last min Flashcards
assay
a method to analyse or quantify a particular biomarker of a sample
a test
the use of a specific assay within a specific context
screen
the use of a specific assay used to test for disease in healthy people
Helsinki extras to nuremberg
protocol no vulnerable population publish data withdrawal ETHICS COMMITTEE INFORMED CONSENT INDEPENDENT RELATIONSHIP BETWEEN PARTICIPANT AND PHYSICIAN PATIENT CLEAR OF RESEARCH BOUNDARIES
hypothesis
a tentative and testable answer to a scientific question
why cant case control be used to calculate risk
due to the entire at risk population not being included
case-control use
odds
cohort study is the best study to
record effect of suspected risk factor
due to randomisation which reduces confounding
it can be assumed that outcomes are due to the intervention
confounding variables
is an outside influence that changes the effect of a dependent and independent variable.
paradigm shift
new evidence which contradicts the current paradigm
what can influence rational drug design
knowledge of the disease
- can give scientists a focus for the drug
- save time and money
monogenic
single gene defect e.g. CF
polygenic
environmental and genetic influenced e.g. not guaranteed to get it
linkage
a measure of how resistant to recombination a genetic marker and phenotype are
i.e. the closer the genes are on the chromosome the more likely they are to be cross over together
randomisation
based on chance participants are equally likely to be assigned to the control or intervention group
what does randomisation do
reduce the impact of confounding
how does randomisation reduce confounding
reduces differences between groups by equally distributing people with specific characteristics among all trial arms
how does randomisation reduce bias
by reducing bias associated with patient and investigator expectations
blinding
this means that neither the participant, managers of the trial, data collectors or researchers are aware what treatment arm the participant is in
- means researchers not influenced by knowledge of the participants intervention
bias
a process where scientists who are performing the study influence the results in order to portray certain otucomes
Intention to treat
means that participants are always analysed in the way they were intended to be
e.g. if they cross over- still analysed as part of the original group
ITT reduces the effect of
confounding
- maintain composition of groups
- reduce confounding due to difference in baseline characteristics
QALY
life expectancy x HR-QOL
HR-QOL
EQ:5D
standard gamble
TTO
visual analogous
EQ:5D
mobility usual activities self care pain/discomfort depression/anxiety
ICER
incremental cost effectiveness ratio
ICER=
cost treatment A- cost treatment B/ QALYs A- QALYs B
threshold per QALY
20,000- will pay up to 30,000
