Evaluation of a Multidisciplinary Integrated Treatment Approach Versus [SMC] for Functional Gastrointestinal Disorders (FGIDS), 2022, Bray et al

[Andy]

Full title: Evaluation of a Multidisciplinary Integrated Treatment Approach Versus Standard Model of Care for Functional Gastrointestinal Disorders (FGIDS): A Matched Cohort Study

Abstract

Background
Functional gastrointestinal disorders (FGID) are linked to a variety of potential causes, and treatments include reassurance, life-style (including diet), psychological, or pharmacologic interventions.

Aims
To assess whether a multidisciplinary integrated treatment approach delivered in a dedicated integrated care clinic (ICC) was superior to the standard model of care in relation to the gastrointestinal symptom burden.

Methods
A matched cohort of 52 consecutive patients with severe manifestation of FGID were matched with 104 control patients based upon diagnosis, gender, age, and symptom severity. Patients in the ICC received structured assessment and 12-weeks integrated treatment sessions provided as required by gastroenterologist and allied health team. Control patients received standard medical care at the same tertiary center with access to allied health services as required but no standardized interprofessional team approach. Primary outcome was reduction in gastrointestinal symptom burden as measured by the Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS). Secondary outcome was reduction in anxiety and depressive symptoms as measured by the Hospital Anxiety and Depression Scale (HADS).

Results
Mixed models estimated the within ICC change in SAGIS total as −9.7 (95% CI −13.6, −5.8; p < 0.0001), compared with −1.7 (95% CI −4.0, 0.6; p = 0.15) for controls. The difference between groups reached statistical significance, −7.6 (95% CI −11.4, −3.8; p < 0.0001). Total HADS scores in ICC patients were 3.4 points lower post-intervention and reached statistical significance (p = 0.001).

Conclusion
This matched cohort study demonstrates superior short-term outcomes of FGID patients in a structured multidisciplinary care setting as compared to standard care.

Open access, https://link.springer.com/article/10.1007/s10620-022-07464-1

 

[Hutan]

This is an Australian study, mostly Brisbane.

What do they mean by functional?

Functional gastrointestinal disorders (FGIDS) are chronic, heterogeneous disorders of the intestinal tract defined by a combination of gastrointestinal (GI) symptoms that are not explained by structural abnormalities [1], with irritable bowel syndrome and functional dyspepsia among the most common [2, 3] and often overlap [4, 5]. As proposed by the Rome Foundation, these gastrointestinal symptoms arise from perturbed gut-brain interactions, and they share a combination of physiological features such as visceral hypersensitivity, dysmotility, mucosal and immune dysfunction, altered gut microbiota, and central nervous system (CNS) dysregulation [1]. A biopsychosocial conceptualization of FGIDs has been proposed as a model for understanding FGIDs [1], implicating interactions between early life factors, psychosocial factors, physiological functioning, and the brain-gut axis influence the patient’s subjective experience of the illness.

Yeah, it's a bit hard to know. I think they are saying 'we don't really know, but we are happy to assume everything is having an effect and it's certainly not just biological


They note that a 50-60% 'efficiency gain' is reported in patients with IBS from standard pharmacological or diet treatments and that

clinical trials show pharmacological treatment only has 7–15% therapeutic gain over placebo

So, they have no excuse for not realising that surveys of 'how do you feel now' are not going to be reliable.

With currents treatments not really working, why not try a 'multidisciplinary integrated intervention'?

Therefore, due to treatment challenges and insufficient patient response to existing routine management of FGIDs, there is a need for a novel, more efficacious approach to management that considers the heterogeneity of FGIDs and offers customized personalized care. There is a general consensus that a multidisciplinary integrated intervention including pharmacologic and behavioral interventions is potentially a strategy for treatment

Our primary aim was to examine whether a structured 12-week integrated care clinic (ICC) approach with a multidisciplinary integrated treatment program for patients who had failed to respond to standard medical reduced the overall symptom burden in FGID patients compared to standard treatment in the setting of a busy gastroenterology department.

So, it's a retrospective analysis of patient records. I think there's quite a lot of scope for bias in the selection of patients with the integrated care clinic treatment and of the patients who got standard care. Patients attending, and remaining, in the 12 week program of the integrated care clinic were likely to be highly self-selecting. Patients who had already tried dietary changes and exercise and who didn't think psychological issues were causing their condition would be much less to agree to the treatment. And researchers keen on the concept of integrated care may have let bias creep in to their selection of the matched controls.

A digital database was searched to identify consecutive patients who had been clinically diagnosed with functional dyspepsia (FD), irritable bowel syndrome (IBS) or FD/IBS overlap who had received a multidisciplinary treatment approach through the integrated care clinic (ICC) between November 2017 and February 2019. The study included ICC patients (N = 52) who were matched to historical controls patients (N = 104) who had been clinically diagnosed with FD, IBS, or FD/IBS overlap, and had received standard care (standard assessment and routine management) within the Gastroenterology OPD between 2016 and 2017.

There was no data on anxiety and depression in the standard medical care cohort - so no control data to anchor the reported levels of anxiety and depression in the integrated care cohort.

Integrated care involved psychological treatment, dietary advice and exercise.The psychological treatment included psychoeducation:

All patients were provided with psychoeducation regarding IBS, including an explanation of the relationships that exist between psychological factors and the gut and the rationale for psychological treatment.

The dietary advice almost certainly was more comprehensive and tried different approaches, compared to the standard medical care.

 

[Hutan]

Outcome measures
It won't come as any surprise to hear that the primary outcome measure was a self-reported assessment of symptoms. (Placebo effect (enhanced by a bit of psychoeducation), what placebo effect?)

The Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS)
This validated self-report scale was used to measure the intensity of 22 upper and lower gastrointestinal symptoms (0 = no problem to 4 = very severe problems). Primary outcome was change in the number of items scored moderate or above (indicating problems which cannot be ignored) on the SAGIS between pre-and post-intervention. Secondary outcome was change in total symptom burden score (range from 0 to 88) on the SAGIS pre-and post-intervention Minimally clinically important change is considered a 8 points reduction on the SAGIS post-intervention which corresponds to a Cohen’s d value of 0.5, a moderate effect size.

And the HADS (anxiety and depression) scale, for the integrated care patients only.

 

[Hutan]

A mixed linear model for data analysis - always a bit of a black box, a chance for data fiddling.

Due to the 2:1 control to case matching which may induce some within-cluster correlation, mixed linear models estimated via maximum likelihood have been employed. This approach also allows all available data to be used, including for patients who did not complete therapy. The inclusion of all available data and treating all patients as belonging to whichever study group they were assigned is consistent with the intention-to-treat approach to statistical analysis. The model included case–control status, time and the interaction between these factors, with the interaction term being used to determine whether the change from pre- to post-therapy was greater for cases than controls. Patient diagnosis group was included in the model.

Eighty patients started the 12-week ICC treatment, and 28 patients did not continue the intervention after at least 1 consultation.

Just to repeat that, of the eighty patients that they managed to convince to try one session, 35% dropped out before the end of the treatment. No mention of that in the abstract. Do we think that drop out rate and the mixed linear model data fiddling might have influenced results? I certainly do. (The data relates to a time before Covd-19 - the pandemic is not an excuse here.)

Some of the 52 patients who did complete the treatment did not do any psychological sessions at all, some did no exercise sessions at all - we aren't told how many patients were in these groups.

They don't give us the raw data, only the results that popped out of their mixed linear model.

This is indeed psychosomatic research - what you wish to be true becomes the truth. This study looks so good in the abstract, but it takes only a quick read to see that it has so many problems as to not constitute reliable evidence.

 

[Hutan]

I honestly approached this study with an open mind - I thought, maybe stress can impact on gastro-intestinal symptoms. But this is a really bad paper, it is unusable as far as evidence goes. I'm going to record the researchers names here.

Nicola A. Bray,
Natasha A. Koloski,
Michael P. Jones,
Anh Do,
Siong Pang,
Jeff S. Coombes,
Sarah McAllister,
Jane Campos,
Leela Arthur,
Paul Stanley,
Katherine DeMaria,
Che-yung Chao,
Rachel Catague,
Amanda Whaley,
Nicholas J. Talley &
Gerald J. Holtmann

Professor Gerald Holtmann is the corresponding author

Prof Gerald Holtmann is an internationally recognized Academic Gastroenterologist with substantial research contributions in the field of Neurogastroenterology, Microbiome, and Health Service Innovation. In addition to his research accomplishments, he has substantial managerial and leadership experience as CEO or non-executive director of large organizations in the healthcare and research setting.

Funding

This study was supported by a grant from Department of QLD Health, NHMRC Centre of Research Excellence in Digestive Health, 2020 Metro South Health Research Support Scheme (MSH RSS) Project Grant.

 

[Hutan]

I think there might be a problem with the presentation of the data in the chart too.



It's hard to tell with no tick marks on the axis, but this is what we are told:

Mixed models estimated the within ICC change in SAGIS total as −9.7 (95% CI −13.6, −5.8; p < 0.0001), compared with −1.7 (95% CI −4.0, 0.6; p = 0.15) for controls (Fig. 1).

So, the text says that the control's 95% confidence interval for change in symptoms is from 0.6 [worsening] to 4.0 [improvement], with a mean of 1.7. The upper confidence interval marker on the chart does not go anywhere near 4*. And the lower confidence interval marker on the chart is clearly 0, not 0.6. The effect of the differences is to minimise the actual change for the controls in the chart.

* In case you think it's a tick mark issue, look at the upper confidence interval marker that is supposedly representing 4 for the controls, and then look at the lower confidence interval marker for the ICC that is supposedly representing 5.8.

Am I misunderstanding something here? (Edit, I was a bit, see later post, but there are still problems.) If I'm not, then my confidence that their mixed linear model manipulations are reasonable is even lower than it was before.

 

[Sean]

Primary outcome was reduction in gastrointestinal symptom burden as measured by the Structured Assessment of Gastrointestinal Symptoms Scale (SAGIS). Secondary outcome was reduction in anxiety and depressive symptoms as measured by the Hospital Anxiety and Depression Scale (HADS).

Both subjective self-report.

Stopped there.

 

[Jonathan Edwards]

Patients in the ICC received structured assessment and 12-weeks integrated treatment sessions provided as required by gastroenterologist and allied health team. Control patients received standard medical care at the same tertiary center with access to allied health services as required but no standardized interprofessional team approach.

This means absolutely nothing.
How can standards medical care be the one without the standardised approach?
It is gibberish. I thought the whole point of multidisciplinary care was that it was person tailored and not standardised?

How come there were two ways of treating patients at the same centre without there being a trial at the time? This looks to me tantamount to misrepresentation.

It was of course published on April 1st.

 

[Hutan]

So, the text says that the control's 95% confidence interval for change in symptoms is from 0.6 to 4.0, with a mean of 1.7. The upper confidence interval marker on the chart does not go anywhere near 4*. And the lower confidence interval marker on the chart is clearly 0, not 0.6. The effect of the differences is to minimise the actual change for the controls in the chart.

I've just realised I did misunderstand a bit - the 95% confidence interval for change for the controls was 0.6 worse to 4.0 better. (All the numbers except for the 0.6 are negative, indicating improvements.)

There's still issues with the chart though.

 

[Milo]

To assess whether a multidisciplinary integrated treatment approach delivered in a dedicated integrated care clinic (ICC) was superior to the standard model of care in relation to the gastrointestinal symptom burden

Basically a 12 steps program for your bowels

 

[Trish]

This links the SAGIS questionnaire. As usual it's a whole list of symptoms with the patient grading them from 0 (no problem) to 4 (very severe problem).
https://cdn.ueg.eu/ueg-week-2015/posters-and-videos/P1800.pdf

The five GI symptom clusters were labelled as
abdominal pain/discomfort (seven items),
diarrhea/incontinence (five items),
gastroesophageal reflux disease/regurgitation symptoms (four items), nausea/vomiting (three items)
and difficult defecation and constipation (2 items).

So it looks like it's intended mainly to record which aspects of the gut are causing a patient problems, and how bad they think they are.
Adding them all up to create an overall score seems pretty meaningless to me. And of course it's all subjective, so vulnerable to change as a result of persuasion to interpret symptom severity differently.

As for this so called research, it is so vague as to be useless in terms of what treatment differences there were between the two treatment regimes which were compared on the basis of a retrospective look at patient records before and after the change in provision at the clinic. Maybe they recruited a more persuasive CBT therapist who convinced the patients to fill in their forms differently, or maybe they went in harder on persuading patients with IBS to stick to a low FODMAP diet, or maybe they changed the medication of those with acid reflux. There seems to be nothing in the research to say what they were actually researching.

 

[Jonathan Edwards]

There seems to be nothing in the research to say what they were actually researching.

This is an important point. Studies of treatments are only valuable if they are generalisable to new populations. 'Individualised, integrated multidisciplinary care' or whatever is by definition not generalisable, unless it invokes evidence-based indications as to who will benefit from which individualisable modality - which have to be derived from standard (non-individualised) trials stratified for the relevant variables.

A trial like this may be able to tell us that the way that Mary, Fred and Louise treat people is better than the way Susan, Greg and Elisa do but it tells us nothing about how good Isobel, George and Harriett will be at it.

 

[rvallee]

As proposed by the Rome Foundation, these gastrointestinal symptoms arise from perturbed gut-brain interactions

Oh, wow, someone, possibly someone eminent, proposed something? Well that's just the same as a fact in BPSland.

The state of things in psychosomatic medicine:

1. Speculations presented as validated facts, on an ongoing basis dating back well over a century
2. If it's possible, only need 1 chance in a billion, that psychology can explain something, it must, literally guilty until proven innocent

These ideas are all "conceived as" or "can be conceptualized" or are variously "proposed" and "suggested". This is the old pre-science way of doing things. Literally, when all science, natural philosophy at the time, was based on rhetoric and making a sales pitch.

Not sure if legitimate quote, but this is basically how this pre-science way of winging science used to work, and exactly where and when psychosomatic medicine is stuck at, all that matters is that the audience loves it, this is the Wessely school of thought in its full glory:

So I gave my lecture yesterday. Despite lack of preparation, I spoke quite well and without hesitation, which I ascribe to the cocaine I had taken beforehand. I told about my discoveries in brain anatomy, all very difficult things that the audience certainly didn't understand, but all that matters is that they get the impression that I understand it.

This is the very definition of a con: bullshit with confidence, and you can sell anything.

 

[Hutan]

This is the very definition of a con: bullshit with confidence, and you can sell anything.

Indeed. It appears that in 2019, Nicola Bray was at a conference in San Diego making presentations with these titles on the basis of this research.

273 – A Multidisciplinary Integrated Treatment Approach is Superior to Standard Care for Functional Gastrointestinal Disorders (FGIDS): A Case-Control Study

Tu1618 – Patients with Functional Gastrointestinal Disorders (FGIDS) Benefit from a Multidisciplinary Integrated Treatment Approach to Reduce Anxiety and Depressive Symptoms.

There seems to be nothing in the research to say what they were actually researching.

Studies of treatments are only valuable if they are generalisable to new populations.

Yes. The point I made above about us not even knowing if many people had a particular intervention

Some of the 52 patients who did complete the treatment did not do any psychological sessions at all, some did no exercise sessions at all - we aren't told how many patients were in these groups.

probably bears elaboration:

The mean total number of allied health consultations over the 12-wk intervention was 24 (range 3 to 27), the mean number of psychological consultations was 5 (range 0–12), the mean number of dietician consultations was 2 (range 0–6), and the mean number of exercise physiologist consultations was 5 (range 0–13).

Some people had no psychological consultations, for example. Of the psychological consultations, we are told that they might have been for any of these: "cognitive-behavioral therapy (CBT), Acceptance and Commitment Therapy (ACT), relaxation techniques, or Mindfulness".
And so it goes for the diet and exercise interventions too.

It's also mentioned that the following medical people were involved in the treatment:

The gastroenterologist specialist was the responsible consultant for all patients treated. Besides the gastroenterologists, a GI fellow and a primary care physician were other physicians involved in the treatment. The primary care physician’s responsibility was primarily to develop ongoing management plans for patients utilizing health care services routinely available in the primary care setting.

So, there was also biological treatment, and a GP helping the person access community 'health care services'.

You would hope that something in all of that would help. But the use of subjective outcomes means we can't even say with confidence 'if we offer patients with FGIDS everything we think might be useful, a significant number will get better' on the basis of this study.


It's interesting to look at this study, evaluating a low FODMAP diet for older adults, something just some of the people in the FGID study were taught about.
A Low FODMAP Diet Is Nutritionally Adequate and Therapeutically Efficacious in Community Dwelling Older Adults with Chronic Diarrhoea

At baseline the predominant symptoms were urgency to empty bowels, loose stools, excessive gas, pain prior to bowel motion, and diarrhea (Table S1). After six weeks of the strict LFD (phase 1), there were significant improvements in the overall SAGIS score, as seen by a reduction in the score from pre to post diet. The pre diet mean score was 21.15/88 (SD = 10.99) compared to the post diet mean score of 9.8/88 (SD = 9.85) p < 0.001

The people in the FODMAP study seemed to have gastrointestinal symptoms that were far from normal at baseline, and yet their SAGIS score of 21 at baseline is not much different to the SAGIS score reported for the participants of this study after this extended period of being offered all sorts of therapies (the mean was about 18).

So, the clinic in the FGID study gave patients a wide range of treatments including psychoeducation, surely at considerable expense, and the mean reported SAGIS score after treatment was comparable to the baseline condition of a cohort of older adults with chronic diarrhoea bad enough to have first undergone a colonoscopy. This "Multidisciplinary Integrated Care" is clearly a long way from a cure for "FGIDs".