Dear Rosalee
This is fascinating - where can we obtain the document and is it accessible
on the net?
Lesley Hobbs
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> From: Rosalee  Shaw <[log in to unmask]>
> To: 
> Cc: [log in to unmask]
> Subject: RE: term breech trial
> Date: Monday, October 23, 2000 23:20
> 
> David,
> thanks for your comments. I found the study protocol difficult and the 
report very poorly written. I agree that there were babies who died and who
were included  in the analysis, when it was obvious that the trial protocol
was not followed 
> * 41.9 weeks = 42.2 does it not ?, and therefore outside the parameters.
> * interuterine death of a twin also is outside the parameters which
required singleton pregnancies
> * the baby discharged well, but died sometime later during sleep may have
been a cot death, but without PM results it's congecture
> * PM results would have been useful for the next baby listed who showed
some abnormalities that could have been indicative of a gentetic problem.
> *another baby discharged home well, but died some time late of the D & Vs
surely shouldn't be  included.
> *Only frank or complete breeches were (should have been ) included, but
one baby who died is recorded as "uncertain type of breech" 
> * Again the baby who died before enrollment should have been removed as
the trial required living foetus. This makes me question whether or not the
trial protocol which required very specific FHS monitoring was actually
followed.
> * The poor baby with the ruptured myelomeningocele may or may not have
had the same outcome with another method of delivery. Need to know a bit
more.
> 
> I question the decision not to stratify by centre, which leaves  out any
chance of unmasking unskilled accoucheurs, (which may have been useful),
given that the choice of delivery manouvres and much of the decision making
 was left to the judgement of the clinician.
> 
> I also question the assumption that a uterine scar  is not considered
morbidity, and that  the post natal recovery from abdominal surgery is
"normal". 
> 
> 
> I find the emotive  aspects of the discussion somewhat at odds with the
expected objectivity of such a report. In parts it is almost apologetic,
which leaves me uneasy.
> 
> My biggest concern is the definition of "experienced" and the assessment
of this experience. The skill of the accoucheur is not always related to
time - and there is a vast amount of literature to support this. The
accoucheur was self nominated as "experienced" and this was supported by
the signature a a department head - which leaves us open for a discussion
on power, politics and aspects of ego - all subjective.
> I would have liked a tighter definition, perhaps also a challenge test,
or record of past performance.
> 
> I am not convinced that this  study  is conclusive,  and agree with you
that the conclusions only relate to the study protocols, which don't seem
as if they were always adhered to. 
> 
>  I look foreward to more discussion.
> Rosalee
> 
> >>> Dr David Simon <[log in to unmask]> 10/24/00 06:22AM >>>
> Rosalee
> No doubt there will be a lot of discussion, and many will share your
> concerns.
> Mortality in low PMR countries like Australia for the planned vaginal
birth
> was 3/511 (0.6%). (Table 5) See Table 4 for details of deaths. Case 1-3
are
> from countries like Australia. Take out case 2 - probably dead before
> enrolment. Case 1 and 3 both induced for post-maturity at 41.9 and 41.1
> (from details in the non-PDF version on-line). I wouldn't induce or
augment,
> though there are many who would, and the evidence is probably there
saying
> its safe. My caesar rate would thus perhaps be higher than the trials,
but
> perhaps the death rate lower (lots of 'perhaps'). Take out these 3 cases
> with a different study protocol and there are no deaths in low PMR
> countries.
> You could use this information to say that for planned vaginal breech
> delivery using the study protocol (including experienced clinician
> present)with the baby alive before labour, the risk of the baby dying is
> 2/510 or about one in two hundred and fifty.
> I'm not sure that you could say that if the study protocol didn't include
> induction there would have been no deaths, because, say, there may have
been
> increased stillbirth because of post-maturity. Anything outside the study
> protocol becomes conjecture.
> I think this sort of analysis of the morbidity outcomes will also be done
by
> someone, and the long term outcomes for these babies will be interesting
to
> read about in the future planned reviews.
> I think the trial's data will be helpful in counselling, it certainly
can't
> be ignored. I think it would need to be given (as for all information) in
> the context of your local setting and experience. A friend said to me he
> practised with three ingredients - evidence, experience and patient
> preference. For me, the trial adds to the first ingredient.
> David
> 
> 


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