Psychosomatic therapy for patients frequently attending primary care with MUS,the CORPUS trial: study protocol for an RCT-Wortman et al 2019

Sly Saint

Senior Member (Voting Rights)
Psychosomatic therapy for patients frequently attending primary care with medically unexplained symptoms, the CORPUS trial: study protocol for a randomised controlled trial
Open access, published Dec 2019
Abstract
Background

Medically unexplained symptoms (MUS) are highly prevalent and pose a burden both on patients and on health care. In a pilot study psychosomatic therapy delivered by specialised therapists for patients with MUS showed promising results with regard to patient’s acceptability, feasibility and effects on symptoms. The aim of this study is to establish whether psychosomatic therapy by specialised psychosomatic exercise therapists is cost- effective in decreasing symptoms and improving functioning in patients who frequently consult their general practitioner (GP) with MUS.

Methods
A randomised effectiveness trial with an economic evaluation in primary care with 158 patients aged 18 years and older who are frequently consulting their GP with MUS. Patients will be assigned to psychosomatic therapy in addition to usual care or usual care only. Psychosomatic therapy is a multi-component and tailored intervention, aiming to empower patients by applying psycho-education, relaxation techniques, mindfulness, cognitive approaches and/or graded activity. Patients assigned to the psychosomatic therapy receive 6 to 12 sessions of psychosomatic therapy, of 30–45 min each, delivered by a specialised exercise or physical therapist.

Primary outcome measure is patient-specific functioning and disability, measured with the Patient-Specific Functional Scale (PSFS). Secondary outcome measures are symptom severity, consultation frequency and referrals to secondary care, patient satisfaction, quality of life and costs. Assessments will be carried out at baseline, and after 4 and 12 months.

An economic evaluation alongside the trial will be conducted from a societal perspective, with quality-adjusted life years (QALYs) as outcome measure. Furthermore, a mixed-methods process evaluation will be conducted.

Discussion
We expect that psychosomatic therapy in primary care for patients who frequently attend the GP for MUS will improve symptoms and daily functioning and disability, while reducing consultation frequency and referrals to secondary care. We expect that the psychosomatic therapy provides value for money for patients with MUS.

Trial registration
Netherlands Trial Register, ID: NL7157 (NTR7356). Registered 13 July 2018.
Trial status

The protocol version number and date: version 10, 8 May 2018. Patient recruitment started in January 2019. The recruitment of participants was ongoing at the time of the submission of this manuscript. Follow-up assessments of patients are expected to be completed in January 2021.

https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3913-3
 
These approaches often include some kind of education or explanation on how symptoms supposedly arise.

I think this may be a significant source of bias because it presumably involves patients being told fairly clearly what behaviour and results are expected from them. For example if patients are told that their symptoms have an emotional basis and aren't the doctor's responsibility, that could discourage them from seeing their GP. If they are told that the symptoms will improve with the treatment they're given then they're more likely to change their symptom reporing accordingly. That could result inpatients downplaying their symptoms and visiting their GP less. Presumably the proponents of this approach think this is a perfectly good result because there never was any justification for the patient's behaviour in the first place, due to there being no findings consistent with a known disease. The possibility that these patients have a difficult to diagnose disease or one that is not yet diagnosable is not apparently given serious consideration.

I understand that it makes not much sense if patients continue seeing a GP that can't help them but getting patients to believe in some unfalsifiable idea in order to change their behaviour is not appropriate. This helps the GP but maybe not the patient.
 
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Isn't there a point at which people working in this field find issue with the fact that it's just the same 2 things being done near identically over and over again? Are they OK with this? Don't realize it? I'm not sure which is worse.

I guess the "innovation" here is the opposite of the recent trend, of making it super obvious that they mean psychosomatic rather than pretending they imply nothing of the sort. Wow. So novel. No one's ever tried "there is no disease, you can aim for 100% recovery" before. Nope. Well, they did, many times, nearly identically, but better do it 100x more times just to be sure. Once while wearing a fake mustache. Once while singing during the CBT. Once more singing with a fake mustache during the CBT. Once with the patient wearing the fake mustache. Once more with the therapist wearing a difference mustache than the patient. And on and on and on.

Because this isn't like the 200+ Alzheimer's drugs that were tested and failed. It's more like trying 200+ with the exact same drug but with differently colored packages or pill form, or maybe some random ritual before taking it, irrelevant differences that change nothing to the fact that it's the same thing stuck in a loop for decades.

Complete waste of funding. I don't get it, it serves absolutely no purpose other than employing people who can't do science, but would otherwise have plenty of work anyway. The cluelessness is just staggering:
They report that they experience a lack of empathy and support, feel stigmatised and not taken seriously, and are worried because neither they nor their physicians understand where the symptoms come from
Literally doing exactly that. Responding to lack of empathy with even more lack of empathy. Brilliant. What is the explanation for being so utterly blind about every damn thing they do?
A Cochrane review assessing the effects of non-pharmacological interventions for MUS concluded that when all psychological therapies included in the review are combined they seem to be superior to usual care or waiting list controls in terms of reduction of symptom severity
"Yes, we've tried them all, but have we tried them all together all at once?!" GENIUS!

The fact that there is an economic analysis says everything about the goals, especially given this approach has already proven to be useless. Not just counting your chickens before they hatch but actually selling the eggs your future chickens may produce, for tomorrow's breakfast.

Look closely and this is largely a copy of PACE, comparing a few treatment arms with no discernible reason. Didn't bother with objective outcomes this time, though, saves them the trouble of having to justify dropping them later on. Primary outcome is a single self-reported questionnaire over perceived limitations, then a bunch of random questionnaires scrambled by mathemagics. Allows everything to be interpreted to whatever conclusion they already reached (you'll never guess which one!).

People involved in the funding and approval of this study are making very poor use of public academic resources.
A strength of our study is that the psychosomatic therapy is a well-accessible intervention already delivered in primary care by physical therapists with special interests in MUS
So the "treatment" is already in common use. Which would imply it should be effective, otherwise it would be insane that it would commonly used. But obviously not, because that's not how BPS rolls, first you deploy despite small-scale failure, then you test and argue that it's been in use for a while so might as well not waste all that sunk cost even when it is clearly useless.
In conclusion, if proven cost-effective, psychosomatic therapy would provide a valuable additional treatment option for adult patients with MUS.
But it's already in common use, you just said that a few paragraphs before, how can it be an additional option? Oh nevermind, nobody expects consistency here.

Weird that none of the references are any of the other identical prior trials. It's groundhog day, every day, amnesia-based evidence.
 
Its probably important to look at the primary and secondary outcomes to get an idea if the trial is going to give any meaningful information,

Primary outcome measure is patient-specific functioning and disability, measured with the Patient-Specific Functional Scale (PSFS). Secondary outcome measures are symptom severity, consultation frequency and referrals to secondary care, patient satisfaction, quality of life and costs. Assessments will be carried out at baseline, and after 4 and 12 months.

A form for the patient specific functionalscale us here
http://www.tac.vic.gov.au/__data/assets/pdf_file/0020/27317/Patient-specific.pdf

It looks like its basically self reported ability to perform up to three activities. So given the 'psychosomatic therapy' is about getting people to think differently about their abilities then the trial is probably meaningless. I really think ethics committees should not be allowing such trials to happen they give no useful information and so are unethical.
 
One thing that continues to strike me with this stuff is the follow-up length.

A few months or a year is not enough time to gather convincing evidence of sustained improvement when these treatments are presumably supposed improve your functioning for the entire course of your life. Certainly not with self-report, but even with verifiable 'behavioral' outcomes - hours in work or school, actometry - which may be subject to a transient motivational boost.

This is akin to the 'new manager boost' in football. Just ask Manchester United how things are working out. Something like yo-yo dieting would also be comparable.

It would be potentially much more convincing if data were gathered at 5, even 20 years on, to make sure there is no 'boost'. Of course enough data would have to be collected, and there would have to be enough 'disinterested' supervision such that you could show that people weren't being unduly coerced to achieve the verifiable metrics. It seems possible to do, although maybe it is not actually feasible.

The fact that these MUS types don't have the ambition to do it suggests to me that they really don't expect these therapies to make any difference for patients. Other than maybe making them buzz off from asking for actually useful and costly support, in which case they would actually be expecting to make life more difficult for their patients.
 
I think this may be a significant source of bias because it presumably involves patients being told fairly clearly what behaviour and results are expected from them.
This times a million.

Hmmm. I would have guessed that "psychosomatic therapy" was where practitioners offered psychological advice because it makes them feel better.
Yes, for whose benefit is this study?
 
In case anyone was wondering how they got "CORPUS"...

COst-effectiveness of psychosomatic theRapy for patients frequently attending Primary care with medically Unexplained Symptoms
https://www.trialregister.nl/trial/7157

Apparently the Dutch are capable of even worse acronyms than the British! Someone should do a systematic review and public perception survey of worst medical research acronyms for the BMJ. Call it the VOMIT study (Vulgar Orwellian Mean Ignorant Test).
 
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