Research Evaluation Block 1 Flashcards
Define Prevalence
Number of occurrences at one particular time
Obtained from cross-sectional studies, no timeline, only snap shot in time
Define Incidence
Occurrence, rate, frequency of disease
Obtained from Cohort Studies and follows cohort through time
Define Correlation Coefficient
“r”
Absolute value of coefficient telling how strong relationship is between variables
-1 - 1, closer to them is stronger relationship
Closer to 0, weaker relationship
Define Relative Risk
Likelihood an event will occur w/in a population
Experimental Event Rate/Control Event Rate
Makes insignificant findings APPEAR significant
Define Sensitivity
People w/ disease compared to people with a positive test for the disease
(tests ability to identify correctly who have the test)
Rules out disease
Define Specificity
People without disease who have a negative test
(ability of test to correctly ID those who don’t have the disease)
Rules disease in
Define Two-Stage testing
Calculates net sensitivity and net specificity of using both tests in sequence
After completion, loss of net sensitivity and gain of specificity
Define Simultaneous Testing
PT is positive if tested pos on one or more tests
PT is negative if tested neg on ALL tests
Net gain in sensitivity and loss of specificity
Define External Validity
Ability to apply results obtained from studied population to broader populations
AKA generalization
Define Internal Validity
W/in confines of study, results appear to be accurate and investigators interpretation is supported
Define Confidence Interval
More important than p-value and a better determination of significance
95% CI= 95% certain that true value is within the CI range, narrower the better
Define Number Needed to Treat
of PTs needed to receive new intervention instead of standard alternative in order for ONE additional patient to benefit, used for prophylactic measures
Very effective treatments range: 2-4
10 or less for therapy
20 or less for prevention
Define Number Needed to Harm
Treatment is detrimental
Will have negative absolute risk reduction
Define P-Value
Probability level, chance of random error
Likelihood that difference observed between two interventions happened by chance
Define Efficacy Trial
Attempt to learn if drug, procedure or program works under ideal conditions
Define Type I Error
Reject the null when null was true
Finding an effect that isn’t real
Convicting innocent man to prison
Considered worse than Type II
Define Type II Error
Failure to reject null hypothesis
Missing an effect that does exist
Not convicting guilty man
Define Confounding
Variables that correlate in/directly with in/dependent variable
Define Case Report
Literature identifying single incident and discussing pertinent factors related to PT
Define Case Series
Study analyzes number of individual cases that share a commonality, usually w/ relatively low number of subjects
Define Case-Control
Studies w/ PTs already w/ condition/case compared to those who don’t have it (control)
Researcher looks back
Define Systematic Review
Thorough, comprehensive, explicit way of interpreting medical literature
Define Meta-analysis
Method for combining study data from several studies to justify quantitative summary to develop single conclusion with greater statistical power
Define Prospective Cohort Study
IDs group of PTs already taking treatment/have exposure and follows them forward over period of time
Define Retrospective Cohort Study
Starts w/ cohort and goes back in time to evaluate past exposures to risk factors
Define Cross-sectional Study
Examines relationship between outcome and other variables of interest at one particular time
Determines prevelance
Cannot show casuality
Does not establish temporal relationship
Define Quasi-experimental study
Non-randomized control study
Control group predetermined w/out random assignment and compared to control group
Define Case-Crossover study
Type of Case-Control study
Each case becomes own individual control
Used for transient exposures
Define Measures of Central Tendency
Mean- average, sum divided by number in set
Median- middle point
Mode- score occurring most frequently; least precise measure; bimodal distribution- 2 most common values
Define Positive Predictive Value
Define Negative Predictive Value
Pos- proportion of PTs who have disease and a pos test
Neg- PTs who do not have disease and a negative test
Define Likelihood Ratio
Likelihood of someone with disease/likelihood someone without disease
W/WO
Define Odds Ratio
Measures strength of association between exposure and disease
Define Epidemiology
Study of distribution and determinants of health-related events in populations and application of the study to control health problems
Define Biostatistics
Branch of stats dealing with data relating to living organisms
Difference between Descriptive and Analytical Research?
Descriptive:
observational
patterns of disease occurrence
generates hypothesis
Analytical:
analyzes
investigates relationships
tests hypothesis
Examples of descriptive studies?
Individual:
Case reports
Clinical series
Population:
Ecologic studies
Define Explanatory Studies
Attempt to provide insight into etiology/determine better PT outcome
What are the two types of Explanatory studies?
Experimental
Observational
Define an Experimental Explanatory Study?
Give examples
Active intervention from investigator Controlled trial Clinical trial Educational intervention Healthcare trial Intervention trial
Define an Observational Explanatory study?
Give examples
Investigator observes nature Case control Follow up Cross sectional Cohort
What are the layers of Quality of Evidence Pyramid?
Meta Analysis Systematic Review Critically Appraised literature Evidence Based Practice Randomized Control Trials Non-Random Control Trials Cohort Studies Case series/studies Individual case reports Background info/expert opinion/non-EBM guidelines
What are the two types of Analytic Descriptive studies?
Experimental:
Clinical trial
Community trial
Education intervention
Observational:
Case control
Cohort f/u
Cross sectional
What are Case Series used for?
Examine adverse events/effects
Catalog new diseases/outbreaks
Determine feasibility/safeguards of new treatment/intervention
Potential efficacy of new treatment
What do both Case Reports and Case Series lack?
Sufficient methodological rigor
Evidence not applicable to large populations, may be circumstantial or confounding factors were present
Purpose of Descriptive Study Ecologic Study
Determine relationship between exposure and disease among a population, not just individuals
What are the strengths of Cross Sectional Studies?
Assesses multiple outcomes/exposures simultaneously
Completed quickly
Data gathered leads to further studies
Generates Prevalence
What are the limitations of Cross Sectional Studies
No time reference- "snapshot" Common conditions only Doesn't calculate incidence, is a prevalence study Results dependent on study population Only useful for common conditions
What type of study may follow a case series study?
Case-control study, retrospective look at causes
What are the strengths of Case Control studies?
Good for Rare Outcomes Evaluates many exposures Ideal for ideal/explanatory ides Simple/fast/efficient Inexpensive
What are the limitations of Case-control studies?
Single outcome
High risk of bias/confounding variables
No prevalence/incidence/relative risk
Define Nested Case-Control study?
A case control study
Large enrollment study within large cohorts for people at risk of disease/outcome
Define Case-Cohort
Same as nested case-control but with controls randomly chosen at beginning of study
Define Cohort
Groups of people who share common characteristic/experience and remain in a group for period of time
What is the strongest observational study?
Cohort Study
Potential biases in Case Control Studies
Selection bias Information bias Researcher/observer bias Voluntary response bias Matching Multiple controls
Potential biases in Cohort studies?
Selection bias- lost to f/u
Information bias- observer bias
What are the strengths of cohort studies?
Studies multiple effects of single exposure
IDs temporal relationship between exposure and outcome
Confirms cause/effect and the magnitude
Measures incidence
Calculates relative risk
What study has the highest validity of observational study design?
Cohort study
What are the limitations of Cohort Studies?
Expensive/time consuming Ineffective for rare diseases Lose participant f/u Risk of confounding variables Presence of records/recall
What is the purpose of randomization?
Prevent potential bias by investigator, strives for comparability
The term “controlled” in randomized control studies implies predefined 6 things
Hypothesis Endpoint to address hypothesis Enrollment/ f/u methods Eligibility/exclusion criteria Rigorous monitoring Analysis plan/stop rules
Why are randomized control studies controlled?
Eliminate confounding variables
Minimize bias
Define single, double and triple blind
Single- concealed from one group
Double- concealed from both groups
Triple- concealed from subjects, administers and interpreters
What is the Gold Standard?
Double blinded Randomized Control Trial, minimizes chance of bias
Huge strength of randomized control studies
What are the limits of Randomized Control Studies?
Large trials Long term f/u Compliance Expensive Ethics
What does “Primum Non Nocere” mean?
First do no harm
What are the limitations of Non-randomized control studies?
Study group characteristics not balance w/ baseline confounding study’s results
What are the 4 major areas of methodological concern in Non/randomized control studies?
Enrollment
Allocation
F/u
Analysis
What parts of the EBM pyramid represent the strongest evidence?
Top 2
Systematic reviews
Meta-analyses
What are the strengths of systematic reviews?
Review of current literature Less costly Less time Generalized results Reliable/accurate than individual studies Evidence-based resource
What are the limitations of Systematic reviews?
Time/labor consuming
Not easy to combine studies
What is the meta-analysis conclusion statistically stronger than any single study?
Increased subject numbers
Diversity
Accumulated effects/results
What are the limitations of meta-analysis?
Difficult/time consuming Lack of adequate data Advanced statistic techniques Hetergeneity Non-reproducible results Publication/Selection/Misclassification bias