By David Tuller, DrPH
On February 4th, the Norwegian Directorate of Health published a draft of a “national professional guideline” for diagnosis, management and treatment of “long-term fatigue—including ME/CFS.” A consultation period for the draft lasts for three months. All comments must be received by May 4th.
The draft is intended to replace a 2015 document called “National Guide for Patients with CFS/ME: Assessment, Diagnostics, Treatment, Rehabilitation, Nursing and Care.” An advisory group of 21 stakeholders with diverse views and backgrounds provided input to the Health Directorate. Trude Shei, assistant secretary general of Norway’s ME Association, served on the working group as a “user representative.”
According to the draft, the new guideline is designed so that:
*”Patients with long-term fatigue, including ME/CFS, receive evidence-based, individually tailored health care that contributes to increased quality of life, coping and recovery.”
*”Healthcare professionals experience having clear advice for carrying out assessment, treatment and follow-up and that meetings between patients and healthcare professionals are characterised by trust and security.”
Norway, along with the other Scandinavian countries, has long been a stronghold of the so-called biopsychosocial (BPS) approach to ME/CFS and other symptom-defined conditions. A self-important group that refers to itself as the Oslo Fatigue Consortium has whined about the 2021 guideline from the U.K.’s National institute for Health and Care Excellence, which rescinded its previous recommendations for cognitive behavior therapy and graded exercise therapy. The Lightning Process, a mind-body program founded by British faith healer and osteopath Phil Parker, is taken seriously by medical officials.
Given that general orientation, it isn’t a surprise that the draft guideline falls short. It is pretty muddled—just like you’d expect from a document that smushes together long-term fatigue and ME/CFS. The decision to combine them serves to blur the important distinctions between a symptom, fatigue, that is one of the most common medical complaints and the specific clinical entity, or cluster of entities, currently being called ME/CFS.
Four committee members, representing the interests of the BPS ideological brigades, dissented from the draft. They argued that its recommendations went too far in cautioning about activity and would enable people in their sickness rather than helping them get well.
Trude Shei has also sent the Health Directorate a letter formally dissenting from the draft, although for much different reasons. Via e-mail, I asked Shei about the draft and the guideline development process. Below is an edited version of her responses. (This exchange occurred before her formal dissented; the answers generally parallel the arguments outlined in the letter she sent to the Health Directorate.)
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Interview with Trude Shei
What was the involvement of the ME Association?
We had one representative in the working group advising Hdir on the guidelines. The working group had representatives from the four administrative health regions in Norway, patient representatives, and representatives from different health professions, like family doctors (GPs), physiotherapists and ergotherapists, as well as from the welfare authorities.
The working group was not supposed to reach any conclusions—just to discuss various questions asked by Hdir, and give voice to different views. The discussions in the group were well-mannered and focused on what we all could agree on, and we never really got into the hard questions. My impression when we started was that the NICE review of the science would be one of the pillars of the work, but in the draft NICE is only mentioned with regards to the lack of evidence for pharmacological treatment. That is a huge disappointment.
We have also commented extensively on three earlier drafts. In January, I submitted 29 pages of comments on a previous 45-page draft, and I did not know until the new draft was published what would actually be in it.
The people who have “dissented” did so before the current draft was published, and must have done so based on the penultimate draft.
What is the impact of combining chronic fatigue and ME/CFS in one set of guidelines?
We know that both late diagnosis and under diagnosis of ME/CFS, as well as no diagnosis at all, are problems in Norway. By combining the guidelines, and giving the same advice for everyone, Hdir says that they are trying to circumvent this problem. Whether PEM is present or not becomes more important than the diagnosis. (What is in a name…) (There is just the problem that what “taking PEM into account/considering PEM” is not operationalised).
While this is a way of circumventing a real problem, it also seems to be admitting defeat when it comes to creating awareness of and building knowledge/competence on ME/CFS as a recognized disease in which fatigue is only one of many symptoms. It muddies the waters. In the long run, I believe conflating general fatigue and ME/CFS will cause more problems for ME patients than it solves.
Of course, Long Covid is part of the challenge here – the guidelines are supposed to cover them as well, and we then run into the problem of whether Long Covid with PEM is the same as ME/CFS or not. Why not make a guideline for post-infectious syndromes?
What are the positives of the guidelines? Negatives?
Positives(ish):
First, The guidelines are clear about the GP’s duty to evaluate patients and be proactive in the process. They clearly communicate that ME/CFS should be considered at six months’ duration and involves a 50% loss of function.
Second, the guidelines are clear that all treatment should be individualised and based on a thorough evaluation of the patient’s functional capacity, including PEM, and their situation in life. The evaluation, and any treatment, must take PEM and the consequences of PEM into account.
But – what this means is unclear. Unlike NICE, the guideline does not tell you how to screen for PEM or explain how to take PEM into account. It does not explain the consequences of PEM and does not offer advice on pacing if it is present.
Third, there is no recommendation of CBT or GET for patients with PEM.
But – the wording is so muddled that this is not immediately apparent.
Negatives, in no particular order:
- We lose sight of ME/CFS as a separate disease
- Overall, the guideline is confusing.
- Getting an ME/CFS diagnosis has no implications for further treatment.
- Doctors do not have to make a diagnosis, even if symptoms are present.
- Other symptoms of ME/CFS are not addressed, like POTS.
- The very real danger of deterioration as a result of too much activity/exercise/repeated PEM is not communicated in a meaningful way. Compare that to the section of medication, where side effects are clearly communicated! Patient participation and informed consent in treatment is an important thing in Norway, but how can a patient give informed consent to treatment if the risks are not communicated?
- There is no mention of the fact that ME/CFS can be life-long, and that patients will need ongoing care.
- There is no mention that many experience a fluctuating course of illness, and that care may have to be adjusted over time. The guideline suggests functional capacity evaluation as a one-time thing – but patients will have varying degrees of severity over time, and will need varying levels of help.
- The guidelines give an unrealistically positive impression of likely prognosis and of the possibility that a case of ME/CFS will be of short duration. This bias could create problems for patients. If schools, welfare officials and health care personnel expect improvement as the standard course, they may end up blaming the patients themselves for their illness. This issue arises currently when child protection services get involved because children with ME/CFS do not improve as expected.
- The severity of ME/CFS is inadequately addressed. There is chapter about “care in the home” but the perspective of severe ME/CFS is absent in the other parts of the guideline.
- The guidelines are supposed to be based on both research, patient experience and clinical experience. Consensus documents on treatment, like Euromene and ICC, or clinical experience from Bateman Horne, are, however, not taken into account. Hdir claims doing so would “undermine” the work in the working group, and that they are only looking at Norwegian experience (???? Based on the two GPs who were there, who had seen a very limited number of patients???) When it comes to patient experience, they do not cite any of our survey reports, and they compare a few anecdotes from Recovery Norway with reports large, structured surveys. This gives equal weight to a large body of well-documented experiences, and a few anecdotes.
- The guideline is wordy but vague and unclear. This leaves it open to interpretation, and my fear is that if it stands, everyone can find something in there to support their own point of view.
What comes next?
There is an open comment period until May 4th, during which anyone can submit their views about the draft.
The Norwegian ME Association will use a survey to ask our members about their opinions. We have a group who will look at the survey data, and then write a comment. Part of the process will be to decide if we can support any part of the guidelines, or if we need to put our foot down and say that there are parts we absolutely cannot accept.
The approach to PEM will probably be central to this.
- We need a good description of PEM, and how to screen for it.
- We need clear advice on how to manage PEM – namely avoid it as much as possible through pacing and staying within the “energy envelope” is a dealbreaker.
- We need a warning about the danger of relapse if PEM is not managed properly.
- We need an affirmative statement that CBT/GET is not recommended for patients with PEM—not just the lack of such a recommendation
We also need a greater focus on the fact that, according to survey data, 60% of patients are mostly housebound, 15% bedbound. Only 25% have “mild ME” per the ICC criteria—but the guidelines seem developed mostly for the mild patients.