Maintaining musculoskeletal health using a behavioural therapy approach: a population-based rct, (the MAmMOTH Study), 2021, Macfarlane et al

Argh. Mammoth Study - doesn't that sound offensive?

Short story: So they did the study, at that ridiculously great (mammoth) expense, found it didn't work, but of course claimed success anyway. When will the madness stop?

We don't seem to have a thread on it yet:

Maintaining musculoskeletal health using a behavioural therapy approach: a population-based randomised controlled trial (the MAmMOTH Study)
https://ard.bmj.com/content/80/7/903
  1. http://orcid.org/0000-0003-2322-3314Gary J Macfarlane1,
  2. Marcus Beasley1,
  3. Neil Scott2,
  4. Huey Chong3,
  5. Paul McNamee3,
  6. John McBeth4,
  7. Neil Basu5,
  8. http://orcid.org/0000-0002-2588-1006Philip C Hannaford6,
  9. http://orcid.org/0000-0003-0016-7591Gareth T Jones1,
  10. Phil Keeley7,
  11. Gordon J Prescott8,
  12. Karina Lovell9

Abstract
Objective Cognitive–behavioural therapy (CBT) has been shown to be effective in the management of chronic widespread pain (CWP); we now test whether it can prevent onset among adults at high risk.

Methods A population-based randomised controlled prevention trial, with recruitment through UK general practices. A mailed screening questionnaire identified adults at high risk of CWP. Participants received either usual care (UC) or a short course of telephone CBT (tCBT). The primary outcome was CWP onset at 12 months assessed by mailed questionnaire. There were seven secondary outcomes including quality of life (EuroQol Questionnaire-five dimensions-five levels/EQ-5D-5L) used as part of a health economic assessment.

Results 996 participants were randomised and included in the intention-to-treat analysis of which 825 provided primary outcome data. The median age of participants was 59 years; 59% were women. At 12 months there was no difference in the onset of CWP (tCBT: 18.0% vs UC: 17.5%; OR 1.05; 95% CI 0.75 to 1.48). Participants who received tCBT were more likely to report better quality of life (EQ-5D-5L utility score mean difference 0.024 (95% CI 0.009 to 0.040)); and had 0.023 (95% CI 0.007 to 0.039) more quality-adjusted life-years at an additional cost of £42.30 (95% CI −£451.19 to £597.90), yielding an incremental cost-effectiveness ratio of £1828. Most secondary outcomes showed significant benefit for the intervention.

Conclusions A short course of tCBT did not prevent onset of CWP in adults at high risk, but improved quality of life and was cost-effective. A low-cost, short-duration intervention benefits persons at risk of CWP.
 
The following seems to say a lot (first 3 paras is one para I have broken into 3, my bolding):

Why did the trial clearly not change the likelihood of CWP onset while showing positive effects for a range of secondary outcomes (including quality of life)? First, it may be that CBT is not effective in relation to preventing CWP onset. We know that there is a large body of evidence that CBT (including tCBT) is effective in relation to managing CWP, and also for managing some of the symptoms which characterised people at high risk, but it may not be effective at improving the pain in CWP. Our previous trial using CBT in the management of CWP while showing large improvement in patient perception of their condition and in quality of life, did not demonstrate any benefit in terms of the Chronic Pain Grade.10

Doesn't it say more about the measures used vs the spoonfeeding the 'treatment' might involve in relation to said scales? Please see final quote and comment (as I didn't want to interrupt the order of this para) at the bottom

And yes, looking at the next sentence that giving better answers to these perception-based scales doesn't change the outcome. And it perhaps it more obvious when someone tries to do a study were there is a time-order that means claims of causation can't be muddied/cart-before-horse self-kiddology isn't possible?

Second, our risk model may not be the causal model. A change in hypothesised risk factors would only effect a change in outcome if the relationship was causal. This suggests that it would be beneficial to explore, among those at risk, what is the underlying causal mechanism. Altered hypothalamic–pituitary–adrenal axis function is one possible underlying causal mechanism which has been investigated.28 Third, it is understood that there are life-course influences, specifically early life factors, on the development of CWP,29 so it could be that intervening across the adult age range is too late to be effecting a change by means of a short-term intervention.

.... or if you really want to kid yourself then claim it's because you didn't catch people early enough because 'it happened in childhood' :banghead: really? why is it we live in a world where people think they can get away with that and won't be laughed out of rooms?

Fourth, it may be that CWP was a poor choice as the primary outcome. There is evidence that people with CWP can move in and out of meeting criteria30 and indeed it may be that we have identified people who commonly experience CWP but recruited them at a time when they did not meet criteria—and the interpretation would be that the intervention did not move participants off that trajectory. Recent data from a longitudinal study in Norway have shown that the transition, among people with pain, to CWP did not represent a clinically significant change in state.31

There we go ... the classic BPSm lesson, never feel you have to stick with the primary outcome that you sold/got funded for the project on if it doesn't work and watch out for anything objective in particular, the more objective and less subjective the worse. Goodness knows why whether people were 'moving in and out of meeting criteria' in some sort of claimed pattern or if it was 'one way' shouldn't really make a difference for a study that helps prevent things surely - unless they are trying to say it works for those who were diagnosed because they can fluctuate back, but those who weren't might have been in an 'ebb' and timing meant they'd fluctuate back in within a year like some sort of cycle of the moon meaning more would be likely to wax 'back in' if they were 'on the wane' when recruited?

Is that ... straw-clutching?

It is already known that CBT is effective in the management of fibromyalgia11 and this study provides evidence that a wider range of patients may benefit in terms of quality of life. In total 54.5% of the intervention group considered their health had improved (between a little and very much) compared with 36.9% of the UC group, as well as improvements in fatigue, distress and changes in response to symptoms. The incremental cost per QALY gained of £1828 (which was robust to different assumptions modelled in various sensitivity analyses) means that this intervention is highly likely to be cost-effective at the limit, which NICE in the UK, is willing to pay.

Doesn't that prove that the causality isn't there... even if you 'treat symptoms' and get people to report they perceive them as better it makes little difference to whether they go on to end up meeting the criteria for the condition - so basically the condition isn't caused by these things then.

I'm also puzzled quite how they've claimed the quality of life year calcs

I note that the introduction includes the following claims of healthcare usage/costs:

The road to diagnosis is often tortuous and can take many years. Using general practitioner records in the UK, Hughes et al 5 noted that people diagnosed with fibromyalgia had higher rates of primary care visits (average 25 visits/year), prescriptions (11/year) and testing from at least 10 years prior to diagnosis, in comparison with matched persons without such a diagnosis (12 visits/year and 4.5 prescriptions/year).

I find the claim of average 25 visits/year to primary care hard to believe. This would mean getting an appointment once a fortnight, which even in 2015 would have been impossible for most and certainly not something that would have continued for that long without some sort of red flag at most GPs given triage etc was happenning back then. It's also pretty impossible if you are trying to keep a job to be able to get to said appointments.

Undertaking a primary prevention study presents different challenges to undertaking a treatment study. Most people eligible for the trial probably would not have known what CWP is, nor that they were at high risk of its development. Thus, the intervention was described as ‘maintaining musculoskeletal health’ and introduced in the context of participants having reported pain and other symptoms.

So basically what was different here is the fact that for the primary outcome itself, because it is a prevention study they can't mention the illness or prime people for it. And so that's the measure they can't change because how can you 'disappear something' when you can't describe anything close to it? :jawdrop::laugh::laugh::laugh:

It would be like trying to do cfs-CBT gaslighing people they only have false beliefs that exertion makes them worse, encouraging them that 'too much rest is making them tireder' and having to describe it as 'maintaining cardiovascular health'. Even if people were better at managing the perception of things in order to report what is desired on the questionnaire, they blinking obviously know and still notice when whatever it is that is underlying it is objectively getting worse and needs checking out. And it isn't like they can train them to answer the 'future medic's questions' without giving away the game. ?

.... unlike most of the dodgy BPSm 'CBT' studies where the treatment is 'talking' and 'reframing what people say to cerain quesions' priming people what they need to reply specifically to the questions that they will have asked of them later, and basically a learn-by-rote training session where their answers get fudged upwards and drilled in by the therapist in preparation for 'surprise surprise they said they focus on their symptoms less by one point on the scale' because their therapist has spent the whole sessions gaslighting them that it's 'on them' and 'over-focusing is bad'. ...
 
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