GETSET - Graded Exercise Therapy guided Self-hElp Treatment (GETSET)

Bob

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Edit: New! See the trial protocol here:
http://forums.phoenixrising.me/inde...-conference-abstract.44749/page-4#post-733501

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The GETSET trial has arrived.


Edit: it seems that the full paper hasn't been published yet, but just the abstract (posted below) as part of a list of conference abstracts: The conference of the European Association for Psychosomatic Medicine (EAPM) is titled: "Transforming health through evidence and empathy."
http://eapm2016.com/

There is previous discussion about GETSET here (I'm not sure if I should have started a new thread):
http://forums.phoenixrising.me/inde...ite-at-it-again-now-its-a-getset-trial.15619/

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Conference abstract.

Graded Exercise Therapy guided Self-hElp Treatment (GETSET) for patients with chronic fatigue syndrome: a randomised controlled trial in secondary care
Clark LV, McCrone P, Ridge D, Cheshire A, Vergara-Williamson M, Pesola F, White PD.
Journal of Psychosomatic Research, June 2016, Volume 85, 59-60.
http://www.jpsychores.com/article/S0022-3999(16)30233-1/abstract

Background:

Previous trial findings show that graded exercise therapy (GET) can be an effective treatment for chronic fatigue syndrome, but therapy is expensive and requires attendance at hospital. This trial aimed to assess the efficacy and safety of Guided Exercise Self-help (GES).

Method:

In our randomised and controlled trial, patients meeting NICE criteria for chronic fatigue syndrome were recruited from two secondary care clinics in the UK and randomly allocated by computer-generated sequence to receive specialist medical care (SMC) alone or SMC supplemented with guided exercise self-help (GES). Primary outcomes were fatigue (Chalder fatigue questionnaire; CFQ) and physical function (short form-36 subscale score; SF-36) 12 weeks after randomisation, and safety was also assessed.

Primary outcomes were rated by participants, who were necessarily unmasked to assignment; the statistician was masked to treatment arm assignment for the analysis. We analysed unadjusted outcomes and also used linear regression to adjust for baseline values. The analysis was based on intention to treat.

Results:

We recruited 211 eligible patients (97% of target), of whom 107 were allocated to GES and 104 to SMC alone. At 12-weeks the GES group scored 4.1 (95% CI: 2.2 to 6.0) points lower on the CFQ and 6.3 (95% CI: 1.7 to 10.8) higher on the SF-36 compared to the SMC group (p < 0.001; p = 0.007) (adjusted model). Effect sizes were 0.5 and 0.2 respectively. Subgroup analysis of 141 participants meeting CDC criteria for CFS and 159 meeting Oxford criteria for CFS yielded equivalent results. Serious adverse events were recorded in 1 (1%) of the 107 GES group and 2 (2%) of the 104 SMC alone group.

Conclusion:

Guided exercise self-help is a moderately effective and safe intervention for symptomatic relief of fatigue. Its effectiveness in increasing physical functioning is also significant but smaller.
 
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Bob

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user9876

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I think we can expect a lot of bad publicity, wild claims from them as they release these papers. I suspect that the SMC will bring out the usual hate speech against patients with ME so that White and friends can avoid the difficult questions and gloss over the issues with PACE.

It will be interesting to see whether they have stuck to the protocol.
 

Denise

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Apologies if this has been already been noted.
It looks as though the paper will be discussed in Sweden on 17 June:


E. Chronic fatigue syndrome
Chairs: Bernd Löwe, Peter White


Authors


Title

ML Joustra, I Minovic, KAM Janssens, SJL Bakker, JGM Rosmalen

Vitamin and mineral status in chronic fatigue syndrome and fibromyalgia syndrome: a systematic review and meta-analysis

TE Williams, L Pangiotopoulou, T Chalder, M Sharpe, PD White

Is chronic fatigue syndrome heterogeneous? A review of the literature and new study of the lumping versus splitting debate for functional somatic syndromes

LV Clark, P McCrone, D Ridge, A Cheshire, M Vergara-Williamson, F Pesola, et al.

Graded Exercise Therapy guided Self-hElp Treatment (GETSET) for patients with chronic fatigue syndrome: a randomised controlled trial in secondary care

Anna Cheshire, D Ridge, L Clark, P White

Why patients with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis improve or deteriorate with graded exercise therapy

http://eapm2016.com/sessions/



There are several other sessions at this meeting that are of concern - among them....

E. Chronic fatigue syndrome: an update on mechanisms and implications for treatment
Chair: Simon Wessely


Authors


Title

Megan Roerink

Is postural orthostatic tachycardia a useful diagnostic marker in chronic fatigue syndrome patients?

S Fischer, J Strahler, C Markert, MB Kappert, U Nater

Psychoendocrine alterations in individuals with chronic fatigue syndrome

R Strawbridge, M-L Sartor, AH Young, AJ Cleare

Is chronic fatigue syndrome an inflammatory disorder?

S Kempke

Personality and chronic fatigue syndrome: a biopsychosocial perspective


C. Physical symptom disorders / MUS: a roadmap for future research into primary care interventions
Chairs: Chris Burton, Tim Olde Hartman


Authors


Title

M Rosendal

The classification of MUS from a primary care perspective

C Burton, S Chowdhury

Outcome measures for intervention trials in somatic symptom disorders

M Wortman, TC olde Hartman, P Lucassen, WJJ Assendelft

Lessons from a randomised pilot trial of a new intervention for MUS in primary care

A Aamland, A Fosse, E. Ree, E Abildsnes, K Malterud

General practitioners successful strategies in managing patients with medically unexplained symptoms (MUS). A focus-group study
 

Esther12

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I think we can expect a lot of bad publicity, wild claims from them as they release these papers. I suspect that the SMC will bring out the usual hate speech against patients with ME so that White and friends can avoid the difficult questions and gloss over the issues with PACE.

It will be interesting to see whether they have stuck to the protocol.
I wonder if anything will have changed post-Tuller. Will be interesting to see.
 

Bob

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Bob

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NOTE that Chalder fatigue is a post-hoc primary outcome...
Primary Outcome Measures

1. SF-36 physical function subscale (SF-36PF) measured 12 weeks from randomisation

Added 21/07/2015:
2. Chalder fatigue scale measured at 12 weeks and 1 year

Secondary Outcome Measures

Clinical global impression change (CGI) score measured 12 weeks from baseline
https://www.ukctg.nihr.ac.uk/trials/trial-details/trial-details?trialId=13898&query=%7B%22query%22%3A%22Graded%20Exercise%20Therapy%20guided%20SElf-help%20Treatment%20for%20CFS%2FME%22%2C%22facetDef%22%3A%7B%7D%2C%22rows%22%3A%2225%22%2C%22offset%22%3A50%2C%22openurl%22%3A%22yes%22%7D
 

Valentijn

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Full abstract is at http://www.sciencedirect.com.sci-hub.cc/science/article/pii/S0022399916302331

They used NICE criteria, but recruited from secondary care (their clinics presumably). They used the Chalder Fatigue Scale and SF36 physical function subscale. It only lasted 12 weeks, probably because PACE taught them that brainwashing doesn't hold up long-term :oops:

At 12-weeks the GES group scored 4.1 (95% CI: 2.2 to 6.0) points lower on the CFQ and 6.3 (95% CI: 1.7 to 10.8) higher on the SF-36 compared to the SMC group (p b 0.001; p = 0.007) (adjusted model).
These are tiny "improvements", especially for the SF-36. A 6.3 point improvement means that patients marked one question one step better than at baseline. They don't say if Chalder Fatigue scoring was bimodel, likert, or their preferred mishmash of both. They also only list "adjusted" scores, so unadjusted scores probably show no improvement.

Subgroup analysis of 141 participants meeting CDC criteria for CFS and 159 meeting Oxford criteria for CFS yielded equivalent results.
Of course they stay far away from anything where PEM is mandatory.

Serious adverse events were recorded in 1 (1%) of the 107 GES group and 2 (2%) of the 104 SMC alone group.
No indication of what qualifies as a serious adverse event. Probably death or being bedbound for 6+ months (during a 3 month trial) :rolleyes:
 
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user9876

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Trial Registry...

ISRCTN22975026
Graded Exercise Therapy guided SElf-help Treatment for CFS/ME
http://www.isrctn.com/ISRCTN22975026
Note that they have already changed the protocol:

Study hypothesis
On 21/07/2015 the target number of participants was changed from 178 to 218.

On 30/07/2015 the overall trial end date was changed from 31/03/2014 to 01/12/2015.
Primary Outcomes
Added 21/07/2015:
2. Chalder fatigue scale measured at 12 weeks and 1 year
So my guess is that they were not having success with the sf36 scale or thinking they wouldn't. I assume it is another open label trial.

The initial end of the trial was end March 2014 then on the 21 July 2015 they extend it to include more patients and extend the end date to 01/12/2015. But then the recruitment end date is now set at 1st Dec 2014 and no recordings of changes. So something odd is happening with end dates. My suspicion is that the change is wrongly recorded and that the original end date was the 31st March 2015 as this would be 3 months after the recruitment end date.

So the extended the end of trial. This could be because the added a new primary outcome of the CFQ at 12 weeks and 1 year which would fit with the timing changes,

It is not clear how/when they added additional patients to raise the number from 178 to 218 but I think they need to explain this and show the figures for the original 178 so that people can tell if they extended the numbers with the hope of getting better results. (I bet they won't do this).


The also added in an additional primary outcome. So it will be interesting to see if the sf36 results are poor. In the trial registration they don't say how they will judge success.

It is interesting how they extended the judgement time period and using an additional primary outcome after the original end of the trial.
 

user9876

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SF-36 physical function (the pre-specified primary outcome) had a small effect size (0.2), which is acknowledged in the abstract. So no surprise that they added the post-hoc Chalder fatigue primary outcome which had a moderate effect size (0.5).
Its interesting that this appears to have been allowed after the end of the open label trial. If an ethics committee has approved this we should be calling for their resignation.
 

Bob

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The initial end of the trial was end March 2014 then on the 21 July 2015 they extend it to include more patients and extend the end date to 01/12/2015.
It is not clear how/when they added additional patients to raise the number from 178 to 218 but I think they need to explain this and show the figures for the original 178 so that people can tell if they extended the numbers with the hope of getting better results. (I bet they won't do this).
So it will be interesting to see if the sf36 results are poor. In the trial registration they don't say how they will judge success.
We know from the abstract that the SF-36 physical function outcome is poor. I wonder if the outcome wasn't statistically significant with the lower number of patients which is why they decided to increase the numbers.

In the trial registration they don't say how they will judge success.
The trial registry says that a positive result will be statistical significance for physical function: "GETSET will be more effective at improving physical disability than usual specialist medical care alone as shown by a statistically significant difference between the two arms of the trial three months after randomisation."
 

user9876

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The trial registry says that a positive result will be statistical significance: "GETSET will be more effective at improving physical disability than usual specialist medical care alone as shown by a statistically significant difference between the two arms of the trial three months after randomisation."
That is an interesting one. If there is a statistical difference between the two arms but SMC were better then they could declare success! It is a very weak outcome. They also talk about recruitment outcomes there. The don't transfer that into the primary outcome piece but I guess that is about as weak as they could possibly make success of a trial.