> I've found as a clinician that identifying the question(s) is the key
> part of any consultation.

I agree with this statement, as many others since the Roman times: "QUI
BENE INTEROGAT, BENE DIAGNOSCIT."

With all due respect, I do not see the problem with RCT as you have
indicated.  Research clinical trials are designed to study a drug, a
device, a therapeutical concept, or an intervention. They have a test
and a control group, and a common outcome(s) to compare groups. The
control group must have an incidence of "failure" that should be
improved by the test drug. RCT are usually designed to have failure rate
of about 20%; therefore, if test group shows this incidence of about
10%, the success has been achieved and superiority of the new therapy
statistically confirmed. If not, then equivalence could be claimed. I
have not seen a RCT claiming opposite --  failure rate of the new
therapy to be significantly worse than the control one. 
Translated into the language of a clinician or GP, it means that his
patient, if exposed to the new drug, will have probability of failure of
about 10%. Both physician and his client want better probability that
may be achieved with individualized dose, duration of therapy, or else.
Why bother than with strict implementation of RCT conclusions? 
Individual benefit versus evidence-based population benefit and vice
versa. How could we solve this problem?

Dr Nenad Markovic
Professor Emeritus of Oncology and 
Internal Medicine

Toby Lipman wrote:
> 
> In message <[log in to unmask]>, alistair grant
> <[log in to unmask]> writes
> >
> >This debate has prompted me to ask the list about a problem that I have
> >often considered with the evidence based practice model. If Sackett et al's
> >definition of evidence based medicine is acceptable ( essentially evidence
> >based medicine involves the use of quality, up-to-date reliable research
> >evidence INTEGRATED with clinical judgement and expertise)then there would
> >appear to be a relative imbalance in our approach to using evidence based
> >medicine. This is because although much debate occurs over the 'quality' of
> >research evidence, little attention is given to the value of clinical
> >judgement. Surely even the highest level of research evidence needs clinical
> >judgment (of equal value?) to assist in the implementation of that evidence?
> >Is this not also one of the multi-factoral reasons why research evidence is
> >so difficult to get into clinical practice?
> >
> 
> On the one hand we have evidence from analytic research (of which by
> definition the greatest internal validity is achieved by randomised
> controlled trials), and on the other we have patients and clinicians
> whose problems and interactions are complex and cannot be reduced to
> 'pure' questions which can be unequivocally answered by 'pure' (high
> quality, high in the hierarchy) evidence.
> 
> We therefore have a spectrum of implementation. At one end is high
> quality evidence from RCTs which is being 'poorly implemented' (a
> recurrent theme in literature about implementation). At this end of the
> spectrum evidence-based practice is seen as being about implementation
> of research, and therefore the hierarchy of evidence is important in
> order to select which research to implement.
> 
> At the other end are individual patients and clinicians. In certain
> situations, the patient may have a well defined condition for which high
> quality evidence exists about effective therapy. This is the case
> particularly with cardiovascular disease - ischaemic heart disease,
> atrial fibrillation and so on. So good is the evidence that it is
> possible to draw up lists detailing ideal practice such as the National
> Service Frameworks in the UK. However evidence about implementation even
> of known effective therapies suggests that at the individual
> clinican/patient level life gets very complicated. There is a very nice
> study by Howitt and Armstrong (BMJ 1999;318:1324-7) in which a group of
> very keen GPs tried to identify all their patients with atrial
> fibrillation and warfarinise those who would benefit. They put in a lot
> of effort, held long consultations in which they explained the benefits
> and harms, but still found that:
> 
> "Out of 13 239 patients, 132 had a history of atrial fibrillation of
> which 100 were at risk of thromboembolism. After the study, 52 patients
> were taking warfarin. Of the remaining 48 patients (of whom 41 were
> taking aspirin), eight were too ill to participate, 16 were unable to
> consent, four refused the interview, and 20 declined warfarin. Patients
> declining warfarin were inclined to seek a higher level of benefit than
> those taking it, as measured by the minimal clinically important
> difference. Qualitative data obtained during the interviews suggested
> that patients' health beliefs were important factors in determining
> their choice of treatment."
> 
> So patients' beliefs and values (and also probably the degree to which
> clinicans are prepared to 'sell' a therapy) influence uptake as much as
> the merits of the therapy itself or the clinician's knowledge. I also
> suspect that the 'implementers' are rather too optimistic where it comes
> to the realistic likelihood of applying research in practice. It is also
> relevant I think that many interventions promoted by the implementation
> lobby have been demonstrated to be effective on populations but, by the
> nature of RCTs, cannot be demonstrated to be effective for any
> particular individual. The individual clinican and patient then have to
> grapple with the paradox of the ecological fallacy.
> 
> It is even more difficult where the diagnosis is unclear, the symptoms
> confusing, the patient's needs complex and perhaps multiple, even
> contradictory. Here, knowing which therapy has the highest quality
> evidence supporting its use may be irrelevant because to use such
> evidence you need to have a clear objective - Scott Richardson's "what
> can we hope to achieve by doing this?". This is where clinical skills
> combine with human skills such as listening and empathising in order to
> discover what question most needs to be answered to go further. This has
> been studied by researchers such as Pendleton, Balint, Byrne, Long and
> others and there is an extensive general practice literature about it -
> most of which is qualitative and comes nowhere in the hierarchy of
> evidence. However if we want to understand how clinicians come to
> identify the most useful questions and answer them we need to use this
> kind of work, and will get little help from analytic studies of any
> kind.
> 
> I've found as a clinician that identifying the question(s) is the key
> part of any consultation. This is not quite the same as formulating a
> structurable answerable questions (although that may follow). There are
> several types of questions: "what is going on here?", "what does this
> patient want/need/expect?", "what could we achieve by...?". If they were
> research questions the first two would be answerable by qualitative
> methodology, only the last by analytic studies. In primary care,
> clarification of the first two may be all that is needed. In many or
> most situations the clinician may know the answer to the last without
> having to search for additional information - however the skill in
> evidence-based practice is to be alert to what we don't know, and to be
> vigilant not to kid ourselves that we know more than we really do. Or to
> ask "why do we always...?" and revisit practice traditions.
> 
> Thus clinicians need to understand much more than the conclusions of
> RCTs - and need to incorporate much more than that into their management
> of individual patients. When addressing the complexity of individuals
> issues of applicability become more important, and an RCT with high
> internal validity may be very difficult to apply - because the
> therapeutic intervention cannot be blinded in routine practice, because
> each individual's response will vary, because any confounding factors
> cannot be corrected for by randomisation! Most important of all, unless
> the success or failure of the outcome is detectable in and known to the
> individual, the outcome itself cannot replicate the outcome in a group.
> Thus an individual will know whether or not epigastric pain has been
> relieved by a proton pump inhibitor, but not whether a stroke has been
> prevented by warfarin.
> 
> Therefore, although the hierarchy of evidence is valid for classifying
> the weight to be given to evidence about the clinical effectiveness of
> an intervention, it may still play only a minor part in the decision
> making process in real life clinical practice, and is of little help in
> studying or understanding that process.
> 
> >Apart from the existing obvious 'measurements' of clinical performance
> >(post-graduate qualification etc.) which I presume have not been thoroughly
> >investigated in the context of evidence based practice is anyone aware of
> >research in this area?
> >
> I'm currently (still - it takes a long time!) analysing GPs' accounts of
> how they make decisions about acutely ill preschool children. The next
> step is to measure how well the factors they have said influence them
> (which they have learned by experience) predict outcomes. Watch this
> space!
> 
> Toby
> --
> Toby Lipman
> General practitioner, Newcastle upon Tyne
> Northern and Yorkshire research training fellow
> 
> Tel 0191-2811060 (home), 0191-2437000 (surgery)


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