The effects of a structured communication tool in patients with medically unexplained physical symptoms: a cluster randomized trial 2023 Abrahamsen

Andy

Andy

Senior Member (Voting rights)
Background
Medically Unexplained Physical Symptoms (MUPS) are prevalent among primary care patients and frequently lead to diminished quality of life, increased healthcare costs, and decreased work participation. We aimed to examine the effects of a work-focused structured communication tool based on cognitive-behavioral therapy in patients with MUPS.

Methods
In a Norwegian two-arm cluster randomized trial, the effectiveness of the structured communication tool Individual Challenge Inventory Tool (ICIT) was compared to usual care for patients with MUPS using a two-arm cluster randomized design. Enrollment period was between March 7 and April 1, 2022. Ten groups (clusters) of 103 General Practitioners (GPs) were randomized to provide the ICIT or usual care for 11 weeks. Patients received two or more sessions with their GP, and outcomes were assessed individually. Primary outcome was patient-reported change in function, symptoms, and quality of life measured by the Patient Global Impression of Change (PGIC). Secondary outcomes included sick leave, work-related self-efficacy (RTW-SE), health-related quality of life (RAND-36), and patient experiences with consultants (PEQ). The trial was registered on ClinicalTrials.gov (NCT05128019).

Findings
A total of 541 patients with MUPS were enrolled in the study. In the intervention group 76% (n = 223) showed a significant overall improvement in function, symptoms, and quality of life as measured by the PGIC, compared to 38% (n = 236) in the usual care group (mean difference −0.8 ([95% CI −1.0 to −0.6]; p < 0.0001). At 11 weeks, the intervention group had a 27-percentage point decrease in sick leave (from 52.0 to 25.2), compared to 4-percentage point decrease (from 49.7 to 45.7) in the usual care group. Furthermore, compared to usual care, the intervention group reported significant improvements in work-related self-efficacy, health-related quality of life, and greater satisfaction with the communication during the consultations. No adverse events were reported.

Interpretation
The implementation of the structured communication tool ICIT in primary care significantly improved patient outcomes and reduced sick leave among patients with MUPS.

Open access, https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00439-X/fulltext#
 
From Methods.

Participants in the study were selected by their GP if they were aged 18 years or older and had experienced one or more of 23 physical complaints listed in the "Robbins list" for at least three months14 (Table 1). This selection procedure aligns with previous research.3 Additionally, participants had to meet the following criteria: (1) functional impairment with sick leave constantly or on and off over a long period of time, and/or (2) withdrawal or avoidance from social activities due to MUPS, (3) gone through adequate medical assessment with no explanatory pathology, and (4) symptom duration of at least three consecutive months to exclude transient ailments.

Table 1
1. Back pain
2. Joint pain
3. Extremity pain
4. Headaches
5. Weakness
6. Fatigue
7. Sleep disturbance
8. Difficulty concentrating
9. Loss of appetite
10. Weight change
11. Restlessness
12. Thoughts slower
13. Chest pain
14. Shortness of breath
15. Palpitations
16. Dizziness
17. Lump in throat
18. Numbness
19. Nausea
20. Loose bowels
21. Gas or bloating
22. Constipation
23. Abdominal pain
 
This study is getting popular in Norway. I've seen it mentioned several times, as for instance from today in this article written by the University of Oslo.

Ny studie gir håp for pasienter med medisinsk uforklarlige plager og symptomer
google translation: New study offers hope for patients with medically unexplained ailments and symptoms

I wonder if there is a Freudian slip in the Norwegian title. "Medisinsk uforklart sykdom"/MUS is medically unexplained illness, but here they've written "uforklarlig" which is "unexplainable". In other words they've concluded that it's unexplainable, instead of something that is not yet explained.

quote from article:
After 11 weeks, the patients in the group where the tool was used had a reduction in sickness absence of 27 percent. In the control group it was 4 percent.

The patients also gave positive feedback on the treatment. No side effects were reported either.

– The conversation tool, based on principles from cognitive therapy and tailored for general practice, gives the patients an explanation for their complaints when conventional tests do not show anything abnormal. Furthermore, it helps them to draw up concrete plans for how they can get better both in their private life and at work, explains Abrahamsen.
 
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Kalliope said:
I wonder if there is a Freudian slip in the Norwegian title. "Medisinsk uforklart sykdom"/MUS is medically unexplained illness, but here they've written "uforklarlig" which is "unexplainable". In order words they've concluded that it's unexplainable, instead of something that is not yet explained.
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Perhaps here is another Freudian slip, from the 'Added value of this study' summary:
This study compromises of 541 patients with MUPS and 103 GPs.
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Rather than 'comprising', this study 'compromises' both patients and GPs
'Compromising' definitions:
  • (of information or a situation) revealing an embarrassing or incriminating secret about someone. e.g. "compromising letters and blackmail"
  • expediently accept standards that are lower than is desirable. e.g. "we were not prepared to compromise on safety"
  • weaken or harm by accepting standards that are lower than is desirable. "he won't accept any decisions which compromise his principles"
  • bring into disrepute or danger by indiscreet, foolish, or reckless behaviour. e.g. "situations in which his troops could be compromised"
  • cause to become vulnerable or function less effectively e.g. "yo-yo dieting can compromise your immune system"
 
I've never heard of the Robbin's List before. I took a look at the reference (no. 14) :
  1. 14.
    • Robbins J.M.
    • Kirmayer L.J.
    • Hemami S.
    Latent variable models of functional somatic distress.
    J Nerv Ment Dis. 1997; 185: 606-615
    View in Article
Click to expand...

It's old. And if you follow the reference further you can find the whole paper the reference is for linked in Google Scholar (but the link for it is very, very long). It's absolutely typical 1990s (and later) BPS stuff - blame the patient and their mental health. It refers to Fibromyalgia, CFS, Chronic Fatigue, and IBS, plus the inevitable Depression and Anxiety. It refers to the symptoms as being "functional".

(I couldn't bring myself to read all of reference 14 - it is the kind of thing I've read many times before.)

Edit : I found lots of references in the text to the "DIS" and this is what it is :

NIMH Diagnostic Interview Schedule (DIS: Robins et al., 1981)
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I think that sick leave outcome can be explained by the bias in participant selection.

Participants were excluded from the study if: (1) they did not speak Norwegian sufficiently to answer the questionnaire, (2) they were currently undergoing medical assessment with indications of specific pathology, (3) they did not share the GPs opinion of their complaints and requested further medical examination, or (4) had alcohol or drug addiction.
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If a GP started suggesting to a patient with persisting symptoms that they could just think better and be well, there's a reasonable chance that that patient isn't going to turn up for the second session of being told that. They might even decide that it's time for a new GP.

It's very likely that the participants who stuck with the doctor were either improving anyway or were able to push through their symptom when encouraged to do so, at least for a while. so, I think it would be wrong to assume that that apparent benefit of reduced sick leave could be applied to the general population of people with persisting symptoms.
 
Hutan said:
I think that sick leave outcome can be explained by the bias in participant selection.



If a GP started suggesting to a patient with persisting symptoms that they could just think better and be well, there's a reasonable chance that that patient isn't going to turn up for the second session of being told that. They might even decide that it's time for a new GP.

It's very likely that the participants who stuck with the doctor were either improving anyway or were able to push through their symptom when encouraged to do so, at least for a while. so, I think it would be wrong to assume that that apparent benefit of reduced sick leave could be applied to the general population of people with persisting symptoms.
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Oh, hey, Simpsons did that one, too.

m7fygk8v82371.jpg


This is why they talk a lot about patients buying into the steps of the program. If the patients comply, regardless of their condition, easy win. They simply keep out anyone who would resist harming themselves, and of course giving up is usually written off as having improved.

Literally more red flags of pseudoscience than a red flag warehouse.
 
rvallee said:
This is why they talk a lot about patients buying into the steps of the program. If the patients comply, regardless of their condition, easy win. They simply keep out anyone who would resist harming themselves, and of course giving up is usually written off as having improved.
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Yes, it's the perfect therapy, from the point of view of the medical professional.

Belief that the therapy will cure is the therapy. If you don't believe, then you don't want or get the therapy (and you don't want to be well enough). If you aren't cured, then you didn't believe well enough.

The 'medical professional' can never be found to be inadequate, only the patient.
 
The Lancet at it again :banghead:

The bias here is so obvious :facepalm:

Only allow pts into the trial if they confirm to the researchers world view at the outset. Then marvel at how it works out.

Long laundry list of differing symptoms and conditions. Some likely to ve self limiting/regression to the mean etc.

If a pts was generally improving naturally, then they would likely benefit from some support and interaction with a helpful person to find their feet, confidence and re-engage in valued activities including work.
 
Kalliope said:
From the paper:
It is estimated that up to 40% of all consultations in primary care involve patients presenting with MUPS.
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Surely if you go a Doctor & they cannot explain your symptoms then one explanation is -- well the Doctor is poor? If the Doctor asks colleagues maybe the % decreases --- apart from identifying gaps in medical knowledge I don't think this tells us much.
Yes, I can imagine Paul Garner might classify a high percentage!
 
Joan Crawford said:
The Lancet at it again :banghead:

The bias here is so obvious :facepalm:

Only allow pts into the trial if they confirm to the researchers world view at the outset. Then marvel at how it works out.

Long laundry list of differing symptoms and conditions. Some likely to ve self limiting/regression to the mean etc.

If a pts was generally improving naturally, then they would likely benefit from some support and interaction with a helpful person to find their feet, confidence and re-engage in valued activities including work.
Click to expand...
Using that methodology, I have it on good authority that Scientology works 100% of the time. As confirmed by the church of Scientology. Hey, if you can't trust people who dedicate themselves to helping others, who can you trust?! They'll get rid of those ghosts of dead aliens causing mental illness.

If you believe in it. Belief is key. Not like in alternative medicine. Well, OK, just like with alternative medicine. But it's official, so it's completely different. OK, it's the same, actually it's worse, but you can't apply this thinking with non-official pseudoscience, it only works if it's a licensed professional doing the same thing.

It's all so damn lazy. They have this obvious belief that their authority and credibility is a given and can never be lost, that they can say and do whatever, no matter how obviously absurd, and never face any consequences, never lose any trust. Even as they write so often about that lost trust, then how to manipulate their way into getting it back. It's all so freaking insane.
 
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rvallee said:
But it's official, so it's completely different.
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That makes all the difference. I met a group of UFO spotters once, but I knew they were genuine as they all had laminated ID cards with their photos and every thing. Obviously their observations were scientifically verifiable as they had clip boards and preprinted recording sheets to make sure they noted everything systematically.
 
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