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70 Cards in this Set
- Front
- Back
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Bias
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An association between exposure and subsequent development of disease is influence by erroneous data.
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Case-Control Study
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Compares 2 groups of ppl. Those with the disease or condition under study (cases) and a similar group of ppl who do not have the disease or condition (controls)
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Case-Report Study
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An analysis of detailed reports of symptoms, diagnosis and treatment of individuals.
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Cohort Study
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Measures a pop. at baseline and follows them forward to determine the association of baseline characteritics with subsequent disease outcomes
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Confounding
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An association between exposure and disease is influenced by an additional variable that is itself related to both the factor and disease
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Control Group
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Participants in study who resemble the treament group but do not recieve active medication
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Cross sectional study
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Examines the associations between disease and other factors as they exist in a specified pop. at a particular time
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Determinant
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An influencing or determing agent or factor
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Ecological Study
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Uses readily available pop. data to determine association between disease rates and exposures in pops.
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Endpoint
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What researchers measure to evaluate the result of a new treatment being tested
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Etiology
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Cause of a disease
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Experimental Study
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The researcher controls the groups in the study by deciding which ppl are exposed to a new preventitive measure
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Incidence
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Refers to how common new cases of disease are at a specific period in time
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Match
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To ensure that cases and controls are alike as much as possible in all characteristics except the disease and the characteristics being studied
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Non randomized trial
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An experiment in which groups of ppl consents to participate in a study. PPl are not randomyly assigned but chosen to participate by interest
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Observational Study
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The researcher observes and analyzes rate of disease in pops. and derives factors that influence the rate
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Placebo
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Inactive substance such as a sugar pill or saline injection that is administered as a control in testing
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Prevalence
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Refers to the presence of a disease at a specific period and measures all cases
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Protocol
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A document that describes the objectives, design, methodology, statistical considerations and organization of a trial. Provides background and rationale for trial
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Randomization
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Random assignment of participants to either treatment or control groups to reduce biase
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Randomized trial
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An experiment in which individuals are randomly assigned to 2 or more group
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Treatment group
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participants in a study who are given the treatment being tested
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2x2 Factorial Study
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A randomized study of 2 interventions in same trial
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Biomarker
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A laboratoy measurment that is used to measure progression of disease or effect of treatment
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Blinding
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This refers to keeping the investigators and/or study participants unaware of their randomly assigned treatmentq
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Clinical Trial
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Experimental study of different interventions. Focus here is on trials in which individuals who recieve test intervention and don't are determined by randomization
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Confounding by indication
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Confounding resulting from a treatment being used based on participant's disease condition
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Endpoint
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A primary or secondary outcome used to judge the effectiveness of a treatment
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Exclusion criteria
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Criteria used to determine whether a person should not participate in a clinical trial or not
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Experimental Study
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Researcher controls the groups int he study by deciding which ppl are exposed to experimental intervention
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Fixed allocation ratio
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The ratio of the number of study participants in one treatment group to another 1:1 refer to equal numbers in each treatment group
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Inclusion criteria
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Criteria that must be met in order for a person to participate in a clinical trial
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Informed consent
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The process of learning the key facts about a clinical trail before deciding whether or not to participate.
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Intention to treat
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An analysis of all randomized participants according to the randomized assignment
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Lost to follow up
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a trial participant for whom the outcome of interest is not known
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Phase IV trial
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A trial of liscensed drugs
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Primary endpoint
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the main outcome used to compare treatments
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Secondary endpoint
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Other outcomes that will be used to characterize the relative efficacy of the treatments and safety outcomes
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Surrogate Outcome
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Laboratory measurement used as a substitue for a clinicly meanigful endpoint that measures directly how a participant feels, functions, survives
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Certificate of confidentiality
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Document that protects partiipants privacy obtained by the NIH
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Clinical Research
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Research designed to ask specific questions about mech. risk factors of disease or about the safety and effectiveness of new therapies
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Confidentiality
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The expectation that a research participant's privacy will be protected
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Conflict of interest
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Situation in which an individual exploits his or her position for personal or financial gain.
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IRB
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Institutional Review Board. Ensure protection of human subjects in trials
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Investigator
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a person responsible for the conduct of the clinical trial at trial site
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Justice
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Distributing burdens and benefits equally.
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Stages of justice
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In equal share
According to individual need according to individual effort according to societal contribution according to merit |
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Phase I trial
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Usually the first use of testing a new therapy in humans. Done using healthy volunteers
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Privacy
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All information that a research participant is willing to share during the time they are involved in clinical
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Alternative hypothesis
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An assumption articulated prior to the start of a clinical trial that can be concluded if the null hypothesis is rejected
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Biostatistics
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Science of using data to draw conclusions in human health studies
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Censored observations
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In survival time study, data for a patient who does not experience an occurrence of the event of interest.
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Chi-Squared test (x2)
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Compares proportions of outcomes in 2 groups to determine if those proportions are significantly different
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Confidence interval
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range of values calculated from a data set such that there is a specified probablity that the true value of a parameter is within the interval
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Descriptive stats
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Stats used to summarize
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Dichotomous outcome
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Either the outcome occurs or it doesn't
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Fisher Exact Test
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Compares the proportions of outcomes in 2 groups to determine of those portions are significantly different. Usually requires a computer
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Kaplan Meier Curves
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A technique for estimating how many ppl are still free of the event of interest at various points within a study
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Log Rank Statistic
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A widly accepted stats. test used to determine whether 2 kaplan meier curves are different
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Null Hypothesis
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The assumption that treatments being tested in a clinical trial are not different
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Outcome Variable
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A quantifiable characteristic of change that represents the effect of a study treatment on an individual
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p value
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probablility of obtainin a given outcome due to chance alone
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Poison distribution model
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Model that provides an estimate of the count of events that occur across a fixed period of time
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Power
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The probability of obtaining a statistically significant result when the alternative hyp. is true
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Quantitative Outcomes
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The evaluation of the effects of the experimental treatment by using numerial laboraty measurements
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Rate of change
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Across a time period, how much did a variable change relative to the time change, typically represented by slope
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Relative risk
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Ratio of the risk that a negative outcome may occur in group A vs Group B
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Survival curves
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Technique for estimating how many ppl are still free of the event of interest at various pts in the study
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Treatment effect
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The difference between the effect of the placebo and the effect of the study treatment in trial
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T test
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stats tests that analyzes whether the means of 2 groups are statistally different from one another used in small sample
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