Critical Appraisal Flashcards
Confounder
confounders make it appear as if there is a direct relationship between an exposure and an outcome. They may also mask a true relationship. A confounder must have an association with exposure but not be a consequence of it. It must also be associated with the outcome but independently of the exposure.
Selection bias
where the individuals, group or data selected for a study is not appropriately randomised meaning the sample is not representative of the desired population. This will normally be identifyed by differences in the baseline characteristics between exposure and control groups.
Bias
Anything that influences the study in a non random way deviating the results from the truth.
observation bias
When there is differences between how the data is gathered in a study and how the outcome is measured. Such that the results may be unduly influenced by the expectations of the researchers or subjects.
cross sectional studies
studies a group at a specific point in time
ecological studies
study a community or population
pragmatic studies
take place in a real life setting e.g. hospital or clinic, gives good effectiveness data and external validity
case reports
observational and descriptive, prone to chance association and bias. useful for generating hypothesis and as for setting for clinical reminders.
cohort studies
recruiting subjects based on a risk factor being present or absent and then study going forward. May be expensive to set up and long time from exposure to outcome. Also bias may be present if subject drop otu. They are prospective, good if risk factor is rare
case control studies
recruiting subjects who either have or haven’t had an outcome and then look back on data (retrospective). The disadvantages of these are that they rely on memory, old records. and can be difficult to recruit a matching control group, good if outcome is rare
temporality of exposure
did exposure proceed outcome
gradient of exposure
increased exposure leads to increased risk
analogy of exposure
is the association analogous to any previous proved causal association
factorial studies
use more than one intervention at a tme to see how they interact
meta analysis
combines results of more than one study to create a quantitative assessment
phase 0
microdosing for pharmacokinetics/bioavailabilty etc
phase 1
in healthy individuals
phase 2
in relevant illness subjects
phase 3
large group in clinical setting
phase 4
post marketing surveillance
exclusion criteria
a common exclusion criteria is to exclude those too unwell, co-morbid or with confounding factors. Too much exclusion criteria and may reduce effectiveness of data/ cause selection bias
simple random sampling/representative sampling/proportionate sampling
everyone in TP has equal chance of being selected
systematic sampling
every nth person selected after first randomly chosen
stratified sampling
subjects are divided into suubgroups and equal number are drawn from each
cluster sampling
subjects are divided into clusters and some are sampled some are not. disadvantages are that differences between clusters and that different sized clusters may be given same weighting
SB: berkson admission rate bias
sample taken from hospital setting
SB: diagnostic purity bias
excludes those with comorbidities
SB: survival bias/neyman/incidence-prevalence
end up analysing those who have survived or lasted long enough, therefore milder forms of disease are represented
SB: membership bias
those from a specific group e.g. cancer charity
SB: historical control bias
where groups are chosen at different times this may mean they encountered different treatments/RFs/disease
SB: response bias
those more likely to respond are more likely to be motivated etc
randomisation
allocation of different subjects to intervention groups
adaptive randomisation
adjustment of study arms to maintain similarity
open label trial
no blinding, therefore observation bias is an issue
triple blinding
subject, researcher and analyst dont know
surrogate endpoints
a biomarker used as a substitute for a clinical endpoint e.g. LDL level. Useful as can be shorter as dont need to wait for outcome but not necessarily reflective of clinical outcome
composite endpoints
composite of several clinical endpoints e.g. death, MI, stroke
validity
the extent to which a test measures what it is supposed to measure
reliability
how consistent a test may be on repeated measurements
criterion validity
compared to an existing test
relevance of a large drop out
if in the experimental arm could suggest intolerable treatment or lack of efficacy of treatment, if in placebo arm may indicate individuals in group may have required treatment
difference between systematic error and random error
random error is variable, systematic error is consistent e.g. scales that measure 1gram too low