Stats Flashcards
EBM
the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients. The practice of EBM means integrating individual clinical expertise with the best available external clinical evidence from systematic research
Advantages of EBM
improves clinical appraisal skills
leads to the abandonment of unhelpful practices
makes the process of decision making transparent to patients and colleagues
leads to a better appreciation of uncertaintly in clinical practice
Disadvantages of EBM
sometimes is impossible
time consuming and expensive
excessively rigorous criteria may lead to useful papers being disregarded
Evidence can be manipulated
evidence is frequently out of date
RCTs are treated a gold standard, but in some settings other designs are more appropriate
Good clinical practice
n interntational standard for the design, conduct, performance,
monitoring, auditing, recording, analyses, and reporting of clinical trials that provides
assurance that the data and reported results are credible and accurate, and that the rights,
integrity, and confidentiality of trial subjects are protected
Levels of evidence (NHMRC)
1 - systematic review of all relevant RCTs
2 - RCT
3/1 - pseudorandomised trial of high quality
3/2 - cohort study or case control study - with a control group
3/3 - cohort study with historical controls or no control group
4 - case series
Grades of recommendation
A - consistent with level 1 studies
B - consistnet with level 2 or 3 studies, or extrapolations from level 1
C - level 4 studies or extrapolations from level 2 or 3
D - level 5 (oxford definitions - expert opinion) or inconsistent studies of any level
CONSORT
consolidated standards for reporting trials
- governs the reporting of trial data
- designed to produce literature with the highest degree of transparency
Absolute risk
Actual event rate in the group
Essentially is the incidence rate
Number of cases in group/total number of group
Absolute risk reduction
AR in exposed - AR in unexposed
NNT
1/ARR
relative risk
the difference in event rates between 2 groups, expressed as proportion of the event rate in the untreated group
AR in treatment group/AR in control group
relative risk reduction
1 - relative risk
attributable risk
a measure of the absolute effect of the risk of those exposed compared to the unexposed -
INcidence (exposed) - incidence( unexposed)
sensitivity
the ability of a test to correctly identify those with the disease (true positive rate)
true positives / (true positives + false negatives)
specificity
the ability of the test to correctly identify those without the disease (true negative rate).
true negatives / (true negatives + false positives)
POsitive predictive value
true positives / total positives
Negative predictive value
true negatives / total negatives
positive likihood ratio
sensitivity / (1- specificity)
negative liklihood ratio
specificity / (1 - sensitivity)
power
the probobility that a statistical test correctly rejects the null hypothesis when the null hypothesis is false
1 - false positive rate
or
1 - beta error
prevelance
number of affected individuals / total number in population
incidence
number of affected individuals / total exposed population
phases of clinical trial
in vitro activity
Animal model
Phase 1 - healthy volunteers
Phase 2 - patients with the disease of interest
Phase 3 - large scale trial on the patients with disease
Pahse 4 - post marketing experience