Multiple Symptoms Study 3: pragmatic trial of a community based clinic for patients with persistent (medically unexplained) physical symptoms

[Hoopoe]

Chris Burton, who is on the NICE panel reviewing the ME/CFS guidelines, is behind this study apparently.

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. Persistent physical symptoms 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.

The commonest (at least among professionals and researchers) is “medically unexplained symptoms” (MUS). Some persistent physical syndromes are grouped into clusters (syndromes) such as irritable bowel syndrome, fibromyalgia and chronic fatigue.

Note that an earlier version used the term chronic fatigue syndrome instead of chronic fatigue.

The intervention being assessed is a psychologically informed medical consultation (Symptoms Clinic) delivered by a specially trained ER-GP. The consultations include detailed medical history taking, explanation (including discussion of a ppropriate diagnosis) and advice about management. Consultations do not include physical examination unless there is a specific indication. 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.

Patients will be individually randomised (1:1) and will be allocated to the Symptoms Clinic plus usual care or usual care alone

http://www.isrctn.com/editorial/retrieveFile/6b3d6b51-92b3-4825-89a8-9060bf0da471/35773

The outcomes are all subjective of course. It's the usual clinical trial with uncontrolled bias affecting outcomes that calls itself randomized controlled trial. Although the intensity of treatment seems so low that they might struggle to obtain any results regardless.

 

[Trish]

It's the protocol for a study that is funded and about to start. I've posted about it here, so I won't repeat myself.

 

[Hoopoe]

Yes. There is no chance that Chris Burton will be able to acknowledge any of the problems with PACE and the rest of the CBT/GET/MUS literature. He is following the same recipe.

 

[Jonathan Edwards]

It isn't a controlled trial. But then...

The value of pragmatic trials was, I thought, that they occurred in real life clinical setting. However, presumably for this trial patients have to consent to either being in the trial or not. If they not in the trial presumably they just get usual treatment. If they in the trial they might get something more - or might not. So if they got the something more they would have to indicate they are grateful for that...

 

[Sly Saint]

they have updated the protocol for this trial
protocol Feb 2019
https://njl-admin.nihr.ac.uk/document/download/2028504

 

[rvallee]

they have updated the protocol for this trial
protocol Feb 2019
https://njl-admin.nihr.ac.uk/document/download/2028504

We have developed a model of “rational explanation” [14] which enables clinicians to integrate knowledge from central sensitisation with patients’ reported experiences to develop explanations for symptoms.

So the FINE "rousing reassurance" model, just taken down a notch. A model that failed, obviously, because it's incredibly stupid.

How can there be a "rational explanation" for "medically unexplained symptoms"?.

Let's parse this down a bit: medically, unexplained, symptoms. Unexplained. Rational explanation.

Say that out loud, very slowly. Which they probably did, to a committee, which then found it reasonable to give funding to this.

Because meanwhile the proposals for actual ME research are allegedly turned down because they are of poor quality. Clearly poor quality is not an issue to funding, it's almost a requirement, it seems, to have an internal contradiction in the opening paragraph.

They're aware these are people's lives, right? Real people? Not disposable cartoons? But I guess if no one actually measures anything objective, the harm doesn't exist, right?

 

[Amw66]

So the FINE "rousing reassurance" model, just taken down a notch. A model that failed, obviously, because it's incredibly stupid.

How can there be a "rational explanation" for "medically unexplained symptoms"?.

Let's parse this down a bit: medically, unexplained, symptoms. Unexplained. Rational explanation.

Say that out loud, very slowly. Which they probably did, to a committee, which then found it reasonable to give funding to this.

Because meanwhile the proposals for actual ME research are allegedly turned down because they are of poor quality. Clearly poor quality is not an issue to funding, it's almost a requirement, it seems, to have an internal contradiction in the opening paragraph.

They're aware these are people's lives, right? Real people? Not disposable cartoons? But I guess if no one actually measures anything objective, the harm doesn't exist, right?

Central sensitisation is the new means of latching onto funding. Seems to be miles from its original meaning ( highlighted recently by mike van elzakker on Twitter) .
It makes it seem more science-y.

Is this not Per Fink' s theory?

 

[Esther12]

We have developed a model of “rational explanation” [14] which enables clinicians to integrate knowledge from central sensitisation with patients’ reported experiences to develop explanations for symptoms. These rational explanations make sense of symptoms in terms of brain and body processes and are acceptable to doctor and patient [15, 16]. They leave room for psychosocial influences without placing them as the cause, and they provide opportunities to guide self-management. In rational explanations, psychological factors such as heightened vigilance to symptoms or persistent worry about symptoms are presented as understandable mechanisms by which symptoms persist rather than signs that symptoms have a “psychosomatic” cause. In contrast, previously advocated explanatory models such as somatisation are rejected by patients as too simplistic [9, 10] and leave patients with persistent physical symptoms dissatisfied with the explanations they receive.

So now a “rational explanation” seems to be nothing more than a narrative that fits in with their prejudices and that they can manipulate some patients into 'accepting'.

The Burton paper on 'rational explanation':

Burton, C., et al., Explaining symptoms after negative tests: towards a rational explanation. Journal of the Royal Society of Medicine, 2015. 108(3): p. 84-88.

The paper showing how 'acceptable' these are to patients:

den Boeft, M., et al., Negotiating explanations: doctor–patient communication with patients with medically unexplained symptoms—a qualitative analysis. Family Practice, 2017. 34(1): p. 107-113.

Burton's inclusion on the NICE ME/CFS committee just shows what disdain they have for patients.

 

[ME/CFS Skeptic]

The whole idea seems to be a label that notifies doctors that the patient needs less investigation and lab tests and more psychotherapy, without the patient realizing this.