The feasibility and acceptability of an early intervention in primary care to prevent CFS in adults: randomised controlled-O'Dowd, Crawley 2020

[Sly Saint]

The feasibility and acceptability of an early intervention in primary care to prevent chronic fatigue syndrome (CFS) in adults: randomised controlled trial

Abstract
Background
Chronic fatigue syndrome (CFS, also known as myalgic encephalomyelitis (ME)) is defined as fatigue that is disabling, is accompanied by additional symptoms and persists for ≥ 4 months. Treatment of CFS/ME aims to help patients manage their symptoms and make lifestyle adjustments. We do not know whether intervening early in primary care (< 4 months after onset of fatigue) can prevent the development of CFS/ME.

Methods
This was a feasibility randomised controlled trial with adults (age ≥ 18 years) comparing usual care with usual care plus an early intervention (EI; a combination of psycho-education and cognitive behavioural therapy, CBT). This study took place in fourteen primary care practices in Bristol, England and aimed to identify issues around recruitment and retention for a full-scale trial. It was not powered to support statistical analysis of differences in outcomes. Integrated qualitative methodology was used to explore the feasibility and acceptability of recruitment and randomisation to the intervention.

Results
Forty-four patients were recruited (1 August 2012–November 28, 2013), falling short of our predicted recruitment rate of 100 patients in 8 months. Qualitative data from GPs showed recruitment was not feasible because it was difficult to identify potential participants within 4 months of symptom onset. Some referring GPs felt screening investigations recommended by NICE were unnecessary, and they had difficulty finding patients who met the eligibility criteria. Qualitative data from some participant interviews suggested that the intervention was not acceptable in its current format. Although the majority of participants found parts of the intervention acceptable, many reported one or more problems with acceptability. Participants who discontinued the intervention or found it problematic did not relate to the therapeutic model, disliked telephone consultations or found self-reflection challenging.

Conclusions
A randomised controlled trial to test an early intervention for fatigue in adults in primary care is not feasible using this intervention and recruitment strategy.

https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-020-00595-0

 

[Jaybee00]

Failure!!!

“Psycho-education” from Psychos.

Very important contribution from the Highly Regarded Journal of Pilot and Feasibility Studies [Not!]

 

[rvallee]

Being unable to properly diagnose patients because of incompetence and ideological fanaticism is indeed problematic in doing early intervention. Or any intervention at all. Including the intervention used in clinical practice for well over a decade, timing is irrelevant when there is no basis for it. The one in official guidelines. You know, the one people who actually know what ME is said was useless junk. The one that is an immoral failure, a human rights disaster of grotesque cruelty.

Just go away. Forever. Nobody cares about your belief system.

 

[Amw66]

There has been a number of papers in the same vein recently.
Cynically I cant help wonder pre COVID if extending the original consultation period for NICE was in part due to these being ," in the works"?

Or am I just indulging conspiracy theories?

 

[Esther12]

There has been a number of papers in the same vein recently.
Cynically I cant help wonder pre COVID if extending the original consultation period for NICE was in part due to these being ," in the works"?

Or am I just indulging conspiracy theories?

This is a really old study that only released results after an FOI request. They then said that they'd failed to get a paper published. There was some talk from people of using the data to then do a paper about the study, and about the failure to publish results in a journal, and now we've had this released. Having these results out doesn't do anything to assist CBT with NICE.

 

[Sean]

Would help if they stopped being so obsessed with 'fatigue'.

 

[wigglethemouse]

Wow, TEN people put their name to this work!

• 1. Hazel O’Dowd,
• 2. Lucy Beasant,
• 3. Jenny Ingram,
• 4. Alan Montgomery,
• 5. Will Hollingworth,
• 6. Daisy Gaunt,
• 7. Simon M. Collin,
• 8. Sarah Horne,
• 9. Beth Jones &
• 10. Esther Crawley

Paper is worth a quick scan for things like this

Participant 6: I was disappointed to not get into the um – be selected for the other group. Um mainly because I think presenting to your doctor with this is quite difficult. I certainly felt I needed to be assertive in saying I’d like these tests, I’m not – you know, er I want something, er not – not necessarily drugs, but I want some exploration....I was heard but maybe not listened to initially (female > 40 years, usual care)

and

Participant 10: I’ve been taking amphetamine when I have to, to get me through the day …I went to the doctor’s for help but I just felt like I was brushed off. (female < 40 years, usual care)

And this is FUDGE FUDGE FUDGE awful. Why the FUDGE go to the doctor if they won't FUDGE investigate. Here's the proof.

All 12 GPs discussed the importance of blood screens to exclude physical causes of fatigue, but few of the GPs involved routinely carried out the full range of screening needed for the early intervention study. Only 1 GP said the study bloods were standard.

 

[MEMarge]

Dreadful interview with Maria Loades has just finished on BBC 2 news, 12.20.

Interview started at 12.16.

How is this not just common sense, of course lockdown will impact children and adolescents!

 

[Trish]

Dreadful interview with Maria Loades has just finished on BBC 2 news, 12.20.

Erk. I've just watched it. Platitudes and assumptions and making stuff up.
I'll refrain from commenting on her strange manner. I guess she can't help that.

 

[rvallee]

Would help if they stopped being so obsessed with 'fatigue'.

It would help us. In fact it would save millions of lives. It would also destroy their reputations and careers.

That choice was made long ago. Escalation of commitment is a harsh and unforgiving master.

 

[alktipping]

I always think about the comparison they use care as usual = abandonment by disinterested gps how can you compare that with anything .

 

[ME/CFS Skeptic]

This section warrants a comment:

Not all the participants found the intervention acceptable. This is not consistent with previous trials in CFS/ME which have shown a high level of patient satisfaction and low drop-out rates with similar treatment approaches

CBT is quite controversial in CFS. Everyone who is somewhat involved with the CFS patient or research community should know this.

 

[rvallee]

This section warrants a comment:

CBT is quite controversial in CFS. Everyone who is somewhat involved with the CFS patient or research community should know this.

I am doubly puzzled by that statement because it is blatantly false, almost exaggeratedly so. In every experiment in fact it seems they have trouble recruiting, with some literally being cancelled because of this, and there are always high % of drop-outs. Plus the "satisfaction" is almost always reserved for having the opportunity to meet other patients and the social element it brings, basically as good as any support group. It's not even the "treatment" themselves that have satisfaction. Coming from people who argued that support groups are bad for patients, no less, an assertion that they themselves debunked but still parrot.

Plus there are thousands of complaints, including from participants in the experiments. How did such a blatant lie make it into published research? Or it would have had they decided to publish it, but this is typical of BPS research and would have gotten published without issue. An even more important question is how often do such blatant lies make it into published research? Because this suggests that it must be A LOT. This is Potemkin research, all surface and no depth.

 

[Dolphin]

I wonder whether there is anything interesting in these i.e. this journal has open peer-review
https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-020-00595-0/peer-review

Peer Review reports
From: The feasibility and acceptability of an early intervention in primary care to prevent chronic fatigue syndrome (CFS) in adults: randomised controlled trial

Original Submission
24 May 2019 Submitted Original manuscript
25 Jun 2019 Reviewed Reviewer Report - Natasha Noble
2 Jul 2019 Reviewed Reviewer Report - Gregory Parkin-Smith
3 Jul 2019 Reviewed Reviewer Report - Martyn Lewis
3 Jul 2019 Reviewed Reviewer Report - John Edwards
2 Aug 2019 Author responded Author comments - Hazel O.Dowd
29 Aug 2019 Reviewed Reviewer Report - Gregory Parkin-Smith
4 Sep 2019 Reviewed Reviewer Report - Martyn Lewis
2 Oct 2019 Author responded Author comments - Hazel O.Dowd
Resubmission - Version 2
2 Aug 2019 Submitted Manuscript version 2
7 Nov 2019 Reviewed Reviewer Report - Martyn Lewis
23 Jan 2020 Reviewed Reviewer Report - Kim Madden
15 Feb 2020 Author responded Author comments - Hazel O.Dowd
Resubmission - Version 3
15 Feb 2020 Submitted Manuscript version 3
25 Feb 2020 Reviewed Reviewer Report - Martyn Lewis
3 Mar 2020 Reviewed Reviewer Report - Kim Madden
Resubmission - Version 4
Submitted Manuscript version 4
Publishing
7 Apr 2020 Editorially accepted
12 May 2020 Article published 10.1186/s40814-020-00595-0
You can find further information about peer review here.

 

[dave30th]

Dreadful interview with Maria Loades has just finished on BBC 2 news, 12.20.

she peer-reviewed the bogus CBT and music therapy study. To her credit, she expressed confusion about whether it was a feasibility study or a randomized trial, and she thought the conclusions in the draft of the paper were too strong.

 

[Amw66]

Was Loades not also involvedin the n=1 study of exercise for a severely affected adolescent and did not apparently correlate the inability to speak with the degree of severity?

A painful paper to read where the lack of knowledge is truly concerning.

 

[ME/CFS Skeptic]

To her credit, she expressed confusion about whether it was a feasibility study or a randomized trial, and she thought the conclusions in the draft of the paper were too strong

Yes but if it is not clear if a manuscript presents a full trial or a feasibility study, one would ask to see the protocol, trial registration, statistical analysis plan or grant application, some document where the purpose of the study was described before the results were in. Here she simply took the author's word for it. She and the editors let them decide how they wanted to present their results.

 

[ME/CFS Skeptic]

Here she simply took the author's word for it.

Or correction: the editors took their word for it. It's probably more their responsibility than the peer-reviewer who at least brought it up.

 

[Andy]

 

[MSEsperanza]

This is a really old study that only released results after an FOI request. They then said that they'd failed to get a paper published. There was some talk from people of using the data to then do a paper about the study, and about the failure to publish results in a journal, and now we've had this released.

Thread discussing the protocol and the data requested by JohnTheJack here.