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random error cause
chance variations in measurements, participant differences that aren’t controlled, environmental factors that aren’t constant
how to reduce random error
repetition, larger sample size
random error measurement
p value
systematic error
bias, consistent, repeatable error associated with flawed study design either intentional, inadvertent, or unavoidable
random error accuracy/precision
accurate but not precise
systematic error accuracy and precision
precise but not accurate
internal validity
correct study design, were variables measured in a reasonable way?
external validity/generalizability
how well results of this study can be applied to larger population
bias can occur…
at beginning of study, during study, or at completion
non probability sampling
probability that a subject is selected is unknown and may reflect selection biases of the person doing the study
does not fulfill requirements of randomness needed to estimate sampling errors
probability sampling
each member of the population has a known chance of being selected
types of probability sampling used in medicine
simple random, systematic, stratified, cluster
non probability sampling usage
exploratory and qualitative research
representative sample
contains all attributes of the population in the same proportion they exist in the population
allows one to generalize and make inferences
simple random sampling
each unit of population has equal probability of being included in the sample and probability is independent of previous drawings
simple random sampling method
table of random numbers or computer generated list of random numbers
systematic sampling
population is arranged according to some order and units are selected at regular intervals
cluster sampling
selecting intact groups, not individuals, within defined population sharing similar characteristics
selection bias
selecting or retaining individuals, groups, or data for a study leads to a sample not truly representative of larger population study aims to understand
admission rate bias
hospital patients tend to be sicker
healthy worker effect
people who can work are generally healthier than the overall population
late look bias
excludes patients who have already died or recovered and makes disease look more or less severe
typically in cross sectional studies
non response bias
people that actually respond differ from those who don’t
volunteer bias
people who volunteer for a study differ in significant ways from those who do not
confounding bias
outside factor affects dependent and independent variables
publication bias
typically only successful studies are published
reverse causality bias
condition and cause being investigated may actually be reversed
placebo effect
thinking you’re getting treatment makes symptoms improve
allocation bias
people who actually receive the treatment are impacted by researchers
cointervention
caretakers give additional treatment
3 questions for every study
are results valid, what are results, how can i apply results to my patients
are results valid further questions
were patients randomized and in study groups with respect to prognostic variables?
was group allocation sealed?
what extent was study blinded?
was follow up complete?
was trial stopped early?
were pts analyzed in groups they were first assigned?
groups that should be blind to treatment assignment
patient, clinician, data collectors, adjudicators of outcome, data analysts
absolute risk
risk of an event
absolute risk calculation
# patients experiencing adverse events / # participants
absolute risk reduction
absolute difference in rate of events between control and treatment groups
absolute risk reduction calculation
control group risk - treatment group risk
relative risk
ratio of risk of an event among treatment group to risk among the control group
intention to treat
participants assigned to group stay in group no matter what they actually do
what are the results further questions
how large was the treatment effect?
how precise was the estimate to the treatment effect?
relative risk reduction
reduction rate of the adverse event in the treatment compared to the rate in the control group
MC reported measure of treatment effects
relative risk reduction calculation
absolute risk reduction / risk of control group OR 1 - relative risk
p value
probability value, measure of probability that a result is purely due to chance
p value cutoff
0.05 or greater than 5% means statistically insignificant/due to chance
confidence intervals
range of values within which one can be confident the true effect lies
narrow confidence interval
point estimate is more precise to true effect
factors affecting confidence interval width
number of patients, frequency of study outcome
how can i apply results to my patients further questions
were the study patients similar to mine?
were all patient important outcomes considered?
are likely tx benefits worth potential harm and cost?
number needed to treat
how many patients must be treated with an intervention to produce one positive outcome or prevent one negative outcome
number needed to treat calculation
100 / ARR
number needed to harm
how many patients must be treated for one to experience a particular adverse event
grandmother test
outcomes that would be valued by the average person (like someone’s grandmother) are clinically important
attributable risk
risk of harm in control - risk in treatment group
risk of harm calculation
find # individuals experiencing adverse effect in each group
number needed to harm calculation
find attributable risk and take reciprocal (1 / AR)
best diagnostic study
prospective cohort study
spectrum bias
if a dx test is evaluated only in a narrow or unrepresentative group its performance may look better than it would in a broader, more typical clinical setting
verification bias
not all patients recieve the reference (gold) standard test to confirm the presence/absence of disease
likelihood ratio
how many times more/less likely a test result is to be found in diseased vs non diseased people
likelihood ratio calculation
p(person w/condition having test result) / p(person w/out condition having same test result)
benefit of likelihood ratio
incorporates sensitivity and specificity of test into single measure
sensitivity
p(test is positive) given pt has the disease
specificity
p(test is negative) given pt does NOT have the disease
meaning of highly sensitive test
low false negative rate
meaning of highly specific test
low false positive rate
positive likelihood ratio
p(positive test in person w/disease) / p(positive test in person w/out disease)
positive likelihood ratio calculation
sensitivity / 1- specificity
high positive likelihood ratio meaning
positive test is much more likely in someone w/disease than someone w/out
negative likelihood ratio
p(negative test in person w/disease) / p(negative test in person w/out disease)
meaning of low negative likelihood ratio
negative test result is less likely in someone with disease compared to someone w/out