Australia: RACGP: GET for CFS

[Sly Saint]

Very PACE trial based information.

eg"
Adverse effects
Surveys by patient groups of their members have suggested that GET may be harmful to some people with CFS. However, this finding is believed to be due to inappropriately planned or progressed exercise programs, possibly undertaken independently or under supervision from a person without appropriate experience.

Availability
GET should be supervised by a physiotherapist or exercise therapist, preferably with specific experience and training in applying GET to patients with CFS.

The PACE trial has produced a comprehensive GET therapist manual (and a manual for patients), which can be downloaded free of charge by going to PACE trial website and selecting the relevant manuals from the trial information section."

https://www.racgp.org.au/clinical-r...ded-exercise-therapy-chronic-fatigue-syndrome

(The RACGP is cited on the Wikipedia page for GET "Some prominent health organisations support the usefulness of GET for chronic fatigue syndrome, the Royal Australian College of General Practitioners[2]).")

 

[CRG]

This a section is from an online handbook: https://www.racgp.org.au/clinical-resources/clinical-guidelines/handi

"The Handbook of Non-Drug interventions (HANDI) is making effective non-drug treatments more visible and easier to use.

HANDI aims to make ‘prescribing’ a non-drug therapy almost as easy as writing a prescription.

The topics in HANDI have been developed by the HANDI Project team and is supported by appropriate evidence."

On the left hand column is a link to a Provide Feedback page: https://www.racgp.org.au/clinical-resources/clinical-guidelines/handi/provide-feedback

Might it be worth compiling an S4ME response ?

 

[dave30th]

This is a current publication??

 

[Barry]

Very PACE trial based information.

eg"
Adverse effects
Surveys by patient groups of their members have suggested that GET may be harmful to some people with CFS. However, this finding is believed to be due to inappropriately planned or progressed exercise programs, possibly undertaken independently or under supervision from a person without appropriate experience.

[my bold/underline]

Not very sound evidence then for ignoring reporting of harms

 

[Snow Leopard]

This is a current publication??

It says First published: March 2015.

 

[dave30th]

It says First published: March 2015.

thanks. yeah, I see that. that explains why it was written this way. it's weird that it's still up, as if time has stood still for six years.

 

[Art Vandelay]

thanks. yeah, I see that. that explains why it was written this way. it's weird that it's still up, as if time has stood still for six years.

The RACGP is still very much in the dark ages when it comes to ME/CFS (much like most Australian medical professionals).

As an example, there's this advice from the RACGP on CBT for ME/CFS which falsely claims that CBT for other serious illnesses like MS and RA is equivalent to the CBT offered for ME/CFS.

Moreover, the RACP's ME/CFS guidelines are from 2002. They won't withdraw them even though the NHMRC has said that they are clearly out of date.

 

[Andy]

Trial By Error: Awaiting Response on Chalder Paper; Australian GPs Still Promoting GET and Citing PACE

"The website of the Royal Australian College of General Practitioners (RACGP) hosts a section called “Graded exercise therapy: chronic fatigue syndrome.” The section indicates that it was posted in March, 2015, with no sign that it has been since reviewed or updated. Not surprisingly, the text reads as if PACE hadn’t been publicly and widely discredited; in fact, PACE is a key reference. And the section highlights the 1994 Fukuda case definition, which does not require post-exertional malaise as a symptom.

The section is part of RACGP’s Handbook of Non-Drug Interventions, or HANDI. The chair of the HANDI project is Paul Glasziou, a professor of evidence-based medicine at Australia’s Bond University. Previously, he served as director of the Centre for Evidence-Based Medicine at Oxford University. According to his HANDI bio, “his key interests include identifying and removing the barriers to using high quality research in everyday clinical practice.”"

https://www.virology.ws/2022/01/04/...lian-gps-still-promoting-get-and-citing-pace/

I have also posted this on the thread for the other article mentioned here, Chronic Fatigue Syndrome and Occupational Status: A Retrospective Longitudinal Study, 2021, Chalder et al

 

[Hutan]

Thanks to @Three Chord Monty for noting that the RACGP guidance on ME/CFS has been updated:

First published: March 2015
Updated: April 2024
Incremental physical activity for chronic fatigue syndrome (CFS) /myalgic encephalomyelitis (ME)

I've copied the guidance here in full, so we can track any future changes better.

Intervention
Incremental physical activity for CFS/ME includes the establishment of a patient-specific baseline of achievable and sustainable exercise or physical activity, followed by slow increments in the duration of physical activity.

Incremental physical activity aims to gradually increase the patient’s ability to undertake physical activity and reduce their feeling of fatigue. How it works is not understood but it may prevent/ reverse the secondary physical deconditioning and exercise intolerance related to prolonged (relative) inactivity.

There are different models for implementation that show likely benefit. A shared element in randomised clinical trials (RCTs) showing benefit is that the activity or exercise is slowly increased over time. Incremental physical activity differs from adaptive pacing therapy (APT) by encouraging the participant to extend their physical activity beyond their baseline in a programmed stepwise progression rather than staying well within (~70%) of their perceived energy expenditure envelope.

Indication
Incremental physical activity has also been shown to improve muscle strength, cardiovascular endurance and symptoms in a wide variety of conditions that have chronic fatigue as a symptom, such as heart disease, cancer, chronic obstructive pulmonary disease and post-viral fatigue.

*Note: There have been many definitions (and multiple names) for the condition, given that diagnosis is essentially based on symptoms and the exclusion of other illnesses, with no current internationally agreed definition. Most of the clinical trials used an older, more inclusive definition. More recent narrower definitions will exclude many patients with a chronic fatigue problem. Hence incremental physical activity is likely to be helpful for the broader group but applicability is less clear for the more recent narrowly defined groups. The US Centers for Disease Control and Prevention website outlines the history of case definitions and criteria.

Precautions/Adverse effects
Unaccustomed activity can produce or exacerbate many CFS/ME symptoms. A mild and transient increase in symptoms is explained as a normal response to an increase in physical activity; however, a more severe or sustained exacerbation suggests the activity was excessive. Patients may feel shamed or blamed if it is implied they are too fearful of activity or too fearful of exacerbating their symptoms of post-exertional malaise (PEM). Onset of PEM may be delayed for up to 3 days after exercise.

Surveys by patient groups of their members have suggested that incremental physical activity may be harmful to some people with CFS/ME and advocate against such programs. This is a valid concern, but may be due to inappropriately planned or progressed exercise programs, possibly undertaken independently or under supervision from a person without appropriate experience, or subgroups within the spectrum of CFS/ME who are more vulnerable to more severe PEM. Implementation needs to be very sensitive to these concerns and be aware that many patients and carers will be very aware of the strong advocacy specifically against such programs. Trust and acknowledgement of these concerns, with appropriate caution is likely to be crucial.

Availability
Incremental physical activity should be supervised by a physiotherapist or accredited exercise physiologist, preferably with specific experience and training in working with people with CFS/ME. Costs vary significantly depending on the type of exercise. In some cases, health insurance may cover some costs.

The PACE trial has produced a comprehensive graded exercise therapy (GET) therapist manual (and a manual for patients), which can be downloaded free of charge by going to the PACE trial website and selecting the relevant manuals from the trial information section.

Description
Graded exercise therapy (GET) is a program of incremental physical activity used in the largest of the seven RCTs to date. It is delivered in three phases over several sessions (e.g., 15 sessions in the PACE trial – see Table 1).

After assessment of the patient’s current physical capacity, and mutual negotiation of meaningful and functional physical goals, a baseline of physical activity is agreed upon and commenced, at a manageable low level of intensity.

Any activity that can be incrementally increased in terms of duration, intensity, frequency is appropriate, including walking, swimming, and the use of exercise machines. These activities can be alternated, noting that a change in activity may require adjustment to the duration, intensity, frequency of the activity.

Physical activity can be increased by:

• Increments of duration: duration of physical activity is increased slowly (10–20%), once every 1–2 weeks provided any PEM has been only mild and transient (see Precautions). (note other RCTs showing benefit from exercise used much smaller/slower increments)
  
  
• Increasing intensity: intensity is increased by encouraging the patient to do an activity faster e.g., speed up the pace of their walk or swim.
  

However, increase in intensity is done with care and is likely to be done in stages. It can be useful to build up the intensity by adding in shorter bursts of higher intensity activity to the program; for example, starting with 1 minute of fast walking interspersed with 2 minutes of normal pace.

If increased symptoms occur after an increment, the patient is encouraged to stick at the current level until symptoms reduce, and then increase afterwards. However, activity is mutually reviewed on a regular basis, and plans may be adjusted depending on the patient’s general health and symptoms.

Tips and challenges
Although GET has been extensively tested in clinical trials, it remains controversial within some support groups.

The PACE trial highlighted a number of clinically important considerations, including:

• Individualising treatments and a flexible physical activity prescription
• Encouraging variety and maintaining physical activity levels
• Encouraging physical activity and strategies for planning physical activity
• The importance of not exceeding the planned level of physical activity
• The importance of relying on HR, rather than a sense of effort
• The importance of achieving a healthy balance of physical activity.

Compliance
Most trials have found few dropped out of GET, and no more than other treatments. Increased long-term rest is not recommended and can lead to further deconditioning. Exercise and physical activity considered a safe intervention with numerous health benefits, including physical and mental health. However, participating in an uncontrolled manner can increase symptoms temporarily.

Rate of Progression
It may be tempting for the patient and therapist to increase the rate of physical activity progression after initial success as one might in other exercise interventions. However, this may be the trigger for the poor outcomes widely reported among the CFS/ME community.

Communication
CFS/ME patients often have a history of feeling poorly heard, feeling blamed for their symptoms as being primarily mental health or activity avoidance, or unsuccessful trials of other interventions. A trusting collaborative approach is likely to be crucial.

Mental Health Disorders
More than two-thirds of patients with CFS/ME in the trials meet diagnostic criteria for mental health disorders such as anxiety disorders, dysthymia, or depression. Whether this is due to the CFS/ME or not, it should be treated so that the patient can better manage their CFS/ME. Many therapies have been tried in CFS/ME but only CBT and incremental exercise therapy appear to produce meaningful benefit. However, neither of these treatments are “curative”, but can help patients improve their function and quality of life.

Grading
Moderate. (We are moderately confident in this research evidence. Future research is likely to refine/ change the recommendation. This has been downgraded from ‘Strong’ due to concerns about definition/ inclusion criteria and implementation concerns/ experience)

Consumer resources
For patient information about the PACE trial Graded Exercise Therapy, go to PACE trial website, select trial information and then click on 6. GET participant manual.

References

1. White PD, Goldsmith KA, Johnson AL, et al.; PACE trial management group. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet 2011;377:823–36.
2. Larun L, Brurberg K, Odgaard-Jensen J, et al. Exercise therapy for chronic fatigue syndrome. Cochrane Database of Systematic Reviews 2019 Oct 2;10(10):CD003200. doi: 10.1002/14651858.CD003200.pub8. PMID: 31577366. Note: Cochrane is currently updating this review with a new author team.
3. Fawzy NA, Abou Shaar B, Taha RM, et al. A systematic review of trials currently investigating therapeutic modalities for post-acute COVID-19 syndrome and registered on WHO International Clinical Trials Platform. Clin Microbiol Infect. 2023 May;29(5):570-577.
4. Note: The advent of long covid has triggered considerable new research with over 388 registered trials including rehabilitation in 169 of those – and is likely to provide additional evidence in the near future.

 

[Hutan]

I note that the capacity of people with ME/CFS to make decisions about their health and accurately report their symptoms is undermined by suggesting they have a high rate of mental health disorders and often have a history of feeling poorly heard and being upset about being blamed for their symptoms.

Also, one of the three references is Larun et al 2019 - the Cochrane review.

 

[Hutan]

Consumer resources
For patient information about the PACE trial Graded Exercise Therapy, go to PACE trial website, select trial information and then click on 6. GET participant manual.

Some days this all feels like a very long nightmare.

 

[Hutan]

Paul Glasziou seems to be responsible for this

The section is part of RACGP’s Handbook of Non-Drug Interventions, or HANDI. The chair of the HANDI project is Paul Glasziou, a professor of evidence-based medicine at Australia’s Bond University. Previously, he served as director of the Centre for Evidence-Based Medicine at Oxford University. According to his HANDI bio, “his key interests include identifying and removing the barriers to using high quality research in everyday clinical practice.”"

Will someone please save us from Professors of Evidence-Based Medicine?
https://www.cochrane.org/news/recommended-dose-episode-5-paul-glasziou

Episode 5: Professor Paul Glasziou
Professor of Evidence-Based Medicine, Bond University, Robina, Queensland, Australia;
and part-time General Practitioner
Paul Glasziou (aka The Surfing Professor) joins Ray this week to share insights from his stellar career as both a family doctor in Brisbane and a global evidence guru at Oxford and Bond Universities. He explores big picture health issues like overdiagnosis, overtreatment and the implications of genomic testing, alongside important questions for our everyday health - like how you can find and use evidence and put it to good use when visiting or choosing your own doctor or specialist.

Paul Glasziou's link with Hilda Bastian - manager of Cochrane's 'coming one day' new Exercise therapy for CFS review. I know, the fact that she was a student of his is old news, and we gave her the benefit of the doubt, thinking that she could be independent of both him and Cochrane. But, the years tick by....

Seventy-Five Trials and Eleven Systematic Reviews a Day: How Will We Ever Keep Up?

• Hilda Bastian ,
• Paul Glasziou,
• Iain Chalmers

 

[bobbler]

Some days this all feels like a very long nightmare.

Also, one of the three references is Larun et al 2019 - the Cochrane review.

Is there an Australian patient association who signed the petition who could organise allies there to send this as evidence of it not being withdrawn causing active harm?

As a complaint to the Charity Commission, if that is the basis on which they act.


It feels clear they are leaving it there (when it shouldn't have even been there in the first place) as long as possible in order for this sort of option to be taken by those who want to sell propaganda or old harmful treatments to maintain their status quo and 'fish for' dodge evidence to make it seem their argument has current basis.

The section is part of RACGP’s Handbook of Non-Drug Interventions, or HANDI. The chair of the HANDI project is Paul Glasziou, a professor of evidence-based medicine at Australia’s Bond University. Previously, he served as director of the Centre for Evidence-Based Medicine at Oxford University.

The same Paul Glaszou who is part of this page: Chapter 15: Interpreting results and drawing conclusions | Cochrane Training

 

[Simone]

Australia: RACGP: GET for CFS
RACGP claim to have updated their guidance on GET for CFS, but it looks to be still completely mired in the dark ages.

Worse than stuck in the dark ages. It’s sneakily trying to entrench the dark ages.

There are so many bad bits here (like they just rename GET as “incremental physical activity, and they still cite the PACE trial manual as a guide for how to implement GET), but the bit that really got under my skin, was the framing of advocacy.

This is in the Adverse effects/precautions section:

Surveys by patient groups of their members have suggested that incremental physical activity may be harmful to some people with CFS/ME and advocate against such programs. This is a valid concern, but may be due to inappropriately planned or progressed exercise programs, possibly undertaken independently or under supervision from a person without appropriate experience, or subgroups within the spectrum of CFS/ME who are more vulnerable to more severe PEM.

Implementation needs to be very sensitive to these concerns and be aware that many patients and carers will be very aware of the strong advocacy specifically against such programs. Trust and acknowledgement of these concerns, with appropriate caution is likely to be crucial.

So the caution is: Beware advocacy!

 

[Sean]

If anybody has wondered over the years why I am not active on the Australian scene, this is exactly why.

We do have some good researchers trying their hardest to scrape up research funds for actually useful work, and occasionally succeeding.

But at the clinical level the profession here are deep in the psychosomatic fantasy, and always have been.

 

[Sean]

Citing PACE in support of GET says everything you need to know about how shitty the situation is here with the medical establishment.

The hijacking and perversion of all attempts to stop the harm and reform the shit show, and blaming the victims for the establishment's failures, continues on without relief.

 

[Sean]

Consumer resources
For patient information about the PACE trial Graded Exercise Therapy, go to PACE trial website, select trial information and then click on 6. GET participant manual.

Citing that as the only reference for consumer resources / patient information is so dishonest and low.

Not citing NICE is pretty revealing and condemning.

Worth noting that, as I understand it, the Australian government health department has said they are being guided by the NICE 2021 guidelines. So there might be a split there worth looking at.

 

[tornandfrayed]

Very PACE trial based information.

eg"
Adverse effects
Surveys by patient groups of their members have suggested that GET may be harmful to some people with CFS. However, this finding is believed to be due to inappropriately planned or progressed exercise programs, possibly undertaken independently or under supervision from a person without appropriate experience.

Availability
GET should be supervised by a physiotherapist or exercise therapist, preferably with specific experience and training in applying GET to patients with CFS.

The PACE trial has produced a comprehensive GET therapist manual (and a manual for patients), which can be downloaded free of charge by going to PACE trial website and selecting the relevant manuals from the trial information section."

https://www.racgp.org.au/clinical-r...ded-exercise-therapy-chronic-fatigue-syndrome

(The RACGP is cited on the Wikipedia page for GET "Some prominent health organisations support the usefulness of GET for chronic fatigue syndrome, the Royal Australian College of General Practitioners[2]).")

"However, this finding is believed to be due to inappropriately planned or progressed exercise programs, possibly undertaken independently or under supervision from a person without appropriate experience."

This commonly repeated assertion makes no sense. Patients only seem to be subjected to GET by official clinics, not maverick therapists. Many of us have harmed ourselves by attempting to push through, as we had no support or information, but that's not GET. Those making this assertion of poor practice were those running or working in the clinics, or close associates, so essentially criticising themselves.

 

[Trish]

"However, this finding is believed to be due to inappropriately planned or progressed exercise programs, possibly undertaken independently or under supervision from a person without appropriate experience."

They are repeating what is said in the PACE trial documents and in the Cochrane review. It is factually incorrect. Surveys specifically about GET led by specialist therapists using the PACE model show very high rates of both physical and mental harm from GET.

Maybe someone should send them our latest letter to Cochrane spelling out all the evidence about harms.

 

[Maat]

Apart from the obvious ethical problem of providing an entire service based on a single Trial which has been internationally debunked (the fact that it has still not be retracted is in itself a cause of iatrogenic harm as evidenced in this thread, ongoing), why are they unable to rely on their own systems evidence?

Are they recording clinical incidents of harm following therapy on Datix? Clinical incident management – Purpose and principles (health.wa.gov.au)

"A clinical incident is an event or circumstance resulting from health care provision (or lack thereof) which could have or did lead to unintended or unnecessary physical or psychological harm to a patient.

The purpose of clinical incident management is to ensure implementation of consistent and accountable processes and systems for the management of clinical incidents with the goal to prevent harm to patients and improve patient safety."

I've been looking into this system recently because I wondered if, during the NICE review process, to counter patient safety surveys showing harms (which they claim NICE placed over reliance on) whether or not the Royal Collages produced a systems report from Datix to show lack of harm, which the NHS use and has done since, I think, 1986. UK based company.


4 June 2020 - An example of it's use: Lessons learned: using adverse incident reports to investigate the characteristics and causes of prescribing errors (bmj.com)


"This study has a number of limitations. First, it includes only one NHS board. Thus, findings are not necessarily generalisable. However, the methodology is transferable, given the ubiquity of incident reporting systems. Second, analysis of the presence and contribution of error producing factors depended on both the level of detail in the reporter’s description of the incident (which varied), and subjective evaluation by the researcher, risking interpersonal variation and bias. Third, evidence suggests that incident-reporting systems significantly under-report the frequency of prescribing errors.7 Furthermore, bias may exist in the type and severity of patient safety incidents reported. Thus, the analysed incidents are unlikely to represent the rates or characteristics of all prescribing errors locally."


But NHSE (or any government) using Datix or similar incident reporting systems, must be capable of requesting this information be produced locally and then produce a country wide report on ME/CFS - both on therapy and hospitalizations.


If any healthcare authority is unable to do this, then that is not only evidence of systemic non-reporting of harm, but may also be clear evidence that the NHS treats this illness as a psychogenic one and that any harm is self inflicted by non adherence to therapy management/rehabilitation techniques.


Examples in the UK


Customising RLDatix creates greater efficiencies for University Hospitals Bristol. | RLDatix


incident-reporting.pdf (rcpsych.ac.uk)


RLDatix & West London NHS Trust


10866.pdf (shropscommunityhealth.nhs.uk)

What happens when I submit a Datix? (scot.nhs.uk)


Severity Mapping and Examples (england.nhs.uk)