Protocol: Persistent physical symptoms reduction intervention: a system change and evaluation (PRINCE), 2015 onwards, Chalder, Moss-Morris, et al

Jonathan Edwards said:
As we have been told on another thread these 40% of cases do not actually have a medical condition. They need to play chess. Psychotherapists are much too expensive these days.
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See now that would be a more interesting trial : PBT (playing boardgames therapy) versus CBT.

Although I have no doubt that, given the way they do these trials, they could 'prove' that almost anything results in improvement.
 
A pragmatic randomised controlled trial (RCT) was designed to evaluate the clinical and cost-effectiveness of cognitive behavioural therapy (CBT) + Standard Medical Care (SMC) versus Standard Medical Care alone, in the treatment of patients with PPS.
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Can someone please explain to me how this is classified as an RCT? A + B v A isn’t my understanding of a controlled trial.
 
Simbindi said:
In the words of Matt Hancock: Secretary of State for Health and Social Care Matt Hancock said: “Personalised care is the future and there’s growing evidence that supporting people to access community services and activities, such as chess clubs or dance classes, has the power to improve people’s health and wellbeing. For the first time ever, millions of people across the country will soon be able to access care that is truly tailored to their individual needs."

Link at: https://www.england.nhs.uk/2019/01/army-of-workers-to-support-family-doctors/

Summary Plain English version available at: https://www.networks.nhs.uk/editors-blog/in-the-consulting-room-social-prescribing
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I would love to be able to join a dance class, play squash, go skiing or even walk for 5 mins without pain.
However I fear that replacement spines are further away than effective ME treatments!!

I'm not complaining re my lot. Following major spinal fusion and then decompression ops when I was 18 I was able to continue a full and active life till my spine started collapsing again aged 35. My daughter however has had her life effectively on hold since age 16, ie for the last 8 years.
Until she got ME she was doing weekly trampolining and ballet alongside fulltime at school, with the usual social life for her age!!!
 
Robert 1973 said:
Can someone please explain to me how this is classified as an RCT? A + B v A isn’t my understanding of a controlled trial.
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Edzard Ernst wrote a good piece on A+B vs A, unfortunately I think that 'no treatment' is still considered a control so technically it is an RCT (A+treatment vs A+nothing). It's a constant frustration to me that all RCTs are often considered similarly strong evidence when un-blinded no-treatment control subjective RCTs are in fact complete worthless junk.
 
wdb said:
unfortunately I think that 'no treatment' is still considered a control so technically it is an RCT
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Aha, not so fast!
A controlled trial is not just a trial with controls. It is a trial with appropriate, or adequate, controls.

In a similar vein a fastened seat belt is not just a seat belt with fasteners.

Unfortunately, that 'controlled' implies 'adequately controlled' is never mentioned, unless someone considers the controls inadequate. In which case the comment is 'this trial is not adequately controlled'. So it is easy for people who follow 'procedures' or recipes or whatever you call them to miss the meaning of 'controlled'. I suspect a lot of 'expert statisticians' fall into that category.

It has to mean adequately controlled because one can think of any number of trials with comparators, like standard care, that are very clearly not performing the function of a controlled trial. They do not allow you to discount irrelevant contextual influences.

Whether Ernst really understands this sort of thing or not I would not know.
 
Jonathan Edwards said:
A controlled trial is not just a trial with controls. It is a trial with appropriate, or adequate, controls.
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Where is that definition from, I certainly agree that is what it ought to mean ?
NICE for example just give this definition
A study in which a number of similar people are randomly assigned to 2 (or more) groups to test a specific drug, treatment or other intervention. One group (the experimental group) has the intervention being tested, the other (the comparison or control group) has an alternative intervention, a dummy intervention (placebo) or no intervention at all. The groups are followed up to see how effective the experimental intervention was. Outcomes are measured at specific times and any difference in response between the groups is assessed statistically. This method is also used to reduce bias.
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wdb said:
Where is that definition from, I certainly agree that is what it ought to mean ?
NICE for example give this definition
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Yes but NICE is run by recipe-followers. It has no academic credibility. Throughout my career NICE was consider risible in the department of medicine. They always got things wrong because they followed rules that made no sense.

A controlled trial is just one instance of a controlled experiment - which is something that scientists have been involved with for centuries. A controlled experiment is one with credible, adequate or appropriate controls.
 
when standard health care = abandonment to your own devices doesn't that negate all of pace and many other trials that use standard health treatments as a comparison especially in a medical profession where budgeting gets prioritised first second and last. I have read a lot of papers on Medscape over the last year where the priority is cost rather than benefit to patient. the medical insurance companies have a lot to answer for when it comes to how patients are treated or abused . edited to ad this may only be the case on Medscape as I do not have access to other med publishers .
 
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I don't think there is a recipe. A controlled trial is one with adequate controls - and as in all science what counts as adequate is dependent on the detailed contextual factors of every experiment. Every situation is different, just as in ordinary life. If you want to know if the are iron stains on the shirts are from the washing machine you need different controls from when you want to know why the tulips did not flower this year. No two trials are the same.
 
Merged thread

This is from her lecture in March 2019
We know that between all of these so-called medically unexplained symptoms that there is a huge overlap between them. They have shared pain, distress, disability, all sorts of different things to varying degrees. Its very rare that you would see a patient in clinic who has one symptom without the other.

So we also know that cognitive behavioural responses to symptoms are common across different medically unexplained conditions.

For example we know that avoidance to activity is transdiagnostic, focussing on symptoms attentional bias can be transdiagnostic, and we’ve also got some evidence from the anxiety and depression literature that these transdiagnostic approaches an unified treatment protocols like for example anxiety depression and eating disorders, have been shown to be effective
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So we’re now coming to the end of a RCT where we have developed a transdiagnostic treatment approach which targets those transdiagnostic processes in a range of MUS.

Really with the main aim of improving peoples quality of life we’ve therefore chosen the social adjustment scale as the primary outcome.

We randomised 322 patients. The intervention itself consisted of 8 CBT sessions which were delivered by qualified high intensity therapists, over a period of 20 weeks, and we’ve got outcomes up to 52 weeks.

We haven’t analysed that yet so that’ll be happening mid this year.

I must say though that what was really interesting supervising the therapists was that many of these patients had an awful lot of problems, they had a lot of trauma as well which was quite difficult in only 8 sessions to deal with so we’ll watch this space as to what happened in terms of the results
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reading between the lines this transdiagnostic approach seems to me to be a further step towards a Per Fink style BDS and presumably they can then 'sell' it to IAPT as a more economical treatment as it purports to deal with multiple 'disorders'/symptoms.
 
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https://www.uea.ac.uk/documents/246046/11919343/LTCMUS Pathfinder Evaluation Phase 1.pdf/bccbe428-ba4d-44ff-b2f8-09cb43cdb62b

IAPT LTC/MUS Pathfinder Evaluation Project
Phase 1
Final report

University of Surrey, November 2013 (Revised April 2014)
University of Surrey Evaluation Team


"As a component of some Pathfinder projects, training was provided for GPs and physical health clinicians. The projects began during organisational upheaval in primary care, as general practices were preparing for the clinical commissioning groups introduced by the Health & Social Care Act 2012. Only twelve from over 30 general practices approached by Devon Pathfinder responded to the offer of training for practitioners in detecting and referring people with MUS. In Berkshire twenty GPs were trained in managing MUS in primary care by Per Fink..."

​
I think this was in 2010; he was invited to the UK to train Berkshire GPs in the TERM Model.
 
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"We know that between all of these so-called medically unexplained symptoms that there is a huge overlap between them. They have shared pain, distress, disability, all sorts of different things to varying degrees"

These symptoms are common to all chronic illnesses and many acute ones. They simply ignore all the symptoms that differentiate them. They also take a term like PEM and make it general. If you ask anyone, healthy or ill, if they feel worse after exercise the vast majority will say they do. Ask if they feel fine after exercise but collapse three days later most will have never thought that possible.
 
https://clinicaltrials.gov/ct2/show/study/NCT02426788

I think the results of this RCT are going to be presented at 9th World Congress of Behavioural and Cognitive therapies (Berlin July 17th-20th 2019)

see:
https://wcbct2019.org/Downloads/abstract-book-1.pdf

A CBT-Based Transdiagnostic Approach for Persistent Physical Symptoms: Results of a Randomised Controlled Trial
Trudie Chalder, Meenal Patel, Kirsty James, Matthew Hotopf, Philipp Frank, Katie Watts, Rona Moss-Morris & Sanbine Landau,
King's College London, United Kingdom
Background:
Cognitive behavioural therapy (CBT) has demonstrated both short- and long-term efficacy with small to medium effect sizes for people with
persistent physical symptoms (PPS), also known as medically unexplained symptoms (MUS). A transdiagnostic approach assumes that
similar psychological processes such as avoidance, unhelpful beliefs and attentional processes maintain symptoms and disability across
conditions.
Methods/Design:
A randomised controlled trial (RCT) has been conducted to evaluate the efficacy and cost-effectiveness of transdiagnostic cognitive
behaviour therapy for PPS. Participants with PPS were recruited from secondary care clinics and randomised to CBT plus standard medical
care (SMC) or SMC alone. 8 CBT sessions were delivered by a qualified therapist over a period of 20 weeks. The primary outcome of the
work and social adjustment scale was assessed at 9, 20, 40 and 52 weeks post randomisation. Secondary outcomes included mood,
symptom severity and clinical global impression at 9, 20, 40 and 52 weeks.
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Results:
These are currently being analysed blind by the trial statistician and will be presented at the conference.
Discussion:
This trial will evaluate the efficacy and cost-effectiveness of a transdiagnostic approach in addition to SMC versus SMC alone for patients
with PPS. It will also provide valuable information about potential healthcare pathways for patients with PPS within the National Health
Service (NHS) in the UK.
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Daisymay said:
Call me cynical, but I strongly suspect you don't need to go to the conference to hear the results, they'll have been a foregone conclusion from the word go.
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That's the difference between a cruise ship, the HMS PACE, and an exploration vessel: it has a predetermined destination and in fact the whole of the journey is built around arriving at the destination at a time set far in advance.

The outcomes used are so random, as if they just threw darts at a board, then took shots and shouted random questionnaires. Might as well measure how quickly can someone solve a rubik's cube for all that it's relevant.

Once again the question: how is anyone OK with being so careless with their funds? If at least they were self-funded it would only be half as bad. After all, if their BS worked they should have no problem finding private funders.
 
Sean said:
Awful lot of assuming going on with these clowns.
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By what illogic is a 100% psychological model transdiagnostic? There is not a single aspect to their model that is not wholly psychosomatic. It even reduces it further by strictly limiting to imaginary thoughts and beliefs, which make up a tiny segment of psychology.

Especially when it literally stands in opposition to an actual transdiagnostic understanding involving multiple organ systems and disciplines.

It's like their whole "holistic" nonsense, claiming they consider the whole individual when actually it reduces everything to one dimension of one aspect through an extremely narrow interpretation. And ironically does not even consider the psychological aspects since they reject everything we tell them so they don't even acknowledge the very aspect they wrongly claim to focus on. Ultimately it is all about their psychology and their own thoughts and beliefs.
 
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