The
Prevention of Hemorrhagic Stroke
A Review of the Rational and Ethical
Principles of Clinical Trials
on Unruptured Intracranial Aneurysms
and Arteriovenous Malformations
J.
Raymond, JP Mohr, the Team-Aruba
collaborative groups
Summary - There is currently no evidence
that preventive treatment of unruptured
aneurysms or AVMs is beneficial
and randomized trials have been
proposed to address this clinical
uncertainty. Participation in
a trial may necessitate a shift
of point of view compared to a
certain habitual clinical mentality.
A review of the ethical and rational
principles governing the design
and realization of a trial may
help integrate clinical research
into expert clinical practices.
The treatment of unruptured aneurysms
and AVMs remains controversial,
and data from observational studies
cannot provide a normative basis
for clinical decisions. Prevention
targets healthy individuals and
hence has an obligation of results.
There is no opposition between
the search for objective facts
using scientific methods and the
ethics of medical practice since
a good practice cannot forbid
physicians the means to define
what could be beneficial to patients.
Perhaps the most difficult task
is to recognize the uncertainty
that is crucial to allow resorting
to trial methodology. The reasoning
that is used in research and analysis
differs from the casuistic methods
typical of clinical work, but
clinical judgement remains the
dominant factor that decides both
who enters the trial and to whom
the results of the trial will
apply. Randomization is still
perceived as a difficult and strange
method to integrate into normal
practice, but in the face of uncertainty
it assures the best chances for
the best outcome to each participant.
Some tension exists between scientific
methods and normal practice, but
they need to coexist if we are
to progress at the same time we
care for patients.
‘It
is from one’s
results rather than by reasoning
that one ought to show one’s
art’
Galen,
An outline of empiricism