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cause
characteristic about disease, without it the disease doesn’t occur
association
linkage between variables
exposure
contact with the factors that are linked with a bad outcome
necessary cause
when a factor is required for the disease to occur
(deterministic causality)
sufficient cause
when a factor that is sufficient by itself to guaranteed to produce the disease
(deterministic causality)
necessary and sufficient deterministic causality
when the factor and disease are present, the factor is the only thing needed to cause the disease
very uncommon
sufficient and not necessary deterministic causality
When the factor may be present when the disease occurs, the factor can be one of the causes
necessary and not sufficient deterministic causality
factor must be present for disease to occur, but factor by itself does not guarantee the disease occurrence
not necessary and not sufficient deterministic causality
factor may/may not be present for disease to occur
most common
causal pie model
Pie diagram for a disease arranged by causes (deterministic causality)
Necessary cause is always present with non-necessary variables (A in pic)
Component cause: other causes accompanying the necessary cause
sufficient cause complex: whole pie, all the causes together create a sufficient cause

probability causality
Type of causality where a factor increases the probability of a disease
deterministic causality
Type of causality where a factor directly causes a disease
stochastic model
model for probability causality

associations
when variables are connected positively and negatively
(+) association → when variables go the same way
(-) association → when variables have opposite directions
measurable by statistics, tests determine causation
directed acyclic graph (DAG)
Graphing approach for causal relationships
arc: single-headed arrow that connects variables - direct links
node: points/variables (letters in pic)
path: unbroken route along nodes
direct: single-headed arrow sequence (A→B→E)
backdoor: non-causal pathway (B,D,C all connect to → E, all factors)

clinical trial
Experimental study design that focuses on the individual
measures incidence - subjects do not have outcome
used to test therapies
2 types: prophylactic and therapeutic trials
prophylactic trial
type of clinical trial
focus is on preventing disease by testing preventative treatment
measures incidence
therapeutic trial
type of clinical trial
focus on testing treatments and outcome
measures prevalence
single blind trial
characteristic of clinical trial
when the participant does not know what control they have
double blind trial
characteristic of clinical trial
when the researchers and participant do not know what control the participants are assigned to
Phase 1 clinical trial
Beginning phase of a clinical trial
testing new volunteers for adverse physiological side effects from treatment
<100 participants
Phase 2 clinical trial
clinical trial phase
a sample from population is taken and tested
tests physiological responses and clinical reactions
100-200 participants
Phase 3 clinical trial
phase of clinical trial
large scale testing in target population, compares incidence against general population
tests efficacy - how the treatment performs under tight circumstances
Phase 4 clinical trial
phase of clinical trial
post-marketing research into a drug
monitors side effects/effectiveness not under controlled circumstances
clinical trial advantages
Control:
exposures
time/frequency
observation period
disadvantages of clinical trials
artificial experiment
might have ethical boundaries
tight adherence protocols
community trials
quasi-experimental trial at the community level
focuses on health/behavioral changes in a target population
measures policy/program effectiveness through incidence
community trial disadvantage
hard to control: outcome monitoring, intervention delivery
affected by population dynamics
hard to randomly assign study units, affects comparability
observational studies
study design that compares disease frequencies
cohort study
Study design where participants share a common exposure/characteristic - individual level
sample from population is followed to see if disease develops - subjects lack disease
measures incidence and changes in markers for disease
population-based
exposure based
population-based cohort study
type of cohort study
participants are broadly chosen from a target population
exposures are unknown until baseline measurement are taken
exposure-based cohort study
type of cohort study
participants are specifically chosen by exposure status
non exposed group chosen to align with exposed group by characteristics (not exposure)
prospective studies
studies that take present subjects and follow them for possibility of disease in the future
measures incidence
retrospective study
studies that get a baseline from the past and compare it to present data
measures prevalence
cohort study advantages
time sequencing
studies outcomes and rare exposures
cohort study disadvantaging
long time periods
costly to follow participants
participants can be lost to follow up
hard to follow rare diseases
selection bias
relative effect measures
divides frequencies to show strength of relationships
risk ratio
incidence rate ratio
risk ratio
used for cohort and CT studies, type of relative effect measure
tells if the risk of disease if different in exposed vs. non-exposed
“The exposed have __ times the risk of disease compared to non-exposed".”
absolute effect measures
risk differences to measure impact
risk difference
population risk difference
etiological fraction
incidence rate ratio
used for cohort and CT studies, relative effect measure
compares incidence between exposed and non exposed groups
requires person-time
risk difference
used for cohort and CT studies, absolute effect measure
shows excess number of cases in exposed group
etiologic fraction
used in cohort and CT studies, absolute effect measure
shows how much exposure is a cause of disease in exposed group
population risk difference
identifies number of cases that would be eliminated if exposure was eliminated
Ip = overall incidence in population
“(exposure) results in excess number of cases of (disease) in total population
case-control study design
observational study design that compares people who have a disease (case) to those who do not (control) - individual level
retrospectively uses data to make observations in present - measures prevalence
population-based, control group should match case group closely
case-control advantages
quick
cost -effective
good to measure rare diseases
case-control limits
unclear temporal relationship with exposure
requires recalling because its retrospective
uses an indirect estimate of risk
odds ratio
relative effect measure for case-control and cross sectional studies
measure association between exposure and disease
cross sectional
study design on the individual
uses survey to estimate prevalence, exposure and disease measures, to describe the magnitude/distribution of disease, and show risk factors over time (usually not done in the same person over time)
used to compare trends and plan health services
cross sectional advantages
low cost
easy to generalize
cross sectional limits
does not show incidence
hard to determine temporality from exposure (collected after exposure)
self-reporting
ecological study design
study design for the group level
uses secondary data → census, government data, and investigations
used to test/develop a hypothesis and determine causation
ecologic fallacy
observation at the group level may not be true at the individual level, so it is hard to make inferences for the individual from ecologic studies
external validity
the ability to generalize a study to a different target population or a general population
validity outside the study
internal validity
validity inside a study
when there are correct measurements of the exposure, outcome, and associations
“truth”
desired outcome of the study → results are true
hope to show probabilistic causality - shows causation
“chance”
when a study’s results show causation but it happened by random chance
due to errors - often from statistical testing errors
type 1 error
type of error that shows a result
does not align with reality - not true
type 2 error
type of error to that does not show the correct truth that aligns with reality
random error
error around a value of a parameter
sampling error: wrong people in sample
poor precisions: data not measured precisely
validity in measurements: variability around results due to conflicting results
reducing random error
increasing sample size
raising the number of measurements
systematic error
bias - error in study design, data collection, data interpretation, and reporting
selection bias
information bias
observer bias
confounding
selection bias
systematic error type
exposure/disease is different in participants than the ideal sample
observer bias
systematic error type
when participants perform differently because they know they’re being watched by observers
information bias
systematic error type
when the measurement/information about the disease/exposure is reported inaccurately
reducing systematic error
using objective definitions in the study
having higher participation rates
using memory aids - not based on one persons recall
blinding
standardized rules for research team
standardized procedure for data collection/analysis
clear/understandable questions
confounder
a variable that that may distort associations or provide an alternate explanation for association btw disease and exposure
confounder criteria
must be a risk factor for the disease
must be associate with exposure
cannot be an intermediate step in the causal pathway (exposure cannot cause the confounder)
controlling the confounding in study design
randomization: equal distributions of confounders in each group
restriction: restricting participants to align with a known confounder
matching: matching subjects in groups according to known confounders
randomization (confounding) advantage/limits
advantages: convenient and addresses unknown
limit: need control over exposures to assign groups
need to have a high sample size
restriction (confounding) advantage/limits
advantage: have complete control over the known
limit: do not have control of unknown
matching (confounding) advantage/limits
advantage: requires fewer subjects
limit: costly because extensive searching
controlling confounding in analysis
stratification: performing analysis in strias (levels)
multivariate: advances statistical analysis