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

TiredSam

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Is chronic fatigue syndrome heterogeneous? A review of the literature and new study of the lumping versus splitting debate for functional somatic syndromes
A review of the literature? Can't they just be honest and say "A review of our literature"? Or will they be including the IOM report and the latest biomedical findings?
 

Snowdrop

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That has to be the briefest abstract I've ever seen. It literally says nothing that isn't already in the title.
Since they're audience is true believers I'm sure details just clutter up the important point--keep shoving this crap down the throats of those confused ME'ers
 

SilverbladeTE

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White, Wessely, Sharp and co set out to help ME victims with exercise....


but at the end ONE, yes ONE hero emerges! that is a triumph of modern medicine and proves the regime works!
the other 99% who don't are merely a statistical anomaly!


 

Dolphin

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Here it is:


20

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

L.V. Clarka, P. McCroneb, D. Ridgec, A. Cheshirec, M. Vergara-Williamsond, F. Pesolaa, P.D. Whitea

aBarts and the London School of Medicine and Dentistry, Queen Mary University, UK

bHealth Services and Population Research, Kings College London, UK

cFaculty of Science and Technology, University of Westminster, UK

dKent & Medway NHS and Social Care Partnership Trust, UK

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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Simon

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At 12-weeks the GES group scored:
  • 4.1 (95% CI: 2.2 to 6.0) points lower on the CFQ [fatigue. effect size 0.5], and
  • 6.3 (95% CI: 1.7 to 10.8) higher on the SF-36 [physical function, effect size 0.2]
compared to the SMC group (p < 0.001; p = 0.007) (adjusted model).
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.
So that's a moderate effect size on a self-report scale for fatigue at 12 weeks, in an unblinded trial, which is hardly impressive, particularly as it was uncontrolled (reference group had no equivalent treatment: it was SMC + nothing versus SMC + GET).

Does that prove much, especially without longer-term follow-up? Shouldn't this significant limitation be discussed in the abstract?

The effect size of GETSET on SF36 physical function, 0.2, is trivial.
 
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Sean

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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
So, not only the usual lack of support from objective outcome measures, they have learned from PACE & FINE not to even use them any more.

Yep, no surprises there.
 

A.B.

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Comet

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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).
We're not even worth the cost of visits to Physical Therapy or the hospital for GET now.
 

Comet

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https://www.ukctg.nihr.ac.uk/trials/trial-details/trial-details?trialId=27181&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
Intervention


A copy of the GETSET booklet, one 30 minute consultation face-to-face, by Skype or telephone, and 3 further Skype of telephone contacts. Intervention over 9 weeks.
I didn't realize... you get a booklet!
 

wdb

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Edzard Ernst wrote a good piece on A vs A+B trials

No negatives please, we are alternative!
Since several years, researchers in this field have adopted a study-design which is virtually sure to generate nothing but positive results. It is being employed widely by enthusiasts of placebo-therapies, and it is easy to understand why: it allows them to conduct seemingly rigorous trials which can impress decision-makers and invariably suggests even the most useless treatment to work wonders.
 
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if I read this right - there was one 30 min chat, the 3 x30 min skype calls as a treatment for ME/CFS? 120 minutes total

This study, and others, do not account for 'therapy effect' and 'placebo' which may account for the tiny changes in SF-36 and fatigue scores - but these authors continually using subjective scales and avoiding more objective measures is very telling. My analysis from reading the literature is that psychotherapy, even by skype, may make you feel slightly better in yourself, but may have no impact on your physical function. I cant think of other areas of science whereby the scientists invoved ignore methods that might show objective findings in favour of methods that show very subjective findings. - funders must look to other scientists to look at this area and apply alternative methodological approaches with fresh eyes.

+ while here I should say hello to Prof White and his team as I understand they are avid followers of this patient forum *eg quoting from forum quotes in the FOI tribunal case