Effectiveness of a symptom-clinic intervention ... multiple and persistent physical symptoms, 2024, Burton, Deary et al

rvallee

rvallee

Senior Member (Voting Rights)
https://www.sheffield.ac.uk/scharr/research/centres/ctru/mss3

I don't see a thread on this. The list of contributors imply a very expensive price tag for doing copy-paste research that's been done many times before. No idea if ME is an exclusion criteria, very few details.

Multiple Symptoms Study 3: Pragmatic trial of a community based clinic for patients with persistent (medically unexplained) physical symptoms
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Multiple Symptoms Study 3 is a large randomised controlled trial to test the effectiveness of a Symptoms Clinic for people with persistent “medically unexplained” physical symptoms.
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Obviously not a controlled study but I guess words have no meaning anymore.

Contributors include: Burton, Deary, Greco. With this many involved it looks like a PACE-scale trial.
This project is funded by the National Institute for Health Research, Health Services and Delivery Research (NIHR HS&DR) Programme (project number 15/136/07).
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Not even sure this is actually a trial, let alone controlled. Reducing health care utilization appears to be the goal, but I can't find protocol so don't know what are the outcomes used. There's a video but it's generic fluff.

Another one to follow, @dave30th.

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First publication - the protocol - from this study linked here:
Protocol: Multiple Symptoms Study 3: a pragmatic, randomised controlled trial of a clinic for patients with PPS/MUS 2022 Mooney, Deary et al

Published report linked here:
United Kingdom: Multiple Symptoms Study 3 (ScHARR) - NIHR funded MUS treatment trial

Also:
Cost-effectiveness of an extended-role [GP] clinic for [PPS]: results from the Multiple Symptoms Study 3 (MSS3)... 2024 Deary, Burton et al
 
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Professor Chris Burton, the leader of this study, is on the ME/CFS guideline committee. Science for ME wrote a letter expressing serious concerns about his suitabillity for the role and his conflicts of interest. These included the fact that he is running this trial while on the guideline committee, and his own methodology has the same flaws as the research being reviewed by the Guideline committee.

https://www.s4me.info/threads/s4me-letter-to-nice-concerning-chris-burton.7774/
 
This sounds awful. There's a short video at the link. 'Common syndromes' are mentioned, with IBS and fibromyalgia given as examples. The closest the list on the accompanying slide comes to ME/CFS is 'fatigue'.

material at the link said:
Persistent physical symptoms (which cannot be adequately attributed to physical disease) affect around 1 million people (2% of adults) in the UK. They affect patients’ quality of life and account for at least one third of referrals from GPs to specialists. These referrals give patients little benefit but have a real cost to health services in terms of time and diagnostic resources. When patients are told that medical tests do not show a cause for their symptoms they are commonly disappointed in their interactions with clinicians.
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It makes no sense to look retrospectively at the patients who were sent for tests and had no medical cause identified for their symptoms and say 'there was no benefit and only a cost to the health care system'. It ignores that fact that many of the patients who have tests do have a medical cause identified and treatment can start to cure or reduce life-limiting symptoms.

It's just like saying that when people who participate in a screening program, for bowel cancer or whatever, and are subsequently found to not have bowel cancer that there was no benefit and only a cost to the health-care system.

(I bet if Chris Burton suddenly developed a condition that prevented him from earning a living and doing many of the things he enjoys, or his child developed a condition that prevented them from going to school and required him to stay home to provide care, he might want some tests done to rule out possible diagnoses.)

And, if you accept that the medical system should in fact test to rule out other conditions, and the PPS clinic only gets people after they have been through an effective diagnosis system, then there really isn't any basis to suggest that vast sums of money are going to be saved in avoided testing.

I wonder if someone in the UK could sign up to get the screening questionnaire, or even participate?
 
I had the impression from my memory of reading about this when we were preparing the letter to NICE about Burton, that recruitment is via referral from GP's in the Sheffield area. I dont think it's one asking for volunteers.

The patients would have to be selected by their GP as fitting the category of MUS, having been through whatever diagnostic process the GP had ordered, and still returning to the GP with symptoms.
 
Trish said:
I had the impression from my memory of reading about this when we were preparing the letter to NICE about Burton, that recruitment is via referral from GP's in the Sheffield area. I dont think it's one asking for volunteers.

The patients would have to be selected by their GP as fitting the category of MUS, having been through whatever diagnostic process the GP had ordered, and still returning to the GP with symptoms.
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I wonder whether we have any members of the Sheffield ME&Fibro Group here?

I joined just because I have really appreciated their monthly webinars, but am completely out of area.

I will send an email so the committee can keep a careful eye on what is happening in the City.
 
@Hutan picked up important fallacies about testing. Though, on the point that the "Symptoms Clinic" wouldn't save the expense of tests done prior to patients' referrals, it actually might once it is set up. GPs could be asked to redirect their patients to this clinic after only one inconclusive blood test and/or one specialist consultation. Those who do not want to take on the burden of patients with "unexplained" symptoms may be happy to do so as it seems like an easy solution.

The description of this intervention/clinic highlights does not fail to highlight that its purpose is cost saving:
The Symptoms Clinic is a set of up to four medical appointments designed to help people make sense of persistent physical symptoms (especially if medical tests have been negative) and to reduce the impact of symptoms on daily life. Consultations will take place via video link with a doctor who has had special training for the Symptoms Clinic Intervention.

The consultations include detailed medical history taking, explanation (including discussion of appropriate diagnosis) and advice about management. The Symptoms Clinic involves an initial long consultation of approximately 50 minutes followed up by two or three medium length consultations of 15-20 minutes.
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- A "telehealth clinic" is much cheaper to set up and to run than a physical one
- The intervention is a short-term intervention (4 consultations), after which the patients are left on their own -- much cheaper than long-term care
- Only 1 long consultation is provided, the other 2-3 follow-ups not being longer than a standard GP appointment and so not more expensive per se (they might be if they're considered as a "specialist" consultation)
- I suspect the intervention itself revolves around telling patients not to focus on their symptoms and thus to avoid consulting their GP for their PPS, saving costs again down the line.

If only this money could go towards biomedical research.
 
found the project here:

https://www.journalslibrary.nihr.ac.uk/programmes/hsdr/1513607/#/

It started in 2018.
Cost: £1,466,568.27

Abstract
BACKGROUND Persistent physical symptoms, which are disproportionate to biomedical disease affect around 1 million people (2% of adults) in the UK. These medically unexplained symptoms (MUS) cause distress to patients and account for over one third of referrals to specialists. Although most persistent symptoms can be explained, many patients do not receive adequate explanations for their symptoms.

We have rigorously developed the Symptoms Clinic treatment model, to focus on explaining symptoms and guide self-management. In preliminary studies it was acceptable to patients and showed promising results.

AIMS AND RESEARCH QUESTIONS
We aim to examine the effectiveness of a Symptoms Clinic by conducting a pragmatic RCT to test the primary hypothesis that compared to usual care alone, the Symptoms Clinic plus usual care leads to a clinically meaningful improvement in patients' symptoms. The secondary hypothesis is that healthcare use will be reduced in a cost-effective way. Within the trial we will conduct a detailed process evaluation of the Symptoms Clinic.

METHODS
The trial will take place in three UK centres, delivered in newly configured Symptoms Clinics by specially trained GPs. Adults aged 18 or over will be recruited from GP practice lists using a three stage procedure: clinical record search, GP record screening and postal questionnaire. Inclusion criteria will be multiple persistent physical symptoms of moderate severity (PHQ-15 between 10 and 20) and repeated referral for diagnostic tests or specialist opinion. Patients will be excluded if their symptoms are primarily attributable to biomedical illness, or if they have severe disability. Patients will be randomised to receive either the Symptoms Clinic plus usual care or usual care alone.

INTERVENTION
The Symptoms Clinic Intervention (SCI) comprises extended psychologically -informed medical consultations. Patients receive an initial 50 minute consultation and 2-3 follow ups of 20 minutes. Clinic doctors explain symptoms as understandable bodily processes, and aim that patients feel understood and more able to self-manage.
OUTCOMES
The primary outcome will be symptoms (PHQ15) at 52 weeks after randomisation. Secondary outcomes will include healthcare use over 52 weeks (GP consults, referrals & tests), symptoms at 13 weeks and quality of life (conventional and capabilities based measures) at 13 and 52 weeks.

ANALYSIS
Outcomes will be analysed on an intention to treat basis using a general linear model correcting for baseline values. A sample size of 188 in each arm provides 90% power to detect a meaningful 2 point difference in PHQ15 allowing for 25% loss to follow up.

PROCESS EVALUATIONS
Pre-specified content analysis of consultations and interviews with selected patients and stakeholders will inform detailed process evaluations.

HEALTH ECONOMIC EVALUATION
Within-trial cost-effectiveness analysis will estimate cost per QALY.

BENEFITS AND IMPACTS FOR NHS.
The intervention is designed to improve patients' symptoms and reduce their healthcare use, particularly referral for specialist opinion and tests. We have seen improvement in symptoms in both our preliminary studies. In the longer run it is plausible that Symptom Clinics will act as a focus for the development and testing of further treatments, allow for the diffusion of skills into wider practice and contribute to the wider public discourse about persistent physical symptoms
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https://www.journalslibrary.nihr.ac.uk/programmes/hsdr/1513607/#/abstract
 
dave30th said:
Interesting point. has this just popped up again now because they've relaunched recruitment for it?
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In the video he talks about doing a larger trial to see if improvement in wellbeing is sustained for a longer period alongside reduced healthcare use/costs.

They are now recruiting in 3 areas: Sheffield, Tyneside and Manchester/Lancashire
 
Looks identical to FINE. More FINE than PACE anyway.

FINE had null results. It formed the basis of an NHS training module for what they called "chronic fatigue". Obviously because it's nonsense.

What is it called to do the same thing over and over again expecting different results? Too bad it's not something these people should be aware of.
 
It's M.E. Linda said:
I wonder whether we have any members of the Sheffield ME&Fibro Group here?

I joined just because I have really appreciated their monthly webinars, but am completely out of area.

I will send an email so the committee can keep a careful eye on what is happening in the City.
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NelliePledge said:
@Gecko i think
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Yep I'm a member and sometimes volunteer. And yes keeping an eye but do always feel welcome to drop our communications officer Elyane a line on info@sheffieldmegroup.co.uk

I would guess NICE won't consider this a major conflict of interest for Chris Burton as it's not studying ME/CFS...

This has been on our radar a while, unsure why it has just popped up again now. I thought there was an old thread on here about it somewhere but I can't find it - possible it was just discussed in relation to the NICE ctte.

As others have said tho - this will provide no good evidence on anything much.
 
Cara Mooney, the trial manager has replied to my emailed questions about recruitment and scope. Here are the answers:

Yes we are still recruiting participants to the study however their GP practice does need to be signed up to take part in the study and be willing to run the searches and send the invitation letters. So yes referral from a GP practice is required. We are currently recruiting GP practices in Yorkshire, Greater Manchester and Newcastle/Gateshead.

Would people with a diagnosis of CFS potentially be eligible? We do not include CFS in our search criteria so if this is the primary diagnosis it is unlikely that they would be eligible.
 
Hutan said:
[Cara Mooney replied:] Would people with a diagnosis of CFS potentially be eligible? We do not include CFS in our search criteria so if this is the primary diagnosis it is unlikely that they would be eligible.
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In the MSS3 trial protocol, the selection and inclusion criteria do not I believe refer to chronic fatigue or chronic fatigue syndrome. However, a paragraph in the protocol introduction gives three examples of MUS syndromes, one of these examples is 'chronic fatigue'. I don't know whether this may be an indication that 'chronic fatigue' may be a search term.

My recollection is there is a list of amendments towards the beginning of the protocol, in which it was stated that the word 'syndrome' was removed from the term 'chronic fatigue syndrome' in this general introductory paragraph.

In this para, the term 'chronic fatigue' was listed with the MUS syndromes fibromyalgia and IBS. (Fibromyalgia and IBS are listed as examples of eligible syndromes in the section on selection criteria.) So even though the word 'syndrome' was removed, the sentence describes 'chronic fatigue' (a single symptom) as a syndrome:
Some persistent physical syndromes [sic] are grouped into clusters (syndromes) such as irritable bowel syndrome, fibromyalgia and chronic fatigue.
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This appears to be the sole mention of 'chronic fatigue [syndrome]' in the trial protocol.

The selection and inclusion criteria does not exhaustively list MUS syndromes that would be included (or excluded), beyond giving examples of fibromyalgia and IBS, and does not, I believe, refer to chronic fatigue [syndrome] at all.

A third version of the protocol was apparently published on 18 Jan 2019.

I think it is the case that the MSS3 trial builds on a couple of other papers on the development of this 'Symptoms Clinic Intervention' under evaluation, and that for one of those, 'chronic fatigue syndrome' was explicitly mentioned in the inclusion criteria.

Regardless of whether 'chronic fatigue' is a search criterion in the MSS3 trial, it would seem from the selection criteria that ME/CFS patients may be picked up due to other criteria re negative investigation:
The GP PIC sites will complete a computer search on the practice clinical system to identify patients whose records include: (a) at least one code for an MUS syndrome (e.g. irritable bowel syndrome, fibromyalgia) or at least two codes for negative investigations (e.g. CT Scan normal); [etc]
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I also wonder if long covid will now be included in search criteria, or if people with long covid that have not had a positive test result may be picked up.
 
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