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26 Terms
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Pros of RCTs asdfasdasdf
ability to randomize = reduces likelihood that grps will differ significantly, can control for known & unknown confounders; provide the greatest control over:
\- amount of exposure
%%- timing & freq. of exposure%%
%%- period of observation%%
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\ \ \ asdfkljasdf
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Selection Bias
the procedures used to select subjects & factors that influence participation in a study that distorts the causal relationship b/w exposure & outcome; can happen due to
\- procedures used to include/exclude subjects
\- differences b/w participants & nonparticipants
\- differences in follow-up/drop-out rates that differ according to a causal exposure
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Minimizing Selection Bias
\- keep non-response as low as possible
\- if possible, collect info on non-responders
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Information Bias
the incorrect determination of exposure and/or outcome; types of bias include:
\- diagnostic bias: exposed may be followed more intensively than unexposed (suspicion) or the probability of being classified as having the disease is related to exposure status (classification)
\- recall bias: diseased participants may recall exposure differently than non-diseased participants (relevant in case-control & cross-sectional studies)
\- bias in abstracting records: when abstracting medical records to find cases, exposure status may influence the depth of the inquiry in the record (ex. looking at influence of anxiety on heart attacks -> look more closely at cases w/ anxiety -> see more of a relationship b/s anxiety & heart attacks)
\- interview bias: interviewers not blinded to the exposure/disease status might ask questions differently according to exposure/disease status
\- analytic bias: when statisticians/epidemiologists analyze data with a preference for a specific outcome -> could consciously/unconsciously influence analysis process toward preferred outcome
\- Hawthorne effect: participants in a study change their behaviors because they know they're in a study
\- Social Desirability: tendency of people to respond to survey questions in a manner that will be viewed favorably by others
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Minimizing Information Bias
address in design stage of study (can also be done for selection bias)
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Confounding
the causal relationship b/w exposure and outcome is distored b/c of association of the exposure w/ other factors that influence the outcome (is there an extraneous factor blurring the effect)?
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Statistical Significance
when p
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Benefits of randomization
\- only way to control for known/unknown factors
\- randomization uses study design to control for potential confounding
\- investigators, participants, & analysts can be blinded, allows for some degree of subjectivity when assessing many outcomes (ex. patient answers more accurately b/c they don't know if they're in tx or control grp)
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Why RCTs are best
\- population is controlled
\- confounding controlled through randomization
\- treatment is controlled (chosen by investigator)
\- natural history of disease is controlled (use of a control grp)
\- blinding
\- specific data is collected (control data quality)
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Randomized Control Trials
RCTs (uses RR as measure of association); an experiment designed to assess relative efficacy of a test intervention in comparison to one/more alt interventions, in comparable grps of humans
\- participants randomized
\- can see what would have happened to exposed if they weren't exposed
\- control grp is as similar to intervention grp as possible, with regard to every feature besides exposure status- best in terms of hierarchy of study designs
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Threats to randomization
unintended crossovers (ex. patient in tx grp don't do activity required of them, patient in control grp performs the activity instead)
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Intent to Treat Analysis
maintains original randomization -\> potential confounders remain equally distributed across grps (best strategy)
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Treatment Received Analysis
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Cons of RCTs
\- artificial setting
\- limited scope of potential impact
\- adherence to protocol
\- ethical dilemmas (informed consent, data & safety monitoring, monitoring for side effects, protecting interest of participants, trials in special populations)
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Screening Test
a test that checks for specific diseases in people who do not have the disease yet, types include:
\- mass: applied to whole population
\- multiple/multiphasic: more than one test
\- targeted: applied to grp of exposures (ex. occupational/environmental epidemiology)
\- case-finding/opportunistic: when patients consult w/ a provider for another purpose
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Validity
extent to which a method measures what it's supposed to
\- face validity: extent to which a measure appears to measure what it's supposed to measure
\- construct validity: whether a particular measure relates as it should to other measures (ex. 2 different depression measures, if they correlate with each other = construct validity)
\- criterion validity: how well one measure predicts an outcome for another measure; a test has this type of validity if it is useful for predicting performance/beh in another situation)
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Reliability
ability of method to measure consistently & reproduce the same results with repeated measurements
\- test-retest reliability: consistency of participant's responses over time
\- inter-rater reliability: consistency among raters for the same measure
\- internal consistency reliability: consistency among the items in a scale that are supposed to measure the same construct (having the questions be relevant/easy to understand for the reader)
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Sensitivity
proportion of people WITH the disease who are correctly identified by the test
\ Sens = TP/(TP+FN)
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Specificity
proportion of people WITHOUT the disease who are correctly identified by the test
\ Spec = TN/(TN+FP)
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Positive Predictive Value
PPV; proportion of people who have a positive test result who are actually positive
\ PPV = TP/(TP+FP)
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Negative Predictive Value
NPV; proportion of all people who test negative who are actually negative
\ NPV = TN/(TN+FN)
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Social Determinants
aspects of society and the social environment that impact on health
\- general socioeconomic, cultural, & environmental conditions