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

Barry said:
To me, anything that can have an effect on someone at all, can potentially have either a positive or a negative effect. In a sense you can broadly perceive an effect as being on an analogue scale, ranging from negative through zero to positive. What we think of as benefits would be the positive side of the scale, and detriments/harms on the negative side. The notion that any intervention has an effect range which magically truncates at zero (i.e. lops off the negative side) is nonsensical. If something has the potential to benefit, then it has the potential to have an effect; if it has the potential to have an effect, then it could be anywhere across the whole range. It's just not safe to presume otherwise.

If something has the potential to benefit then it must be assumed it has the potential to harm, no matter what the treatment.
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This is also relevant with regard to complementary and alternative therapies and "natural" therapies.
 
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Tom Kindlon said:
In case it is of interest/use, I have posted a thread with some extracts here:





https://twitter.com/TomKindlon/status/1291178102811484163
https://www.facebook.com/TomKindlonMECFS/posts/1717762998371818
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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.
 
Barry said:
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.
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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
4.2. Poor reporting of harms in RCTs, particularly for non-pharmacological interventions

Evidence across various medical domains suggests the reporting of harms in clinical trials has been especially inadequate and receives less attention than efficacy outcomes (110-113). As one group of authors noted, “Reporting harms may cause more trouble and discredit than the fame and glory associated with successful reporting of benefits” (114). Breau also observed that, in general, “[t]rialists may not evaluate adverse outcomes because they believe the safety of the intervention has already been established. However, this assumption is often invalid since the adverse effects of an intervention may differ depending on the indication or population subjected to treatment” (57).

To help remedy this, the CONSORT group issued a statement extension in 2004 focusing on harms (56). This extension consisted of a 22-item checklist that researchers should consider in the process of designing, carrying out, and publishing their studies. The checklist includes “clarify[ing] how harms-related information was collected”, “list[ing] addressed adverse events with definitions for each”, and “describ[ing] for each arm the participant withdrawals that are due to harms and their experiences with the allocated treatment” (56).

Harms reporting for nonpharmacologic RCTs is generally inferior to that for pharmacologic RCTs. A study focusing on the reporting of harm in RCTs of mental health interventions found that no report of nonpharmacologic treatment trials adequately reported harms (115). Another group of researchers compared the reporting of harm in pharmacologic (n=119) and nonpharmacologic (n=74) RCTs of treatments for rheumatic disease (74). Pharmacologic treatment reports included information related to harms more often than nonpharmacologic treatment reports. This information consisted of collection methods, blinded assessment, reporting of adverse events, causal relationship between the treatment and adverse events, withdrawals due to the events, and severity of the events. A greater proportion of the space in the results section was allocated to harms in pharmacologic than nonpharmacologic treatment reports. These differences remained with adjustment for sample size, medical area, funding, and multicenter trials. Fewer than half of the nonpharmacologic treatment trials assessed reported any harm-related data at all.

The authors commented (74): “Presupposed lower toxicity profiles of nonpharmacologic treatment, such as exercise therapy, complementary and alternative medicine, and behavioral interventions, could explain a lower interest in the evaluation of adverse events. However, most therapy entails the risk for adverse events, including serious events.” The aforementioned CONSORT statements provide a framework against which to evaluate the quality of RCTs. Reporting of harms from trials of nonpharmacologic trials should be as systematic as the reporting recommended for pharmacologic trials.
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Barry said:
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.
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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.
 
Invisible Woman said:
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.
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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.
 
Barry said:
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.
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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.
 
Barry said:
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.
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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
 
Sly Saint said:
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
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A key message from both the above, this quote being from the second:
When someone undergoes psychotherapy, the hope, obviously, is that they will recover. But if they don’t, what is the worst that can happen? That the therapy will prove ineffective? In fact, therapy can be harmful, with research showing that, on average, approximately 10 per cent of clients actually get worse after starting therapy
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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:

Unheeded recommendations

NICE, which picked up the ball that had been dropped by SERNIP, thought so too. Like its short lived predecessor, in 2003 NICE approved TVT for the treatment of stress urinary incontinence, but did so with a raft of caveats. If all of them had been heeded, today’s mesh crisis might have been largely averted.

When NICE issued its final appraisal of Ethicon’s Gynecare TVT device in January 2003 it stated clearly that it was recommending the procedure as only “one of a range of surgical options for women with uncomplicated urodynamic stress incontinence in whom conservative management has failed.”

Furthermore, properly selected patients should be “fully informed of the advantages and drawbacks” and the procedure should be done “only by surgeons who have received appropriate training in the technique, and who regularly carry out surgery for stress incontinence in women.”

This advice reads like a checklist of the complaints made by women who have subsequently come forward to say they were harmed by mesh—that they weren’t offered alternative surgical or non-invasive interventions, that they weren’t warned of the dangers of TVT, and that their surgery was carried out by an inexperienced surgeon.

There were, NICE noted, few data on longer term complications, though problems that had been seen already included “erosion of the tape material into the bladder, urethra, or vagina.” The available data “suggest that this occurs at a rate of about 1%,” but further long term data were required.

Crucially, NICE also recommended that observational data on effectiveness and safety of the procedure should be collected over at least 10 years. Preferably, “this should be nationally co-ordinated in the form of a registry of audit data to include both the numbers of procedures carried out and measures of outcome and adverse events.”9

Again, had that advice been adopted, either by the NHS or the various professional groups whose members were rushing to embrace mesh procedures, by 2013 a decade of data would have been available, offering crucial insights into long term complications that might have spared many more women from experiencing problems.
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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.
 
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
 

Attachments

Caroline Struthers said:
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
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whoops - just noticed repeated text in the pdf...never mind, they will get the point!
 
Caroline Struthers said:
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
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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?
 
It's M.E. Linda said:
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?
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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"
 
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