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Does
this result demonstrate morphine intake provides adequate
“assay sensitivity”?
You answered:
No. This
result demonstrates that measurement of morphine intake
but not pain provided adequate "assay sensitivity"
for the evaluation of Drug K as an analgesic.
CORRECT
Demonstration
of a significant difference in an outcome suggests that
one has carried out a clinical assay sensitive enough to
measure an effect on that outcome, but as discussed in the
previous question, it is not clear that the reduction in
PCA morphine administration is due to pain relief or to
something else. The failure to show a difference in pain
scores may not be an assay sensitivity problem, but may
reflect that Drug K is just not an effective analgesic in
postoperative pain. Alternatively, there may have been a
deficiency in the study methods or execution that would
have obscured a true analgesic effect. Many analgesic experts
agree that allowing patients to self-administer opioids
during the study, while sometimes ethically necessary, reduces
assay sensitivity. Devising
outcome measures that combine pain report and requirements
for rescue medication may restore part of this sensitivity,
but requires the assumption that analgesic self-administration
is an accurate reflection of pain.
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