charles shepherd
Senior Member
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The MEA has decided to produce a detailed critique of the GETSET trial - for reasons set out below
It can be read in full here:
http://www.meassociation.org.uk/201...antly-improve-physical-function-28-june-2017/
Dr Charles Shepherd
Hon Medical Adviser, MEA
ME Association Review: GETSET fails to demonstrate GET can significantly improve physical function | 28 June 2017
Guided graded exercise self-help plus specialist medical care versus specialist medical care alone for chronic fatigue syndrome (GETSET): a pragmatic randomised controlled trial
In view of the fact that the results from this clinical trial are going to form part of the research evidence that NICE will be examining over the coming weeks in relation to making a decision as to whether the 2007 NICE guideline on ME/CFS needs to be revised, MEA trustees decided that the MEA should make a very careful and thorough response to the paper in The Lancet.
This is set out below and is also available for DOWNLOAD.
For the benefit of anyone who just requires a summary of the key points and concerns we are making, our main criticisms of the GETSET trial are:
1. GES had little or no effect on physical function and did not result in participants claiming that GES had any significant overall effect on their ME/CFS
2. The study design – i.e. addition of a new primary outcome measure – was altered after the trial had started
3. Patients were recruited using the very broad NICE diagnostic criteria for ME/CFS – which meant a significant proportion did not meet Fukada and are unlikely to have met the Canadian diagnostic criteria for ME/CFS
4. The trial recruited an unrepresentative number of people who were likely to have been in the mild category of illness severity, could exercise, and were enthusiastic about taking part. This is not representative of the overall ME/CFS population
5. The trial relied on self-reported and subjective outcome measures rather than employing any form of objective outcome measure (e.g. use of an actometer) for measuring changes in physical activity levels
6. Examining and reporting on the results after only 12 weeks of treatment is far too short to draw any meaningful conclusions about the efficacy and safety of GES
7. The study was not blinded – for obvious reasons. However, we believe that this sort of approach to activity management, where there has to be considerable individual variation in approach, is not really suitable for assessment in randomised controlled trials that rely on subjective outcome measures
Dr Charles Shepherd
Hon Medical Adviser, ME Association
It can be read in full here:
http://www.meassociation.org.uk/201...antly-improve-physical-function-28-june-2017/
Dr Charles Shepherd
Hon Medical Adviser, MEA
ME Association Review: GETSET fails to demonstrate GET can significantly improve physical function | 28 June 2017
Guided graded exercise self-help plus specialist medical care versus specialist medical care alone for chronic fatigue syndrome (GETSET): a pragmatic randomised controlled trial
In view of the fact that the results from this clinical trial are going to form part of the research evidence that NICE will be examining over the coming weeks in relation to making a decision as to whether the 2007 NICE guideline on ME/CFS needs to be revised, MEA trustees decided that the MEA should make a very careful and thorough response to the paper in The Lancet.
This is set out below and is also available for DOWNLOAD.
For the benefit of anyone who just requires a summary of the key points and concerns we are making, our main criticisms of the GETSET trial are:
1. GES had little or no effect on physical function and did not result in participants claiming that GES had any significant overall effect on their ME/CFS
2. The study design – i.e. addition of a new primary outcome measure – was altered after the trial had started
3. Patients were recruited using the very broad NICE diagnostic criteria for ME/CFS – which meant a significant proportion did not meet Fukada and are unlikely to have met the Canadian diagnostic criteria for ME/CFS
4. The trial recruited an unrepresentative number of people who were likely to have been in the mild category of illness severity, could exercise, and were enthusiastic about taking part. This is not representative of the overall ME/CFS population
5. The trial relied on self-reported and subjective outcome measures rather than employing any form of objective outcome measure (e.g. use of an actometer) for measuring changes in physical activity levels
6. Examining and reporting on the results after only 12 weeks of treatment is far too short to draw any meaningful conclusions about the efficacy and safety of GES
7. The study was not blinded – for obvious reasons. However, we believe that this sort of approach to activity management, where there has to be considerable individual variation in approach, is not really suitable for assessment in randomised controlled trials that rely on subjective outcome measures
Dr Charles Shepherd
Hon Medical Adviser, ME Association