Netherlands Journal

netherlands journal of critical care
Table 3: Assessment/scoring of the strengths listed in Table 2.
0=unimportant, 10=of great importance.
Strengths 1 2 3 4 5 6 7 8 Avg Sd Order
Promising initial clinical data 6 7 9 9 10 8 9 9 8,4 1,3 1
New concept/ mechanism of action 6 8 8 5 10 9 9 9 8,0 1,7 2
Relatively low side-effects in heterogeneous patient-groups 9 8 9 7 10 5 7 8 7,9 1,6 3
Consistent in vitro/in vivo data 8 5 8 7 10 6 9 9 7,8 1,7 4
Works in fungi and yeast 8 5 8 7 10 5 7 9 7,4 1,8 5
No resistance issue 8 8 8 4 10 2 8 9 7,1 2,7 6
Promising in vitro data 7 5 8 5 10 5 9 8 7,1 2,0 7
Makes sense 5 0 8 7 10 7 8 8 6,6 3,0 8
Synergism with antifungal drugs 4 5 0 5 10 2 7 9 5,3 3,4 9
Table 4: Scoring of the weaknesses listed in Table 2.
Weaknesses 1 2 3 4 5 6 7 8 Avg Sd Order
Probably expensive 8 10 10 10 9 9 9 9 9,3 0,7 1
Unclear effect on long-term mortality in recent study by
Pachl et al. [ref. 50]
8 9 8 8 9 9 7 8 8,3 0,7
2
Unknown optimal dose 8 8 8 10 6 9 7 7 7,9 1,3 3
Lack of clinical data 8 8 8 4 10 10 7 7 7,8 1,9 4
No proven superiority over standard drugs 8 7 7 8 8 9 8 7 7,8 0,7
5
Unknown pharmacokinetic/PD profile 8 7 8 10 9 8 7 4 7,6 1,8 6
Unknown optimal duration 8 8 8 10 6 9 7 5 7,6 1,6
7
Unknown additional effects of HSP90 8 6 4 10 8 10 7 7 7,5 2,0 8
Few data on combinations with other anti-fungal drugs 8 7 8 6 8 7 8 6 7,3 0,9 9
the treatment of invasive fungal infections, and (lipid formulations
of )amphotericin-B represented the main therapeutic option. Indeed
amphotericin-B remains the gold standard for antifungal treatment
even at this time.
The participants were then asked which functionaries in their hospital
would be involved in the decision to introduce a new and potentially
expensive drug such as Mycograb ® in their hospital. The
functionaries mentioned by the participants are listed in table 1.
Subsequently, the participants were asked to score the importance
of these functionaries on a scale of 0-10, with 0 indicating (almost)
no influence and 10 indicating great influence over the decision. The
results are also listed in Table 1.
Table 1. Role of different hospital functionaries in the decision to acquire
and start using an expensive novel treatment such as Mycograb,
and the influence of these functionaries as estimated by the participants
expressed on a scale of 0-10. Columns 1-6 show the scores of
the individual participants, the last two columns show the average
scores with standard deviations.
The ICU chairman/ICU management were thought to have the most
influence on n this type of decision, closely followed by the hospital
antibiotics committee (in which intensivists, microbiologists, infectious
disease specialists and pharmacists are most frequently represented).
One of the participants remarked that actually none of the parties
had decisive influence, but that many had the power of veto, i.e.
would be able to block the use of a new drugs. The introduction of
this type of new drug into a hospital would thus require a certain
degree of consensus among various functionaries. In many hospitals
there is a form of structured discussion between intensivists, microbiologists
and infectiologists regarding the use of novel antibiotics
and antifungal therapy. Other participants disagreed; they indicated
that in their hospital they had a certain budget for drugs in the ICU,
which they could spend more or less as they wished. Certainly if the
numbers as reported in the study by Pachl et al. hold up, the use of
Mycograb ® would be efficacious and cost-effective, and thus would
be likely to find its way to the patient without too much difficulty.
Most of the participants agreed but reserved judgement because the
results were still preliminary (the study had not yet been published
at the time of the round table meeting), and no confirmatory studies
were yet available.
After the introduction and initial discussion the participants in
the round table meeting were asked to perform a so-called SWOT
(strengths, weaknesses, opportunities and threats) analysis for the
use of Mycograb. In this regard strengths of Mycograb ® would be
properties inherent to the drug that would increase the likelihood of
its use; conversely, potential weaknesses are properties inherent to
the drug that would hamper its use. Opportunities and threats are
external factors, not directly linked to the drug itself, which could
nevertheless influence its use. For example, the target mechanism of
Mycograb (blocking HSP90) is inherent to the drug, and could be regarded
as a strength; the side effects associated with currently available
treatments are not inherent to Mycograb, but could still help its
usage and thus represent an opportunity.
After the procedure had been explained the participants were asked
to name strengths and weaknesses of Mycograb, followed by opportunities
and threats. When these factors had been named the participants
were asked to score the arguments for relevancy and importance,
again (as explained above) on a scale of 0-10, with 0 indicating
total disagreement and 10 indicating total agreement. The results are
shown in Tables 2, 3 and 4.
neth j crit care • volume 10 • no 5 • october 2006
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