[HSF] The fallacy of surgical research
Tea Acuff
tacuff at swbell.net
Thu Aug 2 22:21:39 EDT 2007
As to the "comic opera" of surgery, Walpole, and maybe others said:
"Life is a comedy to those that think and a tragedy to those that feel."
Those that laugh at the surgery literature are thinking rightly, but if they believe that the medical literature is better it must be because they are feeling, and that is a tragedy at least to thinking.
I agree with much that Ani has said but am unclear whether he is thinking or feeling.
If I understand what Ben said (turn around fair play), he is suggesting that data mining (raw data analysis without prior hypothesis) in a randomized trial is important. Likely so.This may be the problem with Ani's term "research". Research is an academic highfalutin word that means to surgeons and the rest of us simple souls: observation. As I understand scientific trial, it means and only means, an a priori prediction of a specific outcome to a provocation. This is simply a special but not necessarily better case of observation (as noted by our opera critic). Secondary outcomes are fudging bonus points. All of the mathematical manipulation that Ben is asking for is actually just plain old (but stastistical) observation of a population as are most surgical reports. Unfortunately it is done in the name of a trial and acquires some of the sacred qualities that seemed to flow from Ani's initial outburst (or rant).
Observation is the key and only key to information for us nonsacred mortals. Trials are only a special form of such observation. In medicine we observe not particles, but systems (practice systems, individual patients, organs, cells, mitochondria, etc) which is observed from a system (medical practice) and for the surgeon the "test" is a system (CAB, ligation of LAA) not a particle (ASA, metoprolol). Not surprizing that there is a lot of confusion when we try talk about any surgical trial (RCT or other) being scientific research.
With systems since they can adjust, context is as least as important as logic and linear testing (a priori or otherwise). That is a major reason that social science or surgery science seems much less predictable.
Lastly, of course, measuring anything and on some accounts on the quantum level just thinking about measuring, changes that which is measured. (At least as observed by "our" rules!) The ways to measure the "tested" especially in systems are infinite even for us mortals. We easily forget, as in my anterior leafet approximation as mitral valve repair critique, that we are not finding the nature of the system tested, but the nature of the nature of the new result of the one of infinte choices of impact on the tested.
Thus since context is so important to understanding the states of the systems that we are testing, and since observation (including some population information, e.g., series,trials) is our only connection to the tested , it is not surprizing that someone like our own Dr. Frater who has decades of observation in dozens of contexts should have much more wisdom than the next stinkin' RCT. This is especially true since Dr. Frater has been shown to be an astute observor who will likely adjust some of his thinking to that afore mentioned trial. It doesn't hurt that he was more interested in the sytem being tested then being recognized for his own system of impact. To win something as political as the Nobel prize you have to either be accidently in the present consensus thinking or change the consensus to your system. To learn to be a master surgeon you have to learn to think and observe like Dr. Frater.
Call that research if you like.
tea
"Basic research is what I am doing, when I don't know what I am doing."
Wernher von Braun
And that would be another story....
----- Original Message ----
From: Ben Bidstrup <benjamin.bidstrup at bigpond.com>
To: OpenHeart-L at lists.hsforum.com
Sent: Thursday, August 2, 2007 3:14:22 PM
Subject: Re: [HSF] The fallacy of surgical research
Many RCTs are so badly designed they do not tell us much. Look at the
debate going on about various drugs in Journals such as the NEJM.
In one of the editorials that accompanied Mangano's paper in Jan
2006, there was a call for a better understanding of propensity
analysis to help us with looking at
outcomes of drug use.
But even these need to be done properly.
Many so called surgical RCTs are underpowered - how many of them
truly give the details of the power calculations. The Bart study is
and the Guardian and Expedition studies did also. I was not involved
in the pexelizumab ones but I imagine they were as well.
But as Prasanna says, we have so many variables and many of those
relate to the surgical approach. Take transfusions - I detect about
20 different approaches to it on the HSF. Hal is very liberal thinks
nothing of using 10-20 donor packs for a case, whereas Prasanna is
the opposite - no access makes you much more aware of avoiding
problems.
If they swapped places, Prasanna would maintain his aggressive non
transfusion approach, and Hal would learn a few things very quickly.
And I am sure he would return home with a different attitude!
So, an RCT can answer a question, but is it the right question, was
it asked the right way and is the conclusion we draw from the answer
one that will help us. All too often, the question is not answered so
another is addressed as data dredging gave us a p<0.05 for a
different outcome!
One thing that might help us understand these things is for the raw
data to be made available. With availability of bandwidth and storage
so cheap, a clean de-identified dataset could be made available for
many studies. Allows the knowledgeable reader to look at the data as
this is often best way to understand what is going on.
>Ani, I did not say that RCT's are the only form of evidence.
>Unfortunately with the variables that exist in surgery proof of
>concept is easier to talk of that prove. Just take the pharma
>industry and see the daily mess they do with chemicals !!
>There will be errors based on presumptions but hopefully there are
>some pioneering people who do some basal work. This has always been
>the case in science more so in surgery.
>Prasanna
>Ani Anyanwu wrote:
>>Prasanna
>> The often calls for RCTs or the belief that RCTs are what is meant
>>when one asks for 'scientific proof' is a misconception. The
>>majority of questions in surgery do not require an RCT to proof the
>>answer; the RCT is appropriate only in few circumstances in
>>Surgery. Depending on the question, different research techniques
>>are required to find the answer. Like in your example of CPB all
>>one needs is a case report or case series for at the time there was
>>no alternative. Same applies for interventions like insulin or
>>penicillin or blood transfusion. An RCT is not required in this
>>setting. Similarly to discover whether your ligation method is
>>effective in obliterating the LAA we do not need an RCT but a
>>carefully conducted cohort study. Surrogate markers are of little
>>value in clinical research except where there is definite proof of
>>a link with outcome (for example creatinine clearance as a
>>surrogate for renal failure). However, for the cardioplegic
>>solutions the fact that one has less CK release than another does
>>not mean it is superior (if so does it then mean PCI is more
>>protective than OPCAB which is more protective than ONCAB?).
>>Surrogate markers are the requirement for animal experimentation
>>and initial clinical work but to show efficacy, one needs a
>>clinical outcome that matters. Hans Troidl has written excellently
>>on the subject of choosing surgical endpoints and more often than
>>not, the endpoints we use are the wrong one, such as the often use
>>of 'patint was extubated next morning' as a surrogate for success
>>in a complex case presented to the forum. As regards day to day
>>practice, as Don says, little of what we do is based on evidence.
>>There is nothing wrong with basing what we do on anecdote or what
>>we were taught but that is no proof that what we are doing is
>>effective or correct. On this forum however we often portray things
>>as fact or gospel when we have no evidence, and younger surgeons
>>like myself may be deceived into taking some of these surgical
>>myths as fact. For example two weeks ago I challenged anyone to
>>bring forth evidence that obliterating the LAA reduces strokes and
>>no one could provide any except 'I ligate or excise them all and
>>have seen no strokes'. Or there was some discussion as to why a 7/0
>>needle or suture is superior to a 8/0 needle or suture - again
>>presented as fact but backed by no data or evidence or even
>>biological logic. I wondered to myself - so why not a 9/0 suture
>>then? Of course we can have our opinions but we should not present
>>them as scientific fact. If you actually go to measure what you do,
>>you will be surprised how far your perceptions are from reality. A
>>last anecdote, as a trainee I once had charted the mortality rate
>>for 5 surgeons - there were no identifiers attached. One surgeon
>>looked at it and said it cant be right that I must have missed one
>>or two of his deaths (he was thought his mortality was slightly
>>worse than the 1% credited to Surgeon A) - unknown to him he was
>>not the surgeon A with the best results but surgeon E with a 7%
>>mortality. Ani
>>
>>
>>
>>>Date: Thu, 2 Aug 2007 07:31:58 +0530> From:
>>>prasannasimha at gmail.com> To: OpenHeart-L at lists.hsforum.com>
>>>Subject: Re: [HSF] The fallacy of surgical research> CC: > > Of
>>>course and yes the research is based on animal experimentation
>>>etc > etc but unfortunately we cannot excise our test human
>>>specimens to > determine wet versus dry weight and so on and so
>>>forth . We thus have to > end up with surrogate markers. Laughing
>>>it all off may be easy but then > try setting a true "EBM based
>>>RCT" which by itself has been questioned. > Yes Eminence based
>>>medicine can be questioned but if you see most of > surgical
>>>research including your bread and butter the heart lung machine >
>>>- one survivor of 6 patients of Gibbon would not muster as
>>>scientific > and probably even unethical yet you are using this
>>>everyday. Do not > think that even the physical sciences have
>>>"absolute proofs or RCT's > etc" they simply don't if you go about
>>>rigorously examining them. Nice > in theory but difficult in
>>>practice. Its always easy to be contrarian > but unfortunately
>>>most (practically all) of medical science is based on > rejection
>>>of a null hypothesis and not proving the test hypothesis.>
>>>Prasanna> Ani Anyanwu wrote:> > The other issue the discussions on
>>>myocardial protection brings up is the fallacy of surgical
>>>research and the poor understanding of research method by
>>>surgeons. This is what prompted the Lancet editor many years ago
>>>to describe surgical research as 'comic opera'. The reality is
>>>that few in academics or research takes us surgeons seriously.
>>>Look at the representation of surgeons in key research bodies,
>>>funding of surgical research by NIH or similar bodies, surgical
>>>influence in research groups, surgical publications in key
>>>journals, guidelines committees, involvement in key
>>>epidemiological efforts etc. The only Nobel prize received by a
>>>surgeon in the recent era wasn't even for surgical research. The
>>>problem is we as surgeons believe too much in our individual
>>>selves and individual methods that we become blinkered as to the
>>>requirements of the scientific method.> > > > Examples
>>>include> > > > - there is evidence that such and such an additive
>>>to cardioplegia is of benefit (this evidence comes from isolated
>>>animal hearts, animal experiments and at best clinical measures of
>>>surrogate markers - these do not mean the additive is benefit in
>>>the human, indeed it could be worse)> > > > - it has worked well
>>>in my cases so it is okay (but as Dr Salerno and Prasanna say the
>>>heart has great reserve - that nothing goes wrong does not mean
>>>all is okay)> > > > - i have had no deaths (the patient came to
>>>you alive; why is it an achievement that he remains alive after
>>>surgery? (unless the aim of surgery was to save life))> > > > -
>>>Kirklin and Buckberg or Cleveland clinic demonstrated...(i.e.
>>>eminence based medicine; but how many have ever read work of
>>>Kirklin or Buckberg? Do they stand up to the requirements of
>>>scientific proof? Indeed did either really show clinical benefit
>>>of the things we attribute to them? For example the 'seminal'
>>>Cleveland clinic NEJM paper purpurtedly showing benefit of IMA
>>>over SVG barely constitutes evidence of such)> > > > - There was
>>>no enzyme rise (has anyone cared to show any relationship between
>>>enzyme rise and any outcome of interest after surgery? Does the
>>>patient really care what his CK, troponin or coronary sinus
>>>lactate are? Why do we look at outcomes of no relevance to the
>>>patient?)> > > > - Ventricular fibrillation means bad protection (
>>>but has anyone shown so scientifically? maybe fibrillation is
>>>intrinsic to some techniques and rare with others and is a
>>>reflection of the technique rather than the degree of protection;
>>>certainly a fibrillating heart in Salerno's beating heart
>>>technique has different implications to an Arch done by Martin on
>>>DHCA)> > > > - The patient was extubated the next day (and so
>>>what? Several times you go back to ask what happened to the
>>>patient 2 months later and you hear a different story. This
>>>outcome is of no relevance at all unless aim of surgery was to
>>>allow extubation in patient previously ventilator
>>>dependent)> > > > - My method of cold myocardial preservation
>>>works (but how do you know that that is what is working? As
>>>Salerno says if you don't know the myocardial temperature how do
>>>you know it is the hypothermia, and not some other factor, that is
>>>in play?)> > > > - Since I changed I use less inotropes (but you
>>>decide what you use- could you not be just biased towards the
>>>success of your change? Maybe you should compare two methos
>>>objectively)> > > > - Multiple defibrillation harms the heart and
>>>leads to bad outcome (maybe but could it be the condition
>>>requiring defibrillation that is resulting in the bad outcome
>>>rather than the shock?)> > > > - I have done it this way for 10
>>>years and never had problems (how do you know? Have you actually
>>>measured the outcomes on all your patients? Kocher said the same
>>>about his thyroidectomies and was shocked when he recalled his
>>>patients and found the majority had myxedema)> > > > etc> > The
>>>inability to critique within the scientific framework and a lack
>>>of understanding of, or refusal to apply the research method, is a
>>>major problem in surgery and is in part the reason why we are so
>>>diverse in opinion and yet so opinionated and firm in our belief
>>>that what we do is right (when yet examined there is often no
>>>evidence to support it). No internist or scientist or
>>>epidemiologist would approve a drug based on any of the criteria
>>>we list above yet we swear by what we do to the degree that we
>>>suggest alternative approaches are inferior. > > > > Until we
>>>start thinking in a scientific and epidemiological manner, we as
>>>surgeons will remain the laughing stock of academic
>>>medicine.> > > > Ani> >> > > >> Date: Thu, 2 Aug 2007 04:52:48
>>>+1000> To: OpenHeart-L at lists.hsforum.com> From:
>>>benjamin.bidstrup at bigpond.com> Subject: Re: [HSF] Inotropes,
>>>ventricular fibrillation and myocardial protection> CC: > > What
>>>this does is once again ask the question, how do we measure >
>>>myocardial preservation?> > We can look at the highly sensitive
>>>markers such as Troponin which > indicate some element of damage
>>>to components of the myofibrils. and > so on. Echo - RWMA ECG and
>>>the list goes on.> We need to look at use of inotropes, IABP,
>>>survival. Khuri published > on his intramyocardiall pH device
>>>stating that poor preservation as > reflected by pH changes
>>>resulted in altered long term survival.> > Much of the cocktails'
>>>components have been determined by isolated > rat heart
>>>experiments. They have translated well to the human, but it > is
>>>very hard to measure total water content of an intact heart or >
>>>regional blood flow distribution in a human model.> > Why is it
>>>that there is no universal cocktail. Put 100 cardiac teams > in a
>>>room and you will have 120 different ways of preserving the >
>>>myocardium.> I review papers that look at different methods of
>>>preservation and > they use markers such as inotrope use to
>>>determine improvement. How > variable that is is a whole new
>>>debate.> > > > > >Tomas,> >> > A fibrillating heart is a dying
>>>heart? Is this an edict of some > >sort? I've seen plenty of
>>>hearts that fibrillated during some part > >of their open heart
>>>operation only to have a completely, and I mean > >completely,
>>>normal EF on remote echo. Speaking in absolutes serves > >no
>>>purpose.> >> >> >> >Hal> >> >> >-----Original Message-----> >From:
>>>Salerno, Tomas <TSalerno at med.miami.edu>> >To:
>>>OpenHeart-L at lists.hsforum.com> >Sent: Wed, 1 Aug 2007 11:19
>>>am> >Subject: Re: [HSF] Inotropes, ventricular fibrillation
>>>and > >myocardial protection> >> >> >> >> >A fibrillating heart
>>>is. "Dying" heart.> >The brain does not have seizure during CPB;
>>>neither should the heart > >fibrillate.> >Tomas> >> >-----
>>>Original Message -----> >rom:
>>>openheart-l-bounces at lists.hsforum.com > ><openheart-l-bounces at lists.hsforum.com>> >o:
>>>OpenHeart-L at lists.hsforum.com
>>><OpenHeart-L at lists.hsforum.com>> >ent: Wed Aug 01 10:45:53
>>>2007> >ubject: Re: [HSF] Inotropes,ventricular fibrillation and
>>>myocardial > >rotection> >Ani,> >aving graduated from voodoo
>>>homemade cocktails to blood and its> >ariants, you would easily be
>>>able to see that the bad cardioplegia's> >id have a higher (more
>>>accurately uniform) incidence of fibrillation> >hich came down
>>>with better modifications of cardioplegia's. That does> >ake us
>>>wary and anyway fibrillation is not something by any
>>>stretch> >ormal.Transient defibrillation may appear innocuous but
>>>then it has> >een shown that such hearts have indeed been
>>>improperly preserved (from> >orks of Buckberg and
>>>Kirklin).Remember that sometimes speed etc etc may> >ompensate but
>>>this may become an issue in longer case.> >rasanna> >ni Anyanwu
>>>wrote:> > I still do not understand why we are alarmed about
>>>transient ventricular> >ibrillation on reperfusion and why using
>>>drugs to suppress it will have any> >mpact on outcome.> >> >
>>>Ani> >> >> >> > > >> Date: Wed, 1 Aug 2007 11:51:47 +0530> From:
>>>prasannasimha at gmail.com> To:> >penHeart-L at lists.hsforum.com>
>>>Subject: Re: [HSF] Inotropes, ventricular> >ibrillation and
>>>myocardial protection> CC: > > I am not saying that the> >rocaine
>>>or lignocaine is still acting. What I> meant is that since
>>>the> >ibrillation is occurring with the hotshot delivery> with
>>>high local lignocaine> >hanging the drug class may be beneficial.>
>>>Prasanna> > On 8/1/07, Ben
>>>Bidstrup> >benjamin.bidstrup at bigpond.com> wrote:> >> > I beg
>>>respectfully to differ. The> >idocaine (a fast Na channel> >
>>>blocker) is all but gone after a short while in> >he
>>>cardioplegia> > scenario. Getting a suitable level back into
>>>the > >circulation> >nd thus> > the heart at release of the clamp
>>>is what is > >needed.> >> > Perhaps a> >andomised study is in the
>>>offing.> >> > > >http://circ.ahajournals.org/cgi/content/abstract/79/5/1106>> >> >
>>>This reference relates to defib energy levels but i think you
>>>will> > see> >here I am coming from.> >> > At James Cook, I was
>>>involved in the development> >f a non> > depolarising cardioplegia
>>>solution, which is slowly > >working its way>> > up the
>>>development path. The main components are lidocaine and> >
>>>adenosine.>> >> >> >> >> > >Ben,> > >I use Amiadorone in the pump
>>>for all emazes > >>(and postop)> >nd> > >Amiadorone in the pump
>>>for all aortic valves. Since the St Thomas> >> >Cardioplegia
>>>(which we mix in blood) already has
>>>procaine > >adding> > >Lignocaine> >ould be
>>>redundant.(Incidentally Amiadorone is very cheap> > >in India
>>>!!)> >> >Prasanna> > >Ben Bidstrup wrote:> > >>Why the amiodarone.
>>>Surely with some> >erfusion, the electrolyte> > >>imbalances
>>>within the myocardium would correct> >nd SR ensue.
>>>If> > >>anything use lidocaine. Less toxic and cheaper, not
>>>a> >egative> > >>inotrope. It is what Yacoub taught me many years
>>>ago, and I have>> > >>used it to good effect (infrequently I
>>>might > >add).> > >>> > >>>Tohru,> > >>>> > did an AVR on an 87 yo
>>>man as a 2nd case just a couple of> > >>>hours ago.> >gain, no LV
>>>vent, only a sump. While closing the> > >>>aortotomy, I began
>>>the>> > >>>continuous warm retrograde blood. The heart began
>>>fibrillating> > >>>after> > couple of> > >>>minutes. I gave amio
>>>and then cardioverted. The > >heart had a> >> >>>slow
>>>junctional> > >>>rhythm until the clamp was released. A sinus
>>>rhythm> >eveloped shortly> > >>>afterwards. He came off with no
>>>inotropes. It's much> >asier on> > >>>the heart and> > >>>your
>>>nerves to cardiovert a > >clamped, flaccid> >eart rather
>>>than> > >>>trying to do it> > >>>after the clamp has
>>>been> >eleased.> > >>> I look forward to your visit at the STS. As
>>>I said before,> >'ll> > try to> > >>>have a couple of interesting
>>>cases for you and other> >nterested> > >>>members of HSF> > >>>to
>>>watch and criticize to your
>>>heart's> >ontent.> > >>>> > >>>Hal> > >>>> > >>>> > >>>> > >>>**************************************> >et
>>>a sneak peek of the> > >>>all-new
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--
Ben Bidstrup FRACS FRCSEd FEBCTS
Consultant Cardiothoracic Surgeon
Two things are infinite; the universe and human stupidity; and I am
not sure about the universe.
Albert Einstein
The greatest obstacle to discovery is not ignorance --- it is the
illusion of knowledge.
Daniel J Boorstin
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