Health outcomes of patients in the Complex Chronic Diseases Program, 2025, Meagher, Nacul, et al.

[Dolphin]

Now published, see post #4
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Free:
https://www.medrxiv.org/content/10.1101/2024.05.25.24307912v1

Complex Chronic Diseases Program: Program Description & Health Outcomes Assessment from a Clinical Data Registry
Emily Meagher, Tianna Magel, Travis Boulter, Carola Muñoz, Nicole Prestley, Wee-Shian Chan, Cassandra Bryden, Luis Nacul
doi: https://doi.org/10.1101/2024.05.25.24307912


Abstract
Introduction

The Complex Chronic Diseases Program (CCDP) was funded by the BC Ministry of Health to address gaps in health services provision for Complex Chronic Diseases (CCDs). The Program offers medical interventions and education on self-management for people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), Fibromyalgia (FM), and Chronic Lyme-Like Syndrome (CLLS). The CCDP Data Registry was created in 2017 for monitoring participant outcomes and program evaluation.

Methods

This research outlined the CCDP model of care and analyzed patient-reported questionnaires and clinical data collected longitudinally from consented CCDP Data Registry participants spanning June 2017 through September 2022. T-tests and linear regression modelling were conducted to ascertain changes in symptom presentation across program involvement. These analyses specifically targeted data at the following time points: baseline, 6 months follow-up, and discharge.

Results

Data reported in this study represented 668 eligible participants from the 1-year Program. Demographically, the average age was 49 years old (SD=13), 90% were women (n=557), 54% were diagnosed with ME/CFS and FM (n=360), and 36% reported being on long term illness/disability (n=219). Between baseline and discharge, participants with ME/CFS and FM reported improvements in overall physical and mental health, but no significant improvement in other symptom domains such as sleep, fatigue, and pain. The duration of disease at baseline was only related to sleep quality. The previous, more individualized model of care showed better mental health outcomes at 6-months follow-up.

Discussion

This analysis showed that CCDP patients experienced relatively severe and persistent symptom presentations. Participants involved in the Program experienced some health benefits at discharge, but further research and interventions are needed to optimize health outcomes. The reliance on self-report of symptoms and the absence of a control group without intervention limit the significance of these findings. A Strategic Direction Plan was developed by the CCDP which emphasized improved training, decentralized services, fast-tracking of eligible individuals, and enhanced education for better patient outcomes.

https://twitter.com/user/status/1796166482834964680

 

[ME/CFS Science Blog]

Patients reported no significant improvement in pain, sleep or fatigue over time.

 

[Joan Crawford]

On quick skim through:

- Whether the patients were seem by doctors or nurses neither made significant difference to the patients self reported outcomes apart from teeny tiny reduction in reported level of anxiety / improved MH. And anxiety/low mood scores were not on average raised much at beginning......

Need new ideas. This is getting no one anywhere

 

[Dolphin]

Merged thread
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Start on page 174

BC MEDICAL JOURNAL VOL. 67 NO. 5 | JUNE 2025

https://bcmj.org/sites/default/files/BCMJ_Vol67_No5_complete.pdf

Health outcomes of patients in the Complex Chronic Diseases Program

New approaches and research are urgently needed to improve therapeutic interventions for patients with complex chronic diseases.

CLINICAL: ORIGINAL RESEARCH

Emily Meagher, MPH, Tianna Magel, MSc, Travis Boulter, Carola Muñoz, Nicole Prestley, Wee-Shian Chan, MD, FRCPC, Cassandra Bryden, Luis Nacul, MD, PhD



ABSTRACT

Background:

Complex chronic diseases affect almost 3% of Canadians and lead to persistent, debilitating symptoms. The BC Ministry of Health funded the Complex Chronic Diseases Program to address service gaps for affected individuals. We evaluated health outcomes of the program’s patients.

Methods:

Analysis of data from the Complex Chronic Diseases Program Data Registry (June 2017–September 2022) focused on patient reported outcomes and clinical measures at baseline, 6-month follow-up, and discharge, and on changes in symptoms across these time points.

Results:

Among the 668 participants included in the study, slight improvements in overall physical and mental health were observed between baseline and discharge. However, symptoms such as sleep dysfunction, fatigue, and pain showed no significant changes.

Conclusions:

While participation in the Complex Chronic Diseases Program yielded some health benefits, further research and interventions are required to address symptoms and optimize patient outcomes. The further development and use of objective outcome markers are needed for improved program evaluation.

Ms Meagher and Ms Magel were research assistants at the Women’s Health Research Institute, BC Women’s Hospital and Health Centre, at the time of writing. Mr Boulter is a research coordinator at the Women’s Health Research Institute. Ms Muñoz is a research manager at the Women’s Health Research Institute. Mrs Prestley is a research and knowledge translation manager at the Women’s Health Research Institute. Dr Chan is an investigator at BC Children’s Hospital; head of the Department of Medicine, BC Women’s obstetric medicine lead, BC Women’s; and a clinical professor in the Department of Medicine, University of British Columbia. Ms Bryden was an occupational therapist in the Complex Chronic Diseases Program at BC Women’s at the time of writing. Dr Nacul is a clinical scientist at the Women’s Health Research Institute; a clinical associate professor in the Department of Family Practice, Faculty of Medicine, UBC; and a clinical associate professor in the Department of Clinical Research, CureME, London School of Hygiene & Tropical Medicine. Corresponding author: Ms Emily Meagher, emily.meagher@cw.bc.ca. This article has been peer reviewed.

 

[SNT Gatchaman]

Direct links —

Link | PDF (British Columbia Medical Journal) [Open Access]

 

[Hutan]

However, symptoms such as sleep dysfunction, fatigue, and pain showed no significant changes.

I appreciate the honesty there.

While participation in the Complex Chronic Diseases Program yielded some health benefits, further research and interventions are required to address symptoms and optimize patient outcomes. The further development and use of objective outcome markers are needed for improved program evaluation.

While I agree with much of what the authors are saying in the abstract, they are claiming 'some health benefits' for their CCD Program. It's possible, perhaps even likely, that the program wasn't even responsible for that. Perhaps the passage of time and the adjustment and learning that tends to come naturally with that time account for any minor benefit.

 

[Trish]

It seems from the abstract that there was no meaningful improvement for patients on the program beyond therapist effect.

 

[Hutan]

From the BC Women's Hospital Complex Chronic Diseases Program

Even if you have had a CCD for a long time, there are steps you can take to feel better and gradually improve your condition. Having your CCD diagnosed as early as possible will help with a better and more rapid recovery.

There's a terrible "Adapt: Returning to physical activity" handout. Have we talked about it already?

It notes that exercise is not recommended as an intervention for people with PEM and that any exercise for people with post-viral fatigue should be guided by a professional with an experience with the condition. BUT, then it goes on to differentiate between physical activity and exercise. And there's no warning about physical activity.

That 10% progression is symptom-contingent Graded Activity Therapy. It's even got the joy-sapping, will-to-live destroying calculation of walking for 10 minutes per day one week and then increasing to 11 minutes/day the next week. They don't call it an exercise program, it's a 'movement program'.

How can these people not understand that, if people can increase activity, they almost surely will, and they don't need a health professional making it more complicated than it is? And it's all written assuming recovery will happen, so long as you put in the work.

I feel quite concerned about this program. Luis Nacul has had plenty of exposure to ME/CFS communities. He should be doing better than this. It's certainly time their materials were reviewed.

Edit to add - it says that the approach has been adapted from the John Hopkins Medical Center. So, that is another organisation that needs to update its approach.

 

[Utsikt]

While participation in the Complex Chronic Diseases Program yielded some health benefits, further research and interventions are required to address symptoms and optimize patient outcomes. The further development and use of objective outcome markers are needed for improved program evaluation.

If it doesn’t work with subjective outcomes, there is no way that it’s going to work with objective outcomes.

Scrap the whole thing and start over.

 

[rvallee]

So, they funded a clinic to supply a treatment model that has never been shown to be effective in clinical trials, found that it's not effective, and conclude the same as the trials that found that it's not effective: they should try again, the same way. Maybe this time with objective outcomes, which they could have used in the first place, but did not bother with, mostly because they know it would yield null results. Same as the flawed research that is used to support what has been a standard model for years, despite not being any effective.

A treatment model that explicitly focuses on useless nonsense. As pointed out above, no one suffering from chronic illness needs this kind of support. It basically amounts to physical rehabilitation where someone just keeps going "left foot, right foot, left foot, right foot" in a loop, as if the problem with someone being unable to walk after, say, a stroke, is that they forgot the correct sequence of steps required to walk.

This happened over 5 years, then 3 more to turn it into a paper that essentially reports zero useful information. This entire methodology is the most inefficient process ever used by professionals. It's absurd how wasteful and inefficient it is, it literally costs millions of dollars to get a single bit of useless data: we should do it again, with no meaningful differences. Which is the same bit of data they started with.

This entire discipline has to be completely reformed. It straight up does not work.

 

[Utsikt]

Responding to a deleted post about healthcare professionals insisting that the person is not optimally allocating their limited energy reserves.

That’s probably because they believe that you budget is mostly limited by you being deconditioned, so they believe that they are addressing the core issue.

Essentially, they don’t believe in your reality.

 

[Hutan]

It's especially sad because Luis Nacul came from the UK ME/CFS Biobank. He surely knew that this graded activity stuff was not helpful before he took on the job running this program. I think if you search the forum there will be comments that track members' trajectories from hope to despair about Nacul and this program. Here's some of my comments about a presentation at a 2023 conference:

Luis Nacul - basically an extended ad for his Canadian clinic. He promoted a whole range of unevidenced therapies; they offer things like acupressure, some therapy called "Beneath the surface" - goodness knows what that is. He supports use of aripiprazole.

It's possible my quick notes were coloured by my view of a previous talk Nacul gave about the centre, and my disappointment then that he had not taken the opportunity to run a really science-based centre. I mean, the clinic could have been churning out studies, to refine treatments. Nacul has been at that centre for a while now.

Nacul made a lot of claims that the clinic service overall was helping, putting up multiple charts of SF-36 results (i.e. self-reported outcomes). That is a big part of what prompted my comment that the presentation was an ad. I don't think he said anything about the fact that some of those people will be recovering naturally, being still in the relatively early stages of their disease. Some would have improved in function a bit as they adjusted to their illness e.g. by giving up work. And, the situation is a subjective report collected in a situation where the patients who make it to the point where they are given a survey to fill out are going to be more likely to report improvements (survivorship bias, wanting to please the assessor, wanting to convince themselves that something is better).

For sure, it didn't sound as though anyone was being forced into a mindfulness course, and the fact that it's a group course is nice, and probably helpful. But I really don't like the courses being spread out like a buffet, with a course on pacing (which is just strategies for adapting to the constraints imposed by the disease) being given only as much weight as various alternative therapies. I mean, people can find other ways to get mindfulness and naturopathy if that's what they want. If the clinic didn't spend money on providing acupressure etc, then potentially they could see more people to give them useful advice on pacing and pem. I don't know how that centre is funded. If it's a government funded clinic, then I think it should be doing a lot more research to refine its therapy options.

 

[Hutan]

Actually, just reading that last comment of mine, what this study shows is that the whole package of those alternative therapies are not worth anything much. And therefore, neither are the individual therapies. If mindfulness or acupressure or naturopathy and whatever else the clinic has been offering made any significant difference, this clinic would not be finding that people reported no significant changes in symptoms.

In fact, it's quite possible that there is some harm being done, which is not being measured, because people who think they are being harmed by a clinic don't tend to stick around to fill out surveys at discharge.

Of course it could be argued that this poor result proves that pacing doesn't help either. I'd argue that
1. This clinic does not seem to be offering very good advice, even on pacing, making it overly complicated and essentially pacing up, and
2. Probably most of the people attending the clinic had already worked out much of their pacing strategy before they came to the clinic. It comes naturally - you do stuff, you get clobbered by PEM, eventually you learn to do a bit less and do it a bit differently, and

So, it is evidence that providing (poor) advice on pacing at the time when people eventually get to a specialist clinic is not helpful, but it is not evidence that an adaption to the constraints imposed by ME/CFS is not helpful.


I think this paper is incredibly important. It is essentially the result of a long experiment. It blows the whole idea of a 'multi-disciplinary clinic' out of the water. The package this clinic offered is similar to what is promoted by Peter Gladwell and what the MEA seems to be totally on board with. @Russell Fleming, @sarahtyson - you need to look carefully at the paper. AfME too, and the people working on the new Australian guideline @Simone. Specialist clinics where all sorts of woo is allowed to run free and that don't have a really clear focus on research are a waste of everyone's time, funds, hope and effort.

If Luis Nacul does genuinely care about people with ME/CFS, he will now make it abundantly clear around the world that this model does not work, and that it slows progress towards a better understanding of the illness. I don't know if anyone here knows him? If so, perhaps he could be encouraged to now make a positive difference? He is in a unique position to do so.

 

[Utsikt]

Of course it could be argued that this poor result proves that pacing doesn't help either. I'd argue that
1. This clinic does not seem to be offering very good advice, even on pacing, making it overly complicated and essentially pacing up, and
2. Probably most of the people attending the clinic had already worked out much of their pacing strategy before they came to the clinic. It comes naturally - you do stuff, you get clobbered by PEM, eventually you learn to do a bit less and do it a bit differently, and

So, it is evidence that providing (poor) advice on pacing at the time when people eventually get to a specialist clinic is not helpful, but it is not evidence that an adaption to the constraints imposed by ME/CFS is not helpful.

The average wait time is above 2 years, so most patients will not be new to their own illnesses.

Due to continued high demand, the current wait time for care is approximately 28 months.

And average illness duration is 11 years:

We may not have seen the impacts of greater disease duration in our study because most participants had long-standing illness (median = 11 years), so early-stage improvements were not observed.

 

[Utsikt]

This is the second recent study to show that the «standard» treatments doesn’t make a substantial difference.

The Norwegian G93.3 register study also showed that the wage development did not improve after diagnosis, even though the welfare authorities (NAV) consistently require ME/CFS patients to go through rehabilitation, CBT, physiotherapy, attempting to work with adaptations, etc. in order to get benefits. NAV have admitted that they do not know if these required interventions actually make a difference, and it has been shown that both NAV and the courts discriminates against pwME/CFS by being much stricter than for any other diagnosis.

If any of these interventions made any difference, the people with a G93.3 diagnosis should have had a positive wage development.

 

[Utsikt]

If Luis Nacul does genuinely care about people with ME/CFS, he will now make it abundantly clear around the world that this model idoes not work, and that it slows progress towards a better understanding of the illness.

We can always hope, but the conclusion states that we should do even more of the same:

We recommend a coordinated investment and expansion of services that integrate primary care, community providers, and specialist expertise and are supported by continuing education and research. Although challenging in an environment of limited resources, improving early intervention and access to expert guidance could enhance patient satisfaction, reduce morbidity, and generate long-term economic savings.

 

[Hutan]

It's absolutely mind boggling, isn't it?

We see this in papers every week - It didn't work, but, but, if only we just tweak our offerings, measure it in a different way...

And now the rise of the cleverer BPS proponents not even bothering with patient outcomes, but instead securing research funding to measure the success they have in convincing clinicians to slap psychosomatic labels on people, purely on the basis of them having a common symptom for which the clinician is not immediately able to identify a cause.

 

[Utsikt]

It's absolutely mind boggling, isn't it?

The worst part is that these things are expensive, so it’s something politicians should jump at and cut immediately to save money.

It’s the same madness with the Norwegian National Advisory Unit for CFS/ME (home of Helland). It was supposed to only last for 10 years, and the Norwegian MEA have asked the politicians to shut it down. It’s on year 12, and it’s still going strong for now.

 

[forestglip]

Letter to the editor and author reply:

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Re: Health outcomes of patients in the Complex Chronic Diseases Program

Spencer Cleave, Thea Gilks, Isaac Rodin

Selected paragraphs
"We disagree with the authors’ conclusion that the absence of meaningful clinical improvement in their study indicates that patients with fibromyalgia and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) have illnesses that are too “severe and persistent” to respond meaningfully to treatment. We believe the more urgent implication of this study is that these patients’ suffering was not ameliorated because the treatment provided by the CCDP does not address their complex psychosocial needs.

Patients with fibromyalgia and ME/CFS have a high proportion of childhood physical abuse, emotional neglect, and sexual trauma.[1,2] This trauma contributes to profound attachment disruptions and, when combined with the chronicity of their illness and the stigma they face, fosters deep epistemic mistrust toward the health care system. Establishment of a longitudinal, trusting relationship with a consistent care provider offers a supportive attachment, which is essential for these patients to engage in care and experience recovery."

Web | PDF | BCMJ | Open Access

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Re: Health outcomes of patients in the Complex Chronic Diseases Program. Authors reply

Luis Nacul

Selected paragraphs
"However, our team disagrees with the assessment that the conclusion of our article indicates that ME/CFS and fibromyalgia are “too severe and persistent to respond to treatment.” Instead, the article concludes that there were some improvements in mental and physical health indicators and the severity of ME/CFS, which were nevertheless limited.[2] The intended conclusion was to point to the chronic and individualized nature of these diseases and the difficulty of treating them, not least due to the current absence of evidence-based curative treatments for ME/CFS,[3] not that they are untreatable. The Complex Chronic Diseases Program (CCDP) prioritizes the biological as well as the psychosocial health of patients and has a full team of interprofessionals, including mental and physical health specialists. While overall improvements were small, it is significant that mental health scores of patients with complex chronic diseases improved during the COVID-19 pandemic, a period when the general population experienced a particularly high risk of developing or worsening mental health problems."

---

"Regarding the authors’ claim that childhood trauma can explain the disease etiology in part or in full, the evidence of childhood trauma as a risk factor for complex chronic diseases is rather weak and nonspecific. Studies suggesting this relationship have been of poor quality (as reported by Häuser and colleagues’ meta-analysis, cited by Cleave and colleagues in their letter).[5] That study specifically indicated that “study quality was mostly poor,” confounding the findings.[5]"

---

"Suggesting childhood trauma as an explanation for complex chronic diseases is very problematic, is not patient centred, and does a disservice to this often-neglected population by psychologizing physical health problems."

Web | PDF | BCMJ | Open Access

 

[Utsikt]

I’m glad the trauma babble gets called out based on how poor the research is. It’s rare to have someone acknowledge the fundamental flaws.

Although that makes it quite ironic that they seem to keep defending their own approach based on equally terrible data and results. Do as I say but not as I do..