions.1
Click to expand...
They didn't include how much physical activity the participants undertook in the past week as requested by Anna Wood.
The protocol notes that to “measure departure from intended treatment, participants will be asked at follow-up whether they adhered to the booklet and guidance, and how much PA [physical activity] they undertook in the past week.”3 It would be useful if Clark and colleagues could now also publish such data.
Click to expand...

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)30619-6/fulltext
 
We have already acknowledged the small size of the effect on physical functioning (0·20), but our finding that the effect size was greater in those with the worst baseline physical functioning suggests this might represent a ceiling effect.
Click to expand...
It is disappointing that there are again making this point without sharing information about the other subgroup i.e. with the higher baseline scores.

I tried to deal with this in my (unpublished) letter.
(Copied from an earlier message)
I decided to focus on a specific point that I did not see others raising in discussions. Most of my other letters use more references:

Response to: Guided graded exercise self-help plus specialist medical care versus specialist medical care alone for chronic fatigue syndrome (GETSET): a pragmatic randomised controlled trial

The SF-36 physical functioning (PF) outcomes for those in the guided graded exercise selfhelp (GES) group who had a baseline SF-36 PF score ≥45 (call them group B) must have been particularly poor in the GETSET trial.1 We are told that those with a baseline score ≤40 (group A) made up approximately 40% of the sample and ended with average score of 56.9. This means the average outcome for group B, the higher functioning group at baseline, was actually lower, at around 54.9. Also, by definition, group A increased by an average of at least 16.9 (56.9-40). However the whole sample only increased by an average of 8.4. This means that an upper bound on the average increase for group B would be only approximately 2.7, in comparison to the increase of 16.9 for group A. This is an extreme scenario and the difference in improvements was most likely higher than 14.2. It would be interesting if Clark and colleagues could give the exact figure so everyone would be aware of the magnitude of the difference in the response.

Clark and colleagues say the poor results may be due to a ceiling effect. More than 90% of healthy working-age people score 90 or more.2 Therefore, the mean score of 54.9 for group B and 55.7 overall suggests that if there is a ceiling in the effectiveness of GES, it is a long way below normal functioning. I do not believe this was made clear to readers.

Tom Kindlon

Competing interests: I work in a voluntary capacity for the Irish ME/CFS Association.

References:

1. Clark LV, Pesola F, Thomas J, 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. The Lancet. June 22, 2017 doi:10.1016/S0140-6736(16)32589-2

2. Wilshire CE, Kindlon T, Matthees A, McGrath S. Can patients with chronic fatigue syndrome really recover after graded exercise or cognitive behavioural therapy? A critical commentary and preliminary re-analysis of the PACE trial. Fatigue. 2017;5:1–4.
Click to expand...
---

The journal did take a long time to reply (over 6 months): I am left wondering whether they asked the investigators for their opinion. I could imagine the researchers might try to put the journal off the letter.


Anyway I've posted it on PubMed Commons: https://www.ncbi.nlm.nih.gov/pubmed/28648402#cm28648402_78211
It is now on PubPeer
https://pubpeer.com/publications/C6228BA4BCA3E4859CDF9F8CF00663
There's a reasonable possibility those in the group with an initial score of 45+ on the SF-36 physical functioning subscale actually decreased on average.
 
Last edited:
I have not read the paper, and do not know if it is at all relevant, but is there a NNT figure ( as in the quoted 7 for PACE) ?
 
Tom Kindlon said:
It is disappointing that there are again making this point without sharing information about the other subgroup i.e. with the higher baseline scores.
Click to expand...

I'm trying to get my head round why this makes a difference. Surely the difference in the increases between the subgroups is an indication of regression to the mean, in addition to any ceiling effect?

I guess I'm not clear what they are trying to say and why this is a problem. This is from the main paper:
Our finding that GES was more useful in those with worse physical functioning is reassuring and has been reported previously,[11] but further exploration is necessary because it might be related to a ceiling effect in those with good physical functioning at baseline. This ceiling effect might also explain the relatively smaller difference in the effect size for physical function, which would reduce the overall difference between study groups.
Click to expand...

A general point about correspondence - if there are lots of letters on an issue, the journal will not generally publish all those that deal with the same point, and will probably ask the authors of the original paper which ones they want to address. There won't necessarily be the in-house expertise to know which letters are most important, so it is likely that the authors will be given this task.
 
Regression to the mean is an interesting possibility.

I'm not 100% sure what you're saying: they are saying that because the higher group didn't do as well, that's likely because they were already near the maximum (ceiling effects). There could be situations where this arises.

However, based on the figures here we have enough information to know that the patients in the higher functioning group only approved by a maximum of 2.7 points and may actually have decreased. A final score of around 55 is not near a maximum score unless one is accepting that graded exercise therapy can only bring people up to a very low level which the authors have never conceded.

Unlike us, the authors have the figures. It would be pretty clear if they gave the figures that their interpretation is not valid. But by not giving the figures people could be taken in by it.
 
You must log in or register to reply here.
Back
Top Bottom