Ash & Amy, As you well know it, there is no perfect decision- every decision can be false-positive or false-negative…This goes for the funding agencies,
judges, experts etc So, the real question here is if the consequences of false-positive decision (recommending breast augmentation that this patient so desperately sought with minimal surgical complications but at the expense of public funds) is worse than
false-negatives (denying surgery, which may result in beneficial medical outcomes according the qualified expert, and, which in the end would cost only a fraction of money that was spent on litigation). You clearly think that false positives are more important
in this case than false-negatives. I wonder if everyone on the list agrees with you- I suspect 50-50% split?
Also, if this case was brought to the court, I am not so certain that the jury would side with the judge…I think there were several cases in the US when
doctor acted according to the EBM guidelines (two immediately comes to my mind- physicians did not screen for glaucoma in a low risk patient, or did not order PSA test to detect prostate cancer etc) but the jury found against physicians (I realize that this
is not the same as refusal to fund a procedure, but it illustrates the key issue at stake here- the jury may sometimes side with the experts rather than with EBM).
ben
Dear Ben,
I'm intrigued at your statement 'However, I am fairly certain that the same evidence (or, lack of it) and the same expert opinion would be interpreted in diametrically opposite
direction on this side of Atlantic'.
Why are you so certain that it would be interpreted differently in the US Courts of Law?
If there is nothing before
the Court which throws doubt upon the expert evidence then the court must accept it. However, the Court relies upon the medical
expert witness to be up to date, to be honest and to be familiar
with the relevant medical literature. It has need to be on guard against the over-dogmatic expert, the expert who feels that
his or her reputation or amour propre is at stake, or the expert
who has developed a scientific prejudice. Agreeing to act as a medical expert witness is not a decision to be taken lightly,
wantonly or ill-advisedly. Not only does it involve a lot of hard work, but may expose the expert's shortcomings in an all
too public way (Ref: Expert Witnesses Criticised; Journal of Clinical Risk;
Clin Risk 2011;17:1-2; doi:10.1258/cr.2010.010033)
In addition, the Missouri Supreme Court in a recent case (Jana Kivland and Kristin K Bold versus Columbia Orthopaedic Group and Robert Gaines)[No SC 90708, dated 25.01.2011] said as part of the judgment, and I quote 'The jury will decide whether to accept the
expert's analysis of the facts and the data. Elliot v. State, 215 S.W.3d 88, 95 (Mo. banc 2007) ("'Any weakness in the factual underpinnings of the expert's opinion ... goes to the weight that testimony should be given and not its admissibility.'") (omission
in original) (quoting Alcorn, 50 S.W.3d at 246). Similarly, "any concern about the accuracy of the [expert's] instruments [can be] made known to the jury and goes to the weight the evidence should receive." Murell v. State, 215 S.W.3d 96, 111 (Mo. banc 2007)'.
Regards,
Ash
Dr Ash Paul
Medical Director
NHS Bedfordshire
21 Kimbolton Road
Bedford
MK40 2AW
Tel no: 01234897224
Email:
[log in to unmask]
From: Evidence based health (EBH) [mailto:[log in to unmask]]
On Behalf Of Ash Paul
Sent: Sunday, March 27, 2011 7:04 PM
To: [log in to unmask]
Subject: Re: Prioritisation in the NHS (patient example)
The patient didn't have to pay a single penny for the case Amy, the British tax payer funded it all under the 'British Legal Aid' System.
In the UK, to qualify for Legal Aid, your disposable monthly income can’t be more than £733.
It cost the NHS more than 250000 pounds to defend itself in court, money that could have gone, more appropriately, into patient care.
Dr Ash Paul
Medical Director
NHS Bedfordshire
From: Dr. Amy Price <[log in to unmask]>
To: [log in to unmask]
Sent: Sunday, 27 March 2011, 23:36
Subject: Re: Prioritisation in the NHS (patient example)
Although I can’t pretend to understand the He/She mindset my ‘system 1’ perspective tells me that manufactured breasts won’t solve the
problem and for the litigation costs involved the patient could have paid privately and had the requested appendages in a week. I was not impressed with the ‘expert’....I don’t see the evidence for gender reassignment adding to long term quality of life or
mental stability either but I have little experience here so this could be a personal bias.
Here is a real life example. I had serious trauma injuries from a crash. I was offered self administered diamorphine or a surgically
implanted pain pump...I passed on these options. My GP suggested a combo of Baclofen and Neurontin. Combined in subclinical doses these worked great, I could function and pain was reduced. I was encouraged to titrate down or up but to keep the products in
my blood stream. Neither product worked well alone. At some point Neurontin for off label usage went on the no fly zone. I would have had no problem claiming exceptionality except these drugs were relatively inexpensive so I just had them prescribed privately
in another country, after some time I was able to add them back in. Now I don’t need them but for years they were a lifeline.
My experience is that many patients lack the skills to navigate the system when a policy decision adversely affects them and their voices
are not heard. Sometimes I think that responders on the wrong end of the statistical stick or drugs that are useless alone but effective combined get inappropriate bad press and prescribing habits of MDs are affected by this. I also see useless painkillers
prescribed regularly. I wonder if aggressive marketing campaigns by pharmaceutical companies feed into this problem and if that should not be somehow held to accountability particularly in medical schools...
It seems clinicians could provide case study/series for policy makers and if substantial numbers arrived from various clinicians this
could provide some justification for an RCT. If individual clinicians won’t make the effort than I have to wonder what they would expect a policy maker to do. Maybe this is all impossible and naive on my part but I would like to see creative solutions that
are practical and useful.
From: Evidence based health (EBH) [mailto:[log in to unmask]]
On Behalf Of Djulbegovic, Benjamin
Sent: 27 March 2011 11:16 AM
To: [log in to unmask]
Subject: Re: Prioritisation in the NHS
Rakesh, I think this is exactly a type of the case that we ought to be debating here…so, we should not be hesitating asking the questions
you are asking…(Ash: thanks for this fascinating case). I hope the members of this group will take their time to read it, but it does boil down to the issue of whether it is good use of societal resources to fund treatments in light of absence (of high quality
public) evidence that treatment works (vs. “evidence of absence” i.e. evidence that treatment does not work). And, indeed, in a just society: whose fault is that high quality evidence has not been generated?
I could not agree more with Neil’s post (that just came in as I was typing this reply to encourage others to read the document Ash provided
a link to): ultimately everything gets process through our brains. But, it appears that we are reluctant to accept what we cannot easily understand- hence the ruling is based on systematic review rather on the expert opinion. However, I am fairly certain that
the same evidence (or, lack of it) and the same expert opinion would be interpreted in diametrically opposite direction on this side of Atlantic.
Again, this is a type of the case we ought to be debating- hope others will join in.
From: Evidence based health (EBH) [mailto:[log in to unmask]]
On Behalf Of Rakesh Biswas
Sent: Sunday, March 27, 2011 7:21 AM
To: [log in to unmask]
Subject: Re: Prioritisation in the NHS
Recently, on 11th March 2011, the UK Court of Appeal delivered a landmark judgment, upholding the NHS Commissioners rights to refuse funding to an indiviudal
patient on grounds of exceptionality.
This was inspite of the patient (who had originally brought the case against the NHS Commissioners) bringing in expert clinical witnesses including a Professor
of Psychiatry who said that in his ' opinion' (read 'intuition' instead of 'opinion' within the context of our present discussions) the funding request was exceptional and warranted funding. The Court of Appeal, which included the Master of the Rolls, went
along with the NHS Commissioners who presented a systematic review of the evidence to argue that the case was not exceptional.
You might want to read the Court of Appeal judgment at:
Dr Ash Paul
Medical Director
NHS Bedfordshire
Sent: Sunday, 27 March 2011, 0:08
Subject: Re: Prioritisation in the NHS
A thought...It may be that learning and optimizing the processes involved in decision making systems 1+2 would help a medical professional to discern the effective timing
and implementation for both systems so they do not try to present a system 1 process instead of a system 2 in the system 2 only framework. (I can’t count the number of times I have heard loss of freedom to practice medicine, big pharma conspiracy and government
interference used to excuse a lack of diligent foresight, research and preparation)
Also within a system 2 presentation there may be room for judiciously placed system 1 inferences...good decision making is a clear approach to discernment, timing and
opportunity and takes a lot of practice which can be accomplished in system one friendly situations. I think it is even advisable to practice in the trenches before one take on the big leagues.
From: Evidence based health (EBH) [mailto:[log in to unmask]]
On Behalf Of Djulbegovic, Benjamin
Sent: 26 March 2011 04:19 PM
To:
[log in to unmask]
Subject: Re: Prioritisation in the NHS
I raised my previous point in the context of different decision-making mechanisms (system I vs. system II)… a number of people acknowledged- yourself included- importance
of intuition for decision-making… yet, when it comes to decision-making of the types you described, we almost exclusively rely on the rational (system II) approach as you detailed below…This is particularly reflected in your following sentence “If you want
to prescribe drug A to your patient when it is not ordinarily funded by the commissioners, you will have to prove to the commissioners that your request is truly exceptional.” That proof, we would probably all agree, will never be accepted based on tacit,
intuitive knowledge despite our clear understanding of the importance of these processes…
PS I guess all what we can say that scientific method (based on system II reasoning process using public knowledge accessible equally to all observers), as fallible as
it is, remains the best and probably only tool at our disposal to make rational decisions…(which is not to say that we should not attempt to use science to understand the processes that are occurring at subconscious levels, as pointed earlier by Neal and others).
PSS Although on the face of it, this is a theoretical, academic discussion, the points we are discussing here have enormous practical relevance, as when, for example,
individual decision-making (based on “private”, intuitive evidence) conflicts with EBM guidelines (using public evidence that others, similarly trained people can understand).
Dear Ben,
Prioritisation doesn't work so arbitarily like that in England.
We have national organisations like NICE who issue Technology Appraisal Guidance (TAG) on certain high cost drugs and medical devices, on the basis of clinical and cost effectiveness. The NHS is legally bound to fund them within 3 months of a positive NICE
TAG, but will not fund them if the TAG is negative.
But there are lots of drugs and devices that NICE does not pronounce judgment on, because they don't have the capacity and resources to do so.
Then this is what happens.
You need to remember a couple of things before you read on, because it will give you the context in which we NHS Commissioners operate. Firstly the commissioners are allocated their fixed annual budget (from the beginning of April to end of March the following
year). Secondly, the commissioners are statutorily bound by law not to exceed their annual budget by even an extra penny (they have to remain within their allocated resource limit). It's the classical case of Charles Dickens's Mr Micawber in David Copperfield
- income 20 shillings; expenditure 19 shillings 6 pence; result happpiness/ income 20 shillings; expenditure 20 shillings 6 pence; result misery.
Let's suppose you are a consultant who wishes to use a new drug A or device B which has not been NICE'd. We consider that as a 'service development'. So, you will need to write down a business case and submit it to the commissioners for consideration during
the annual prioritisation round. The annual prioritisation round takes place in December/January and all business cases have to compete against each other to be prioritised. The business cases are prioritised against a set of ethical and commissioning principles
with criteria and weights (attached to each criteria) and scored. Those that score above a pre-agreed minimum score are prioritised and then sent to a group of local clinicians and commissioners who match the prioritised services against the annual budget
available (in an open, transparent and 'Wednesbury' reasonable way). If your drug A does not meet the cut, the commissioners will not fund it that year.
Herein, lies the crunch. Ordinarily, if you say you won't fund it, no resident in your local population should have access to the drug/device. The principles of social justice and equity demand that it should be an 'all or none' phenomenon. Lawyers have repeatedly
advised us that NHS commissioners can/should take recourse to this action. But politicians are always jittery about the dreaded 'R' word being officially bandied around. So commissioners in the NHS have agreed on a loop-hole (pretty unsatisfactory, in my opinion)
to get around this system and keep the politicians happy ie through the exceptional funding route. If you want to prescribe drug A to your patient when it is not ordinarily funded by the commissioners, you will have to prove to the commissioners that your
request is truly exceptional. Your request for funding is sent to an Individual Funding Request (IFR) Panel, comprised of commissioners, clinicians, the public and lay members of the Board of the Commissioning PCT, which will decide whether your exceptional
funding request merits approval. All off-license/unlicensed funding requests and also funding requests for drugs/devices not approved by NICE TAG's must similarly be sent to the IFR Panel (these are the Panels that Sarah Palin et al refer to the NHS Death
Panels, which, by the way, is a completely false description of these Panels).
If your funding request is refused by the Panel, you can appeal against the decision, and your appeal will be heard by an Appeals Panel, the composition of which is entirely different from the original IFR Panel. The decision of the Appeals Panel is final.
The unsuccessful patient can, however, take the commissioners to court and request a judicial review of the funding decision.
Hope you find this useful.
Regards,
Ash
Dr Ash Paul
Medical Director
NHS Bedfordshire
And, of course, we need to add to this, as pointed by Jim Walker, the famous Godel’s proof that we can know something even if cannot prove it…
But, Ash, how does this discussion bode to EBMers including your own decision-making when you try to rationally and fairly allocate scarce resources as you have eloquently
discussed it on this group on a number of occasions… What do you tell to people who tell you “I know (from my experience) that this treatment works and you are telling me that there is no evidence to fund this therapy”.
I am afraid we are coming full circle, and seems to me that we simply do not have any other recourse but to rely on our meager neocortex ( Jim’s “the
conscious tip of a fully integrated iceberg”) , at least when it comes to decision-making involving others…And, as I pointed out in my earlier post, justification for this is that rational inferential system (=EBM) is more often right than intuition (although
is far from “idiot-proof”…)
Benjamin Djulbegovic, MD, PhD
University of South Florida & H. Lee Moffitt Cancer Center & Research Institute
From: Evidence based health (EBH) [mailto:[log in to unmask]]
On Behalf Of Ash Paul
Sent: Saturday, March 26, 2011 4:18 AM
To:
[log in to unmask]
Subject: Re: Clinical Decision Making and Diagnostic Error
It's interesting to note that Albert Einstein was a great protagonist of the powers of intuition. However, to my mind, his quotes are much more apt for the psyche of the inventor/discoverer,
than they are for medics charged with routinely saving lives using proven treatments.
Einstein's scientific writings are littered with quotes on the subject:
1. 'I believe in intuition and inspiration…at times I feel certain I am right while not knowing the reason'.
2. 'The intuitive mind is a sacred gift and the rational mind is a faithful servant. We have created a society that honors the servant and has forgotten the gift'.
3. 'The intellect has little to do on the road to discovery. There comes a leap in consciousness, call it intuition or what you will, and the solution comes to you, and you don’t know how or why'.
Einstein was, ofcourse, preceeded by the immortal Aristotle who wrote 'Intutition is the source of scientific knowledge'.
Regards,
Dr Ash Paul
Medical Director
NHS Bedfordshire
A quote from Steve Gilman ( posted by Arin Basu in a different context for a different forum):
"Much that you learn will be learned at a level below consciousness. Use this. Even as you guide your thoughts consciously, allow for the intuitive. This interplay between the conscious and unconscious is where the art of thinking really blossoms."
Copyright Steve Gillman.
Article Source: http://EzineArticles.com/616048
Just a lame attempt on my part to summarize this rich discussion. Also the line marked copyright makes me wonder about its true place in a web based meta-cognitive future.
:-)
