McDermott et al: Feasibility study for a community based intervention for adults with severe CFS/ME

[mango]

Feasibility study for a community based intervention for adults with severe Chronic Fatigue Syndrome/ME

Clare McDermott1, George Lewith1, Selwyn Richards2, Diane Cox2,Sarah Frossell3, Geraldine Leydon1, Caroline Eyles1, Hilly Raphael3, Rachael Rogers4, Michelle Selby2, Charlotte Adler2, Jo Allam2

1 Primary Care and Population Science, University of Southampton,Southampton, SO16 5ST, United Kingdom;
2 University of Cumbria, Carlisle,United Kingdom;
3 Rebuilding Your Life Project, Oxford, United Kingdom;
4 Oxfordshire CFS/ME Service, Oxford, United Kingdom Correspondence:Clare McDermott; George Lewith

BMC Complementary and Alternative Medicine 2017, 17(Suppl 1): p119

Background
Chronic Fatigue Syndrome/ME (CFS/ME) is characterised by debilitating fatigue with many bedbound patients. The study aims were

* To determine whether a new intervention could be successfully delivered.
* To collect quantitative outcome data to guide the design of future studies.
* To explore qualitatively the experience of patients, carers and clinicians.

Methods
Mixed-methods feasibility study with qualitative and quantitative evaluation.

Participants: 12 UK patients who were housebound with severe CFS/ME.

Intervention: Based on recovery skills identified through a 2.5 year Patient and Public Involvement development process involving individuals with first-hand experience of recovery from CFS/ME, as well as current patients and clinicians.

The resulting one year intervention, delivered by a multi-disciplinary team, included domiciliary therapy visits and optional peer support group.

Quantitative outcome measures: Patient-reported and therapist-reported outcome measures (including fatigue, physical function, anxiety, depression and other variables) and electronic activity measurement.

Results
The study recruited and engaged twelve participants with no serious adverse events or dropouts. At end of intervention, 5/12 participants had improved in fatigue, physical function. Group mean scores improved overall for fatigue (Chalder fatigue scale), physical function (activity and physical function scale) and anxiety.

Qualitative interviews suggested that the intervention was acceptable to patients, whilst also highlighting suggestions for improvement.

Participants will be followed up for a further year to find out if improvements are sustained.

Conclusion
This is the largest study ever conducted in severe CFS/ME and shows significant recovery suggesting further studies are indicated. Treatment is uniquely based on a patient inspired intervention.

http://insight.cumbria.ac.uk/id/eprint/3074/1/Cox_FeasibilityStudy.pdf

 

[Alvin2]

The resulting one year intervention, delivered by a multi-disciplinary team, included domiciliary therapy visits and optional peer support group

What the hell does this mean?
Also how did they measure improvement?

Also

This is the largest study ever conducted in severe CFS/ME and shows significant recovery suggesting further studies are indicated. Treatment is uniquely based on a patient inspired intervention.

If 12 patients is the largest study ever conducted they must live on a small planet the size of a small city.

 

[Jenny TipsforME]

How many participants were there in the FINE trial?

 

[Jenny TipsforME]

There were 296 participants in the unsuccessful FINE trial

http://www.bmj.com/content/340/bmj.c1777

They could be defining things differently of course. Actually looking again the FINE trial isn't clear its for Severe ME, we tend to interpret it that way because it was home based.

 

[A.B.]

The treatment is not described. It sounds like it's the Recover your Life approach http://theedge.nhsiq.nhs.uk/wp-content/uploads/2016/10/RyL-information.pdf

Acknowledging ME as a neurobiological condition, we aim to view each person's recovery journey from their personal perspective, starting from where they are when they arrive in the community. We use a range of strategies
from Neuro-Linguistic Programming (NLP) and coaching, essentially processes with the potential to transform the biology in the brain and body.

Another quack treatment to fight against.

 

[Jenny TipsforME]

Another quack treatment to fight against.

Just what we need

 

[Jenny TipsforME]

I didn't read all that PDF but obviously a question people will have is, did the people who recovered have ME? Annie is interesting. She had a classic teenage glandular fever trigger and a mid thirties relapse. This is a pattern talked about on here but I don't think many people know about that ME pattern.

But then when you look at her key learning from the programme, I do also believe/know those things and it hasn't improved my health! It isn't convincing that it would unless you were mainly experiencing anxiety/depression rather than multisystemic ME. Confusing.

 

[Karen Kirke]

There were 296 participants in the unsuccessful FINE trial

http://www.bmj.com/content/340/bmj.c1777

They could be defining things differently of course. Actually looking again the FINE trial isn't clear its for Severe ME, we tend to interpret it that way because it was home based.

Yes, only 11% of the FINE trial participants were "non-ambulatory".

 

[MEMum]

So, no comment on electronic activity measurements? Just self-reported measures again.

 

[trishrhymes]

This calls itself a feasibility study, yet claims to be a big success and the biggest study ever on severely effected patients???

Its a tiny pilot study. No control group, no mention of results of electronic activity measurement, no mention of size of improvement in the 5 patients who improved.

If you take 12 patients and do nothing, you would expect random fluctuations would give perhaps 5 getting a bit better , 5 getting a bit worse and 2 staying the same. It's a fluctuating illness. This is all nonsense.

I wonder if someone could request the raw data for analysis.

I assume they are using this as the basis for a funding request for a bigger study.

 

[trishrhymes]

I've just noticed that Michelle Selby is one of the authors. Oh dear. She is an OT who ran the Dorset ME service based at Wareham hospital. I don't know if she's still there.

At the time we had contact with her she was running groups based on pacing, and a home visit service based also on pacing and relaxation.

At the time the PACE trial came out in 2011 I had a good conversation with her, and she agreed with me that it was flawed, though neither of us realised how flawed back then.

However, on my last visit from her a few months later she had been drawn into the Lightning Process nonsense, and I gave up and didn't request any further contact.

Looks like she's now got tangled up in this nonsense. Sad, as she's a genuine person who really wants to help patients, but she doesn't have the scientific background to see through quackery.

The doctors involved are harder to understand and forgive.
I shall definitely continue to avoid the Dorset ME clinic.

 

[trishrhymes]

I've just written to the University of Cumbria data repository editor that holds the data (I think) to request the raw data. Don't hold your breath.

 

[snowathlete]

Claiming 5/12 participants improving? I guess such a claim is quite achievable if the improvement is achieved through subjective rather than objective measures.

Housebound = severe in this study. Not saying that is wrong, necessarily, but some other studies might consider that as moderate with the bed-bound being severe.

I've been housebound most of the time I have been ill and some of the time I guess I would label myself as severe but at other times moderate. I haven't looked in any detail how the questionnaire scores in this study compare with other studies using the same questionnaires on severe patients, such as FINE which certainly did appear to have some participants who would be considered severe based on those scores.

 

[Barry53]

Claiming 5/12 participants improving? I guess such a claim is quite achievable if the improvement is achieved through subjective rather than objective measures.

Housebound = severe in this study. Not saying that is wrong, necessarily, but some other studies might consider that as moderate with the bed-bound being severe.

I've been housebound most of the time I have been ill and some of the time I guess I would label myself as severe but at other times moderate. I haven't looked in any detail how the questionnaire scores in this study compare with other studies using the same questionnaires on severe patients, such as FINE which certainly did appear to have some participants who would be considered severe based on those scores.

If you are severely afflicted, then just having anyone show any interest at all is going to make you answer most self-perception questions more positively I would think.

 

[ukxmrv]

This sounds like the study AFME gave pride of place to at their "severely affected" day in 2014

Discussed previously here

http://forums.phoenixrising.me/inde...-for-individuals-with-severe-cfs-me-uk.32205/

and

http://forums.phoenixrising.me/inde...-in-our-severe-m-e-symposium-from-home.33473/

 

[Invisible Woman]

Looks like she's now got tangled up in this nonsense. Sad, as she's a genuine person who really wants to help patients, but she doesn't have the scientific background to see through quackery.

....and that right there is part of the problem. There are many folk who genuinely want to help, but either simply bow to authority or just don't have the curiosity or wit to look further than the end of their noses.

I had a relative who worked in high security mental health wards in the 50s and 60s and had loads of absolute horror stories about how patients were treated. Interestingly, she never felt in any way accountable personally. She would just shrug and say that's how "they" were treated in those days.

I reckon that's what these unquestioning do gooders will one day say about us.

 

[Valentijn]

It only seems to exist as an abstract for some event. Their data is probably too weak to get published as an actual paper.

 

[JohnM]

If there is no full paper, then no worries .. no need to go to all that effort, when you know that only abstracts will be reviewed, for the purposes of a surveillance review. Heck, you can even get a 'qualitative study' nested within an unpublished [SMILE] trial used to justify no change to the guidelines.

If you take 12 patients and do nothing, you would expect random fluctuations would give perhaps 5 getting a bit better, 5 getting a bit worse and 2 staying the same. It's a fluctuating illness. This is all nonsense.

You'll find quite a few studies within the CG53 "Surveillance proposal consultation document" with similarly small numbers if memory serves?

Wishing everyone improved health and every happiness. John

 

[Snow Leopard]

It only seems to exist as an abstract for some event. Their data is probably too weak to get published as an actual paper.

Yep. Cherry pick results to sound good in abstract, when the real results are null.

 

[Valentijn]

Yep. Cherry pick results to sound good in abstract, when the real results are null.

It's probably good enough for NICE No complicated paper getting in the way of all the spin!