On 17 Nov 2000, at 14:46, DOUGLAS W MCCULLOCH wrote:

> Allowing preferences to enter at all means the trial is not controlled. 
...  much sensible stuff deleted here on cost/benefit trade off ...

> I don't think you can allow patients to choose their path from hospital 
> to home. It matters, because you want to know whether the new 
> intervention would work with other patients elsewhere, who have no 
> information on which to choose between the two approaches. That, 
> after all, is why we DO science, to get results which are universal.
> 
> Good luck with it, anyway - an interesting problem.

I'm sure others will have commented on this by now but I couldn't 
let this go.  Various legal and ethical things insist that certain 
choices are inalienable rights.  Declaration of Helsinki, Human 
Rights Act .... As a "natural" scientist, a technologist or a engineer 
of medical systems one may abhor this but there it is.  

That means that if Douglas meant what he said in the first quote 
above, there are _NO_ controlled trials of ethically important 
interventions as it is simply not ethically allowed not to allow the 
choice to opt into the study or not.  I think it would be useful to 
follow that argument through and conclude that, since there are no 
truly controlled trials whose results can be confidently generalised 
to the entire population of future patients in a situation to chose 
between paths of care, we are overrating the RCT.  I doubt if that's 
what Douglas meant and I wouldn't push it far but it would be good 
for those of us who work in situations in which RCTs are either 
frankly meaningless or else are either ethically or logistically 
impossible, to have that idea followed through.

The second quote is equally incredible.  We should allow no choice 
despite the fact that even where we do have excellent "scientific" 
evidence, typically it leaves huge amounts of evidence 
un"explained", it is limited in generalisability, and is generally 
backed by a scandalous lack of evidence that it is replicable in 
routine care or evidence that we have event tried to explore 
predictors.

Sorry to get up on the soap box but this is seriously out of touch 
with the healthcare world.  In the UK the political slogan of a 
"patient-led" service, however much it may be largely spin, moves 
us even further from the notion of healthcare research as 
engineering of universals and we need to get on with working in the 
real (and politicised) world.

(Steps down from soap box ruefully!)

Best wishes all,


Chris

Chris Evans <[log in to unmask] or [log in to unmask]>
Consultant Psychiatrist in Psychotherapy,
Rampton Hospital; Associate R&D Director,
Tavistock & Portman NHS Trust;
Hon. SL Institute of Psychiatry
*** My views are my own and not representative 
of those institutions ***


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