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

Simbindi said:
So they're using the (subjective) PHQ 15 as the primary outcome measure!

https://reference.medscape.com/calc...alth-questionnaire-15-phq-15#about-references

https://reference.medscape.com/calculator/460/patient-health-questionnaire-15-phq-15
Click to expand...

So, this PHQ basically asks "Are you bothered?" or rather "Over the last week have you been bothered by x"

There are then 3 options:
  • Not at all
  • Bothered a little
  • Bothered a lot
It sounds to me more like a Catherine Tate sketch than serious research.

The 15 Qs are on:
  • stomach pain, back pain, pain in arms/legs/joints, menstrual cramps, headaches
  • dizziness, heart racing, shortness of breath, pain during sex
  • constipation/diarrhoea, nausea/indigestion
  • tired/low energy, trouble sleeping, chest pain, fainting spells.
 
"Bothered" is a weasel word. It does not acknowledge that a symptom is really happening, it is a word used in everyday language as a trivial description, and a thing can bother one person while another barely notices. They can also be outraged that anyone could possibly believe that they meant it any other way than a simple term to ask how bad a patient feels.
 
Merged thread

Protocol: Multiple Symptoms Study 3: a pragmatic, randomised controlled trial of a clinic for patients with PPS/MUS 2022 Mooney, Deary et al


Full title: Study protocol for the Multiple Symptoms Study 3: a pragmatic, randomised controlled trial of a clinic for patients with persistent (medically unexplained) physical symptoms

Abstract

Introduction
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 General Practitioners (GPs) to specialists. These referrals give patients little benefit but have a real cost to health services time and diagnostic resources. The symptoms clinic has been 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.

Methods and analysis
This pragmatic, multicentre, randomised controlled trial will assess the clinical and cost-effectiveness of the symptoms clinic intervention plus usual care compared with usual care alone. Patients were identified through GP searches and mail-outs and recruited by the central research team. 354 participants were recruited and individually randomised (1:1). The primary outcome is the self-reported Physical Health Questionnaire-15 at 52 weeks postrandomisation. Secondary outcome measures include the EuroQol 5 dimension 5 level and healthcare resource use. Outcome measures will also be collected at 13 and 26 weeks postrandomisation. A process evaluation will be conducted including consultation content analysis and interviews with participants and key stakeholders.

Ethics and dissemination
Ethics approval has been obtained via Greater Manchester Central Research Ethics Committee (Reference 18/NW/0422). The results of the trial will be submitted for publication in peer-reviewed journals, presented at relevant conferences and disseminated to trial participants and patient interest groups.

Open access, https://bmjopen.bmj.com/content/12/11/e066511
 
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Tucked away in supplementary materials, https://bmjopen.bmj.com/content/bmj...ne-supplementary-material-3.pdf?download=true.

"The Symptoms Clinic Intervention

The Recognition, Explanation, Action and Learning (REAL) intervention was structured as follows.

Recognition takes place during the history-taking phase of the intervention. It includes explicit recognition of, and belief in, the reality and legitimacy of the patient’s experience. It also includes explicit recognition that persistent physical symptoms are within the scope of these medical consultations and can be understood without recourse to primary psychological causes. Recognition also seeks to build therapeutic alliance between ER-GP and patient.

Explanation seeks to propose and negotiate explanations for symptoms in terms of body physiology, and sensory signal processing. Explanations seek to portray symptoms as understandable (in contrast to the idea of “medically unexplained symptoms”) adaptive responses in body processes. ER-GPs delivering the Symptoms Clinic are encouraged to use the names of syndromes such as irritable bowel syndrome and fibromyalgia where criteria for these are met. However, explanations aim to provide mechanisms for the symptoms which extend beyond simply attributing a symptom to a syndrome.

Action to manage symptoms is proposed after explanations have been offered and negotiated. Actions can include attending to the body, thoughts and emotions, and the personal or social environment. Body-focused actions include breathing techniques (diaphragmatic breathing, slow paced breathing), relaxation, sensory grounding and simple guided imagery20. Actions around thoughts and emotions range include addressing catastrophic or symptom-focused thinking. Actions around behaviors include pacing, effective rest and behavioural activation (where dysphoria was an issue). For some patients recommended action includes taking steps to engage with psychological therapies – for instance where trauma emerges as part of the explanation.

Learning comes from the participant implementing agreed actions and evaluating the impact of them on their symptoms. Learning also relates to the importance of summing up sessions and the course of treatment with key take-homes. This is also facilitated by letters to the patient’s usual GP (copied to the patient) after the first and final consultation summarizing some of the key points covered in the clinic.

The Symptoms Clinic intervention is described in a manual provided to the ER-GPs; however it is designed to be delivered flexibly and in a person-centred way which allows the clinician considerable freedom to focus on aspects of the patient’s problem that they deem most appropriate and in forms of words they personally feel comfortable with."
 
I hope I never get sent to such a clinic.

Reading between the lines, I'd say it's all the same old stuff about doctors pretending they believe symptoms are real and have a physiological cause, then undermining this message with patient blaming stuff about symptom focusing and catastrophising.

The real message I'd get if this was inflicted on me would be - stop bothering your doctor with this trivial stuff, get a grip and stop imagining it's worse than it is. Now fill in this questionnaire to show you've learned your lesson.
 
The paper said:
Recognition takes place during the history-taking phase of the intervention. It includes explicit recognition of, and belief in, the reality and legitimacy of the patient’s experience. It also includes explicit recognition that persistent physical symptoms are within the scope of these medical consultations and can be understood without recourse to primary psychological causes. Recognition also seeks to build therapeutic alliance between ER-GP and patient.
Click to expand...
So, clearly performative "recognition" that is explicitly not recognition. It's the same old lying to patients in order to gain their trust and better betray it afterward. Just dripping with insincerity, and they don't seem to understand how it does the exact opposite. There is an uncanny valley of sincerity, and they are way out there in the badlands with the car salespeople and the MLM scammers.

This is pure pseudoscientific gobbledygook:
Explanation seeks to propose and negotiate explanations for symptoms in terms of body physiology, and sensory signal processing. Explanations seek to portray symptoms as understandable (in contrast to the idea of “medically unexplained symptoms”) adaptive responses in body processes.
Click to expand...
 
Andy said:
Tucked away in supplementary materials, https://bmjopen.bmj.com/content/bmj...ne-supplementary-material-3.pdf?download=true.

"The Symptoms Clinic Intervention

The Recognition, Explanation, Action and Learning (REAL) intervention was structured as follows.

Recognition takes place during the history-taking phase of the intervention. It includes explicit recognition of, and belief in, the reality and legitimacy of the patient’s experience. It also includes explicit recognition that persistent physical symptoms are within the scope of these medical consultations and can be understood without recourse to primary psychological causes. Recognition also seeks to build therapeutic alliance between ER-GP and patient.

Explanation seeks to propose and negotiate explanations for symptoms in terms of body physiology, and sensory signal processing. Explanations seek to portray symptoms as understandable (in contrast to the idea of “medically unexplained symptoms”) adaptive responses in body processes. ER-GPs delivering the Symptoms Clinic are encouraged to use the names of syndromes such as irritable bowel syndrome and fibromyalgia where criteria for these are met. However, explanations aim to provide mechanisms for the symptoms which extend beyond simply attributing a symptom to a syndrome.

Action to manage symptoms is proposed after explanations have been offered and negotiated. Actions can include attending to the body, thoughts and emotions, and the personal or social environment. Body-focused actions include breathing techniques (diaphragmatic breathing, slow paced breathing), relaxation, sensory grounding and simple guided imagery20. Actions around thoughts and emotions range include addressing catastrophic or symptom-focused thinking. Actions around behaviors include pacing, effective rest and behavioural activation (where dysphoria was an issue). For some patients recommended action includes taking steps to engage with psychological therapies – for instance where trauma emerges as part of the explanation.

Learning comes from the participant implementing agreed actions and evaluating the impact of them on their symptoms. Learning also relates to the importance of summing up sessions and the course of treatment with key take-homes. This is also facilitated by letters to the patient’s usual GP (copied to the patient) after the first and final consultation summarizing some of the key points covered in the clinic.

The Symptoms Clinic intervention is described in a manual provided to the ER-GPs; however it is designed to be delivered flexibly and in a person-centred way which allows the clinician considerable freedom to focus on aspects of the patient’s problem that they deem most appropriate and in forms of words they personally feel comfortable with."
Click to expand...

Andy said:
Learning comes from the participant implementing agreed actions and evaluating the impact of them on their symptoms.
Click to expand...

Errm - so are we at this stage thinking given the medical professional isn't mentioning they want to hear about 'the impact' this is where it all starts to go off the rails into 'only one right answer, we are the type of people who make up what the world is to fit what we want it to be..'

Then this is where it gets sinister. I've said it somewhere else but this seems to be an issue that really needs looking into for this area: of implied risk due to usage of explicit threats, which deprive people of access to essential to life or health or human rights 'if they misbehave by contradicting ones theory'. The word 'facilitated' in the following sounds like a 'behavioural psychology' punishment-reward for 'doing what we want' technique.

How is that anything other than crude manipulation with no demonstration of 'to what' being in the patients best interests at all, but certainly removing choice and right to express truth or fact about their own body?

Andy said:
This is also facilitated by letters to the patient’s usual GP (copied to the patient) after the first and final consultation summarizing some of the key points covered in the clinic.
Click to expand...

Does this also not make explicit a method by which such manipulation and punishment/reward is enacted by those wishing to influence what patients are allowed to report and how future medical professionals might believe them? You'd like to think, legally, having this written down (at least from the authors) would prove this type of correspondence is used for certain purposes?
 
Andy said:
negotiate explanations for symptoms
Click to expand...
Doctor: My opening bid, your symptoms can be explained by catastrophising.

Patient: No, I'm not. I'm ill.

Doctor: But you must concede you're focussing a lot on your symptoms. You brought a list.

Patient: Well, I'm ill and that makes me forget things so I thought a list would be helpful.

Doctor: Indeed. And to write a symptom list you must have been focussing on your symptoms. Well, that's agreed then.

Patient [about to faint from the exertion of visiting the clinic]: Whatever.

Doctor [scribbles down]: 'Patient affirms catastrophising. Treat for health anxiety.'
 
This trial has been running for several years already.

The lead researcher Chris Burton was on the NICE ME/CFS guideline committee. S4ME wrote to the chair of the committee in January 2019 after Burton's appointment was announced to protest his inclusion on the grounds of conflict of interest because of this trial using the same flawed research methodology as PACE etc.
Our letter and the reply are here:
S4ME Letter to Nice Concerning Chris Burton
 
Trish said:
Attention has been drawn back to this because Burton et al have published the protocol for their trial referred to in our letter, see this thread:
https://www.s4me.info/threads/unite...-mus-treatment-trial.18696/page-2#post-447008
To discuss the trial, go to that thread.

I have raised it here because we were reassured conflicts of interest would be taken into account in who was allowed to contribute to parts of the guideline writing process. I'm wondering whether any of the COI's we raised were considered, specifically whether Burton was excluded from decisions relating to research methodology and the definition of ME/CFS and its relationship to 'MUS'. @adambeyoncelowe
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Edit: Answered the wrong thing. Deleted most of my post and summarised the relevant parts to spare you all the eyestrain.

For the record, I don't think Chris Burton could have negatively influenced discussions on trial design (and if he tried, he failed, because we pointed out those flaws numerous times).

In terms of the research itself, it's still going to be poor quality, so won't account for much at NICE. Its purpose may just be to justify service provision, rather than shape NICE, so they may feel they can get away with cheap and low quality.

I am pleased that ME is not lumped in with MUS or PPS in this trial, but I'm disappointed that those conceptions of illness continue largely unchanged.

That means the problem is still there, and many pwME will be at risk of getting the wrong diagnosis in order that services can give them harmful treatments.

The change in language, however, does express a shift to sound more patient-focused, which could be an opportunity for us if there are any patients who have the capacity to engage with researchers proactively.

Often researchers need to show they have co-designed their trials with patients now, so it's better we get involved rather than Recovery Norge (an "astroturf" organisation if ever I've seen one).
 
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Thanks, @adambeyoncelowe for that detailed and thoughtful response. I agree there's not point asking NICE to do anything further about Chris Burton now - our letter to NICE was a response to his appointment in 2019. I don't think anyone is suggesting any further approach to NICE.

It's good to hear he seemed open to learning about better approaches to research.

I agree in principle that it's good to get patients in at the start in research design, but I worry that there are very few patients who really understand the issues. I certainly wouldn't have been nearly as useful back before I became involved in forum discussions and learned a lot about research methodology and flaws.
 
Trish said:
I agree in principle that it's good to get patients in at the start in research design, but I worry that there are very few patients who really understand the issues. I certainly wouldn't have been nearly as useful back before I became involved in forum discussions and learned a lot about research methodology and flaws.
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While obviously it is ideal to have fully informed patients involved, from my experience common sense can get you a long way. And, on balance, I would far prefer to have a patient involved than not.
 
Trish said:
Thanks, @adambeyoncelowe for that detailed and thoughtful response. I agree there's not point asking NICE to do anything further about Chris Burton now - our letter to NICE was a response to his appointment in 2019. I don't think anyone is suggesting any further approach to NICE.
Click to expand...

Many apologies, Trish! I was confused by being tagged in multiple threads at once, and thought you were suggesting following up with NICE.

Hence my response was primarily about the COI process and whether this paper represented Chris Burton's views at the time or not, or whether those views impacted the GL, rather than the trial at hand (which I hadn't looked at).

Sadly, regardless of any apparent learning during the NICE process, this trial still seems to be using the same old poor quality design, so I have changed my comment accordingly.
It's good to hear he seemed open to learning about better approaches to research.

I agree in principle that it's good to get patients in at the start in research design, but I worry that there are very few patients who really understand the issues. I certainly wouldn't have been nearly as useful back before I became involved in forum discussions and learned a lot about research methodology and flaws.
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While you may be right, part of the problem is that "no patients allowed" almost guarantees garbage.
Andy said:
While obviously it is ideal to have fully informed patients involved, from my experience common sense can get you a long way. And, on balance, I would far prefer to have a patient involved than not.
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Exactly. My only regret now is not engaging with him more, as perhaps I could've been that person!

But it may have been that, for this particular trial, I wouldn't have been able to make any changes anyway.

As I said in my essay upthread (before basically deleting it all), we did discuss better trial design several times, including lots of options for more objective measures. Some of those ideas seemed quite good. But it seems none were used here.

I guess another complicating factor is that "PPS" is such a hodgepodge that no one set of measures would apply to all symptoms, unless you go for something so vague and broad as to be useless. Which is precisely what's happened...
 
Another frustrating piece of research. I worry that it will seem like common sense - look at symptoms then treat them - so any criticism by us will make it seem we are antiscience just like they say.

The only way to get by with ME is to become your own doctor. With no medical input, we need to look at each symptom we have, work out why it is happening, then see if something would help. It would be marvellous to talk to a professional about things; it is one of the valuable aspects of this forum.

But I do not want to talk to anyone who uses the word catastrophising!
 
Mithriel said:
Another frustrating piece of research. I worry that it will seem like common sense - look at symptoms then treat them - so any criticism by us will make it seem we are antiscience just like they say.

The only way to get by with ME is to become your own doctor. With no medical input, we need to look at each symptom we have, work out why it is happening, then see if something would help. It would be marvellous to talk to a professional about things; it is one of the valuable aspects of this forum.

But I do not want to talk to anyone who uses the word catastrophising!
Click to expand...
I agree. The wording is designed to sound reasonable. It's certainly less offensive than older stuff. In some ways, that's better if it leads to fewer people holding offensive views, but it still doesn't address the core problems.

We should be getting better quality trials and we shouldn't be looking at vague population groups. All it does is produce more unusable data.

Some of the objective measures Chris Burton and I discussed were things like HRV monitoring, reaction speed tests at different times of the day, and an AI programme/app Oxford Brookes had pitched.

The app would apparently record sound throughout the day and attempt to correlate this against other reported/measured changes.

So the sound of people speaking might help indicate the amount of social activity undertaken, while the sound of the TV or radio might indicate cognitive activity, and the sound of plates and splashing water might indicate physical activity in the form of chores, etc.

If you had a map of patient-reported symptom flares and activity via the app; HRV and reaction speed test results from different time periods in the day; and then all this data from audio recordings (and potentially vibrations/movement), the AI could have attempted to chart any connections between all that noise.

No doubt that would have been expensive, but the university were working on that sort of stuff anyway, so it's not impossible. It would have been much, much better.
 
Merged thread

Commentary re newly published? trial on MUS in the Lancet.

Silje Endresen Reme

https://doi.org/10.1016/S0140-6736(24)01138-3

https://www.thelancet.com/journals/...=cover24&utm_source=twitter&utm_medium=social

Highlights "Furthermore, the trial does not address whether symptom improvements led to better real-life functioning, such as decreased work disability."

Used subjective primary outcome measure in unblinded trial.

No objective assessment of any real world benefits. :banghead:

Same old, same old. The Lancet learned nothing from PACE.

First part:
For years, the term medically unexplained symptoms has been used to describe patients with persistent physical symptoms but no detectable disease. In clinical care, these patients have often been referred to as heartsink patients, a term reflecting the frustration of both patient and doctor in finding effective treatments for their symptoms. But are these symptoms really unexplained?

Physical symptoms, like all perceptual experiences, come from complex neural activity in the brain. Although these symptoms often are triggered by bodily signals, such as tissue damage, the same symptoms can arise without any such input.

For example, the brain generates pain whenever it anticipates or believes there is a reason for us to feel pain.

This process explains why we can experience severe pain without injury and, conversely, experience severe injury without any pain.

Studies of hypnotic suggestions to induce pain have shown that the hypnotic pain triggers neural activation in pain-related areas, as if the pain was caused by tissue damage.

Furthermore, associative learning enables physical symptoms to be triggered by sounds
or smells, and even viewing distressing pictures can trigger physical symptoms. Compared with healthy control individuals, the effect of distressing pictures on symptoms is considerably more pronounced among patients with persistent physical symptoms; the neural correlates of this effect involve somatosensory and nociceptive brain patterns, regions intimately connected to pain processing.......

Seems to be referring to

Burton C Mooney C Sutton L et al.
Effectiveness of a symptom-clinic intervention delivered by general practitioners with an extended role for people with multiple and persistent physical symptoms in England: the Multiple Symptoms Study 3 pragmatic, multicentre, parallel-group, individually randomised controlled trial.
Lancet. 2024; 403: 2619-2629

That article is not coming up from the Google Scholar link.
 
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Paper

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)00700-1/fulltext

Effectiveness of a symptom-clinic intervention delivered by general practitioners with an extended role for people with multiple and persistent physical symptoms in England: the Multiple Symptoms Study 3 pragmatic, multicentre, parallel-group, individually randomised controlled trial

Prof Christopher Burton, MD

Cara Mooney, MSc

Laura Sutton, PhD

David White, MPH

Prof Jeremy Dawson, PhD

Aileen R Neilson, MSc

et al.

Open AccessPublished:June 15

2024DOI:https://doi.org/10.1016/S0140-6736(24)00700-1
 
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