Early identification of functional somatic disorders in an internal medicine diagnostic clinic: The DISTRESS trial 2025 Madsen, Fink et al

[Andy]

Abstract​

Background​

Functional Somatic Disorders (FSDs) affect approximately 10 % of the general population (1) and often lead to reduced quality of life, extensive diagnostic evaluations and increased healthcare costs. The DISTRESS (Diagnostic Intervention in Secondary care Targeting patients Referred for Evaluation of bodily Stress Symptoms) trial protocol describes a randomised clinical trial evaluating a novel FSD Diagnostic Clinic, with the aim of providing early diagnosis and thereby helping patients and clinicians bring the diagnostic odyssey to a definitive and meaningful conclusion.

Methods/design​

This pragmatic, randomised trial employs allocation concealment and blinded outcome assessment, although patients and clinicians cannot be blinded due to the nature of the intervention. Patients with suspected FSD are randomised 1:1 to either the FSD Diagnostic Clinic, where internal medicine specialists (internists) undertake the FSD diagnostic process, or to usual diagnostic assessment. The two co-primary outcomes evaluate (a) healthcare utilization and (b) costs-effectiveness, assessed alongside health-related quality of life measured by the SF-36 survey at 12 months post-intervention. Secondary outcomes include relevant clinical outcomes and overall public expenses.

Discussion​

The DISTRESS trial addresses challenges in diagnosing FSDs by evaluating a novel Diagnostic Clinic model and its impact on patient outcomes, cost-effectiveness, and healthcare utilization. Insights from separately conducted qualitative studies will complement the trial by assessing the clinic's acceptability and integration within the healthcare system. By training internists to diagnose and manage FSDs using approaches typically employed by FSD specialists, the FSD Diagnostic Clinic expands access to timely care within a stepped care model.

Paywall

 

[Trish]

Protocol:
https://clinicaltrials.gov/study/NCT06025617

Study Start (Actual)
2019-06-01
Primary Completion (Estimated)
2025-12
Study Completion (Estimated)
2026-09
Enrollment (Actual)
290
Study Type
Interventional

Experimental: Intervention arm Patients referred by their GP under suspicion of suffering from FSD are randomized to the intervention arm.

Other: Diagnostic evaluation at the Diagnostic Clinic for Functional Disorders The intervention consists of being examined at the Diagnostic Clinic for Functional Disorders. If an FSD diagnosis is established, the patient receives feed-back of on the FSD diagnosis and patient education about the condition. Subsequently, the clinic provides guidance to the GP regarding recommended management and treatment options tailored to each individual patient.

Active Comparator: Control arm Patients referred by their GP under suspicion of suffering from FSD are randomized to "Diagnostic as usual" in the control arm.

Other: Diagnostic as usual "Diagnostic as usual" consists in being referred to be examined at another existing specialist clinic in the secondary sector, as specified by the patient's GP.

 

[Trish]

That description seems to imply it's simply a comparison of outcomes between their clinic and other available clinics. They don't specify what patient education and recommended management they use, saying it's individualised, so the results will be completely useless apart from providing advertising for their clinic if it comes out better than other clinics in the study.

 

[bobbler]

There’s a real issue behind all these papers and authors that I’m starting to realising seems to circle around an issue to do with accountability.

And trying to provide a veil of it being their whilst actually it’s a switch and bait of moving out any normal measures by which these things would normally be accountable and distracting from it either other ‘jangly keys’

I’m watching it closely and hoping the words come to me soon

But I can’t help but think of the further down the line stuff of eg the PROMs project and how it’s the bacme staff low down in the clinics that are getting left holding the baby on the accountability whilst these manifesto writers just assert false claims of things definitely working

And I’m not sure any proms currently will work either for the patients or the staff on the front line to keep them from being stitched up if they are being KPId as if treatment that can’t work and can harm should ‘produce results’

It makes me think differently about the audience if these things because I can imagine any sensible union in another industry but when I look at the make-up of the power-base in bacme and the cfs clinics and the staff delivering vs those running the kingdoms and companies etc it starts to sound like ‘starting with convincing the low down staff who will be in the front line’ etc . And the higher ups of where ‘if it goes wrong it’s not the choice of treatment but just be going wrong in delivery’ type thing or am I just smelling a bit of pushing about of accountability?

It talks about sf-36 as primary outcome in the abstracts methods but in the discussion switches to cost effectiveness and healthcare utilization rather than whether anyone’s health was objectively measured to be better rather than worse. Then bangs in either distraction about acceptability and integration being ‘the important bit anyway’.

Anyway just my thoughts for now.

 

[Turtle]

I can't see beyond the paywall, but this kind of research seems to be done for insurers that have to pay the bills.
@bobbler mentioned this already: "cost effectiveness and healthcare utilisation".

More BPS papers show how cost effective they can be. The numbers of interventions seem to come down too. Somewhere on s4me I saw a paper that it could be done in two sessions.
Don't mention pain, don't mention fatigue and we'll teach you how to fill in the next questionaire. Over and done with. Time to pay out.

Drop out rates, who cares? Has the patient improved, who cares?
No one (doctors) could find something wrong anyway, so BPS can get away with that too.
As long as their bills het paid, who cares?

 

[rvallee]

Functional Somatic Disorders (FSDs) affect approximately 10 % of the general population

Obviously they don't. It doesn't get better from there. The fact that junk nonsense like this takes 7 years to show nothing is emblematic of how bankrupt this entire ideology is. They're not just running out the clock, they're running out lives.

Plus they call this an interventional trial, and it's not even that, just some useless evaluation between things that don't work. Words have been completely stripped of all meaning here.

 

[Jonathan Edwards]

I cannot make sense of an abstract with no results that says how good the treatment is.
If it is a pragmatic trial it will prove nothing anyway.

For years I have given people the benefit of the doubt but if they publish stuff as bad as this I no longer need to.

 

[Kitty]

I reserve the right to assume any publication with a judgement-laden title like DISTRESS is a drunken student prank, because obviously no grown adult would do something that mindless.