Persistent SOMAtic symptoms ACROSS diseases [SOMACROSS]—from risk factors to modification: scientific framework & overarching protocol, 2022

MSEsperanza

MSEsperanza

Senior Member (Voting Rights)
Löwe B, Andresen V, Van den Bergh O, et al
Persistent SOMAtic symptoms ACROSS diseases — from risk factors to modification: scientific framework and overarching protocol of the interdisciplinary SOMACROSS research unit (RU 5211)
BMJ Open 2022;12:e057596. doi: 10.1136/bmjopen-2021-057596

Abstract

Introduction

Persistent somatic symptoms (PSS) are highly prevalent in all areas of medicine; they are disabling for patients and costly for society. The subjective symptom burden often correlates poorly with the underlying disease severity, and patients’ needs for effective treatment are far from being met. Initial evidence indicates that, in addition to disease-specific pathophysiological processes, psychological factors such as expectations, somatosensory amplification and prior illness experiences contribute to symptom persistence in functional as well as in somatic diseases. However, prospective studies investigating the transition from acute to chronic somatic symptoms, integrating pathophysiological, psychological and social factors, are scarce. A better understanding of the multifactorial mechanisms of symptom persistence is crucial for developing targeted mechanism-based interventions for effective prevention and treatment of PSS. Thus, the overall aim of the interdisciplinary SOMACROSS research unit is to identify generic and disease-specific risk factors and aetiological mechanisms of symptom persistence across a range of diseases.

Methods and analysis

Seven projects will investigate risk factors and mechanisms of symptom persistence in a total of 3916 patients across 10 medical conditions. All study designs are prospective and share common assessment points, core instruments and outcome variables to allow comparison and validation of results across projects and conditions. Research will focus on the identification of generic and disease-specific mechanisms associated with unfavourable symptom course. The development of a multivariate prediction model will facilitate the understanding of the course of PSS across diseases.

Ethics and dissemination

All individual SOMACROSS studies were approved by the ethics committees of the Medical Chambers Hamburg and Münster, Germany. Findings will be disseminated through peer-reviewed publications, scientific conferences and the involvement of relevant stakeholders, patients and the lay public. This interdisciplinary research unit will fundamentally contribute to earlier recognition of patients at risk, and to the development of prevention and tailored treatment concepts for PSS.
 
The subjective symptom burden often correlates poorly with the underlying disease severity
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No. The actual symptom burden correlates poorly with what is assumed to be the underlying disease severity. You have no idea what the disease is. When we do understand the disease mechanism and its biomarkers, I would suggest the correlation will turn out to be very, very good.
 
Given that the protocol publication appears under the heading Mental Health, and the lead author is a professor of psychosomatic medicine, and several other authors are psychologists, it's easy to see what the slant of this research will be even before it starts.
 
Novelty and innovation
SOMACROSS takes on a fundamentally new perspective, by including two new ways of thinking in medicine: first, the abandonment of the concept of medical inexplicability in the diagnostic concepts of functional and somatoform disorders; and second, the shift away from the idea that subjective suffering can essentially be explained by the extent of the underlying physiological pathology.

Assuming that biological markers alone do not sufficiently explain aetiology and development of PSS, we will investigate the interaction of biological, psychological and social factors regarding their contribution to subjective symptom severity and symptom persistence in 10 different medical conditions.

In this way, SOMACROSS will critically challenge the still prevalent dualistic mind–body disease model in medicine. The use of a trans-symptomatic and trans-diagnostic approach will enable the identification of patterns, risk factors and aetiological mechanisms of symptom persistence across diseases and syndromes.
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Extra breaks added for ease of reading.

Surely there's nothing new or innovative in this - it's based on what psychosomatic medicine has assumed for years - in fact it's the whole basis of psychosomatics.

Working hypotheses of the overall project
Hypothesis 1: In all syndromes and diseases examined in SOMACROSS, biological, psychological and social factors contribute to the persistence of somatic symptoms individually or/and in interplay.

Hypothesis 2: Persistence of somatic symptoms is predicted by common risk factors across syndromes and diseases.

Hypothesis 3: Generic and syndrome-specific and/or disease-specific risk scores accurately predict the risk of persistence of somatic symptoms.

Hypothesis 4: Expectations play a relevant role in the development of PSS. Thus, the modification of dysfunctional expectations constitutes a promising starting point for interventions to improve symptom severity in PSS.
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In theory, done well, this could provide good evidence of how little effect psychological factors have on the course of many chronic diseases. In practice, being led by psychosomatic specialists with preconceived ideas, and being assessed with questionnaires, I suspect it will just reinforce their prejudices.
 
This is the 'umbrella' protocol for the individual projects of SOMACROSS which is 'inspired' by EURONET-SOMA see this thread.

Biomedical clinician scientists are also on that ship as principal investigators, e.g. in the research groups on irritable bowel syndrome and ulcerative colitis (SOMA.GUT), on, Fatigue in Primary Biliary Cholangitis (SOMA.LIV) on chronic kidney disease (SOMA.CK) and also in the 'associated' project on Long Covid (SOMA.COV) -- there are still more.

See e.g. for SOMA.GUT:

https://www.uke.de/english/physicians-and-scientists/arztprofilseite_christoph_schramm.html

I'm afraid by expanding their concept to allegedly disproportionate severity of symptoms in medically 'established' disease, proponents of a cognitive-behavioral approach to medicine want to prove a common 'main' contributing factors to all those both-hard-to-treat-and-hard-to-objectify chronic symptoms like fatigue, pain, gut issues, independently from the underlying disease.

It seems to me that line of thinking is also something that can be observed in research on fatigue in MS.

Clinicians and researchers haven't been able yet to find a correlation between biomarkers and severity of fatigue, cognitive or motor fatiguability in MS.

Not sure about which biomarkers exactly have been looked at with this regard in MS, but seems to be mostly quantity of lesions and probably standard testing of nerve conduction.

Don't know if researchers have looked for example at special patterns of lesions or on abnormal alterations in nerve conduction pre/post exercise /or dependent on temperature. (Also no idea of that actually made sense.)

So even if researchers find distinct, objectively measurable signs of motor fatigue, if the measures don't correlate with the measures of known / established biomarkers, they don't see the need to search for additional biomarkers but rather fill in the gaps with psychosomatic beliefs. Or give up searching in their fields of expertise if there hyoptheses proved wrong (see this thread.)

It seems to me that there are biomedical clinicians and researchers who appreciate if the gaps in their knowledge and treatment options can be filled by their psychosomatic colleagues.

Just not sure how big the proportion of those clinicians is among biomedical clinicians in general. My gut feeling is it's more an more a majority.
 
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Have to resume my forum break now but I think it would be worthwhile to post the protocols of this research group's individual projects too.

So if anyone felt up to it, they are here.

Couldn't find the protocol for the Long Covid sub-project though.

I think a critique of that project is urgently needed -- I'm sure David Tuller's blog is a useful source for that purpose, i.e. the need to scrutinize not only the study design but also the references this group uses as an evidence base. @dave30th

A critique seems even more warranted as this research group's agenda could be very much in line with the newly funded research on ME/CFS in the Netherlands -- see this thread. Judith Rosmalen is both on the SOMA-CROSS advisory board and a member of EURONET-SOMA.

For people new to the forum -- info about DrPH David Tuller's blog is here: https://crowdfund.berkeley.edu/project/37217
 
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Protocol for the Long Covid sub-project now published, see this thread:

Andy said:
Open access, https://www.cambridge.org/core/jour...rial-somacov/9124BF04CA5960D429B93705B2956AE0
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Apologies for repeating myself:
MSEsperanza said:
I think a critique of that project is urgently needed -- I'm sure David Tuller's blog is a useful source for that purpose, i.e. the need to scrutinize not only the study design but also the references this group uses as an evidence base. @dave30th
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A critique seems even more warranted as this research group's agenda could be very much in line with the newly funded research on ME/CFS in the Netherlands -- see this thread. Judith Rosmalen is both on the umbrella research group (SOMA-CROSS) advisory board and a member of EURONET-SOMA.
 
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