Defining the prevalence and symptom burden of those with self-reported severe CFS/ME: a ... community pilot study... (2017) Strassheim et al

John Mac

John Mac

Senior Member (Voting Rights)
Objectives To define the prevalence of severe chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) and its clinical characteristics in a geographically defined area of Northern England. To understand the feasibility of a community-based research study in the severely affected CFS/ME group.

Design A two-phase clinical cohort study to pilot a series of investigations in participants own homes.

Setting Participants were community living from the area defined by the Northern clinical network of the UK.

Participants Adults with either a medical or a self-reported diagnosis of CFS/ME. Phase 1 involved the creation of a database. Phase 2: five participants were selected from database, dependent on their proximity to Newcastle.

Interventions The De Paul fatigue questionnaire itemised symptoms of CFS/ME, the Barthel Functional Outcome Measure and demographic questions were collected via postal return. For phase 2, five participants were subsequently invited to participate in the pilot study.

Results 483 questionnaire packs were requested, 63 were returned in various stages of completion. 56 De Paul fatigue questionnaires were returned: all but 12 met one of the CFS/ME criteria, but 12 or 22% of individuals did not fulfil the Fukuda nor the Clinical Canadian Criteria CFS/ME diagnostic criteria but 6 of them indicated that their fatigue was related to other causes and they barely had any symptoms. The five pilot participants completed 60% of the planned visits.

Conclusions Severely affected CFS/ME individuals are keen to participate in research, however, their symptom burden is great and quality of life is poor. These factors must be considered when planning research and methods of engaging with such a cohort
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https://bmjopen.bmj.com/content/8/9/e020775
 
Were these home visits ?
If you can' t get out of your bed/ house then I' m assuming that they were.

If otherwise, it seems simply set up to fail.

Or was proving how difficult things are basically the point?

Edit - added last sentence
 
Amw66 said:
Were these home visits ?
If you can' t get out of your bed/ house then I' m assuming that they were.

If otherwise, it seems simply set up to fail.

Or was proving how difficult things are basically the point?

Edit - added last sentence
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I think the conclusion is that they have shown it is possible to engage with people with severe ME so they shouldn’t be excluded from being researched.
 
483 questionnaire packs were requested, 63 were returned in various stages of completion.
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This looks like a terrible return rate.
However, there were 2 different cohorts:

The initial phase of the project was advertised in GP practices, the five local CFS/ME services and national charities and via social media. The project was also promoted by visiting each of the five services and several of the local support groups. Fifty-eight people volunteered to take part and were sent a questionnaire pack that contained four items: an expression of interest and three questionnaires.
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38 of these 58 people returned questionnaires, which is actually not bad (66%).

Permissions for a change in protocol were granted following advice from the local charity ME North East. The charity identified those members known to be severely affected by CFS/ME and questionnaire packs were sent directly from them.
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425 questionnaire packs were sent out by ME North East, but only 25 were returned.
 
The group that didn't satisfy either the Fukuda or the Canadian criteria were an odd group:
The 71 symptoms documented in the De Paul Fatigue Questionnaire were analysed as to whether they complied with the Fukuda and Canadian CFS/ME criteria. The participants were analysed within their subgroups: who fully complied with both criteria, the yes group; who partially complied with the criteria, the yes/no group; and those who complied with neither criteria, the no group.

Those who complied with both criteria, the yes group, experienced most symptoms (mean 39.9, SD 11.1). While those who do not comply with either criteria, the no group, barely experienced any of the symptoms (mean 1.08, SD 1.75). Those participants who complied with one but not both criteria, the yes/no group, symptoms experience fell between the two conclusive groups (mean 24.1, SD 6.7).
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I'm not sure how they managed to get into the study. Anyway, I don't think one can say from this that there are loads of people saying they have with severe ME who don't have it upon examination.
 
I was a little frustrated when I first read about the response rate in phase 2. However, it was only the 4th visits that participant 1 and participant 3 missed. It looks quite likely that if the study went on longer they might have been able to be accommodated.


figure 2.png

Four visits were planned to be completed within a 3-month period to control the burden on this physically limited group of individuals. The five participants were given a second consent form and patient information sheet specific to phase 2.
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Phase 2

Figure 2 shows the participation and completion rates of phase 2. Three of the five phase 2 participants completed all the visits. Between 45% and 100% of the assessments were completed by the volunteers.

Participant 1 attempted the active stand; however, it was abandoned after 90 s by mutual agreement. The subject’s heart rate increased above 120 bpm, pallor deteriorated and they began to experience significant orthostatic symptoms.

Participant 4 refused to complete several neurocognitive questionnaires in part due to cognitive impairment. However, participant 4 became very upset when confronted with the extent of their cognitive impairment and was unable to complete the digital symbol substitution test and the neuropsychiatry assessment.

Participant 4 also declined to complete the active stand in visit one. However, on examination in visit 4, it became apparent that the active stand and many of the activities in visit 4 would have been impossible to perform. It was reasoned that extensive bilateral adaptive shortening in their Achilles tendon, mid and hind foot due to prolonged bed-rest would have prevented standing.

Finally, the non-attendance of participants 1 and 3 for visit 4 was due to ill health. In the case of participant 1, they had been impeded by personal ill health, ill health of their preschool child and finally a family bereavement. These multiple burdens were experienced alongside severe CFS/ME throughout the 3-month time frame.
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I just read this study (a bit late!).
I filled in the (massive) questionnaires for phase one, so met one of the researchers. She seemed great.

I am pretty confused generally about papers like this, and why they seem pretty ok all the way through then switch on the BPS speak at the end. She references two such papers at the end, and one about mortality rates by Wessley himself! It may be that there are no others to reference, but it feels like a betrayal of trust, and that these researchers are disregarding our reality. Can’t they get published in the BMJ without saying the magic word “biopsychosocial”? Or do they really not understand the harms?

I actually read this paper to see if it contained anything like this as I remember reading another paper (a lit review I think) by Strassheim which uncritically referred to the PACE trial.

I would really like to see a bit of solidarity and obvious rejection of the BPS brigade from U.K. researchers. Referencing the BPS school only continues to bolster their careers and these things are counted in academic circles.

The Newcastle team seem to be doing some great work, but this just puts me off.

One of the references about MUS I can’t really understand but speaks about the MUS problem pointing to a need to move away from evidence based medicine as it’s clearly not working! There may be a finer point being made, but I couldn’t understand some of the terminology.

Am I over reacting?!
 
Dolphin said:
The group that didn't satisfy either the Fukuda or the Canadian criteria were an odd group:

I'm not sure how they managed to get into the study. Anyway, I don't think one can say from this that there are loads of people saying they have with severe ME who don't have it upon examination.
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Yes I found this very strange. I think 6 gave another explanation for their symptoms (maybe they had being diagnosed as having CFS and that’s why they were captured?) and six had barely any symptoms at all, which is quite strange. I was glad the researchers didn’t speculate about why these people were claiming not only to have CFS but to be severely affected and practically housebound.
 
ProudActivist said:
I am pretty confused generally about papers like this, and why they seem pretty ok all the way through then switch on the BPS speak at the end. She references two such papers at the end, and one about mortality rates by Wessley himself! It may be that there are no others to reference, but it feels like a betrayal of trust, and that these researchers are disregarding our reality. Can’t they get published in the BMJ without saying the magic word “biopsychosocial”? Or do they really not understand the harms?
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Thanks for your comments, @ProudActivist. I don't think I read more than the abstract when it came out. I've had a closer look now. I agree the last paragraph of the conclusion is odd.

It is necessary to acknowledge that individuals with multiple comorbidities and overlapping symptoms may conform to the definition of complex disability.25 In doing so they must be afforded the resources of such a category. It is important to understand severely disabled individuals within the context of the International Classification of Function and Disability.26 27This holistic approach would allow identification of all the biopsychosocial28 29 factors that make certain people more susceptible to the severe expression of CFS/ME and other outcomes. Research has identified that suicide specific, standardised mortality rates are higher in the CFS/ME population group compared with general population.30 Through early identification of those vulnerable to significant deterioration and other risk factors, the development of holistic management and prevention strategies could be made to limit the impact of the illness.
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Specifically this sentence:
This holistic approach would allow identification of all the biopsychosocial factors that make certain people more susceptible to the severe expression of CFS/ME and other outcomes.
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I think they are saying people with ME whose ME is severe seem also to have lots of other co-morbidities, and somehow deducing that it is biopsychosocial factors that make them particularly susceptible to getting severe ME.

On the surface that is logically true. There must be some factor that makes them susceptible to getting severe ME, and that factor could be
- biological (like genetic predisposition, or some biological process gone more badly wrong),
- psychological (like believing you have to exercise your way to health and crashing repeatedly as a result, and misreading body signals to stop)
- social (like getting bad medical advice or lack of support).

In that sense, the last sentence:
the development of holistic management and prevention strategies could be made to limit the impact of the illness
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could be interpreted as a benign desire to find out properly what can be done to prevent patients' ME reaching the severe and very severe stages. (like abandoning CBT/GET and giving patients adequate support).

If that's what they mean, then it's fine, but it seems more likely that they are using the term in the BPS way we know and hate that is really a focus away from biological to psychological factors both in perpetuating the illness and in treatment strategies.
 
Trish said:
Thanks for your comments, @ProudActivist. I don't think I read more than the abstract when it came out. I've had a closer look now. I agree the last paragraph of the conclusion is odd.



Specifically this sentence:


I think they are saying people with ME whose ME is severe seem also to have lots of other co-morbidities, and somehow deducing that it is biopsychosocial factors that make them particularly susceptible to getting severe ME.

On the surface that is logically true. There must be some factor that makes them susceptible to getting severe ME, and that factor could be
- biological (like genetic predisposition, or some biological process gone more badly wrong),
- psychological (like believing you have to exercise your way to health and crashing repeatedly as a result, and misreading body signals to stop)
- social (like getting bad medical advice or lack of support).

In that sense, the last sentence:

could be interpreted as a benign desire to find out properly what can be done to prevent patients' ME reaching the severe and very severe stages. (like abandoning CBT/GET and giving patients adequate support).

If that's what they mean, then it's fine, but it seems more likely that they are using the term in the BPS way we know and hate that is really a focus away from biological to psychological factors both in perpetuating the illness and in treatment strategies.
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And 'holistic' to me seems to mean much the same as 'biopsychosocial'.
 
Overall, I'm glad that researchers are starting to look at severe and very severe ME. There's something a bit bull-in-a-china-shop about these early attempts.

Four visits were planned to be completed within a 3-month period to control the burden on this physically limited group of individuals.
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I have severe, not very severe, ME, and this would be astronomically beyond what I can do. It would completely rule me out of participating in the study, due to the extent of the exacerbation that would follow even one of these visits, never mind 4 in 3 months. It's clear they sought and got input from mild/moderate patients and a charity, but I'm not sure they've really grasped the severity. I do understand that some with severe and even very severe ME might be able for this, but I suspect that others are like me and couldn't dream of it.

I share others' wonderings about the 12/56 who didn't fulfill criteria. I would have liked to hear more.

It reminded me of question 10 of the MEA's 2010 survey, where 18/3594 people reported that they had none of what were judged (debatably, in my opinion) as the key features of ME by Dr Charles Shepherd, who wrote the discussion sections:

Muscle Fatigue
Cognitive Dysfunction
Pain (esp in muscles & joints)
Sleep Problems
Mobility Problems

I found the many grammatical and editing errors really off-putting in a journal article. There are so many in the first few paragraphs alone.

I've read Victoria Strassheim's other papers and she does seem to be coming at this from the angle of severe and very severe ME being an avoidable aberration, i.e. very much informed by the deconditioning theory. She's not alone in this. My experiences with doctors would suggest that this is the mainstream view, and hers is at least more nuanced, with recognition of autonomic factors.

I think we need health professionals to accept that ME has severe and very severe forms, just like other diseases/illnesses. One of the most distressing parts of deteriorating from mild to severe ME has been the increasing blame. To put it simply, when I was mild I got a lot of positive feedback from doctors about how good my attitude was, how proactive I was being, and now that I am severe I get the opposite. My attitude and approach have not changed, only my level of illness, but I am now a "bad" patient in their eyes. Reconditioning didn't work, so I'm bad.
 
My gut reaction is that you cannot tell the feasibility of doing research on people with severe ME unless you specify what sort of research it is going to be. If I had severe ME I would be very picky about what sort of researchers with what sorts of reasons I was prepared to let in my house.
 
ProudActivist said:
Is it this?
http://www.strokecenter.org/wp-content/uploads/2011/08/barthel.pdf
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Thank you. I'm a bit confused about this. If this is the scale they are using then I can't make sense of this paragraph:
Of 63, 48 (76%) Barthel Functional Outcome questionnaires were returned, with a mean score of 14.5 (range 5–20). Twelve is a pivotal score at which point a person moves from independence to dependence. Of 48, 14 (30%) of those participants who returned the functional questionnaire scored 12 or under indicating functional dependence on a third party.Of 48, 18 (67%) scored less than 17 suggesting they needed help to perform activities of daily living.17
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The say 12 is the pivotal score at which you move from independence to dependence, but on that scale, just being able to eat without help and being doubly continent and able to use the loo would score you 40. And that's without being able to wash or dress or anything else.

Can anyone else make sense of this?
 
Trish said:
Thank you. I'm a bit confused about this. If this is the scale they are using then I can't make sense of this paragraph:


The say 12 is the pivotal score at which you move from independence to dependence, but on that scale, just being able to eat without help and being doubly continent and able to use the loo would score you 40. And that's without being able to wash or dress or anything else.

Can anyone else make sense of this?
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Independence on this scale, it should be noted, includes the use of aids. It's not true independence.
 
@Trish I think they must be using the modernized Barthel - where the scoring is changed to 0-20. So unable to do something scores 0, needing assistance scores 1, and independence scores 2. I’m fairly certain this was designed for stroke, so I don’t personally think it’s a good tool for ME. It is a pretty crude measure even for stroke....
 
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