PRINCE Secondary: transdiagnostic CBT is not effective for persistent physical symptoms, 2021, Tack and Tuller

Abstract
PRINCE Secondary was a randomised trial to test the efficacy and cost-effectiveness of therapist-delivered, transdiagnostic cognitive behavioural therapy (TDT-CBT) for patients with persistent physical symptoms (PPS) (Chalder et al., 2021). In total, 324 PPS patients were randomised to receive either TDT-CBT plus standard medical care (SMC) or SMC alone. The trial's primary outcome was the mean score on the Work and Social Adjustment Scale (WSAS) at follow-up assessment 52 weeks post-randomisation. The trial also included several secondary outcomes.

In the conclusion of the abstract, the authors state that the trial provides ‘preliminary evidence that TDT-CBT + SMC may be helpful for people with a range of PPS’. This statement is misleading since it ignores the null findings of the trial's primary outcome. Although the intervention group reported a modest benefit on the WSAS over the SMC group, it was not statistically or clinically significant. For the WSAS, the authors designated a reduction of −3.6 as a minimum clinically important difference (MCID). At 12 months, the mean for the intervention group was −1.48 points less than that for the SMC group, with a 95% confidence interval of −3.44 to 0.48. The confidence interval thus excluded what the authors had predefined as the MCID. This indicates that the trial was adequately powered to provide strong and actionable evidence of efficacy but that it failed to do so.

Open access, https://www.cambridge.org/core/jour...cal-symptoms/C6086F0F86BB3EA1A19DBD49C1617847

 

@Michiel Tack @dave30th It’s a job which shouldn’t be necessary but you do it well. Thank you. In the context of medical activism and politics apparent today around the NICE guideline it is a breath of fresh air to see this published.

 

What @Skycloud said.

Thank you @Michiel Tack and @dave30th -- and congratulations to getting a letter published in Psychological Medicine.

 

This looks to be a response, at least in part, to Michiel and David's letter.

https://www.cambridge.org/core/jour...al-symptoms/DD2770CFD116BF4B3405499630491299#

 

"Persistent physical symptoms (PPS) are associated with distress, disability, and high costs within the working population (Bermingham, Cohen, Hague, & Parsonage, 2010)."

interesting that they avoid stating exactly how much, given their previous continuous misquoting of the actual costs.

see https://www.s4me.info/threads/trial...ts-to-the-nhs-david-tuller.20282/#post-340693

 

Invited Letter Rejoinder (response to David and Michiel) said:

So this large trial was only a preliminary trial? Is this how RCTs that fail to deliver the expected results are usually called?

But isn't that the point? The abstract's conclusion doesn't mention the null findings at 52 weeks/ the final follow up.

Invited Letter Rejoinder (response to David and Michiel) also said:

I admit I'm confused about the primary outcome being the WASAS results at every of the four follow-up time points. From skimming the paper and protocol I also don't understand how the "follow-up time points" relate to the duration and the end of the intervention (active treatment or standard medical care).

Anyway, if the primary outcome was the WASAS at all four follow-up time points then shouldn't the results of all of them also be reported, both in the abstract and the paper's conclusion?

I think though this isn't clear in the paper's conclusion either. The paper's conclusion acknowledges the null findings at the final follow up (52 weeks), but the immediately following lines imply that (some) secondary outcome measures are indeed evidence for a benefit and to that evidence it seems the primary outcome measure at the end of treatment (20 weeks) would add more evidence.

PRINCE Secondary paper's conclusion said:

Why? Is this not a large enough trial? If it was badly designed why develop it further instead of doing a study with a better design?

(Edited for clarity.)

 

Of course this is totally ridiculous. It was not a "preliminary" trial. These people are just a disgrace.

 

I just noticed this:

“Bona-fide researchers” meaning all data requests from filthy plebs (ie patients) will be denied.

 

How can sharing data with "bona fide researchers "be permitted if no consent was provided for sharing with third parties? Anyone not a party to the original research is a third party.

 

Always bring your own spoons. Never try to bend spoons brought by other people, they don't have the magical property (of being a soft alloy).

 

Agreed. It’s also telling that they deliberately chose not to do what most trials these days do which is to obtain written consent for data sharing.

Not that it’s even necessary to reanalyse the original dataset in this case. Unlike in PACE where the data analyses were fraudulent, here it’s transparent from the results section that the trial did not meet its primary endpoint and that most of the secondary outcomes were non-significant also. The only issue here is that the abstract deliberately misrepresents the results because they know that most busy clinicians will only read the abstract.

 

Money spent that doesn't add value, adds costs, doesn't increase revenue. Good for science, bad for business. The journals have no incentives when clearly not enough people care about it. In fact most seem content with the lowest possible quality standards, it allows below-average researchers to thrive whereas in a functioning system many would simply have to find a different career.

In psychology they are content with the fiction that they find 100% of what they set out to find, even when the findings contradict other findings. Everyone gets a participation trophy and one's value and reputation is based on how many participation trophies they can put on display.

To drive the point further, clinical psychology is almost universally driving in the direction of lowering standards even further to preserve the damn biopsychosocial ideology. There is no interest in fixing any of this within the profession. Only from people like us who can see the harm it causes, and medicine being completely insular, they don't listen to anyone but themselves.

 

From the Invited Letter Rejoinder:

"...further work is needed to maintain or maximize effects."

From what we've seen with how pwME are treated by disability systems, and health care, governments have little appetite for funding our community or those similar.Therefore, it appears unlikely that long term funding would be available to "maintain or maximize effects", that is, for individuals in these studies.

On the other hand, if the intent is not to provide longer term support to previous study subjects, but to produce more studies to work on how to "maintain and maximize effects", then we may see these.

ETA: added clarification.