Patient Safety Commissioner proposal - First Do No Harm IMMDSReview, 2020, Cumberlege et al

This is also relevant with regard to complementary and alternative therapies and "natural" therapies.

 

In case it is of interest/use, I have posted a thread with some extracts here:
https://twitter.com/user/status/1291170883936096258

https://twitter.com/user/status/1291171759224426497

https://twitter.com/user/status/1291174284900147200

https://twitter.com/user/status/1291175918346678272

https://twitter.com/user/status/1291177071440547840

https://twitter.com/TomKindlon/status/1291178102811484163
https://www.facebook.com/TomKindlonMECFS/posts/1717762998371818

 

It must be well understood and accepted that psychological interventions have the potential to negatively affect a person. Many years ago, when trying to deal with some issues, I was told by a psychiatrist after being assessed, that he felt that in my case I was sorting things pretty well on my own, and that treatment would be very intrusive and could do more harm than good. And I've always respected him for that advice. My point being it must be already well understood within the profession, that psychological treatments carry the potential for harming a person, therefore must know it is nonsense to presume otherwise.

Surely there must be studies already done examining harms incurred from psychological interventions. I'm not meaning specific to ME/CFS, not at all. But harms from psychological interventions for any condition. And not specifically physical harms, but also psychological harms. My point being that if there is good evidence already out there that people can be harmed, in any way, from psychological interventions, then that is a serious peg in the ground.

If harms can result due to any form of officially condoned medical (including psychological) treatment, how can it possibly be excluded from any kind of patient safety mechanism - just plainly illogical. Feels like it should be illegal. Discrimination? Feels like the same lack of critical thinking that pervades BPS-psychology itself.

 

An extract from my 2011 paper, Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, for what it is worth:
https://www.iacfsme.org/assets/Reporting-of-Harms-Associated-with-GET-and-CBT-in-ME-CFS.pdf

 

Apart from @Tom Kindlon's paper I don't know of any.

Any trial should look for harms as well as cures. Different standards have been allowed for far to long in the field of mental health.

They get away with it because, if the patient becomes worse or hurts themselves, then they can blame the patient claiming it is due to the mental health condition and not due to the treatment of that condition.

Even with drugs used in the field of mental health when patients have ended up much, much worse or dead, their families have faced huge uphill battles to have the role of dangerous drugs acknowledged in the harm caused.

They don't chain patients to the wall anymore but they still play fast and loose with their health.

 

And of course harms should not just include dropping dead or crippled for life. It should include the "negative versions" of benefits. So if one measure of benefit from a psychological intervention were to be socialising more, then a harm (or at least detriment) might be if someone socialised less instead. And of course if a benefit is evidence of having more energy available, then a detriment/harm would be having less available.

I think there is also an issue that "negative benefits", or detriments/harms, should not only be counted within averaged outcome figures in trials, because the consequences to patients can be disproportionate, and those consequences therefore lost also. If within a trial of 100 people 5 of them lose 75% of their social interactions, then the numbers themselves would likely get lost, as only showing a modest detrimental effect overall. But to those 5 individuals it could be catastrophic to them. The measurement of harms/detriments should not simply be about the bald numbers, which trials can so easily subsume into the broader results; it should be about human impact to individuals.

A better indication of the 'value' of harms is likely to be found in legal damages paid out for human injury, be it mental or physical. The consequences of harms and detriments just cannot be treated as being "part of the mix". If 2 people are seriously injured, and 8 less seriously so, in an incident in football stadium packed with 10,000, you cannot get away with saying "well, 9,990 had a great time so the overall detriment was very minor ... and so pretend it never happened. Harms and detriments have to be weighted differently somehow.

 

See, now you're just talking sense @Barry. They don't like that!

 

Yes, deteriorations can be missed in average figures. This has been recognised in the reporting of harms: good reporting of harms includes that.

Note that good reporting of harms in trials covers all problems that arise, even though sometimes problems can arise by chance e.g. just because one person had a heart attack (say), doesn't mean that the intervention definitely caused that to happen. So interpretation can be required and the collation of data from different trials and sources.

 

At last!!!

 

yes, many.
eg first couple of articles in a search
A Synopsis of the Side Effects of Psychotherapy – What Should Clinicians Know?
Posted on:July 24, 2017
Last Updated: March 11, 2020
https://psychscenehub.com/psychinsights/the-side-effects-of-psychotherapy/
When therapy causes harm
https://thepsychologist.bps.org.uk/volume-21/edition-1/when-therapy-causes-harm

 

A key message from both the above, this quote being from the second:

This indicating that it's not only about distinctly different deterioration, but also can be about worsening of the same symptoms that are supposed to be improved by the therapy.

 

I was reading this 2018 BMJ article on the mesh issues, and it reminded me of how the most important thing is how people actually behave, and that warnings in NICE guidelines can easily be ignored:

https://www.mjauk.org/wp-content/uploads/2019/05/Mesh-1.pdf

I definitely have a concern that an improvements in ME/CFS NICE guidelines can easily be sidestepped if people like Crawley maintain their positions.

 

The recovered memories fiasco lead to innocent parents being tried in court and left some families devastated and split to this day.

It also made the patients believe all sorts of things they then had to deal with as if they had actually experienced them. Terrible.

 

https://www.bmj.com/content/370/bmj.m3593

Letter from Caroline Struthers has appeared on the bmj website. Paywalled

@Caroline Struthers

 

There is a non-toll link too...bit weird but I think it works https://www.bmj.com/content/370/bmj.m3593.full?ijkey=DqSCPGpoZr6nehN&keytype=ref

 

Hi there

I attended the meeting of the All Party Group First Do No Harm https://firstdonoharmappg.org.uk/20...inancial-and-pecuniary-interests-for-doctors/. My main question was not picked up by Fiona Godlee although I posted it in the chat box as soon as I joined the meeting. That was a bit annoying. It was

"Would you agree that a register of interests should cover doctors who develop and conduct publicly funded trials on social and psychological interventions? These trials influence national guidelines so are even more influential on patients than individual doctors. By the same token, shouldn’t the scope of a Patient Safety Commissioner include harm caused by the promotion of such therapies when the evidence may have been generated by doctors with vested interests?"

I also wrote the attached long letter to the APPG yesterday and was assured it will be passed on to Baroness C and colleagues. It's pretty much the same as the HealthWatch blog

 

whoops - just noticed repeated text in the pdf...never mind, they will get the point!

 

I have recently been sharing both of the petitions (one international, one Gov.uk) calling for a mechanism to report harms. I returned to all my gathered ‘Yellow Card’ info and came across your work again Caroline.

Did you ever get a reply from the APPG and/Or Lady Cumberlege @Caroline Struthers please?

 

I did not. I feel like something may have filtered through because of her appearance at the questioning of the new health minister about The Pause. I can follow up if you think it would be a good idea. I could forward my latest letter to Cochrane at the same time..."for information"